After stent implantation, a three-month regimen of dual antiplatelet therapy (DAPT) was more effective than a one-month regimen at reducing adverse events without increasing bleeding risk in patients with a high bleeding risk (HBR), according to a Late-Breaking Clinical Trial presented at ACC.25 in Chicago. Furthermore, in patients with a low bleeding risk (LBR), a three-month regimen was found to be superior to 12 months for reducing bleeding risk and comparable in reducing adverse events.

The investigator-initiated multicenter study enrolled nearly 4,900 patients in South Korea, one-third (1,598) with HBR (average age 73.8 years, 33.5% women) and two-thirds (3,299) with LBR (average age 63.2 years, 20.9% women).

“Ours is the first study to examine the question of the optimal DAPT duration in patients at both high and low risk of bleeding,” said principal investigator, Hyo-Soo Kim, MD, PhD, FACC.

The HBR group was randomized to either one month (n=798) or three months (n=800) of DAPT while the LBR group was randomized to three (n=1649) or 12 months (n=1650) of DAPT. Use of a P2Y12 inhibitor either during the DAPT period or as a monotherapy agent after DAPT was left to clinician discretion.

Investigators examined three primary endpoints: 1) net adverse clinical events (NACE), including all death, myocardial infarction (MI), stent thrombosis, stroke or major bleeding; 2) major adverse cardiac or cerebral events (MACCE), including cardiovascular disease, MI, stent thrombosis or ischemic stroke; and 3) any actionable bleeding at 12 months.

At 12 months, in the HBR group, those who received three months of DAPT had less NACE and MACCE than those who received one month (14.4% vs. 18.4%; 6.4% vs. 10.3% respectively). There was no significant difference in bleeding episodes (17.9% for three-month DAPT vs. 15.6% for one-month DAPT).

In the LBR group, outcomes were similar between the three-month and 12-month DAPT groups for NACE and MACCE (4% vs. 5.7%; 2.5% vs. 2.8%), but those in the three-month arm had significantly less bleeding than those in the twelve-month (9.2% vs. 13.7%).

The trial will continue to follow patients for three years to observe long-term effects of different durations of DAPT.

A limitation of the study is that it was conducted entirely in South Korea, and about 80% of study patients received clopidogrel as their second antiplatelet drug, which is the standard regimen in East Asia, said Kim. Previous randomized clinical trials have shown that patients in East Asia had better outcomes when treated with clopidogrel rather than with the more potent ticagrelor that is used in other regions. Nevertheless, Kim said, the optimal duration of DAPT derived from this study might be applied to patients regardless of the drug type.

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Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: ACC Annual Scientific Session, ACC25, Dual Anti-Platelet Therapy, Stents