Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.
Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Vasc Med. 2024 Apr;29(2):182-188. doi: 10.1177/1358863X241228261. Epub 2024 Mar 8.
Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions.
This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration.
The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively ( < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased ( < 0.001 and = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years ( = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years ( = 0.69 and 0.20, respectively).
This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration.
虽然氟聚合物药物洗脱支架（FP-DES）在治疗有症状的外周动脉疾病（PAD）的真实世界股腘动脉病变中的 1 年临床结果是有利的，但它们在 1 年以上的表现仍不清楚。本研究旨在确定 FP-DES 治疗真实世界股腘动脉病变的 3 年临床结果。
这是一项多中心、前瞻性、观察性研究，共纳入 1097 例 PAD 患者的 1204 条肢体（慢性肢体威胁性缺血，34.8%；平均病变长度 18.6±9.9cm，慢性完全闭塞：53.2%）接受 FP-DES 治疗股腘动脉病变。主要终点是 3 年再狭窄。次要终点包括 3 年闭塞性再狭窄、支架血栓形成、靶病变血运重建（TLR）和动脉瘤样变性。
3 年累积再狭窄发生率为 27.3%，闭塞性再狭窄、支架血栓形成和 TLR 发生率分别为 16.1%、7.3%和 19.6%。第 1、2 和第 3 年的再狭窄年发生率分别下降 12.0%、9.5%和 5.8%（<0.001）。同样，闭塞性再狭窄和支架血栓形成的发生率也有所下降（<0.001 和=0.007），而 3 年内 TLR 率保持不变（=0.15）。3 年时动脉瘤样变性的发生率（15.7%）与 1 年和 2 年时无显著差异（=0.69 和 0.20）。
本研究强调了 FP-DES 在真实世界实践中的良好长期临床效果，强调了监测闭塞性再狭窄和支架血栓形成的重要性，同时需要考虑动脉瘤样变性的潜在发生。
