Sung-Jin Hong1, Gary S Mintz2, Chul-Min Ahn1, Jung-Sun Kim1, Byeong-Keuk Kim1, Young-Guk Ko1, Tae-Soo Kang3, Woong-Chol Kang4, Yong Hoon Kim5, Seung-Ho Hur6, Bum-Kee Hong7, Donghoon Choi1, Hyuckmoon Kwon7, Yangsoo Jang1, Myeong-Ki Hong8. 1. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. 2. Cardiovascular Research Foundation, New York, New York. 3. Dankook University College of Medicine, Cheonan, Korea. 4. Gil Hospital, Gachon University College of Medicine, Incheon, Korea. 5. Kangwon National University School of Medicine, Chuncheon, Korea. 6. Keimyung University College of Medicine, Daegu, Korea. 7. Gangnam Severance Hospital, Seoul, Korea. 8. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.
Abstract
OBJECTIVES: The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up. BACKGROUND: The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up. METHODS: The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receiveIVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat. RESULTS: Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031). CONCLUSIONS: Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486).
RCT Entities:
OBJECTIVES: The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up. BACKGROUND: The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up. METHODS: The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat. RESULTS: Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031). CONCLUSIONS: Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486).
Authors: Ata Doost; James Marangou; Thato Mabote; Gerald Yong; Sharad Shetty; Alan Whelan; Matthew Erickson; Michael Nguyen; Christopher Judkins; Anthony Putrino; Abdul Rahman Ihdayhid; Richard Clugston; James Rankin Journal: AsiaIntervention Date: 2022-03-15
Authors: Adem Aksoy; Vedat Tiyerili; Nora Jansen; Muntadher Al Zaidi; Maximillian Thiessen; Alexander Sedaghat; Marc Ulrich Becher; Felix Jansen; Georg Nickenig; Sebastian Zimmer Journal: Int J Cardiol Heart Vasc Date: 2021-12-09