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      Clinical observation of Furongtongmai capsule on the lower extremity Atherosclerotic Occlusive Disease after Intervention Operation

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          Abstract

          Objective: To investigate the effect of Furongtongmai capsule on the in-stent restenosis (ISR) of superficial femoral artery after interventional operation in lower extremity Arteriosclerosis Occlusion (ASO). Methods: A total of 110 inpatients with ASO who performed Superficial femoral artery stent implantation were randomly divided into observation group and control group, with 55 cases in each group．Both groups received Aspirin 100 mg/d and Clopidogrel 75 mg/d. The observation group was given Furongtongmai capsule on the basis of routine treatment. After continuous treatment for 6 months, the clinical efficacy, Ankle Brachial Index (ABI), high-sensitivity C-reactive protein (Hs-CPR) and ISR were compared between the two groups. Results: At 6 months after operation, the plasma levels of Hs-CRP in the two groups were significantly lower than those in the control group ( P < 0.05). The ABI of treatment group was significantly higher than the control group ( P < 0.05). There was a statistically significant difference in ISR incidence between the treatment group and the control group 6 months after surgery (9.09% vs 27.78%, P < 0.05). Conclusion: Furongtongmai Capsule can inhibit Hs-CRP in patients with ASO after femoral artery intervention, improve the ankle brachial index and reduce the incidence of ISR.

          Highlights

          The restenosis rate in patients with lower extremity Arteriosclerosis Obliterans was higher after the bare stent implantation, and the effect of double resistance was not good. In this paper, the effect of Furongtongmai capsule on restenosis after stent implantation was observed by clinical trial. Furongtong mai capsule can reduce the restenosis rate in patients after operation by multiple targets, such as reducing the vascular inflammation, raising ABI and increasing the blood flow of the lower limbs. it is on the threshold of the application of Chinese medicine for Arteriosclerosis Obliterans of lower extremities.

          Most cited references13

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          Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.

          Matthew Laird, Kunjan Dave, Alexandra Lansky … (2010)
          Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.
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            Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results.

            L Machan, Michael D. Dake, Lisa J White … (2011)
            Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457). Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.
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              Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.

              D Ansel, Michael R Jaff, H Bob Smouse … (2013)
              A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement. Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established. In the RCT, patients were randomly assigned to primary DES implantation (n = 236) or PTA (n = 238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n = 61) or BMS (n = 59) placement. The single-arm study enrolled 787 patients with DES treatment. Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 26.5%, p < 0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT. Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Yao Wei
                Journal
                Journal ID (nlm-ta): TMR MOD Herb Med
                Title: TMR Modern Herbal Medicine
                Publisher: TMR Modern Herbal Medicine Editorial Board (Cockle Bay Rd, Auckland, New Zealand )
                ISSN (Electronic): 2537-9798
                Publication date Collection: 25 October 2018
                Publication date (Electronic): 25 October 2018
                Volume: 1
                Issue: 4
                Pages: 203-208
                Affiliations
                [1-2537-9798-1-4-203] 1 Cangzhou Hospital of Integrated TCM-WM Hebei, Cangzhou, Hebei, China.
                Author notes
                *Correspondence to: Wei Yao, Cangzhou Hospital of Integrated TCM-WM Hebei, Cangzhou, Hebei, China. E-mail: 13613271693@ 123456163.com .
                Article
                Publisher ID: 2537-9798-1-4-203
                DOI: 10.12032/TMRmhm2017A27
                SO-VID: 442c409c-0e53-4ddb-88ea-96ba776cbd34
                License:

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

                History
                Date accepted : 23 April 2018
                Funding
                This work was partly supported by Hebei administration of traditional Chinese medicine (2014123)
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Medicine,Pharmacology & Pharmaceutical medicine,Health & Social care,Complementary & Alternative medicine
                Keywords: Furongtongmai capsule,Lower extremity atherosclerotic occlusive disease,intervention operation,restenosis rate,Hs-CRP
                Data availability:
                ScienceOpen disciplines: Medicine, Pharmacology & Pharmaceutical medicine, Health & Social care, Complementary & Alternative medicine
                Keywords: Furongtongmai capsule, Lower extremity atherosclerotic occlusive disease, intervention operation, restenosis rate, Hs-CRP

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