TOPLINE

Drug-coated balloon angioplasty demonstrated comparable 12-month safety and efficacy to drug-eluting stent implantation for de novo coronary artery lesions across seven randomized trials.

METHODOLOGY

• Researchers conducted a systematic review and meta-analysis of randomized controlled trials comparing drug-coated balloon angioplasty with drug-eluting stent implantation for treating adults with de novo coronary lesions.
• They searched multiple databases and references from relevant studies through October 2025 and included seven trials involving 7138 patients (mean age, 64 years; 71.4% men). Patients were randomly assigned to undergo drug-coated balloon angioplasty (n = 3570) or drug-eluting stent implantation (n = 3568).
• Six trials used paclitaxel-coated balloons, while one used sirolimus-coated balloons; 58.1% of cases involved large-vessel (diameter ≥ 3 mm) lesions. Three trials randomly assigned patients before lesion preparation, while four randomly assigned them after predilation.
• The primary endpoint was the device-oriented composite endpoint at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.
• Researchers evaluated the risk for bias and heterogeneity (I²) of the studies.

TAKEAWAY

• At the 12-month follow-up, no significant difference in the device-oriented composite endpoint was noted between the balloon angioplasty and stent implantation strategies, with moderate heterogeneity across studies (seven trials; I² = 52.3%). The risk for bias was generally low.
• Risk for cardiac death was comparable for the groups (seven trials; I² = 0.0%), as was the risk for target-vessel myocardial infarction (six trials; I² = 19.9%).
• Risk for clinically driven target lesion revascularization and target vessel revascularization were not significantly different for the two strategies (five trials each; I² = 35.4% and 30.2%, respectively).
• Trials that randomly assigned patients before lesion preparation had higher bailout stenting rates than those who did so after predilation (mean rate, 15.0% vs 5.2%), with an overall bailout drug-eluting stent rate of 9.4%.

IN PRACTICE

“The durability of the DCB [drug-coated balloon] performance beyond 12 months remains unresolved and an important question that ongoing trials must address to confirm whether avoidance of permanent implants translates into sustained clinical benefit,” the researchers of the study wrote.

SOURCE

The study was led by Diego Mondragon, Universite de Fribourg in Fribourg, Switzerland. It was published online on July 20 in Heart.

LIMITATIONS

All trials had open-label designs. Researchers could not assess publication and conduct reliable subgroup analyses owing to the limited number of trials. Follow-up duration was limited to 12 months.

DISCLOSURES

The study received funding from Fonds Scientifique Cardiovasculaire (Freiburg). The authors did not declare any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.