Preventive percutaneous coronary intervention for non-flow-limiting vulnerable atherosclerotic coronary plaques in diabetes: the PREVENT trial

Abstract

Background and aims: The efficacy and safety of preventive percutaneous coronary intervention (PCI) for treating vulnerable plaques in diabetic patients remain unclear.

Methods: The PREVENT (Preventive Coronary Intervention on Stenosis with Functionally Insignificant Vulnerable Plaque) trial was a randomized clinical trial that compared preventive PCI plus optimal medical therapy with optimal medical therapy alone in patients with non-flow-limiting (fractional flow reserve >0.80) vulnerable plaques identified via intracoronary imaging. Randomization was stratified by diabetes status. The primary endpoint was a composite of cardiac death, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalization for unstable or progressive angina at 2 years.

Results: Among 1606 randomized patients, 490 (30.5%) had diabetes. Diabetic patients underwent PCI for non-target lesions before randomization more frequently than non-diabetics (40.6% vs. 33.8%, P = .009). There were no significant differences in the incidence of the primary endpoint between diabetic and non-diabetic patients [1.8% vs. 1.9%; hazard ratio 0.98; 95% confidence interval 0.45-2.14); P = .956]. However, the primary endpoint at 2 years was less frequent with preventive PCI compared with optimal medical therapy alone in both diabetic (0% vs. 3.7%; P = .004) and non-diabetic patients (0.5% vs. 3.2%; hazard ratio 0.16; 95% confidence interval 0.05-0.55; P = .004), without a significant interaction between diabetic status and randomized strategy.

Conclusions: The risk of adverse clinical events was similar between diabetic and non-diabetic patients with non-flow-limiting vulnerable coronary plaques. However, preventive PCI was associated with a lower incidence of the primary endpoint at 2 years, regardless of diabetes status.

Keywords: Diabetes mellitus; Fractional flow reserve; Percutaneous coronary intervention; Vulnerable coronary plaques.