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

Results of a real-world study investigating the safety and efficacy of clopidogrel versus aspirin monotherapy beyond 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 bleeding) and MACCE (death, MI, stent thrombosis, stroke) and a numerical decrease in clinically relevant major or non-major bleeding (BARC hemorrhage type 2, 3, or 5), compared with aspirin monotherapy. The results were presented today as late-breaking clinical research at the 2022 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions (SCAI).

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

A total of 8,377 consecutive patients at high risk of bleeding and thrombosis were identified from the prospective Fuwai PCI registry if they met one clinical criterion and one angiographic criterion. Patients who received antiplatelet monotherapy (aspirin or clopidogrel) for more than 12 months and were free of ischemic and bleeding events 12 months after PCI without prolonged duration of DAPT were included. The primary endpoint was net adverse clinical events (NACE) from 12 to 30 months. The primary secondary endpoints were major adverse cardiac or cerebral events (MACCE) and clinically relevant major or non-major bleeding (BARC type 2, 3, or 5).

“These results show for the first time that clopidogrel monotherapy is associated with a reduced risk of long-term NACE and MACCE,” said Hao-Yu Wang, Center for Cardiometabolic Medicine, Center for Coronary Heart Disease, Department of Cardiology, Fuwai Hospital, State Key Laboratory of Cardiovascular Diseases, National Center for Cardiovascular Diseases, 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, either aspirin or clopidogrel, for the secondary prevention of ischemic events in the high-risk PCI population.”

Of 7,392 high-risk patients without events after the first year and adherent to DAPT, 5,664 patients who received antiplatelet monotherapy (clopidogrel monotherapy: n = 1,974 and aspirin monotherapy: n = 3,690) were included in the present analysis. The researchers found that between 12 and 30 months, net adverse clinical events were lower with clopidogrel monotherapy compared to aspirin monotherapy (Kaplan-Meier estimate: 2.5% versus 5.0%; Adjusted RR: 0.566, 95% CI: 0.403-0.795). Clopidogrel monotherapy was associated with a lower risk of MACCE (Kaplan-Meier estimate: 1.0% versus 3.1%, log-rank p=0.001), as well as lower incidence rates of death from all causes, MI and stroke. The difference in risk between the groups was statistically similar for clinically relevant major or non-major bleeding (Kaplan-Meier estimate: 1.5% versus 2.1%, log-rank p = 0.199).

The researchers recommended that their findings be studied further in a randomized clinical trial.

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