1. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial
- Author
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Petronio, Anna, Valgimigli, Marco, Gagnor, Andrea, Calabró, Paolo, Frigoli, Enrico, Leonardi, Sergio, Zaro, Tiziana, Rubartelli, Paolo, Briguori, Carlo, Andò, Giuseppe, Repetto, Alessandra, Limbruno, Ugo, Cortese, Bernardo, Sganzerla, Paolo, Lupi, Alessandro, Galli, Mario, Colangelo, Salvatore, Ierna, Salvatore, Ausiello, Arturo, Presbitero, Patrizia, Sardella, Gennaro, Varbella, Ferdinando, Esposito, Giovanni, Santarelli, Andrea, Tresoldi, Simone, Nazzaro, Marco, Zingarelli, Antonio, De Cesare, Nicoletta, Rigattieri, Stefano, Tosi, Paolo, Palmieri, Cataldo, Brugaletta, Salvatore, Rao, Sunil V, Heg, Dik, Rothenbühler, Martina, Vranckx, Pascal, Jüni, Peter, Matrix, Investigators, Valgimigli, M, Gagnor, A, Calabró, P, Frigoli, E, Leonardi, S, Zaro, T, Rubartelli, P, Briguori, C, Andò, G, Repetto, A, Limbruno, U, Cortese, B, Sganzerla, P, Lupi, A, Galli, M, Colangelo, S, Ierna, S, Ausiello, A, Presbitero, P, Sardella, G, Varbella, F, Esposito, Giovanni, Santarelli, A, Tresoldi, S, Nazzaro, M23, Zingarelli, A, de Cesare, N, Rigattieri, S, Tosi, P, Palmieri, C, Brugaletta, S, Rao, Heg, Rothenbühler, Vranckx, J. ü. n., I., Calabro', Paolo, Esposito, G, Nazzaro, M, Rao, Sv, Heg, D, Rothenbühler, M, Vranckx, P, Jüni, P, Matrix, Investigators, and Cardiology
- Subjects
Male ,angiocardiography ,procedure ,Prasugrel ,medicine.medical_treatment ,Blood Loss, Surgical ,Femoral artery ,EMTREE drug terms: acetylsalicylic acid ,heparin ,Coronary Angiography ,Peripheral ,cause of death ,hirulog ,cardiovascular disease ,Surgical ,femoral acce ,Medicine ,treatment outcome MeSH: Acute Coronary Syndrome ,Blood Loss ,acute coronary syndromes ,Myocardial infarction ,610 Medicine & health ,Stroke ,catheterization ,comparative study ,coronary artery bypass surgery ,Medicine (all) ,non st segment elevation acute coronary syndrome ,enoxaparin ,General Medicine ,femoral artery ,Survival Rate ,aged ,myocardial infarction ,female ,radial artery ,Treatment Outcome ,priority journal ,Cardiology ,cerebrovascular accident ,Ticagrelor ,360 Social problems & social services ,medicine.drug ,Human ,Acute Coronary Syndrome ,Aged ,Catheterization, Peripheral ,Cause of Death ,Female ,Humans ,Percutaneous Coronary Intervention ,Femoral Artery ,Radial Artery ,medicine.medical_specialty ,Acute coronary syndrome ,vascular acce ,radial acce ,Article ,ticagrelor ,acute coronary syndrome ,coronary artery bypass graft ,medicine.artery ,Internal medicine ,adverse effect ,invasive management ,controlled study ,Radial artery ,Acute coronary syndromes ,radial access, myocardial infarction ,outcome assessment ,clopidogrel ,ST segment elevation myocardial infarction ,business.industry ,radial access ,fondaparinux ,Percutaneous coronary intervention ,medicine.disease ,major clinical study ,mortality ,Surgery ,prasugrel ,radial versus femoral access ,multicenter study ,randomized controlled trial ,troponin EMTREE medical terms: acute coronary syndrome ,business - Abstract
Summary 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. © 2015 Elsevier Ltd.
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- 2015