Guntipalli Manojna, Obi Ogechukwu, Jeswin Teenu Maria, Naidoo Rushern, Ghenai Mohamed Amine, Kansara Nishi, Gardezi Syed Karam, Chathemparambil Mani Sandra, Sheriff Taqiyah, Hidri Sinda, Ehsan Muhammad, Rehman Wajeeh Ur, Munasar Asmaa
GITAM Institute of Medical Sciences and Research, Visakhapatnam, India.
New York Institute of Technology College of Osteopathic Medicine, New York, USA.
Ann Med Surg (Lond). 2024 Dec 12;87(8):5165-5172. doi: 10.1097/MS9.0000000000003496. eCollection 2025 Aug.
Drug-coated balloons (DCBs) have emerged as a potential option for treating in-stent restenosis (ISR). We aimed to assess the efficacy and safety of DCB compared to uncoated balloons (UCBs) for patients with ISR.
We systematically searched Embase, MEDLINE, and Cochrane Library for randomized controlled trials comparing drug-coated balloons with uncoated balloons for coronary in-stent restenosis (ISR). Dichotomous and continuous outcomes were pooled using Revman 5.4 under a random-effects model. All the outcomes were assessed in a 6-month to 1-year follow-up period.
A total of seven RCTs involving 1407 patients were included in our review. DCBs significantly reduced the rate of target lesion revascularization (TLR) (RR 0.28; 95% CI: 0.16, 0.48), target vessel revascularization (TVR) (RR 0.36; 95% CI: 0.14, 0.90), major adverse cardiovascular events (MACE) (RR 0.39; 95% CI: 0.26, 0.58), and MI (RR 0.56; 95% CI: 0.35, 0.91). However, no significant difference was observed between the two groups regarding all-cause mortality, cardiovascular mortality, and stent thrombosis. DCB significantly improved angiographic outcomes such as binary restenosis (RR 0.23; 95% CI: 0.12, 0.43), late lumen loss (MD -0.44; 95% CI: - 0.55 to -0.33), and percent diameter stenosis (MD -13.91; 95% CI: - 24.15 to -3.67) compared to the UCB group.
Our meta-analysis showed that drug-coated balloons have superior efficacy and safety compared to uncoated balloons in coronary in-stent restenosis patients.
药物涂层球囊（DCB）已成为治疗支架内再狭窄（ISR）的一种潜在选择。我们旨在评估与未涂层球囊（UCB）相比，DCB治疗ISR患者的疗效和安全性。
我们系统检索了Embase、MEDLINE和Cochrane图书馆，以查找比较药物涂层球囊与未涂层球囊治疗冠状动脉支架内再狭窄（ISR）的随机对照试验。在随机效应模型下，使用Revman 5.4汇总二分法和连续性结果。所有结果均在6个月至1年的随访期内进行评估。
我们的综述共纳入了7项涉及1407例患者的随机对照试验。DCB显著降低了靶病变血运重建（TLR）率（RR 0.28；95%CI：0.16，0.48）、靶血管血运重建（TVR）率（RR 0.36；95%CI：0.14，0.90）、主要不良心血管事件（MACE）发生率（RR 0.39；95%CI：0.26，0.58）和心肌梗死（MI）发生率（RR 0.56；95%CI：0.35，0.91）。然而，两组在全因死亡率、心血管死亡率和支架血栓形成方面未观察到显著差异。与UCB组相比，DCB显著改善了血管造影结果，如二元再狭窄（RR 0.23；95%CI：0.12，0.43）、晚期管腔丢失（MD -0.44；95%CI：-0.55至-0.33）和直径狭窄百分比（MD -13.91；95%CI：-24.15至-3.67）。
我们的荟萃分析表明，在冠状动脉支架内再狭窄患者中，药物涂层球囊比未涂层球囊具有更高的疗效和安全性。
