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Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial

Jochen Wöhrle, Bruno Scheller, Julia Seeger, Ahmed Farah, Marc-Alexander Ohlow, Norman Mangner, Sven Möbius-Winkler, Daniel Weilenmann, Georg Stachel, Gregor Leibundgut, Peter Rickenbacher, Marco Cattaneo, Nicole Gilgen, Christoph Kaiser, Raban V Jeger & BASKET-SMALL 2 Investigators

abstract

OBJECTIVES
The study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions.

BACKGROUND
For treatment of de novo coronary small vessel disease, DCBs are noninferior to DES.

METHODS
In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.

RESULTS
In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction).

CONCLUSIONS
The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534).
   
citation Wöhrle J, Scheller B, Seeger J, Farah A, Ohlow M A, Mangner N, Möbius-Winkler S, Weilenmann D, Stachel G, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Jeger R V, BASKET-SMALL 2 Investigators . Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial. JACC Cardiovasc Interv 2021; 14:1789-1798.
   
type journal paper/review (English)
date of publishing 2021
journal title JACC Cardiovasc Interv (14/16)
ISSN electronic 1876-7605
pages 1789-1798
PubMed 34412797
DOI 10.1016/j.jcin.2021.06.025