Do-Yoon Kang1, Cheol Hyun Lee1, Pil Hyung Lee1, Jung-Min Ahn1, Seung-Whan Lee1, Young-Hak Kim1, Seong-Wook Park1, Chang Wook Nam2, Yun Seok Choi3, Seung-Woon Rha4, Jang Hyun Cho5, Weon Kim6, Sung-Ho Her7, Myung Ho Jeong8, Joo-Young Yang9, Bong-Ki Lee10, Hun Sik Park11, Duk-Woo Park1, Seung-Jung Park1. 1. Asan Medical Center, Heart Institute, University of Ulsan College of Medicine. 2. Department of Medicine, Keimyung University Dongsan Medical Center. 3. Department of Internal Medicine, Division of Cardiology, Yeouido St Mary's Hospital. 4. Cardiovascular Center, Korea University Guro Hospital. 5. Cardiovascular Center, St Carollo General Hospital, Soonchun. 6. Cardiovascular Center, Division of Cardiology, Kyunghee University Hospital, Seoul. 7. The Catholic University of Korea, Daejeon St Mary's Hospital, Daejeon. 8. Department of Cardiology, Chonnam National University Medical School, Gwangju. 9. Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital, Goyang. 10. Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, South Korea. 11. Department of Internal Medicine, Kyungpook National University Hospital, Daegu.
Abstract
BACKGROUND: Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. METHODS AND RESULTS: This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). CONCLUSION: For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.
RCT Entities:
BACKGROUND: Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. METHODS AND RESULTS: This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). CONCLUSION: For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.
Authors: Endrin Koni; Wojciech Wanha; Jakub Ratajczak; Zhongheng Zhang; Przemysław Podhajski; Rita L. Musci; Giuseppe M. Sangiorgi; Maciej Kaźmierski; Antonio Buffon; Jacek Kubica; Wojciech Wojakowski; Eliano P. Navarese Journal: J Clin Med Date: 2021-03-19 Impact factor: 4.241