Medical

International Journal of Medical and Pharmaceutical Research

2026, Volume-7 Issue-1

One-Year Outcomes of Drug-Eluting Balloons versus Drug-Eluting Stents in Diabetic Patients with Coronary Artery Disease: A Systematic Review and Meta-Analysis

Abstract Background: Diabetes mellitus is linked with increased risk of restenosis and hostile cardiovascular outcomes following percutaneous coronary intervention (PCI). Drug-eluting stents (DES) are the standard of care, but drug-eluting balloons (DEB) may offer a stentless alternative by delivering antiproliferative drugs locally while avoiding permanent implants. This study involved a systematic review and meta-analysis aimed at assessing the comparative one-year outcomes of DEB versus DES in individuals with diabetes undergoing PCI for de-novo CAD. Methods: The guidelines of PRISMA 2020 are followed in this review. Randomized controlled trials (RCTs) and observational cohort studies reporting diabetic subgroup outcomes were identified through PubMed, Scopus, Web of Science, and Cochrane databases (March 2024). Eligible studies included adults with diabetes (≥18 years) undergoing PCI for de-novo CAD, treated with either DEB or DES, and reporting clinical outcomes at 12 months. Two reviewers independently carried out data extraction and evaluated study quality. Risk of bias in randomized controlled trials was assessed using the Cochrane RoB 2 tool (RCTs), while observational studies were appraised with the Newcastle–Ottawa Scale. For pooled analyses, we utilized RevMan version 5.4 (The Cochrane Collaboration, Copenhagen, Denmark). Results: Twenty studies were included, comprising 6,452 diabetic patients (DEB: 2,890; DES: 3,562). At one year, the occurrence of major adverse cardiovascular events (MACE) was similar between DEB and DES (OR 0.97, 95% CI: 0.77–1.22; p = 0.78; I² = 0%). DEB significantly reduced target lesion revascularization (TLR) compared with DES (OR 0.74, 95% CI: 0.56–0.98; p = 0.04; I² = 19%). No significant differences were observed in target vessel revascularization (TVR; OR 1.00, 95% CI: 0.64–1.55; p = 0.99) or myocardial infarction (MI; OR 1.07, 95% CI: 0.89–1.30; p = 0.47). Assessment through funnel and Galbraith plots demonstrated no discernible evidence of publication bias. However, the trial sequential analysis emphasized that, despite the current findings, additional large-scale, adequately powered randomized trials are warranted to ensure the robustness and reliability of the evidence base. Conclusion: DEB are non-inferior to DES for MACE and MI and superior in reducing TLR in diabetic patients undergoing PCI for de-novo CAD. They represent a safe and effective alternative to DES, particularly in patients at high risk of restenosis or bleeding. Large-scale randomized trials, especially with newer sirolimus-coated DEB, are warranted to confirm long-term efficacy Keywords Drug-eluting balloon Drug-eluting stent Diabetes mellitus Coronary artery disease Percutaneous coronary intervention Systematic review Meta-analysis. INTRODUCTION Diabetes mellitus is a major contributor to cardiovascular morbidity and mortality and poses significant challenges in the management of coronary artery disease (CAD). Patients with diabetes undergoing percutaneous coronary intervention (PCI) have higher rates of restenosis, stent thrombosis, and repeat revascularization compared with non-diabetic individuals, largely due to endothelial dysfunction, chronic vascular inflammation, and impaired vascular healing (Löhrle et al., 2021; Verdoia et al., 2024). Although drug-eluting stents (DES) have markedly improved PCI outcomes by reducing restenosis and the need for repeat interventions, their efficacy in diabetic patients remains limited. This is attributed to delayed endothelialization, persistent inflammation, and the prolonged requirement for dual antiplatelet therapy, which increases bleeding risk (Murphy et al., 2023). Drug-eluting balloons (DEB) have emerged as a promising alternative, providing localized delivery of antiproliferative drugs without leaving a permanent implant. This approach may mitigate long-term device-related complications such as stent thrombosis and chronic inflammation and could be particularly advantageous in high-risk populations like diabetic patients (Li et al., 2022). Despite these potential benefits, direct comparisons of DEB versus DES in diabetic patients with de-novo CAD remain limited. Existing studies often include heterogeneous patient populations, complicating interpretation for this high-risk group (Refaat et al., 2025). Therefore, a systematic review and meta-analysis focusing on one-year outcomes is warranted to provide robust evidence on the safety and efficacy of DEB relative to DES, guide clinical decision-making, and inform optimal revascularization strategies in diabetic patients. MATERIALS AND METHODS This systematic review and meta-analysis was designed and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines (Page et al., 2021) and followed the methodological standards outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins et al., 2022). Eligibility Criteria We included studies that enrolled adult patients (≥18 years) with diabetes mellitus undergoing percutaneous coronary intervention (PCI) for de novo coronary artery disease (CAD). The intervention of interest was drug-eluting balloon (DEB) angioplasty, with drug-eluting stent (DES) implantation serving as the comparator. Eligible studies were required to report at least 12-month clinical outcomes, including major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), or all-cause mortality. Both randomized controlled trials (RCTs) and well-conducted observational cohort studies were considered. Studies were excluded if they: focused exclusively on in-stent restenosis, were animal or pre-clinical studies, were reviews, case reports, conference abstracts, or editorials, or lacked extractable data for diabetic subgroups. Outcomes of Interest The primary outcome was the incidence of MACE at one year, as defined by each study (commonly a composite of death, MI, and repeat revascularization). Secondary outcomes included the individual components of MACE—MI, TLR, TVR, cardiac death, and all-cause mortality. Search Strategy A comprehensive literature search was conducted in PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to September 2025. The search strategy combined relevant terms and synonyms, including: drug-eluting balloon, drug-coated balloon, DCB, DEB, drug-eluting stent, DES, References of included articles and prior systematic reviews were hand-searched to identify additional eligible studies (Liberati et al., 2009). Study Selection and Data Extraction Two reviewers independently screened records in a two-stage process (titles/abstracts followed by full texts). Discrepancies were resolved through consensus or adjudication by a third reviewer. Data were extracted using a standardized template capturing study design, first author, year, country, sample size, patient demographics, lesion and procedural characteristics, and reported outcomes at 12 months. When diabetic subgroup data were not explicitly presented, supplementary material was checked, and authors were contacted for clarification (Verdoia et al., 2024). Risk of Bias Assessment Quality assessment was performed independently by two reviewers. RCTs were appraised using the Cochrane Risk of Bias 2 (RoB 2) tool, evaluating domains such as randomization process, deviations from intended intervention, missing outcome data, outcome measurement, and selective reporting (Sterne et al., 2019). Observational studies were assessed using the Newcastle–Ottawa Scale (NOS), which examines cohort selection, comparability, and outcome assessment (Wells et al., 2013). Data Synthesis and Statistical Analysis Effect sizes were expressed as risk ratios (RRs), odds ratios (ORs), or hazard ratios (HRs) with corresponding 95% confidence intervals (CIs). A random-effects model (DerSimonian and Laird, 1986) was applied, given the expected clinical and methodological heterogeneity. Analyses were performed using RevMan version 5.4 (The Cochrane Collaboration, Copenhagen, Denmark). Statistical heterogeneity was quantified using the I² statistic, with thresholds of 25%, 50%, and 75% indicating low, moderate, and high heterogeneity, respectively (Higgins et al., 2003). A p-value <0.10 on Cochran’s Q test was considered evidence of significant heterogeneity. Sensitivity analyses were conducted using a leave-one-out approach to assess robustness of results. Assessment of Publication Bias and Subgroup Analyses Publication bias was evaluated by visual inspection of funnel plots and tested with Egger’s regression test when ≥10 studies were available for an outcome (Egger et al., 1997). Predefined subgroup analyses were performed by study design (RCT vs. observational), type of drug coating (paclitaxel vs. sirolimus), and lesion type (small-vessel vs. mixed populations). Additional sensitivity analyses excluded small trials and lower-quality studies to test consistency of findings. RESULTS 3.1 Study Selection A total of 255 records were identified through database searching. After removing duplicates and screening, 20 studies met the inclusion criteria. Of these, 13 provided explicit diabetic subgroup data suitable for analysis. The PRISMA flow diagram of study selection is shown in Figure 1.