Kyung Woo Park1, Joo Myung Lee1, Si-Hyuck Kang1, Hyo-Suk Ahn1, Hyun-Jae Kang1, Bon-Kwon Koo1, Jay Young Rhew2, Sun Ho Hwang3, Sung Yoon Lee4, Tae Soo Kang5, Choong Hwan Kwak6, Bum-Kee Hong7, Cheol Woong Yu8, In-Whan Seong9, Taehoon Ahn10, Han Cheol Lee11, Sang Wook Lim12, Hyo-Soo Kim13. 1. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. 2. Department of Internal Medicine and Cardiovascular Center, Presbyterian Medical Center, Jeonju, Republic of Korea. 3. Department of Internal Medicine and Cardiovascular Center, Gwangju Veterans Hospital, Gwangju, Republic of Korea. 4. Department of Internal Medicine and Cardiovascular Center, Inje University Ilsan Paik Hospital, Ilsan, Republic of Korea. 5. Department of Internal Medicine and Cardiovascular Center, Dankook University Hospital, Cheonan, Republic of Korea. 6. Department of Internal Medicine and Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Republic of Korea. 7. Department of Internal Medicine and Cardiovascular Center, Gangnam Severance Hospital, Seoul, Republic of Korea. 8. Department of Internal Medicine and Cardiovascular Center, Sejong General Hospital, Sejong Heart Institute, Bucheon, Republic of Korea. 9. Department of Internal Medicine and Cardiovascular Center, Chungnam University Hospital, Daejeon, Republic of Korea. 10. Department of Internal Medicine and Cardiovascular Center, Gachon University Gil Hospital, Incheon, Republic of Korea. 11. Department of Internal Medicine and Cardiovascular Center, Busan National University Hospital, Busan, Republic of Korea. 12. Department of Internal Medicine and Cardiovascular Center, CHA Bundang Medical Center and CHA University, Seongnam, Republic of Korea. 13. Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.
Abstract
OBJECTIVES: This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. BACKGROUND: DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. METHODS: Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. RESULTS: Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). CONCLUSIONS: After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.
OBJECTIVES: This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. BACKGROUND:DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. METHODS:Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. RESULTS: Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DMpatients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DMpatients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). CONCLUSIONS: After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DMpatients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.
Authors: Joo Myung Lee; Ki Hong Choi; Bon-Kwon Koo; Hakim-Moulay Dehbi; Joon-Hyung Doh; Chang-Wook Nam; Eun-Seok Shin; Christopher M Cook; Rasha Al-Lamee; Ricardo Petraco; Sayan Sen; Iqbal S Malik; Sukhjinder S Nijjer; Hernán Mejía-Rentería; Eduardo Alegria-Barrero; Ali Alghamdi; John Altman; Sérgio B Baptista; Ravinay Bhindi; Waldemar Bojara; Salvatore Brugaletta; Pedro Canas Silva; Carlo Di Mario; Andrejs Erglis; Robert T Gerber; Olaf Going; Tobias Härle; Farrel Hellig; Ciro Indolfi; Luc Janssens; Allen Jeremias; Rajesh K Kharbanda; Ahmed Khashaba; Yuetsu Kikuta; Florian Krackhardt; Mika Laine; Sam J Lehman; Hitoshi Matsuo; Martijin Meuwissen; Giampaolo Niccoli; Jan J Piek; Flavo Ribichini; Habib Samady; James Sapontis; Arnold H Seto; Murat Sezer; Andrew S P Sharp; Jasvindar Singh; Hiroaki Takashima; Suneel Talwar; Nobuhiro Tanaka; Kare Tang; Eric Van Belle; Niels van Royen; Hugo Vinhas; Christiaan J Vrints; Darren Walters; Hiroyoshi Yokoi; Bruce Samuels; Chris Buller; Manesh R Patel; Patrick Serruys; Javier Escaned; Justin E Davies Journal: JAMA Cardiol Date: 2019-09-01 Impact factor: 14.676