Torsello Giovanni Federico, Stavroulakis Konstantinos, Chlouverakis Gregory, Torsello Giovanni Battista
Institute of Radiology, University of Göttingen, Göttingen, Germany.
Department of Vascular and Endovascular Surgery, Ludwig-Maximilians-University Hospital, Munich, Germany.
J Endovasc Ther. 2024 Dec 23:15266028241306068. doi: 10.1177/15266028241306068.
To compare the performance of a new-generation cobalt-chromium balloon-expandable bare metal stent with a stainless steel platform for the treatment of iliac occlusive disease.
Consecutive patients treated for symptomatic iliac occlusive disease between 2014 and 2021 with the cobalt-chromium Dynetic-35 or the stainless steel Dynamic platform were retrospectively evaluated. Outcome measures included technical success, device- or procedure-related death, clinically-driven target lesion revascularization (CD-TLR), primary patency, and major index limb amputation up to 12 months.
In total, 222 Cobalt chromium (CC) stents were used in 159 patients (34.6% female; mean age 66.9 ± 9.5 years) for the treatment of 216 lesions, while 234 iliac lesions of 182 patients (34.6% female; mean age 66.3 ± 9.9 years) were treated with 252 stainless steel (SS) stents. The mean lesion length (30.2 ± 12.8 mm vs 28.7 ± 22.5 mm, p=0.36) and the mean calcification grade (2.0 vs 1.9, p=0.07) did not differ significantly between the 2 groups. Patients treated by the CC platform were more frequently on statins (p<0.001), whereas more active smokers and subjects with higher Rutherford class underwent a SS deployment (p<0.001). Technical success was significantly higher in the SS group (100% vs 97.3%; p=0.01). This was due to longitudinal deformation or stent dislocation after passing the Dynetic-35 with endovascular material. After 1 year, no difference was found following CC and SS stent deployment in terms of device- or procedure-related deaths (0.6% vs 1.1%, p=0.99), target limb amputations (1.9% vs 1.6%, p=0.99), primary patency (91.3% vs 93.5%), and CD-TLR (6.5% vs 2.8% p=0.07).
Through 1 year, cobalt-chromium and stainless steel balloon-expandable stents are safe and effective in the treatment of iliac occlusive disease. Enhanced attention should be given passing the cobalt-chromium stent with endovascular devices to avoid procedural complications.
Stents with a thin-strut structure improve the flexibility and deliverability. The lower profile also increases the applicability lowering the risk of vascular access complications. In this study newer-generation cobalt chromium balloon-expandable stent did not confer advantages over stainless steel bare metal stent. On contrary, the technical success was inferior to stainless steel stents as longitudinal deformation or dislocation of the Dynetic-35 occurred. Therefore, enhanced attention should be given passing a Cobalt chromium stent with wires, catheters or sheaths to avoid stent deformation.
比较新一代钴铬合金球囊扩张式裸金属支架与不锈钢平台支架治疗髂动脉闭塞性疾病的性能。
回顾性评估2014年至2021年间接受钴铬合金Dynetic-35或不锈钢Dynamic平台治疗有症状髂动脉闭塞性疾病的连续患者。观察指标包括技术成功率、与器械或手术相关的死亡、临床驱动的靶病变血运重建（CD-TLR）、原发性通畅率以及至12个月时主要指标肢体截肢情况。
总共159例患者（女性占34.6%；平均年龄66.9±9.5岁）使用222枚钴铬合金（CC）支架治疗216处病变，而182例患者（女性占34.6%；平均年龄66.3±9.9岁）的234处髂动脉病变使用252枚不锈钢（SS）支架治疗。两组间平均病变长度（30.2±12.8毫米对28.7±22.5毫米，p = 0.36）和平均钙化分级（2.0对1.9，p = 0.07）无显著差异。接受CC平台治疗的患者更常使用他汀类药物（p<0.001），而更多活跃吸烟者和卢瑟福分级较高的受试者接受了SS支架植入（p<0.001）。SS组的技术成功率显著更高（100%对97.3%；p = 0.01）。这是由于使用血管内材料通过Dynetic-35后出现纵向变形或支架移位。1年后，在CC和SS支架植入后，在与器械或手术相关的死亡（0.6%对1.1%，p = 0.99）、靶肢体截肢（1.9%对1.6%，p = 0.99）、原发性通畅率（91.3%对93.5%）和CD-TLR（6.5%对2.8%，p = 0.07）方面未发现差异。
在1年时间里，钴铬合金和不锈钢球囊扩张式支架治疗髂动脉闭塞性疾病安全有效。使用血管内器械通过钴铬合金支架时应格外注意，以避免手术并发症。
具有薄支柱结构的支架提高了柔韧性和输送性。更低的外形也增加了适用性，降低了血管入路并发症的风险。在本研究中，新一代钴铬合金球囊扩张式支架相较于不锈钢裸金属支架并无优势。相反，由于Dynetic-35出现纵向变形或移位，其技术成功率低于不锈钢支架。因此，使用导丝、导管或鞘通过钴铬合金支架时应格外注意，以避免支架变形。
