Ziyad Muhammad, Shah Syed Tahir, Rauf Muhammad Abdur, Shah Syed Muzammil, Ullah Sana, Ullah Rafi, Khan Muhammad Ilyas
Cardiology, Kuwait Teaching Hospital, Peshawar, PAK.
Cardiology, Kuwait Teaching Hospital, Peshawar Medical College, Peshawar, PAK.
Cureus. 2025 Feb 3;17(2):e78436. doi: 10.7759/cureus.78436. eCollection 2025 Feb.
Background This prospective cohort study aimed to evaluate the short-term clinical outcomes of drug-eluting balloons (DEBs) versus stenting in provisional bifurcation lesions, focusing on procedural success, safety, and major adverse cardiac events (MACE). The study specifically assessed key adverse outcomes, including restenosis, target lesion revascularization (TLR), myocardial infarction (MI), stent thrombosis, and mortality. Bifurcation lesions present significant challenges in interventional cardiology due to their complex anatomy, which contributes to a higher risk of restenosis, side-branch occlusion, and thrombotic events. This study compared the efficacy, safety, and procedural complexity of DEBs and stenting. Methodology Fifty patients with bifurcation lesions were enrolled and divided into two equal groups: 25 (50%) treated with DEBs and 25 (50%) treated with provisional stenting. The primary outcome measure was the incidence of MACE, including TLR, MI, stent thrombosis, and death. The study was conducted over one year, with follow-up assessments at one- and three months post-intervention. After the intervention, all patients were put on dual antiplatelet therapy (DAPT) comprising aspirin, clopidogrel, and high-intensity statins. Additionally, other medications were prescribed based on patient-specific needs. Results The DEB group exhibited an overall MACE rate of 2 (8%) compared with 3 (12%) in the stenting group (p = 0.58). Restenosis occurred in 1 (4%) of the DEB group and in 2 (8%) of the stenting group, whereas TLR was required in 1 (4%) and 2 (8%) of the patients, respectively. The incidence of MI was low in both groups 1 (4%), with no reported cases of stent thrombosis or death. No significant differences were observed between the groups in any of the clinical outcome measures (p > 0.05). The DEB group achieved treatment success without necessitating side-branch stenting or additional kissing balloon inflation, whereas the stenting group demonstrated comparable success, but increased procedural complexity. Conclusion DEBs and stenting showed comparable short-term efficacy and safety for provisional bifurcation lesions, offering the potential advantage of procedural simplicity. This study supports the viability of DEBs as an effective treatment option for selected bifurcation lesions, avoiding the additional complexities associated with stenting. However, larger studies with extended follow-up are necessary to validate these findings and inform clinical decision-making.
背景 这项前瞻性队列研究旨在评估药物洗脱球囊(DEB)与支架置入术治疗临时分叉病变的短期临床结局,重点关注手术成功率、安全性和主要不良心脏事件(MACE)。该研究特别评估了关键不良结局,包括再狭窄、靶病变血运重建(TLR)、心肌梗死(MI)、支架血栓形成和死亡率。分叉病变因其复杂的解剖结构在介入心脏病学中带来重大挑战,这导致再狭窄、分支闭塞和血栓形成事件的风险更高。本研究比较了DEB与支架置入术的疗效、安全性和手术复杂性。
方法 招募了50例分叉病变患者,平均分为两组:25例(50%)接受DEB治疗,25例(50%)接受临时支架置入术治疗。主要结局指标是MACE的发生率,包括TLR、MI、支架血栓形成和死亡。该研究进行了一年,在干预后1个月和3个月进行随访评估。干预后,所有患者均接受包括阿司匹林、氯吡格雷和高强度他汀类药物的双联抗血小板治疗(DAPT)。此外,根据患者的具体需求开具其他药物。
结果 DEB组的总体MACE发生率为2例(8%),而支架置入组为3例(12%)(p = 0.58)。DEB组1例(4%)发生再狭窄,支架置入组2例(8%)发生再狭窄;两组分别有1例(4%)和2例(8%)患者需要进行TLR。两组的MI发生率均较低,均为1例(4%),无支架血栓形成或死亡病例报告。两组在任何临床结局指标上均未观察到显著差异(p > 0.05)。DEB组无需进行分支支架置入或额外的球囊对吻扩张即可取得治疗成功,而支架置入组虽取得了类似的成功率,但手术复杂性增加。
结论 对于临时分叉病变,DEB与支架置入术显示出相当的短期疗效和安全性,具有手术操作简单的潜在优势。本研究支持DEB作为选定分叉病变的有效治疗选择的可行性,避免了与支架置入术相关的额外复杂性。然而,需要进行更大规模、更长随访期的研究来验证这些发现,并为临床决策提供依据。