Everolimus-eluting stents or bypass surgery for left main coronary artery disease.

Stone, GW; Sabik, JF; Serruys, PW; Simonton, CA; Généreux, P; Puskas, J; Kandzari, DE; Morice, MC; Lembo, N; Brown, WM; Taggart, DP; Banning, A; Merkely, B; Horkay, F; Boonstra, PW; van Boven, AJ; Ungi, I; Bogáts, G; Mansour, S; Noiseux, N; Sabaté, M; Pomar, J; Hickey, M; Gershlick, A; Buszman, P; Bochenek, A; Schampaert, E; Pagé, P; Dressler, O; Kosmidou, I; Mehran, R; Pocock, SJ; Kappetein, AP

Journal article

Everolimus-eluting stents or bypass surgery for left main coronary artery disease.

Abstract:: 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.

Publication status:: Published

Peer review status:: Peer reviewed

Actions

Email

Email this record

Send the bibliographic details of this record to your email address.

Your Email
Please enter the email address that the record information will be sent to.

-
Your message (optional)
Please add any additional information to be included within the email.
Share
Cite

Cite this record

APA Style

Stone, G. W., Sabik, J. F., Serruys, P. W., Simonton, C. A., Généreux, P., Puskas, J., Kandzari, D. E., Morice, M. C., Lembo, N., Brown, W. M., Taggart, D. P., Banning, A., Merkely, B., Horkay, F., Boonstra, P. W., van Boven, A. J., Ungi, I., Bogáts, G., Mansour, S., … Kappetein, A. P. (2016). Everolimus-eluting stents or bypass surgery for left main coronary artery disease. New England Journal of Medicine, 375(23), 2223–2235.

MLA Style

Stone, GW, et al. “Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.” New England Journal of Medicine, vol. 375, no. 23, 2016, pp. 2223–35.

Chicago Style

Stone, GW, JF Sabik, PW Serruys, et al. 2016. “Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.” New England Journal of Medicine 375 (23): 2223–35.
Print