Robbert J. de Winter, Jaya Chandrasekhar, Deborah N. Kalkman, Melissa B. Aquino, Pier Woudstra, Marcel A. Beijk, Samantha Sartori, Usman Baber, Jan G. Tijssen, Karel T. Koch, George D. Dangas, Antonio Colombo, Roxana Mehran, Tiong Kiam Ong, Michael Lee, Andres Iniguez, Stephen Rowland, Newsha Ghodsi, Steven Marx, Douglas DiStefano, Jesse Weinberger, Shing Chiu Wong, Bruce Darrow, David Kaufman, Mark Milstein, Melissa Aquino, Clayton Snyder, Theresa Franklin-Bond, Jin Young Cha, Lynn Vandertie, Emma Whittaker, Kate Allen, Birgit Vogel, Serdar Farhan, Sabato Sorrentino, Zhen Ge, Marc Carlier, Suzanne Pourbaix, Borislav Borisov, Borislav Atzev, Dobrin Vasilev, Christos Christou, Ladislav Pešl, Zdeněk Coufal, Petr Kala, Petr Jeřábek, Petr Hájek, Alexander Schee, Roman Ondrejcak, Vladimír Rozsíval, Jan Matějka, Martin Mates, Ahmed Khashaba, Hazem Warda, Sulev Margus, Bryan Yan, Cheuk Sum Lam, Tak Sun Chung, Li Wah Tam, Alan Ka Chun Chan, Ping Tim Tsui, Kin Lam Tsui, Teguh Santoso, Muhammad Munawar, Muhammad Syukri, Dasdo Antonius Sinaga, Alessandro Lupi, Carlo Briguori, Oteh Maskon, Sazzli Kazim, Chuey Yan Lee, Houng Bang Liew, Rosli Mohammad Ali, Ramesh Singh, Peter Den Heijer, Jaroslaw Wojcik, Vladan Vukčević, Martin Hudec, Anton Farkaš, Stanislav Juhás, Monika Jankajová, Milan Dragula, Carlos Cuellas Ramon, Paula Tejedor, Fernando Lozano Ruiz-Poveda, Alfonso Torres Bosco, Essia Boughzela, Medhi Slim, Habib Haouala, Dhaker Lahidheb, Mohamed Rachid Boujnah, Grahame K. Goode, Sukhbir Dhamrait, Robert Gerber, Piers Clifford, Timothy Kinnaird, Gabriel Varnagy, Pedro J. Aguiar R., Thuong Van Huynh, Ian B Menown, Peter den Heijer, Arnoud WJ van't Hof, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Philippe Muller, Jan Tijssen, Robbert J de Winter, Marcel A Beijk, Karel Koch, and Deborah N Kalkman
Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)