Dong-Ho Shin1, Sung-Jin Hong2, Gary S Mintz3, Jung-Sun Kim4, Byeong-Keuk Kim4, Young-Guk Ko4, Donghoon Choi4, Yangsoo Jang5, Myeong-Ki Hong6. 1. Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea. 2. Department of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul, South Korea. 3. Cardiovascular Research Foundation, New York, New York. 4. Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea. 5. Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea. 6. Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: mkhong61@yuhs.ac.
Abstract
OBJECTIVES: The aim of this study was to evaluate the clinical usefulness of intravascular ultrasound (IVUS)-guided new-generation drug-eluting stent (DES) implantation using a meta-analysis of individual patient-level data from randomized trials. BACKGROUND: Published randomized trials that compare IVUS-guided versus angiography-guided new-generation DES implantation are scarce. METHODS: Searches of the MEDLINE, Embase, and Cochrane databases were performed to find randomized trials that compared IVUS-guided versus angiography-guided new-generation DES implantation. A total of 2,345 patients from 3 randomized trials were identified, and all patients were treated for long lesions or chronic total occlusions. Individual patient-level data were obtained. The primary endpoint was a major adverse cardiac event, a composite of cardiac death, myocardial infarction, or stent thrombosis. An intention-to-treat analysis and per protocol analysis were performed. RESULTS: By 1 year post-procedure, major adverse cardiac events had occurred in 0.4% of the patients who underwent IVUS-guided DES implantation versus 1.2% of those who underwent angiography-guided DES implantation (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.99; p = 0.040). For the IVUS-guided group, favorable clinical outcomes were observed for myocardial infarction (0% vs. 0.4%; HR: 0.09; p = 0.026). In addition, the clinical benefit of IVUS guidance was stronger in the per protocol analysis (HR: 0.32; 95% CI: 0.12 to 0.89; p = 0.021). CONCLUSIONS: Compared with angiographic guidance, IVUS-guided new-generation DES implantation was associated with favorable outcomes in terms of major adverse cardiac events, the composite of cardiac death, myocardial infarction, or stent thrombosis. These findings must be interpreted only for complex lesions, because all identified patients had long lesions or chronic total occlusions.
OBJECTIVES: The aim of this study was to evaluate the clinical usefulness of intravascular ultrasound (IVUS)-guided new-generation drug-eluting stent (DES) implantation using a meta-analysis of individual patient-level data from randomized trials. BACKGROUND: Published randomized trials that compare IVUS-guided versus angiography-guided new-generation DES implantation are scarce. METHODS: Searches of the MEDLINE, Embase, and Cochrane databases were performed to find randomized trials that compared IVUS-guided versus angiography-guided new-generation DES implantation. A total of 2,345 patients from 3 randomized trials were identified, and all patients were treated for long lesions or chronic total occlusions. Individual patient-level data were obtained. The primary endpoint was a major adverse cardiac event, a composite of cardiac death, myocardial infarction, or stent thrombosis. An intention-to-treat analysis and per protocol analysis were performed. RESULTS: By 1 year post-procedure, major adverse cardiac events had occurred in 0.4% of the patients who underwent IVUS-guided DES implantation versus 1.2% of those who underwent angiography-guided DES implantation (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.99; p = 0.040). For the IVUS-guided group, favorable clinical outcomes were observed for myocardial infarction (0% vs. 0.4%; HR: 0.09; p = 0.026). In addition, the clinical benefit of IVUS guidance was stronger in the per protocol analysis (HR: 0.32; 95% CI: 0.12 to 0.89; p = 0.021). CONCLUSIONS: Compared with angiographic guidance, IVUS-guided new-generation DES implantation was associated with favorable outcomes in terms of major adverse cardiac events, the composite of cardiac death, myocardial infarction, or stent thrombosis. These findings must be interpreted only for complex lesions, because all identified patients had long lesions or chronic total occlusions.
Authors: Christopher Noble; Kent Carlson; Erica Neumann; Bradley Lewis; Dan Dragomir-Daescu; Amir Lerman; Ahmet Erdemir; Melissa Young Journal: Med Nov Technol Devices Date: 2020-08-24