Abstract

Background
The impact of drinking status on outcomes in patients treated with drug-coated balloon (DCB) versus drug-eluting stent (DES) for de novo coronary lesions remains unclear.

Methods
REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2,272 patients to paclitaxel-coated balloon with the option of rescue stenting (DCB group) or second-generation sirolimus-eluting stents (DES group) for treating de novo coronary lesions, regardless of vessel diameter. In this subgroup analysis, participants were stratified by baseline drinking status into non-drinkers and drinkers. The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. Cox proportional hazards regression with inverse probability of treatment weighting (IPTW) was used to compare between-group differences.

Results
Among 2,128 (93.7%) participants with available baseline drinking status, 513 (24.1%) were drinkers. At 2 years, compared to non-drinkers (83/1615 [5.2%]), drinkers (22/513 [4.3%]) were associated with a numerically similar risk of DoCE (HR IPTW : 0.89, 95%CI 0.47–1.70; P = 0.727). For non-drinkers, DoCE occurred in 53/816 (6.5%) and 30/799 (3.8%) of participants in the DCB group and DES group (HR IPTW : 1.67, 95%CI 1.05–2.67; P = 0.032) respectively. For drinkers, DoCE occurred in 15/250 (6.0%) and 7/263 (2.7%) of participants in the DCB group and DES group (HR IPTW : 2.17, 95%CI 0.80–5.84; P = 0.120) respectively. There was no significant interaction between drinking status and treatment strategies ( P interaction = 0.628).

Conclusions
Compared to non-drinkers, drinkers were associated with a numerically similar risk of DoCE. The treatment effect of DCB versus DES did not differ significantly according to drinking status. However, given the observational nature of the study, these results should be interpreted as hypothesis-generating only.

Trial registration
Registered on ClinicalTrials.gov (NCT04561739) on September 3, 2020.