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Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial.
- Source :
-
Lancet . 9/8/2018, Vol. 392 Issue 10150, p849-856. 8p. - Publication Year :
- 2018
-
Abstract
- <bold>Background: </bold>Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES).<bold>Methods: </bold>BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention were randomly allocated (1:1) to receive angioplasty with DCB versus implantation of a second-generation DES after successful predilatation via an interactive internet-based response system. Dual antiplatelet therapy was given according to current guidelines. The primary objective was to show non-inferiority of DCB versus DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation) after 12 months. The non-inferiority margin was an absolute difference of 4% in MACE. This trial is registered with ClinicalTrials.gov, number NCT01574534.<bold>Findings: </bold>Between April 10, 2012, and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group. Non-inferiority of DCB versus DES was shown because the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3·83 to 3·93%, p=0·0217). After 12 months, the proportions of MACE were similar in both groups of the full-analysis population (MACE was 7·5% for the DCB group vs 7·3% for the DES group; hazard ratio [HR] 0·97 [95% CI 0·58-1·64], p=0·9180). There were five (1·3%) cardiac-related deaths in the DES group and 12 (3·1%) in the DCB group (full analysis population). Probable or definite stent thrombosis (three [0·8%] in the DCB group vs four [1·1%] in the DES group; HR 0·73 [0·16-3·26]) and major bleeding (four [1·1%] in the DCB group vs nine [2·4%] in the DES group; HR 0·45 [0·14-1·46]) were the most common adverse events.<bold>Interpretation: </bold>In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups.<bold>Funding: </bold>Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CORONARY heart disease treatment
*DRUG-eluting stents
*TREATMENT effectiveness
*PERCUTANEOUS coronary intervention
*RANDOMIZED controlled trials
*THERAPEUTIC use of biomedical materials
*CARDIOVASCULAR system
*COMPARATIVE studies
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL care
*MEDICAL cooperation
*MYOCARDIAL revascularization
*RESEARCH
*TRANSLUMINAL angioplasty
*EVALUATION research
*PROPORTIONAL hazards models
Subjects
Details
- Language :
- English
- ISSN :
- 01406736
- Volume :
- 392
- Issue :
- 10150
- Database :
- Academic Search Index
- Journal :
- Lancet
- Publication Type :
- Academic Journal
- Accession number :
- 131745974
- Full Text :
- https://doi.org/10.1016/S0140-6736(18)31719-7