1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass

Reijnen, Michel M.P.J.; Walraven, Laurens A. van; Fritschy, Wilbert M.; Lensvelt, Mare M.A.; Zeebregts, Clark J.; Lemson, M.S.; Wikkeling, O.R.; Smeets, Luuk; Holewijn, Suzanne

doi:10.1016/j.jcin.2017.09.013

Cited by 56 publications

(44 citation statements)

References 16 publications

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“…1,2 The trials have shown the superiority of a covered stent over a bare nitinol stent, with a patency rate for the covered stent that is comparable to that of surgical bypass. 2,3 These findings have substantially influenced the latest clinical guidelines, which now conditionally recommend the use of an endovascular-first approach for complex FP lesions. 4 However, it remains unclear whether the high performance shown in these clinical trials would be true for a real-world population.…”

Section: Introductionmentioning

confidence: 99%

One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

et al. 2020

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Purpose: To evaluate the real-world primary patency of heparin-bonded stent-graft therapy for femoropopliteal (FP) occlusive disease and identify any clinical factors, including the prothrombotic state, associated with the loss of patency. Materials and Methods: This multicenter study prospectively enrolled 424 limbs of 371 patients (mean age 75±8 years; 247 men) scheduled for Viabahn stent-graft placement in the FP segment. A full-coverage strategy using only a Viabahn stent-graft was preferred, but “spot stenting” with the Viabahn was also allowed. The prothrombotic state was assessed by measuring platelet reactivity. Vascular morphology was evaluated using intravascular ultrasound (IVUS). Primary patency was estimated using the Kaplan-Meier method in the subgroup of patients having full lesion stent-graft coverage (n=343 limbs, 81.1%). The secondary outcomes were major amputation, surgical reconstruction, target lesion revascularization (TLR), and thrombotic occlusion. Regression analyses were used to explore associations of baseline and clinical variables with loss of patency; the results are given as the odds ratio (OR) and 95% confidence interval (CI). Results: The 1-year primary patency estimate was 80.3% (95% CI 75.5% to 85.1%) in the full-coverage group. There were 7 surgical reconstructions, 46 TLRs, 21 acute thrombotic occlusions, and 1 major amputation during the 1-year follow-up in the full-coverage group. Only angiography- and IVUS-determined vessel diameters were significantly associated with loss of patency, with crude ORs of 0.64 (95% CI 0.45 to 0.89, p=0.009) and 0.67 (95% CI 0.51 to 0.90, p=0.009), respectively, per 1-mm increase, whereas other variables, including the prothrombotic state (p=0.74), were not. Multivariable analysis demonstrated that only IVUS-determined vessel diameter was independently associated with loss of patency (adjusted OR per 1-mm increase 0.72, 95% CI 0.52 to 1.00, p=0.049). Conclusion: FP stent-graft placement achieved acceptable patency at 1 year in a real-world setting. A smaller vessel size was significantly associated with loss of patency, whereas the prothrombotic state was not.

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Section: Introductionmentioning

confidence: 99%

One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study

et al. 2020

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“…The results of our study are consistent with the results of other foreign literature. [9][10][11][12][13][14][15] And no patient has serious complications such as myocardial infarction, heart failure, renal failure and so on, and the clinical effect is obvious. Although the recent effect of the interventional treatment of PAD is good, there are still many difficulties, and the effect is still to be further studied.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Stent Implantation Combined with Balloon Dilatation in the Treatment of Severe Peripheral Arterial Occlusive Disease of Lower Extremity in Macao—A Single Center Experience

Man¹,

Zhu²,

Pan³

et al. 2018

MCMR

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Objective: To investigate the feasibility and clinical efficacy of stent implantation and balloon angioplasty in the treatment of severe lower extremity arterial ischemia. Methods: Twentytwo patients with severe lower extremity ischemia were enrolled from January 2016 to December 2016. According to the scope of the patient's lesions, we choose the appropriate length of the balloon, according to different degrees of balloon dilation lesion stenosis or occlusion of the adjacent multiple short part of the lesion, as far as possible the formation of long balloon. Metallic stents were implanted in the dilated vessels to prevent restenosis. The incidence of postoperative complications, the rate of technical success and the clinical efficacy were observed, and the primary patency rate was evaluated through follow-up. Results: The total of 22 patients had 42 vessels with varying degrees of stenosis and occlusion, with an operative success rate of 100%. The primary patency rate was 90.9% and 81.8% at 6 and 12 months respectively. The ankle brachial index was significantly higher than that before the operation, and the Rutherford classification of most patients was significantly improved after the operation (P<0.05). No serious complications or death cases were found in this study. The average postoperative hospital stay was 4.3 days. Conclusion: For the severe ischemic disease of the lower extremities, interventional therapy is more effective than surgical treatment, with fewer complications and faster recovery. Stent implantation combined with balloon therapy does not affect the postoperative blood supply of the affected limb. The initial technical and clinical success rate is very high. It is a safe and effective method for the treatment of severe arterial ischemia disease of the lower extremities.

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“…At end of 1 year, the patency rates of primary, primary‐assisted and secondary patency of endoluminal and surgical groups were similar: 64.8% versus 63.6%, 78.1% versus 79.8%, and 85.9% versus 83.3% respectively. Also, no difference was noted in need for reintervention and time to failure between two groups …”

Section: Interventional Trials In Lower Extremity Padmentioning

confidence: 95%

“…Also, no difference was noted in need for reintervention and time to failure between two groups. 1 Perhaps even more bold, was the TECCO trial which was a randomized trial comparing surgery to stent-based intervention for the treatment of de novo lesions in the common femoral artery. There was an early reduction in perioperative morbidity and length of hospital stay in the percutaneous group as well as a significant reduction in mortality.…”

mentioning

confidence: 99%