Clopidogrel monotherapy associated with reduced risk of net adverse clinical events, study findings

Results of a field study on the safety and effectiveness of clopidogrel versus aspirin monotherapy at 12 months after PCI in high-risk patients during the chronic maintenance period. This study found that clopidogrel monotherapy was associated with a reduced risk of net adverse clinical events (NACE; all-cause death, MI, stent thrombosis, stroke, or BARC type 2, 3, or 5 haemorrhage) and MACCE (death, MI, stent thrombosis, stroke) and a numerical reduction in major or clinically relevant non-major bleeds (BARC type 2, 3 or 5 bleeds), compared to aspirin monotherapy. The findings were presented today as groundbreaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions.

P2Y12 inhibitor monotherapy reduces the risk of bleeding without increasing the risk of ischemic events compared to dual antiplatelet agents (DAPT), especially in the first 12 months after percutaneous coronary intervention (PCI). Recent research showed that in patients who were event-free six to 18 months after PCI and successfully received the target duration of DAPT, clopidogrel monotherapy was superior to aspirin monotherapy in terms of NACE. However, optimal antiplatelet monotherapy during the chronic maintenance period longer than 12 months after PCI with drug-eluting stents in high-risk patients in real-life settings is unknown so far.

A total of 8,377 consecutive patients at high risk for both bleeding and thrombosis were identified from the prospective Fuwai PCI registry if they met one clinical and one angiographic criterion. Patients who received antiplatelet therapy (aspirin or clopidogrel) monotherapy for greater than 12 months and who were free of ischemic and bleeding events with no prolonged DAPT duration 12 months after PCI were included. The primary endpoint was net adverse clinical events (NACE) from 12 to 30 months. The key secondary endpoints were major adverse cardiac or cerebral events (MACCE) and major or clinically relevant non-major bleeding events (BARC type 2, 3, or 5).

“These findings show for the first time that clopidogrel monotherapy is associated with a reduced risk of NACE and MACCE in the long term,” said Hao-Yu Wang, Cardiometabolic Medicine Center, Coronary Heart Disease Center, Department of Cardiology, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Center of Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. “Our results may have important practical implications for determining the optimal treatment for patients requiring a single antiplatelet drug, aspirin or clopidogrel, for secondary prevention of ischemic events in a high-risk PCI population.”

Of the 7,392 high-risk patients who were event-free and on DAPT after the first year, 5,664 patients receiving antiplatelet monotherapy (clopidogrel monotherapy: n=1974 and aspirin monotherapy: n=3690) were included in the current analysis. Researchers found that between 12 and 30 months, net adverse clinical events were lower with clopidogrel monotherapy than with aspirin monotherapy (Kaplan-Meier estimate: 2.5% vs. 5.0%; adjusted HR: 0.566, 95% CI : 0.403-0.795). Clopidogrel monotherapy was associated with a lower risk of MACCE (Kaplan-Meier estimate: 1.0% vs. 3.1%, log-rank p = 0.001), as well as a lower incidence of all-cause death, MI, and stroke . The difference in risk between groups was statistically similar for major or clinically relevant non-major bleeding events (Kaplan-Meier estimate: 1.5% vs. 2.1%, log-rank p = 0.199).

Researchers recommended further exploring their findings through a randomized clinical trial.

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