Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Issue 10261 (7th November 2020)

• Record Type: Journal Article
• Authors: Jeger, Raban V; Farah, Ahmed; Ohlow, Marc-Alexander; Mangner, Norman; Möbius-Winkler, Sven; Weilenmann, Daniel; Wöhrle, Jochen; Stachel, Georg; Markovic, Sinisa; Leibundgut, Gregor; Rickenbacher, Peter; Osswald, Stefan; Cattaneo, Marco; Gilgen, Nicole; Kaiser, Christoph; Scheller, Bruno; Ammann, Peter; Awad, Belal; Baumgartner, Margarete; Boehm, Michael; Bohl, Steffen; Bruch, Leonhard; Buckert, Dominik; Buser, Peter; Butter, Christian; Clever, Yvonne P.; Cremers, Bodo; Cuculi, Florim; Dannberg, Gudrun; Erne, Paul; Ewen, Sebastian; Fahrni, Gregor; Franz, Marcus; Haager, Philipp; Harder-Allgoewer, Andrea; Hoffmann, Andreas; Höllriegel, Robert; Hölschermann, Frank; Jerichow, Timo; Joerg, Lucas; Kapos, Ioannis; Keweloh, Boris; Kherad, Behrouz; Kühne, Michael; Lauer, Bernward; Lenk, Karsten; Lenz, Corinna; Von Lewinski, Dirk; Linke, Axel; Luha, Olev; Maeder, Micha; Mahfoud, Felix; Mueller, Christian; Neuss, Michael; Niederl, Ella; Noutsias, Michel; Nuessli, Dominique; Oenal, Ismet; Otto, Sylvia; Paliskyte, Rima; Perl, Sabine; Pieske, Burkert; Plicht, Bjoern; Poerner, Tudor C; Richter, Stefan; Rickli, Hans; Riede, Florian; Roelli, Hans; Roettgen, Alexandra; Rohner, Franziska; Schirmer, Stephan; Schmidt, Albrecht; Schreiber, Matthias; Seidel, Mirko; Stephan, Frank-Peter; Sticherling, Christian; Struck, Berthold; Surber, Ralf; Tambor, Grit; Toggweiler, Stefan; Trachsel, Lukas; Twerenbold, Raphael; Wagner, Andreas; Wein, Bastian; Winkler, Sebastian; Winzer, Ephraim; Wolf, Alexander; Zellweger, Michael; Krackhardt, Florian; Zweiker, Robert;
• Is Part Of: Lancet. Volume 396:Issue 10261(2020)
• Page Start: 1504
• Page End: 1510
• Publication Date: 2020-11-07
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Medicine; Electronic journals; Periodicals; 610.5
• DOI: 10.1016/S0140-6736(20)32173-5
• Languages: English
• ISSNs: 0140-6736

Abstract

Summary: Background: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. Methods: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3–5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. Findings: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68–1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63–2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45–1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58–1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62–1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07–1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17–1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. Interpretation: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. Funding: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.