Kai Xu1, Xinming Liu1, Yi Li1, Yunuo Wang1, Hongyun Zang2, Liang Guo3, Yuan Wang4, Wei Zhao1, Xiaozeng Wang1, Yaling Han5. 1. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China. 2. Department of Cardiology, No. 463 Hospital of PLA, Shenyang, China. 3. Department of Cardiology, First Hospital of China Medical University, Shenyang, China. 4. Department of Cardiology, Shenzhou Hospital Affiliated to Shenyang Medical College, Shenyang, China. 5. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China. hanyalingnh@126.com.
Abstract
OBJECTIVES: 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. 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, 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.
RCT Entities:
OBJECTIVES: 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. 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, 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.
Authors: Chul Kim; Jidong Sung; Jong Hwa Lee; Won Seok Kim; Goo Joo Lee; Sungju Jee; Il Young Jung; Ueon Woo Rah; Byung Ok Kim; Kyoung Hyo Choi; Bum Sun Kwon; Seung Don Yoo; Heui Je Bang; Hyung Ik Shin; Yong Wook Kim; Heeyoune Jung; Eung Ju Kim; Jung Hwan Lee; In Hyun Jung; Jae Seung Jung; Jong Young Lee; Jae Young Han; Eun Young Han; Yu Hui Won; Woosik Han; Sora Baek; Kyung Lim Joa; Sook Joung Lee; Ae Ryoung Kim; So Young Lee; Jihee Kim; Hee Eun Choi; Byeong Ju Lee; Soon Kim Journal: Korean Circ J Date: 2019-11 Impact factor: 3.243