Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2

Nicole Gilgen, Ahmed Farah, Bruno Scheller, Marc-Alexander Ohlow, Norman Mangner, Daniel Weilenmann, Jochen Wöhrle, Peiman Jamshidi, Gregor Leibundgut, Sven Möbius-Winkler, Robert Zweiker, Florian Krackhardt, Christian Butter, Leonhard Bruch, Christoph Kaiser, Andreas Hoffmann, Peter Rickenbacher, Christian Mueller, Frank-Peter Stephan, Michael Coslovsky, Raban Jeger, BASKET-SMALL 2 Investigators, Nicole Gilgen, Ahmed Farah, Bruno Scheller, Marc-Alexander Ohlow, Norman Mangner, Daniel Weilenmann, Jochen Wöhrle, Peiman Jamshidi, Gregor Leibundgut, Sven Möbius-Winkler, Robert Zweiker, Florian Krackhardt, Christian Butter, Leonhard Bruch, Christoph Kaiser, Andreas Hoffmann, Peter Rickenbacher, Christian Mueller, Frank-Peter Stephan, Michael Coslovsky, Raban Jeger, BASKET-SMALL 2 Investigators

Abstract

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.

Keywords: Angioplasty; Coronary Artery Disease; Drug-Coated Balloon; Randomized Controlled Trial; Small Coronary Vessel; Trial Design.

Conflict of interest statement

NG: B. Braun (travel support); BS: Coinventor of 2 patent applications by Charité University Hospital, Berlin, Germany, B. Braun (lecture fees and travel support); MAO: Biosensors (proctoring honoraria, travel support); and RJ: B. Braun (lecture honoraria and travel support). The other authors declare no other conflict of interest.

© 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
Patient flowchart. Abbreviations: DCB, drug coated balloon; DES, drug‐eluting stent; MACE, major adverse cardiac events; MI, myocardial infarction; POBA, plain old balloon angioplasty; TVR, target vessel revascularization

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