Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea.
Korea University Anam Hospital, Seoul, Republic of Korea.
Eur J Vasc Endovasc Surg. 2021 Feb;61(2):287-295. doi: 10.1016/j.ejvs.2020.10.008. Epub 2020 Nov 20.
There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease.
A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics.
The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p = .021) or total occlusions (43.5% vs. 77.5%, p < .001) and showed shorter lesion lengths (164.2 ± 105.4 mm vs. 194.8 ± 86.8 mm, p = .009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4 ± 0.6 vs. 5.1 ± 0.7, p = .025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p < .001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27-0.96, p = .032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17-0.89, p = .021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62-5.52, p = .26).
In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease.
在股腘动脉疾病的治疗中，药物洗脱支架（DES）和药物涂层球囊（DCB）的临床对比试验有限。本回顾性和前瞻性队列研究旨在比较 DES 和 DCB 治疗原发性股腘动脉疾病的疗效。
2013 年 1 月 19 日至 2018 年 5 月 5 日，在韩国的两个血管内治疗中心，共有 288 条肢体（242 例患者）接受了 DES（Zilver PTX；102 条肢体）或 DCB（IN.PACT Admiral；186 条肢体）治疗。中位随访时间为 19.6 个月。主要终点是主要临床通畅率。采用倾向评分匹配（PSM，162 条肢体）和逆概率加权（IPW）调整，以调整混杂的基线特征。
DCB 组病变中 TASC II 型 C/D （55.9% vs. 70.6%，p=0.021）或完全闭塞（43.5% vs. 77.5%，p<0.001）的比例较低，病变长度较短（164.2±105.4mm vs. 194.8±86.8mm，p=0.009）。PSM 后，两组的基线临床和病变特征相当，除 DES 组的参考血管直径较大（5.4±0.6 vs. 5.1±0.7，p=0.025）外。DCB 组中有 32.1%的患者进行了辅助动脉粥样斑块切除术，DES 组中只有 2.5%（p<0.001）。DCB 组中有 14.8%的患者需要临时支架置入。在两年的随访中，DCB 组的主要临床通畅率更高（74.6% vs. 56.7%，风险比[HR]0.51，95%置信区间[CI]0.27-0.96，p=0.032），无靶病变血运重建率（85.9% vs. 71.3%，HR 0.39，95% CI 0.17-0.89，p=0.021）也更高。两组的全因死亡率无差异（87.6% vs. 92.1%，HR 1.85，95% CI 0.62-5.52，p=0.26）。
在本项由两个中心开展的队列研究中，DCB 联合选择性使用辅助动脉粥样斑块切除术的治疗方法，在治疗原发性股腘动脉疾病方面优于 DES。
