Key result
Six-month DAPT shows comparable BARC 3 or 5 bleeding to 12-month therapy in HBR patients.
Why the study?
The optimal DAPT duration after PCI in high bleeding risk (HBR) patients is unclear.
Does 6-month DAPT reduce bleeding compared to 12-month DAPT in high bleeding risk patients after PCI?
Cohort (n=2,737)
Does 6-month DAPT reduce bleeding compared to 12-month DAPT in high bleeding risk patients after PCI?
Absolute Event Rate: 3.07% vs 2.76%
p-value: p=1.00
In high bleeding risk patients undergoing PCI, 6-month DAPT demonstrated comparable safety and efficacy to 12-month DAPT over a 4-year follow-up period.
Comparable safety with 6-month DAPT in high bleeding risk PCI does not yet justify practice change; leaves optimal duration open for randomized trials.
OBJECTIVES: To explore the impact of 6- versus 12-month dual antiplatelet therapy (DAPT) on the clinical prognosis of high bleeding risk (HBR) patients. BACKGROUND: The optimal DAPT duration after percutaneous coronary intervention (PCI) in HBR patients is unclear. METHODS: This study is a post hoc analysis of the 4-year clinical follow-up results of the I LOVE IT 2 study. Prevalence and prognosis of HBR patients were explored, and clinical outcomes of HBR patients who underwent 6- versus 12-month DAPT were compared. The primary outcome was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. The secondary outcomes were BARC type 2-5 bleeding and net clinical adverse events (NACE), defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven revascularization, stroke, stent thrombosis, or any bleeding events. RESULTS: HBR occurred in 440 of 2,737 patients (16.0%). HBR patients were associated with a higher risk of BARC type 3 or 5 bleeding (2.95 vs. 1.52%, p = .03), NACE (31.82 vs. 25.99%, p = .01), all-cause death (5.68 vs. 3.13%, p = .008) and stroke (9.09 vs. 3.83%, p < .001) than non-HBR patients at 4 years. There were no significant differences in BARC type 3 or 5 bleeding (3.07 vs. 2.76%, p = 1.00) or NACE rate (31.9 vs. 33.8%, p = .72) between patients who underwent 6- and 12-month DAPT. CONCLUSIONS: HBR patients are at a higher risk of long-term bleeding and ischemic events than non-HBR patients. The safety and efficacy of 6- and 12-month DAPT were comparable in HBR patients.
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Zhang et al. (2021) conducted a cohort in High bleeding risk after percutaneous coronary intervention (n=2,737). 6-month dual antiplatelet therapy (DAPT) vs. 12-month DAPT was evaluated on Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (p=1.00). Six-month dual antiplatelet therapy resulted in comparable rates of BARC type 3 or 5 bleeding compared to 12-month therapy in high bleeding risk patients (3.07% vs 2.76%; p=1.00).
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