Abstract
Background
The REC-CAGEFREE trial showed that drug-coated balloons (DCB) did not achieve non-inferiority in the treatment of non-complex de novo lesion compared to a strategy of drug-eluting stents (DES). However, a prespecified subgroup analysis of arteries sized <3.0 mm revealed no difference in the device-oriented outcome compared to DES. The aim of present study was to validate that finding in a real-world registry by comparing DCB and DES in non-complex lesions with arteries <3.0 mm.
Methods
The Swedish Coronary Angiography and Angioplasty registry (SCAAR) was used to identify all segments with small non-complex coronary artery lesions treated with DCB or DES between January 2016 and May 2024. One-to-one propensity score (PS) matching was used to address confounding. The primary outcome comprised the composite of target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and all-cause mortality after 5 years. Outcome was assessed using Kaplan-Meier estimates and univariable Cox proportional analysis.
Results
After PS-matching, 1439 pairs of DCB and DES treated segments where formed and baseline characteristics were similar across the two groups. Compared to DCB, treatment with DES was associated with lower rates of the primary outcome 19.2 % vs 14.7 % (HR, 0.76; 95 % CI, 0.61–0.95; P = 0.016) and TV-MI 3.4 % vs 1.3 % (HR, 0.52; 95 % CI, 0.29–0.94; P = 0.029). No statistically significant difference was observed for TLR or all-cause mortality.