Safety and efficacy of policosanol in patients with high on-treatment platelet reactivity after drug-eluting stent implantation: two-year follow-up results.

SummaryObjectives To investigate safety and efficacy of policosanolin patients with high on-treatment platelet reactivity after drug-eluting stentimplantation. Background Certain number of patients has high residual platelet reactivity on clopidogrelafter coronary intervention, and their risk of thrombotic events is high. Method In this prospective, randomized trial conducted in four Chinese sites, 350 patients with high on-treatment platelet reactivity (HPR, defined as platelet aggregation >65%) were randomized by the ratio of 1:3:3 to: group A, clopidogrel75 mg/d for 1 year (n=50); group B, clopidogrel150 mg/d for 30 days followed by 75 mg/d until 1 year (n=150); or group C, policosanol40 mg/d for 6 month and clopidogrel75 mg/d for 1 year (n=150). All of them were treated with aspirin. The primary endpoint was the reversion rate of HPR at 1 month (reversion was defined as platelet aggregation <65%). The secondary endpoints were 6-month major adverse cardiac events (MACE), which included cardiac death, nonfatal myocardial infarction, or ischemic symptoms driven target vessel revascularization. Results At 30 days, the reversion rate of HPR was 34.0%, 55.2%, and 48.7% in group A, group B, and group C, respectively (P=.029). Major adverse cardiac events occurred in 4 (8.0%), 6(4.0%), and 5(3.3%) patients (P=.342). There was 1 (0.7%) major bleeding and 1 (0.7%) minor bleeding event in high maintenance dose clopidogrelgroup, no major or moderate bleeding in the other two groups. The minimal bleeding in group B was significantly higher than group C (10.7% vs 2.7%, P=.022). At 2-year follow-up, the benefits of policosanolon bleedings persisted compared with group B. Conclusions Policosanolreduced platelet reactivity to a similar extent as high maintenance doseof clopidogrelwithout increasing bleeding rate.