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P2Y12 Inhibitor or Aspirin Monotherapy for Chronic Coronary Disease: A Nationwide Cohort Study
Minyoul Baik1, Jimin Jeon1, Joonsang Yoo1
1Department of Neurology, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin-si, Gyeonggi-do, Republic of Korea, yonsei.ac.kr.
Insights
P2Y12 inhibitor monotherapy showed similar outcomes to aspirin monotherapy in chronic coronary disease patients. However, P2Y12 inhibitors may reduce major gastrointestinal bleeding events, supporting guideline recommendations.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- The 2024 European Society of Cardiology (ESC) guideline suggests clopidogrel as an alternative to aspirin monotherapy for chronic coronary disease (CAD).
- This study aimed to validate this recommendation by comparing P2Y12 inhibitor monotherapy with aspirin monotherapy in CAD patients.
Purpose of the Study:
- To compare the long-term prognosis of patients with chronic CAD on P2Y12 inhibitor monotherapy versus aspirin monotherapy.
- To assess the safety and efficacy of P2Y12 inhibitor monotherapy in a real-world setting.
Main Methods:
- Retrospective cohort study using a Korean nationwide health claims database.
- Included patients with chronic CAD 18 months post-percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- 1:1 propensity score matching was used to compare P2Y12 inhibitor monotherapy and aspirin monotherapy groups, analyzing a composite outcome of death, myocardial infarction, ischemic stroke, and major bleeding.
Main Results:
- P2Y12 inhibitor monotherapy (n=42,692) showed comparable outcomes to aspirin monotherapy (n=42,692) regarding the primary composite outcome (HR: 0.98; 95% CI: 0.92-1.05).
- Secondary analyses revealed a trend towards reduced major bleeding with P2Y12 inhibitors (HR: 0.86; 95% CI: 0.72-1.02).
- A significant reduction in major gastrointestinal bleeding was observed with P2Y12 inhibitors (HR: 0.79; 95% CI: 0.63-0.97; p=0.027).
Conclusions:
- P2Y12 inhibitor monotherapy is comparable to aspirin monotherapy in long-term outcomes for Korean patients with chronic CAD after DES PCI.
- P2Y12 inhibitor monotherapy may offer a potential advantage in reducing gastrointestinal bleeding.
- Findings support the feasibility of P2Y12 inhibitor monotherapy, aligning with 2024 ESC guidelines, but further prospective studies are needed.
Background:
The 2024 European Society of Cardiology (ESC) guideline newly recommended clopidogrel as a safe and effective alternative to aspirin monotherapy in patients with chronic coronary disease (CAD). We aimed to validate the 2024 ESC guideline recommendation by comparing the prognosis of patients with chronic CAD treated with P2Y12 inhibitor monotherapy and aspirin monotherapy.
Methods:
This retrospective cohort study included patients with chronic CAD (18 months after percutaneous coronary intervention [PCI] with drug-eluting stents [DES] in 2019-2023), based on a nationwide health claims database in Korea. A 1:1 propensity score matching was performed between P2Y12 inhibitors and aspirin monotherapy groups. The primary composite outcome included all-cause death, myocardial infarction, ischemic stroke, and major bleeding. Stratified Cox regression models were used to compare risks between groups.
Results:
Of 127,127 patients with chronic CAD (mean age: 63.1 years; 73.7% men), 84,440 (66.4%) patients received P2Y12 inhibitor monotherapy, and 42,727 (33.6%) received aspirin monotherapy. After propensity score matching, 42,692 pairs were generated. During a median follow-up of 3 years, P2Y12 inhibitor monotherapy did not reduce the risk of the primary composite outcome (hazard ratio [HR]: 0.98; 95% confidence interval [CI]: 0.92-1.05; p = 0.577) compared with aspirin monotherapy. In secondary analyses, P2Y12 inhibitors showed a trend toward reduced major bleeding (HR: 0.86; 95% CI: 0.72-1.02; p = 0.082) and a significant reduction in major gastrointestinal bleeding (HR: 0.79; 95% CI: 0.63-0.97; p = 0.027).
Conclusions:
Among Korean patients with chronic CAD in the long-term maintenance period after PCI using DES, P2Y12 inhibitor monotherapy demonstrated overall outcomes comparable with aspirin monotherapy, with a potential advantage in reducing bleeding, particularly of gastrointestinal origin. These findings support the safety and feasibility of P2Y12 inhibitor monotherapy, in line with the 2024 ESC guideline recommendations, while emphasizing the need for further prospective studies to confirm its clinical benefit.
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