Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease
Stone, Gregg W; Sabik, Joseph F; Serruys, Patrick W; Simonton, Charles A; Généreux, Philippe; Puskas, John; Kandzari, David E; Morice, Marie-Claude; Lembo, Nicholas; Brown, W Morris; Taggart, David P; Banning, Adrian; Merkely, Béla; Horkay, Ferenc; Boonstra, Piet W; van Boven, Ad J; Ungi, Imre; Bogáts, Gabor; Mansour, Samer; Noiseux, Nicolas; Sabaté, Manel; Pomar, José; Hickey, Mark; Gershlick, Anthony; Buszman, Pawel; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Dressler, Ovidiu; Kosmidou, Ioanna; Mehran, Roxana; Pocock, Stuart J; Kappetein, A Pieter; van Es, Gerrit-Anne; Leon, Martin B; Gersh, Bernard; Chaturvedi, Seemant; Kint, Peter-Paul; Valgimigli, Marco; Colombo, Antonio; Costa, Marco; Di Mario, Carlo; Ellis, Stephen; Fajadet, Jean; Fearon, William; Kereiakes, Dean; Makkar, Raj; Mintz, Gary S; Moses, Jeffrey W; Teirstein, Paul; Ruel, Marc; Sergeant, Paul; Mack, Michael; Fontana, Greg; Mohr, Frederick-Wilhelm; Nataf, Patrick; Smith, Craig; Boden, Bill; Fox, Keith; Maron, David; Steg, Gabriel; Blackstone, Eugene; Juni, Peter; Parise, Helen; Wallentin, Lars; Bertrand, Michel; Krucoff, Mitchell; Turina, Marko; StÃ¥hle, Elisabeth; Tijssen, Jan; Brill, David; Atkins, Cary; Applegate, Bob; Argenziano, Michael; Faly, Richard C; Dauerman, Harold; Davidson, Charles; Griffith, Bartley; Reisman, Mark; Rizik, David; Sakwa, Marc; Shemin, Richard; Romano, Mauro; Hamm, Christian; Gummert, Jan; Tamburino, Corrado; Alfieri, Ottavio; Savina, C; de Bruyne, Bernard; Machado, Francisco Pereira; Uva, Souza; Moccetti, Tiziano; Siclari, Francesco; Hildick-Smith, David; Szekely, Laszlo; Erglis, Andrejs; Stradins, Peteris; Abizaid, Alex; Bento Sousa, Luis Carlos; Belardi, Jorge; Navia, Daniel; Park, S J; Lee, Jay-Wo; Meredith, Ian; Smith, Julian; Yehuda, Ori-Ben; Schneijdenberg, Rob; Ronden, Jacintha; Jonk, Judith; Jonkman, Anja; van Remortel, Eric; de Zwart, Ingrid; Elshout, Liliane; de Vries, Ton; Andreae, Rick; Tol van, Judith; Teurlings, Eva; Balachandran, Saranya; Breazna, Aurora; Jenkins, Paul; McAndrew, Tom; Marx, Steven O; Connolly, Mark W; Hong, Mun K; Weinberger, Jesse; Wong, Shing Chiu; Dizon, Joe; Biviano, Angelo; Morrow, John; Wang, Daniel; Corral, Maria; Alfonso, Maria; Sanchez, Raquel; Wright, Douey; Djurkovic, Champika; Lustre, Mitchel; Jankovic, Ivana; Sanidas, Elias; LaSalle, Laura; Maehara, Akiko; Matsumura, Mitsuaki; Sun, Eric; Iacono, Stephen; Greenberg, Tess; Jacobson, Jaclyn; Pullano, Anthony; Gacki, Marek; Liu, Shen; Cohen, David J; Magnuson, Elizabeth; Baron, Suzanne J; Wang, Kaijun; Traylor, Kendra; Worthley, Stephen; Stuklis, Robert; Barbato, Emanuele; Stockman, Bernard; Dubois, Christophe; Meuris, Bart; Vrolix, Mathias; Dion, Robert; Abizaid, Alexandre; Bento de Souza, Luis Carlos; Costantini, Costantino; Woitowicz, Vinicius; Hueb, Whady; Stolf, Noedir; Beydoun, Hussein; Baskett, Roger; Curtis, Michael; Kieser, Teresa; Doucet, Serge; Pellerin, Michel; Hamburger, Jaap; Cook, Richard; Kutryk, Michael; Peterson, Mark; Madan, Minakshi; Fremes, Stephen; Mehta, Shamir; Cybulsky, Irene; Prabhakar, Manu; Peniston, Charles; Welsh, Robert; MacArthur, Roderick; Berland, Jacques; Bessou, Jean Paul; Carrié, Didier; Glock, Yves; Darremont, Oliver; Deville, Claude; Grimaud, Jean-Phillipe; Soula, Philippe; Lefèvre, Thierry; Maupas, Eric; Durrleman, Nicolas; Silvestri, Marc; Houel, Remi; Pratt, Alain; Francis, Juthier; Van Belle, Eric; Vicentelli, André; Luchner, Andreas; Hilker, Michael; Endemann, Dierk-Hannes; Felix, Stephan; Wollert, Hans-Georg; Walther, Thomas; Erbel, Raimund; Jacob, Heinz; Kahlert, Philipp; Kupatt, Christian; Näbauer, Michael; Schmitz, Christoph; Scholtz, Werner; Börgermann, Jochen; Schuler, Gerhard; Borger, Michael; Davierwala, Piroze; Fontos, Geza; Székely, László; Bedogni, Francesco; Panisi, Paolo; Berti, Sergio; Glauber, Mattia; Marzocchi, Antonio; Di Bartolomeo, Roberto; Merlo, Maurizio; Guagliumi, Giulio; Fenili, Francesca; Napodano, Massimo; Gerosa, Gino; Ribichini, Flavio; Faggian, Giuseppe; Saccà , Salvatore; Giacomin, Alessandro; Mignosa, Carmelo; Tumscitz, Carlo; Savini, Carlo; Van Mieghem, Nicolas; von Birgelen, C; Grandjean, J; Kubica, Jacek; Anisimowicz, Lech; Zmudka, Krzysztof; Sadowski, Jerzy; Lee, Jae Won; Park, Seung Jung; Hernández GarcÃa, Jose; Such, Miguel; Macaya, Carlos; RodrÃguez Hernández, José Enrique; Maroto, Luis; Serra, Antonio; Padro, Jose; Tenas, Manel Sabaté; De Souza, Anthony; Egred, Mohaned; Clark, Stephen; Trivedi, Uday; Jain, Ajay; Uppal, Rakesh; Redwood, Simon; Young, Christopher; Stables, Rodney H; Pullan, Mark; Uren, Neal; Pessotto, Renzo; Abu-Fadel, Mazen; Peyton, Marvin; Allaqaband, Suhail; O’Hair, Daniel; Bachinsky, William; Mumtaz, Mumbashir; Blankenship, James; Casale, Al; Brott, Brigitta; Davies, James; Brown, David; Cannon, Louis; Talbott, James; Chang, George; Macheers, Steven; Choi, James; Henry, Carl; Cutlip, Donald; Khabbaz, Kamal; Das, Gladwin; Liao, Kenneth; Diver, Daniel; Thayer, John; Dobies, David; Fliegner, Karsten; Fischbein, Michael; Feldman, Ted; Pearson, Paul; Foster, Malcolm; Briggs, Richard; Giugliano, Gregory; Engelman, Daniel; Gordon, Paul; Ehsan, Afshin; Grantham, James; Allen, Keith; Grodin, Jerrold; Jessen, Michael; Gruberg, Luis; Taylor, James R Jr; Gupta, Sandeep; Hermiller, James Jr; Heimansohn, David; Iwaoka, Robert; Chan, Barry; Kander, N Howard; Duff, Steve; Brown, William; Karmpaliotis, Dimitri; Kini, Annapoorna; Filsoufi, Farzan; Kong, David; Lin, Shu; Kutcher, Michael; Kincaid, Edward; Leya, Ferdinand; Bakhos, Mamdouh; Liberman, Henry; Halkos, Mike; Lips, Daniel; Eales, Frazier; Mahoney, Paul; Rich, Jeffrey; Barreiro, Christopher; Cheng, Wen; Metzger, Chris; Greenfield, Tyler; Moses, Jeffrey; Palacios, Igor; MacGillivray, Thomas; Perin, Emerson; Del Prete, Jennifer; Pompili, Vincent; Kilic, Ahmet; Ragosta, Michael; Kron, Irving; Rashid, John; Mueller, Dale; Riley, Robert; Reimers, Carl; Patel, Nirav; Resar, Jon; Shah, Ashish; Schneider, Joel; Landvater, Lance; Shah, Alpesh; Reardon, Michael; Shavelle, David; Baker, Craig; Singh, Jasvindar; Maniar, Hersh; Smith, Conrad; Wei, Lawrence; Strain, Janet; Zapolanski, Alex; Taheri, Hamid; Ad, Niv; Tannenbaum, Mark; Prabhakar, Ganga; Waksman, Ron; Corso, Paul; Wang, John; Fiocco, Michael; Wilson, B Hadley; Steigel, R Mark; Chadwick, Stephanie; Zidar, Frank; Oswalt, John
BACKGROUND:Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS:We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS:At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS:In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).
PMID: 27797291
ISSN: 1533-4406
CID: 5451162