At 10 years, PCI equal to CABG for left main coronary artery disease
Data are limited on outcomes beyond 5 years in recipients of either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) who have left main coronary artery disease (LMCAD). Recently, a follow-up extension of the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) examined 10-year outcomes and found no significant difference in rates of death, myocardial infarction (MI), stroke, or target vessel revascularization between patients who underwent PCI and those who underwent CABG, reported Duk-Woo Park, MD, of Asian Medical Center, Seoul, South Korea.
Prior studies, notably the EXCEL and NOBLE studies published in late 2019, showed conflicting results, he said, with some reporting “a trend of late catch-up or crossover in the incidence of the primary composite outcome or all-cause mortality favoring CABG over PCI during extended follow-up.”
PRECOMBAT also showed that more patients who underwent PCI had to have a repeat PCI than those who underwent CABG.
The clinical trial randomized 600 patients with unprotected LMCAD to either PCI with sirolimus-eluting stents or CABG at 13 medical centers in South Korea between 2004 and 2009. The primary outcome was occurrence of a major adverse cardiac or cerebrovascular event, defined as death from any cause, MI, stroke, or ischemia-driven target-vessel revascularization.
The mean age of patients at treatment was 62.3 years; 76.5% were men, 32% had diabetes mellitus, slightly more than half had hypertension, and approximately 40% had hyperlipidemia. Twice as many patients in the PCI arm had peripheral vascular disease than in the CABG arm (5% vs 2.3%). Approximately half of the patients enrolled had stable angina or silent ischemia.
About 40% in each arm had left main plus three-vessel disease and two thirds in each arm had bifurcation left main involvement. Complete revascularization was attained in 68.3% of the PCI arm and 70.3% of the CABG arm. The mean SYNTAX score was 24.4 in the PCI arm and 25.8 in the CABG arm.
In the PCI arm, a mean of 1.6 stents were implanted in the left main artery. Overall, the mean number of stents per patient was 2.7. The one-stent technique was used for treatment of bifurcation in 46.3% of patients. In the CABG group, the mean number of grafts per patient was also 2.7.
Follow-up results at 1 year and 5 years, published previously, reported no significant differences between the two groups for the primary endpoint or for any of its components; however, patients who underwent PCI were more likely to require a second PCI.
At 10 years, approximately, 96% in each arm had complete follow-up data. A primary outcome event occurred in 29.8% of the PCI group versus 24.7% of the CABG group (hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.69; P = 0.14).
The 10-year composite of death, MI, or stroke occurred in 18.2% of the PCI arm versus 17.5% of the CABG arm (HR, 1.00; 95% CI, 0.70-1.44; P = 0.98). Death from any cause occurred in 14.5% versus 13.8% of the PCI and CABG arms, respectively (HR, 1.13; 95% CI, 0.75-1.70; P = 0.57). Ischemia-driven target vessel revascularization was significantly more frequent after PCI than after CABG (16.1% vs 8.0%; HR, 1.98; 95% CI, 1.21-3.21; P = 0.006).
Dr. Park noted that the study was underpowered, owing to the limited number of patients and low event rates, and, thus, the results should be considered hypothesis generating, and they do highlight the need for further research.
“Because we evaluated the first-generation drug-eluting stents, our findings should be confirmed or refuted through longer follow-up of the trials involving contemporary drug-eluting stents,” he said.
“What these data definitely show is that if we have a patient who is not a good candidate for coronary revascularization surgically, we can expect an acceptable result with PCI in some high-risk patients, and this was actually a pretty low-risk group based on SYNTAX scores,” commented Marc R. Moon, MD, Washington University School of Medicine, St. Louis, who was not involved in the study.
The findings were published online in Circulation at the time of presentation. PRECOMBAT was funded by the Cardiovascular Research Foundation. Duk-Woo Park, MD reported nothing to disclose; Marc R. Moon, MD disclosed Consultant Fees/Honoraria MEDTRONIC.