Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (W. Wańha, P.P., T.Z.P., W. Wojakowski).
DCB Academy, Milano, Italy (W. Wańha, S.I., B.C.).
Circ Cardiovasc Interv. 2024 Sep;17(9):e014064. doi: 10.1161/CIRCINTERVENTIONS.124.014064. Epub 2024 Jul 25.
Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting.
All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up.
A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; =0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; =0.062) and major adverse cardiovascular events (20.8% versus 17.1%; =0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; =0.329), target vessel revascularization (14.0% versus 13.1%; =0.822), myocardial infarction (7.2% versus 4.5%; =0.186), all-cause death (5.7% versus 4.2%; =0.476), and major adverse cardiovascular event (21.5% versus 17.6%; =0.242) between DES and SCB treatment.
In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
有证据表明，药物涂层球囊可能有益于支架内再狭窄（ISR）的治疗。然而，在这种情况下，新型西罗莫司涂层球囊（SCB）与最新一代药物洗脱支架（DES）的疗效尚未得到研究。
所有在 EASTBORNE（所有患者西罗莫司涂层球囊欧洲注册研究）和 DEB-DRAGON（DES-ISR 中 DEB 与 Thin-DES：长期结果）登记研究中接受经皮冠状动脉介入治疗治疗 DES-ISR 的患者均纳入本研究。主要研究终点为 24 个月时的靶病变血运重建。次要终点为 24 个月时的主要不良心血管事件、全因死亡、心肌梗死和靶血管血运重建。我们的目标是评估在长期随访中 SCB 与薄支架 DES 在 ISR 中的疗效和安全性。
共有 1545 例 1679 处 ISR 病变的患者纳入了汇总分析，其中 621 例（40.2%）患者的 621 处病变接受了薄支架 DES 治疗，924 例（59.8%）患者的 1045 处病变接受了 SCB 治疗。未匹配队列中，靶病变血运重建的发生率无差异（10.8%比 11.8%；=0.568）；然而，SCB 组心肌梗死（7.4%比 5.0%；=0.062）和主要不良心血管事件（20.8%比 17.1%；=0.072）的发生率有下降趋势。在倾向评分匹配（每组 335 例患者）后，两组靶病变血运重建率（11.6%比 11.8%；=0.329）、靶血管血运重建率（14.0%比 13.1%；=0.822）、心肌梗死率（7.2%比 4.5%；=0.186）、全因死亡率（5.7%比 4.2%；=0.476）和主要不良心血管事件发生率（21.5%比 17.6%；=0.242）均无显著差异。
在 ISR 患者中，与薄支架 DES 相比，SCB 血管成形术的靶病变血运重建、靶血管血运重建、心肌梗死、全因死亡和主要不良心血管事件发生率在 2 年内相似。
