Clopidogrel monotherapy after just one month of dual-antiplatelet therapy (DAPT) may help reduce the risk of major bleeding events when diabetic patients undergo percutaneous coronary intervention (PCI), according to a new study published in JACC: Cardiovascular Interventions.[1]
“Recently, several randomized controlled trials have suggested that the strategy of shorter duration of DAPT followed by P2Y12 inhibitor monotherapy reduces major bleeding events without increasing cardiovascular events after PCI,” wrote first author Ko Yamamoto, with the department of cardiovascular medicine at Kyoto University Graduate School of Medicine in Japan, and colleagues. “Nevertheless, it is well known that diabetes is associated with an increased risk for ischemic events, and in the current European, American, and Japanese guidelines, patients with diabetes have been suggested as one of the types of patients in whom we should consider adopting prolonged duration of DAPT.”
To see if clopidogrel could help diabetic patients avoid 12 months of DAPT, Yamamoto et al. performed a subgroup analysis of the STOPDAPT-2 trial. The study focused on data from nearly 6,000 PCI patients, including 2,030 patients with diabetes and another 3,947 patients without diabetes.
Patients with diabetes were slightly older and more likely to have a higher BMI. They were also more likely to have a history of prior coronary revascularization, prior myocardial infarction, prior stroke, heart failure, anemia, chronic obstructive pulmonary disease, peripheral artery disease, chronic kidney disease, hypertension or hyperlipidemia.
All patients in the analysis were treated with an initial month of DAPT with aspirin and clopidogrel or prasugrel. Patients were then randomized to continue DAPT for up to 12 months or switch to clopidogrel monotherapy.
The study’s primary endpoint was a composite of cardiovascular events (cardiovascular death, myocardial infarction, definite stent thrombosis or stroke) and bleeding events after one year.
Overall, among patients with diabetes, that endpoint was seen in 3.58% of patients in the clopidogrel monotherapy group and 4.12% of patients in the 12-month DAPT group. Among patients without diabetes, that endpoint was seen in 2.46% of patients in the clopidogrel monotherapy group and 2.49% of patients in the 12-month DAPT group.
When looking specifically at bleeding events among diabetic patients, meanwhile, the authors noted that they were much less likely to happen if the patient was treated with clopidogrel monotherapy (0.30%) as opposed to 12 months of DAPT (1.5%).
The authors did identify certain limitations to their research. For example, many eligible patients were not enrolled into the STOPDAPT-2 trial due to “physician choice or patient refusal,” and many of those patients may have faced a higher risk of experiencing a cardiovascular or bleeding event after PCI.
“Therefore, the present study patients represent a somewhat lower risk population than those encountered in real clinical practice,” they wrote. “In fact, the incidence of the cardiovascular and bleeding events in this study was very low.”
The team concluded that additional studies are still necessary to determine the optimal monotherapy strategy for diabetic patients undergoing PCI.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.