Italo Porto1, Leonardo Bolognese2, Dariusz Dudek3, Patrick Goldstein4, Christian Hamm5, Jean-François Tanguay6, Jurrien Ten Berg7, Petr Widimský8, Nicolas Le Gall9, Anthony J Zagar10, LeRoy A LeNarz10, Debra Miller10, Gilles Montalescot11. 1. Interventional Cardiology Unit, Gemelli Hospital, Catholic University of the Sacred Heart, Rome, Italy. 2. Cardiovascular and Neurological Department, Azienda Ospedaliera Arezzo, Arezzo, Italy. Electronic address: leonardobolognese@hotmail.com. 3. Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland. 4. SAMU and Emergency Department, Lille University Hospital, Lille, France. 5. Kerckhoff Heart and Thoraxcenter, Bad Nauheim and Medical Clinic I, University of Giessen, Giessen, Germany. 6. Montreal Heart Institute, Université de Montréal, Montreal, Ontario, Canada. 7. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands. 8. Third Medical Faculty of Charles University and University Hospital Royal Vineyards, Prague, Czech Republic. 9. inVentiv Health Clinical Canada, Burlington, Ontario, Canada. 10. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana. 11. Université Paris 06, ACTION Study Group, INSERM-UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière University Hospital, Paris, France.
Abstract
OBJECTIVES: This study assessed whether the choice of vascular access site influenced outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients enrolled in the ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction NCT01015287). BACKGROUND:Transfemoral access (TFA) has been associated with the risk of bleeding and increased mortality that is elevated compared to transradial access (TRA) in acute coronary syndromes, although less consistently in NSTE acute coronary syndrome (NSTE-ACS) than in STE-ACS. METHODS: The ACCOAST study evaluated a prasugrel loading dose of 60 mg given at the start of percutaneous coronary intervention (PCI) versus a split loading dose of 30 mg given at the time of diagnosis of NSTE-ACS (prior to coronary angiography), followed by 30 mg given at the start of PCI. In the study, choice of access site was at the investigator's discretion. We compared ischemic and bleeding outcomes with TFA versus those with TRA, using propensity score correction. RESULTS:Of 4,033 patients, 1,711 (42%) underwent TRA. Use of TRA varied widely by country. TFA was not associated with significant increases in noncoronary bypass graft (CABG)-related thrombolysis in myocardial infarction (TIMI) (hazard ratio [HR] for TFA = 1.46; 95% confidence interval [CI]: 0.59 to 3.62; p = 0.42), nor in GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) or STEEPLE (Safety and Efficacy of Enoxaparin in PCI) major bleeding after propensity score correction. TFA, however, increased combined non-CABG TIMI major or minor bleeding (HR for TFA = 2.34; 95% CI: 1.17 to 4.69; p = 0.017). Primary ischemic outcomes did not differ by access site, albeit individual endpoint analysis suggested an association between TFA with an increase in urgent revascularizations and reduced risk of procedure-related stroke. CONCLUSIONS: In the ACCOAST trial, TFA did not significantly increase TIMI major bleeding, although TRA was associated with a reduction in TIMI major or minor bleeding. Further study is needed to determine whether wider application of radial approach to NSTE-ACS patients at high risk for bleeding improves overall outcomes. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).
RCT Entities:
OBJECTIVES: This study assessed whether the choice of vascular access site influenced outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients enrolled in the ACCOAST (A Comparison of prasugrel at the time of percutaneous Coronary intervention Or as pre-treatment At the time of diagnosis in patients with non-ST-segment elevation myocardial infarction NCT01015287). BACKGROUND: Transfemoral access (TFA) has been associated with the risk of bleeding and increased mortality that is elevated compared to transradial access (TRA) in acute coronary syndromes, although less consistently in NSTE acute coronary syndrome (NSTE-ACS) than in STE-ACS. METHODS: The ACCOAST study evaluated a prasugrel loading dose of 60 mg given at the start of percutaneous coronary intervention (PCI) versus a split loading dose of 30 mg given at the time of diagnosis of NSTE-ACS (prior to coronary angiography), followed by 30 mg given at the start of PCI. In the study, choice of access site was at the investigator's discretion. We compared ischemic and bleeding outcomes with TFA versus those with TRA, using propensity score correction. RESULTS: Of 4,033 patients, 1,711 (42%) underwent TRA. Use of TRA varied widely by country. TFA was not associated with significant increases in noncoronary bypass graft (CABG)-related thrombolysis in myocardial infarction (TIMI) (hazard ratio [HR] for TFA = 1.46; 95% confidence interval [CI]: 0.59 to 3.62; p = 0.42), nor in GUSTO (Global Utilization Of Streptokinase and Tpa for Occluded arteries) or STEEPLE (Safety and Efficacy of Enoxaparin in PCI) major bleeding after propensity score correction. TFA, however, increased combined non-CABG TIMI major or minor bleeding (HR for TFA = 2.34; 95% CI: 1.17 to 4.69; p = 0.017). Primary ischemic outcomes did not differ by access site, albeit individual endpoint analysis suggested an association between TFA with an increase in urgent revascularizations and reduced risk of procedure-related stroke. CONCLUSIONS: In the ACCOAST trial, TFA did not significantly increase TIMI major bleeding, although TRA was associated with a reduction in TIMI major or minor bleeding. Further study is needed to determine whether wider application of radial approach to NSTE-ACS patients at high risk for bleeding improves overall outcomes. (A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction [ACCOAST]; NCT01015287).
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