Association of DAPT duration with bleeding and ischemic outcomes after percutaneous coronary intervention with drug-coated balloons: a meta-analysis

Clinical Research in Cardiology https://doi.org/10.1007/s00392-026-02934-2 ORIGINAL PAPER Association of DAPT duration with bleeding and ischemic outcomes after percutaneous coronary intervention with drug‑coated balloons: a meta‑analysis Giuseppe Panuccio1,2,3 · Nicole Carabetta4 · Martina Sportelli4 · Giuseppe Tartaglione4 · Kambis Mashayekhi5 · Emmanouil S. Brilakis6 · David M. Leistner7,8,9 · Sabato Sorrentino3,4 · Youssef Abdelwahed2,10 · Ulf Landmesser2,10,11 · Salvatore De Rosa3,4 · Daniele Torella1,3 Received: 25 January 2026 / Accepted: 26 April 2026 © The Author(s) 2026 Abstract Introduction Drug-coated balloons (DCB) represent a promising tool in percutaneous coronary intervention (PCI), enabling a “leave nothing behind” strategy. Evidence guiding the optimal duration of dual antiplatelet therapy (DAPT) after DCB angioplasty remains limited. Methods A systematic review and meta-analysis was conducted according to PRISMA guidelines. Pooled DAPT duration was analyzed. The primary analysis assessed bleeding events (according to BARC criteria) and ischemic events including target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE). Metaregression and subgroup analyses were performed to assess the association between DAPT duration and clinical outcomes. Results A total of 52 studies including 18,856 patients were analyzed. The pooled mean DAPT duration after DCB angioplasty was 133 days (95% CI 92–174). The overall rate of bleeding was 2.4% (95% CI 2.0–2.7). Meta-regression analysis showed a significant association between longer DAPT duration and higher bleeding rates (coefficient 0.0174; 95% CI 0.012–0.024; p < 0.001; p < 0.001). Subgroup analysis showed significantly lower rates of bleeding with 1-month DAPT regimen vs. 3–6 months and 6 months (0.9% vs 4.6% vs. 5.3%; p = 0.01). No significant association was observed between DAPT duration and ischemic outcomes, including TLR, TVR, or MACE (all p > 0.05). Conclusions Short DAPT (≤ 1 month) following DCB angioplasty is associated with lower reported bleeding rates at the study level, while no ischemic signal was detected across DAPT durations. These hypothesis-generating findings support a rationale for tailoring antiplatelet therapy duration after DCB. Dedicated randomized trials are warranted to define the optimal DAPT strategy in the DCB setting. Graphical Abstract Extended author information available on the last page of the article Vol.:(0123456789) Clinical Research in Cardiology Keywords Drug-coated balloons · Drug eluting balloons · Antiplatelet therapy · High bleeding risk · Precision medicine · Coronary artery disease · Percutaneous coronary intervention Introduction Percutaneous coronary intervention (PCI) with drug eluting stents (DES) implantation represents the gold-standard treatment for coronary artery disease (CAD) [1]. The optimal duration of dual antiplatelet therapy (DAPT) after PCI has been extensively studied in patients treated with DES. Current guidelines recommend a minimum of 6 months of DAPT for patients with DES and at least 12 months for those with acute coronary syndromes (ACS) [2, 3]. Drug-coated balloons (DCB) represent an established alternative to stentbased revascularization, delivering antiproliferative drugs to the vessel wall without leaving a permanent scaffolding. By combining mechanical plaque modification with local drug delivery, DCB angioplasty inhibits neointimal hyperplasia while preserving the native vessel architecture [4]. This “leave nothing behind” strategy erases the risk associated with metallic stents—such as late thrombosis, malapposition, and underexpansion—and has shown to be safe and effective in several CAD scenarios including in-stent restenosis (ISR), small-vessel disease (SVD), and bifurcations [5–7]. Recently, DCB have also been evaluated for de novo coronary lesions, showing comparable angiographic and clinical outcomes compared with DES, with some of these studies including high bleeding risk (HBR) patients [8, 9]. While current guidelines provide clear recommendations for DAPT duration after DES implantation, the optimal duration of antiplatelet therapy after stentless PCI remains poorly defined. Emerging data suggest that a shorter DAPT regimen might be safe in terms of ischemic protection while minimizing bleeding complications [10]. However, in patients treated with DCB, DAPT duration is largely empirical and varies substantially across clinical scenarios, reflecting the lack of dedicated randomized evidence. To date, no quantitative synthesis has systematically evaluated real-world DAPT duration after DCB angioplasty or explored its association with bleeding and ischemic outcomes. Therefore, this systematic review and meta-analysis aimed to define the contemporary DAPT duration after DCB angioplasty and to explore study-level associations between DAPT duration and bleeding and ischemic outcomes. Methods This systematic review and meta-analysis was performed in accordance with the Cochrane Collaboration and PRISMA guidelines [11, 12]. The analysis is registered in PROSPERO, the international prospective register of systematic reviews (PROSPERO record ID = CRD42025642790). Study search A comprehensive screening was performed to detect studies related to the use of DCB. Up to August 2025, articles were screened using PubMed/MEDLINE (https://pubmed.ncbi. nlm.nih.gov/) and Web of Science (WOS). The search strategy was intentionally designed to be broad and focused on identifying all studies involving DCB angioplasty in coronary artery disease. Because DAPT duration is frequently reported as a secondary procedural characteristic rather than a primary outcome, DAPT-related terms were not included in the search string to avoid missing relevant DCB studies. DAPT duration and outcomes were subsequently extracted during full-text review. The research string adopted was: (((((drug coated balloons) OR (drug eluting balloons)) AND (coronary artery disease)). Database-specific search strategies were adapted according to the characteristics of each platform. In PubMed, Medical Subject Heading (MeSH) terms and filters for clinical studies were applied. Study selection with inclusion/exclusion criteria Two co-authors (GP, DT) independently assessed study eligibility. Disagreements were addressed through consensus. Studies were considered eligible for inclusion according to the following criteria: (a) studies on adult patients undergoing PCI with DCB, either for de novo lesions or in-stent restenosis; (b) reported the duration of DAPT after DCB; and (c) provided data on bleeding and/or ischemic outcomes. Editorials, review articles, case reports, or studies lacking reported clinical outcomes were excluded. Data extraction was conducted by co-authors GP and DT, including study design, year, population characteristics, lesion setting (de novo vs. in-stent restenosis), DAPT duration, and clinic (...truncated)