Abstract：
BACKGROUND: Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain.
OBJECTIVE: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions.
METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months.
RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370).
CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).
OBJECTIVE: This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions.
METHODS: A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months.
RESULTS: A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370).
CONCLUSIONS: This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).
摘要：
背景：药物涂层球囊（DCB）血管成形术对于特定的新冠状动脉病变似乎是安全有效的选择。然而,血管内超声(IVUS)引导下的DCB血管成形术在新生病变中的有益效果仍不确定.
目的：本研究旨在评估在新冠状动脉病变的DCB血管成形术中，IVUS引导相对于血管造影引导的益处。
方法：共260例出血风险较高的患者发生了新冠状动脉病变（参考血管直径2.0-4.0mm，并且病变长度≤15mm）被随机分配到IVUS引导或血管成形术引导的DCB血管成形术组。主要终点是手术后7个月的段内晚期管腔丢失（LLL）。次要终点是6个月时的目标血管衰竭。
结果：共有2例血管造影引导组患者和7例IVUS引导组患者接受了救助支架植入术（P=0.172）。7个月LLL的主要终点是血管造影指导下的0.03±0.52mm，与IVUS指导下的-0.10±0.34mm（平均差0.14mm；95％CI：0.02-0.26；P=0.025）。与血管造影引导相比,IVUS引导还与较大的7个月最小管腔直径(2.06±0.62mmvs1.75±0.63mm;P<0.001)和较小的直径狭窄(28.15%±13.88%vs35.83%±17.69%;P=0.001)相关。在6个月时发生了5次目标血管故障，血管造影引导组4例(3.1%),IVUS引导组1例(0.8%)(P=0.370)。
结论：这项研究表明，与血管造影指导相比，IVUS指导的DCB血管成形术与新冠状动脉病变患者的LLL降低相关。（血管内超声与血管造影引导的药物涂层球囊[ULTIMATE-III]；NCT04255043）。
目的：本研究旨在评估在新冠状动脉病变的DCB血管成形术中，IVUS引导相对于血管造影引导的益处。
方法：共260例出血风险较高的患者发生了新冠状动脉病变（参考血管直径2.0-4.0mm，并且病变长度≤15mm）被随机分配到IVUS引导或血管成形术引导的DCB血管成形术组。主要终点是手术后7个月的段内晚期管腔丢失（LLL）。次要终点是6个月时的目标血管衰竭。
结果：共有2例血管造影引导组患者和7例IVUS引导组患者接受了救助支架植入术（P=0.172）。7个月LLL的主要终点是血管造影指导下的0.03±0.52mm，与IVUS指导下的-0.10±0.34mm（平均差0.14mm；95％CI：0.02-0.26；P=0.025）。与血管造影引导相比,IVUS引导还与较大的7个月最小管腔直径(2.06±0.62mmvs1.75±0.63mm;P<0.001)和较小的直径狭窄(28.15%±13.88%vs35.83%±17.69%;P=0.001)相关。在6个月时发生了5次目标血管故障，血管造影引导组4例(3.1%),IVUS引导组1例(0.8%)(P=0.370)。
结论：这项研究表明，与血管造影指导相比，IVUS指导的DCB血管成形术与新冠状动脉病变患者的LLL降低相关。（血管内超声与血管造影引导的药物涂层球囊[ULTIMATE-III]；NCT04255043）。
