285 results on '"D Heg"'
Search Results
2. Heavy weekly alcohol consumption versus binge drinking after an acute coronary syndrome and risk of major adverse cardiovascular events at one year follow up
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E Tessitore, M Branca, D Heg, D Nanchen, R Auer, L Raber, R Klingenberg, S Windecker, T F Luscher, C M Matter, N Rodondi, D Carballo, F Mach, and B Gencer
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Cardiology and Cardiovascular Medicine - Abstract
Background The association between heavy weekly alcohol consumption or binge drinking and the risk of major adverse cardiovascular events (MACE) after acute coronary syndromes (ACS) is still unclear. Purpose To determine the risks of MACE at one year follow up according to baseline alcohol consumption, especially in patients with heavy weekly alcohol consumption or binge drinking. Methods We analyzed data of 6053 patients hospitalized in 4 Swiss centres for an ACS and followed over 12 months. Data on alcohol consumption were collected at baseline and at one year follow up after ACS. Binge drinking was defined as the consumption of ≥6 units of alcohol on one occasion, for the 12-months period preceding the one-year follow up. We defined MACE as a composite of cardiac death, myocardial infarction, stroke or clinically indicated target vessel coronary revascularization. We applied Cox regression to assess the risk of MACE associated with heavy alcohol weekly consumption (>14 standard units/week) compared to light consumption ( Results At baseline, 817 (13.4%) patients reported heavy weekly alcohol consumption and 717 (11.8%) reported to have at least one episode of binge drinking per month. The risk for MACE at one year follow up was not increased in those with heavy weekly consumption compared to light consumption (8.7% vs. 8.5%, HR 0.96, 95% CI 0.69–1.33, P=0.80) or no consumption (8.7% vs. 10.3%, HR 1.26, 95% CI 0.88–1.80, P=0.21). However, the risk of MACE was higher in those reporting binge drinking with less than one episode a month (9.4% vs. 7.7%, HR 1.67, 95% CI 1.32–2.12, P Conclusion In contrast to regular heavy alcohol consumption, binge drinking behavior is associated with significant increased risk of MACE 12 months after ACS. Funding Acknowledgement Type of funding sources: None.
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- 2022
3. Potential candidates for transcatheter tricuspid valve interventions after transcatheter aortic valve implantation: predictors and prognosis
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T P Pilgrim, M W Wild, Stefan Stortecky, Taishi Okuno, D Heg, F P Praz, S Windecker, Jonas Lanz, and Daijiro Tomii
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medicine.medical_specialty ,Tricuspid valve ,medicine.anatomical_structure ,Transcatheter aortic ,business.industry ,Internal medicine ,Psychological intervention ,Cardiology ,Medicine ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background The importance of concomitant tricuspid regurgitation (TR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) remains unclear. Objectives To document the prevalence of concomitant TR before and after TAVI, to correlate TR severity after TAVI with clinical outcome, to quantify suitability for transcatheter tricuspid valve interventions (TTVI), and to report clinical outcome in patients eligible for TTVI. Methods In a prospective TAVI registry, the severity of TR at baseline and after TAVI was retrospectively evaluated. Results Among 2,008 eligible patients, 1,659 patients (82.6%) had ≤mild TR, 242 (12.1%) had moderate TR, 57 (2.8%) had severe TR, and 50 (2.5%) had massive TR. More than half of all patients with ≥moderate TR had an improvement of TR severity after TAVI. In contrast to baseline TR, >moderate TR after TAVI was associated with an increased risk of mortality (HRadjusted 1.89; 95% CI 1.03–3.46, HRadjusted 2.11; 95% CI 1.07–4.16, respectively) compared with ≤mild TR. After TAVI, 30 out of 101 patients with baseline ≥severe TR (29.7%) were deemed suitable candidates for TTVI. They had a 2-fold increased risk of mortality between 30 days and 1 year (HRadjusted: 1.97; 95% CI: 1.17–3.31) and a higher risk of persistent heart failure symptoms (RRadjusted: 2.75; 95% CI: 1.75–4.31). Conclusions Severity of TR improved in more than half of all patients after TAVI. More than moderate TR after TAVI was associated with a twofold increased risk of death at one year. Xx% of patients with relevant TR are anatomically suitable for TTVI. Funding Acknowledgement Type of funding sources: None. Figure 1
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- 2021
4. Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation
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D T Tomii, T O Okuno, H D Heg, C G Grani, J L Lanz, F P Praz, S S Storteckey, S W Windecker, T P Pilgrim, and D R Reineke
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Cardiology and Cardiovascular Medicine - Abstract
Background Progressive dilatation of the aortic root is a common finding in patients with aortic stenosis. Although ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT), its clinical significance has not been adequately studied. Purpose We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Methods In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter index to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. Results Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83±6 vs. 82±6 vs. 81±6; p Conclusions Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in AS patients undergoing TAVI. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2
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- 2021
5. Ticagrelor monotherapy beyond 1 month versus standard dual antiplatelet therapy after drug-eluting coronary stenting: a pre-specified per-protocol analysis of the GLOBAL LEADERS trial
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R J van Geuns, S Windecker, Peter Jüni, Felice Gragnano, Marco Valgimigli, Pascal Vranckx, Patrick W. Serruys, Giuseppe Gargiulo, R Van Amsterdam, Global Leaders Study Investigators, P.G Steg, Christian W. Hamm, N Hagenbuch, Kurt Huber, Marcel Zwahlen, and D Heg
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Drug ,medicine.medical_specialty ,Aspirin ,Intention-to-treat analysis ,business.industry ,media_common.quotation_subject ,Coronary arteriosclerosis ,Coronary stenting ,Clinical research ,Pharmacotherapy ,Internal medicine ,medicine ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,Ticagrelor ,media_common ,medicine.drug - Abstract
Background In the GLOBAL LEADERS trial, the intention-to-treat (ITT) effect of ticagrelor monotherapy after 1 month of dual antiplatelet therapy (DAPT) was not superior to that of 12-month DAPT followed by aspirin alone in the prevention of 2-year all-cause mortality or new Q-wave myocardial infarction (MI) after coronary stenting. Intention-to-treat analyses can be affected by incomplete protocol adherence. We present a pre-specified per-protocol analysis. Purpose To determine whether 1 month of ticagrelor plus aspirin followed by 23 months of ticagrelor monotherapy is superior to 12 months of DAPT followed by aspirin alone in the per-protocol population of the GLOBAL LEADERS (NCT01813435). Methods The GLOBAL LEADERS compared two antiplatelet strategies after drug-eluting stenting for stable coronary artery disease or acute coronary syndromes. Per-protocol population consisted of randomized patients fulfilling enrollment criteria and receiving protocol-mandated treatment. Adherence to the allocated antiplatelet therapy was evaluated at discharge, 30 days, and 3, 6, 12, 18, and 24 months, with non-adherence reasons categorized following a hierarchical approach. A protocol-deviation was defined in the case of high perceived bleeding/thrombotic risk, a medical decision without evident clinical reason, patients unwilling to take study drugs, prescription error, logistical issues, unclear reasons. Baseline characteristics, including (but not limited to) age, sex, diabetes, prior PCI, were used to construct time-varying inverse probabilities for not deviation from the protocol to reconstruct a study population with no protocol-deviations. Protocol deviators were artificially censored at the time at which they deviated. The primary endpoint was the composite of 2-year all-cause mortality or non-fatal new Q-wave MI. We used a weighted pooled logistic regression to estimate the per-protocol rate ratio (RR) of experimental vs. control treatment for the primary endpoint. Results Of the 15,968 randomized patients, 805 out of 7,980 (10.1%) in experimental group and 537 out of 7,988 (6.7%) in control group were classified as protocol deviators and artificially censored by month 12, not contributing events in the second year. The events for the adherence-adjusted analysis were 279 in experimental group and 325 in control group (25 and 24 less than in ITT analysis, respectively). The estimated adherence-adjusted RR was 0.87 (95% CI: 0.74–1.02; p=0.09), comparable to the ITT RR (0.87; 95% CI: 0.75–1.01; p=0.07). Conclusion At per-protocol analysis, ticagrelor monotherapy after 1 month of DAPT was not superior to conventional treatment, in line with the previously reported ITT effect. Similar per-protocol and ITT effects can be accounted for similar per-protocol and ITT populations, as a substantial proportion of patients were non-adherent due to clinically grounded reasons (anticipated in the protocol) and, accordingly, not considered as protocol deviators. Funding Acknowledgement Type of funding source: Other. Main funding source(s): GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company.
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- 2020
6. 5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents
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Stéphane Cook, Daniel Weilenmann, S Windecker, Juan F. Iglesias, David Tueller, Peter Jüni, Marco Roffi, D Heg, Christoph Kaiser, I Moarof, O Muller, Thomas Pilgrim, and Marco Valgimigli
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Acute coronary syndrome ,medicine.medical_specialty ,business.industry ,Everolimus eluting stent ,medicine.disease ,Biodegradable polymer ,Surgery ,Sirolimus ,Durable polymer ,Medicine ,In patient ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland
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- 2020
7. Uncontrolled hypertension and elevated NT-proBNP predict acute kidney injury and cardiac death in all-comer patients 1 year after acute coronary syndromes
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David Nanchen, S Windecker, Andrea Denegri, Nicolas Rodondi, Roland Klingenberg, T F Luescher, Baris Gencer, L Raeber, D Heg, François Mach, and Christian M. Matter
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medicine.medical_specialty ,business.industry ,Internal medicine ,Composite outcomes ,Acute kidney injury ,Cardiology ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,medicine.disease - Abstract
Background Hypertension is a recognized cardiovascular (CV) risk factor and, although many highly effective antihypertensive drugs have been developed, most patients fail to achieve recommended blood pressure target levels. This may increase major adverse CV events after acute coronary syndromes (ACS) such as acute kidney injury (AKI) and cardiac death (CD). Purpose We assessed the prognostic value of uncontrolled hypertension (UH) and elevated NT-proBNP among 2,168 all-comer patients admitted to 4 Swiss University Hospitals for acute coronary syndromes (ACS) enrolled in the prospective multicenter SPUM registry. Methods Patients with UH defined as a systolic blood pressure≥140 mmHg, and a NT-proBNP>900 ng/l were considered for the analysis. The composite primary endpoint was AKI and CD. Adjusted Cox proportional hazards regression models were implemented to determine risk prediction for UH and elevated NT-proBNP levels. Results Out of 2,168 ACS patients, 235 patients (10.8%) showed UH and NT-proBNP>900 ng/l (Fig. 1A). Compared to the general ACS population, those with UH and elevated NT-proBNP were more likely to be older (41.7% vs 20.0%, p Conclusions Among a real-world cohort of ACS patients, coexistence of UH with elevated levels of NT-proBNP confers increased risk for AKI and CD up to one year after ACS. These observations might help clinicians to identify ACS patients at risk using simple clinical parameters and biomarkers and to target them for more intense preventive therapies. Figure 1. A: GRADE1 = 140–159 mmHg and/or 90–99 mmHg; GRADE2 = 160–179 mmHg and/or 100–109 mmHg; GRADE3 = ≥180 mmHg and/or ≥110 mmHg; ISH (isolate systolic hypertension) = ≥140 mmHg and Funding Acknowledgement Type of funding source: None
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- 2020
8. The Perilousness of Antidepressant Drugs in a Real-world Cohort of Patients with Acute Coronary Syndrome
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François Mach, Nicolas Rodondi, D Heg, Baris Gencer, Stephan Windecker, Christian M. Matter, L Raeber, Andrea Denegri, D Nanchen, and Thomas F Luescher
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medicine.medical_specialty ,Acute coronary syndrome ,lcsh:Diseases of the circulatory (Cardiovascular) system ,Valve surgery ,business.industry ,medicine.disease ,Icd therapy ,lcsh:RC666-701 ,Internal medicine ,RC666-701 ,Cohort ,medicine ,Antidepressant ,Diseases of the circulatory (Cardiovascular) system ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,Stroke - Published
- 2020
9. 98Mitral annular calcification, mitral valve diseases and clinical outcomes in patients undergoing transcatheter aortic valve replacement for severe aortic stenosis
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Fabien Praz, S Windecker, Stefan Stortecky, F Khan, L Raeber, Taishi Okuno, Masahiko Asami, R Hoeller, Mohammad Kassar, Thomas Pilgrim, Jonas Lanz, and D Heg
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Aortic valve ,medicine.medical_specialty ,Transcatheter aortic ,business.industry ,Calcification mitral valve ,medicine.medical_treatment ,medicine.disease ,Stenosis ,medicine.anatomical_structure ,Valve replacement ,Aortic valve stenosis ,Internal medicine ,cardiovascular system ,medicine ,Cardiology ,Mitral Valve Disorder ,In patient ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Mitral annular calcification (MAC) and mitral valve diseases (MVD) have been identified as strong predictors of mortality in patients undergoing transcatheter aortic valve replacement (TAVR). However, the association between MAC and MVD, and the prognostic implications in these patients remain unclear. Purpose This study sought to investigate the association between severity of MAC and the prevalence of MVD as well as to assess the prognostic impact of MAC depending on the presence or absence of MVD in patients undergoing TAVR. Methods We identified 967 patients who have comprehensive echocardiographic and computed tomographic assessment of MVD and MAC from our institutional registry that is a part of the Swiss TAVI registry (NCT01368250) between August 2007 and June 2017. Results Among these patients, mild or moderate MAC was present in 45.2% and severe MAC was present in 17.8%. The prevalence of MVD was significantly higher in severe MAC patients, while the prevalence in patients with mild and moderate MAC was similar to patients without MAC. Compared to patients without severe MAC and MVD, an increased risk of all-cause death at 1 year was observed in patients with severe MAC and MVD (hazard ratio [HR]: 2.81, 95% confidence interval [CI]: 1.72–4.59, p Conclusions Severe MAC was associated with higher prevalence of MVD. Severe MAC concomitant with MVD was associated with increased risks of mortality at 1 year and conduction abnormalities after TAVR, whereas severe MAC without MVD was not.
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- 2019
10. P1968Five-year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents
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Stéphane Cook, S Windecker, Juan F. Iglesias, Marco Roffi, Daniel Weilenmann, I Moarof, Fabio Rigamonti, Marco Valgimigli, Thomas Pilgrim, P Jueni, O Muller, Jonas Lanz, David Tueller, Christoph Kaiser, and D Heg
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medicine.medical_specialty ,business.industry ,Everolimus eluting stent ,Urology ,medicine.disease ,Biodegradable polymer ,Sirolimus ,Diabetes mellitus ,Durable polymer ,medicine ,In patient ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Background Patients with diabetes mellitus (DM) remain at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with non-diabetic individuals. Among available drug-eluting stents (DES), thin-strut durable polymer everolimus-eluting stents (DP-EES) were shown to provide the best safety and efficacy profile in diabetics. Whether biodegradable polymer DES provide additional long-term clinical benefit compared with DP-EES among diabetic patients remains uncertain. Purpose To compare the long-term performance of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus DP-EES for PCI in patients with insulin-requiring and non-insulin-requiring DM. Methods We performed a prespecified subgroup analysis of the randomized, multicenter, non-inferiority BIOSCIENCE trial (NCT01443104). Patients with stable coronary artery disease or acute coronary syndrome were randomly assigned to treatment with ultrathin-strut BP-SES or thin-strut DP-EES. Patients were further divided according to diabetic status. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (MI) and clinically-indicated target lesion revascularization (TLR), within 12 months. Results Among 2'119 patients enrolled between March 2012 and May 2013, 486 (22.9%) presented with DM (insulin-requiring, 33.1%). Compared with non-diabetics, patients with DM were older and had a greater baseline cardiac risk profile, including higher prevalence of hypertension, hypercholesterolaemia, peripheral artery disease, chronic renal failure and prior PCI, coronary artery bypass graft surgery, or stroke. At 5 years, TLF occurred similarly in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (RR 1.23; 95% CI 0.87–1.73; p=0.24) in diabetics, and in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (RR 0.98; 95% CI 0.77–1.26; p=0.90) in non-diabetics (p for interaction=0.31). Cumulative incidences of cardiac death (14.9% vs. 9.5%; p=0.10), target-vessel MI (11.4% vs. 11.0%; p=0.81), clinically-indicated TLR (16.9% vs. 15.8%; p=0.68), and definite thrombosis (3.0% vs. 2.5%; p=0.63) at 5 years were similar among diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusion In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout five years between diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Acknowledgement/Funding BIOSCIENCE was an investigator-initiated trial supported by a dedicated research grant from Biotronik, Bülach, Switzerland
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- 2019
11. 127Validation of high-risk features for stent-related ischaemic events as proposed by the 2017 DAPT guidelines
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Thomas Pilgrim, Marco Valgimigli, Thomas Zanchin, Georgios Siontis, Michael Billinger, K C Koskinas, Lukas Hunziker, S Windecker, Alexios Karagiannis, Christian Zanchin, D Heg, Fabien Praz, Yasushi Ueki, Lorenz Räber, and Stefan Stortecky
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Internal medicine ,Cardiology ,Medicine ,Stent ,Cardiology and Cardiovascular Medicine ,business - Published
- 2018
12. 3400Neutrophil count and neutrophil/lymphocyte ratio predict cardiac death and acute kidney injury after acute coronary syndromes independently from smoking status
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R Klingenberg, Slayman Obeid, Andrea Denegri, Nicolas Rodondi, Thomas F Luescher, Joachim M. Buhmann, S Windecker, Valentina A. Rossi, Christian M. Matter, François Mach, D Heg, Baris Gencer, Frank Ruschitzka, and L Raeber
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medicine.medical_specialty ,medicine.anatomical_structure ,business.industry ,Internal medicine ,Lymphocyte ,Acute kidney injury ,medicine ,Smoking status ,Cardiology and Cardiovascular Medicine ,medicine.disease ,business ,Gastroenterology - Published
- 2018
13. P6405Implications of the local haemodynamic forces on plaque morphology: A serial intravascular ultrasound and optical coherence tomography analysis
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D Heg, Lorenz Räber, Lambros K. Michalis, A. I. Sakellarios, Anantharaman Ramasamy, Thomas Zanchin, Patrick W. Serruys, S Windecker, Andreas Baumbach, Kyohei Yamaji, D.I. Fotiadis, Christos V Bourantas, Alexios Karagiannis, Hector M. Garcia-Garcia, and Masanori Taniwaki
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Optical coherence tomography ,medicine.diagnostic_test ,business.industry ,Intravascular ultrasound ,medicine ,Hemodynamics ,Plaque morphology ,Cardiology and Cardiovascular Medicine ,business ,Biomedical engineering - Published
- 2018
14. P2480Baseline inflammatory markers, NT-proBNP and LVEF predict heart failure and cardiac death one year after acute coronary syndromes
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Roland Klingenberg, Andrea Denegri, S Windecker, David Niederseer, Baris Gencer, François Mach, L Raeber, Valentina A. Rossi, Nicolas Rodondi, Christian M. Matter, Slayman Obeid, Frank Ruschitzka, Thomas F Luescher, and D Heg
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medicine.medical_specialty ,Ejection fraction ,business.industry ,Internal medicine ,Heart failure ,Cardiology ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,medicine.disease - Published
- 2018
15. Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute ST-Segment Elevation Myocardial Infarction
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Peiman Jamshidi, Raffaele Piccolo, Stéphane Cook, Olivier Muller, Marco Roffi, Thomas Pilgrim, Juan F. Iglesias, Stephan Windecker, Daniel Weilenmann, Anna Franzone, D Heg, David Tüller, Christoph Kaiser, and André Vuilliomenet
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medicine.medical_specialty ,Everolimus ,business.industry ,medicine.medical_treatment ,Everolimus eluting stent ,Percutaneous coronary intervention ,030204 cardiovascular system & hematology ,equipment and supplies ,medicine.disease ,Revascularization ,03 medical and health sciences ,surgical procedures, operative ,0302 clinical medicine ,Internal medicine ,Sirolimus ,Durable polymer ,medicine ,Cardiology ,In patient ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Among patients with acute ST-segment elevation myocardial infarction (STEMI), early-generation drug-eluting stents (DES) have been associated with a reduction in target-vessel revascularization compared with bare-metal stents after primary percutaneous coronary intervention. However, this early
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- 2016
16. P205Clinical significance of Pulse Pressure on the recurrence of myocardial infarction and on mortality after an Acute Coronary Syndrome
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Lorenz Räber, David Carballo, P.Y. Courand, S Windecker, Pierre Lantelme, D Nanchen, O Muller, Baris Gencer, R Klingenberg, Nicolas Rodondi, Brahim Harbaoui, François Mach, Christian M. Matter, D Heg, and T.F. Lucher
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medicine.medical_specialty ,Acute coronary syndrome ,business.industry ,Internal medicine ,medicine ,Cardiology ,Electrocardiography in myocardial infarction ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,medicine.disease ,business ,Pulse pressure - Published
- 2017
17. 2191Impact of non-cardiovascular multimorbidity after acute coronary syndrome
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D Nanchen, O Muller, Thomas F Luescher, François Mach, David Carballo, S Windecker, Nicolas Rodondi, Christian M. Matter, D Heg, L Raeber, Baris Gencer, Roland Klingenberg, and S. Canivell
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medicine.medical_specialty ,Acute coronary syndrome ,360 Social problems & social services ,business.industry ,Internal medicine ,medicine ,Cardiology ,610 Medicine & health ,Cardiology and Cardiovascular Medicine ,business ,medicine.disease - Published
- 2017
18. P1399Thrombus aspiration in acute coronary syndromes: Prevalence, procedural success, change in serial troponin T levels and clinical outcomes in a contemporary Swiss cohort
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Roland Klingenberg, Thomas F Luescher, S Windecker, Soheila Aghlmandi, David Carballo, P. Jueni, Nicolas Rodondi, François Mach, Ulf Landmesser, Christian M. Matter, Baris Gencer, L Raeber, D Nanchen, D Heg, and A. von Eckardstein
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medicine.medical_specialty ,Troponin T ,business.industry ,Internal medicine ,Cohort ,medicine ,Cardiology and Cardiovascular Medicine ,business - Published
- 2017
19. 5704Validation of the SCAI definition of periprocedural myocardial infarction for prediction of one-year mortality following elective percutaneous coronary interventions
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Thomas Zanchin, Alexios Karagiannis, Robert A. Byrne, Gjin Ndrepepa, S Windecker, J. Hieber, K C Koskinas, L Raeber, Sebastian Kufner, D Heg, Adnan Kastrati, and Lukas Hunziker
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One year mortality ,medicine.medical_specialty ,Percutaneous ,business.industry ,Internal medicine ,Emergency medicine ,Psychological intervention ,Cardiology ,Medicine ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,medicine.disease - Published
- 2017
20. P169Eligibility for PCSK9 inhibitors according to ESC/EAS and ACC recommendations after acute coronary syndromes
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François Mach, Thomas F. Lüscher, Nicolas Rodondi, Christian M. Matter, K C Koskinas, Alexios Karagiannis, David Nanchen, Roland Klingenberg, L Raeber, Baris Gencer, S Windecker, Sebastian Carballo, David Carballo, and D Heg
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360 Social problems & social services ,business.industry ,Medicine ,610 Medicine & health ,Cardiology and Cardiovascular Medicine ,Bioinformatics ,PCSK9 Inhibitors ,business - Published
- 2017
21. Rationale and design of the Hunting for the off-target propertIes of Ticagrelor on Endothelial function and other Circulating biomarkers in Humans (HI-TECH) trial
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Maarten A.H. van Leeuwen, Stephan Windecker, Marco Valgimigli, Gladys N. Janssens, Kristiaan Martijn Akkerhuis, Salvatore Brugaletta, Sara Ariotti, Sergio Leonardi, Diego Rizzotti, Gloria Francolini, Luis Ortega-Paz, Jan C van den Berge, Emrush Rexhaj, D Heg, Cardiology, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias
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Male ,Ticagrelor ,Acute coronary syndrome ,medicine.medical_specialty ,Adenosine ,Prasugrel ,Administration, Oral ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,P2Y12 ,Randomized controlled trial ,law ,Internal medicine ,Secondary Prevention ,Humans ,Medicine ,030212 general & internal medicine ,610 Medicine & health ,Reactive hyperemia ,Cross-Over Studies ,Dose-Response Relationship, Drug ,business.industry ,Graft Occlusion, Vascular ,medicine.disease ,Clopidogrel ,Crossover study ,Vasodilation ,Treatment Outcome ,Anesthesia ,Purinergic P2Y Receptor Antagonists ,Cardiology ,Female ,Stents ,Endothelium, Vascular ,Cardiology and Cardiovascular Medicine ,business ,360 Social problems & social services ,Biomarkers ,Follow-Up Studies ,medicine.drug - Abstract
Background Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels. Methods The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order. The primary objective was to evaluate whether ticagrelor, at treatment steady state (ie, after 30 ± 5 days of drug administration), as compared with both clopidogrel and prasugrel, is associated with an improved endothelial function, assessed with peripheral arterial tonometry. Thirty-six patients undergoing evaluable endothelial function assessment for each of the assigned P2Y12 inhibitor were needed to provide 90% power to detect a 10% relative change of the reactive hyperemia index in the ticagrelor group. Conclusion The HI-TECH study is the first randomized, crossover study aiming to ascertain whether ticagrelor, when administered at approved regimen in post-ACS patients, improves endothelial function as compared with both clopidogrel and prasugrel.
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- 2017
22. Observed links between heatwaves and wildfires across Northern high latitudes
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D Hegedűs, A P Ballinger, and G C Hegerl
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heatwaves ,wildfires ,land surface temperature ,burned area ,arctic ,remote sensing ,Environmental technology. Sanitary engineering ,TD1-1066 ,Environmental sciences ,GE1-350 ,Science ,Physics ,QC1-999 - Abstract
Data on Arctic and Sub-Arctic summer heat events are limited due to the sparse network of surface observation stations. Here, we analyze large heat events within 60°–80°N using land surface temperature (LST) observations from the moderate resolution imaging spectroradiometer (MODIS) sensor aboard the Terra satellite. Our heatwave (HW) detection method uses exceedances of the climatological 90th percentile of LST across summer months, and a spatio-temporal density-based clustering algorithm to distinguish space-time coherent events across Northern Hemispheric high latitudes for the summers of 2000–2022. We find a close link between HW duration, spatial extent and amplitude across the study region (correlations ranging from 0.63 to 0.73). MODIS-derived burned area data show that wildfire seasons are significantly correlated to summer HW activity, particularly in Siberia ( r = 0.87 at p
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- 2024
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23. Effect of Diabetes Mellitus on Frequency of Adverse Events in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention
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Thomas Pilgrim, Lorenz Räber, Raffaele Piccolo, Peter Jüni, Sigmund Silber, Julie Rat-Wirtzler, Stefan Stortecky, Marco Valgimigli, Patrick W. Serruys, Stephan Windecker, Anna Franzone, Konstantinos C. Koskinas, D Heg, Piccolo, Raffaele, Franzone, Anna, Koskinas, Konstantinos C., Räber, Lorenz, Pilgrim, Thoma, Valgimigli, Marco, Stortecky, Stefan, Rat-Wirtzler, Julie, Silber, Sigmund, Serruys, Patrick W., Jüni, Peter, Heg, Dik, and Windecker, Stephan
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Male ,medicine.medical_specialty ,Acute coronary syndrome ,Prognosi ,medicine.medical_treatment ,Comorbidity ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Postoperative Complications ,Internal medicine ,Diabetes mellitus ,medicine ,Diabetes Mellitus ,Humans ,In patient ,030212 general & internal medicine ,Myocardial infarction ,Acute Coronary Syndrome ,610 Medicine & health ,Adverse effect ,Non-ST Elevated Myocardial Infarction ,Aged ,Proportional Hazards Models ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,business.industry ,Proportional hazards model ,Percutaneous coronary intervention ,Diabetes Mellitu ,Middle Aged ,medicine.disease ,Prognosis ,Cardiology ,Proportional Hazards Model ,ST Elevation Myocardial Infarction ,Female ,Postoperative Complication ,business ,Cardiology and Cardiovascular Medicine ,360 Social problems & social services ,Human - Abstract
Few data are available on the timing of adverse events in relation to the status of diabetes mellitus and the type of acute coronary syndrome (ACS). We investigated this issue in diabetic and nondiabetic patients admitted with a diagnosis of non-ST-segment elevation ACS (NSTE-ACS) or ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. Patient-level data from 6 studies (n = 16,601) were pooled and only patients with ACS are included (n = 9,492). Early (0 to 30 days), late (31 to 365 days), and overall (0 to 365 days) events were analyzed. Diabetes mellitus was present in 1,927 patients (20.3%). At 1 year, all-cause mortality was highest for diabetic patients with STEMI (13.4%), followed by diabetic patients with NSTE-ACS (10.3%), nondiabetic patients with STEMI (6.4%) and nondiabetic patients with NSTE-ACS (4.4%; p 10% in both STEMI and NSTE-ACS. Notwithstanding the high absolute rates, the temporal distribution of adverse events related to the type of ACS is similar between diabetic and nondiabetic patients.
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- 2016
24. Bleeding incidence in a contemporary ACS cohort adjudicated by three different classifications
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L Raeber, Roland Klingenberg, François Mach, Thomas F Luescher, Ulf Landmesser, David Carballo, D Heg, Christian M. Matter, S Windecker, and Nicolas Rodondi
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Acute coronary syndrome ,medicine.medical_specialty ,Prasugrel ,Unstable angina ,business.industry ,medicine.disease ,Clopidogrel ,Surgery ,Angina ,Internal medicine ,medicine ,cardiovascular diseases ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,TIMI ,Mace ,medicine.drug - Abstract
Purpose: Bleeding constitutes an important adverse event of therapy after an acute coronary syndrome (ACS). Currently there is no classification uniformly used to ascertain bleeding events rendering the comparison of different clinical trials difficult. This work addresses i) the incidence of bleeding events occurring within 30 days after an ACS ii) the concordance of three classifications currently used (BARC, GUSTO and TIMI) in a prospectively recruited large patient cohort. Methods: All patients aged ≥18 years presenting within 5 days after pain onset with the main diagnosis of STEMI, NSTEMI or unstable angina were included in the study. Patients had symptoms compatible with angina pectoris and at least one of the following inclusion criteria a) ST-segment elevation or depression, T inversion or dynamic ECG changes, new LBBB; b) evidence of positive Troponin; c) known coronary artery disease (status after myocardial infarction, CABG or PCI or newly documented during the acute catheterization). Exclusion criteria comprised severe physical disability, dementia or less than 1 year of life expectancy for non-cardiac reasons. Adjudicated 30-day bleeding incidence after an ACS was determined according to GUSTO, TIMI and BARC (overt bleeding) criteria in 1470 patients prospectively enrolled between 12/2009 and 12/2011 at 4 Swiss University Hospitals. MACE was defined as composite of death, recurrent myocardial infarction and stroke. 30-day follow-up comprised all enrolled patients including deceased individuals. Concordance between classifications was determined by Kendall's tau-b correlation test. Results: Among 1470 patients enrolled with ACS, 4.2% had unstable angina; 41.8% had NSTEMI and 54.0% had STEMI. 1451 patients (98.7%) had a complete 30-day follow-up. Adjudicated 30-day bleeding incidence was 3.9% (n=57 first events). Adjudicated 30-day MACE rate was 3.2% (n=47). Medications prescribed at hospital discharge to 1452 patients were aspirin in 99.2%, clopidogrel in 53.7%, prasugrel in 38.9% and/or coumadin in 6.1%. Comparison of the 3 classifications yielded a high concordance for bleeding severity between TIMI vs. BARC (Kendall tau-b 0.75, p
- Published
- 2013
25. Derivation and Validation of the PRECISE-HBR Score to Predict Bleeding After Percutaneous Coronary Intervention.
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Gragnano F, van Klaveren D, Heg D, Räber L, Krucoff MW, Raposeiras-Roubän S, Ten Berg JM, Leonardi S, Kimura T, Corpataux N, Spirito A, Hermiller JB, Abu-Assi E, Chan Pin Yin D, Azzahhafi J, Montalto C, Galazzi M, Bär S, Kavaliauskaite R, D'Ascenzo F, De Ferrari GM, Watanabe H, Steg PG, Bhatt DL, Calabrò P, Mehran R, Urban P, Pocock S, Windecker S, and Valgimigli M
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Background: Accurate bleeding risk stratification after percutaneous coronary intervention (PCI) is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of high bleeding risk patients. We derived and validated a novel bleeding risk score by augmenting the PRECISE-DAPT score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria., Methods: The derivation cohort comprised 29,188 patients undergoing PCI, of whom 1136 (3.9%) had a Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year, from four contemporary real-world registries and the XIENCE V USA trial. The PRECISE-DAPT score was refitted with a Fine-Gray model in the derivation cohort and extended with the ARC-HBR criteria. The primary outcome was BARC 3 or 5 bleeding within 1 year. Independent predictors of BARC 3 or 5 bleeding were selected at multivariable analysis (p<0.01). The discrimination of the score was internally assessed with apparent validation and cross-validation. The score was externally validated in 4578 patients from the MASTER DAPT trial and 5970 patients from the STOPDAPT-2 total cohort., Results: The PRECISE-HBR score (age, estimated glomerular filtration rate, hemoglobin, white-blood-cell count, previous bleeding, oral anticoagulation, and ARC-HBR criteria) showed an area under the curve (AUC) for 1-year BARC 3 or 5 bleeding of 0.73 (95% CI, 0.71-0.74) at apparent validation, 0.72 (95% CI, 0.70-0.73) at cross-validation, 0.74 (95% CI, 0.68-0.80) in the MASTER DAPT, and 0.73 (95% CI, 0.66-0.79) in the STOPDAPT-2, with superior discrimination than the PRECISE-DAPT (cross-validation: Δ AUC, 0.01; p=0.02; MASTER DAPT: Δ AUC, 0.05; p=0.004; STOPDAPT-2: Δ AUC, 0.02; p=0.20) and other risk scores. In the derivation cohort, a cut-off of 23 points identified 11,414 patients (39.1%) with a 1-year BARC 3 or 5 bleeding risk ≥4%. An alternative version of the score, including acute myocardial infarction on admission instead of white-blood-cell count, showed similar predictive ability., Conclusions: The PRECISE-HBR score is a contemporary, simple 7-item risk score to predict bleeding after PCI, offering a moderate improvement in discrimination over multiple existing scores. Further evaluation is required to assess its impact on clinical practice.
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- 2024
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26. Ten-year clinical outcomes after drug-eluting stents implantation according to clinical presentation-Insights from the DECADE cooperation.
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Starnecker F, Coughlan JJ, Jensen LO, Bär S, Kufner S, Brugaletta S, Räber L, Maeng M, Ortega-Paz L, Heg D, Laugwitz KL, Sabaté M, Windecker S, Kastrati A, Olesen KKW, and Cassese S
- Abstract
Background: Investigations of very long-term outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) according to clinical presentation are scarce. Here, we investigated the 10-year clinical outcomes of patients undergoing DES-PCI according to clinical presentation., Methods: Patient-level data from five randomized trials with 10-year follow-up after DES-PCI were pooled. Patients were dichotomized into acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) groups as per clinical presentation. The primary outcome was all-cause death. Secondary outcomes were cardiovascular death, myocardial infarction (MI), definite stent thrombosis (ST) and repeat revascularization involving the target lesion (TLR), target vessel (TVR) or non-target vessel (nTVR)., Results: Of the 9700 patients included in this analysis, 4557 presented with ACS and 5143 with CCS. Compared with CCS patients, ACS patients had a higher risk of all-cause death and nTVR in the first year, but comparable risk thereafter. In addition, ACS patients had a higher risk of MI [adjusted hazard ratio 1.21, 95% confidence interval (1.04-1.41)] and definite ST [adjusted hazard ratio 1.48, 95% confidence interval (1.14-1.92)], while the risk of TLR and TVR was not significantly different up to 10-year follow-up., Conclusions: Compared to CCS patients, ACS patients treated with PCI and DES implantation have an increased risk of all-cause death and repeat revascularization of remote vessels up to 1 year, with no significant differences thereafter and up to 10-year follow-up. ACS patients have a consistently higher risk of MI and definite ST. Whether these differences persist with current antithrombotic and secondary prevention therapies requires further investigation., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)
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- 2024
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27. Eligibility for marine omega-3 fatty acid supplementation after acute coronary syndromes.
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Follonier C, Rabassa G, Branca M, Carballo D, Koskinas K, Heg D, Nanchen D, Räber L, Klingenberg R, Haller ML, Carballo S, Windecker S, Matter CM, Rodondi N, Mach F, and Gencer B
- Abstract
Background and Aims: The 2019 European Society of Cardiology guidelines for the management of dyslipidemia consider the use of high-dose marine omega-3 fatty acid (FA) eicosapentaenoic acid (EPA) supplementation (icosapent ethyl 2 × 2g/day) to lower residual cardiovascular risk in high-risk patients with hypertriglyceridemia. This study aimed to assess the eligibility for omega-3 FA-EPA supplementation in patients with acute coronary syndromes (ACS)., Methods: In a prospective Swiss cohort of patients hospitalized for ACS, eligibility for marine omega-3 FA-EPA, defined as plasma triglyceride levels ranging from 1.5 to 5.6 mmol/l, was assessed at baseline and one-year follow-up and compared across subgroups. Lipid-lowering therapy intensification with statin and ezetimibe was modelled to simulate a hypothetical systematic treatment and its effect on omega-3 FA-EPA supplementation eligibility., Results: Of 2643 patients, 98 % were prescribed statin therapy at discharge, including 62 % at a high-intensity regimen; 93 % maintained it after one year, including 53 % at a high-intensity regimen. The use of ezetimibe was 3 % at discharge and 7 % at one year. Eligibility was observed in 32 % (32 % men, 29 % women) one year post-ACS. After modelling systematic treatment with statins, ezetimibe, and both, eligibility decreased to 31 %, 25 % and 24 %, respectively. Eligibility was higher in individuals aged <70 (34 vs 25 %), smokers (38 vs 28 %), diabetics (46 vs 29 %), hypertensive (35 vs 29 %), and obese patients (46 vs 22 % for normal weight), all with p-values <0.001., Conclusion: In a contemporary Swiss cohort of patients with ACS, up to 32 % would be eligible for omega-3 FA-EPA supplementation one year after ACS, highlighting an opportunity to mitigate residual cardiovascular risk in patients with ACS and hypertriglyceridemia., (© 2024 The Authors.)
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- 2024
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28. Geographical Variations in the Effectiveness and Safety of Abbreviated or Standard Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients at High Bleeding Risk.
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Ozaki Y, Hong SJ, Heg D, Frigoli E, Vranckx P, Morice MC, Chevalier B, Onuma Y, Windecker S, Di Biasi M, Whitbourn R, Dudek D, Raffel OC, Shimizu K, Calabrò P, Fröbert O, Cura F, Berg JT, Smits PC, and Valgimigli M
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- Humans, Hemorrhage chemically induced, Hemorrhage epidemiology, Hemorrhage prevention & control, Treatment Outcome, Male, Percutaneous Coronary Intervention methods, Platelet Aggregation Inhibitors therapeutic use, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors administration & dosage
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- 2024
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29. Consecutive or selectively included high bleeding risk patients in the MASTER DAPT screening log and trial.
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Landi A, Heg D, Frigoli E, Tonino PAL, Vranckx P, Pourbaix S, Chevalier B, Iñiguez A, Pinar E, Lesiak M, Kala P, Donahue M, Windecker S, Roffi M, Smits PC, and Valgimigli M
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- Humans, Male, Aged, Female, Middle Aged, Aged, 80 and over, Risk Factors, Anticoagulants adverse effects, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Risk Assessment, Patient Selection, Dual Anti-Platelet Therapy adverse effects, Dual Anti-Platelet Therapy methods, Hemorrhage chemically induced, Hemorrhage epidemiology, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors adverse effects, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Aims: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial., Methods and Results: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24)., Conclusions: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population., (Copyright © 2024. Published by Elsevier B.V.)
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- 2024
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30. Ultrasound-assisted catheter-directed thrombolysis versus surgical pulmonary embolectomy for intermediate-high or high-risk pulmonary embolism: a randomized phase II non-inferiority trial.
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Stortecky S, Barco S, Windecker S, Heg D, Kadner A, Englberger L, and Kucher N
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- Aged, Female, Humans, Male, Middle Aged, Fibrinolytic Agents therapeutic use, Fibrinolytic Agents administration & dosage, Treatment Outcome, Ultrasonography, Interventional methods, Embolectomy methods, Pulmonary Embolism surgery, Pulmonary Embolism therapy, Thrombolytic Therapy methods
- Abstract
Objectives: We hypothesized that ultrasound-assisted thrombolysis (USAT) is non-inferior to surgical pulmonary embolectomy (SPE) to improve right ventricular (RV) function in patients with acute pulmonary embolism (PE)., Methods: In a single-centre, non-inferiority trial, we randomly assigned 27 patients with intermediate-high or high-risk acute PE to undergo either USAT or SPE stratified by PE risk. Primary and secondary outcomes were the baseline-to-72-h difference in right-to-left ventricular (RV/LV) ratio and the Qanadli pulmonary occlusion score, respectively, by contrast-enhanced chest-computed tomography assessed by a blinded CoreLab., Results: The trial was prematurely terminated due to slow enrolment. Mean age was 62.6 (SD 12.4) years, 26% were women, and 15% had high-risk PE. Mean change in RV/LV ratio was -0.34 (95% CI -0.50 to -0.18) in the USAT and -0.53 (95% CI -0.68 to -0.38) in the SPE group (mean difference: 0.152; 95% CI 0.032-0.271; Pnon-inferiority = 0.80; Psuperiority = 0.013). Mean change in Qanadli pulmonary occlusion score was -7.23 (95% CI -9.58 to -4.88) in the USAT and -11.36 (95% CI -15.27 to -7.44) in the SPE group (mean difference: 5.00; 95% CI 0.44-9.56, P = 0.032). Clinical and functional outcomes were similar between the 2 groups up to 12 months., Conclusions: In patients with intermediate-high and high-risk acute PE, USAT was not non-inferior when compared with SPE in reducing RV/LV ratio within the first 72 h. In a post hoc superiority analysis, SPE resulted in greater improvement of RV overload and reduction of thrombus burden., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2024
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31. Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial.
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Maurhofer J, Kueffer T, Knecht S, Thalmann G, Badertscher P, Kozhuharov N, Krisai P, Jufer C, Iqbal SUR, Heg D, Servatius H, Tanner H, Kühne M, Roten L, Sticherling C, and Reichlin T
- Abstract
Background: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy., Objective: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF., Methods: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients., Results: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes., Conclusion: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)
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- 2024
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32. Myocardial analysis from routine 4D cardiac-CT to predict reverse remodeling and clinical outcomes after transcatheter aortic valve implantation.
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Bernhard B, Schütze J, Leib ZL, Spano G, Boscolo Berto M, Bakula A, Tomii D, Shiri I, Brugger N, De Marchi S, Reineke D, Dobner S, Heg D, Praz F, Lanz J, Stortecky S, Pilgrim T, Windecker S, and Gräni C
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- Humans, Male, Female, Aged, 80 and over, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Prospective Studies, Aged, Echocardiography methods, Transcatheter Aortic Valve Replacement, Ventricular Remodeling, Four-Dimensional Computed Tomography methods
- Abstract
Purpose: Our study aimed to determine whether 4D cardiac computed tomography (4DCCT) based quantitative myocardial analysis may improve risk stratification and can predict reverse remodeling (RRM) and mortality after transcatheter aortic valve implantation (TAVI)., Methods: Consecutive patients undergoing clinically indicated 4DCCT prior to TAVI were prospectively enrolled. 4DCCT-derived left- (LV) and right ventricular (RV), and left atrial (LA) dimensions, mass, ejection fraction (EF) and myocardial strain were evaluated to predict RRM and survival. RRM was defined by either relative increase in LVEF by 5% or relative decline in LV end diastolic diameter (LVEDD) by 5% assessed by transthoracic echocardiography prior TAVI, at discharge, and at 12-month follow-up compared to baseline prior to TAVI., Results: Among 608 patients included in this study (55 % males, age 81 ± 6.6 years), RRM was observed in 279 (54 %) of 519 patients at discharge and in 218 (48 %) of 453 patients at 12-month echocardiography. While no CCT based measurements predicted RRM at discharge, CCT based LV mass index and LVEF independently predicted RRM at 12-month (OR
adj = 1.012; 95 %CI:1.001-1.024; p = 0.046 and ORadj = 0.969; 95 %CI:0.943-0.996; p = 0.024, respectively). The most pronounced changes in LVEF and LVEDD were observed in patients with impaired LV function at baseline. In multivariable analysis age (HRadj = 1.037; 95 %CI:1.005-1.070; p = 0.022) and CCT-based LVEF (HRadj = 0.972; 95 %CI:0.945-0.999; p = 0.048) and LAEF (HRadj = 0.982; 95 %CI:0.968-0.996; p = 0.011) independently predicted survival., Conclusion: Comprehensive myocardial functional information derived from routine 4DCCT in patients with severe aortic stenosis undergoing TAVI could predict reverse remodeling and clinical outcomes at 12-month following TAVI., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Bernhard reports a career development grant from the Swiss National Science Foundation. Dr. Dobner reports travel grants from Pfizer and Alnylam, speaking fees from Boehringer Ingelheim. D. Heg is employed by the CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. Dr. Stortecky reports research grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientific and Abbott, as well as personal fees from Boston Scientific, Teleflex and BTG. Dr. Pilgrim reports research grants to the institution from Biotronik, Boston Scientific and Edwards Lifesciences; speaker fees from Biotronik, Boston Scientific, Abbott, and Medtronic; Clinical event committee for study sponsored by HighLifeSAS. Stephan Windecker reports research, travel or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc. Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. Stephan Windecker served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Gräni further received funding from the Swiss National Science Foundation, InnoSuisse, from the Center for Artificial Intelligence in Medicine Research Project Fund University Bern and Gambit foundation, outside of the submitted work. All other authors report no conflicts., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)- Published
- 2024
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33. Association of atrial fibrillation with survival in patients with low-flow low-gradient aortic stenosis with preserved ejection fraction undergoing TAVI.
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Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Lanz J, Reineke D, Windecker S, and Pilgrim T
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- Humans, Male, Female, Aged, 80 and over, Prospective Studies, Survival Rate trends, Aged, Prognosis, Ventricular Function, Left physiology, Follow-Up Studies, Risk Factors, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis mortality, Transcatheter Aortic Valve Replacement, Stroke Volume physiology, Atrial Fibrillation physiopathology, Atrial Fibrillation complications, Registries
- Abstract
Aims: There is limited evidence on the prognostic significance of atrial fibrillation (AF) in patients with low flow, low-gradient aortic stenosis with preserved ejection fraction (LFLG-pEF AS). We aimed to evaluate the recovery of stroke volume after transcatheter aortic valve implantation (TAVI) and clinical outcomes in patients with LFLG-pEF AS stratified by presence or absence of AF., Methods and Results: In a prospective TAVI registry, patients with preserved left ventricular ejection fraction (LVEF ≥ 50%) were stratified according to flow-gradient status and presence of AF. Among 2259 TAVI patients with preserved LVEF between August 2007 and June 2021, 765 had high-gradient AS (HG AS) and 444 had LFLG-pEF AS. AF was observed in 199 patients with HG AS (26.0%) and 190 patients with LFLG-pEF AS (42.8%). At 1 year, stroke volume index (SVi) was significantly improved in LFLG-pEF AS patients without AF, while SVi remained low in patients with AF (from 25.9 ± 8.5 mL/m2 to 37.2 ± 9.9 mL/m2 and from 26.8 ± 5.1 mL/m2 to 26.1 ± 9.1 mL/m2, respectively). LFLG-pEF AS patients with AF had an increased risk of 1-year all-cause mortality compared with those without AF (adjusted hazard ratio (HRadjusted) 2.57; 95% confidence interval [CI] 1.44-4.59). LFLG-pEF AS patients without AF had similar mortality compared with HG AS patients without AF (HRadjusted 0.85; 95% CI 0.49-1.46)., Conclusion: Patients with LFLG-pEF AS and AF experienced no relevant recovery of stroke volume after TAVI, but a more than two-fold increased risk of death compared to patients with HG AS or LFLG-pEF AS without AF., Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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34. Ultrathin-strut versus thin-strut stent healing and outcomes in preclinical and clinical subjects.
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Ikegami R, Piao Z, Iglesias JF, Pilgrim T, Ha K, McCarthy JR, Castellanos MI, Kassab MB, Albagdadi MS, Mauskapf A, Spicer G, Kandzari DE, Edelman ER, Libby P, Heg D, Joner M, Tearney GJ, and Jaffer FA
- Subjects
- Animals, Rabbits, Humans, Treatment Outcome, Prosthesis Design, Coronary Artery Disease therapy, Coronary Artery Disease diagnostic imaging, Male, Absorbable Implants, Female, Wound Healing, Drug-Eluting Stents, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention methods, Sirolimus therapeutic use, Sirolimus administration & dosage, Sirolimus pharmacology, Tomography, Optical Coherence
- Abstract
Background: Compared with thin-strut durable-polymer drug-eluting stents (DP-DES), ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) improve stent-related clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Reduced stent strut thickness is hypothesised to underlie these benefits, but this conjecture remains unproven., Aims: We aimed to assess the impact of strut thickness on stent healing and clinical outcomes between ultrathin-strut and thin-strut BP-SES., Methods: First, we performed a preclinical study of 8 rabbits implanted with non-overlapping thin-strut (diameter/thickness 3.5 mm/80 μm) and ultrathin-strut (diameter/thickness 3.0 mm/60 μm) BP-SES in the infrarenal aorta. On day 7, the rabbits underwent intravascular near-infrared fluorescence optical coherence tomography (NIRF-OCT) molecular-structural imaging of fibrin deposition and stent tissue coverage, followed by histopathological analysis. Second, we conducted an individual data pooled analysis of patients enrolled in the BIOSCIENCE and BIOSTEMI randomised PCI trials treated with ultrathin-strut (n=282) or thin-strut (n=222) BP-SES. The primary endpoint was target lesion failure (TLF) at 1-year follow-up, with a landmark analysis at 30 days., Results: NIRF-OCT image analyses revealed that ultrathin-strut and thin-strut BP-SES exhibited similar stent fibrin deposition (p=0.49) and percentage of uncovered stent struts (p=0.63). Histopathological assessments corroÂborated these findings. In 504 pooled randomised trial patients, TLF rates were similar for those treated with ultrathin-strut or thin-strut BP-SES at 30-day (2.5% vs 1.8%; p=0.62) and 1-year follow-up (4.3% vs 4.7%; p=0.88)., Conclusions: Ultrathin-strut and thin-strut BP-SES demonstrate similar early arterial healing profiles and 30-day and 1-year clinical outcomes.
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- 2024
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35. Drinking patterns of alcohol and risk of major adverse cardiovascular events after an acute coronary syndrome.
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Tessitore E, Branca M, Heg D, Nanchen D, Auer R, Räber L, Klingenberg R, Windecker S, Lüscher TF, Carballo S, Matter CM, Gmel G, Mukamal KJ, Rodondi N, Carballo D, Mach F, and Gencer B
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Switzerland epidemiology, Risk Factors, Time Factors, Risk Assessment, Proportional Hazards Models, Alcohol Abstinence, Prognosis, Myocardial Infarction epidemiology, Myocardial Infarction mortality, Prospective Studies, Stroke epidemiology, Stroke mortality, Stroke etiology, Acute Coronary Syndrome mortality, Acute Coronary Syndrome epidemiology, Alcohol Drinking adverse effects, Alcohol Drinking epidemiology, Binge Drinking epidemiology, Binge Drinking complications
- Abstract
Aims: To evaluate the risk of alcohol consumption after acute coronary syndromes (ACS)., Methods and Results: A total of 6557 patients hospitalized for ACS at four Swiss centres were followed over 12 months. Weekly alcohol consumption was collected at baseline and 12 months. Binge drinking was defined as consumption of ≥6 units of alcohol on one occasion. Major adverse cardiovascular events (MACE) were defined as a composite of cardiac death, myocardial infarction, stroke, or clinically indicated target vessel coronary revascularization. Cox regression analysis was performed to assess the risk of MACE in patients with heavy (>14 standard units/week), moderate (7-14 standard units per week), light consumption (<1 standard unit/week), or abstinence, and with binge drinking episodes, adjusted for baseline differences. At baseline, 817 (13.4%) patients reported heavy weekly alcohol consumption. At 1-year follow-up, 695/1667 (41.6%) patients reported having at least one or more episodes of binge drinking per month. The risk for MACE was not significantly higher in those with heavy weekly consumption compared to abstinence [8.6% vs. 10.2%, hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.69-1.36] or light consumption (8.6% vs. 8.5%, HR 1.41, 95% CI 0.97-2.06). Compared to patients with no binge drinking, the risk of MACE was dose-dependently higher in those with binge drinking with less than one episode per month (9.2% vs. 7.8%, HR 1.61, 95% CI 1.23-2.11) or one or more episodes per month (13.6% vs. 7.8%, HR 2.17, 95% CI 1.66-2.83)., Conclusion: Binge drinking during the year following an ACS, even less than once per month, is associated with worse clinical outcomes., Competing Interests: Conflict of interest: Conflicts of interest are detailed in the Declarations Form, and all authors have filled out the ICJME disclosure form., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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36. Does morphine attenuate the Inhibition of Platelet Aggregation for both oral and parenteral P2Y12 inhibitors?
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Landi A, Gargiulo G, Esposito G, Campo G, Biscaglia S, Heg D, and Valgimigli M
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- Humans, Administration, Oral, Platelet Aggregation Inhibitors pharmacology, Platelet Aggregation Inhibitors therapeutic use, Platelet Aggregation drug effects, Morphine pharmacology, Morphine administration & dosage, Purinergic P2Y Receptor Antagonists pharmacology, Purinergic P2Y Receptor Antagonists therapeutic use
- Abstract
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Valgimigli reports grants and/or personal fees from Astra Zeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals-Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers-Squib SA, Biotronik, Boston scientific, Medtronic, Vesalio, Novartis, Chiesi, PhaseBio, outside the submitted work. The other authors report no relationships relevant to the contents of this paper to disclose.
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- 2024
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37. Ticagrelor or Clopidogrel Monotherapy vs Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: A Systematic Review and Patient-Level Meta-Analysis.
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Valgimigli M, Gragnano F, Branca M, Franzone A, da Costa BR, Baber U, Kimura T, Jang Y, Hahn JY, Zhao Q, Windecker S, Gibson CM, Watanabe H, Kim BK, Song YB, Zhu Y, Vranckx P, Mehta S, Ando K, Hong SJ, Gwon HC, Serruys PW, Dangas GD, McFadden EP, Angiolillo DJ, Heg D, Calabrò P, Jüni P, and Mehran R
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- Humans, Purinergic P2Y Receptor Antagonists therapeutic use, Hemorrhage chemically induced, Ticagrelor therapeutic use, Percutaneous Coronary Intervention methods, Clopidogrel therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Dual Anti-Platelet Therapy methods
- Abstract
Importance: Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course of dual antiplatelet therapy (DAPT) depends on the type of P2Y12 inhibitor., Objective: To assess the risks and benefits of ticagrelor monotherapy or clopidogrel monotherapy compared with standard DAPT after PCI., Data Sources: MEDLINE, Embase, TCTMD, and the European Society of Cardiology website were searched from inception to September 10, 2023, without language restriction., Study Selection: Included studies were randomized clinical trials comparing P2Y12 inhibitor monotherapy with DAPT on adjudicated end points in patients without indication to oral anticoagulation undergoing PCI., Data Extraction and Synthesis: Patient-level data provided by each trial were synthesized into a pooled dataset and analyzed using a 1-step mixed-effects model. The study is reported following the Preferred Reporting Items for Systematic Review and Meta-Analyses of Individual Participant Data., Main Outcomes and Measures: The primary objective was to determine noninferiority of ticagrelor or clopidogrel monotherapy vs DAPT on the composite of death, myocardial infarction (MI), or stroke in the per-protocol analysis with a 1.15 margin for the hazard ratio (HR). Key secondary end points were major bleeding and net adverse clinical events (NACE), including the primary end point and major bleeding., Results: Analyses included 6 randomized trials including 25 960 patients undergoing PCI, of whom 24 394 patients (12 403 patients receiving DAPT; 8292 patients receiving ticagrelor monotherapy; 3654 patients receiving clopidogrel monotherapy; 45 patients receiving prasugrel monotherapy) were retained in the per-protocol analysis. Trials of ticagrelor monotherapy were conducted in Asia, Europe, and North America; trials of clopidogrel monotherapy were all conducted in Asia. Ticagrelor was noninferior to DAPT for the primary end point (HR, 0.89; 95% CI, 0.74-1.06; P for noninferiority = .004), but clopidogrel was not noninferior (HR, 1.37; 95% CI, 1.01-1.87; P for noninferiority > .99), with this finding driven by noncardiovascular death. The risk of major bleeding was lower with both ticagrelor (HR, 0.47; 95% CI, 0.36-0.62; P < .001) and clopidogrel monotherapy (HR, 0.49; 95% CI, 0.30-0.81; P = .006; P for interaction = 0.88). NACE were lower with ticagrelor (HR, 0.74; 95% CI, 0.64-0.86, P < .001) but not with clopidogrel monotherapy (HR, 1.00; 95% CI, 0.78-1.28; P = .99; P for interaction = .04)., Conclusions and Relevance: This systematic review and meta-analysis found that ticagrelor monotherapy was noninferior to DAPT for all-cause death, MI, or stroke and superior for major bleeding and NACE. Clopidogrel monotherapy was similarly associated with reduced bleeding but was not noninferior to DAPT for all-cause death, MI, or stroke, largely because of risk observed in 1 trial that exclusively included East Asian patients and a hazard that was driven by an excess of noncardiovascular death.
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- 2024
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38. Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement.
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Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Reineke D, Samim D, Lanz J, Windecker S, and Pilgrim T
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- Humans, Male, Female, Retrospective Studies, Time Factors, Aged, 80 and over, Aged, Risk Factors, Treatment Outcome, Risk Assessment, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis mortality, Aortic Valve surgery, Aortic Valve diagnostic imaging, Aortic Valve physiopathology
- Abstract
Background: Extravalvular cardiac damage caused by aortic stenosis affects prognosis after transcatheter aortic valve replacement (TAVR). The long-term impact of changes in cardiac damage in response to relief from mechanical obstruction has not been fully investigated., Objectives: The authors aimed to investigate changes in cardiac damage early after TAVR and the prognostic impact of the cardiac damage classification after TAVR., Methods: In this single-center observational study, patients undergoing transfemoral TAVR were retrospectively evaluated for cardiac damage before and after TAVR and classified into 5 stages of cardiac damage (0-4)., Results: Among 1,863 patients undergoing TAVR between January 2007 and June 2022, 56 patients (3.0%) were classified as stage 0, 225 (12.1%) as stage 1, 729 (39.1%) as stage 2, 388 (20.8%) as stage 3, and 465 (25.0%) as stage 4. Cardiac stage changed in 47.7% of patients (improved: 30.1% in stages 1-4 and deteriorated: 24.7% in stages 0-3) early after TAVR. Five-year all-cause mortality was associated with cardiac damage both at baseline (HR
adjusted : 1.34; 95% CI: 1.24-1.44; P < 0.001 for linear trend) and after TAVR (HRadjusted : 1.40; 95% CI: 1.30-1.51; P < 0.001 for linear trend). Five-year all-cause mortality was stratified by changes in cardiac damage (improved, unchanged, or worsened) in patients with cardiac stage 2, 3, and 4 (log-rank P < 0.001 for stage 2, 0.005 for stage 3, and <0.001 for stage 4)., Conclusions: The extent of extra-aortic valve cardiac damage before and after TAVR and changes in cardiac stage early after TAVR have important prognostic implications during long-term follow-up. (SwissTAVI Registry; NCT01368250)., Competing Interests: Funding Support and Author Disclosures Dr Heg has no personal conflicts; his employer, Clinical Trials Unit Bern, University of Bern, has a staff policy of not accepting honoraria or consultancy fees. However, Clinical Trials Unit Bern is involved in the design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. Dr Praz has received travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr Stortecky has reported research grants to the institution from Edwards Lifesciences and Medtronic; and has received personal fees from Boston Scientific, Teleflex, and BTG. Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Windecker has reported research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave. Dr Windecker has served as an Advisory Board member and/or member of the Steering/Executive Group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and is a member of the Steering/Executive Committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Pilgrim has reported research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik; and has received speaker fees/consultancy from Biotronik, Medtronic, Abbott, Edwards Lifesciences, and HighLife SAS. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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39. One-Year Outcomes After Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: A Prespecified Analysis of the SWISS-APERO Randomized Clinical Trial.
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Galea R, Meneveau N, De Marco F, Aminian A, Heg D, Chalkou K, Gräni C, Anselme F, Franzone A, Vranckx P, Fischer U, Bedogni F, Räber L, and Valgimigli M
- Subjects
- Humans, Left Atrial Appendage Closure, Warfarin, Anticoagulants, Treatment Outcome, Cardiac Catheterization adverse effects, Atrial Appendage diagnostic imaging, Atrial Appendage surgery, Atrial Fibrillation surgery, Stroke etiology, Stroke prevention & control
- Abstract
Competing Interests: Disclosures Dr Meneveau reports grants and personal fees from Bayer Healthcare, BMS Pfizer, and Abbott, as well as personal fees from Astra Zeneca and Terumo, outside the submitted work. Dr De Marco reports consultancies and paid expert testimonies from Abbott and Boston-Scientific. Dr Aminian is a proctor and consultant for Abbott and Boston-Scientific. Dr Chalkou reports a research grant from Janssen Switzerland (Johnson & Johnson). Dr Gräni reports funding from the Swiss National Science Foundation, InnoSuisse, CAIM foundation, GAMBIT foundation and Novartis foundation, outside of the submitted work. Dr Vranckx reports personal fees from AstraZeneca, Bristol Myers Squibb-Janssen, Bristol Myers Squibb-Pfizer, CSL Behring, and Daiichi-Sankyo, outside the submitted work. Dr Fischer reports grants from Medtronic and other from Medtronic, Stryker, and CSL-Behring, outside the submitted work. Dr Bedogni is a proctor for Abbott, Boston-Scientific, and Medtronic; he reports consultancies from Terumo and Meril. Dr Räber reports research grants to his institution from Abbott-Vascular, Boston-Scientific, Biotronik, Heartflow, and Sanofi, Regeneron. He reports speaker/consultation fees from Abbott-Vascular, Amgen, AstraZeneca, CSL-Behring, Canon, Occlutech, Sanofi, and Vifor. Dr Valgimigli has received grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott-Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia-Pharmaceuticals-Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers-Squibb-SA, iVascular, and Medscape. The other authors report no conflicts.
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- 2024
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40. Higher 1-year mortality on rest days in patients with acute coronary syndromes and decompensated heart failure-A SPUM-ACS sub-study.
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Matter MA, Candreva A, Stähli BE, Heg D, Klingenberg R, Räber L, Windecker S, Rodondi N, Nanchen D, Mach F, Gencer B, Ruschitzka F, Matter CM, and Templin C
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- Humans, Prospective Studies, Treatment Outcome, Proportional Hazards Models, Acute Coronary Syndrome diagnostic imaging, Acute Coronary Syndrome therapy, Heart Failure diagnosis, Heart Failure therapy
- Abstract
Background: Acute coronary syndromes (ACS) occurring on rest days have been associated with higher mortality, but the current literature remains inconsistent in this regard. This study included ACS patients presenting with acute decompensated heart failure (ADHF) investigating the relationship between time of coronary catheterization and outcomes., Methods: Analyses were performed from the prospective, multicentric Special Program University Medicine Acute Coronary Syndromes and Inflammation (SPUM-ACS) Cohort. Patients were divided into two groups according to time of coronary catheterization on either workdays (Monday, 00:00 to Friday, 23:59) or rest days (Saturday, 00:00 to Sunday, 23:59 and public holidays). ADHF was defined by Killip Class III or IV upon presentation. Patients were followed over 1 year., Results: Out of 4787 ACS patients enrolled in the SPUM-ACS Cohort, 207 (4.3%) presented with ADHF. 52 (25.1%) and 155 (74.9%) patients underwent coronary angiography on rest days or workdays, respectively. Baseline characteristics were similar among these groups. ACS patients with ADHF showed increased 1-year mortality on rest days (34.6% vs. 17.4%, p-value = 0.009). After correction for baseline characteristics, including the GRACE 2.0 Score, rest day presentation remained a significant predictor for 1-year mortality (adjusted hazard ratio = 2.42 [95% confidence interval: 1.14-5.17], p-value = 0.022)., Conclusions: One-year all-cause mortality was high in ACS patients with ADHF and doubled for patients admitted on rest days. The present data support the association of a rest day effect and long-term patient survival and indicate a need for further investigations., (© 2023 Wiley Periodicals LLC.)
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- 2024
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41. What neuro-otology specialists need for better care of dizzy patients: a national survey.
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Mantokoudis G, Zwergal A, Heg D, Kerkeni H, Diener S, Kalla R, Korda A, Candreia C, Welge-Lüssen A, and Tarnutzer AA
- Abstract
Background: A substantial fraction of dizzy patients are assessed by neurologists and ear-nose-throat (ENT) physicians. With the differential diagnosis being broad and often different specialties involved, we aimed to assess the interaction with generalists from the specialists' perspective to identify limitations and needs and to define strategies for improvement in patient care and education by the specialist., Methods: One hundred eleven board-certified neurologists ( n = 62) and ENT physicians ( n = 49) working in Switzerland participated in an online survey. Here, we focused on limitations faced in the diagnostic workup and treatment of the dizzy patient and potential strategies to improve the standard of care and the interaction between generalists and specialists. Descriptive statistical analyses were performed. We hypothesized that those specialists applying modern concepts in history-taking and bedside examination techniques reach a specific diagnosis more often and request fewer referrals., Results: Specialists indicated higher confidence in reaching a specific diagnosis for patients presenting with acute dizziness than episodic/chronic dizziness (80% vs. 60%) at the first consultation. Knowledge of the timing-and-trigger concept [odds ratio (OR) = 0.81 (0.67-0.98), p = 0.034], as well as of subtle oculomotor/vestibular signs [OR = 0.80 (0.68-0.94), p = 0.007] was predictive of the self-reported probability of reaching a specific diagnosis in patients with episodic/chronic dizziness, while no such differences were observed in the care of acutely dizzy patients. Further referrals of acutely dizzy patients were significantly higher in neurologists than in ENT physicians (17% vs. 10%, p < 0.001) and in specialists located in the Latin part of Switzerland [OR = 2.84 (1.63-4.93), p < 0.001], while this was not the case for patients with episodic/chronic dizziness. Identified unmet needs included regular communication between physicians (27%/53%; always/often true) and sufficiently detailed information on the previous workup from the referrals (27%/53%). Specialists expressed most interest in hands-on courses/workshops, webinars, and practical guidelines for education., Conclusion: In our survey, bedside state-of-the-art assessments were key in reducing the fraction of unclear dizzy cases. Several gaps were identified that should be addressed. Specifically, referring physicians should provide more comprehensive details regarding urgency, prior diagnostics, and treatment. Specifically, when promoting the knowledge of neurologists and ENT physicians, this should be preferentially done by offering a combination of hands-on courses and webinars., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Mantokoudis, Zwergal, Heg, Kerkeni, Diener, Kalla, Korda, Candreia, Welge-Lüssen and Tarnutzer.)
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- 2024
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42. Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.
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Landi A, Alasnag M, Heg D, Frigoli E, Malik FTN, Gomez-Blazquez I, Pourbaix S, Chieffo A, Spaulding C, Sainz F, Routledge H, Andò G, Testa L, Sciahbasi A, Contractor H, Jepson N, Mieres J, Imran SS, Noor H, Smits PC, and Valgimigli M
- Subjects
- Male, Humans, Female, Aged, Platelet Aggregation Inhibitors therapeutic use, Hemorrhage chemically induced, Hemorrhage epidemiology, Ischemia chemically induced, Percutaneous Coronary Intervention methods, Drug-Eluting Stents, Myocardial Infarction epidemiology, Myocardial Infarction drug therapy, Stroke epidemiology, Stroke etiology, Stroke prevention & control
- Abstract
Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI)., Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR., Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022., Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups., Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB)., Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI., Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events., Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.
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- 2024
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43. What is the current status of care by neuro-otology specialists in Switzerland-A national survey.
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Zwergal A, Mantokoudis G, Heg D, Kerkeni H, Diener S, Kalla R, Korda A, Candreia C, Welge-Lüssen A, and Tarnutzer AA
- Abstract
Background: Vertigo and dizziness are frequent presenting symptoms in the emergency department and in outpatient centers. While the majority of dizzy patients are evaluated by primary care physicians, specialists are often involved in the diagnostic workup. We aimed to gain more insights into the role of specialists in the care of dizzy patients., Materials and Methods: Board-certified neurologists and ear-nose-throat (ENT) physicians working in Switzerland were invited to participate in an online survey. Descriptive statistical analyses were performed, and prospectively defined hypotheses were assessed using correlation analyses., Results: All 111 participating specialists (neurologists = 62; ENT specialists = 49) were familiar with testing for posterior canal benign paroxysmal positional vertigo (BPPV), and 66% regularly applied provocation maneuvers for suspected lateral canal BPPV. Reposition maneuvers for posterior (99%) and lateral (68%) canals were frequently performed. ENT physicians were familiar with lateral canal BPPV repositioning maneuvers significantly more often than neurologists (84 vs. 56%, p ≤ 0.012). Specialists strongly agreed that performing the head impulse test (86%) and looking for deficient eccentric gaze holding (82%) are important. Compared to neurologists, significantly fewer ENT physicians indicated ordering brain MRI in acutely dizzy patients (OR = 0.33 [0.16-0.067], p = 0.002) and physical therapy in patients with acute (50 vs. 20%, p = 0.005) or episodic/chronic dizziness (78 vs. 50%, p = 0.003)., Conclusion: We found substantial differences in the care of dizzy patients by neurologists and ENT physicians. This underlines the need for a standardized, guideline-oriented diagnostic workup and treatment across specialties. Dedicated training for performing lateral canal BPPV repositioning maneuvers should be prioritized for neurologists. Similarly, physical therapy should be considered more often by ENT physicians., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2023 Zwergal, Mantokoudis, Heg, Kerkeni, Diener, Kalla, Korda, Candreia, Welge-Lüssen and Tarnutzer.)
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- 2023
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44. Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial.
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Iglesias JF, Roffi M, Losdat S, Muller O, Degrauwe S, Kurz DJ, Haegeli L, Weilenmann D, Kaiser C, Tapponnier M, Cook S, Cuculi F, Heg D, Windecker S, and Pilgrim T
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- Humans, Sirolimus therapeutic use, Everolimus therapeutic use, Follow-Up Studies, Polymers, Bayes Theorem, Single-Blind Method, Prospective Studies, Treatment Outcome, Absorbable Implants, ST Elevation Myocardial Infarction surgery, ST Elevation Myocardial Infarction drug therapy, Drug-Eluting Stents, Myocardial Infarction etiology, Percutaneous Coronary Intervention methods
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Background: Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain., Methods: BIOSTEMI Extended Survival (BIOSTEMI ES) was an investigator-initiated, follow-up extension study of the BIOSTEMI prospective, multicentre, single-blind, randomised superiority trial that compared biodegradable polymer sirolimus-eluting stents with durable polymer everolimus-eluting stents in patients with STEMI undergoing primary percutaneous coronary intervention at ten hospitals in Switzerland. All individuals who had provided written informed consent for participation in the BIOSTEMI trial were eligible for this follow-up study. The primary endpoint was target lesion failure, defined as a composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target lesion revascularisation, at 5 years. Superiority of biodegradable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents was declared if the Bayesian posterior probability for a rate ratio (RR) of less than 1 was greater than 0·975. Analyses were performed according to the intention-to-treat principle. The study was registered with ClinicalTrials.gov, NCT05484310., Findings: Between April 26, 2016, and March 9, 2018, 1300 patients with STEMI (1622 lesions) were randomly allocated in a 1:1 ratio to treatment with biodegradable polymer sirolimus-eluting stents (649 patients, 816 lesions) or durable polymer everolimus-eluting stents (651 patients, 806 lesions). At 5 years, the primary composite endpoint of target lesion failure occurred in 50 (8%) patients treated with biodegradable polymer sirolimus-eluting stents and in 72 (11%) patients treated with durable polymer everolimus-eluting stents (difference of -3%; RR 0·70, 95% Bayesian credible interval 0·51-0·95; Bayesian posterior probability for superiority 0·988)., Interpretation: In patients undergoing primary percutaneous coronary intervention for STEMI, biodegradable polymer sirolimus-eluting stents were superior to durable polymer everolimus-eluting stents with respect to target lesion failure at 5 years of follow-up. The difference was driven by a numerically lower risk for ischaemia-driven target lesion revascularisation., Funding: Biotronik., Competing Interests: Declaration of interests JFI reports a research grant to their institution, speaker fees, and support for attending meetings from Biotronik; research grants to their institution from Abbott Vascular, Astra Zeneca, Biosensors, Concept Medical, Philips, and Terumo Corporation, outside the submitted work; and speaker fees from AstraZeneca, Biosensors, Biotronik, Bristol Myers Squibb, Cordis, Concept Medical, Medalliance, Medtronic, Novartis, Terumo Corporation, Pfizer, and Philips, outside the submitted work. MR reports research grants to the institution from Biotronik, Boston Scientific, Cordis, Medtronic, and Terumo Corporation, outside the submitted work. SL and DH are employed by the CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organisations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. An up-to-date list of CTU Bern's conflicts of interest can be found online. OM reports a research grant to their institution, and speaker and personal fees from Edwards Lifesciences, outside the submitted work; and speaker fees from Abbott Vascular, outside the submitted work. SD reports research grants to their institution from Abbott Vascular and Biotronik, outside the submitted work; and speaker fees from Biotronik, Medalliance, and Medtronic, outside the submitted work. LH reports research grants to their institution from Abbott Vascular, Abiomed, Amarin, Amgen, AstraZeneca, Bayer, Biosense Webster, Biotronik, Boston Scientific, Bracco, Bristol Myers Squibb, B-Braun, Daiichi-Sankyo, Edwards Lifesciences, GE HealthCare, Medtronic, Microport, Novartis, Pfizer, Vascular Medical, and Zoll, outside the submitted work; speaker fees from Medtronic, outside the submitted work; and support for attending meetings from Daiichi-Sankyo and Biotronik. CK reports consulting fees to the institution from Unimedtec Switzerland; and support for attending meetings from Medtronic, outside the submitted work. SW reports research, travel, or educational grants to their institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bbraun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo Corporation, Vifor, and V-Wave; and served as an advisory board member or member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo Corporation, and V-Wave, with payments to the institution but no personal payments. He is also a member of the steering or executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. TP reports a research grant to their institution from Biotronik; research, travel, or educational grants to their institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens, outside the submitted work; and speaker fees and consultancy fees to their institution from Abbott Vascular, Biotronik, Biosensors, Boston Scientific, Edwards Lifesciences, Highlife, and Medtronic, outside the submitted work. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
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45. Long-term outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve replacement.
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Tomii D, Okuno T, Heg D, Nakase M, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, and Pilgrim T
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- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prospective Studies, Prosthesis Design, Treatment Outcome, Obesity, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis adverse effects, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery
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Background: Both measured and predicted effective orifice area (EOA) indexed to the body surface area (EOAi) have been suggested to define prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve replacement (TAVR). The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used., Aims: We aimed to investigate the long-term clinical impact of PPM in patients undergoing TAVR., Methods: Patients in a prospective TAVR registry were stratified by the presence of moderate (0.65-0.85 or 0.55-0.70 cm
2 /m2 if obese) or severe (≤0.65 or ≤0.55 cm2 /m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM), predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV ), or predicted EOAi based on EOA reference values derived from computed tomography measurements of aortic annulus dimensions (predicted PPMCT )., Results: In an analysis of 2,463 patients, the frequency of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the frequency of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median follow-up of 429 days, 10-year mortality was comparable in patients with versus without measured PPM or predicted PPMCT . In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (adjusted hazard ratio: 0.73, 95% confidence interval: 0.55-0.96)., Conclusions: The use of predicted versus measured EOAi results in a lower estimate of PPM severity. We observed no increased risk of death in patients with PPM over a median follow-up time of 429 days., Clinicaltrials: gov: NCT01368250.- Published
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46. Coronary calcification in patients presenting with acute coronary syndromes: insights from the MATRIX trial.
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Sanz-Sanchez J, Garcia-Garcia HM, Branca M, Frigoli E, Leonardi S, Gagnor A, Calabrò P, Garducci S, Rubartelli P, Briguori C, Andò G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabaté M, Heg D, Vranckx P, and Valgimigli M
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- Humans, Coronary Artery Bypass, Myocardial Infarction complications, Percutaneous Coronary Intervention methods, Randomized Controlled Trials as Topic, Risk Factors, Stroke etiology, Treatment Outcome, Acute Coronary Syndrome complications, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome epidemiology, Coronary Artery Disease complications, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery
- Abstract
Aims: The role of coronary calcification on clinical outcomes among different revascularization strategies in patients presenting with acute coronary syndromes (ACSs) has been rarely investigated. The aim of this investigation is to evaluate the role of coronary calcification, detected by coronary angiography, in the whole spectrum of patients presenting with acute ACS., Methods and Results: The present study was a post hoc analysis of the MATRIX programme. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of all-cause mortality, myocardial infarction (MI), or stroke up to 365 days. Among the 8404 patients randomized in the MATRIX trial, data about coronary calcification were available in 7446 (88.6%) and therefore were included in this post hoc analysis. Overall, 875 patients (11.7%) presented with severe coronary calcification, while 6571 patients (88.3%) did not present severe coronary calcification on coronary angiography. Fewer patients with severe coronary calcification underwent percutaneous coronary intervention whereas coronary artery bypass grafting or medical therapy-only was more frequent compared with patients without severe calcification. At 1-year follow-up, MACE occurred in 237 (27.1%) patients with severe calcified coronary lesions and 985 (15%) patients without severe coronary calcified lesions [hazard ratio (HR) 1.91; 95% confidence interval (CI) 1.66-2.20, P < 0.001]. All-cause mortality was 8.6% in patients presenting with and 3.7% in those without severe coronary calcification (HR 2.38, 1.84-3.09, P < 0.001). Patients with severe coronary calcification incurred higher rate of MI (20.1% vs. 11.5%, HR 1.81; 95% CI 1.53-2.1, P < 0.001) and similar rate of stroke (0.8% vs. 0.6%, HR 1.35; 95% CI 0.61-3.02, P = 0.46)., Conclusion: Patients with ACS and severe coronary calcification, as compared to those without, are associated with worse clinical outcomes irrespective of the management strategy., Competing Interests: Conflict of interest: J.S.S. has received minor speaking honoraria from Terumo, Cordis, Biotronik, and Medtronic. H.M.G.-G. reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips, and Corflow. G.A. reports minor speaking honoraria from Chiesi, Daiichi Sankyo, Boeringer Ingelheim, Bayer, Pfizer, and Biosensors. D.H. has participated on data safety monitoring board or advisory board of switch. S.L. has received consulting fees from AstraZeneca, Bayer, BMS/Pfizer, Chiesi, Daiichi-Sankyo, Icon, and Novonordisk. M.S. has received consulting fees from Abbott Vascular and iVascular. A.v.H. reports unrestricted grants from Medtronic, Abbott Vascular, and Boehringer Ingelheim and consulting fees from Celecor Therapeutics. P.V. reports consulting fees from Daiichi Sankyo, CSL Behring, Pfizer/Bristol Meyers Squibb alliance, Bayer AG, and Novartis; minor speaking honoraria from Daicchi Sankyo and Pfizer/Bristol Meyers Squibb alliance. M.V. reports consulting fees from Abbott, Alvimedica, Bayer Healthcare, Biotronik, Boston Scientific Corporation, Chiesi Farmaceutici, CoreFlow, Daiichi Sankyo, Idorsia, Medtronic, Novartis Pharma, PHASEBIO, Terumo, University of Basel, Vesalio, and Vifor Pharma. The rest of authors have no disclosures to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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47. Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI.
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Piccolo R, Calabrò P, Varricchio A, Baldi C, Napolitano G, De Simone C, Mauro C, Stabile E, Caiazzo G, Tesorio T, Boccalatte M, Tuccillo B, Bottiglieri G, Russolillo E, Di Lorenzo E, Carrara G, Cassese S, Leonardi S, Biscaglia S, Costa F, McFadden E, Heg D, Franzone A, Stefanini GG, Capodanno D, and Esposito G
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- Humans, Platelet Aggregation Inhibitors therapeutic use, Polymers, Hemorrhage chemically induced, Treatment Outcome, Drug Therapy, Combination, Drug-Eluting Stents adverse effects, Percutaneous Coronary Intervention methods, Myocardial Infarction etiology
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Background: Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials., Design: The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI., Summary: The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI., Competing Interests: Disclosures Dr Piccolo reports personal fees from Abbott Vascular, Biotronik, Terumo, Amgen, Boehringer Ingelheim, and Daiichi-Sankyo, outside the submitted work. Dr Esposito reports personal fees from Abbott Vascular, Amgen, Boehringer Ingelheim, Edwards Lifesciences, Terumo, and Sanofi, outside the submitted work and research grants to the institution from Alvimedica, Boston Scientific, and Medtronic, outside the submitted work., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
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48. Impact of right ventricular-pulmonary arterial coupling on clinical outcomes in patients undergoing transcatheter aortic valve implantation.
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Alwan L, Tomii D, Heg D, Okuno T, Lanz J, Praz F, Chong-Nguyen C, Stortecky S, Reineke D, Windecker S, and Pilgrim T
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- Humans, Pulmonary Artery diagnostic imaging, Prospective Studies, Ventricular Function, Right, Transcatheter Aortic Valve Replacement adverse effects, Hypertension, Pulmonary diagnostic imaging, Aortic Valve Stenosis complications, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery
- Abstract
Aims: The interplay between pulmonary hypertension (PH) and right ventricular (RV) function is reflected in an index of RV function to pulmonary artery (PA) systolic pressure (PASP). The present study aimed to assess the importance of RV-PA coupling on clinical outcomes after transcatheter aortic valve implantation (TAVI)., Methods and Results: In a prospective TAVI registry, clinical outcomes of TAVI patients with RV dysfunction or PH were stratified according to coupling or uncoupling of tricuspid annular plane systolic excursion (TAPSE) to PASP, and compared to those of patients with normal RV function and absence of PH. The median TAPSE/PASP ratio was used to differentiate uncoupling (>0.39) from coupling (<0.39). Among 404 TAVI patients, 201 patients (49.8 %) had RVD or PH at baseline: 174 patients had RV-PA uncoupling, and 27 had coupling at baseline. RV-PA hemodynamics normalized in 55.6 % of patients with RV-PA coupling and in 28.2 % of patients with RV-PA uncoupling, and deteriorated in 33.3 % of patients with RV-PA coupling and in 17.8 % of patients with no RVD, respectively, at discharge. Patients with RV-PA uncoupling after TAVI showed a trend towards an increased risk of cardiovascular death at 1 year as compared to patients with normal RV-function (HR
adjusted 2.06, 95 % CI 0.97-4.37)., Conclusion: After TAVI, RV-PA coupling changed in a significant proportion of patients and is a potentially important metric for risk stratification of TAVI patients with RVD or PH. TWEET: "Patients with right ventricular dysfunction and pulmonary hypertension are at increased risk of death after TAVI. Integrated right ventricular to pulmonary artery hemodynamics change after TAVI in a significant proportion of patients and is instrumental to refine risk stratification.", Clinical Trial Registration: https://www., Clinicaltrials: gov: NCT01368250., Competing Interests: Declaration of competing interest Dr. Windecker reports research, travel or educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. Dr. Windecker serves as unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr. Pilgrim reports research grants to the institution from Edwards Lifesciences, Boston Scientifc and Biotronik, personal fees from Biotronik, Boston Scientific, Metronic, Abbott, and HighLife SAS. Dr. Reineke reports travel expenses from Abbott, Edwards Lifesciences and Medtronic. Dr. Stortecky reports research grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientific and Abbott and personal fees from Boston Scientific, Teleflex, and BTG. Dr. Praz reports travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr. Okuno reports speaker fees from Abbott. All other authors have no relationships relevant to the contents of this article to disclose., (Copyright © 2023. Published by Elsevier Inc.)- Published
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49. Concomitant Coronary Atheroma Regression and Stabilization in Response to Lipid-Lowering Therapy.
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Biccirè FG, Häner J, Losdat S, Ueki Y, Shibutani H, Otsuka T, Kakizaki R, Hofbauer TM, van Geuns RJ, Stortecky S, Siontis GCM, Bär S, Lønborg J, Heg D, Kaiser C, Spirk D, Daemen J, Iglesias JF, Windecker S, Engstrøm T, Lang I, Koskinas KC, and Räber L
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- Humans, Proprotein Convertase 9, Lipids, Treatment Outcome, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease drug therapy, Plaque, Atherosclerotic diagnostic imaging, Plaque, Atherosclerotic drug therapy, Myocardial Infarction drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
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Background: The frequency, characteristics, and outcomes of patients treated with high-intensity lipid-lowering therapy and showing concomitant atheroma volume reduction, lipid content reduction, and increase in fibrous cap thickness (ie, triple regression) are unknown., Objectives: This study was designed to investigate rates, determinants, and prognostic implications of triple regression in patients presenting with acute myocardial infarction and treated with high-intensity lipid-lowering therapy., Methods: The PACMAN-AMI (Effects of the PCSK9 Antibody Alirocumab on Coronary Atherosclerosis in Patients with Acute Myocardial Infarction) trial used serial intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography to compare the effects of alirocumab vs placebo in patients receiving high-intensity statin therapy. Triple regression was defined by the combined presence of percentage of atheroma volume reduction, maximum lipid core burden index within 4 mm reduction, and minimal fibrous cap thickness increase. Clinical outcomes at 1-year follow-up were assessed., Results: Overall, 84 patients (31.7%) showed triple regression (40.8% in the alirocumab group vs 23.0% in the placebo group; P = 0.002). On-treatment low-density lipoprotein cholesterol levels were lower in patients with vs without triple regression (between-group difference: -27.1 mg/dL; 95% CI: -37.7 to -16.6 mg/dL; P < 0.001). Triple regression was independently predicted by alirocumab treatment (OR: 2.83; 95% CI: 1.57-5.16; P = 0.001) and a higher baseline maximum lipid core burden index within 4 mm (OR: 1.03; 95% CI: 1.01-1.06; P = 0.013). The composite clinical endpoint of death, myocardial infarction, and ischemia-driven revascularization occurred less frequently in patients with vs without triple regression (8.3% vs 18.2%; P = 0.04)., Conclusions: Triple regression occurred in one-third of patients with acute myocardial infarction who were receiving high-intensity lipid-lowering therapy and was associated with alirocumab treatment, higher baseline lipid content, and reduced cardiovascular events. (Vascular Effects of Alirocumab in Acute MI-Patients [PACMAN-AMI]; NCT03067844)., Competing Interests: Funding Support and Author Disclosures This study was conducted in an independent academic setting and funded by Bern University Hospital. Dr Ueki has received personal fees and nonfinancial support from NIPRO; and has received personal fees from Amgen, Daiichi-Sankyo, Abbott Vascular, Kowa, and Novartis, outside the submitted work. Dr Kakizaki has received speaker fees from Abbott Medical Japan, Philips Japan, Mochida Pharmaceutical Japan, Novartis Japan, Kowa Japan, Takeda Pharmaceuticals Japan, Ono Pharmaceutical Japan, Boehringer Ingelheim Japan, Daiichi-Sankyo Japan, Mitsubishi Tanabe Pharma Japan, and Eli Lilly Japan, outside the submitted work. Dr Hofbauer has received speaker fees from Sanofi. Dr Stortecky has received research grants paid to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular, and Boston Scientific; and has received speaker fees from Boston Scientific. Dr Bär has received research grants paid to the institution from Medis Medical Imaging, Abbott, and Bangerter-Rhyner Stiftung, outside the submitted work; and has received a personal research grant from the Swiss National Science Foundation, outside the submitted work. Dr Spirk has received personal fees from Sanofi (Suisse), outside the submitted work. Dr Räber has received grants from Sanofi, Regeneron, and Infraredx paid to Inselspital; has received speaker fees from Sanofi during the conduct of the study; has received grants from Abbott, Heartflow, Boston Scientific, and Biotronik paid to Inselspital; and has received grants from Abbott, Amgen, AstraZeneca, Occlutech, Sanofi, Canon, and Medtronic for speaker and consultation fees outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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50. Effects of SARS-COV-2 infection on outcomes in patients hospitalized for acute cardiac conditions. A prospective, multicenter cohort study (Swiss Cardiovascular SARS-CoV-2 Consortium).
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Koskinas KC, Twerenbold R, Carballo D, Matter CM, Cook S, Heg D, Frenk A, Windecker S, Osswald S, Lüscher TF, and Mach F
- Abstract
Background: Although the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) causing coronavirus disease 2019 (COVID-19) primarily affects the respiratory system, the disease entity has been associated with cardiovascular complications. This study sought to assess the effect of concomitant SARS-COV-2 infection on clinical outcomes of patients hospitalized primarily for acute cardiac conditions on cardiology wards in Switzerland., Methods: In this prospective, observational study conducted in 5 Swiss cardiology centers during the COVID-19 pandemic, patients hospitalized due to acute cardiac conditions underwent a reverse-transcriptase polymerase chain reaction test at the time of admission and were categorized as SARS-COV-2 positive (cases) or negative (controls). Patients hospitalized on cardiology wards underwent treatment for the principal acute cardiac condition according to local practice. Clinical outcomes were recorded in-hospital, at 30 days, and after 1 year and compared between cases and controls. To adjust for imbalanced baseline characteristics, a subgroup of patients derived by propensity matching was analyzed., Results: Between March 2020 and February 2022, 538 patients were enrolled including 122 cases and 416 controls. Mean age was 68.0 ± 14.7 years, and 75% were men. Compared with controls, SARS-COV-2-positive patients more commonly presented with acute heart failure (35% vs. 17%) or major arrhythmia (31% vs. 9%), but less commonly with acute coronary syndrome (26% vs. 53%) or severe aortic stenosis (4% vs. 18%). Mortality was significantly higher in cases vs. controls in-hospital (16% vs. 1%), at 30 days (19.0% vs. 2.2%), and at 1 year (28.7% vs. 7.6%: p < 0.001 for all); this was driven primarily (up to 30 days) and exclusively (at one-year follow-up) by higher non-cardiovascular mortality, and was accompanied by a greater incidence of worsening renal function in cases vs. controls. These findings were maintained in a propensity-matched subgroup of 186 patients (93 cases and 93 controls) with balanced clinical presentation and baseline characteristics., Conclusions: In this observational study of patients hospitalized for acute cardiac conditions, SARS-COV-2 infection at index hospitalization was associated with markedly higher all-cause and non-cardiovascular mortality throughout one-year follow-up. These findings highlight the need for effective, multifaceted management of both cardiac and non-cardiac morbidities and prolonged surveillance in patients with acute cardiac conditions complicated by SARS-COV-2 infection., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Koskinas, Twerenbold, Carballo, Matter, Cook, Heg, Frenk, Windecker, Osswald, Lüscher and Mach.)
- Published
- 2023
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