VSTENT生物可吸收聚合物西罗莫司洗脱支架治疗冠状动脉病变患者的安全性和有效性：一项前瞻性队列多中心研究。

Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with coronary artery lesions: a prospective, cohort, multicenter study.

作者信息

Tran Hoa, Vu Vu Hoang, Nguyen Khang Duong, Huynh Thuong Van, Pham Nhut Cong, Nguyen Khoa Minh, Phan Thanh Van, Nguyen Trung Vinh, Tran Huan Van, Huynh Cang Trung, Lam Giang Huu, Pham Bang Quoc, Ho Dung Thuong, Nguyen Tan Van, Phan Truc Van, Nguyen Thach, Truong Binh Quang

机构信息

Department of Internal Medicine, University of Medicine and Pharmacy at HCMC, Ho Chi Minh City, Vietnam.

Cardiovascular Center, University Medical Center, Ho Chi Minh City, Vietnam.

出版信息

Cardiovasc Diagn Ther. 2023 Jun 30;13(3):474-486. doi: 10.21037/cdt-22-522. Epub 2023 May 18.

BACKGROUND

The drug-eluting stent was a significant stride forward in the development of enhanced therapeutic therapy for coronary intervention, with three generations of increased advancement. VSTENT is a newly developed stent manufactured in Vietnam that aims to provide coronary artery patients with a safe, effective, and cost-efficient option. The purpose of this trial was to determine the efficacy and safety of a new bioresorbable polymer sirolimus-eluting stent called VSTENT.

METHODS

This is a prospective, cohort, multicenter research in 5 centers of Vietnam. A prespecified subgroup received intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging. We determined procedure success and complications during index hospitalization. We monitored all participants for a year. Six-month and 12-month rates of major cardiovascular events were reported. All patients had coronary angiography after 6 months to detect late lumen loss (LLL). Prespecified patients also had IVUS or OCT performed.

RESULTS

The rate of device success was 100% (95% CI: 98.3-100%; P<0.001). Major cardiovascular events were 4.7% (95% CI: 1.9-9.4%; P<0.001). The LLL over quantitative coronary angiography (QCA) was 0.08±0.19 mm (95% CI: 0.05-0.10; P<0.001) in the in-stent segment and 0.07±0.31 mm (95% CI: 0.03-0.11; P=0.002) in 5 mm within the two ends of the stent segment. The LLL recorded by IVUS and OCT at 6 months was 0.12±0.35 mm (95% CI: 0.01-0.22; P=0.028) and 0.15±0.24 mm (95% CI: 0.02-0.28; P=0.024), respectively.

CONCLUSIONS

This study's device success rates were perfect. IVUS and OCT findings on LLL were favorable at 6-month follow-up. One-year follow-up showed low in-stent restenosis (ISR) and target lesion revascularization (TLR) rates, reflecting few significant cardiovascular events. VSTENT's safety and efficacy make it a promising percutaneous intervention option in developing nations.

背景

药物洗脱支架是冠状动脉介入强化治疗发展中的一项重大进步，历经三代不断发展。VSTENT是越南新研发的一种支架，旨在为冠状动脉疾病患者提供一种安全、有效且经济高效的选择。本试验的目的是确定一种名为VSTENT的新型生物可吸收聚合物西罗莫司洗脱支架的疗效和安全性。

方法

这是一项在越南5个中心进行的前瞻性队列多中心研究。一个预先指定的亚组接受血管内超声（IVUS）或光学相干断层扫描（OCT）成像。我们确定了首次住院期间的手术成功率和并发症情况。我们对所有参与者进行了一年的监测。报告了6个月和12个月时的主要心血管事件发生率。所有患者在6个月后进行冠状动脉造影以检测晚期管腔丢失（LLL）。预先指定的患者还进行了IVUS或OCT检查。

结果

器械成功率为100%（95%置信区间：98.3 - 100%；P<0.001）。主要心血管事件发生率为4.7%（95%置信区间：1.9 - 9.4%；P<0.001）。支架内节段经定量冠状动脉造影（QCA）测得的LLL为0.08±0.19 mm（95%置信区间：0.05 - 0.10；P<0.001），支架节段两端5 mm范围内为0.07±0.31 mm（95%置信区间：0.03 - 0.11；P = 0.002）。6个月时IVUS和OCT测得的LLL分别为0.12±0.35 mm（95%置信区间：0.01 - 0.22；P = 0.028）和0.15±0.24 mm（95%置信区间：0.02 - 0.28；P = 0.024）。