Jeger RV, et al. - Experts evaluated the safety and effectiveness of drug-coated balloons (DCB) for small native coronary artery disease vs drug-eluting stents (DES). Findings suggested non-inferiority of DCB to DES regarding major adverse cardiac events (MACE) up to 12 months in small native coronary artery disease, with similar event rates for both treatment groups.

Methods

• Researchers conducted BASKET-SMALL 2, a multicenter, open-label, randomized non-inferiority trial.
• They randomly allocated (1:1) 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention to receive angioplasty with DCB vs implantation of a second-generation DES after successful predilatation via an interactive internet-based response system.
• Authors gave dual antiplatelet therapy according to current guidelines.
• To show non-inferiority of DCB vs DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularization) after 12 months was the primary objective.
• An absolute difference of 4% in MACE was the non-inferiority margin.

Results

• As per data, between April 10, 2012 and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group.
• Findings demonstrated non-inferiority of DCB vs DES as the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3.83 to 3.93%, p=0.0217).
• After 12 months, in both groups of the full-analysis population (MACE was 7.5% for the DCB group vs 7.3% for the DES group; hazard ratio [HR] 0.97 [95% CI 0.58–1.64], p=0.9180) the proportions of MACE were similar.
• In the DES group and 12 (3.1%) in the DCB group (full analysis population), there were 5 (1.3%) cardiac-related deaths.
• The most common adverse events were probable or definite stent thrombosis (three [0.8%] in the DCB group vs four [1.1%] in the DES group; HR 0.73 [0.16–3.26]) and major bleeding (four [1.1%] in the DCB group vs nine [2.4%] in the DES group; HR 0.45 [0.14–1.46]).