Byeong-Keuk Kim1, Dong-Ho Shin1, Myeong-Ki Hong1, Hun Sik Park1, Seung-Woon Rha1, Gary S Mintz1, Jung-Sun Kim1, Je Sang Kim1, Seung-Jin Lee1, Hee-Yeol Kim1, Bum-Kee Hong1, Woong-Chol Kang1, Jin-Ho Choi1, Yangsoo Jang2. 1. From the Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital (B.-K.K., D.-H.S., M.-K.H., J.-S.K., Y.J.), Severance Biomedical Science Institute (M.-K.H., Y.J.), and Kangnam Severance Hospital (B.-K.H.), Yonsei University College of Medicine, Seoul, Korea; Kyungpook National University Hospital, Taegu, Korea (H.S.P.); Korea University Guro Hospital, Seoul, Korea (S.-W.R.); Cardiovascular Research Foundation, New York, NY (G.S.M.); Sejong General Hospital, Bucheon, Korea (J.S.K.); Soonchunhyang University Cheonan Hospital, Cheonan, Korea (S.-J.L.); Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Korea (H.-Y.K.); Gachon University Gil Hospital, Incheon, Korea (W.-C.K.); and Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (J.-H.C.). 2. From the Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital (B.-K.K., D.-H.S., M.-K.H., J.-S.K., Y.J.), Severance Biomedical Science Institute (M.-K.H., Y.J.), and Kangnam Severance Hospital (B.-K.H.), Yonsei University College of Medicine, Seoul, Korea; Kyungpook National University Hospital, Taegu, Korea (H.S.P.); Korea University Guro Hospital, Seoul, Korea (S.-W.R.); Cardiovascular Research Foundation, New York, NY (G.S.M.); Sejong General Hospital, Bucheon, Korea (J.S.K.); Soonchunhyang University Cheonan Hospital, Cheonan, Korea (S.-J.L.); Catholic University of Korea Bucheon St. Mary's Hospital, Bucheon, Korea (H.-Y.K.); Gachon University Gil Hospital, Incheon, Korea (W.-C.K.); and Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (J.-H.C.). jangys1212@yuhs.ac.
Abstract
BACKGROUND: There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. METHODS AND RESULTS: After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUS-guided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). CONCLUSIONS: Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01563952.
RCT Entities:
BACKGROUND: There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. METHODS AND RESULTS: After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUS-guided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). CONCLUSIONS: Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared with conventional angiography-guided CTO intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01563952.
Authors: Peter Tajti; Dimitri Karmpaliotis; Khaldoon Alaswad; Catalin Toma; James W Choi; Farouc A Jaffer; Anthony H Doing; Mitul Patel; Ehtisham Mahmud; Barry Uretsky; Aris Karatasakis; Judit Karacsonyi; Barbara A Danek; Bavana V Rangan; Subhash Banerjee; Imre Ungi; Emmanouil S Brilakis Journal: Catheter Cardiovasc Interv Date: 2018-01-23 Impact factor: 2.692
Authors: Peter Tajti; Iosif Xenogiannis; Dimitris Karmpaliotis; Khaldoon Alaswad; Farouc A Jaffer; M Nicholas Burke; Imre Ungi; Emmanouil S Brilakis Journal: Curr Cardiol Rep Date: 2018-10-22 Impact factor: 2.931
Authors: Judit Karacsonyi; Khaldoon Alaswad; Farouc A Jaffer; Robert W Yeh; Mitul Patel; John Bahadorani; Aris Karatasakis; Barbara A Danek; Anthony Doing; J Aaron Grantham; Dimitri Karmpaliotis; Jeffrey W Moses; Ajay Kirtane; Manish Parikh; Ziad Ali; William L Lombardi; David E Kandzari; Nicholas Lembo; Santiago Garcia; Michael R Wyman; Aya Alame; Phuong-Khanh J Nguyen-Trong; Erica Resendes; Pratik Kalsaria; Bavana V Rangan; Imre Ungi; Craig A Thompson; Subhash Banerjee; Emmanouil S Brilakis Journal: J Am Heart Assoc Date: 2016-08-20 Impact factor: 5.501