What is the clinical evidence from this study?

Study design: RCT. Population: De novo coronary lesions (n=2128). Intervention: Alcohol consumption vs. Non-drinkers. Primary outcome: Device-oriented composite endpoint (DoCE) at 2 years (HR 0.89, 95% CI 0.47-1.70, p=0.727).

June 14, 2026European journal of medical research0 citationsOpen Access

Impact of drinking status on outcomes with drug-coated balloon versus drug-eluting stent for de novo coronary lesions: insights from the REC-CAGEFREE I trial

HXHongfei XiXijing Hospital CWChen WangUniversité Paris-Sud THTao HuXijing Hospital

Key Result

Alcohol consumption showed a similar risk of the device-oriented composite endpoint at 2 years compared to non-drinkers (HR 0.89), with no significant interaction for DCB versus DES efficacy.

Key Points

This research aims to understand how drinking status affects outcomes in patients treated with drug-coated balloons compared to drug-eluting stents for coronary lesions.
Randomized trial with 2,272 participants across 43 sites in China.
Participants were stratified by drinking status into drinkers and non-drinkers.
Cox proportional hazards regression with inverse probability of treatment weighting was applied to assess outcomes.
For non-drinkers, 6.5% in DCB group versus 3.8% in DES group had device-oriented composite endpoint (HR IPTW: 1.67, 95% CI 1.05–2.67; P=0.032).
For drinkers, 6.0% in DCB group versus 2.7% in DES group had device-oriented composite endpoint (HR IPTW: 2.17, 95% CI 0.80–5.84; P=0.120).
No significant interaction noted between drinking status and treatment strategies (P interaction = 0.628).

Study Design

Type

RCT (n=2,128)

Blinding

Open-label

Randomization

1:1

Multicenter

Yes

Structured PICO

Does drinking status impact the efficacy of paclitaxel-coated balloons versus sirolimus-eluting stents in patients with de novo coronary lesions?

Population

2,128 patients undergoing percutaneous coronary intervention for de novo non-complex coronary lesions, stratified by drinking status and followed for 2 years.

Exposure

Paclitaxel-coated balloon with the option of rescue stenting

Comparator

Second-generation sirolimus-eluting stents

Outcome

Device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 yearscomposite

Drinking status does not significantly impact the relative efficacy of paclitaxel-coated balloons versus sirolimus-eluting stents for treating de novo coronary lesions.

Main Result

Hazard Ratio: 0.89 (95% CI 0.47–1.7)

Absolute Event Rate: 4.3% vs 5.2%

p-value: p=0.727

Limitations

Observational nature of the subgroup analysis, meaning results are exploratory and hypothesis-generating only
Reliance on self-reported drinking status at baseline

Abstract

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.

Ask AI

Helpful

Bookmark

View Full Paper