For selected patients with left main coronary artery disease, is percutaneous coronary intervention (PCI) with a drug-eluting stent an option to replace coronary artery bypass grafting (CABG)?
The authors of this study—which was sponsored by a manufacturer of stents—argue that the results prove that PCI is just as good as CABG for many patients with a left main lesion. A deeper dive into the data suggests that it is not quite so clear. Patients undergoing PCI had fewer early myocardial infarctions, but more later deaths and later myocardial infarctions. There are other benefits to PCI, including shorter hospital stay, lower cost, and faster recovery. But patients should be informed of the tradeoffs, and it is important to look at longer-term outcomes beyond three years (which the investigators promise to do). (Level of Evidence = 1b)
Guidelines in Europe and the United States continue to recommend CABG as the preferred treatment for all patients with left main coronary artery disease. However, subgroup analyses in previous trials suggest that some patients may do just as well with a drug-eluting stent. This study included 1,905 patients with left main coronary artery disease (defined as at least 70% stenosis, or 50% to 70% stenosis judged to be hemodynamically significant) and low to intermediate anatomic complexity (SYNTAX score < 32). The patients were randomized to receive CABG or PCI with a drug-eluting stent. The average age of participants was 66 years, 77% were men, 91% were white, 56% lived in Europe, and 39% lived in the United States. Approximately 29% had diabetes mellitus, 15% had experienced a recent myocardial infarction, 17% had a previous PCI, and 16% had renal insufficiency. The primary end point was a composite of death, stroke, or myocardial infarction at three years. Groups were similar at the start of the study, and analysis was by intention to treat. This study was designed as a noninferiority trial, defining “just as good” as no more than 4.2% worse in terms of the primary composite outcome.
Most patients (935 out of 948 in the PCI group and 923 out of 957 in the CABG group) received their assigned treatment. At three years, there was no significant difference between groups in the composite outcome (15.4% for PCI vs. 14.7% for CABG; P = .98), and this met the criteria for noninferiority. Not surprisingly, the primary outcome was less common in the first 30 days in the PCI group, driven primarily by fewer strokes and myocardial infarctions (4.9% vs. 7.9%; P = .008; number needed to treat to harm [NNTH] = 30). However, buried in Appendix Table S9 was the fact that the primary end point was more common in the PCI group between 30 days and three years, driven primarily by more deaths and more myocardial infarctions (11.5% vs. 7.9%; P = .02; NNTH = 28). All-cause mortality was higher in the PCI group (8.3% vs. 6.0%), although statistical significance is not reported. The need for subsequent revascularization because of ischemia was also higher in the PCI group (12.6% vs. 7.5%; P < .001; NNTH = 20). The study was open label, which may have affected subsequent treatment decisions, including the need to revascularize.
Study design: Randomized controlled trial (nonblinded)
Funding source: Industry
Setting: Outpatient (specialty)
Reference:Stone GW, Sabik JF, Serruys PW, et al.; EXCEL Trial Investigators. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016;375(23):2223–2235.