Format

Send to:

Choose Destination
See comment in PubMed Commons below
Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.

Collaborators (308)

Jolly S, Mehta SR, Avezum A, Budaj A, Cairns J, Chrolavicius S, Diaz R, Dzavik V, Franzosi MG, Granger C, Joyner C, Keltai M, Lanas F, Lewis B, Niemelä K, Rao S, Steg PG, Valentin V, Widimsky P, Xavier D, Yusuf S, Ameriso S, Atra M, Avezum A, Borislav G, Budaj A, Czepiel A, DeRaedt H, Dorobantu M, Fodor G, Gross B, Guimaraes H, Healey J, Happola O, Hartikainen J, Himbert D, Hua Q, Joyner C, Kalvach P, Kim CJ, Kim JH, Laine M, Lamy A, Lang S, Lawrence M, Lewis B, Maggioni A, Narendra J, Peeters A, Penicka M, Piegas L, Pizzolato G, Renkin J, Rokoss M, Runev N, Stockins B, Steg PG, Widimsky P, Zaborski J, Zimlichman R, Yang Y, Sleight P, Anderson JL, DeMets D, Hirsch J, Holmes DR Jr, Johnstone DE, Chrolavicius S, Jedrzejowski B, Lawrence M, Cramp C, Horsman C, Robinson A, Afzal R, Gao P, Xu L, Manojlovic R, Mastrangelo L, Pasadyn E, Blake L, Chen W, Di Diodato S, Lehmann A, Sovereign T, Wasala L, Agrippa C, McClelland M, Berli M, Casali WP, Castellanos CR, Cigalini CM, Conci EC, Covelli G, Hominal MA, Majul CR, Lobo Marquez LL, Pacheco GJ, Payaslian M, Piskorz DL, Pomposiello JC, Salzberg SM, Sanchez A, Santos D, Zapata G, Worthley MI, Worthley SG, Thompson RP, Dangoisse V, Massart PE, Vincent M, Botelho V, Duda NT, Hilgemberg SA, Mangione JA, Mauro MF, Paiva MS, Reis G, Saporito WF, Saraiva JF, Seroqui MV, Timerman A, Tumelero RT, Doganov A, Jorgova-Makedonska J, Manoukov I, Mazhdrakov G, Penev, Anderson TI, Beliveau P, Berlingieri J, Bertrand OF, Boone RH, Brons SW, Cantor WJ, Chan YK, Charbonneau F, Cheema AN, Dery JP, Dzavik V, Fung AY, Gosselin G, Hussain F, Kass M, Kot T, Kutryk MJ, MacCallum DC, Nigro F, Pallie S, Pang JT, Phaneuf DC, Robbins K, Rokoss M, Salehian O, Saw J, Shariff S, Van Kieu C, Betancourt RL, Jofre CP, Flores EE, Lopetegui M, Chen J, Ma G, Han Y, Li T, Xu B, Wang J, Wang D, Wei M, Zhang S, Xie H, Bergovec M, Bocek O, Cech J, Cervinka P, Coufal Z, Groch L, Kala P, Linhart A, Ondrejcak R, Pechman V, Rezek M, Vojacek J, Airaksinen KJ, Eskola M, Kervinen K, Niemelä M, Pietilä M, Vikman S, Ylitalo A, Abergel H, Doyen D, Ducrocq G, Ferrari E, Grollier G, Andersen D, vom Dahl J, Dominick K, Hoffmann S, Laubenthal F, Nienaber C, Bakk S, Nagybaczoni B, Polgár P, Szigeti Z, Baxi H, Jiwani PA, Kodem DR, Kumar S, Kumar PR, Malipeddi BR, Naik SR, Parikh K, Pinto B, Rao MB, Shetty PK, Sinha N, Crean P, Arbel J, Jaffe R, Halabi M, Khader N, Marmor A, Roguin A, Turgeman Y, Cortese B, Limbruno U, Pivaccari G, Pirelli S, Rossi M, Santarelli A, Steffenino G, Tomasi L, Zanini R, Erglis A, Narbute I, Unikas R, Janavicius A, Peng CW, Arenas JL, Ledesma M, Rivera JJ, Ruiz A, Velasco MS, Devlin GP, Harding S, Achremczyk P, Dalkowski MP, Fudal M, Grzeski K, Kalarus Z, Kawecki D, Kopaczewski J, Kowalik V, Kuśnierz B, Maciejewski P, Miekus P, Panin P, Polonski L, Swierad M, Winek D, Wlodarczak AW, Wodniecki J, Wrzosek B, Capalneanu R, Berns S, Koh TH, Kurray P, Margozcy R, Rincon de Arellano A, Canton T, Carrillo P, Ferrer JA, Gomez I, Iñiguez A, Lekuona I, Macaya C, Moreu J, Nuñez JM, Bosa Ojeda F, Fernández-Ortiz A, López-Palop R, Sabate M, Sanchis J, Subinas A, Trillo R, Vargas Torres M, Vazquez N, Hot-Bjelak A, Harnek J, Henareh L, Welin-Berger B, Olivecrona GK, Baumbach A, de Belder A, Kesavan S, Malik I, Pitt M, Hildick-Smith D, Ariani MK, Chambers J, Fulton SK, Goldberg SL, Magno J, Mazhari R, Reiner JS, Saririan M, Singh N, Thew S.

Erratum in

  • Lancet. 2011 Apr 23;377(9775):1408.
  • Lancet. 2011 Jul 2;378(9785):30.

Abstract

BACKGROUND:

Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention.

METHODS:

The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273.

FINDINGS:

Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72-1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28-0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38-0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76-1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43-1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28-0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13-0·71; p=0·006).

INTERPRETATION:

Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach.

FUNDING:

Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.

Copyright © 2011 Elsevier Ltd. All rights reserved.

PMID:
21470671
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk