Clinical and Angiographic Outcomes With Drug‐Coated Balloons for De Novo Coronary Lesions: A Meta‐Analysis of Randomized Clinical Trials

Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease

Fernando Alfonso¹  Fernando Rivero¹  Javier Cuesta¹  Mohamed M. Gad²  Islam Y. Elgendy³  Ahmed N. Mahmoud⁴  Ahmad Mahmoud⁵  Akram Y. Elgendy⁵ 

[1] Cardiology Department Hospital Universitario de La Princesa IIS‐IP CIBER‐CV Universidad Autónoma de Madrid Spain;Department of Medicine Cleveland Clinic Foundation Cleveland OH;Division of Cardiology Massachusetts General Hospital and Harvard Medical School Boston MA;Division of Cardiology University of Washington Seattle WA;Division of Cardiovascular Medicine University of Florida Gainesville FL;

关键词: coronary artery disease;    de novo lesions;    drug‐eluting stent;    drug‐coated balloon;    meta‐analysis;    mortality;   

DOI  :  10.1161/JAHA.120.016224

来源: DOAJ

【 摘 要 】

Background The role of drug‐coated balloons (DCBs) in the treatment of de novo coronary lesions is not well established. Methods and Results Electronic databases and major conference proceedings were searched for randomized controlled trials that compared DCBs with stents or angioplasty for de novo coronary lesions. The primary outcome was target lesion revascularization. Summary estimates were conducted using random‐effects analysis complemented by several subgroup and sensitivity analyses. A total of 14 randomized controlled trials with 2483 patients were included. At a mean follow up of 12 months, DCBs were associated with no difference in the incidence of target lesion revascularization as compared with alternative strategies (risk ratio [RR], 0.79; 95% CI, 0.35–1.76). There was no difference in treatment effect based on the indication (ie, small‐vessel disease, myocardial infarction, bifurcation, or high bleeding risk) (Pinteraction=0.22). DCBs were associated with lower target lesion revascularization compared with bare metal stents and similar target lesion revascularization compared with drug‐eluting stents (Pinteraction=0.03). There was no difference between DCBs and control in terms of major adverse cardiac events, vessel thrombosis, or cardiovascular mortality. However, DCBs were associated with a lower incidence of myocardial infarction (RR, 0.48; 95% CI, 0.25–0.90) and all‐cause mortality (RR, 0.45; 95% CI, 0.22–0.94). Conclusions In patients with de novo coronary lesions, use of DCBs was associated with comparable clinical outcomes irrespective of the indication or comparator device. DCBs had a similar rate of target lesion revascularization compared with drug‐eluting stents. A randomized trial powered for clinical outcomes and evaluating the role of DCBs for all‐comers is warranted.

【 授权许可】

Unknown