What question did this study set out to answer?

To assess whether extended clopidogrel monotherapy is superior to continuing dual antiplatelet therapy with aspirin and clopidogrel after 9 to 12 months of post-PCI treatment in patients with acute coronary syndrome at high ischemic and bleeding risk.

April 17, 2024JAMA CardiologyOpen Access

Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

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Why the study?

P2Y12 inhibitor monotherapy after an initial period of DAPT may be an attractive maintenance option after PCI in patients at both high bleeding and ischemic risk, but whether extended clopidogrel monotherapy is superior to ongoing DAPT remained to be determined.

Does extended clopidogrel monotherapy reduce bleeding compared to ongoing DAPT in birisk patients with ACS who completed 9 to 12 months of DAPT post-PCI?

Population

7758 birisk ACS patients after 9 to 12 months of DAPT post-PCI at 101 China centers

Comparison

Clopidogrel plus placebo vs clopidogrel plus aspirin

Design

Multicenter, double-blind, placebo-controlled randomized clinical trial

Follow-up

9 months

Authors

YLYi LiShenyang Pharmaceutical University JLJing LiGeneral Hospital of Shenyang Military Region BWBin WangShandong University of Traditional Chinese Medicine

Discussion

Member takes

Implication

Clopidogrel monotherapy after 9-12 months DAPT cuts bleeding without raising ischemia in birisk ACS; supports extended monotherapy over continued DAPT.

Key Points

To assess whether extended clopidogrel monotherapy is superior to continuing dual antiplatelet therapy with aspirin and clopidogrel after 9 to 12 months of post-PCI treatment in patients with acute coronary syndrome at high ischemic and bleeding risk.
Multicenter, double-blind, placebo-controlled randomized clinical trial conducted at 101 centers in China evaluating 7,758 patients with acute coronary syndrome who completed 9 to 12 months of dual antiplatelet therapy (DAPT) after drug-eluting stent placement and remained event-free for at least 6 months.
Participants with both high bleeding and ischemic risk were randomly assigned 1:1 to either clopidogrel plus placebo (n = 3,873) or clopidogrel plus aspirin (n = 3,885) for an additional 9 months.
BARC types 2, 3, or 5 bleeding occurred in 2.5% (95 of 3,873) of patients receiving clopidogrel plus placebo compared with 3.3% (127 of 3,885) receiving clopidogrel plus aspirin (HR, 0.75; 95% CI, 0.57–0.97; P = .03 for superiority).
Major adverse cardiac and cerebral events occurred in 2.6% (101 of 3,873) of the clopidogrel monotherapy group versus 3.5% (136 of 3,885) of the dual therapy group (HR, 0.74; 95% CI, 0.57–0.96; P < .001 for noninferiority; P = .02 for superiority).

Structured PICO

Does extended clopidogrel monotherapy reduce bleeding compared to ongoing DAPT in birisk patients with ACS who completed 9 to 12 months of DAPT post-PCI?

Population

7,758 patients with acute coronary syndromes (ACS) at high ischemic and bleeding risk (birisk) who had completed 9 to 12 months of dual antiplatelet therapy (DAPT) after drug-eluting stent implantation and were free from adverse events for at least 6 months, mean age 64.8, 59.0% male, across 101 centers in China.

Intervention

Clopidogrel plus placebo for an additional 9 months

Comparator

Clopidogrel plus aspirin (ongoing DAPT) for an additional 9 months

Outcome

Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomizationsafety

In high-risk ACS patients who are event-free 9 to 12 months post-PCI, dropping aspirin and continuing clopidogrel monotherapy for an additional 9 months significantly reduces bleeding and ischemic events compared to continuing DAPT.

Cite This Study

Li et al. (2024) studied this question.

synapsesocial.com/papers/6a7d16f31ec2a9317b42508f https://doi.org/10.1001/jamacardio.2024.0534

Topics

Percutaneous coronary intervention Dual antiplatelet therapy Chronic total occlusion PCI

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Implication

Clopidogrel monotherapy after 9-12 months DAPT cuts bleeding without raising ischemia in birisk ACS; supports extended monotherapy over continued DAPT.

Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

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