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Background Extracorporeal cardiopulmonary resuscitation (ECPR) is a potential salvage therapy for selected patients with refractory out-of-hospital cardiac arrest (OHCA). Purpose The objective of this study was to describe the characteristics of potential ECPR patients. Methods This retrospective, observational cohort study included 579 patients admitted with refractory OHCA for possible ECPR at all tertiary cardiac arrest centers in Denmark between 2015 and 2020. Presenting characteristics, reasons for refraining from ECPR, and survival to hospital discharge were recorded. Results After initial evaluation, 221 patients (38%) proceeded to ECPR, and 358 (62%) were considered futile. Median prehospital low-flow time was 70 minutes [interquartile range 56–85] in ECPR patients and 62 minutes [48–81] in no-ECPR patients, p Conclusions In this large nationwide study of patients admitted for possible ECPR, 62% were not treated with ECPR. The most frequent reasons to abstain from ECPR were duration of prehospital low flow time, metabolic derangement, and low ETCO2. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The Danish Heart Foundation

Background In refractory out-of-hospital cardiac arrest (OHCA) with prolonged whole-body ischemia, global tissue injury proceeds even after establishment of circulation with extracorporeal cardiopulmonary resuscitation (ECPR). Purpose We aimed to investigate the role of biomarkers reflecting hypoperfusion, inflammation, and organ injury in prognostication of patients with refractory OHCA managed with ECPR. Methods This nationwide retrospective study included 226 adults with refractory OHCA managed with ECPR in Denmark (2011–2020). Biomarkers at admission and consecutively two days after ECPR initiation were retrieved. Odds ratio (OR) of 90-day survival were assessed by logistic regression analyses. Cut-off values were calculated from area under the curve (AUC) via the Youden index. Results Fifty-six patients (25%) survived to hospital discharge, all were still alive after 90-days and 91% had a favorable neurological status at discharge. Factors independently associated with 90-day survival were: male sex, shockable presenting rhythm, low flow time, platelets, pH, lactate, C-reactive protein, lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and creatine kinase MB (CK-MB) level. Comparing the ability of standard predictive variables (age, sex, shockable presenting rhythm, witnessed arrest, and low flow time) and selected biomarkers (from multivariate analyses) in predicting 90-day survival, biomarkers day 2 after OHCA were significantly better than standard variables (AUC 0.79 vs. 0.56, p=0.01). Conclusion Biomarkers of hypoperfusion (low lactate and high pH), inflammation (high platelets and CRP), and organ failure (low LDH, ALP, and CK-MB) were independently associated with 90-day survival. Biomarkers on day 2 after OHCA (d-dimer, ALP, and CK-MB) were more predictive of 90-day survival than standard predictive variables. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Odense University Hospital's and Rigshospitalet's Common Research Foundation

The side branch (SB) compromise after main vessel (MV) stenting remains a significant problem in coronary bifurcation treatment. Currently the two major hypotheses for the mechanism of SB compromise are carina shift from MV into the SB and plaque shift into the ostium of side vessel. It is proposed herein, SB ostial deformation leading to reshaping of the ostium from circle to ellipse is a third possible mechanism. In the current study, the theoretical effects and correlation of ostial deformation with fractional flow reserve (FFR) is explored.Based on angiographic measurements and theoretical analysis formulas, three different SB ostial areas using circular ostial shape assumption and elliptical ostial shape assumption were calculated. Three different types of ostial areas with FFR values after MV stenting in 49 patients from the FIESTA registry were compared and analyzed.It was found that there is significant overestimation of stenosis severity when estimated by the circle formula, than with the ellipse formula - ASc vs. ASds with 25% ± 13%, p0.001, ASc vs. ASmld with 9% ± 10%, p0.001. The elliptical shape assumptions provide more accurate ostial area stenosis, which correlates better with FFR. This finding is more significant in less severe stenosis (70% area stenosis) than in a more severe one.A third possible mechanism of SB compromise after MV stenting of coronary bifurcation stenosis is elliptical ostial deformation at the ostium of SBs. The ostial area, calculated based on elliptical assumption correlates better with FFR, than area stenosis calculated with the traditional circular formula.

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL. Visual summary. 15th consensus document from the European Bifurcation Club.

OBJECTIVES: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).BACKGROUND: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.METHODS: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.RESULTS: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).CONCLUSIONS: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).

Objectives: The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES). Background: Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation. Methods: This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%. Results: A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001). Conclusions: At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent—SORT-OUT VIII; NCT02093845)

Background: Morphine adversely impacts the action of oral adenosine diphosphate (ADP)-receptor blockers in ST-segment elevation myocardial infarction (STEMI) patients, and is possibly associated with differing patient characteristics. This retrospective analysis investigated whether interaction between morphine use and pre-percutaneous coronary intervention (pre-PCI) ST-segment elevation resolution in STEMI patients in the ATLANTIC study was associated with differences in patient characteristics and management. Methods: ATLANTIC was an international, multicenter, randomized study of treatment in the acute ambulance/hospital setting where STEMI patients received ticagrelor 180 mg ± morphine. Patient characteristics, cardiovascular history, risk factors, management, and outcomes were recorded. Results: Opioids (97.6% morphine) were used in 921 out of 1862 patients (49.5%). There were no significant differences in age, sex or cardiovascular history, but more morphine-treated patients had anterior myocardial infarction and left-main disease. Time from chest pain to electrocardiogram and ticagrelor loading was shorter with morphine (both p = 0.01) but not total ischemic time. Morphine-treated patients more frequently received glycoprotein IIb/IIIa inhibitors (p = 0.002), thromboaspiration and stent implantation (both p < 0.001). No significant difference between the two groups was found regarding pre-PCI ≥ 70% ST-segment elevation resolution, death, myocardial infarction, stroke, urgent revascularization and definitive acute stent thrombosis. More morphine-treated patients had an absence of pre-PCI Thrombolysis in Myocardial Infarction (TIMI) 3 flow (85.8% vs. 79.7%; p = 0.001) and more had TIMI major bleeding (1.1% vs. 0.1%; p = 0.02). Conclusions: Morphine-treatment was associated with increased GP IIb/IIIa inhibitor use, less pre-PCI TIMI 3 flow, and more bleeding. Judicious morphine use is advised with non-opioid analgesics preferred for non-severe acute pain. Trial Registration: clinicaltrials.gov identifier: NCT01347580.

AIMS: To determine whether patients treated with drug-eluting stents in the proximal left anterior descending artery (LAD) carried a different long-term prognosis than patients treated in other coronary artery segments.METHODS AND RESULTS: 10-year clinical outcome expressed as all-cause mortality and major adverse cardiac events (MACE: cardiac death, acute myocardial infarction, or target vessel revascularization) was determined for 1,479 patients with a single non-left main coronary stenosis treated with a first-generation drug-eluting stent in the SORT OUT II trial. The outcome of patients treated with stents in the proximal LAD (n=365) was compared with that of patients treated in a non-proximal LAD segment (n=1,114). Follow-up was 99.3% complete. All-cause mortality was 24.9% in the proximal LAD group vs. 26.3% in the non-proximal LAD group (p=0.60). MACE occurred less frequently in the proximal LAD group 24.6% vs. 31.0% with hazard ratio 0.77 (95% confidence interval: 0.61-0.97, p=0.024). After multivariate analysis that included baseline characteristics that were unevenly distributed between the groups, the hazard ratio for MACE was 0.82 (95% confidence interval: 0.65-1.03, p=0.09).CONCLUSIONS: Patients treated with a drug-eluting stent in the proximal LAD have similar, if not better, long-term clinical outcome compared with patients stented in other coronary artery segments.

Background: ATLANTIC was a randomized study comparing pre- and in-hospital treatment with a ticagrelor loading dose (LD) in ongoing ST-segment elevation myocardial infarction (STEMI). We sought to compare patient characteristics and clinical outcomes in France with other countries participating in ATLANTIC.Methods: The population comprised 1862 patients, 660 (35.4%) from France and 1202 from 12 other countries. The main endpoints were reperfusion (>= 70% ST-segment elevation resolution) and TIMI flow grade 3 before (co-primary endpoints) and after percutaneous coronary intervention (PCI). Other endpoints included a composite ischaemic endpoint (death/myocardial infarction/stroke/urgent revascularization/definite stent thrombosis) and bleeding events at 30 days.Results: In France, median times from first LD to angiography and between first and second LDs were 49 and 35 min, respectively, and were similar to other countries. French patients were younger (mean 58.7 vs 61.9 years, p Conclusions: The French population appears to have better outcomes than the rest of the study population, and seems related to differences in demographics and management characteristics. (C) 2017 Elsevier B.V. All rights reserved.

International audience; PRIVATE-ATLANTIC (P2Y12 Receptor Inhibition with VASP Testing using Elisa kit during the ATLANTIC study) is a pre-specified substudy of the randomised, double-blind ATLANTIC trial in patients with ST-segment elevation myocardial infarction, designed to help interpret the main trial results. The primary objective of ATLANTIC was to assess coronary reperfusion prior to percutaneous coronary intervention (PCI) with pre- vs in-hospital ticagrelor 180 mg loading dose (LD). PRIVATE-ATLANTIC assessed platelet inhibition in 37 patients by measurement of vasodilator-associated stimulated phosphoprotein (VASP) platelet reactivity index (PRI) and VerifyNow platelet reactivity units (PRU) before angiogram (T1), immediately after PCI (T2), 1 (T3), and 6 (T4) hours (h) after PCI, and before next study drug administration (T5). The median time difference between the two ticagrelor LD was 41 minutes. Platelet reactivity was unaffected at T1 when measured by VASP-PRI (89.8 vs 93.9 % for pre- and in-hospital ticagrelor, respectively; p = 0.18) or PRU (239 vs 241; p = 0.82). Numerical differences were apparent at T2 and maximal at T3. Morphine administration significantly delayed onset of platelet inhibition at T3 (VASP-PRI 78.2 vs 23.4 % without morphine; p = 0.0116) and T4 (33.1 vs 11.0 %; p = 0.0057). In conclusion, platelet inhibition in ATLANTIC was unaffected by pre-hospital ticagrelor administration at the time of initial angiogram due to the short transfer delay. The maximum difference in platelet inhibition was detected 1 h after PCI (T3). Morphine administration was associated with delayed onset of action of ticagrelor and appeared more important than timing of ticagrelor administration.TRIAL REGISTRATION:ClinicalTrials.gov NCT01347580.

BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.METHODS: Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.RESULTS: At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).CONCLUSIONS: At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877).

OBJECTIVES The aim of this landmark exploratory analysis, ATLANTIC-H(24), was to evaluate the effects of pre-hospital ticagrelor during the first 24 h after primary percutaneous coronary intervention (PCI) in the ATLANTIC (Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial infarction to open the Coronary artery) study. BACKGROUND The ATLANTIC trial in patients with ongoing ST-segment elevation myocardial infarction showed that pre-hospital ticagrelor was safe but did not improve pre-PCI coronary reperfusion compared with in-hospital ticagrelor. We hypothesized that the effect of pre-hospital ticagrelor may not have manifested until after PCI due to the rapid transfer time (31 min). METHODS The ATLANTIC-H(24) analysis included 1,629 patients who underwent PCI, evaluating platelet reactivity, Thrombolysis In Myocardial Infarction flow grade 3, ≥ 70% ST-segment elevation resolution, and clinical endpoints over the first 24 h. RESULTS Following PCI, largest between-group differences in platelet reactivity occurred at 1 to 6 h; coronary reperfusion rates numerically favored pre-hospital ticagrelor, and the degree of ST-segment elevation resolution was significantly greater in the pre-hospital group (median, 75.0% vs. 71.4%; p = 0.049). At 24 h, the composite ischemic endpoint was lower with pre-hospital ticagrelor (10.4% vs. 13.7%; p = 0.039), as were individual endpoints of definite stent thrombosis (p = 0.0078) and myocardial infarction (p = 0.031). All endpoints except death (1.1% vs. 0.2%; p = 0.048) favored pre-hospital ticagrelor, with no differences in bleeding events. CONCLUSIONS The effects of pre-hospital ticagrelor became apparent after PCI, with numerical differences in platelet reactivity and immediate post-PCI reperfusion, associated with reductions in ischemic endpoints, over the first 24 h, whereas there was a small excess of mortality. (Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial infarction to open the Coronary artery [ATLANTIC, NCT01347580]).

OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients.BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH).METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume.RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling.CONCLUSION: In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.

BACKGROUND: There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis or restenosis after DES implantation for treatment of restenosis. METHODS: From January 2002 to June 2005 all consecutive patients with restenosis

BACKGROUND: Elderly patients with ST segment elevation myocardial infarction (STEMI) constitute a particular risk group in relation to primary percutaneous coronary intervention (PPCI).OBJECTIVE: We examined the proportion of octogenarians and nonagenarians undergoing PPCI in Western Denmark, and their short- and long-term mortality rates.METHODS: From 2002 to 2009 all consecutive patients ≥ 80 years with STEMI treated with PPCI were identified in the population based Western Denmark Heart Registry. Cox regression analysis was used to compute hazard ratios, controlling for potential confounding.RESULTS: A total of 1,322 elderly (1,213 octogenarians and 109 nonagenarians), corresponding to 11.6% of the total PPCI treated STEMI population were treated with PPCI between 2002 and 2009. The annual proportion of octogenarians referred for PPCI increased from n = 52 (6.2%) in 2002 to n = 172 (11.8%) in 2009 (P < 0.01), while it remained unchanged in nonagenarians: n = 6 (0.6%) in 2002 to n = 13 (0.8%) in 2009 (P = ns). For octogenarians and nonagenarians, 30-day mortality was 17.2% versus 25.8% (log-rank P = 0.028), 1-year mortality was 27.6% versus 32.5% (log-rank P = 0.18) and 5-year mortality 53.6% versus 57.3% (log-rank P = 0.087), respectively. Adjusted 30-day hazard ratio (HR) = 1.59 (95% confidence interval = CI: 1.07-2.36), 1-year HR = 1.34 (CI: 0.95-1.90), and 5-year mortality HR = 1.39 (CI: 1.04-1.85) was higher in nonagenarians compared with octogenarians.CONCLUSION: The annual proportion of octogenarians with STEMI treated with PPCI doubled from 2002 to 2009, while the proportion of nonagenarians remained unchanged. Although nonagenarians had the highest short- and long-term mortality, we found the outcome acceptable with a 5-year survival of more than 40% in both groups.

OBJECTIVES: This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. BACKGROUND: The randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) trial evaluated the outcome after DES compared with BMS implantation in patients with STEMI undergoing primary percutaneous coronary intervention. METHODS: Patients with a high-grade stenosis/occlusion of a native coronary artery presenting with symptoms

Eur J Clin Invest 2012 ABSTRACT: Objectives: To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial. Background: Currently, only limited data allow direct comparison of clinical outcomes among patients with acute coronary syndrome treated with a second-generation drug-eluting stent (DES) eluting zotarolimus vs. a first-generation DES eluting sirolimus. Methods: Patients with acute coronary syndrome (n = 1052) were randomized to treatment with zotarolimus-eluting (n = 506) or sirolimus-eluting (n = 546) stents and followed for 18 months. The primary composite endpoint, major adverse cardiac events (MACE), was defined as a composite of cardiac death, myocardial infarction or target vessel revascularization. Results: Zotarolimus-eluting stent treatment compared to sirolimus-eluting stent treatment was associated with increased rates of MACE (8·7% vs. 5·0%; hazard ratio (HR), 1·78; 95% confidence interval (CI), 1·10-2·88; P = 0·02) and TVR (6·8% vs. 3·9%; HR, 1·77; 95% CI, 1·03-3·04; P = 0·04), while all-cause death, cardiac death, myocardial infarction and definite stent thrombosis did not differ significantly. In the same trial, stable angina pectoris patients (n = 1206) were randomized to zotarolimus-eluting (n = 614) and sirolimus-eluting (n = 592) stents with similar results. Conclusions: With and without acute coronary syndromes, patients treated with the sirolimus-eluting stent had better clinical outcomes than those treated with the zotarolimus-eluting stent.

BACKGROUND: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV trial was a randomized multicenter, single-blind, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The non-inferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9-month and 18-month follow-up. 1,390 patients were assigned to receive the everolimus-eluting stent, and 1,384 patients were assigned to receive the sirolimus-eluting stent. At 9-month follow-up, 68 [4.9%] patients treated with the everolimus-eluting stent versus 72 [5.2%] patients treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio (HR) =0.94; 95% confidence interval (CI): 0.67-1.31) (p for non-inferiority=0.01). At 18-month follow-up, this differential remained: 99 [7.2%] patients treated with the everolimus-eluting stent versus 105 [7.6%] (HR=0.94, 95% CI: 0.71-1.23). At 9-month follow-up, rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 [0.1%] patients versus 9 [0.7%] patients, (HR=0.22, 95% CI:0.05-1.02)).At 18-monthfollow-up, this difference was sustained (3 [0.2%] patients versus 12 [0.9%] patients; (HR=0.25, 95% CI:0.07-0.88). CONCLUSIONS: The everolimus-eluting stent was found to be non-inferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; NCT00552877.

OBJECTIVES: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). BACKGROUND: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. METHODS: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES. RESULTS: At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80). CONCLUSIONS: At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes. (Scandinavian Organization for Randomized Trials With Clinical Outcome IV [SORT OUT IV]; NCT00552877).

Background: In patients with ST-segment elevation myocardial infarction (STEMI), delay between contact with the health care system and initiation of reperfusion therapy (system delay) is associated with mortality, but data on the associated risk for congestive heart failure (CHF) among survivors are limited. Objective: To evaluate the association between system delay and the risk for readmissions or outpatient contacts due to CHF after primary percutaneous coronary intervention (PPCI) in patients with STEMI. Design: Historical follow-up study using population-based medical registries. Setting: Western Denmark. Patients: Patients with STEMI who were transported by emergency medical service from 1 January 1999 to 7 February 2010 and treated with PPCI within 12 hours of symptom onset and who had a system delay of 6 hours or less (n = 7952). The median duration of follow-up was 3.1 years. Measurements: Cumulative incidence of readmissions or outpatient contacts due to CHF was determined by using competing-risk regression analysis, with death as the competing risk. Crude and adjusted cause-specific hazard ratios for readmissions or outpatient contacts due to CHF were determined for system delay and other covariates. Results: System delays of 60 minutes or less (n = 451), 61 to 120 minutes (n = 3457), 121 to 180 minutes (n = 2655), and 181 to 360 minutes (n = 1389) corresponded with long-term risks for readmissions or outpatient contacts due to CHF of 10.1%, 10.6%, 12.3%, and 14.1%, respectively (P

Patients with ST-elevation myocardial infarction (STEMI) are treated with primary percutaneous coronary intervention (pPCI) or fibrinolysis. pPCI is superior to fibrinolysis when initiated timely. However, geography and weather sometimes become obstacles for transporting the patient to a PCI centre. In this case story teamwork between hospital instances and the military enabled transport to a PCI centre for a PCI intervention even though the weather conditions were unfavourable.

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD).

Udgivelsesdato: 2010-Aug-17 OBJECTIVES: The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The evidence of long-term efficacy and safety after implantation of DES in patients with complex lesions is scarce. METHODS: We randomly assigned 626 patients with STEMI referred within 12 h to have a DES or a BMS implanted in the infarct-related lesion with or without distal protection during primary percutaneous coronary intervention. RESULTS: At 3 years, target lesion revascularization was 6.1% in the DES group compared with 16.3% in the BMS group (p

Udgivelsesdato: 2010-Mar-2 OBJECTIVES: The purpose of this study was to evaluate the long-term effects of distal protection during percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The use of distal filter protection during primary PCI increases procedure complexity and may influence lesion treatment and stent implantation. METHODS: The STEMI patients were assigned to distal protection (DP) (n = 312) or conventional treatment (CT) (n = 314). Clinical follow-up was performed after 1, 6, and 15 months, and angiographic follow-up after 8 months. All target lesion revascularizations (TLRs) were clinically driven. We report the pre-specified end points of stent thrombosis according to the criteria of the Academic Research Consortium, TLR, and reinfarction after 15 months. RESULTS: The total number of stent thrombosis was 11 in the DP group and 4 in the CT group (p = 0.06). The rate of definite stent thrombosis was significantly increased in the DP group as compared with the CT group, with 9 cases versus 1 (p = 0.01). Clinically driven TLRs (31 patients vs. 18 patients, p = 0.05) and clinically driven target vessel revascularizations (37 patients vs. 22 patients, p = 0.04) were more frequent in the DP group. CONCLUSIONS: In primary PCI for STEMI, the routine use of DP increased the incidence of stent thrombosis and clinically driven target lesion/vessel revascularization during 15 months of follow-up. (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction Trial [DEDICATION]; NCT00192868).

Mortality in untreated pulmonary embolism is high and short-term outcome depends on a timely diagnosis. In this case telemedicine involving 12-lead ECG and GSM-based communication between the patient in the ambulance and the telemedical staff resulted in remote pre-hospital suspicion of acute pulmonary embolism. The ambulance was referred directly to the nearest department of cardiology where acute CT and echocardiography confirmed the diagnosis. Acute trombolysis was successful. Telemedicine may be beneficial in other medical emergencies than acute myocardial infarction. Udgivelsesdato: 2008-Feb-25