Marco Valgimigli1, Andrea Gagnor2, Paolo Calabró3, Enrico Frigoli4, Sergio Leonardi5, Tiziana Zaro6, Paolo Rubartelli7, Carlo Briguori8, Giuseppe Andò9, Alessandra Repetto5, Ugo Limbruno10, Bernardo Cortese11, Paolo Sganzerla12, Alessandro Lupi13, Mario Galli14, Salvatore Colangelo15, Salvatore Ierna16, Arturo Ausiello17, Patrizia Presbitero18, Gennaro Sardella19, Ferdinando Varbella2, Giovanni Esposito20, Andrea Santarelli21, Simone Tresoldi22, Marco Nazzaro23, Antonio Zingarelli24, Nicoletta de Cesare25, Stefano Rigattieri26, Paolo Tosi27, Cataldo Palmieri28, Salvatore Brugaletta29, Sunil V Rao30, Dik Heg31, Martina Rothenbühler32, Pascal Vranckx33, Peter Jüni34. 1. Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands. Electronic address: m.valgimigli@erasmusmc.nl. 2. Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy. 3. Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy. 4. Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy; EUSTRATEGY Association, Forli', Italy. 5. UOC Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 6. A.O. Ospedale Civile di Vimercate (MB), Vimercate, Italy. 7. Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy. 8. Clinica Mediterranea, Naples, Italy. 9. Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino", University of Messina, Messina, Italy. 10. UO Cardiologia, ASL 9 Grosseto, Grosseto, Italy. 11. Ospedale Fate bene Fratelli, Milan, Italy. 12. AO Ospedale Treviglio-Caravaggio, Treviglio BG, Italy. 13. University Hospital "Maggiore della Carità", Novara, Italy. 14. Ospedaliera Sant'Anna, Como, Italy. 15. San Giovanni Bosco Hospital, Turin, Italy. 16. Ospedale Sirai-Carbonia, Carbonia, Italy. 17. Casa di Cura Villa Verde, Taranto, Italy. 18. IRCCS Humanitas, Rozzano, Italy. 19. Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy. 20. Division of Cardiology-Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 21. Cardiovascular Department, Infermi Hospital, Rimini, Italy. 22. A.O. Ospedale di Desio (MB), Desio, Italy. 23. San Camillo-Forlanini, Rome, Italy. 24. IRCCS AOU San Martino, Genoa, Italy. 25. Policlinico San Marco, Zingonia, Italy. 26. Interventional Cardiology Sandro Pertini Hospital, Rome, Italy. 27. Mater Salutis Hospital-Legnago, Verona, Italy. 28. Ospedale Pasquinucci, Massa, Italy. 29. Hospital Clinic, University of Barcelona, Thorax Institute, Department of Cardiology, Barcelona, Spain. 30. Duke Clinical Research Institute, Durham, NC, USA. 31. Clinical Trials Unit, University of Bern, Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. 32. Clinical Trials Unit, University of Bern, Bern, Switzerland. 33. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium. 34. Clinical Trials Unit, University of Bern, Bern, Switzerland; Institute of Primary Health Care, University of Bern, Bern, Switzerland.
Abstract
BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access forcoronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.
RCT Entities:
BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.
Authors: Emanuele Barbato; Paul J Barton; Jozef Bartunek; Sally Huber; Borja Ibanez; Daniel P Judge; Enrique Lara-Pezzi; Craig M Stolen; Angela Taylor; Jennifer L Hall Journal: J Cardiovasc Transl Res Date: 2015-10-09 Impact factor: 4.132
Authors: Mert İlker Hayıroğlu; Tufan Çınar; Burhan Bıçakçı; İbrahim Dağaşan; Koray Demir; Muhammed Keskin; Ahmet Öz; Zafer Işılak; Nurgül Keser; Mehmet Uzun Journal: Int J Cardiovasc Imaging Date: 2018-03-17 Impact factor: 2.357