European Journal of Cardiovascular Medicine

Percutaneous coronary intervention (PCI) remains a cornerstone in the management of patients with obstructive coronary artery disease (CAD). Over the past two decades, the introduction and refinement of drug-eluting stents (DES) have substantially improved clinical outcomes compared with bare-metal stents, primarily by reducing neointimal hyperplasia and the need for repeat revascularization [1,2]. Contemporary DES platforms, incorporating thinner struts and advanced antiproliferative agents, have further lowered rates of in-stent restenosis and stent thrombosis, thereby establishing DES-based PCI as the standard of care for de novo coronary lesions across a broad spectrum of clinical presentations [3,4].

Despite these advances, permanent metallic stent implantation is not without limitations. The presence of a lifelong intravascular scaffold may predispose patients to delayed endothelial healing, chronic vascular inflammation, and late adverse events, including very late stent thrombosis and neoatherosclerosis [5–7]. In addition, stent implantation can compromise future treatment options, particularly in small vessels, bifurcation lesions, or patients who may require subsequent surgical revascularization. These concerns have driven interest in alternative “leave-nothing-behind” revascularization strategies.

Drug-coated balloons (DCBs) have emerged as a promising non-stent-based approach to coronary revascularization. DCBs deliver an antiproliferative drug—most commonly paclitaxel—directly to the vessel wall during transient balloon inflation, without leaving a permanent implant behind [8,9]. This strategy allows for homogeneous drug transfer to the intima while preserving native vessel anatomy and vasomotion. Initially, DCB technology demonstrated clear efficacy in the treatment of coronary in-stent restenosis, where multiple randomized trials showed superiority or non-inferiority compared with repeat stenting [10–12]. On the basis of this evidence, DCB angioplasty is now an established treatment option for in-stent restenosis in international guidelines.

Encouraged by these results, investigators have explored the role of DCB angioplasty in de novo coronary artery disease. The theoretical advantages of DCBs in this setting include avoidance of permanent metal implantation, reduced risk of late device-related complications, and the potential for shorter durations of dual antiplatelet therapy—an especially relevant consideration in patients at high bleeding risk [13,14]. These potential benefits are particularly attractive in small-vessel disease, where DES implantation is associated with higher restenosis rates and suboptimal long-term outcomes [15].

Over the past decade, several randomized controlled trials have compared DCB angioplasty with DES implantation for de novo coronary lesions. Many of these trials were designed as non-inferiority studies and focused on specific patient subsets, such as small-vessel disease or acute coronary syndromes [16–20]. While individual trials generally reported comparable angiographic and clinical outcomes between the two strategies, most were limited by modest sample sizes and insufficient statistical power to detect differences in hard clinical endpoints, such as mortality or myocardial infarction. Furthermore, heterogeneity in trial design, lesion characteristics, clinical presentation, and endpoint definitions has complicated the interpretation of individual study findings.

Recent years have seen the publication of larger, multicenter randomized trials evaluating DCBs in broader de novo CAD populations, providing more robust clinical data [21]. Nevertheless, uncertainty persists regarding the comparative safety and efficacy of DCB angioplasty versus DES-based PCI, particularly with respect to major adverse cardiac events, mortality, and repeat revascularization. Importantly, concerns have also been raised about potential signals of increased cardiac mortality associated with paclitaxel-coated devices in peripheral vascular interventions, underscoring the need for careful evaluation of long-term outcomes in the coronary setting [22].

Given the expanding evidence base and ongoing debate, a comprehensive synthesis of randomized data is warranted. Systematic review and meta-analysis offer an opportunity to integrate results across trials, improve statistical power, and provide more precise estimates of treatment effects for clinically relevant outcomes. In particular, pooling trial-level incidence rate or hazard data allows for standardized comparison across studies with varying follow-up durations.

Therefore, the objective of the present systematic review and meta-analysis was to compare the efficacy and safety of drug-coated balloon angioplasty versus drug-eluting stent implantation for the treatment of de novo coronary artery disease. We focused on major adverse cardiac events as the primary outcome, with secondary analyses of cardiac death, all-cause mortality, myocardial infarction, and target lesion revascularization. By synthesizing data from randomized controlled trials with at least one year of follow-up, this study aims to provide contemporary, clinically meaningful evidence to inform decision-making regarding the optimal revascularization strategy for patients with de novo coronary lesions.

Literature Search A comprehensive and systematic literature search was conducted to identify randomized controlled trials comparing drug-coated balloon angioplasty with drug-eluting stent implantation in patients with de novo coronary artery disease. The databases PubMed/MEDLINE, EMBASE, Scopus, and Web of Science were searched from January 2006 to November 2024. Search terms included combinations of “drug-coated balloon,” “drug-eluting stent,” “de novo coronary lesions,” “percutaneous coronary intervention,” and “randomized controlled trial.” Reference lists of relevant reviews and eligible studies were manually screened to identify additional trials. Only peer-reviewed studies with a minimum follow-up of 12 months were considered. Registered with Prospero with number CRD420251276334. Study Selection and Data Extraction Study selection was performed in accordance with PRISMA guidelines [23]. After removal of duplicate records, titles and abstracts were independently screened by two reviewers to identify potentially eligible studies. Full-text articles were subsequently assessed for inclusion based on predefined criteria: randomized controlled design, comparison of drug-coated balloons versus drug-eluting stents, treatment of de novo coronary artery disease, and a minimum follow-up of 12 months. Discrepancies were resolved by consensus or consultation with a third reviewer. Data extraction was conducted independently by two investigators using a standardized form, capturing study design, patient characteristics, procedural details, follow-up duration, and clinical outcomes. Statistical Analysis and Risk of Bias Assessment Statistical analyses were performed using a random-effects meta-analysis framework to account for anticipated clinical and methodological heterogeneity across trials. Effect estimates were expressed as hazard ratios or incidence rate ratios with corresponding 95% confidence intervals. Standard errors were derived from reported confidence intervals when not directly provided. Heterogeneity was quantified using the Cochran Q test and the I² statistic, with values >50% indicating substantial heterogeneity. All analyses were conducted using validated statistical software. Risk of bias for individual studies was independently assessed by two reviewers using the Cochrane Risk of Bias tool, version 2.0 (RoB 2.0), evaluating bias arising from randomization, deviations from intended interventions, missing outcome data, outcome measurement, and selective reporting [24].

Study Population and Baseline Demographics

A total of nine randomized controlled trials were included in the final analysis, encompassing 4,284 patients [24 - 32] with de novo coronary artery disease who were randomly assigned to treatment with drug-coated balloon angioplasty or drug-eluting stent implantation. Across the included studies, sample sizes ranged from small single-center trials to large multicenter investigations, with one contemporary trial contributing more than half of the overall population. The majority of trials employed a non-inferiority design and reported clinical follow-up of at least 12 months. The pooled study population was predominantly male, with men accounting for approximately two-thirds to three-quarters of enrolled participants across trials. The mean age of patients was generally in the early to mid-60s, reflecting a typical population undergoing percutaneous coronary intervention. Cardiovascular risk factors were common, with diabetes mellitus present in roughly one-quarter to one-third of patients and a substantial proportion having a prior history of myocardial infarction. Acute coronary syndrome at presentation was variably represented, ranging from trials exclusively enrolling ACS patients to those including stable and unstable clinical presentations. Most studies focused on small-vessel coronary disease, with mean reference vessel diameters typically below 3.0 mm, although selected trials enrolled all-comer populations without vessel size restrictions. Baseline characteristics were broadly balanced between treatment arms within individual trials, supporting the validity of subsequent comparative outcome analyses.

Table 1. Basic Demographics

Table 2.  Baseline Patient Profiles and Device Characteristics Across Included Randomized Trials

Major Adverse Cardiac Events

Nine randomized trials were included in the analysis of major adverse cardiac events (MACE). The pooled random-effects model demonstrated no significant difference between drug-coated balloon angioplasty and drug-eluting stent implantation (effect size 0.96, 95% CI 0.72–1.20). Moderate heterogeneity was observed across studies (I² = 61.3%), reflecting variability in trial design and patient populations. Individual study estimates showed mixed effects, with no consistent advantage for either strategy. Overall, the forest plot indicates comparable efficacy of drug-coated balloons and drug-eluting stents in reducing MACE among patients with de novo coronary artery disease.

Cardiac Death

Eight randomized trials contributed to the analysis of cardiac death. The pooled random-effects REML model demonstrated a significantly higher risk of cardiac death associated with drug-coated balloon angioplasty compared with drug-eluting stent implantation (pooled effect size 1.36, 95% CI 1.07–1.66). Notably, no between-study heterogeneity was observed (τ² = 0.00; I² = 0%), indicating consistent findings across trials. Larger multicenter studies contributed the majority of statistical weight. Although individual trials showed wide confidence intervals due to low event rates, the overall forest plot suggests a statistically significant increase in cardiac mortality with drug-coated balloons during medium-term follow-up.

Myocardial Infarction                                          

Seven randomized trials were included in the analysis of myocardial infarction. The pooled random-effects REML model showed no statistically significant difference between drug-coated balloon angioplasty and drug-eluting stent implantation (pooled effect size 0.88, 95% CI 0.30–1.46). Moderate heterogeneity was observed across studies (I² = 48.4%), suggesting variability in effect estimates likely related to differences in clinical presentation and trial design. Individual studies demonstrated wide confidence intervals, reflecting low event rates. Overall, the forest plot indicates comparable risks of myocardial infarction between the two treatment strategies.

Target Lesion Revascularization

Eight randomized trials contributed to the analysis of target lesion revascularization (TLR). The pooled random-effects REML model showed no statistically significant difference between drug-coated balloon angioplasty and drug-eluting stent implantation (pooled effect size 1.46, 95% CI 0.69–2.23). However, substantial heterogeneity was observed across studies (I² = 91.6%), indicating marked variability in treatment effects. Several trials, particularly larger all-comer studies, demonstrated a higher rate of TLR with drug-coated balloons, while others showed comparable outcomes. Overall, the forest plot suggests similar TLR risk between strategies, but with considerable between-study heterogeneity warranting cautious interpretation.

All-Cause MortalityNine randomized trials were included in the analysis of all-cause death. The pooled random-effects REML model demonstrated no significant difference in all-cause mortality between drug-coated balloon angioplasty and drug-eluting stent implantation (pooled effect size 0.94, 95% CI 0.79–1.09). There was no observed heterogeneity across studies (I² = 0%), indicating highly consistent findings among trials. Individual study estimates were closely clustered around unity, with overlapping confidence intervals. Overall, the forest plot suggests that both revascularization strategies are associated with comparable all-cause mortality during medium-term follow-up in patients with de novo coronary artery disease.

In this systematic review and meta-analysis of randomized controlled trials, we compared drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation for the treatment of de novo coronary artery disease. The principal finding of this analysis is that DCB angioplasty demonstrated comparable efficacy to DES with respect to major adverse cardiac events (MACE), myocardial infarction, target lesion revascularization, and all-cause mortality during medium-term follow-up. However, a significantly higher risk of cardiac death was observed in the DCB group, despite the absence of heterogeneity across trials for this endpoint.

DES-based percutaneous coronary intervention has long been considered the standard of care for de novo coronary lesions, supported by robust evidence demonstrating reductions in restenosis and repeat revascularization compared with bare-metal stents [33–36]. Nevertheless, the permanent metallic scaffold associated with DES may predispose patients to late adverse events such as neoatherosclerosis, impaired vasomotion, and very late stent thrombosis [37-39]. These limitations have stimulated interest in “leave-nothing-behind” strategies, with DCB angioplasty emerging as a potential alternative.

DCBs deliver an antiproliferative drug directly to the vessel wall without leaving a permanent implant, thereby preserving native vessel architecture and potentially reducing long-term device-related complications [40,41]. This approach has proven efficacy in the treatment of coronary in-stent restenosis and is now guideline-endorsed for this indication [40,41]. Extension of DCB technology to de novo coronary artery disease has been particularly attractive in small-vessel disease and in patients at high bleeding risk, where avoidance of stent implantation and shorter durations of dual antiplatelet therapy may offer clinical advantages [42-54].

In the present analysis, the pooled estimate for MACE showed no significant difference between DCB and DES, although moderate heterogeneity was observed. This variability likely reflects differences in trial design, vessel size criteria, clinical presentation, and procedural techniques. Importantly, most trials were designed as non-inferiority studies and were not individually powered to detect differences in hard clinical endpoints, underscoring the value of pooled analyses.

The finding of a significantly higher risk of cardiac death with DCB angioplasty warrants careful consideration. While event rates were low and confidence intervals wide in several individual trials, the consistency of this signal across studies resulted in a statistically significant pooled effect. This observation contrasts with the neutral findings for all-cause mortality and myocardial infarction and should therefore be interpreted cautiously. Potential explanations include chance findings driven by low event numbers, differences in patient selection, or unmeasured confounding related to lesion complexity or bailout stenting. Notably, prior meta-analyses of paclitaxel-coated devices in coronary interventions have not demonstrated excess mortality, whereas concerns raised in peripheral vascular interventions have not been consistently replicated in the coronary setting [55,56].

Target lesion revascularization outcomes were highly heterogeneous across trials. Larger, all-comer studies tended to show higher revascularization rates with DCB angioplasty, whereas trials focused on small-vessel disease demonstrated more comparable results. This suggests that patient and lesion selection remain critical determinants of DCB performance in de novo coronary artery disease.

Overall, the findings of this meta-analysis support the concept that DCB angioplasty is a viable alternative to DES in selected patients with de novo coronary lesions, particularly in small-vessel disease. However, the observed signal for increased cardiac mortality highlights the need for further large-scale, adequately powered randomized trials with long-term follow-up to more definitively establish the safety profile of DCBs in this setting. Until such data are available, careful patient selection and individualized decision-making remain essential.

This systematic review and meta-analysis demonstrate that drug-coated balloon angioplasty offers comparable efficacy to drug-eluting stent implantation for the treatment of de novo coronary artery disease, with similar rates of major adverse cardiac events, myocardial infarction, target lesion revascularization, and all-cause mortality. However, a higher risk of cardiac death was observed with drug-coated balloons, despite low heterogeneity across studies. These findings support the selective use of drug-coated balloons in appropriately chosen patients, particularly in small-vessel disease, while emphasizing the need for further large, well-powered randomized trials to clarify long-term safety and optimize patient selection. Conflict of Interest The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Funding The authors report no involvement in the research by the sponsor that could have influenced the outcome of this work. Authors’ contributions. All authors contributed equally to the manuscript and read and approved the final version of the manuscript. Acknowledgement This paper is the collaborative work of all authors under the mentorship for the research work from BIR (Biomedical and International Research). We all authors acknowledge this mentorship for this meta-analysis.

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