Drug-coated balloon strategy and major bleeding in high-bleeding-risk acute coronary syndrome
J Yabuta, T Ueda, A Kyodo, K Nogi, Y Hashimoto, S HikosoAbstract
Background
Acute coronary syndrome (ACS) patients at high bleeding risk (HBR) are challenging because prolonged dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation increases bleeding complications, which are strongly associated with adverse prognosis in this population. Drug-coated balloons (DCB) offer a "leave nothing behind" strategy that may reduce bleeding risk by avoiding permanent metallic implants while maintaining efficacy, yet evidence in HBR ACS remains limited.
Purpose
To compare major bleeding outcomes between DCB and DES strategies in ACS patients meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.
Methods
We retrospectively analyzed consecutive ACS patients with de novo lesions treated between January 2017 and March 2024 at a single center. HBR was defined by the Academic Research Consortium for HBR (ARC-HBR) criteria. Patients were stratified by revascularization strategy (DES vs. DCB) according to the operator’s discretion. The primary endpoint was BARC type 3–5 bleeding. To reduce confounding, 1:1 propensity score matching was performed using hemoglobin level, multivessel disease, Killip class, sex, left ventricular ejection fraction, use of oral anticoagulation, serum albumin level, age, presence of peripheral artery disease, and active malignancy as covariates. In the matched cohort, time-to-event outcomes were assessed using Kaplan–Meier analysis and compared using the log-rank test. Hazard ratios were estimated using unadjusted Cox proportional hazards models.
Results
Among 938 ACS patients, 414 met ARC-HBR criteria and were included (DES: 345; DCB: 67). After propensity score matching, 61 pairs (61 vs. 61) were analyzed. The median follow-up duration in the matched cohort was 13.7 months in the DCB group and 10.6 months in the DES group (p=0.963). DAPT duration in the matched cohort was significantly shorter in the DCB group than in the DES group (3.5 [1.0–7.0] vs. 6.0 [3.0–12.0] months; p=0.031). BARC type 3–5 bleeding occurred in 11 patients (18.0%) in the DCB group and 25 patients (41.0%) in the DES group. Kaplan–Meier analysis demonstrated a significantly lower cumulative incidence of bleeding in the DCB group (log-rank p=0.015). In the unadjusted Cox proportional hazards model, DCB treatment was associated with a lower risk of bleeding (HR 0.43, 95% CI 0.21–0.87; p=0.020).
Conclusions
In ACS patients meeting ARC-HBR criteria, DCB was associated with lower BARC type 3–5 bleeding in the propensity-matched analysis, together with substantially shorter DAPT duration. These real-world findings suggest that a DCB-based strategy may be a bleeding-sparing option for selected HBR ACS patients, although prospective studies are warranted to confirm safety and efficacy.BARC 3–5 bleeding in PS-matched cohort