93 results on '"Engstrøm, Thomas"'
Search Results
2. Effect of Alirocumab on Carotid Inflammation by [18F]FDG PET in Patients With Acute Myocardial Infarction.
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Bang, Lia E., Jensen, Jacob Kildevang, Räber, Lorenz, Koskinas, Konstantinos C., Bär, Sarah, Losdat, Sylvain, Matter, Christian M., Lonborg, Jacob, Radu Juul Jensen, Maria D., Kjaer, Andreas, Engstrøm, Thomas, and Ripa, Rasmus Sejersten
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- 2024
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3. The importance of nonobstructive plaque characteristics in symptomatic and asymptomatic coronary artery disease.
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de Knegt, Martina C., Linde, Jesper J., Sigvardsen, Per E., Engstrøm, Thomas, Fuchs, Andreas, Jensen, Andreas K., Elming, Hanne, Kühl, J. Tobias, Hansen, Peter R., Høfsten, Dan E., Kelbæk, Henning, Nordestgaard, Børge G., Hove, Jens D., Køber, Lars V., and Kofoed, Klaus F.
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We examined obstructive and nonobstructive plaque volumes in populations with subclinical and clinically manifested coronary artery disease (CAD) using quantitative computed tomography (QCT). 855 participants with CAD (274 asymptomatic individuals, 254 acute chest pain patients without acute coronary syndrome (ACS), and 327 patients with ACS) underwent QCT of proximal coronary segments to assess participant-level plaque volumes of dense calcium, fibrous, fibrofatty, and necrotic core tissue. Nonobstructive (<50% stenosis) plaque volumes were greater than obstructive plaque volumes, irrespective of population (all p <0.0001): Asymptomatic individuals (mean (95% CI)): 218 [190-250] vs. 16 [12-22] mm
3 ; acute chest pain patients without ACS: 300 [263-341] vs. 51 [41-62] mm3 ; patients with ACS: 370 [332-412] vs. 159 [139-182] mm3 . After multivariable adjustment, nonobstructive fibrous and fibrofatty tissue volumes were greater in acute chest pain patients without ACS compared to asymptomatic individuals (fibrous tissue: 122 [107-139] vs. 175 [155-197] mm3 , p <0.01; fibrofatty tissue: 44 [38-50] vs. 71 [63-80] mm3 , p <0.01. Necrotic core tissue was greater in ACS patients (29 [26-33] mm3 ) compared to both asymptomatic individuals (15 [13-18] mm3 , p <0.0001) and acute chest pain patients without ACS (21 [18-24] mm3 , p <0.05). Nonobstructive dense calcium volumes did not differ between the three populations: 29 [24-36], 29 [23-35], and 41 [34-48] mm3 , p >0.3 respectively. Nonobstructive CAD was the predominant contributor to total atherosclerotic plaque volume in both subclinical and clinically manifested CAD. Nonobstructive fibrous, fibrofatty and necrotic core tissue volumes increased with worsening clinical presentation, while nonobstructive dense calcium tissue volumes did not. [ABSTRACT FROM AUTHOR]- Published
- 2024
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4. Discovery of plasma proteins associated with ventricular fibrillation during first ST-elevation myocardial infarction via proteomics
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Stampe, Niels Kjær, Ottenheijm, Maud Eline, Drici, Lylia, Wewer Albrechtsen, Nicolai J, Nielsen, Annelaura Bach, Christoffersen, Christina, Warming, Peder Emil, Engstrøm, Thomas, Winkel, Bo Gregers, Jabbari, Reza, Tfelt-Hansen, Jacob, and Glinge, Charlotte
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Graphical Abstract
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- 2024
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5. Bleeding risk and P2Y12 inhibitors in all-comer patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention: a single-centre cohort study
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Jacobsen, Mia Ravn, Jabbari, Reza, Engstrøm, Thomas, Grove, Erik Lerkevang, Glinge, Charlotte, Pedersen, Frants, Holmvang, Lene, Køber, Lars, Torp-Pedersen, Christian, Maeng, Michael, Veien, Karsten, Freeman, Phillip, Charlot, Mette Gitz, Kelbæk, Henning, and Sørensen, Rikke
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Graphical AbstractPCI-treated STEMI patients at high bleeding risk and the use of P2Y12 inhibitors according to bleeding risk. PCI, percutaneous coronary intervention; PRECISE-DAPT, predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy; STEMI, ST-segment elevation myocardial infarction.
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- 2023
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6. Heart of the Matter in Complete ACS Revascularization: Physiology Matters.
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Engstrøm, Thomas and Lønborg, Jacob
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[Display omitted] [ABSTRACT FROM AUTHOR]
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- 2023
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7. Coronary CT Angiography as a Guide to Timing of Invasive Treatment in Patients With NSTEACS.
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Kühl, Jørgen T., Kelbæk, Henning, Linde, Jesper J., Sigvardsen, Per E., Hansen, Thomas F., de Knegt, Martina C., Heitmann, Merete, Hansen, Peter R., Høfsten, Dan, Bang, Lia E., Hove, Jens D., Kragelund, Charlotte, Abdulla, Jawdat, Holmvang, Lene, Torp-Pedersen, Christian, Gislason, Gunnar, Engstrøm, Thomas, Køber, Lars V., and Kofoed, Klaus F.
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- 2023
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8. Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third nordic aortic valve intervention trial - NOTION-3.
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Sabbah, Muhammad, Veien, Karsten, Niemela, Matti, Freeman, Phillip, Linder, Rickard, Ioanes, Dan, Terkelsen, Christian Juhl, Kajander, Olli A., Koul, Sasha, Savontaus, Mikko, Karjalainen, Pasi, Erglis, Andrejs, Minkkinen, Mikko, Jørgensen, Troels, Sondergaard, Lars, De Backer, Ole, Engstrøm, Thomas, and Lønborg, Jacob
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Background: Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes.Study Design: The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI.Summary: NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI. [ABSTRACT FROM AUTHOR]- Published
- 2023
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9. Clinical impact of influenza vaccination after ST- and non-ST-segment elevation myocardial infarction - insights from the IAMI trial.
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Fröbert, Ole, Götberg, Matthias, Erlinge, David, Akhtar, Zubair, Christiansen, Evald H., MacIntyre, Chandini R., Oldroyd, Keith G., Motovska, Zuzana, Erglis, Andrejs, Moer, Rasmus, Hlinomaz, Ota, Jakobsen, Lars, Engstrøm, Thomas, Jensen, Lisette O., Fallesen, Christian O., Jensen, Svend E, Angerås, Oskar, Calais, Fredrik, Kåregren, Amra, and Lauermann, Jörg
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Background: Influenza vaccination early after myocardial infarction (MI) improves prognosis but vaccine effectiveness may differ dependent on type of MI.Methods: A total of 2,571 participants were prospectively enrolled in the Influenza vaccination after myocardial infarction (IAMI) trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in eight countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2,467 participants with ST-segment elevation MI (STEMI, n = 1,348) or non-ST-segment elevation MI (NSTEMI, n = 1,119). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. Cumulative incidence of the primary and key secondary endpoints by randomized treatment and NSTEMI/STEMI was estimated using the Kaplan-Meier method. Treatment effects were evaluated with formal interaction testing to assess for effect modification.Results: Baseline risk was higher in participants with NSTEMI. In the NSTEMI group the primary endpoint occurred in 6.5% of participants assigned to influenza vaccine and 10.5% assigned to placebo (hazard ratio [HR], 0.60; 95% CI, 0.39-0.91), compared to 4.1% assigned to influenza vaccine and 4.5% assigned to placebo in the STEMI group (HR, 0.90; 95% CI, 0.54-1.50, P = .237 for interaction). Similar findings were seen for the key secondary endpoints of all-cause death and cardiovascular death. The Kaplan-Meier risk difference in all-cause death at one year was more pronounced in participants with NSTEMI (NSTEMI: HR, 0.47; 95% CI 0.28-0.80, STEMI: HR, 0.86; 95% CI, 0.43-1.70, interaction P = .028).Conclusions: The beneficial effect of influenza vaccination on adverse cardiovascular events may be enhanced in patients with NSTEMI compared to those with STEMI. [ABSTRACT FROM AUTHOR]- Published
- 2023
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10. Employment status at time of acute myocardial infarction and risk of death and recurrent acute myocardial infarction
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Petersen, Jeppe K, Shams-Eldin, Abdulrahman N, Fosbøl, Emil L, Rørth, Rasmus, Sørensen, Rikke, Jabbari, Reza, Engstrøm, Thomas, Holmvang, Lene, Pedersen, Frants, Alhakak, Amna, Krøll, Johanna, Torp-Pedersen, Christian, Køber, Lars, and Butt, Jawad H
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In patients of working age admitted with a heart attack, not being part of the workforce was associated with an increased risk of mortality and new heart attacks following discharge, as compared with patients being part of the workforce.Key findings As compared with patients being part of the workforce, patients who were not part of the workforce had an increased risk of mortality following discharge.As compared with patients being part of the workforce, patients who were not part of the workforce had an increased risk of a new heart attack following discharge.Structured Graphical Abstract
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- 2023
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11. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II
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Gyldenkerne, Christine, Maeng, Michael, Kjøller-Hansen, Lars, Maehara, Akiko, Zhou, Zhipeng, Ben-Yehuda, Ori, Erik Bøtker, Hans, Engstrøm, Thomas, Matsumura, Mitsuaki, Mintz, Gary S., Fröbert, Ole, Persson, Jonas, Wiseth, Rune, Larsen, Alf I., Jensen, Lisette O., Nordrehaug, Jan E., Bleie, Øyvind, Omerovic, Elmir, Held, Claes, James, Stefan K., Ali, Ziad A., Rosen, Hans C., Stone, Gregg W., and Erlinge, David
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- 2023
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12. Soluble ST2 in plasma is associated with post-procedural no-or-slow reflow after primary percutaneous coronary intervention in ST-elevation myocardial infarction
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Søndergaard, Frederik T, Beske, Rasmus P, Frydland, Martin, Møller, Jacob Eifer, Helgestad, Ole K L, Jensen, Lisette Okkels, Holmvang, Lene, Goetze, Jens P, Engstrøm, Thomas, and Hassager, Christian
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- 2023
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13. Coronary CT and timing of invasive coronary angiography in patients ≥75 years old with non-ST segment elevation acute coronary syndromes
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Ratcovich, Hanna, Sadjadieh, Golnaz, Linde, Jesper J, Joshi, Francis R, Kelbæk, Henning, Kofoed, Klaus F, Køber, Lars, Hansen, Peter Riis, Torp-Pedersen, Christian, Elming, Hanne, Gislason, Gunnar Hilmar, Høfsten, Dan Eik, Engstrøm, Thomas, and Holmvang, Lene
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BackgroundThe ability of coronary CT angiography (cCTA) to rule out significant coronary artery disease (CAD) in older patients with non-ST segment elevation acute coronary syndromes (NSTEACS) is unclear since valid cCTA analysis may be limited by extensive coronary artery calcification. In addition, the effect of very early invasive coronary angiography (ICA) with possible revascularisation is debated.MethodsThis is a posthoc analysis of patients ≥75 years included in the Very Early vs Standard Care Invasive Examination and Treatment of Patients with Non-ST-Segment Elevation Acute Coronary Syndrome Trial. cCTA was performed prior to the ICA. The diagnostic accuracy of cCTA was investigated. Presence of a coronary artery stenosis ≥50% by subsequent ICA was used as reference. Patients were randomised to a very early (within 12 hours of diagnosis) or a standard ICA (within 48–72 hours of diagnosis). The primary composite endpoint was 5-year all-cause mortality, non-fatal recurrent myocardial infarction or hospital admission for refractory myocardial ischaemia or heart failure.ResultsOf 452 (21%) patients ≥75 years, 161 (35.6%) underwent cCTA. 19% of cCTAs excluded significant CAD. The negative predictive value (NPV) of cCTA was 94% (95% CI 79 to 99) and the sensitivity 98% (95% CI 94 to 100). No significant differences in the frequency of primary endpoints were seen in patients randomised to very early ICA (at 5-year follow-up, n=100 (46.9%) vs 122 (51.0%), log-rank p=0.357).ConclusionIn patients ≥75 years with NSTEACS, cCTA before ICA showed a high NPV. A very early ICA <12 hours of diagnosis did not significantly improve long-term clinical outcomes.
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- 2023
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14. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR): A Randomized Clinical Trial.
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Nørgaard, Marianne Wetendorff, Færch, Jane, Joshi, Francis R., Høfsten, Dan E., Engstrøm, Thomas, and Kelbæk, Henning
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PERCUTANEOUS coronary intervention ,HEMATOMA ,CONFIDENCE intervals ,TIME ,HEALTH outcome assessment ,MANN Whitney U Test ,EARLY ambulation (Rehabilitation) ,CORONARY angiography ,FEMORAL artery ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,STATISTICAL sampling ,SOCIODEMOGRAPHIC factors ,ODDS ratio ,HEMORRHAGE ,ANGIOPLASTY ,DISEASE risk factors - Abstract
Background: Coronary angiography (CAG) and percutaneous coronary intervention (PCI) are performed via the femoral or radial arteries. In patients examined via transfemoral access, closure devices facilitate hemostasis, but it is unknown whether it is safe to mobilize these patients immediately and how acceptable this may be in terms of patient comfort. Objective: The aims of this study were to investigate bleeding complications in patients mobilized immediately after transfemoral CAG or PCI compared with patients on bed rest (BR) for 2 hours after the procedure and, furthermore, to investigate patient comfort in relation to mobilization and BR. Methods: SAMOVAR was a noninferiority trial with patients randomized to immediate mobilization (IM) or 2 hours of BR after transfemoral CAG or PCI and use of the AngioSeal as a closure device and reversal of heparin effect. The primary end point was development of hematoma greater than 5 cm, pseudoaneurysm, or bleeding requiring blood transfusion. Secondary end points were oozing from the puncture site, small hematoma, and patient comfort. Results: Of 2027 patients (IM, 1010; BR, 1017), 40% underwent PCI. The primary outcome was recorded in 0.7% patients randomized to IM versus 0.5% in BR (P =.58). There was no difference in the incidence of small hematoma, whereas persistent oozing was seen slightly more often after IM compared with BR (12% vs 9%, P =.04). Patients mobilized immediately reported less back pain and micturition problems (P <.001). Conclusions: In patients who had CAG and PCI performed through transfemoral access, reversal of anticoagulation and use of closure devices allowed IM with low rates of complications and improved patient comfort. [ABSTRACT FROM AUTHOR]
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- 2022
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15. Angiographic outcome in patients treated with deferred stenting after ST-segment elevation myocardial infarction—results from DANAMI-3-DEFER
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Nepper-Christensen, Lars, Kelbæk, Henning, Ahtarovski, Kiril A, Høfsten, Dan E, Holmvang, Lene, Pedersen, Frants, Tilsted, Hans-Henrik, Aarøe, Jens, Jensen, Svend E, Raungaard, Bent, Terkelsen, Christian J, Køber, Lars, Engstrøm, Thomas, and Lønborg, Jacob
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Graphical Abstract
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- 2022
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16. Is It Safe to Mobilize Patients Very Early After Transfemoral Coronary Procedures? (SAMOVAR)
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Nørgaard, Marianne Wetendorff, Færch, Jane, Joshi, Francis R., Høfsten, Dan E., Engstrøm, Thomas, and Kelbæk, Henning
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- 2022
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17. The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial.
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Böhm, Felix, Mogensen, Brynjölfur, Östlund, Ollie, Engstrøm, Thomas, Fossum, Eigil, Stankovic, Goran, Angerås, Oskar, Ērglis, Andrejs, Menon, Madhav, Schultz, Carl, Berry, Colin, Liebetrau, Christoph, Laine, Mika, Held, Claes, Rück, Andreas, and James, Stefan K.
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Background: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI.Methods and Results: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint.Conclusion: This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing. [ABSTRACT FROM AUTHOR]- Published
- 2021
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18. Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI.
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El Farissi, Mohamed, Good, Richard, Engstrøm, Thomas, Oldroyd, Keith G., Karamasis, Grigoris V., Vlaar, Pieter J., Lønborg, Jacob T., Teeuwen, Koen, Keeble, Thomas R., Mangion, Kenneth, De Bruyne, Bernard, Fröbert, Ole, De Vos, Annemiek, Zwart, Bastiaan, Snijder, Roel J.R., Brueren, Guus R.G., Palmers, Pieter-Jan, Wijnbergen, Inge F., Berry, Colin, and Tonino, Pim A.L.
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The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI). Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited. The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed. In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50). Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial. [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2021
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19. Long-term prognostic outcomes and implication of oral anticoagulants in patients with new-onset atrial fibrillation following st-segment elevation myocardial infarction.
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Madsen, Jasmine Melissa, Jacobsen, Mia Ravn, Sabbah, Muhammad, Topal, Divan Gabriel, Jabbari, Reza, Glinge, Charlotte, Køber, Lars, Torp-Pedersen, Christian, Pedersen, Frants, Sørensen, Rikke, Holmvang, Lene, Engstrøm, Thomas, Lønborg, Jacob Thomsen, Madsen, Jasmine M Melissa, Jacobsen, Mia R Ravn, Topal, Divan G Gabriel, and Lønborg, Jacob T Thomsen
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Background: New-onset atrial fibrillation (NEW-AF) following ST-segment elevation myocardial infarction (STEMI) is a common complication, but the true prognostic impact of NEW-AF is unknown. Additionally, the optimal treatment of NEW-AF among patients with STEMI is warranted.Methods: A large cohort of consecutive patients with STEMI treated with percutaneous coronary intervention were identified using the Eastern Danish Heart Registry from 1999-2016. Medication and end points were retrieved from Danish nationwide registries. NEW-AF was defined as a diagnosis of AF within 30 days following STEMI. Patients without a history of AF and alive after 30 days after discharge were included. Incidence rates were calculated and multivariate analyses performed to determine the association between NEW-AF and long-term mortality, incidence of ischemic stroke, re-MI, and bleeding leading to hospitalization, and the comparative effectiveness of OAC therapy on these outcomes.Results: Of 7944 patients with STEMI, 296 (3.7%) developed NEW-AF. NEW-AF was associated with increased long-term mortality (adjusted HR 1.48, 95% CI 1.20-1.82, P<.001) and risk of bleeding leading to hospitalization (adjusted HR 1.36, 95% CI 1.00-1.85, P=.050), and non-significant increased risk of ischemic stroke (adjusted HR 1.45, 95% CI 0.96-2.19, P=.08) and re-MI (adjusted HR 1.14, 95% CI 0.86-1.52, P=.35) with a median follow-up of 5.8 years. In NEW-AF patients, 38% received OAC therapy, which was associated with reduced long-term mortality (adjusted HR 0.69, 95% CI 0.47-1.00, P=.049).Conclusions: NEW-AF following STEMI is associated with increased long-term mortality. Treatment with OAC therapy in NEW-AF patients is associated with reduced long-term mortality. [ABSTRACT FROM AUTHOR]- Published
- 2021
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20. Outcome in Elderly Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction
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Ratcovich, Hanna Louise, Josiassen, Jakob, Helgestad, Ole Kristian Lerche, Linde, Louise, Jensen, Lisette Okkels, Ravn, Hanne Berg, Joshi, Francis R., Engstrøm, Thomas, Schmidt, Henrik, Hassager, Christian, Møller, Jacob E., and Holmvang, Lene
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- 2022
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21. Initiation of and persistence with P2Y12inhibitors in patients with myocardial infarction according to revascularization strategy: a nationwide study
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Tajchman, Daniel H, Nabi, Hafsah, Aslam, Mohsin, Butt, Jawad H, Grove, Erik L, Engstrøm, Thomas, Holmvang, Lene, Fosbøl, Emil L, Køber, Lars, and Sørensen, Rikke
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- 2021
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22. Degree of ST-segment elevation in patients with STEMI reflects the acute ischemic burden and the salvage potential.
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Topal, Divan Gabriel, Engstrøm, Thomas, Nepper-Christensen, Lars, Holmvang, Lene, Køber, Lars, Kelbæk, Henning, and Lønborg, Jacob
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Background: ST-segment elevation myocardial infarction (STEMI) is clinically diagnosed by significant ST-segment elevation (STE) in the electrocardiogram (ECG). The importance of the sum of significant ST-segment elevation (∑STE) before primary percutaneous coronary intervention (PPCI) - considered an indicator of the degree of ischemia - is sparse. We evaluated the association of ∑STE before PPCI with respect to area at risk, infarct size and myocardial salvage.Methods: A total of 503 patients with STEMI and available cardiac magnetic resonance (CMR) were included. CMR was performed at day 1 (interquartile range [IQR], 1-1) and at follow-up at day 92 (IQR, 88-96). The ECG before PPCI with the most prominent STE was used for analysis.Results: ∑STE divided into quartiles were progressive linearly associated with area at risk (p < 0.001), final infarct size (p < 0.001) and extent of microvascular obstruction (p < 0.001) and inverse linearly associated with final myocardial salvage (p < 0.001). Similar results were found for linear regression analyses. However, ∑STE was not associated with final myocardial salvage in patients with pre-PCI TIMI (thrombolysis in myocardial infarction) flow 0/1 (p = 0.24) in contrast to patients with pre-PCI TIMI flow 2/3 (p ≤ 0.001).Conclusion: In patients with STEMI presenting within 12 h of symptom onset, the degree of STE in the ECG before PPCI is a marker of the extent of myocardium at risk that in turn affects the infarct size in patients with pre-PCI TIMI flow 0/1, whereas the degree of STE in patients with pre-PCI TIMI flow 2/3 is a marker of the extent of the myocardium at risk as well as myocardial salvage - both affecting the myocardial damage. [ABSTRACT FROM AUTHOR]- Published
- 2020
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23. Clinical outcome following late reperfusion with percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction
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Nepper-Christensen, Lars, Lønborg, Jacob, Høfsten, Dan Eik, Sadjadieh, Golnaz, Schoos, Mikkel Malby, Pedersen, Frants, Jørgensen, Erik, Kelbæk, Henning, Haahr-Pedersen, Sune, Flensted Lassen, Jens, Køber, Lars, Holmvang, Lene, and Engstrøm, Thomas
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- 2021
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24. Clinical outcome following late reperfusion with percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction
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Nepper-Christensen, Lars, Lønborg, Jacob, Høfsten, Dan Eik, Sadjadieh, Golnaz, Schoos, Mikkel Malby, Pedersen, Frants, Jørgensen, Erik, Kelbæk, Henning, Haahr-Pedersen, Sune, Flensted Lassen, Jens, Køber, Lars, Holmvang, Lene, and Engstrøm, Thomas
- Abstract
Background: Up to 40% of patients with ST-segment elevation myocardial infarction (STEMI) present later than 12 hours after symptom onset. However, data on clinical outcomes in STEMI patients treated with primary percutaneous coronary intervention 12 or more hours after symptom onset are non-existent. We evaluated the association between primary percutaneous coronary intervention performed later than 12 hours after symptom onset and clinical outcomes in a large all-comer contemporary STEMI cohort.Methods: All STEMI patients treated with primary percutaneous coronary intervention in eastern Denmark from November 2009 to November 2016 were included and stratified by timing of the percutaneous coronary intervention. The combined clinical endpoint of all-cause mortality and hospitalisation for heart failure was identified from nationwide Danish registries.Results: We included 6674 patients: 6108 (92%) were treated less than 12 hours and 566 (8%) were treated 12 or more hours after symptom onset. During a median follow-up period of 3.8 (interquartile range 2.3–5.6) years, 30-day, one-year and long-term cumulative rates of the combined endpoint were 11%, 17% and 25% in patients treated 12 or fewer hours and 21%, 29% and 37% in patients treated more than 12 hours (P<0.001 for all) after symptom onset. Late presentation was independently associated with an increased risk of an adverse clinical outcome (hazard ratio 1.42, 95% confidence interval 1.22–1.66; P<0.001).Conclusions: Increasing duration from symptom onset to primary percutaneous coronary intervention was associated with an increased risk of an adverse clinical outcome in patients with STEMI, especially when the delay exceeded 12 hours.
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- 2024
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25. Electrocardiogram to predict reperfusion success in late presenters with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.
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Topal, Divan Gabriel, Nepper-Christensen, Lars, Lønborg, Jacob, Ahtarovski, Kiril Aleksov, Tilsted, Hans-Henrik, Sørensen, Rikke, Pedersen, Frants, Joshi, Francis, Bang, Lia E., Fakhri, Yama, Helqvist, Steffen, Holmvang, Lene, Høfsten, Dan, Køber, Lars, Kelbæk, Henning, Vejlstrup, Niels, and Engstrøm, Thomas
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Background: Clinical decision-making in patients with ST-segment elevation myocardial infarction (STEMI) presenting beyond 12 h of symptom onset (late presenters) is challenging. However, the electrocardiogram (ECG) may provide helpful information. We investigated the association between three ECG-scores and myocardial salvage and infarct size in late presenters treated with primary percutaneous coronary intervention (primary PCI).Methods: Sixty-six patients with STEMI and ongoing symptoms presenting 12-72 h after symptom onset were included. Cardiac magnetic resonance was performed at day 1 (interquartile range [IQR], 1-1) and at follow-up at day 93 (IQR, 90-98). The pre-PCI ECG was analyzed for the presence of pathological QW (early QW) as well as Anderson-Wilkins acuteness score (AW-score), the classic Sclarovsky-Birnbaum Ischemia Grading System (classic SB-IG-score) and a modified SB-IG-score including any T-wave morphologies.Results: Early QW was associated with a larger myocardium at risk (39 ± 12 versus 33 ± 12; p = 0.030) and final infarct size (20 ± 11 versus 14 ± 9; p = 0.021) as well as a numerical lower final myocardial salvage (0.52 ± 0.19 versus 0.61 ± 0.23; p = 0.09). The association with final infarct size disappeared after adjusting for myocardium at risk. An AW-score < 3 showed a trend towards a larger final infarct size (18 ± 11 versus 11 ± 11; p = 0.08) and was not associated with salvage index (0.55 ± 0.20 versus 0.65 ± 0.30; p = 0.23). The classic and modified SB-IG-score were not associated with final infarct size (modified SB-IG-score, 17 ± 10 versus 21 ± 13; p = 0.28) or final myocardial salvage (0.53 ± 0.20 versus 0.53 ± 0.26; p = 0.96).Conclusion: Of three well-established ECG-scores only early QW and AW-score < 3 showed association with myocardium at risk and infarct size to some extent, but the association with myocardial salvage was weak. Hence, neither of the three investigated ECG-scores are sufficient to guide clinical decision-making in patients with STEMI and ongoing symptoms presenting beyond 12 h of symptom onset. [ABSTRACT FROM AUTHOR]- Published
- 2020
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26. Early Q-wave morphology in prediction of reperfusion success in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention - A cardiac magnetic resonance imaging study.
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Topal, Divan Gabriel, Lønborg, Jacob, Ahtarovski, Kiril Aleksov, Nepper-Christensen, Lars, Fakhri, Yama, Helqvist, Steffen, Holmvang, Lene, Høfsten, Dan, Køber, Lars, Kelbæk, Henning, Vejlstrup, Niels, and Engstrøm, Thomas
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Background: Pathological Q-wave (QW) in the electrocardiogram (ECG) before primary percutaneous coronary intervention (primary PCI) is a strong prognostic marker in patients with ST-segment elevation myocardial infarction (STEMI). However, current binary QW criteria are either not clinically applicable or have a lack of diagnostic performance. Accordingly, we evaluated the association between duration, depth and area of QW and markers of the effect of reperfusion (reperfusion success).Methods: A total of 516 patients with their first STEMI had obtained an ECG before primary PCI and an acute cardiac magnetic resonance imaging (CMR) at day 1 (interquartile range [IQR], 1-1) and at follow-up at day 92 (IQR, 89-96). The largest measurable QW in ECG was used for analysis of duration, depth and area of QW (QW morphology). The QW morphology was evaluated as a continuous variable in linear regression models and as a variable divided in four equally large groups.Results: The QW morphology as four equally large groups was significantly associated with all CMR endpoints (p ≤ 0.001) and showed a linear relationship (p ≤ 0.001) with final infarct size (for QW duration, β = 0.47; QW depth, β = 0.41 and QW area, β = 0.39), final infarct transmurality (for QW duration, β = 0.36; QW depth, β = 0.26 and QW area, β = 0.23) and final myocardial salvage index (for QW duration, β = -0.34; QW depth, β = -0.26 and QW area, β = -0.24).Conclusion: Although modest, the QW morphology in STEMI patients showed significant linear association with markers of reperfusion success. Hence, it is suggested that the term pathological is not used as a dichotomous parameter in patients with STEMI but rather evaluated on the basis of extent. [ABSTRACT FROM AUTHOR]- Published
- 2020
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27. Impact of Multiple Myocardial Scars Detected by CMR in Patients Following STEMI.
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Ekström, Kathrine, Nepper-Christensen, Lars, Ahtarovski, Kiril A., Kyhl, Kasper, Göransson, Christoffer, Bertelsen, Litten, Ghotbi, Adam A., Kelbæk, Henning, Helqvist, Steffen, Høfsten, Dan E., Køber, Lars, Schoos, Mikkel M., Vejlstrup, Niels, Lønborg, Jacob, and Engstrøm, Thomas
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This study investigated the incidence and long-term prognostic importance of multiple myocardial scars in cardiac magnetic resonance (CMR) in a large contemporary cohort of patients with ST-segment elevation myocardial infarction (STEMI). Patients presenting with STEMI may have multiple infarctions/scars caused by multiple culprit lesions, previous myocardial infarction (MI) or procedure-related MI due to nonculprit interventions. However, the incidence, long-term prognosis, and distribution of causes of multiple myocardial scars remain unknown. CMR was performed in 704 patients with STEMI 1 day after primary percutaneous coronary intervention (PCI) and again 3 months later. Myocardial scars were assessed by late gadolinium enhancement (LGE). T2-weighted technique was used to differentiate acute from chronic infarctions. The presence of multiple scars was defined as scars located in different coronary territories. The combined endpoints of all-cause mortality and hospitalization for heart failure were assessed at 39 months (interquartile range [IQR]: 31 to 48 months). At 3 months, 59 patients (8.4%) had multiple scars. Of these, multiple culprits in STEMI were detected in 7 patients (1%), and development of a second nonculprit scar at follow-up occurred in 10 patients (1.4%). The most frequent cause of multiple scars was a chronic scar in the nonculprit myocardium. The presence of multiple scars was independently associated with an increased risk of all-cause mortality and hospitalization for heart failure (hazard ratio: 2.7; 95% confidence interval: 1.1 to 6.8; p = 0.037). Multiple scars were present in 8.4% of patients with STEMI and were independently associated with an increased risk of long-term morbidity and mortality. The presence of multiple myocardial scars on CMR may serve as a useful tool in risk stratification of patients following STEMI. (DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction [DANAMI-3]; NCT01435408) (Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization [PRIMULTI]; NCT01960933) [ABSTRACT FROM AUTHOR]
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- 2019
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28. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study
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Erlinge, David, Maehara, Akiko, Ben-Yehuda, Ori, Bøtker, Hans Erik, Maeng, Michael, Kjøller-Hansen, Lars, Engstrøm, Thomas, Matsumura, Mitsuaki, Crowley, Aaron, Dressler, Ovidiu, Mintz, Gary S, Fröbert, Ole, Persson, Jonas, Wiseth, Rune, Larsen, Alf Inge, Okkels Jensen, Lisette, Nordrehaug, Jan Erik, Bleie, Øyvind, Omerovic, Elmir, Held, Claes, James, Stefan K, Ali, Ziad A, Muller, James E, Stone, Gregg W, Ahlehoff, Ole, Amin, Azad, Angerås, Oskar, Appikonda, Praveen, Balachandran, Saranya, Barvik, Ståle, Bendix, Kristoffer, Bertilsson, Maria, Boden, Ulrika, Bogale, Nigussie, Bonarjee, Vernon, Calais, Fredrik, Carlsson, Jörg, Carstensen, Steen, Christersson, Christina, Christiansen, Evald Høj, Corral, Maria, De Backer, Ole, Dhaha, Usama, Dworeck, Christian, Eggers, Kai, Elfström, Charlotta, Ellert, Julia, Eriksen, Erlend, Fallesen, Christian, Forsman, Margareta, Fransson, Helena, Gaballa, Mohsen, Gacki, Marek, Götberg, Matthias, Hagström, Lars, Hallberg, Theresa, Hambraeus, Kristina, Haraldsson, Inger, Harnek, Jan, Havndrup, Ole, Hegbom, Knut, Heigert, Matthias, Helqvist, Steffen, Herstad, Jon, Hijazi, Ziad, Holmvang, Lene, Ioanes, Dan, Iqbal, Amjid, Iversen, Allan, Jacobson, Jaclyn, Jakobsen, Lars, Jankovic, Ivana, Jensen, Ulf, Jensevik, Karin, Johnston, Nina, Jonasson, Torfi Fjalar, Jørgensen, Erik, Joshi, Francis, Kajermo, Ulf, Kåver, Frida, Kelbæk, Henning, Kellerth, Thomas, Kish, Mitra, Koenig, Wolfgang, Koul, Sasha, Lagerqvist, Bo, Larsson, Bertil, Lassen, Jens Flensted, Leiren, Olav, Li, Zhe, Lidell, Christer, Linder, Rikard, Lindstaedt, Michael, Lindström, Gunilla, Liu, Shen, Løland, Kjetil Halvorsen, Lønborg, Jacob, Márton, László, Mir-Akbari, Habib, Mohamed, Shameema, Odenstedt, Jacob, Ogne, Christer, Oldgren, Jonas, Olivecrona, Göran, Östlund-Papadogeorgos, Nikolas, Ottesen, Michael, Packer, Erik, Palmquist, Åsa Michelgård, Paracha, Quratulain, Pedersen, Frans, Petursson, Petur, Råmunddal, Truls, Rotevatn, Svein, Sanchez, Raquel, Sarno, Giovanna, Saunamäki, Kari I, Scherstén, Fredrik, Serruys, Patrick W, Sjögren, Iwar, Sørensen, Rikke, Srdanovic, Iva, Subhani, Zuka, Svensson, Eva, Thuesen, Anne, Tijssen, Jan, Tilsted, Hans-Henrik, Tödt, Tim, Trovik, Thor, Våga, Bjørn Inge, Varenhorst, Christoph, Veien, Karsten, Vestman, Emma, Völz, Sebastian, Wallentin, Lars, Wykrzykowska, Joanna, Zagozdzon, Leszek, Zamfir, Manuela, Zedigh, Crister, Zhong, Hang, and Zhou, Zhipeng
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Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs).
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- 2021
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29. Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial
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Jolicoeur, E. Marc, Dendukuri, Nandini, Belisle, Patrick, Range, Grégoire, Souteyrand, Geraud, Bouisset, Frédéric, Zemour, Gilles, Delarche, Nicolas, Harbaoui, Brahim, Schampaert, Erick, Kouz, Simon, Cayla, Guillaume, Roubille, François, Boueri, Ziad, Mansour, Samer, Marcaggi, Xavier, Tardif, Jean-Claude, McGillion, Michael, Tanguay, Jean-François, Brophy, James, Yu, Cheol Woong, Berry, Colin, Carrick, David, Høfsten, Dan Eik, Engstrøm, Thomas, Kober, Lars, Kelbæk, Henning, and Belle, Loic
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Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.
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- 2020
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30. Biomarkers predictive of late cardiogenic shock development in patients with suspected ST-elevation myocardial infarction
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Frydland, Martin, Møller, Jacob E, Lindholm, Matias G, Hansen, Rikke, Wiberg, Sebastian, Lerche Helgestad, Ole Kristian, Thomsen, Jakob H, Goetze, Jens P, Engstrøm, Thomas, Frikke-Schmidt, Ruth, Ravn, Hanne B, Holmvang, Lene, Jensen, Lisette O, Kjaergaard, Jesper, and Hassager, Christian
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Background: Cardiogenic shock complicating ST-elevation myocardial infarction is characterised by progressive left ventricular dysfunction causing inflammation and neurohormonal activation. Often, cardiogenic shock develops after hospital admission. Whether inflammation and a neurohormonal activation precede development of clinical cardiogenic shock is unknown.Methods and results: In 93% of 2247 consecutive patients with suspected ST-elevation myocardial infarction admitted at two tertiary heart centres, admission plasma levels of pro-atrial natriuretic peptide, copeptin, mid-regional pro-adrenomedullin and stimulation-2 were measured on hospital admission. Patients were stratified according to no cardiogenic shock development and cardiogenic shock developed before (early cardiogenic shock) or after (late cardiogenic shock) leaving the catheterization laboratory. In total, 225 (10%) patients developed cardiogenic shock, amongst these patients late cardiogenic shock occurred in 64 (2.9%). All four biomarkers were independently associated with the development of late cardiogenic shock (odds ratio per two-fold increase in risk: 1.19–3.13) even when adjusted for the recently developed Observatoire Régional Breton sur l’Infarctus risk score for prediction of late cardiogenic shock development. Furthermore, pro-atrial natriuretic peptide, copeptin and mid-regional pro-adrenomedullin, but not stimulation-2, added significant predictive information, when added to the Observatoire Régional Breton sur l’Infarctus risk score (area under the receiver-operating characteristic curve, pro-atrial natriuretic peptide: 0.87, p=0.0008; copeptin: 0.86, p<0.05; mid-regional pro-adrenomedullin: 0.88, p=0.006).Conclusions: Pro-atrial natriuretic peptide, copeptin, mid-regional pro-adrenomedullin and stimulation-2 admission plasma concentration were associated with late cardiogenic shock development in patients admitted with suspected ST-elevation myocardial infarction. Pro-atrial natriuretic peptide, mid-regional pro-adrenomedullin and copeptin had independent predictive value for late cardiogenic shock development.
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- 2020
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31. Complete vs Culprit-Lesion-Only Revascularization for ST-Segment Elevation Myocardial Infarction: A Systematic Review and Meta-analysis
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Bainey, Kevin R., Engstrøm, Thomas, Smits, Pieter C., Gershlick, Anthony H., James, Stefan K., Storey, Robert F., Wood, David A., Mehran, Roxana, Cairns, John A., and Mehta, Shamir R.
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IMPORTANCE: Recently, the Complete vs Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI (percutaneous coronary intervention) for STEMI (ST-segment elevation myocardial infarction [MI]) (COMPLETE) trial showed that angiography-guided PCI of the nonculprit lesion with the goal of complete revascularization reduced cardiovascular (CV) death or new MI compared with PCI of the culprit lesion only in STEMI. Whether complete revascularization also reduces CV mortality is uncertain. Moreover, whether the association of complete revascularization with hard clinical outcomes is consistent when fractional flow reserve (FFR)– and angiography-guided strategies are used is unknown. OBJECTIVE: To determine through a systematic review and meta-analysis (1) whether complete revascularization is associated with decreased CV mortality and (2) whether heterogeneity in the association occurs when FFR- and angiography-guided PCI strategies for nonculprit lesions are performed. DATA SOURCES: A systematic search of MEDLINE, Embase, ISI Web of Science, and CENTRAL (Cochrane Central Register of Controlled Trials) from database inception to September 30, 2019, was performed. Conference proceedings were also reviewed from January 1, 2002, to September 30, 2019. STUDY SELECTION: English-language randomized clinical trials comparing complete revascularization vs culprit-lesion-only PCI in patients with STEMI and multivessel disease were included. DATA EXTRACTION AND SYNTHESIS: The combined odds ratio (OR) was calculated with the random-effects model using the Mantel-Haenszel method (sensitivity with fixed-effects model). Heterogeneity was measured using the I2 statistic. Publication bias was evaluated using the inverted funnel plot approach. Data were analyzed from October 2019 to January 2020. MAIN OUTCOMES AND MEASURES: Cardiovascular death and the composite of CV death or new MI. RESULTS: Ten randomized clinical trials involving 7030 unique patients were included. The weighted mean follow-up time was 29.5 months. Complete revascularization was associated with reduced CV death compared with culprit-lesion-only PCI (80 of 3191 [2.5%] vs 106 of 3406 [3.1%]; OR, 0.69 [95% CI, 0.48-0.99]; P = .05; fixed-effects model OR, 0.74 [95% CI, 0.55-0.99]; P = .04). All-cause mortality occurred in 153 of 3426 patients (4.5%) in the complete revascularization group vs 177 of 3604 (4.9%) in the culprit-lesion-only group (OR, 0.84 [95% CI, 0.67-1.05]; P = .13; I2 = 0%). Complete revascularization was associated with a reduced composite of CV death or new MI (192 of 2616 [7.3%] vs 266 of 2586 [10.3%]; OR, 0.69 [95% CI, 0.55-0.87]; P = .001; fixed-effects model OR, 0.69 [95% CI, 0.57-0.84]; P < .001), with no heterogeneity in this outcome when complete revascularization was performed using an FFR-guided strategy (OR, 0.78 [95% CI, 0.43-1.44]) or an angiography-guided strategy (OR, 0.61 [95% CI, 0.38-0.97]; P = .52 for interaction). CONCLUSIONS AND RELEVANCE: In patients with STEMI and multivessel disease, complete revascularization was associated with a reduction in CV mortality compared with culprit-lesion-only PCI. There was no differential association with treatment between FFR- and angiography-guided strategies on major CV outcomes.
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- 2020
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32. Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction
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Nepper-Christensen, Lars, Høfsten, Dan Eik, Helqvist, Steffen, Lassen, Jens Flensted, Tilsted, Hans-Henrik, Holmvang, Lene, Pedersen, Frants, Joshi, Francis, Sørensen, Rikke, Bang, Lia, Bøtker, Hans Erik, Terkelsen, Christian Juhl, Maeng, Michael, Jensen, Lisette Okkels, Aarøe, Jens, Kelbæk, Henning, Køber, Lars, Engstrøm, Thomas, and Lønborg, Jacob
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ObjectiveThe Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction – Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy.MethodsPatients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure.ResultsFrom March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62).ConclusionsIn this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy.Trial registration numberNCT01435408.
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- 2020
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33. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention
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Windecker, Stephan, Lopes, Renato D., Massaro, Tyler, Jones-Burton, Charlotte, Granger, Christopher B., Aronson, Ronald, Heizer, Gretchen, Goodman, Shaun G., Darius, Harald, Jones, W. Schuyler, Aschermann, Michael, Brieger, David, Cura, Fernando, Engstrøm, Thomas, Fridrich, Viliam, Halvorsen, Sigrun, Huber, Kurt, Kang, Hyun-Jae, Leiva-Pons, Jose L., Lewis, Basil S., Malaga, German, Meneveau, Nicolas, Merkely, Bela, Milicic, Davor, Morais, João, Potpara, Tatjana S., Raev, Dimitar, Sabaté, Manel, de Waha-Thiele, Suzanne, Welsh, Robert C., Xavier, Denis, Mehran, Roxana, and Alexander, John H.
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Supplemental Digital Content is available in the text.
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- 2019
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34. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk
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Søndergaard, Lars, Popma, Jeffrey J., Reardon, Michael J., Van Mieghem, Nicolas M., Deeb, G. Michael, Kodali, Susheel, George, Isaac, Williams, Mathew R., Yakubov, Steven J., Kappetein, Arie P., Serruys, Patrick W., Grube, Eberhard, Schiltgen, Molly B., Chang, Yanping, and Engstrøm, Thomas
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Supplemental Digital Content is available in the text.
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- 2019
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35. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial.
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Udesen, Nanna Junker, Møller, Jacob Eifer, Lindholm, Matias Greve, Eiskjær, Hans, Schäfer, Andreas, Werner, Nikos, Holmvang, Lene, Terkelsen, Christian Juhl, Jensen, Lisette Okkels, Junker, Anders, Schmidt, Henrik, Wachtell, Kristian, Thiele, Holger, Engstrøm, Thomas, Hassager, Christian, and DanGer Shock investigators
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Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far.Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies.Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%).Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock. [ABSTRACT FROM AUTHOR]- Published
- 2019
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36. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the...
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Jensen, Lisette Okkels, Maeng, Michael, Raungaard, Bent, Engstrøm, Thomas, Hansen, Henrik Steen, Jensen, Svend Eggert, Bøtker, Hans Erik, Kahlert, Johnny, Lassen, Jens Flensted, and Christiansen, Evald Høj
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Background: In patients with increased bleeding risk during dual antiplatelet therapy, the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent devoid of polymer, has shown superiority compared to a bare-metal stent. The aim of this study was to investigate whether the polymer-free biolimus A9-coated BioFreedom is noninferior to a modern thin-strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.Methods: The multicenter SORT OUT IX trial (NCT02623140) randomly assigned all-comers patients to treatment with the BioFreedom drug-coated stent or the biodegradable polymer Orsiro stent in 4 Danish University Hospitals. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection based on Danish registries will be used and continue through 5 years. Assuming an event rate of 4.2% in each stent group, 1,563 patients in each treatment arm will provide 90% power to detect noninferiority of the drug-coated BioFreedom stent with a noninferiority margin of 2.1%.Results: A total of 3,150 patients have been randomized and enrolled in the study.Conclusions: The SORT OUT IX trial will determine whether the drug-coated BioFreedom stent is noninferior to a modern biodegradable polymer Orsiro stent. [ABSTRACT FROM AUTHOR]- Published
- 2019
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37. Value of Myocardial Perfusion Assessment With Coronary Computed Tomography Angiography in Patients With Recent Acute-Onset Chest Pain.
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Sørgaard, Mathias H., Linde, Jesper J., Kühl, J. Tobias, Kelbæk, Henning, Hove, Jens D., Fornitz, Gitte G., Jørgensen, Tem B.S., Heitmann, Merete, Kragelund, Charlotte, Hansen, Thomas F., Abdulla, Jawdat, Engstrøm, Thomas, Jensen, Jan S., Wiegandt, Yaffah T., Høfsten, Dan E., Køber, Lars V., and Kofoed, Klaus F.
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Abstract Objectives The authors sought to perform a randomized controlled trial to evaluate the clinical efficacy of combined examination with coronary computed tomography angiography (CTA) and computed tomography perfusion imaging (CTP) compared to coronary CTA alone. Background Stress myocardial CTP may increase diagnostic specificity when added to coronary CTA in patients suspected of having ischemic heart disease. Methods Patients recently hospitalized for acute-onset chest pain, who had acute coronary syndrome had been ruled out by normal electrocardiograms, normal troponin levels, and relief of symptoms, and who had a clinical indication for outpatient noninvasive testing, were screened for inclusion in the CATCH-2 (CArdiac cT in the treatment of acute CHest pain 2) trial (NCT02014311). Patients were randomized 1:1 to examination with coronary CTA or coronary CTA+CTP. The primary endpoint was the frequency of coronary revascularization among patients referred for invasive coronary angiography (ICA) based on index computed tomography evaluation. Secondary endpoints were invasive procedural complications at index-related ICA, post-index cardiac death, hospital admittance because of recurrence of chest pain, unstable angina pectoris, or acute myocardial infarction, ICA, and revascularization. Results Among 300 patients allocated to the coronary CTA+CTP group, 41 (14%) were referred for ICA compared with 89 (30%) allocated to coronary CTA (p < 0.0001). The primary endpoint occurred in 50% of coronary CTA+CTP patients versus 48% of invasively examined patients (p = 0.85). The total number of revascularizations was significantly lower in the coronary CTA+CTP group compared to the coronary CTA group (n = 20 [7%] vs. n = 42 [14%]; p = 0.0045). At median follow-up of 1.5 years, the occurrence of secondary endpoints was similar in the 2 groups. Conclusions A post-discharge diagnostic strategy of coronary CTA+CTP safely reduces the need for invasive examination and treatment in patients suspected of having ischemic heart disease. (CArdiac cT in the treatment of acute CHest pain 2–Myocardial CT Perfusion [CATCH2]; NCT02014311) Graphical abstract [ABSTRACT FROM AUTHOR]
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- 2018
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38. Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study.
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Laursen, Peter Nørkjær, Holmvang, Lene, Lønborg, Jacob, Køber, Lars, Høfsten, Dan E., Helqvist, Steffen, Clemmensen, Peter, Kelbæk, Henning, Jørgensen, Erik, Lassen, Jens Flensted, Pedersen, Frants, Høi-Hansen, Thomas, Therkelsen, Christian Juhl, Tilsted, Hans-Henrik, Jensen, Lisette Okkels, Nepper-Christensen, Lars, Sadjadieh, Golnaz, and Engstrøm, Thomas
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Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality.Results: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001).Conclusions: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population. [ABSTRACT FROM AUTHOR]- Published
- 2018
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39. Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk
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Thyregod, Hans Gustav Hørsted, Ihlemann, Nikolaj, Jørgensen, Troels Højsgaard, Nissen, Henrik, Kjeldsen, Bo Juel, Petursson, Petur, Chang, Yanping, Franzen, Olaf Walter, Engstrøm, Thomas, Clemmensen, Peter, Hansen, Peter Bo, Andersen, Lars Willy, Steinbruüchel, Daniel Andreas, Olsen, Peter Skov, and Søndergaard, Lars
- Abstract
Supplemental Digital Content is available in the text.
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- 2019
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40. Importance of elevated heart rate in the very early phase of ST-segment elevation myocardial infarction: Results from the DANAMI-3 trial
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Nepper-Christensen, Lars, Lønborg, Jacob, Ahtarovski, Kiril A, Høfsten, Dan E, Kyhl, Kasper, Schoos, Mikkel M, Göransson, Christoffer, Laursen, Peter N, Sadjadieh, Golnaz, Ghotbi, Adam Ali, Bertelsen, Litten, Køber, Lars, Helqvist, Steffen, Pedersen, Frants, Jørgensen, Erik, Kelbæk, Henning, Vejlstrup, Niels, Holmvang, Lene, and Engstrøm, Thomas
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Background: Elevated heart rate is associated with poor clinical outcome in patients with acute myocardial infarction. However, in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention the importance of elevated heart rate in the very early phase remains unknown. We evaluated the impact of elevated heart rate in the very early pre-hospital phase of ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention on cardiovascular magnetic resonance markers of reperfusion success and clinical outcome.Methods: In this DANAMI-3 substudy, 1560 ST-segment elevation myocardial infarction patients in sinus rhythm without cardiogenic shock were included in the analyses of clinical outcome and 796 patients underwent cardiovascular magnetic resonance to evaluate area at risk, infarct size and left ventricular ejection fraction. Heart rate was assessed on the first electrocardiogram with ST-elevation (time of diagnosis).Results: Despite equal area at risk (33%±11 versus 36%±16, p=0.174) patients with a pre-hospital heart rate ⩾100 beats per minute developed larger infarcts (19% (interquartile range, 9–17) versus 11% (interquartile range, 10–28), p=0.001) and a lower left ventricular ejection fraction (54%±12 versus 58%±9, p=0.047). Pre-hospital heart rate ⩾100 beats per minute was independently associated with an increased risk of all-cause mortality and heart failure (hazard ratio 2.39 (95% confidence interval 1.58–3.62), p<0.001).Conclusions: Very early heart rate ⩾100 beats per minute in ST-segment elevation myocardial infarction was independently associated with larger infarct size, reduced left ventricular ejection fraction and an increased risk of all-cause mortality and heart failure, and thus serves as an easily obtainable and powerful tool to identify ST-segment elevation myocardial infarction patients at high risk.
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- 2019
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41. Early Versus Standard Care Invasive Examination and Treatment of Patients With Non-ST-Segment Elevation Acute Coronary Syndrome
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Kofoed, Klaus F., Kelbæk, Henning, Hansen, Peter Riis, Torp-Pedersen, Christian, Høfsten, Dan, Kløvgaard, Lene, Holmvang, Lene, Helqvist, Steffen, Jørgensen, Erik, Galatius, Søren, Pedersen, Frants, Bang, Lia, Saunamaki, Kari, Clemmensen, Peter, Linde, Jesper J., Heitmann, Merete, Wendelboe Nielsen, Olav, Raymond, Ilan E., Kristiansen, Ole Peter, Svendsen, Ida Hastrup, Bech, Jan, Dominguez Vall-Lamora, Maria Helena, Kragelund, Charlotte, Hansen, Thomas Fritz, Dahlgaard Hove, Jens, Jørgensen, Tem, Fornitz, Gitte G., Steffensen, Rolf, Jurlander, Birgit, Abdulla, Jawdat, Lyngbæk, Stig, Elming, Hanne, Therkelsen, Susette Krohn, Abildgaard, Ulrik, Jensen, Jan Skov, Gislason, Gunnar, Køber, Lars V., and Engstrøm, Thomas
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Supplemental Digital Content is available in the text.
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- 2018
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42. Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial.
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Fröbert, Ole, Götberg, Matthias, Angerås, Oskar, Jonasson, Lena, Erlinge, David, Engstrøm, Thomas, Persson, Jonas, Jensen, Svend E., Omerovic, Elmir, James, Stefan K., Lagerqvist, Bo, Nilsson, Johan, Kåregren, Amra, Moer, Rasmus, Yang, Cao, Agus, David B., Erglis, Andrejs, Jensen, Lisette O., Jakobsen, Lars, and Christiansen, Evald H.
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Background: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI.Methods/design: The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year.Implications: The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. [ABSTRACT FROM AUTHOR]- Published
- 2017
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43. Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease.
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Lønborg, Jacob, Engstrøm, Thomas, Kelbæk, Henning, Helqvist, Steffen, Kløvgaard, Lene, Holmvang, Lene, Pedersen, Frants, Jørgensen, Erik, Saunamäki, Kari, Clemmensen, Peter, De Backer, Ole, Ravkilde, Jan, Tilsted, Hans-Henrik, Villadsen, Anton Boel, Aarøe, Jens, Jensen, Svend Eggert, Raungaard, Bent, Køber, Lars, and Høfsten, Dan Eik
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Background--The impact of disease severity on the outcome after complete revascularization in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. The objective of this post hoc study was to evaluate the impact of number of diseased vessel, lesion location, and severity of the noninfarct-related stenosis on the effect of fractional flow reserve-guided complete revascularization. Methods and Results--In the DANAMI-3-PRIMULTI study (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization), we randomized 627 ST-segment-elevation myocardial infarction patients to fractional flow reserve-guided complete revascularization or infarct-related percutaneous coronary intervention only. In patients with 3-vessel disease, fractional flow reserve-guided complete revascularization reduced the primary end point (all-cause mortality, reinfarction, and ischemia-driven revascularization; hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.17-0.64; P=0.001), with no significant effect in patients with 2-vessel disease (HR, 0.77; 95% CI, 0.47-1.26; P=0.29; P for interaction =0.046). A similar effect was observed in patients with diameter stenosis ≥90% of noninfarct-related arteries (HR, 0.32; 95% CI, 0.18-0.62; P=0.001), but not in patients with less severe lesions (HR, 0.72; 95% CI, 0.44-1.19; P=0.21; P for interaction =0.06). The effect was most pronounced in patients with 3-vessel disease and noninfarct-related stenoses ≥90%, and in this subgroup, there was a nonsignificant reduction in the end point of mortality and reinfarction (HR, 0.32; 95% CI, 0.08-1.32; P=0.09). Proximal versus distal location did not influence the benefit from complete revascularization. [ABSTRACT FROM AUTHOR]
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- 2017
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44. Association Between Early Q Waves and Reperfusion Success in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention.
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Topal, Divan Gabriel, Lønborg, Jacob, Ahtarovski, Kiril Aleksov, Nepper-Christensen, Lars, Helqvist, Steffen, Holmvang, Lene, Pedersen, Frants, Clemmensen, Peter, Saünamaki, Kari, Jørgensen, Erik, Kyhl, Kasper, Ghotbi, Ali, Schoos, Mikkel Malby, Göransson, Christoffer, Bertelsen, Litten, Høfsten, Dan, Køber, Lars, Kelbæk, Henning, Vejlstrup, Niels, and Engstrøm, Thomas
- Abstract
Background--Pathological early Q waves (QW) are associated with adverse outcomes in patients with ST-segment-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) may therefore be less beneficial in patients with QW than in patients without QW. Myocardial salvage index and microvascular obstruction (MVO) are markers for reperfusion success. Thus, to clarify the benefit from primary PCI in STEMI patients with QW, we examined the association between baseline QW and myocardial salvage index and MVO in STEMI patients treated with primary PCI. Methods and Results--The ECG was assessed before primary PCI for the presence of QW (early) in 515 STEMI patients. The patients underwent a cardiac magnetic resonance imaging scan at day 1 (interquartile range [IQR], 1-1) and again at day 92 (IQR, 89-96). Early QW was observed in 108 (21%) patients and was related to smaller final myocardial salvage index (0.59 [IQR, 0.39-0.69] versus 0.65 [IQR, 0.46-0.84]; P<0.001) and larger MVO (1.4 [IQR, 0.0-5.4] versus 0.0 [IQR, 0.0-2.4]; P<0.001) compared with non-QW. QW remained associated with both final myocardial salvage index (β=-0.12; P=0.03) and MVO (β=0.18; P=0.001) after adjusting for potential confounders. Conclusions--Patients presenting with their first STEMI and early QW in the ECG had smaller myocardial salvage index and more extensive MVO than non-QW despite treatment within 12 hours after symptom onset. However, final myocardial salvage index in patients with QW was substantial, and patients with QW still benefit from primary PCI. [ABSTRACT FROM AUTHOR]
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- 2017
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45. The prevalence and prognostic importance of possible familial hypercholesterolemia in patients with myocardial infarction.
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Rerup, Sofie Aagaard, Bang, Lia E., Mogensen, Ulrik M., Engstrøm, Thomas, Jørgensen, Erik, Pedersen, Frants, Torp-Pedersen, Christian, Gislason, Gunnar, James, Stefan, Hagström, Emil, Køber, Lars, and Fosbøl, Emil L.
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Aims: Familial hypercholesterolemia (FH) is a common genetic disorder causing accelerated atherosclerosis and premature cardiovascular disease. The aim of this study was to examine the prevalence and prognostic significance of possible FH in patients with myocardial infarction (MI).Methods and Results: By individual-level linkage of data from the Eastern Danish Heart Registry and national administrative registries, a study population of patients referred for coronary angiography due to MI was selected. The study population was divided into "unlikely FH" and "possible FH" based on the Dutch Lipid Clinic Network criteria, which included a plasma low-density lipoprotein cholesterol (LDL-C) and age for onset of cardiac disease. A score of ≥3 points was used as the cutpoint between the 2 groups. Among the study population of 13,174 MI patients, 1,281 (9.7%) had possible FH. These patients were younger (59.1 vs 65.7 years, P ≤ .0001), had similar levels of comorbidities, and were treated more aggressively with cholesterol-lowering drugs compared with patients with unlikely FH. During a median of 3.3 years of follow-up, the unadjusted and adjusted event rates of recurrent MI were higher in patients with possible FH compared with unlikely FH (16% vs 11%, adjusted hazard ratio 1.28, 95% CI 1.09-1.51, P = .003.). Differences in adjusted all-cause mortality were not statistically significant (17% vs 23%, adjusted hazard ratio 0.89 [0.74-1.04], P = .1).Conclusion: We found that MI patients with possible FH have higher risk of recurrent MI but similar risk of mortality compared with unlikely FH patients. Further studies on secondary prevention are warranted. [ABSTRACT FROM AUTHOR]- Published
- 2016
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46. Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial
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Engstrøm, Thomas, Nepper-Christensen, Lars, Helqvist, Steffen, Kløvgaard, Lene, Holmvang, Lene, Jørgensen, Erik, Pedersen, Frants, Saunamaki, Kari, Tilsted, Hans-Henrik, Steensberg, Adam, Fabricius, Søren, Mouritzen, Ulrik, Vejlstrup, Niels, Ahtarovski, Kiril A, Goransson, Christoffer, Bertelsen, Litten, Kyhl, Kasper, Olivecrona, Goran, Kelbæk, Henning, Lassen, Jens Flensted, Køber, Lars, and Lønborg, Jacob
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ObjectivesReperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI.MethodsIn addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0–1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage evaluated by cardiac MRI after 3 months.ResultsFrom November 2013 to August 2015, a total of 585 patients were randomly enrolled in the trial. Imaging criteria were fulfilled for 79 (high dose), 80 (low dose) and 84 (placebo) patients eligible for the per-protocol analysis. Danegaptide did not affect the myocardial salvage index (danegaptide high (63.9±14.9), danegaptide low (65.6±15.6) and control (66.7±11.7), P=0.40), final infarct size (danegaptide high (19.6±11.4 g), danegaptide low (18.6±9.6 g) and control (21.4±15.0 g), P=0.88) or left ventricular ejection fraction (danegaptide high (53.9%±9.5%), danegaptide low (52.7%±10.3%) and control (52.1%±10.9%), P=0.64). There was no difference between groups with regard to clinical outcome.ConclusionsAdministration of danegaptide to patients with STEMI did not improve myocardial salvage.Trial registration numberNCT01977755; Pre-results.
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- 2018
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47. Cochrane corner: complete versus culprit-only revascularisation in ST segment elevation myocardial infarction with multivessel disease
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Bravo, Claudio A, Hirji, Sameer A, Bhatt, Deepak L, Gluud, Christian, Faxon, David P, Ohman, E Magnus, Kaneko, Tsuyoshi, Engstrøm, Thomas, Høfsten, Dan Eik, and Brennan, J Matthew
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- 2018
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48. Myocardial perfusion 320-row multidetector computed tomography-guided treatment strategy for the clinical management of patients with recent acute-onset chest pain: Design of the CArdiac cT in the treatment of acute CHest pain (CATCH)-2 randomized...
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Sørgaard, Mathias, Linde, Jesper J., Hove, Jens D., Petersen, Jan R., Jørgensen, Tem B.S., Abdulla, Jawdat, Heitmann, Merete, Kragelund, Charlotte, Hansen, Thomas Fritz, Udholm, Patricia M., Pihl, Christian, Kühl, J. Tobias, Engstrøm, Thomas, Jensen, Jan Skov, Høfsten, Dan E., Kelbæk, Henning, and Kofoed, Klaus F.
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Aims: Patients admitted with chest pain are a diagnostic challenge because the majority does not have coronary artery disease (CAD). Assessment of CAD with coronary computed tomography angiography (CCTA) is safe, cost-effective, and accurate, albeit with a modest specificity. Stress myocardial computed tomography perfusion (CTP) has been shown to increase the specificity when added to CCTA, without lowering the sensitivity. This article describes the design of a randomized controlled trial, CATCH-2, comparing a clinical diagnostic management strategy of CCTA alone against CCTA in combination with CTP.Methods: Patients with acute-onset chest pain older than 50 years and with at least one cardiovascular risk factor for CAD are being prospectively enrolled to this study from 6 different clinical sites since October 2013. A total of 600 patients will be included. Patients are randomized 1:1 to clinical management based on CCTA or on CCTA in combination with CTP, determining the need for further testing with invasive coronary angiography including measurement of the fractional flow reserve in vessels with coronary artery lesions. Patients are scanned with a 320-row multidetector computed tomography scanner. Decisions to revascularize the patients are taken by the invasive cardiologist independently of the study allocation. The primary end point is the frequency of revascularization. Secondary end points of clinical outcome are also recorded.Discussion: The CATCH-2 will determine whether CCTA in combination with CTP is diagnostically superior to CCTA alone in the management of patients with acute-onset chest pain. [ABSTRACT FROM AUTHOR]- Published
- 2016
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49. Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.
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Søndergaard, Lars, Steinbrüchel, Daniel Andreas, Ihlemann, Nikolaj, Nissen, Henrik, Kjeldsen, Bo Juel, Petursson, Petur, Anh Thuc Ngo, Olsen, Niels Thue, Yanping Chang, Franzen, Olaf Walter, Engstrøm, Thomas, Clemmensen, Peter, Olsen, Peter Skov, and Thyregod, Hans Gustav Hørsted
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Background--The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. Methods and Results--Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm2 at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). Conclusions--Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. [ABSTRACT FROM AUTHOR]
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- 2016
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50. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial
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Engstrøm, Thomas, Kelbæk, Henning, Helqvist, Steffen, Høfsten, Dan Eik, Kløvgaard, Lene, Clemmensen, Peter, Holmvang, Lene, Jørgensen, Erik, Pedersen, Frants, Saunamaki, Kari, Ravkilde, Jan, Tilsted, Hans-Henrik, Villadsen, Anton, Aarøe, Jens, Jensen, Svend Eggert, Raungaard, Bent, Bøtker, Hans E., Terkelsen, Christian J., Maeng, Michael, Kaltoft, Anne, Krusell, Lars R., Jensen, Lisette O., Veien, Karsten T., Kofoed, Klaus Fuglsang, Torp-Pedersen, Christian, Kyhl, Kasper, Nepper-Christensen, Lars, Treiman, Marek, Vejlstrup, Niels, Ahtarovski, Kiril, Lønborg, Jacob, and Køber, Lars
- Abstract
IMPORTANCE: Ischemic postconditioning of the heart during primary percutaneous coronary intervention (PCI) induced by repetitive interruptions of blood flow to the ischemic myocardial region immediately after reopening of the infarct-related artery may limit myocardial damage. OBJECTIVE: To determine whether ischemic postconditioning can improve the clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, randomized clinical trial, patients with onset of symptoms within 12 hours, STEMI, and thrombolysis in myocardial infarction (TIMI) grade 0-1 flow in the infarct-related artery at arrival were randomized to conventional PCI or postconditioning. Inclusion began on March 21, 2011, through February 2, 2014, and follow-up was completed on February 2, 2016. Analysis was based on intention to treat. INTERVENTIONS: Patients were randomly allocated 1:1 to conventional primary PCI, including stent implantation, or postconditioning performed as 4 repeated 30-second balloon occlusions followed by 30 seconds of reperfusion immediately after opening of the infarct-related artery and before stent implantation. MAIN OUTCOME AND MEASURES: A combination of all-cause death and hospitalization for heart failure. RESULTS: During the inclusion period, 1234 patients (975 men [79.0%] and 259 women [21.0%]; mean [SD] age, 62 [11] years) underwent randomization in the trial. Median follow-up was 38 months (interquartile range, 24-58 months). The primary outcome occurred in 69 patients (11.2%) who underwent conventional primary PCI and in 65 (10.5%) who underwent postconditioning (hazard ratio, 0.93; 95% CI, 0.66-1.30; P = .66). The hazard ratios were 0.75 (95% CI, 0.49-1.14; P = .18) for all-cause death and 0.99 (95% CI, 0.60-1.64; P = .96) for heart failure. CONCLUSIONS AND RELEVANCE: Routine ischemic postconditioning during primary PCI failed to reduce the composite outcome of death from any cause and hospitalization for heart failure in patients with STEMI and TIMI grade 0-1 flow at arrival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01435408
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- 2017
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