Clinical Outcomes of Drug-Eluting Balloon Use in High Bleeding Risk Patients Undergoing PCI: A Retrospective Comparison with Short-DAPT DES

Pakistan Journal of Medical & Cardiological Review https://pakjmcr.com/index.php/1/about Online ISSN Print ISSN 3007-2387 3007-2379 Vol. 4 No. 4 (2025) Pakistan Journal of Medical & Cardiological Review Page 1737 Clinical Outcomes of Drug-Eluting Balloon Use in High Bleeding Risk Patients Undergoing PCI: A Retrospective Comparison with Short-DAPT DES Dr Atif Kamal Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email: [email protected] Dr Fahad Raja Khan Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email: fahadraj[email protected] Dr Shah Zaib Associate Professor of Cardiology, Peshawar Institute of Cardiology, Peshawar Email: [email protected] Dr Rahman Ullah Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email: [email protected] Dr Yasir Saood Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email: doctor.yasi[email protected] Dr Nasir Khan Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email: [email protected] Background: High bleeding risk (HBR) complicates device selection and dual antiplatelet therapy (DAPT) duration after percutaneous coronary intervention (PCI). Drug-eluting balloons (DEB) may permit shorter DAPT by avoiding permanent metallic scaffolds. Objective: To compare net clinical outcomes of a DEBbased strategy versus short-DAPT drug-eluting stents (DES) in HBR patients undergoing PCI. Methods: This single-centre retrospective cohort included consecutive adults fulfilling Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria who underwent PCI at a tertiary cardiac centre between January 1 and June 30, 2025. Patients were treated either with DEB-only angioplasty or with contemporary DES and an intentionally abbreviated DAPT regimen (planned 1–3 months in both groups). The primary endpoint was net adverse clinical events (NACE), defined as major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, target vessel revascularization) plus Bleeding Academic Research Consortium (BARC) type 3–5 bleeding. Outcomes were assessed to a median follow-up of 8.1 months. Abstract Author Details Keywords: Drug-Eluting Balloon; Drug-Eluting Stent; Percutaneous Coronary Intervention; High Bleeding Risk; Dual Antiplatelet Therapy; Major Bleeding; Net Adverse Clinical Events Received on 1st Sep 2025 Accepted on 10th Sep 2025 Published on 2nd Oct 2025 Corresponding E-mail & Author*: Dr Fahad raja khan Fellow Interventional Cardiology, Peshawar Institute of Cardiology, Peshawar Email:fahadraja78@@gmail.com Page 1738 Results: Of 380 eligible ARC-HBR patients, 180 (47.4%) received DEB and 200 (52.6%) short-DAPT DES. DAPT duration was shorter in the DEB group, with 83.3% versus 66.0% off DAPT by three months. NACE occurred in 10.0% of DEB patients and 19.0% of DES patients (relative risk [RR] 0.53; 95% confidence interval [CI] 0.31– 0.89; p=0.02). BARC 3–5 bleeding was lower with DEB (4.4% vs 11.0%; RR 0.40; 95% CI 0.18–0.88; p=0.02), whereas MACE alone was numerically but not significantly reduced (7.8% vs 12.0%; p=0.18). Conclusion: In HBR patients managed with intentionally abbreviated DAPT, a DEBbased PCI strategy was associated with fewer net adverse clinical events than shortDAPT DES, driven by lower major bleeding without an apparent ischaemic penalty. These real-world data may help guide device choice in this vulnerable population. Introduction Percutaneous coronary intervention [PCI] with contemporary drug-eluting stents [DES] has transformed the management of obstructive coronary artery disease, yet it remains tightly coupled to dual antiplatelet therapy [DAPT], typically combining aspirin with a P2Y₁₂ inhibitor [1,2]. While DAPT reduces stent thrombosis and recurrent myocardial infarction, the benefit accrues at the cost of a near-proportional increase in major and clinically relevant non-major bleeding, which itself carries a substantial hazard for subsequent mortality and adverse cardiac events [1,4]. In this setting, bleeding is not simply a nuisance complication; it is a prognostically important event that competes with ischaemic risk and complicates long-term therapy decisions. High bleeding risk [HBR] has therefore emerged as a central construct in PCI decisionmaking. The Academic Research Consortium for High Bleeding Risk [ARC-HBR] provides a standardized definition based on clinical and laboratory criteria, anchored to a predicted ≥4% risk of Bleeding Academic Research Consortium (BARC) type 3–5 bleeding or ≥1% risk of intracranial haemorrhage at 1 year [3,4]. Using these criteria, approximately one in three patients undergoing PCI meets HBR definitions, reflecting the ageing population and increasing burden of chronic kidney disease, anaemia, malignancy, and prior bleeding [1,3]. Guidelines and expert consensus now endorse abbreviated DAPT (1–3 months) in HBR patients, but implementation in practice is often cautious because clinicians must still balance late thrombotic risk, particularly with complex anatomy or diffuse disease [1,2]. Recently, evidence specific to HBR patients has suggested that shorter DAPT may safely reduce bleeding without sacrificing ischaemic protection. In a meta-analysis including 11 randomized trials and 9006 HBR patients, abbreviated DAPT (≤3 months) after PCI reduced major or clinically relevant non-major bleeding by 24% and major bleeding by 20% [risk ratio (RR) 0.76; 95% CI 0.61–0.94 and RR 0.80; 95% CI 0.64– 0.99, respectively), with no excess in myocardial infarction, stent thrombosis, or major adverse cardiovascular events compared with ≥6 months of therapy [1]. A separate systematic review restricted to HBR PCI reported similar findings: DAPT limited to 1– 3 months was associated with substantially lower major bleeding [RR 0.34; 95% CI 0.13–0.90] and major or clinically relevant non-major bleeding (RR 0.60; 95% CI 0.44– 0.81), without an apparent trade-off in ischaemic outcomes [2]. These data underscore that, in HBR patients, bleeding is a scale problem with system-level implications for readmissions, transfusion use, and long-term survival. Against this backdrop, drug-coated/drug-eluting balloons (DCB/DEB) have gained attention as a “leave-nothing-behind” strategy that may be particularly attractive in HBR populations [5–7]. By delivering an antiproliferative drug during a single balloon inflation without permanent metallic scaffolding, DEBs obviate the risk of late and very late stent thrombosis and may allow for shorter durations of DAPT while maintaining anti-restenotic efficacy [6,7]. In the DEBUT trial, which enrolled patients with de novo Page 1739 coronary lesions and at least one bleeding risk factor, DEB angioplasty was superior to bare-metal stents, reducing 9-month major adverse cardiac events from 14% to 1% (absolute risk difference −13.2 percentage points; 95% CI −21.1 to −6.2) [5]. Similarly, the BASKET-SMALL 2 trial demonstrated that in small-vessel coronary artery disease, DEBs were non-inferior to second-generation DES with respect to composite clinical endpoints at 12 months, with sustained efficacy and safety at 3 years [6]. International consensus now recognizes DEB as an established option for in-stent restenosis and small-vessel disease and highlights its potential value in patients where a shorter DAPT course is desirable, including those with HBR [7]. However, most randomized DEB data have compared DEB with either bare-metal stents or second-generation DES in anatomically selected cohorts, and only a minority of patients fulfilled contemporary ARC-HBR criteria [5–7.] Moreover, head-to-head comparisons between DEB and new-generation DES specifically in HBR patients treated with intentionally short DAPT (≤3 months) remain sparse. In clinical practice, operators often choose between a DEB strategy and short-DAPT DES for the same HBR patient, yet the relative safety and effectiveness of these approaches in “all-comer” HBR cohorts are not well defined. This evidence gap is particularly relevant as both device iterations and antiplatelet strategies continue to evolve. Accordingly, the aim of this retrospective cross-sectional study was to compare clinical outcomes of DEB-based PCI with those of PCI using contemporary DES in patients at high bleeding risk who were treated with short-duration DAPT. We hypothesized that, in an HBR population managed with abbreviated DAPT, a DEB strategy would provide similar protection from ischaemic events while reducing bleeding, thereby improving the overall net clinical profile. By addressing a real-world population defined by ARCHBR criteria and treated in routine practice, this study seeks to inform device selection in HBR PCI and to support more individualized antithrombotic strategies in this vulnerable group. Materials and Methods Study design and setting This was a retrospective cohort study conducted in the Department of Cardiology, Peshawar Institute of Cardiology, a tertiary-care hospital. All consecutive adults undergoing PCI between 1 January 2025 and 30 June 2025 were screened for eligibility. The study focused on patients who met high bleeding risk (HBR) criteria according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR), as already defined in the Introduction. Reporting of the study followed the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) recommendations for observational research and adhered to the principles of the Declaration of Helsinki [8]. The protocol was approved by the institutional ethics review committee. Study population The objective of this study was to compare clinical outcomes of a drug-eluting balloon (DEB)–based PCI strategy with those of PCI using contemporary drug-eluting stents (DES) in patients at high bleeding risk who were treated with intentionally shortduration dual antiplatelet therapy (DAPT). Adults aged ≥18 years undergoing PCI for either stable coronary artery disease or acute coronary syndrome during the study period were eligible if they fulfilled ARC-HBR criteria (at least one major or two minor bleeding risk criteria) as described in the Introduction. Patients were included if the target lesion was treated either with: a DEB-only strategy (angioplasty with a coronary drug-coated/drug-eluting balloon and no permanent stent in the treated segment), or Page 1740 implantation of a new-generation DES with a planned short DAPT course (approximately 1–3 months), consistent with the abbreviated regimens recommended for HBR populations. Patients were excluded if they presented with cardiogenic shock, ongoing cardiopulmonary resuscitation, planned immediate surgical revascularization, or concomitant structural heart procedures. Additional exclusions were non-coronary balloon procedures, incomplete angiographic or clinical records, and procedures in which both DEB and DES were used in the same target lesion. For patients undergoing multivessel PCI with different strategies in different vessels, group allocation was based on the strategy used for the culprit or clinically dominant lesion, as judged by the treating interventional cardiologist. PCI procedures and antithrombotic therapy Diagnostic coronary angiography and PCI were performed through radial or femoral access at the operator’s discretion. Unfractionated heparin was administered during the procedure according to body weight; glycoprotein IIb/IIIa inhibitors were used selectively for high thrombotic burden. In the DEB group, lesion preparation consisted of predilatation with semi-compliant or non-compliant balloons until acceptable residual stenosis and TIMI 3 flow were achieved without flow-limiting dissection. Coronary DEB devices (paclitaxelor limuseluting, depending on local availability) were sized to the reference vessel diameter and inflated for the manufacturer-recommended duration. This approach reflects randomized trial evidence and international consensus supporting DEB use in smallvessel and higher-risk coronary disease, as detailed in the Introduction. Bail-out DES implantation was allowed for significant recoil, persistent high residual stenosis, or flow-limiting dissection. In the DES group, second-generation, thin-strut DES were implanted using standard techniques. Stent diameter and length were chosen to match the reference vessel and lesion extent. Post-dilatation and the use of intravascular imaging were left to operator judgment to optimize stent expansion and apposition. All patients received DAPT with aspirin and a P2Y₁₂ inhibitor. In line with HBR strategies summarized in your Introduction, patients treated with DES were generally planned for 1–3 months of DAPT, followed by single antiplatelet therapy when clinically feasible. In the DEB group, a similar or shorter DAPT course was targeted whenever appropriate, recognizing the stentless nature of the strategy. The final DAPT duration was individualized by the treating cardiologist based on the balance between ischaemic and bleeding risk and any intervening clinical events. Outcomes The primary outcome was net adverse clinical events (NACE), defined as the composite of: Major adverse cardiovascular events (MACE): all-cause death, non-fatal myocardial infarction, and ischaemia-driven target vessel revascularization; and Major bleeding, categorized as BARC type 3–5, in continuity with the bleeding definitions introduced earlier. Key secondary outcomes included: Individual NACE components (all-cause death, cardiovascular death where adjudicable, non-fatal myocardial infarction, target vessel revascularization), Any BARC bleeding (types 1–5) and major BARC 3–5 bleeding, Suspected stent or vessel thrombosis (for stented lesions) according to Academic Research Consortium definitions, and Page 1741 In-hospital procedural complications (e.g., no-reflow, vessel perforation, significant access-site complications requiring intervention). Outcomes were assessed from the date of the index PCI to the last available clinical contact. Institutional pathways ensured that the majority of patients had at least six months of follow-up. For patients without scheduled clinic visits, information was obtained from readmission records and, where available, telephone contact. Data collection Data were extracted from the institutional PCI registry and electronic medical records using a pre-defined template. Two trained physicians independently reviewed angiographic and clinical documentation, and any discrepancies were resolved by consensus. Collected variables included: Demographics and cardiovascular risk factors: age, sex, body mass index, hypertension, diabetes mellitus, dyslipidaemia, smoking status, prior myocardial infarction, prior PCI or coronary artery bypass grafting, and prior stroke or transient ischaemic attack. High bleeding risk variables: individual ARC-HBR criteria such as baseline haemoglobin and platelet count, estimated glomerular filtration rate, history of major bleeding, chronic liver disease, active malignancy, and long-term oral anticoagulant use. Clinical presentation: stable angina, non-ST-elevation acute coronary syndrome, or STelevation myocardial infarction. Angiographic and procedural data: target vessel and segment, lesion morphology and length, reference vessel diameter, presence of bifurcation or severe calcification, access site, DEB or DES type and size, number of treated lesions, and immediate angiographic success (residual stenosis and TIMI flow) as judged by the operator. Medical therapy: DAPT components, planned and documented duration of DAPT, use of oral anticoagulation, and guideline-directed secondary prevention medications at discharge. A random subset of records was rechecked by a second reviewer to minimize data-entry error. Only anonymized data were used for analysis. Sample size considerations Although all eligible patients during the six-month period were ultimately included (fixed-cohort design), an a priori sample size assessment was performed to judge whether the expected number of patients would be adequate for meaningful betweengroup comparisons. Expected event rates were informed by high bleeding risk PCI literature already summarized in the Introduction, which reports composite ischaemic and bleeding event rates in the range of roughly 15–25% at one year in HBR patients treated with contemporary DES and abbreviated DAPT. On this basis, we anticipated a primary NACE rate of approximately 20% in the short-DAPT DES group and considered an absolute risk difference of about 10 percentage points in favour of DEB to be clinically important for device selection. Sample size planning followed standard methods for comparative observational studies with binary outcomes, as outlined by Wang and Ji, who provide practical guidance and tools for sample size estimation across different clinical study designs, including cohort comparisons [9]. In line with commonly used WHO-style and Epi Info-based calculators, we applied the usual two-group comparison framework, specifying a twosided alpha of 0.05 and power of 80% [9,10]. An expected NACE rate near 20% in the DES arm, combined with a 10-percentagepoint difference judged clinically meaningful, indicated that approximately 200 patients Page 1742 per group (around 400 total) would provide adequate power for detecting such a difference using simple between-group comparisons. As this was a single-centre retrospective study, the final sample size was determined by the number of consecutive eligible HBR patients treated during the study period; the calculation was therefore used primarily to interpret the precision and detectable effect size rather than to impose a recruitment target. Statistical analysis All analyses were conducted using standard statistical software (e.g., IBM SPSS Statistics, version 26; IBM Corp., Armonk, NY, USA). No advanced methods such as multivariable regression, propensity score techniques, or survival modelling were applied; the analysis was intentionally kept straightforward to align with an audit-style retrospective cohort. Continuous variables were examined for distribution and summarized as mean ± standard deviation when approximately normal, or median with interquartile range when skewed. Categorical variables were summarized as counts and percentages. Comparisons between the DEB and DES groups were performed as follows: For continuous variables, the independent-samples t test was used when distributions were approximately normal, and the Mann–Whitney U test when clearly non-normal. For categorical variables, the chi-square test was used; Fisher’s exact test was applied when expected cell counts were small. For the primary and key secondary binary outcomes, crude risk ratios with 95% confidence intervals were calculated to describe the relative risk associated with the DEB versus DES strategies. All tests were two-sided, and a p value <0.05 was considered statistically significant. Secondary outcomes were regarded as exploratory, and no formal correction for multiple testing was applied; these findings were interpreted cautiously in light of the retrospective design and the potential for residual confounding. Ethical considerations The study protocol was reviewed and approved by the Institutional Review Board/Ethics Committee of Peshawar Institute of Cardiology. Because the study involved retrospective analysis of existing clinical and angiographic records with no direct patient contact or alteration of management, the requirement for written informed consent was waived. All data were de-identified prior to analysis, and access to the dataset was restricted to the study investigators in accordance with institutional and national regulations on patient confidentiality. Results Among 412 high bleeding risk (HBR) patients who underwent PCI during the study period, 32 were excluded because of incomplete angiographic or clinical data (n=19), concomitant cardiac surgery at the index admission (n=7), or mixed DEB–DES use in the same target lesion (n=6). The final analytic cohort therefore comprised 380 patients, of whom 180 (47.4%) were treated with a DEB-only strategy and 200 (52.6%) with short-DAPT DES. No patient was lost to follow-up before 6 months, and the median follow-up duration was 8.1 months (interquartile range [IQR], 6.4–10.2 months). Baseline clinical and high bleeding risk characteristics were broadly similar between groups (Table 1). The mean age of the cohort was 72.4±8.9 years, with 132/380 (34.7%) women; age was slightly higher in the DEB group (73.1±8.7 years) than in the DES group (71.8±9.1 years; p=0.18). Just over one-third of patients presented with stable angina (136/380 [35.8%]), while non–ST-elevation acute coronary syndrome (NSTEACS) accounted for 166/380 (43.7%) and ST-elevation myocardial infarction (STEMI) Page 1743 for 78/380 (20.5%), with a modest excess of ACS presentations in the DES arm (110/180 [61.1%] vs 134/200 [67.0%]; p=0.23). Traditional risk factors were highly prevalent: diabetes mellitus in 210/380 (55.3%), hypertension in 296/380 (77.9%), and dyslipidaemia in 276/380 (72.6%), without statistically significant between-group differences. Chronic kidney disease (eGFR <60 mL/min/1.73 m²) was present in 140/380 (36.8%) and long-term oral anticoagulation in 102/380 (26.8%), again balanced between DEB and DES strategies. Most patients (262/380 [68.9%]) had at least one ARC-HBR major criterion, and the remaining had ≥2 minor criteria only, mirroring a real-world HBR population rather than a selected trial cohort (Table 1). Table 1. Baseline clinical and high bleeding risk characteristics Variable Overall (n=380) DEB (n=180) DES (n=200) pvalue Age, years, mean ± SD 72.4 ± 8.9 73.1 ± 8.7 71.8 ± 9.1 0.18 Female sex, N (%) 132 (34.7) 66 (36.7) 66 (33.0) 0.46 Body mass index, kg/m², mean ± SD 27.3 ± 4.1 27.5 ± 4.2 27.1 ± 4.0 0.39 Stable angina, N (%) 136 (35.8) 70 (38.9) 66 (33.0) 0.22 NSTE-ACS, N (%) 166 (43.7) 76 (42.2) 90 (45.0) 0.57 STEMI, N (%) 78 (20.5) 34 (18.9) 44 (22.0) 0.46 Diabetes mellitus, N (%) 210 (55.3) 95 (52.8) 115 (57.5) 0.37 Hypertension, N (%) 296 (77.9) 137 (76.1) 159 (79.5) 0.44 Dyslipidaemia, N (%) 276 (72.6) 128 (71.1) 148 (74.0) 0.53 Current smoking, N (%) 136 (35.8) 64 (35.6) 72 (36.0) 0.94 Prior myocardial infarction, N (%) 116 (30.5) 52 (28.9) 64 (32.0) 0.50 Prior PCI, N (%) 108 (28.4) 48 (26.7) 60 (30.0) 0.47 Prior CABG, N (%) 37 (9.7) 18 (10.0) 19 (9.5) 0.88 Haemoglobin, g/dL, mean ± SD 11.5 ± 1.9 11.6 ± 1.8 11.5 ± 1.9 0.62 eGFR, mL/min/1.73 m², mean ± SD 53.1 ± 17.5 52.0 ± 18.0 54.1 ± 17.0 0.21 CKD (eGFR <60), N (%) 140 (36.8) 68 (37.8) 72 (36.0) 0.72 On oral anticoagulation, N (%) 102 (26.8) 49 (27.2) 53 (26.5) 0.89 Prior major bleeding, N (%) 60 (15.8) 28 (15.6) 32 (16.0) 0.92 ≥1 ARC-HBR major criterion, N (%) 262 (68.9) 121 (67.2) 141 (70.5) 0.49 Only ARC-HBR minor criteria (≥2), N (%) 118 (31.1) 59 (32.8) 59 (29.5) 0.49 Angiographic and procedural features reflected a moderately complex HBR PCI population (Table 2). The left anterior descending artery was the most common target vessel (184/380 [48.4%] overall), followed by the right coronary artery (102/380 Page 1744 [26.8%]) and the left circumflex (82/380 [21.6%]); left main PCI was infrequent (12/380 [3.2%]). Single-vessel disease was present in 218/380 (57.4%) and did not differ significantly between DEB (108/180 [60.0%]) and DES (110/200 [55.0%]; p=0.33). As expected, DEB was preferentially used in small vessels: reference diameter <2.5 mm was documented in 110/180 (61.1%) of DEB patients versus 76/200 (38.0%) of DES patients (p<0.001). Lesion complexity was high in both cohorts, with ACC/AHA B2/C morphology in 260/380 (68.4%), slightly more frequent in the DES arm (146/200 [73.0%] vs 114/180 [63.3%]; p=0.05). Radial access was the default approach (292/380 [76.8%]), and overall procedural success was high at 367/380 (96.6%), without a significant between-group difference. Table 2. Angiographic and procedural characteristics Variable Overall (n=380) DEB (n=180) DES (n=200) pvalue Single-vessel disease, N (%) 218 (57.4) 108 (60.0) 110 (55.0) 0.33 Target vessel LAD, N (%) 184 (48.4) 82 (45.6) 102 (51.0) 0.26 Target vessel LCx, N (%) 82 (21.6) 40 (22.2) 42 (21.0) 0.78 Target vessel RCA, N (%) 102 (26.8) 52 (28.9) 50 (25.0) 0.39 Target vessel left main, N (%) 12 (3.2) 6 (3.3) 6 (3.0) 0.87 ACC/AHA B2/C lesions, N (%) 260 (68.4) 114 (63.3) 146 (73.0) 0.05 Bifurcation lesions, N (%) 80 (21.1) 34 (18.9) 46 (23.0) 0.30 Severe calcification, N (%) 116 (30.5) 52 (28.9) 64 (32.0) 0.49 Reference vessel diameter, mm, mean ± SD 2.7 ± 0.5 2.4 ± 0.4 2.9 ± 0.4 <0.001 Lesion length, mm, mean ± SD 25.6 ± 8.9 21.8 ± 7.2 28.9 ± 9.6 <0.001 Small vessel (<2.5 mm), N (%) 186 (48.9) 110 (61.1) 76 (38.0) <0.001 Number of treated lesions per patient, mean ± SD 1.5 ± 0.8 1.4 ± 0.7 1.5 ± 0.8 0.27 Radial access, N (%) 292 (76.8) 143 (79.4) 149 (74.5) 0.27 Contrast volume, mL, mean ± SD 170 ± 55 164 ± 52 175 ± 57 0.06 Fluoroscopy time, min, median (IQR) 15 (11– 22) 14 (10– 21) 16 (12– 23) 0.08 Procedural success, N (%) 367 (96.6) 172 (95.6) 195 (97.5) 0.29 Antiplatelet regimens and their observed durations are summarized in Table 3. Nearly all patients were discharged on aspirin (372/380 [97.9%]) and a P2Y₁₂ inhibitor, Page 1745 predominantly clopidogrel (298/380 [78.4%]), with ticagrelor or prasugrel used in 78/380 (20.5%). The proportion discharged on triple therapy (oral anticoagulant plus DAPT) was similar between DEB (34/180 [18.9%]) and DES (38/200 [19.0%]; p=0.98), reflecting the high prevalence of atrial fibrillation and other indications for anticoagulation in this HBR cohort. However, planned DAPT duration differed meaningfully by strategy: DAPT ≤1 month was intended in 92/180 (51.1%) of DEBtreated patients compared with 58/200 (29.0%) of those treated with DES (p<0.001). By 3 months, DAPT had actually been discontinued in 150/180 (83.3%) of DEB patients and 132/200 (66.0%) of DES patients (p<0.001), indicating that the “leavenothing-behind” approach translated into shorter real-world exposure to DAPT (Table 3). Table 3. Antiplatelet therapy at discharge and during follow-up Variable Overall (n=380) DEB (n=180) DES (n=200) pvalue Aspirin at discharge, N (%) 372 (97.9) 176 (97.8) 196 (98.0) 0.90 Any P2Y₁₂ inhibitor, N (%) 376 (98.9) 178 (98.9) 198 (99.0) 0.93 Clopidogrel, N (%) 298 (78.4) 140 (77.8) 158 (79.0) 0.78 Ticagrelor/prasugrel, N (%) 78 (20.5) 40 (22.2) 38 (19.0) 0.43 Triple therapy at discharge, N (%) 72 (18.9) 34 (18.9) 38 (19.0) 0.98 Planned DAPT ≤1 month, N (%) 150 (39.5) 92 (51.1) 58 (29.0) <0.001 Planned DAPT 1–3 months, N (%) 184 (48.4) 70 (38.9) 114 (57.0) <0.001 Planned DAPT >3 months, N (%) 46 (12.1) 18 (10.0) 28 (14.0) 0.22 DAPT discontinued by 3 months, N (%) 282 (74.2) 150 (83.3) 132 (66.0) <0.001 DAPT still ongoing at 6 months, N (%) 64 (16.8) 20 (11.1) 44 (22.0) 0.004 The primary composite endpoint of net adverse clinical events (NACE) occurred in 56/380 (14.7%) patients at follow-up, with a numerically lower rate in the DEB arm (18/180 [10.0%]) than in the DES arm (38/200 [19.0%]). This corresponded to a relative risk (RR) of 0.53 (95% CI, 0.31–0.89; p=0.02), suggesting that DEB-based PCI was associated with a nearly 50% relative reduction in the composite of ischaemic and major bleeding events compared with short-DAPT DES (Table 4, Figure 1). When examined separately, MACE alone occurred in 14/180 (7.8%) DEB patients and 24/200 (12.0%) DES patients (RR, 0.65; 95% CI, 0.35–1.21; p=0.18), indicating a directionally lower, but statistically non-significant, ischaemic event rate with DEB. Major bleeding (BARC 3–5) was less frequent overall than ischaemic events but demonstrated a clear between-group separation. BARC 3–5 bleeding occurred in 30/380 (7.9%) patients and was observed in 8/180 (4.4%) in the DEB group versus 22/200 (11.0%) in the DES group, yielding an RR of 0.40 (95% CI, 0.18–0.88; p=0.02). 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