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
| Autor: | Raphael Twerenbold, Robert Zweiker, Albrecht Schmidt, Christian Mueller, Nicole Gilgen, Georg Stachel, Ismet Oenal, Tudor C. Poerner, Bernward Lauer, Florian Krackhardt, Sylvia Otto, Alexander Wolf, Michael Kühne, Sven Möbius-Winkler, Yvonne P. Clever, Philipp Haager, Peter Ammann, Peter Rickenbacher, Ahmed Farah, Felix Mahfoud, Jochen Wöhrle, Dominik Buckert, Andreas Hoffmann, Ephraim B. Winzer, Alexandra Roettgen, Stefan Toggweiler, Frank Hölschermann, Andrea Harder-Allgoewer, Paul Erne, Dirk von Lewinski, Robert Höllriegel, Christian Butter, Hans Rickli, Andreas Wagner, Bjoern Plicht, Christian Sticherling, Rima Paliskyte, Leonhard Bruch, Frank-Peter Stephan, Lucas Joerg, Lukas Trachsel, Florian Riede, Bastian Wein, Norman Mangner, Michael J. Zellweger, Matthias Schreiber, Gregor Fahrni, Sebastian Ewen, Marc-Alexander Ohlow, Sinisa Markovic, Berthold Struck, Karsten Lenk, Marco E. G. V. Cattaneo, Stephan Schirmer, Margarete Baumgartner, Hans Roelli, Franziska Rohner, Florim Cuculi, Grit Tambor, Bruno Scheller, Raban Jeger, Axel Linke, Ella Niederl, Burkert Pieske, Dominique Nuessli, Stefan Osswald, Belal Awad, Gudrun Dannberg, Stefan Richter, Michel Noutsias, Christoph Kaiser, Steffen Bohl, Boris Keweloh, Michael Neuss, Mirko Seidel, Micha T. Maeder, Michael Boehm, Corinna Lenz, Bodo Cremers, Ioannis Kapos, Behrouz Kherad, Sabine Perl, Peter Buser, Marcus Franz, Daniel Weilenmann, Ralf Surber, Timo Jerichow, Sebastian Winkler, Olev Luha, Gregor Leibundgut |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Population Coronary Artery Disease Kaplan-Meier Estimate 030204 cardiovascular system & hematology Balloon Coronary artery disease 03 medical and health sciences 0302 clinical medicine Angioplasty Internal medicine medicine Clinical endpoint Humans 030212 general & internal medicine Myocardial infarction Angioplasty Balloon Coronary education Aged education.field_of_study business.industry Hazard ratio Percutaneous coronary intervention Drug-Eluting Stents General Medicine medicine.disease Treatment Outcome Cardiovascular Diseases Female business Follow-Up Studies |
| Zdroj: | The Lancet. 396:1504-1510 |
| ISSN: | 0140-6736 |
| DOI: | 10.1016/s0140-6736(20)32173-5 |
| Popis: | 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.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 vessels3 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.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.There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical. |
| Databáze: | OpenAIRE |
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