Division of Cardiology, ASL Biella, Italy; Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.
Department of Translational Medicine, Eastern Piedmont University, Novara, Italy.
Vascul Pharmacol. 2021 Jun;138:106859. doi: 10.1016/j.vph.2021.106859. Epub 2021 Apr 2.
Drug-coated balloons (DCB) have shown promising results for the percutaneous treatment of de novo and restenotic lesions, involving both the coronary and femoropopliteal district. However, clinical outcomes data associated with the use of this devices are still unclear, with potential warnings on increased mortality being raised from initial studies. We aimed at performing an updated and comprehensive meta-analysis comparing DCB with conventional percutaneous revascularization strategies for the treatment of coronary (CAD) or peripheral artery disease (PAD).
Literature and main scientific session abstracts were searched for studies comparing DCB vs a standard percutaneous revascularization strategy, with or without stenting, for the treatment of CAD and PAD. The primary efficacy endpoint was mortality. Secondary endpoints were recurrent acute ischemic events (myocardial infarction or amputation) or target lesion revascularization (TLR).
We included 45 randomized trials, (CAD: 27 studies, PAD: 18 studies) with an overall population of 7718 patients, (56.4%) randomized to a DCB strategy. At a mean follow-up of19.3 ± 15.2 months, death occurred in 5.8% of the patients, with no significant difference between DCB or conventionally treated patients (5.9% vs 5.7%, OR[95%CI] = 0.89[0.71,1.11], p = 0.31; phet = 0.43). We observed a non-significant reduction in recurrent acute ischemic events, whereas the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with PAD and respect to balloon-only angioplasty, while being lower in comparison with stent implantation. No significant interaction was observed with de novo lesions or in-stent restenosis.
Based on the current meta-analysis, the use of drug-coated balloons for the percutaneous treatment of CAD and PAD is associated to a comparable risk of mortality and recurrent acute ischemic events as compared to a conventional revascularization strategy, although offering larger benefits in terms of TLR, especially when compared with balloon-only angioplasty and in femoropopliteal disease.
药物涂层球囊（DCB）在经皮治疗新发和再狭窄病变方面显示出良好的效果，包括冠状动脉和股腘动脉。然而，与该器械使用相关的临床结果数据尚不清楚，初步研究提出了死亡率增加的潜在警告。我们旨在进行一项更新和全面的荟萃分析，比较 DCB 与传统经皮血运重建策略治疗冠状动脉（CAD）或外周动脉疾病（PAD）的效果。
检索文献和主要科学会议摘要，比较 DCB 与标准经皮血运重建策略（伴或不伴支架置入）治疗 CAD 和 PAD 的研究。主要疗效终点是死亡率。次要终点是复发性急性缺血事件（心肌梗死或截肢）或靶病变血运重建（TLR）。
我们纳入了 45 项随机试验（CAD：27 项研究，PAD：18 项研究），共有 7718 例患者，其中 56.4%被随机分配到 DCB 治疗策略。在平均 19.3±15.2 个月的随访中，5.8%的患者死亡，DCB 治疗组和常规治疗组之间无显著差异（5.9%比 5.7%，OR[95%CI]0.89[0.71,1.11]，p=0.31；phet=0.43）。我们观察到复发性急性缺血事件的发生率有所降低，而 DCB 的使用显著降低了 TLR 率，在 PAD 患者和单纯球囊血管成形术患者中获益更大，而与支架植入术相比获益较小。未观察到与新发病变或支架内再狭窄有显著交互作用。
基于目前的荟萃分析，与传统血运重建策略相比，经皮治疗 CAD 和 PAD 时使用药物涂层球囊与死亡率和复发性急性缺血事件的风险相当，但在 TLR 方面提供了更大的获益，特别是与单纯球囊血管成形术相比，在股腘动脉疾病中获益更大。
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