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

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 Ambrogio; Gilgen, Nicole; Kaiser, Christoph; Scheller, Bruno; Ammann, Peter; Awad, Belal; Baumgartner, Margarete; Boehm, Michael C.; Bohl, Steffen; Bruch, Leonhard; Buckert, Dominik; Buser, Peter T; Butter, Christian; Clever, Yvonne P; Cremers, Bodo; Cuculi, Florim; Dannberg, Gudrun; Erne, Paul; Ewen, Sebastian; Fahrni, Gregor; Franz, Marcus; Haager, Philipp K; Harder-Allgoewer, Andrea; Hoffmann, Andreas C.; 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 E.; Neuss, Michael J; NIederl, Ella; Noutsias, Michel; Nuessli, Dominique F.; Oenal, Ismet; Otto, Sylvia; Paliskyte, Rima; Perl, Sabine; Pieske, Burkert Mathias; Plicht, Bjoern; Poerner, Tudor C; Richter, Stefan; Rickli, Hans; Riede, Florian N; Roelli, Hans; Roettgen, Alexandra; Rohner, Franziska; Schirmer, Stephan Henrik; Schmidt, Albrecht; Schreiber, Matthias R.; 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 B.; Wolf, Alexander; Zellweger, Michael J.; Krackhardt, Florian; Zweiker, Robert

doi:10.1016/S0140-6736(20)32173-5

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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

Author(s): Raban V Jeger , Ahmed Farah , Marc-Alexander Ohlow , Norman Mangner , Sven Möbius-Winkler , Daniel Weilenmann , Jochen Wöhrle , Georg Stachel , Sinisa Markovic , Gregor Leibundgut , Peter Rickenbacher , Stefan Osswald , Marco Cattaneo , Nicole Gilgen , Christoph Kaiser , Bruno Scheller , Peter Ammann , Belal Awad , Margarete Baumgartner , Michael Boehm , Steffen Bohl , Leonhard Bruch , Dominik Buckert , Peter Buser , Christian Butter , Yvonne P. Clever , Bodo Cremers , Florim Cuculi , Gudrun Dannberg , Paul Erne , Sebastian Ewen , Gregor Fahrni , Marcus Franz , Philipp Haager , Andrea Harder-Allgoewer , Andreas Hoffmann , Robert Höllriegel , Frank Hölschermann , Timo Jerichow , Lucas Joerg , Ioannis Kapos , Boris Keweloh , Behrouz Kherad , Michael Kühne , Bernward Lauer , Karsten Lenk , Corinna Lenz , Dirk Von Lewinski , Axel Linke , Olev Luha , Micha Maeder , Felix Mahfoud , Christian Mueller , Michael Neuss , Ella Niederl , Michel Noutsias , Dominique Nuessli , Ismet Oenal , Sylvia Otto , Rima Paliskyte , Sabine Perl , Burkert Pieske , Bjoern Plicht , Tudor C Poerner , Stefan Richter , Hans Rickli , Florian Riede , Hans Roelli , Alexandra Roettgen , Franziska Rohner , Stephan Schirmer , Albrecht Schmidt , Matthias Schreiber , Mirko Seidel , Frank-Peter Stephan , Christian Sticherling , Berthold Struck , Ralf Surber , Grit Tambor , Stefan Toggweiler , Lukas Trachsel , Raphael Twerenbold , Andreas Wagner , Bastian Wein , Sebastian Winkler , Ephraim Winzer , Alexander Wolf , Michael Zellweger , Florian Krackhardt , Robert Zweiker

Publication date Created: November 2020

Publication date (Print): November 2020

Journal: The Lancet

Publisher: Elsevier BV

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2018 ESC/EACTS Guidelines on myocardial revascularization

Terje Steigen, Sjoerd Hofma, Robert Xuereb … (2018)

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Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Roxana Mehran, Sunil V Rao, Deepak Bhatt … (2011)

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Clinical end points in coronary stent trials: a case for standardized definitions.

Donald E Cutlip, Stephan Windecker, Roxana Mehran … (2007)

Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.

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Title: The Lancet

Abbreviated Title: The Lancet

Publisher: Elsevier BV

ISSN (Print): 01406736

Publication date Created: November 2020

Publication date (Print): November 2020

Volume: 396

Issue: 10261

Pages: 1504-1510

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DOI: 10.1016/S0140-6736(20)32173-5

SO-VID: 94eb841f-e33d-4c3c-951b-db2d593d1396

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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

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Most cited references 28

2018 ESC/EACTS Guidelines on myocardial revascularization

Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Clinical end points in coronary stent trials: a case for standardized definitions.

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