Related Experiment Video
Updated: Aug 6, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Drug-coated balloons versus drug-eluting stents for de novo coronary lesions: a systematic review and meta-analysis
Diego Mondragon1, Dorian Garin2, Stéphane Cook2
1Faculty of Medicine, Universite de Fribourg, Fribourg, Switzerland.
Insights
Drug-coated balloon (DCB) angioplasty is as safe and effective as drug-eluting stents (DES) for de novo coronary artery disease in the short term. Long-term benefits of avoiding permanent implants require further investigation.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Technology
Background:
- Drug-coated balloon (DCB) angioplasty is a stent-free option for percutaneous coronary intervention (PCI) in de novo coronary artery disease.
- Robust randomized evidence comparing DCB angioplasty with drug-eluting stents (DES) is limited.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) comparing DCB angioplasty with DES for de novo coronary lesions.
- To assess the safety and efficacy of DCB angioplasty versus DES at a minimum follow-up of 9 months.
Main Methods:
- Comprehensive systematic review and meta-analysis of RCTs.
- Searched PubMed, Embase, and Cochrane CENTRAL up to October 2025; manual screening of registries and reference lists.
- Pooled risk ratios (RRs) using random-effects models; assessed heterogeneity with I² and τ² statistics.
Main Results:
- Seven trials with 7138 patients were included.
- No significant difference in the device-oriented composite endpoint (cardiac death, target vessel MI, target lesion revascularisation) at 12 months (RR 1.02, 95% CI 0.63 to 1.64).
- Secondary outcomes, including cardiac death, MI, and revascularisation, were comparable between DCB and DES groups.
Conclusions:
- Drug-coated balloon angioplasty demonstrates comparable short-term safety and efficacy to modern DES for de novo coronary artery disease.
- Long-term follow-up is needed to determine the clinical benefits of avoiding permanent implants with DCB angioplasty.
Background:
Drug-coated balloon (DCB) angioplasty has emerged as a potential stent-free strategy for percutaneous coronary intervention (PCI) in de novo coronary artery disease, but robust randomised evidence on safety and efficacy compared with drug-eluting stents (DES) remains limited.
Methods:
We conducted a comprehensive systematic review and meta-analysis of randomised controlled trials comparing DCB angioplasty with DES for de novo coronary lesions in adult patients reporting clinical outcomes at ≥9 months. PubMed, Embase and Cochrane CENTRAL were searched from inception to October 2025 without language restriction; trial registries and reference lists were screened manually. Studies limited to in-stent restenosis, bifurcation PCI or observational designs were excluded. Data were extracted independently by two reviewers. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models (DerSimonian-Laird method with Hartung-Knapp adjustment). Heterogeneity was assessed with I² and τ² statistics and 95% prediction intervals were reported. Risk of bias was appraised with the Cochrane Risk of Bias 2 tool.
Results:
Seven trials encompassing 7138 patients (DCB 3570; DES 3568) were included. At 12 months, the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and target lesion revascularisation) showed no difference between strategies (RR 1.02, 95% CI 0.63 to 1.64; p=0.93; I²=52%). Secondary outcomes were comparable: cardiac death (1.26, 0.75 to 2.14), target vessel MI (0.71, 0.36 to 1.39), target lesion revascularisation (1.09, 0.52 to 2.30) and target vessel revascularisation (0.98, 0.58 to 1.65). Sensitivity analysis supported the stability of the primary findings. Trials using sirolimus coated balloons demonstrated similar results.
Conclusions:
DCB angioplasty shows comparable short-term safety and efficacy to modern DES for de novo coronary disease. Long-term follow-up is necessary to confirm whether avoidance of permanent implants translates into clinical benefit.
Prospero Registration Number:
CRD420251175063.
Related Concept Videos
01:27Peripheral Artery Disease III: Interprofessional Care
01:18Cardiovascular Drugs: Classification based on Therapeutic Indications
01:25Antianginal Drugs: Calcium Channel Blockers and Ranolazine
CCBs, a diverse class that includes dihydropyridines (nifedipine) and diphenylalkylamines (verapamil and diltiazem), exert their effect by blocking calcium channels in cardiac and smooth muscle cells. This...