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


BACKGROUND
Certain number of patients has high residual platelet reactivity on clopidogrel after coronary intervention, and their risk of thrombotic events is high.


METHODS
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, clopidogrel 75 mg/d for 1 year (n=50); group B, clopidogrel 150 mg/d for 30 days followed by 75 mg/d until 1 year (n=150); or group C, policosanol 40 mg/d for 6 month and clopidogrel 75 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 clopidogrel group, 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 policosanol on bleedings persisted compared with group B.


CONCLUSIONS
Policosanol reduced platelet reactivity to a similar extent as high maintenance dose of clopidogrel without increasing bleeding rate.
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Kai
K
Xu
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Xinming
X
Liu
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Yi
Y
Li
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Yunuo
Y
Wang
Department of Cardiology, No. 463 Hospital of PLA, Shenyang, China.
Hongyun
H
Zang
Department of Cardiology, First Hospital of China Medical University, Shenyang, China.
Liang
L
Guo
Department of Cardiology, Shenzhou Hospital Affiliated to Shenyang Medical College, Shenyang, China.
Yuan
Y
Wang
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Wei
W
Zhao
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Xiaozeng
X
Wang
Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China. hanyalingnh@126.com.
Yaling
Y
Han
D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D002681:China; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005233:Fatty Alcohols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010974:Platelet Aggregation / Q000187:drug effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010979:Platelet Function Tests; D011446:Prospective Studies; D012307:Risk Factors; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
D005233:Fatty Alcohols; D010975:Platelet Aggregation Inhibitors; C080710:policosanol; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
Bleeding; Drug-eluting stent; Platelet reactivity; Policosanol