收稿日期: 2023-06-25
网络出版日期: 2023-12-19
基金资助
河南省高等学校重点科研项目(21A320069);河南省医学科技攻关计划（联合共建）项目(LHGJ20190420)
Clinical efficacy of drugeluting stents for femoral popliteal arteriosclerosis obliterans
Received date: 2023-06-25
Online published: 2023-12-19
目的 比较药物洗脱支架（drug-eluting stents， DES）与金属裸支架（bare metal stent， BMS）治疗股腘动脉硬化闭塞症的临床疗效。 方法 回顾性分析郑州大学第五附属医院2020年10月至2021年6月收治的47例股腘动脉硬化闭塞症患者的临床资料，其中24例行药物洗脱支架治疗（DES组），23例行金属裸支架治疗（BMS组），术后对比两组的近中期临床疗效。 结果 47例患者均顺利完成手术，未发生与手术相关的不良事件。DES组与BMS组相比，术后7 d、3个月两组患者ABI比较差异均无统计学意义，术后6、12、24个月DES组患者ABI增长值均高于BMS组（P < 0.05）。术后6个月一期通畅率差异无统计学意义，术后12、24个月一期通畅率分别为（91.7% vs. 65.2%、83.3% vs. 56.5%，P < 0.05）。术后DES组靶病变血运重建率明显低于BMS组有明显的优势（4.0% vs. 26.1%，P < 0.05）。 结论 DES治疗股腘动脉硬化闭塞症具有较好的近中期疗效，其临床疗效优于BMS治疗。
郑浩哲 , 王兵 , 牛晓阳 , 崔文军 , 王岭 , 吕正佐 . 药物洗脱支架治疗股腘动脉硬化闭塞症的效果分析[J]. 实用医学杂志, 2023 , 39(21) : 2796 -2801 . DOI: 10.3969/j.issn.1006-5725.2023.21.017
Objective To investigate the clinical efficacy of drug eluting stents vs metal bare stents for femoral popliteal arteriosclerosis obliterans. Methods The clinical data of 47 patients with femoral popliteal arteriosclerosis obliterans receiving endovascular therapy from October 2020 to June 2021 were retrospectively analyzed. A total of 24 cases received drug-eluting stents （DES group） and 23 cases underwent metal bare stents （BMS group）. Results All patients successfully completed the operation without any adverse events. There was no statistical difference in ABI between the DES group and the BMS group at 7 days and 3 months after surgery， and ABI growth value of the DES group was higher than that of the BMS group at 6， 12 and 24 months after surgery （P < 0.05）. There was no significant difference in the primary patency rate at 6 months after surgery， However， the primary patency rate in DES group was higher than that in BMS group at 12 and 24 months after surgery （91.7% vs. 65.2%， 83.3% vs. 56.5%， P < 0.05）. For the target lesion revascularization rate of the two groups， DES group had a significant advantage over BMS group （4.0% vs. 26.1%， P < 0.05）. Conclusion DES had better clinical efficacy and advantage over bare metal stent for the treatment of femoral popliteal arteriosclerosis obliterans.
| 1 | PATEL M R， CONTE M S， CUTLIP D E， et al. Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease： Consensus Definitions From Peripheral Academic Research Consortium （PARC）［J］. J Am Coll Cardiol， 2015， 65（9）： 931-941. |
| 2 | SHANMUGASUNDARAM M， MURUGAPANDIAN S， TRUONG H T， et al. Drug-coated balloon in peripheral artery disease［J］. Cardiovasc Revasc Med， 2019， 20（4）： 338-343. |
| 3 | MüLLER-HüLSBECK S， KEIRSE K， ZELLER T， et al. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease［J］. J Endovasc Ther， 2016， 23（5）： 701-707. |
| 4 | 包俊敏， 刘冰， 沈晨阳， 等. 股腘动脉闭塞症的诊断和治疗中国专家共识［J］. 中国循环杂志， 2022， 37（7）： 669-676. |
| 5 | LAIRD J R. Limitations of Percutaneous Transluminal Angioplasty and Stenting for the Treatment of Disease of the Superficial Femoral and Popliteal Arteries［J］. J Endovasc Ther， 2006， 13（）： II-30. |
| 6 | 崔风强， 陈江浩， 王辉， 等. Acotec药物涂层球囊治疗下肢动脉硬化闭塞症的临床效果［J］. 实用医学杂志， 2021， 37（24）： 3184-3187. |
| 7 | KICHIKAWA K， ICHIHASHI S， YOKOI H， et al. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan： 2-Year Results［J］. Cardiovasc Intervent Radiol， 2019， 42（3）： 358-364. |
| 8 | ICHIHASHI S， SHIBATA T， FUJIMURA N， et al. Vessel Calcification as a Risk Factor for In-Stent Restenosis in Complex Femoropopliteal Lesions After Zilver PTX Paclitaxel-Coated Stent Placement［J］. J Endovasc Ther， 2019， 26（5）： 613-620. |
| 9 | PHILLIPS J A， FALLS A， KOLLURI R， et al. Full Drug-Eluting Stent Jacket： Two-Year Results of a Single-Center Experience With Zilver PTX Stenting for Long Lesions in the Femoropopliteal Arteries［J］. J Endovasc Ther， 2018， 25（3）： 295-301. |
| 10 | DAVAINE J M， QUERAT J， KALADJI A， et al. Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents： 12 month Results of the STELLA-PTX Registry［J］. Eur J Vasc Endovasc Surg， 2015， 50（5）： 631-637. |
| 11 | MüLLER-HüLSBECK S. EluviaTM peripheral stent system for the treatment of peripheral lesions above the knee［J］. Expert Opin Drug Deliv， 2016， 13（11）： 1639-1644. |
| 12 | MüLLER-HüLSBECK S， KEIRSE K， ZELLER T， et al. Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment： 3-Year Follow-up［J］. Cardiovasc Intervent Radiol， 2017， 40（12）： 1832-1838. |
| 13 | GRAY W A， KEIRSE K， SOGA Y， et al. A polymer-coated， paclitaxel-eluting stent （Eluvia） versus a polymer-free， paclitaxel-coated stent （Zilver PTX） for endovascular femoropopliteal intervention （IMPERIAL）： a randomised， non-inferiority trial［J］. Lancet， 2018， 392（10157）： 1541-1551. |
| 14 | MüLLER-HüLSBECK S， BENKO A， SOGA Y， et al. Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent［J］. Cardiovasc Intervent Radiol， 2021， 44（3）： 368-375. |
| 15 | YE W， B?HME T， FU W， et al. First peripheral drug-eluting stent clinical results from China： 1-year outcomes of the Zilver PTX China study［J］. Front Cardiovasc Med， 2022， 9： 877578. |
| 16 | GOU?FFIC Y， SAUGUET A， DESGRANGES P， et al. A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions： The BATTLE Trial［J］. JACC Cardiovasc Interv， 2020， 13（4）： 447-457. |
| 17 | GOU?FFIC Y， TORSELLO G， ZELLER T， et al. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease： Primary Results of the EMINENT Randomized Trial［J］. Circulation， 2022， 146（21）： 1564-1576. |
| 18 | 魏立春， 侯培勇， 谷涌泉. 股腘动脉钙化病变腔内治疗技术新进展［J］. 实用医学杂志， 2021， 37（1）： 115-120. |
| 19 | FOLEY T R， COTTER R P， KOKKINIDIS D G， et al. Mid-term outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of femoropopliteal disease［J］. Catheter Cardiovasc Interv， 2017， 89（6）： 1078-1085. |
| 20 | FANELLI F， CANNAVALE A， GAZZETTI M， et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease［J］. Cardiovasc Intervent Radiol， 2014， 37（4）： 898-907. |
| 21 | TEPE G， BESCHORNER U， RUETHER C， et al. Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease： Predictors of Outcome With a Special Emphasis on Calcium［J］. J Endovasc Ther， 2015， 22（5）： 727-733. |
| 22 | MICARI A， NERLA R， VADALà G， et al. 2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease： Evidence From the SFA-Long Study［J］. JACC Cardiovasc Interv， 2017， 10（7）： 728-734. |
| 23 | STAVROULAKIS K， TORSELLO G， BOSIERS M， et al. 2-Year Outcomes of the Eluvia Drug-Eluting Stent for the Treatment of Complex Femoropopliteal Lesions［J］. JACC Cardiovasc Interv， 2021， 14（6）： 692-701. |
| 24 | BAUSBACK Y， WITTIG T， SCHMIDT A， et al. Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients WithFemoropopliteal Arterial Disease［J］. J Am Coll Cardiol， 2019， 73（6）： 667-679. |
| 25 | IIDA O， TAKAHARA M， SOGA Y， et al. 1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice： Predictors of Restenosis and Aneurysmal Degeneration［J］. JACC Cardiovasc Interv， 2022， 15（6）： 630-638. |
/
| 〈 |
|
〉 |