PRECOMBAT: 5-year MACCE similar with PCI, CABG

SAN DIEGO — Patients with unprotected left main coronary artery stenosis who underwent PCI with a sirolimus-eluting stent or CABG had a similar rate of MACCE at 5-year follow-up.

The prospective, open-label, randomized PRECOMBAT study included 600 patients with newly diagnosed unprotected left main coronary artery stenosis (>50% diameter stenosis) and a diagnosis of angina or non-STEMI. The mean age of patients was 62 years, three-quarters were men, three-quarters had left main plus multivessel involvement and one-third had diabetes.

The researchers conducted the study because “the durable effect of PCI remains up for debate, particularly in large randomized trials,” Jung-Min Ahn, MD, from the Heart Institute at the University of Ulsan College of Medicine in Seoul, South Korea, said during a presentation.

The primary outcome measure was a composite of all-cause mortality, MI, stroke or ischemia-driven target vessel revascularization (MACCE).

At 5 years, the cumulative incidence of MACCE was 17.5% in the PCI group vs. 14.3% in the CABG group (HR = 1.27; 95% CI, 0.84-1.9; P = .26). Adjustment for variability between sites demonstrated a similar result as the original analysis (HR = 1.27; 95% CI, 0.83-1.93; P = .28).

The rate of the composite outcome of all-cause mortality, MI or stroke was 8.4% in the PCI group vs. 9.6% in the CABG group (HR = 0.89; 95% CI, 0.52-1.52; P = .66). Individual components of the composite outcome were also similar.

Patients assigned PCI were more likely to have ischemia-driven TVR (11.4% vs. 5.5%; HR = 2.11; 95% CI, 1.16-3.84; P = .012).

In a landmark analysis, more patients in the PCI group had MI at 30 days after randomization (3.5% vs. 0.7%; P = .004) and risk for ischemia-driven TVR was higher in the PCI group at 1 year after randomization. Results of an as-treated analysis demonstrated a low rate of definite/probable stent thrombosis (5-year cumulative incidence, 0.3%). In subgroup analyses, SYNTAX score did not impact rates of all-cause mortality, MI or stroke, but the rate of ischemia-driven TVR was increased in the PCI group (≥33).

“At 5 years, the rate of the primary endpoint of MACCE and the safety endpoint showed no significant differences between PCI and CABG,” Ahn said. “Our findings support current guidelines stating that left main stenting is a feasible revascularization strategy for patients with suitable coronary anatomy.” – by Rob Volansky

References:

Ahn JM, et al. Featured Clinical Research Session I. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.

Ahn JM, et al. J Am Coll Cardiol. 2015;doi:10.1016/j.jacc.2015.03.033.

Disclosure: Ahn reports no relevant financial disclosures.