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

Abstract

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.

Evidence-Experience Gap and Future Perspective on the Treatment of Peripheral Artery Disease

“…As for endovascular techniques in the treatment of reaction unit (PRU) values, a marker of the resistance on P2Y12 inhibition (antiplatelet effect), after the stent-grafting of patients with symptomatic PAD presenting femoropopliteal artery lesions. The study also found no relationship between PRU values and vessel patency 47) , suggesting that the effect of antiplatelet therapy would have a small, if any, influence on vessel patency. Clinical attention is shifting from the intensification of antiplatelet therapy to the introduction of DOACs.…”

Intravascular ultrasound-based decision tree model for the optimal endovascular treatment strategy selection of femoropopliteal artery disease—results from the ONION Study-

“…Iida et al reported that IVUS use in femoropopliteal stenting appears to be associated not only with the procedure's success but also with a higher primary patency rate 56 . Previous reports were based on the IVUS evaluation methodology, such as vessel size, lumen area, wire route, calcification, lesion morphology, and vessel dissection after balloon angioplasty (Iida et al 2021;Kozuki et al 2021;Kurata et al 2020;Miki et al 2020a;Miki et al 2020b). Some parameters that influenced patency outcomes were shown, including calcification, vessel dissection, and post stent area and position (Iida et al 2015;Mori et al 2017;Norgren et al 2007).…”

Individual patient data meta‐analysis of patients treated with a heparin‐bonded Viabahn in the femoropopliteal artery for chronic limb‐threatening ischemia

“…If the authors did not respond, after a second email, the study was excluded. Seven authors responded positively and agreed to join and signed clinical investigation and data transfer agreements 5,6,8,11–14 . Six authors did not respond to either the first or second email.…”