Trial reportBMC medicine2026
Impact of sex on outcomes in patients treated with drug-coated balloons versus drug-eluting stents for de novo coronary artery lesions: Insights from the REC-CAGEFREE I trial.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04561739 (Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Paclitaxel-coated Balloon for the Treatment of De-novo Non-complex Coronary Artery Lesions: an Open-label, Multicentre, Randomised, Non-inferiority Trial
Who cites it
1 citing paper in PubMed.
- Drug-coated balloons vs. drug-eluting stents for coronary artery disease: an updated systematic review and meta-analysis of randomized controlled trials with lesion-specific insights.Frontiers in cardiovascular medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors.
Funding
Abstract
backgroundThe anatomical and pathophysiological characteristics of coronary artery disease vary between the sexes. This study investigated the impact of sex on outcomes in patients with de novo coronary artery lesions treated with drug-coated balloons (DCB) or drug-eluting stents (DES).
methodsREC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China from Feb 5, 2021, to May 1, 2022, which randomized 2,272 patients for treating de novo coronary lesions, regardless of vessel diameter. After successful lesion pre-dilatation, eligible patients were randomized (1:1) to either DCB angioplasty with the option of rescue stenting or intended DES deployment. In this prespecified subgroup analysis, patients were analyzed by sex based on their medical records. The primary endpoint was device-oriented composite endpoint (DoCE), including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization at 2 years. Between-group differences were compared by Cox proportional-hazards models, and imbalances in baseline characteristics were adjusted with inverse probability of treatment weighting (IPTW). The analyses were conducted in the intention-to-treat population.
resultsA total of 2,272 participants underwent randomization, of which 698 (30.7%) were female and 1,574 (69.3%) were male. At 2 years, no statistically significant differences in the incidence of DoCE were observed between sexes (36 [5.2%] for females and 74 [4.7%] for males, HR
conclusionsFor patients with de novo, non-complex coronary artery disease, DCB was associated with a significantly higher risk of 2-year DoCE compared with DES in males, whereas a consistent but non-significant trend was observed in females.
trial registrationClinicalTrials.gov identifier: NCT04561739.
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