Abbreviated DAPT Regimens Across the Entire Spectrum of Bleeding Risk According to the PRECISE-HBR Score.
The XIENCE Short DAPT program pooled 3,364 high-bleeding-risk patients across three single-arm studies of everolimus-eluting stents, stratifying by PRECISE-HBR score into non-high (≤22, 10.7%), high (23-26, 22.1%), and very high (≥27, 67.2%) tiers.
One-month versus three-month DAPT reduced BARC 3-5 bleeding only in the score ≥27 group (HR 0.59, 95% CI 0.39-0.88; P-interaction = 0.012), with ischemic risk unchanged across all strata (P-interaction = 0.40).
Event rates for bleeding (0.3% / 2.5% / 5.6%) and death or MI (2.9% / 4.6% / 9.8%) rose in lockstep with the score.
Read this for what it is: a post hoc, propensity-stratified analysis of pooled single-arm registries, not a randomized comparison of DAPT durations.
BACKGROUND: Among high-bleeding risk (HBR) patients undergoing coronary stenting, abbreviated dual antiplatelet therapy (DAPT) reduces bleeding without ischemic risk trade-off; whether these benefits persist across the entire spectrum of bleeding risk has not been investigated. OBJECTIVES: The aim of this study is to explore the value of the novel PRECISE-HBR score as a risk stratification tool to guide DAPT duration in patients at high bleeding risk. METHODS: The XIENCE Short DAPT program combined 3 international single-arm studies of HBR patients treated with cobalt-chromium everolimus-eluting stents who discontinued DAPT at 1 month (XIENCE 28 USA/Global) or 3 months (XIENCE 90), if event free and treatment adherent. Bleeding risk was classified as nonhigh (PRECISE-HBR score ≤22), high (score 23-26), or very high (score ≥27). Clinical outcomes were assessed between 1 and 12 months using propensity score stratification. RESULTS: Among 3,364 patients, the PRECISE-HBR score was ≤22, 23-26, and ≥27 in 359 (10.7%), 744 (22.1%), and 2,261 (67.2%), respectively. Rates of BARC (Bleeding Academic Research Consortium) type 3-5 bleeding (0.3%, 2.5%, 5.6%) and death or myocardial infarction (2.9%, 4.6%, 9.8%) increased progressively across risk categories. One- versus 3-month DAPT was associated with a significant reduction in BARC type 3-5 bleeding in patients with a score ≥27 (HR: 0.59, 95% CI: 0.39-0.88) but not in those <27 (HR: 2.31, 95% CI: 0.89-5.99; P-interaction = 0.012). Ischemic risk was similar between 1- and 3-month DAPT, irrespective of the PRECISE-HBR score (P-interaction = 0.40). CONCLUSIONS: The PRECISE-HBR score identified patients at increased risk for both bleeding and ischemic events who seemed to derive greater benefit from 1-month DAPT after stent implantation.
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