한빛사논문
- 조회140
Young-Guk Ko1*†, Seung-Jun Lee1†, Chul-Min Ahn1, Sang-Hyup Lee1, Yong-Joon Lee1, Byeong-Keuk Kim1, Myeong-Ki Hong 1, Yangsoo Jang1, Tae-Hoon Kim2,3, Ha-Wook Park3, Ji Yong Jang4, Jae-Hwan Lee5,6, Jae-Hyeong Park6, Su Hong Kim7, Eui Im8, Sang-ho Park9, and Donghoon Choi1*; on behalf of the IVUS-DCB investigators
1Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemungu, Seoul 03722, Korea;
2Division of Cardiology, Hanil General Hospital, Seoul, Korea;
3Division of Cardiology Cardiovascular Center, Bucheon Sejong Hospital, Bucheon, Korea;
4Division of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Korea;
5Division of Cardiology, Chungnam National University Sejong Hospital, Sejong, Korea;
6Division of Cardiology, Chungnam National University Hospital, Daejeon, Korea;
7Division of Cardiology, Busan Veterans Hospital, Busan, Korea;
8Division of Cardiology, Yongin Severance Hospital, Seoul, Korea; and
9Cardiology Department, Soonchunhyang University Cheonan Hospital, Cheonan, Korea
*Corresponding authors : Y.-G.K., D.C.
†The first two authors contributed equally to the study.
Abstract
Background and aims: Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs.
Methods: This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency.
Results: Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03).
Conclusions: Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.
논문정보
- Research article
- 2024년 07월 (BRIC 등록일 2024-07-11)
- 국내 연구진
- 의약학 > 분자세포의학
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