Key result
Ongoing RCT tests drug-coated balloons vs. drug-eluting stents for small coronary artery lesions.
Why the study?
The treatment of coronary small vessel disease remains unresolved due to limited efficacy of drug-eluting stents caused by increased instent-restenosis from late lumen loss.
RCT (n=758)
Open-label
1:1
Yes
Primary results needed before considering drug-coated balloons in small vessels; leaves open noninferiority to drug-eluting stents.
The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.
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Gilgen et al. (2018) conducted an RCT in Coronary small vessel disease (de novo lesions in vessels <3 mm) (n=758). Drug-coated balloon (paclitaxel-iopromide) vs. Drug-eluting stent (everolimus-eluting or paclitaxel-eluting) was evaluated on Composite of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization (MACE) at 12 months. Drug-coated balloons are being evaluated for noninferiority against drug-eluting stents in patients with de novo lesions in small coronary arteries, with primary clinical results pending.
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