While the benefits of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor are recognized, its primary complication is the occurrence of bleeding events, which negatively impact patient morbidity and mortality.
Additionally, about 10% of patients undergoing percutaneous coronary intervention (PCI) are on oral anticoagulant therapy, which significantly increases the risk of bleeding when combined with DAPT. The optimal duration of DAPT with oral anticoagulation remains uncertain.
To address this uncertainty, researchers conducted a multicenter prospective study to evaluate the effects of 1-month versus 3-month DAPT in patients with and without oral anticoagulation (OAC).
The primary endpoint (PEP) was a combination of all-cause death or acute myocardial infarction (AMI), while the secondary endpoint (SEP) focused on the bleeding rate according to BARC classification 2 to 5.
The study included a total of 3364 patients; 43% of them were on anticoagulation, and 56% were not. In the OAC group, 644 patients received 1 month of DAPT and 818 patients received 3 months of DAPT. On the other hand, in the group without oral anticoagulation, 748 patients received 1 month of DAPT and 1154 patients received 3 months of DAPT.
Read also: CAPTIS, a Novel Cerebral Embolic Protection System in TAVR.
Patients in the OAC group were younger, with a higher prevalence of men and a history of myocardial revascularization surgery. They had lower rates of renal insufficiency, anemia, and history of major bleeding. Patients who received 1 month of DAPT, both in the OAC and non-OAC groups, were older and had a higher prevalence of renal insufficiency. The most frequent clinical presentation was non-ST elevation myocardial infarction (NSTEMI) and these patients more frequently received clopidogrel at discharge.
The results showed that, in terms of the PEP, the combined risk of death or AMI was similar between 1 month and 3 months of DAPT for patients with oral anticoagulation (7.4% vs. 8.8%; hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.49-1.11; P = 0.139) and for patients without oral anticoagulation (8.4% vs. 7.3%; HR 1.17; 95% CI: 0.82-1.65; P =0.390).
However, upon an analysis of the individual components of the PEP, patients with oral anticoagulation who received 1 month of DAPT had a lower risk of all-cause death compared with those who received 3 months of DAPT (HR: 0.58; 95% CI: 0.34-0.98; P = 0.043), a difference that was not observed in the group without oral anticoagulation (HR: 1.33; 95% CI: 0.85-2.08; P = 0.206). Regarding the risk of AMI, there were no significant differences between 1 month and 3 months of DAPT in both groups (OAC Group = 3.4% vs. 3.5%; HR: 0.93; 95% CI: 0.51- 1.71; P = 0.814; non-OAC Group = 3.0% vs. 4.3%; HR: 0.72; 95% CI: 0.42-1.23; P = 0.226).
Regarding the SEP, patients with oral anticoagulation had a higher rate of BARC 2 to 5 bleeding. The analysis according to the DAPT duration revealed a lower risk of bleeding for patients with oral anticoagulation in the 1-month group compared with the 3-month DAPT group (HR: 0.71; 95% CI: 0.51-0.99; P = 0.046), and a non-significant trend towards lower bleeding in the group without oral anticoagulation (HR: 0.74; 95% CI: 0.50-1.09; P = 0.124).
Conclusion
In summary, treatment with 1 month of DAPT, compared with 3 months, had similar rates of all-cause death or AMI but was associated with a significant reduction in BARC 2 to 5 bleeding, regardless of anticoagulant treatment.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: 1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI.
Reference: Marco Valgimigli, MD, PHD et al J Am Coll Cardiol Intv 2023.
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