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药物洗脱支架联合药物涂层球囊策略在长段股腘动脉疾病血管内治疗中的应用

Application of Drug-Eluting Stent With Drug-Coated Balloon Strategy for the Endovascular Treatment of Long-Segment Femoropopliteal Artery Disease.

作者信息

Tsukizawa Tomofumi, Fujihara Masahiko, Yazu Yuko

机构信息

Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada, Japan.

Department of Clinical Engineer, Kishiwada Tokushukai Hospital, Kishiwada, Japan.

出版信息

J Endovasc Ther. 2024 Nov 26:15266028241292459. doi: 10.1177/15266028241292459.

DOI:10.1177/15266028241292459
PMID:39588950
Abstract

PURPOSE

Endovascular therapy (EVT) has emerged as a primary approach for managing femoropopliteal artery (FPA) lesions, leveraging drug-eluting stents (DESs), and drug-coated balloons (DCBs), to enhance clinical outcomes. Although a full DES coverage strategy is effective in treating complex lesions, concerns over long-term complications prompt the exploration of alternative strategies. The aim of this study was to investigate clinical result of combination therapy of DES with DCB and compare them with full DES implantation.

MATERIALS AND METHODS

This retrospective, single-center study analyzed 131 patients with occlusive FPA lesions treated at our institution between 2019 and 2022. Patients with Rutherford classification stages 2 to 5 who underwent successful EVT were included. The study compared the outcomes of the drug-within-drug (DWD) strategy, ie, combining DES for failed vessel preparation segments and DCB for successful ones, with those of full DES implantation. The primary outcomes were the primary patency rates, and the secondary outcomes included clinically-driven target lesion revascularization (CD-TLR) rates, restenosis patterns, and survival outcomes.

RESULTS

Of the 131 patients initially considered, 118 met the inclusion criteria, with 45 in the DWD group and 73 in the full metal jacket (FMJ) stent group. The DWD group demonstrated equivalent 1-year primary patency rates (85.3%) to the FMJ group (87.9%, p=0.239). Similarly, no significant differences in CD-TLR rates were found between the 2 groups. The restenosis patterns and subsequent treatment strategies were not significantly different.

CONCLUSION

The DWD strategy offers a viable alternative to full DES coverage in treating long-segment FPA lesions, with comparable restenosis and target lesion revascularization (TLR) rates. This approach may mitigate risks associated with full-length stenting, such as thrombosis, and challenges in repeat revascularizations by tailoring treatment to lesion characteristics. The DWD strategy represents a promising approach for complex FPA lesions, providing a balanced solution that potentially reduces long-term complications while maintaining effective patency and revascularization rates.

CLINICAL IMPACT

The efficacy of drug-eluting stents (DES) in treating femoropopliteal artery (FPA) lesions has been well demonstrated. However, concerns remain regarding complications such as thrombotic occlusion and aneurysmal degeneration, especially when full stemt coverage of whole lesions is performed. The "Drug-with-Drug" (DWD) strategy, which involves implanting DES only at sites with severe dissection or residual stenosis after pre-balloon dilation and using drug coated balloons (DCB) for segments successfully prepared without stenting, has shown comparable outcomes to full stent coverage. Unlike traditional bailout stenting or spot stenting, the DWD approach maximizes the benefits of drug technology and presents a valuable option for treating long-segment FPA lesions.

摘要

目的

血管内治疗(EVT)已成为管理股腘动脉(FPA)病变的主要方法,利用药物洗脱支架(DES)和药物涂层球囊(DCB)来改善临床结果。尽管完全DES覆盖策略在治疗复杂病变方面有效,但对长期并发症的担忧促使人们探索替代策略。本研究的目的是调查DES与DCB联合治疗的临床结果,并将其与完全DES植入进行比较。

材料与方法

这项回顾性单中心研究分析了2019年至2022年在本机构接受治疗的131例FPA闭塞性病变患者。纳入成功接受EVT的卢瑟福分类2至5期患者。该研究比较了药物内药物(DWD)策略(即对血管准备失败段使用DES,对成功段使用DCB)与完全DES植入的结果。主要结局是主要通畅率,次要结局包括临床驱动的靶病变血运重建(CD-TLR)率、再狭窄模式和生存结局。

结果

在最初考虑的131例患者中,118例符合纳入标准,其中DWD组45例,全金属外套(FMJ)支架组73例。DWD组的1年主要通畅率(85.3%)与FMJ组(87.9%,p = 0.239)相当。同样,两组之间的CD-TLR率没有显著差异。再狭窄模式和后续治疗策略没有显著差异。

结论

在治疗长段FPA病变时,DWD策略是完全DES覆盖的可行替代方案,再狭窄和靶病变血运重建(TLR)率相当。这种方法可以减轻与全长支架置入相关的风险,如血栓形成,以及通过根据病变特征调整治疗来应对重复血运重建的挑战。DWD策略是治疗复杂FPA病变的一种有前景的方法,提供了一种平衡的解决方案,有可能减少长期并发症,同时保持有效的通畅率和血运重建率。

临床影响

药物洗脱支架(DES)在治疗股腘动脉(FPA)病变方面的疗效已得到充分证明。然而,对于血栓闭塞和动脉瘤样变性等并发症仍存在担忧,特别是在对整个病变进行全支架覆盖时。“药物内药物”(DWD)策略,即在预球囊扩张后仅在严重夹层或残余狭窄部位植入DES,并对未置入支架成功准备的段使用药物涂层球囊(DCB),已显示出与全支架覆盖相当的结果。与传统的补救支架置入或局部支架置入不同,DWD方法最大限度地发挥了药物技术的优势,为治疗长段FPA病变提供了一个有价值的选择。

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