Marie-Claude Morice1, Patrick W Serruys2, A Pieter Kappetein2, Ted E Feldman2, Elisabeth Ståhle2, Antonio Colombo2, Michael J Mack2, David R Holmes2, James W Choi2, Witold Ruzyllo2, Grzegorz Religa2, Jian Huang2, Kristine Roy2, Keith D Dawkins2, Friedrich Mohr2. 1. From the Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de santé, Massy, France (M.-C.M.); Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands (P.W.S., A.P.K.); Evanston Hospital, Evanston, IL (T.E.F.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milan, Italy (A.C.); Medical City Hospital, Dallas, TX (M.J.M.); Mayo Clinic, Rochester, MN (D.R.H.); Baylor Heart and Vascular Hospital, Dallas, TX (J.W.C.); Institute of Cardiology, Warsaw, Poland (W.R., G.R.); Boston Scientific Corporation, Natick, MA (J.H., K.R., K.D.D.); University of Leipzig Heart Center, Leipzig, Germany (F.M.). mc.morice@icps.com.fr. 2. From the Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de santé, Massy, France (M.-C.M.); Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands (P.W.S., A.P.K.); Evanston Hospital, Evanston, IL (T.E.F.); University Hospital Uppsala, Uppsala, Sweden (E.S.); San Raffaele Scientific Institute, Milan, Italy (A.C.); Medical City Hospital, Dallas, TX (M.J.M.); Mayo Clinic, Rochester, MN (D.R.H.); Baylor Heart and Vascular Hospital, Dallas, TX (J.W.C.); Institute of Cardiology, Warsaw, Poland (W.R., G.R.); Boston Scientific Corporation, Natick, MA (J.H., K.R., K.D.D.); University of Leipzig Heart Center, Leipzig, Germany (F.M.).
Abstract
BACKGROUND: Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. METHODS AND RESULTS: The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive eitherPCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95-1.59]; P=0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58-1.32]; P=0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12-0.92]; P=0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28-2.57]; P<0.01). Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores (≥33). CONCLUSIONS: At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.
RCT Entities:
BACKGROUND: Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. METHODS AND RESULTS: The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95-1.59]; P=0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58-1.32]; P=0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12-0.92]; P=0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28-2.57]; P<0.01). Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores (≥33). CONCLUSIONS: At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.
Authors: Salvatore Cassese; Sebastian Kufner; Erion Xhepa; Robert A Byrne; Johanna Kreutzer; Tareq Ibrahim; Klaus Tiroch; Marco Valgimigli; Ralph Tölg; Massimiliano Fusaro; Heribert Schunkert; Karl-Ludwig Laugwitz; Julinda Mehilli; Adnan Kastrati Journal: Clin Res Cardiol Date: 2015-12-22 Impact factor: 5.460
Authors: Javier A Valle; Hector Tamez; J Dawn Abbott; Issam D Moussa; John C Messenger; Stephen W Waldo; Kevin F Kennedy; Frederick A Masoudi; Robert W Yeh Journal: JAMA Cardiol Date: 2019-02-01 Impact factor: 14.676