Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial.
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.


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.


BACKGROUND
http://www.clinicaltrials.gov. Unique identifier: NCT00114972.
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.
Marie-Claude
MC
Morice
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.).
Patrick W
PW
Serruys
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.).
A Pieter
AP
Kappetein
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.).
Ted E
TE
Feldman
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.).
Elisabeth
E
Ståhle
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.).
Antonio
A
Colombo
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.).
Michael J
MJ
Mack
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.).
David R
DR
Holmes
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.).
James W
JW
Choi
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.).
Witold
W
Ruzyllo
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.).
Grzegorz
G
Religa
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.).
Jian
J
Huang
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.).
Kristine
K
Roy
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.).
Keith D
KD
Dawkins
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.).
Friedrich
F
Mohr
D000328:Adult; D001026:Coronary Artery Bypass / Q000379:methods* / Q000401:mortality; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D017239:Paclitaxel / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods* / Q000401:mortality; D012307:Risk Factors; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use
D050257:Tubulin Modulators; D017239:Paclitaxel
percutaneous coronary intervention; stents