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Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial
Open accessAbstract
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.
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Cites
Authors/Task Force Members, Steg, P. G., James, S. K., Atar, D., Badano, L. P., Lundqvist, C. B., Borger, M. A., Di Mario, C., Dickstein, K., Ducrocq, G., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs215 · Cited by 6,829
Self-citationClinical End Points in Coronary Stent Trials: A Case for Standardized Definitions
Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G.-A., Gabriel Steg, P., Morel, M.-A., Mauri, L., Vranckx, P., et al. (2007) · Circulation · doi:10.1161/circulationaha.106.685313 · Cited by 5,497
Self-citationBraunwald, E., Antman, E. M., Beasley, J. W., Califf, R. M., Cheitlin, M. D., Hochman, J. S., Jones, R. H., Kereiakes, D., Kupersmith, J., Levin, T. N., et al. (2000) · Circulation · doi:10.1161/01.cir.102.10.1193 · Cited by 4,487
WRITING COMMITTEE MEMBERS, Smith, S. C., Feldman, T. E., Hirshfeld, J. W., Jacobs, A. K., Kern, M. J., King, S. B., Morrison, D. A., O’Neill, W. W., Schaff, H. V., et al. (2006) · Circulation · doi:10.1161/circulationaha.105.170815 · Cited by 2,218
Jolly, S. S., Yusuf, S., Cairns, J., Niemelä, K., Xavier, D., Widimsky, P., Budaj, A., Niemelä, M., Valentin, V., Lewis, B. S., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60404-2 · Cited by 2,125
Self-citationBivalirudin during Primary PCI in Acute Myocardial Infarction
Stone, G. W., Witzenbichler, B., Guagliumi, G., Peruga, J. Z., Brodie, B. R., Dudek, D., Kornowski, R., Hartmann, F., Gersh, B. J., Pocock, S. J., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0708191 · Cited by 1,867
2012 Writing Committee Members, Jneid, H., Anderson, J. L., Wright, R. S., Adams, C. D., Bridges, C. R., Casey, D. E., Ettinger, S. M., Fesmire, F. M., Ganiats, T. G., et al. (2012) · Circulation · doi:10.1161/cir.0b013e318256f1e0 · Cited by 1,090
King, S. B., Smith, S. C., Hirshfeld, J. W., Jacobs, A. K., Morrison, D. A., Williams, D. O., 2005 WRITING COMMITTEE MEMBERS, Smith, S. C., Feldman, T. E., Hirshfeld, J. W., et al. (2008) · Circulation · doi:10.1161/circulationaha.107.188208 · Cited by 1,014
Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures
Agostoni, P., Biondi-Zoccai, G. G. L., De Benedictis, M. L., Rigattieri, S., Turri, M., Anselmi, M., Vassanelli, C., Zardini, P., Louvard, Y., & Hamon, M. (2004) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2004.04.034 · Cited by 993
Self-citationRadial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome
Romagnoli, E., Biondi-Zoccai, G., Sciahbasi, A., Politi, L., Rigattieri, S., Pendenza, G., Summaria, F., Patrizi, R., Borghi, A., Di Russo, C., et al. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.06.017 · Cited by 974
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Self-citationRoffi, M., Patrono, C., Collet, J.-P., Mueller, C., Valgimigli, M., Andreotti, F., Bax, J. J., Borger, M. A., Brotons, C., Chew, D. P., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehv320 · Cited by 8,261
Self-citation2018 ESC/EACTS guidelines on myocardial revascularization
Neumann, F.-J., Sousa-Uva, M., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., Byrne, R. A., Collet, J.-P., Falk, V., Head, S. J., et al. (2019) · European Heart Journal · doi:10.1093/eurheartj/ehy394 · Cited by 7,167
Self-citation2023 ESC Guidelines for the management of acute coronary syndromes
Byrne, R. A., Rossello, X., Coughlan, J. J., Barbato, E., Berry, C., Chieffo, A., Claeys, M. J., Dan, G.-A., Dweck, M. R., Galbraith, M., et al. (2023) · European Heart Journal · doi:10.1093/eurheartj/ehad191 · Cited by 5,333
Self-citationAboyans, V., Ricco, J.-B., Bartelink, M.-L. E. L., Björck, M., Brodmann, M., Cohnert, T., Collet, J.-P., Czerny, M., De Carlo, M., Debus, S., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehx095 · Cited by 3,293
Metadata
- Authors
- 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, G., Santarelli, A., Tresoldi, S., Nazzaro, M., Zingarelli, A., de Cesare, N., Rigattieri, S., Tosi, P., Palmieri, C., Brugaletta, S., Rao, S. V., Heg, D., Rothenbühler, M., Vranckx, P., & Jüni, P.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 385
- Issue
- 9986
- Pages
- 2465-2476
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2112255365
- Cited by
- 1,303
- References
- 28
- FWCI
- 116.31
- Type
- journal article
- Language
- en
- Open access
- green
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- The paper
- 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., . . . Jüni, P. (2015). Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. The Lancet. https://doi.org/10.1016/s0140-6736(15)60292-6
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