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Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.

Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.

Collaborators (188)

Salomone M, Frigoli E, Occhilupo P, Lodolini V, Monti M, Mazzone MG, Delos E, Caruso MT, Testa M, Ciociano N, Lazzero M, Gazzotti D, Cagliari L, Shahmohammadi L, Caiazza M, Virga V, Guerra E, Michalska E, Castellini S, Serino V, Visconti G, Pendenza G, Portolan M, Anzini M, Silvetti E, Coco T, Costa F, Ariotti S, Valli L, Adamo M, Marino M, Vranckx P, Leonardi S, Tricoci P, Jüni P, Rothenbühler M, Heg D, Valgimigli M, Gagnor A, Calabrò P, Rubartelli P, Garducci S, Andò G, Santarelli A, Galli M, Garbo R, Bramucci E, Ierna S, Briguori C, Cortese B, Limbruno U, Violini R, Presbitero P, de Cesare N, Sganzerla P, Ausiello A, Tosi P, Sardella G, Sabate' M, Brugaletta S, Saccone G, Vandoni P, Zingarelli A, Liso A, Rigattieri S, Pertini S, Di Lorenzo E, Vigna C, Palmieri C, Falcone C, De Caterina R, Caputo M, Chieti A, Esposito G, Lupi A, Mazzarotto P, Varbella F, Zaro T, Nazzaro M, Rao SV, van't Hof AW, Omerovic E, Calabrò P, van't Hof AW, Sabate' M, Brugaletta S, Omerovic E, Campo G, Valgimigli M, Uguccioni L, Nord M, Tamburino C, Presbitero P, Zavalloni-Parenti D, Ferrari F, Ceravolo R, Santarelli A, Tarantino F, Calabrò P, Pasquetto G, Esposito G, Ierna S, Casu G, Mameli S, Stochino ML, de Cesare N, Mazzarotto P, Cremonesi A, Saia F, Saccone G, Abate F, Limbruno U, Picchi A, Violini R, Nazzaro M, Garbo R, Colangelo S, Boccuzzi G, Tosi P, Guiducci V, Vigna C, Zingarelli A, Gagnor A, Varbella F, Garducci S, Zaro T, Tresoldi S, Vandoni P, Contarini M, Liso A, Dellavalle A, Curello S, Mangiacapra F, Rubartelli P, Evola R, Andò G, Palmieri C, Falcone C, Liistro F, Creaco M, Colombo A, Chieffo A, Perkan A, De Servi S, Fischetti D, Rigattieri S, Sciahbasi A, Pertini S, Pucci E, Romagnoli E, Moretti C, Moretti L, De Caterina R, Caputo M, Zimmarino M, Chieti A, Sganzerla P, Ferrario M, Bramucci E, Di Lorenzo E, Briguori C, Turturo M, Bonmassari R, Penzo C, Loi B, Mauro C, Ausiello A, Petronio AS, Gabrielli G, Sardella G, Micari A, Belloni F, Lupi A, Amico F, Comeglio M, Fresco C, van't Hof AW, Van Mieghem N, Diletti R, Regar E, Omerovic E, Brugaletta S, Sabaté M, Gómez JA, Díaz Fernández JF, Jiménez JR, Mainar V, de la Torre Hernandez JM.

Author information

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 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.

PMID:
25791214
DOI:
10.1016/S0140-6736(15)60292-6
[Indexed for MEDLINE]
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