在新发冠状动脉病变中使用西罗莫司涂层球囊；多中心真实人群的长期临床结果。

IF 2.1 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Catheterization and Cardiovascular Interventions Pub Date : 2024-10-03 DOI:10.1002/ccd.31244

Sandeep Basavarajaiah MD, FESC, Vinoda Sharma MD, MRCP, Alessandro Sticchi MD, Gianluca Caiazzo MD, PhD, Filiberto Fausto Mottola MD, Bhagya Harindi Loku Waduge MBBS, Sampath Athukorala MD, MRCP, Mazaya Fawazy MD, MRCP, Luca Testa MD, Antonio Colombo MD

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引用次数: 0

摘要

背景：西罗莫司涂层球囊（SCB）是一种相对新颖的技术，因其药物特性（安全性和有效性）而颇具吸引力，西罗莫司仍是支架的首选药物。然而，有关 SCB 的长期数据十分有限。在这项研究中，我们根据实际情况探讨了在新发病变中使用西罗莫司涂层球囊后的临床效果：我们分析了 2016 年至 2023 年期间在英国和意大利的四个高容量中心接受SCB治疗的所有新发病变患者。测量的结果包括心源性死亡、靶血管心肌梗死（TVMI）、靶病变血运重建（TLR）和主要心脏不良事件（MACE）。在研究期间，771 名患者在新发病变中接受了 SCB 治疗。36%的患者（280人）患有糖尿病，其中14%（108人）依赖胰岛素。52%的病例（398例）属于急性冠状动脉综合征（ACS），其中51例（7%）为ST段抬高型心肌梗死。小血管（≥ $\ge $ 20 mm）。SCB的平均直径为2.6 ± 0.4 mm，平均长度为25 ± 10.39 mm。9%的病变（n = 67）需要在SCB后进行保送支架植入术。在中位随访 640 天期间，有 39 名患者（5%）死亡，其中有 10 名患者（1.3%）发生心源性死亡。20名患者（2.6%）发生了TVMI。TLR和TVR分别为5.6%和5.8%。总体MACE发生率为8%。我们没有记录到急性血管闭塞的病例：在真实世界人群中进行的长期随访结果令人鼓舞，尽管患者群体复杂，但硬终点发生率较低，TLR 和 MACE 发生率尚可接受。我们的数据表明，SCB 在冠状动脉介入治疗中是安全的，长期临床效果良好。

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Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population

Background

Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice.

Aims

To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions.

Methods and Results

We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE).

During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( $\geq$ 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67).

During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure.

Conclusions

The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

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来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.