Donald E. Cutlip, Roxana Mehran, S Sharma, Gheorghe Doros, Brian Jefferson, Giulio Stefanini, S Dohad, Antoinette Neylon, Itsik Ben-Dor, Dwijesh Patel, Bassem M Chehab, Anay Pradhan, Roberto Nerla, Pascal Vranckx, Marie‐France Poulin, Allen Jeremias, Eric A. Osborn, Ron Waksman, Pascal Vranckx, Alexandre Abizaid, Rodolfo Staico, Marcos Wainstein, Olivier Bertrand, Sanjit Jolly, Michael Curtis, Antoinette Neylon, Jacques Berland, Jérôme Roncalli, L. Mock, Giulio Stefanini, Roberto Nerla, Giuseppe Tarantini, Marco De Carlo, José P.S. Henriques, Michiel Voskuil, Joanna J. Wykrzykowska, Itsik Ben-Dor, Brian Case, Gautam Kumar, Joseph Thomas, Jinnette Dawn Abbott, Jinnette Dawn Abbott, S Sharma, Chad Zack, Jarrod Frizzell, Diljon Chahal, Marie‐France Poulin, Anay Pradhan, Amir Kaki, Ramon Quesada, Jordan Safirstein, Vinoy Prasad, Mike Kourany, Tim Fischell, Khaled Ziada, Katherine Kunkel, Daniel Soffer, Kevin Croce, S Dohad, Jasvinder Singh, Steven Pfau, Allen Jeremias
BACKGROUND: Drug-eluting stents (DESs) are recommended treatment for coronary in-stent restenosis (ISR) but are not used in >20% of cases. OBJECTIVES: The aim of the SELUTION4ISR (SELUTION SLR 014 In-stent Restenosis) trial was to assess the safety and effectiveness of a novel sirolimus drug-eluting balloon (DEB). METHODS: After successful lesion predilation, patients with ISR were randomly assigned to the SELUTION Sustained Limus Release (MedAlliance) DEB or a control strategy of usual care, including any approved DES or balloon angioplasty (BA) on the basis of operator selection prerandomization. Randomization to selected BA control treatment was limited to 20% of patients. The primary outcome was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) assessed at 1 year in the per protocol group (all treated eligible patients with complete primary endpoint follow-up). Noninferiority was established if the upper limit of the 2-sided 95% credible interval was smaller than 10%. A sequential secondary hypothesis test was performed comparing DEB with DES in patients with single-layer ISR. RESULTS: = 0.0026). CONCLUSIONS: The sirolimus DEB was noninferior to a usual care control strategy including 80% repeat DES but not noninferior to DES for single-layer ISR for TLF at 12 months. There was significant interaction on the basis of operator selection of DES vs BA. (SELUTION SLR 014 In-stent Restenosis [SELUTION4ISR]; NCT04280029).