In the BASKET-SMALL 2 randomized controlled trial, researchers compared the effect of a drug-coated balloon (DCB) against drug-eluting stents (DES) in patients with small coronary artery disease, either with or without high-bleeding risk (HBR), undergoing percutaneous coronary intervention. According to the article in Circulation: Cardiovascular Interventions, “DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk.”
DCBs in Small Coronary Artery Disease Treatment
The study’s lead author, Bruno Scheller, wrote that these findings were based on a subgroup analysis of a 758 small coronary artery disease cohort from a multicenter, randomized, noninferiority trial undergoing percutaneous coronary intervention with DCB (n = 382) or second-generation DES (n = 376). Of the enrolled patients, 155 (20%) had HBR.
In the article, the authors reported that patients with HBR had a higher mortality rate at three years compared to those without bleeding risk (hazard ratio [HR], 3.09; 95% confidence interval [CI], 1.78–5.36; p <0.001). The rate of major bleeding events were low overall, but specifically “tended to be lower after DCB versus DES (1.6% versus 3.7%; p = 0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%).” Moreover, there was no difference in major adverse cardiac events between DCB and DES, regardless of bleeding risk (hazard ratio [HR] = 1.16; 95% CI, 0.51–2.62; p = 0.719; and HR = 0.96; 95% CI, 0.62–1.49; p = 0.863, respectively).
In closing, the authors also described that “there was a trend towards a reduction of severe bleeding events at 3 years,” with DCB, supporting their conclusion that high bleeding risk did not compromise the advantages of DCB in patients with small coronary artery disease.
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