Seung-Whan Lee1, Pil Hyung Lee1, Jung-Min Ahn1, Duk-Woo Park1, Sung-Cheol Yun2, Seungbong Han3, Heejun Kang1, Soo-Jin Kang1, Young-Hak Kim1, Cheol Whan Lee1, Seong-Wook Park1, Seung Ho Hur4, Seung-Woon Rha5, Sung-Ho Her6, Si Wan Choi7, Bong-Ki Lee8, Nae-Hee Lee9, Jong-Young Lee10, Sang-Sig Cheong11, Moo Hyun Kim12, Young-Keun Ahn13, Sang Wook Lim14, Sang-Gon Lee15, Shirish Hiremath16, Teguh Santoso17, Wasan Udayachalerm18, Jun Jack Cheng19, David J Cohen20, Toshiya Muramatsu21, Etsuo Tsuchikane22, Yasushi Asakura23, Seung-Jung Park1. 1. Department of Cardiology (S-W.L., P.H.L., J.-M.A., D.-W.P., H.K., S.-J.K., Y.-H.K., C.W.L., S.-W.P., S.-J.P.), Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 2. Biostatistics (S.-C.Y.), Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea. 3. Department of Applied Statistics, Gachon University, Seongnam, Korea (S.H.). 4. Department of Cardiology, Keimyung University Dongsan Medical Center, Daegu, Korea (S.H.H.). 5. Department of Cardiology, Korea University Guro Hospital, Seoul (S.-W.R.). 6. Department of Cardiology, The Catholic University of Korea, Daejeon St. Mary's Hospital (S.-H.H.). 7. Department of Cardiology, Chungnam National University Hospital, Daejeon, Korea (S.W.C.). 8. Department of Cardiology, Kangwon National University Hospital, Chuncheon, Korea (B.-K.L.). 9. Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Korea (N.-H.L.). 10. Department of Cardiology, Kangbuk Samsung Medical Center, Seoul, Korea (J.-Y.L.). 11. Department of Cardiology, Gangneung Asan Hospital, Korea (S.-S.C.). 12. Department of Cardiology, Dong-A University Hospital, Busan, Korea (M.H.K.). 13. Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea (Y.-K.A.). 14. Department of Cardiology, CHA Bundang Medical Center, Seongnam, Korea (S.W.L.). 15. Department of Cardiology, Ulsan University Hospital, Korea (S.-G.L.). 16. Department of Cardiology, Ruby Hall Clinic, Pune, India (S.H.). 17. Department of Cardiology, Medistra Hospital, Jakarta, Indonesia (T.S.). 18. Department of Cardiology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand (W.U.). 19. Department of Cardiology, Shin Kong Hospital, Taipei, Taiwan (J.J.C.). 20. Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.). 21. Department of Cardiology, Tokyo General Hospital, Japan (T.M.). 22. Toyohashi Heart Center, Aichi, Japan (E.T.). 23. Department of Cardiology, Hakujikai Memorial Hospital, Tokyo, Japan (Y.A.).
Abstract
BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS:Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.
RCT Entities:
BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.
Authors: Carlos Cortés; Thomas W Johnson; Sigmund Silber; Piotr P Buszman; Tudor C Poerner; Francesco Lavarra; Borja Ibáñez; Yongcheol Kim; Karl Mischke; Miłosz Jaguszewski; Juan Luis Gutiérrez-Chico Journal: Cardiol J Date: 2020 Impact factor: 2.737