Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2.

BACKGROUND

Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitäts Trial-Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions).

METHODS

BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization).

RESULTS

Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment-elevation myocardial infarction; 109 patients [50.9%], non-ST-segment-elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [95% CI, 0.19-1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67-2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect (

CONCLUSIONS

In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01574534.