Aspirin vs Clopidogrel for Long-term Maintenance After Coronary Stenting in Patients With Diabetes
Authors: Rhee Tae-Min , Bae Jang-Whan , Park Kyung Woo , Rha Seung-Woon , Kang Jeehoon , Lee Heesun , Yang Han-Mo , Kwak Soo-Heon , Chae In-Ho , Shin Won-Yong , Kim Dae-Kyeong , Oh Ju Hyeon , Jeong Myung Ho , Kim Yong Hoon , Lee Nam Ho , Hur Seung-Ho , Yoon Junghan , Han Jung-Kyu , Shin Eun-Seok , Koo Bon-Kwon , Kim Hyo-Soo ,   HOST-EXAM Investigators, Won Ki-Bum , Park Tae-Ho , Kim Bum Soo , Lim Sang Wook , Cho Yoon Haeng , Jeon Dong Woon , Kim Sang-Hyun , Han Kyoo-Rok , Moon Keon-Woong , Oh Seok Kyu , Kim Ung , Rhee Moo-Yong , Kim Doo-Il , Kim Song-Yi , Lee Sung-Yun , Lee Seung Uk , Kim Sang-Wook , Kim Seok Yeon , Jeon Hui-Kyung , Cha Kwang Soo , Jo Sang-Ho , Ryu Jae Kean , Suh Il-Woo , Choi Hyun-Hee , Woo Seoung-Il 
Published: April 2023

Importance

Selecting the optimal antiplatelet agent in patients who have received percutaneous coronary intervention is especially important in those with diabetes due to the heightened risk of ischemic events in this population. Studies on the efficacy and safety of clopidogrel vs aspirin for long-term maintenance after percutaneous coronary intervention in patients with diabetes are lacking.

Objective

To investigate cardiovascular outcomes with clopidogrel vs aspirin in patients with and without diabetes.

Design, Setting, and Participants

This was a post hoc analysis of the HOST-EXAM randomized clinical trial, an investigator-initiated, prospective, randomized, open-label, multicenter trial performed at 37 centers in Korea. Patients who received dual antiplatelet therapy without clinical events for 6 to 18 months after percutaneous coronary intervention with drug-eluting stents were enrolled from March 2014 to May 2018 with follow-up at 6, 12, 18, and 24 months. All 5438 patients in the original trial were included in this analysis, which was conducted from June to October 2021.

Interventions and Exposures

Enrolled patients were randomized 1:1 to clopidogrel or aspirin monotherapy. Subgroup analyses were performed by the presence of diabetes.

Main Outcomes and Measures

The main outcome was primary composite end point of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding (Bleeding Academic Research Consortium type 3 or 5) at 24-month follow-up.

Results

Of 5438 patients (mean [SD] age, 63.5 [10.7] years; 1384 [25.5%] female), 1860 (34.2%) had diabetes (925 in the clopidogrel arm and 935 in the aspirin arm), and 5338 (98.2%) completed follow-up. The rate of the primary composite end point was significantly lower in the clopidogrel group compared to the aspirin group in patients with diabetes (6.3% vs 9.2%; hazard ratio [HR], 0.69; 95% CI, 0.49-0.96; P = .03; absolute risk difference [ARD], 2.7%; number needed to treat [NNT], 37) and without diabetes (5.3% vs 7.0%; HR, 0.76; 95% CI, 0.58-1.00; P = .046; ARD, 1.6%, NNT, 63; P for interaction = .65). The presence of diabetes was not associated with a difference in benefit observed with clopidogrel monotherapy over aspirin for the thrombotic composite end point (HR, 0.68; 95% CI, 0.45-1.04 for patients with diabetes vs HR, 0.68; 95% CI, 0.49-0.93 for those without; P for interaction = .99) and any bleeding with Bleeding Academic Research Consortium 2, 3, or 5 (HR, 0.65; 95% CI, 0.39-1.09 for patients with diabetes vs HR, 0.74; 95% CI, 0.48-1.13 for those without; P for interaction = .71).

Conclusion and Relevance

In this study, clopidogrel monotherapy was associated with a lower rate of the primary composite end point compared to aspirin monotherapy as long-term maintenance therapy after dual antiplatelet therapy for coronary stenting in both patients with and without diabetes. Clopidogrel might thus be considered rather than aspirin in patients who have undergone coronary stenting and successfully completed dual antiplatelet therapy, regardless of diabetes status.

Trial Registration

ClinicalTrials.gov Identifier: NCT02044250