|
|
比较紫杉醇药物球囊与金属裸支架治疗下肢动脉硬化闭塞症的对照临床研究
|
Abstract:
目的：观察药物涂层球囊(drug-coated balloon, DCB)与金属裸支架( bare metal stent, BMS)治疗下肢动脉硬化闭塞症(ASO)长段病变的疗效。方法：笔者通过选取2016年12月至2019年12月青岛大学附属医院血管外科接受介入治疗的老年下肢ASO患者，共73条患肢(病变长度 ≥ 20 cm)。每条患肢在选择合适的手术入路后使用普通球囊预扩张，然后选取符合靶病变的药物涂层球囊(DCB)或金属裸支架(BMS)植入，其中接受DCB治疗(包括单纯DCB和DCB + 短支架植入)的有36条患肢(DCB组)，接受BMS治疗的有37条患肢(BMS组)。观察术后1个月、3个月、6个月、9个月、12个月血管通畅率及靶病变血管再重建率，期间无患者死亡、截肢。采用SPSS 22.0软件进行统计分析。根据数据类型，组间比较采用t检验或χ2检验。结果：73条患肢均获得技术成功，且随访率为100%。观察2组患肢术后12个月血管通畅率及靶病变重建率。结果：DCB组的术后12月靶病变通畅率为86.1%，BMS组的通畅率86.4%，差异无统计学意义(P > 0.05)，但是DCB组术后12月的临床驱动的靶病变重建率更低(DCB: 11.1% VS BMS: 48.6%)，差异有统计学意义(P < 0.05)。结论：药物涂层球囊在治疗下肢动脉硬化闭塞症(病变长度 ≥ 20 cm)与金属裸支架在近期疗效上无显著差异，但相较于金属裸支架植入，药物涂层球囊有更少的术后管腔丢失，更低的血管再重建率。
Objective: To observe the efficacy of drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of long-segment lesions of lower extremity arteriosclerosis obliterans (ASO). Methods: The author selected 73 elderly patients with lower extremity ASO (lesion length ≥ 20 cm) who underwent interventional treatment in the Department of Vascular Surgery, Qingdao University Affiliated Hospital from December 2016 to December 2019. After selecting the appropriate surgical approach, each affected limb is predilated with a common balloon, and then a drug-coated balloon (DCB) or bare metal stent (BMS) that meets the target lesion is selected for implantation, and DCB treatment (including simple DCB and DCB + short stent implantation) had 36 affected limbs (DCB group), and 37 affected limbs (BMS group) received BMS treatment. The primary vascular patency rate and target lesion vascular remodeling rate were observed at 1 month, 3 months, 6 months, 9 months, and 12 months postoperatively. During this period, no patients died or had amputations. We use SPSS 22.0 software for statistical analysis. According to the data type, the t test or the χ2 test is used for comparison between groups. Results: All 73 affected limbs were technically successful, and the follow-up rate was 100%. The primary vascular patency rate and target lesion reconstruction rate were observed in the two groups at 12 months postoperatively. Results: In DCB group, the patency rate of target lesion was 86.1% 12 months after operation, and the patency rate of target lesion in the BMS group was 86.4%. The difference was not statistically significant (P > 0.05). However, the clinical driven target lesion reconstruction rate was lower in DCB group 12 months after surgery (DCB: 11.1% VS BMS: 48.6%), and the difference was statistically significant (P < 0.05). Conclusion: There is no significant difference
| [1] | Sethi, S.S. and Lee, M.S. (2016) Drug-Coated Balloons for Infrainguinal Peripheral Artery Disease. Journal of Invasive Cardiology, 28, 281-286. |
| [2] | Liu, J., et al. (2020) Drug-Coated Balloons Used in Peripheral Artery Disease: Experience from a Single Center. Journal of International Medical Research, 48. https://doi.org/10.1177/0300060520940157 |
| [3] | Sigala, F., et al. (2018) Prognostic Factors in Patients Treated with Drug-Coated Balloon Angioplasty for Symptomatic Peripheral Artery Disease. Vascular Specialist International, 34, 94-102. https://doi.org/10.5758/vsi.2018.34.4.94 |
| [4] | Ouriel, K., et al. (2019) Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC: Cardiovascular Interventions, 12, 2515-2524. https://doi.org/10.1016/j.jcin.2019.08.025 |
| [5] | Al-Bawardy, R.F., Waldo, S.W. and Rosenfield, K. (2017) Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons. Current Cardiology Reports, 19, 99. https://doi.org/10.1007/s11886-017-0913-3 |
| [6] | Peterson, S., et al. (2017) IN.PACT Admiral Drug-Coated Balloon: Durable, Consistent and Safe Treatment for Femoropopliteal Peripheral Artery Disease. Advanced Drug Delivery Reviews, 112, 69-77.
https://doi.org/10.1016/j.addr.2016.10.003 |
| [7] | Torii, S., et al. (2019) IN.PACT Admiral Drug-Coated Balloons in Peripheral Artery Disease: Current Perspectives. Medical Devices (Auckland, N.Z.), 12, 53-64. https://doi.org/10.2147/MDER.S165620 |
| [8] | Mohapatra, A., et al. (2020) Nationwide Trends in Drug-Coated Balloon and Drug-Eluting Stent Utilization in the Femoropopliteal Arteries. Journal of Vascular Surgery, 71, 560-566. https://doi.org/10.1016/j.jvs.2019.05.034 |
| [9] | Yerasi, C., et al. (2020) Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. Journal of the American College of Cardiology, 75, 1061-1073. https://doi.org/10.1016/j.jacc.2019.12.046 |
| [10] | 刘俊超, 王兵. 药物涂层球囊治疗股腘动脉支架内再狭窄的研究进展[J]. 中国普通外科杂志, 2016, 25(12): 1796-1800. |
| [11] | Kokkinidis, D.G. and Armstrong, E.J. (2020) Current Developments in Endovascular Therapy of Peripheral Vascular Disease. Journal of Thoracic Disease, 12, 1681-1694. https://doi.org/10.21037/jtd.2019.12.130 |
| [12] | Banerjee, S., et al. (2015) Drug-Coated Balloon and Stent Therapies for Endovascular Treatment of Atherosclerotic Superficial Femoral Artery Disease. Current Cardiology Reports, 17, 36. https://doi.org/10.1007/s11886-015-0586-8 |
| [13] | Imran, H.M., Hyder, O.N. and Soukas, P.A. (2019) Efficacy and Safety of Adjunctive Drug-Coated Balloon Therapy in Endovascular Treatment of Common Femoral Artery Disease. Cardiovascular Revascularization Medicine, 20, 210-214.
https://doi.org/10.1016/j.carrev.2018.06.018 |
| [14] | Bausback, Y., et al. (2019) Drug-Eluting Stent versus Drug-Coated Balloon Revascularization in Patients with Femoropopliteal Arterial Disease. Journal of the American College of Cardiology, 73, 667-679.
https://doi.org/10.1016/j.jacc.2018.11.039 |
| [15] | Mohiaddin, H., et al. (2018) Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review. Cardiology and Therapy, 7, 127-149.
https://doi.org/10.1007/s40119-018-0121-2 |
| [16] | Betala, J.V., Langan, I.E. and LaBerge, M. (2014) Drug-Coated Percutaneous Balloon Catheters. Critical Reviews in Biomedical Engineering, 42, 193-212. https://doi.org/10.1615/CritRevBiomedEng.2014011578 |
| [17] | Caradu, C., et al. (2019) Systematic Review and Up-dated Meta-Analysis of the Use of Drug-Coated Balloon Angioplasty versus Plain Old Balloon Angioplasty for Femoropopliteal Arterial Disease. Journal of Vascular Surgery, 70, 981-995.e10. https://doi.org/10.1016/j.jvs.2019.01.080 |
| [18] | de Boer, S.W., et al. (2017) Short-Term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon with Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial Femoral Artery Lesions. Journal of Endovascular Therapy, 24, 783-792. https://doi.org/10.1177/1526602817725062 |
| [19] | Liistro, F., et al. (2013) Drug-Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery: The DEBATE-SFA Randomized Trial (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery). JACC: Cardiovascular Interventions, 6, 1295-1302. https://doi.org/10.1016/j.jcin.2013.07.010 |
| [20] | Anantha-Narayanan, M., et al. (2020) Safety and Efficacy of Paclitaxel Drug-Coated Balloon in Femoropopliteal In-Stent Restenosis. Expert Review of Medical Devices, 17, 533-539. https://doi.org/10.1080/17434440.2020.1770593 |
| [21] | Herten, M., et al. (2016) Drug-Coated Balloons in the Treatment of Peripheral Artery Disease (PAD). History and Current Level of Evidence. Radiologe, 56, 240-253. https://doi.org/10.1007/s00117-015-0073-7 |
| [22] | Colleran, R., et al. (2016) Drug Coated Balloon Angioplasty in the Treatment of Peripheral Artery Disease. Expert Review of Medical Devices, 13, 569-582. https://doi.org/10.1080/17434440.2016.1184969 |
| [23] | Pleva, L., et al. (2017) Efficacy of a Seal-Wing Paclitaxel-Eluting Balloon Catheters in the Treatment of Bare Metal Stent Restenosis. BMC Cardiovascular Disorders, 17, Article Number: 168.
https://doi.org/10.1186/s12872-017-0602-6 |
