Vascular and Endovascular Surgery Department, Faculty of Medicine, Al-Azhar University, Assiut, Egypt.
Vascular and Endovascular Surgery Department, Faculty of Medicine (Girls), Al-Azhar University, Cairo, Egypt.
Ann Vasc Surg. 2024 Jun;103:58-67. doi: 10.1016/j.avsg.2023.12.078. Epub 2024 Feb 29.
This study was carried out to assess the effectiveness of alprostadil (prostaglandin E1) when used as an adjuvant therapy with indirect revascularization in patients with critical limb ischemia (CLI) after the failure of direct revascularization (DR).
At our centers, 120 patients suffering from infrainguinal peripheral arterial disease with CLI underwent a failed trial of DR procedure, all revascularization procedures were endovascular. Median follow-up was 2 years and 2.5 years for patients with and without diabetes mellitus (DM). In the alprostadil group, the mean age was 63.41 ± 12.52; 36 (60%) for males and 24 (40%) for females. Post-endovascular intervention alprostadil was administrated immediately postoperatively by intravenous infusion of 40 μg alprostadil diluted in 100 ml of normal saline, over 2 hr every 12 hr for 6 days.
In the alprostadil group, the mean ± standard deviation (SD) of the baseline ankle-brachial index (ABI) was 0.45 ± 0.175, while the mean ± SD of ABI at the end of our study was 0.65 ± 0.216 with a difference from the baseline of 0.2 ± 0.041 (P value = 0.08, <0.05 meaning that it is significant). Our 1-month primary patency rate was 93.3%, while our 3- and 6-month patency rate was 92.9%. In the control group, the mean ± SD of the baseline ABI was 0.68 ± 0.22, while the mean ± SD of ABI at the end of our study was 0.69 ± 0.23 with a difference from the baseline of 0.01 ± 0.01 (P value >0.05 meaning that it is nonsignificant) 1-month patency rate was 89%, while 3- and 6-month patency rate was 75%. When we compared the patient's leg vessels before and after our intervention, we found that the percentage of the no-runoff-vessels group decreased from 10 (16.7%) to 4 (6.67%). One-runoff-vessel group percentage dropped from 40 (66.7%) to 36 (60%), whereas, in the two-runoff-vessel group, the percentage increased from 10 (16.7%) to 20 (33.3%). We evaluate leg arteries; we do no pedal arch intervention in the alpostradil group. Out of the total of 60 patients, limb salvage occurred in 58 (96.7%) patients, and 2 (3.3%) patients underwent below-the-knee amputation before the study ended.
Our results show the efficacy and safety of alprostadil as an adjuvant therapy with indirect angiosomal revascularization in patients with tissue loss due to CLI.
本研究旨在评估前列地尔（前列腺素 E1）在直接血运重建失败后作为辅助治疗与间接血管生成治疗用于伴组织缺血性溃疡的严重肢体缺血（CLI）患者的效果。
在我们中心，120 例患有下肢动脉硬化性疾病伴 CLI 的患者接受了直接血运重建术的失败试验，所有血管重建术均为血管内治疗。中位随访时间为糖尿病患者 2 年和 2.5 年，非糖尿病患者 2 年和 2.5 年。在前列地尔组中，平均年龄为 63.41 ± 12.52 岁；男性 36 例（60%），女性 24 例（40%）。血管内介入治疗后，立即通过静脉输注 40μg 前列地尔稀释在 100ml 生理盐水，每 12 小时输注 1 次，每次 2 小时，共 6 天。
在前列地尔组中，基线踝肱指数（ABI）的平均值 ± 标准差（SD）为 0.45 ± 0.175，而我们研究结束时 ABI 的平均值 ± SD 为 0.65 ± 0.216，与基线相比差异为 0.2 ± 0.041（P 值=0.08，<0.05 表示差异具有统计学意义）。我们的 1 个月一期通畅率为 93.3%，3 个月和 6 个月的通畅率分别为 92.9%。在对照组中，基线 ABI 的平均值 ± SD 为 0.68 ± 0.22，而我们研究结束时 ABI 的平均值 ± SD 为 0.69 ± 0.23，与基线相比差异为 0.01 ± 0.01（P 值>0.05 表示差异无统计学意义）。1 个月通畅率为 89%，3 个月和 6 个月的通畅率分别为 75%。当我们比较患者干预前后的下肢血管时，我们发现无再通血管组的比例从 10 例（16.7%）降至 4 例（6.67%）。单再通血管组的比例从 40 例（66.7%）降至 36 例（60%），而在双再通血管组中，比例从 10 例（16.7%）增至 20 例（33.3%）。我们评估了腿部动脉；我们在前列地尔组中不进行足底弓干预。在总共 60 例患者中，58 例（96.7%）患者肢体得以保存，2 例（3.3%）患者在研究结束前接受了膝下截肢。
我们的结果表明，前列地尔作为间接血管生成治疗的辅助治疗在伴组织缺血性溃疡的 CLI 患者中具有疗效和安全性。
