Individual Patient Data Meta-Analysis of GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface for Treatment of Femoro-Popliteal Arterial Disease (INSIGHT VSX)

Vollständiger Abstract

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Objective: This study aims to analyze available data on patients the latest-generation heparin-bonded Viabahn endoprosthesis in the femoropopliteal artery. Design: This study is an individual patient data (IPD) meta-analysis. Methods: This study incorporated all available cases from databases that reported outcomes of patients treated with the heparin-bonded Viabahn endoprosthesis in the femoropopliteal artery. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 IPD Guidelines were followed. All eligible centers were invited to contribute. Authors were asked to provide anonymized patient information: patient characteristics at baseline, lesion, procedural, and hospitalization details, and data of all follow-up visits. Results: A total of 977 patients were included (1023 treated limbs). One-year primary, primary-assisted, and secondary patency rates were 80.6%, 89.1%, and 95.7%, respectively, and 5-year rates were 54.8%, 68.9%, and 85.3%, respectively. Freedom from target lesion revascularization was 85.3%, 77.2%, and 63.0% at 1-, 2-, and 5-year follow-up, respectively. Major amputations were performed in 15/1023 limbs (1.5%); 12 presented with chronic limb-threatening ischemia at baseline. Freedom from major adverse limb events was 82.4%, 72.5%, and 56.6% through 1-, 2-, and 5-year follow-up, respectively. Sustained clinical benefit was observed by improved ankle-brachial index and Rutherford classification throughout follow-up. Younger age (hazard ratio [HR] 0.947, P < .001) and female sex (HR 1.752, P = .002) were predictors for loss of 1-year primary patency. Occlusive lesions failed more often in 1-year primary (HR 1.615, P = .017), primary-assisted (HR 2.141, P = .013), and secondary patency (HR 2.240, P = .028) compared with stenotic lesions. One-year primary patency was significantly lower in smaller (5-6 mm) compared with larger endoprosthesis (7-8 mm); 78.8% versus 90.0% ( P < .001), although not an independent predictor of failing patency (HR 1.921, P = .096). No differences were observed in loss of primary patency in subgroups based on Rutherford classification, the number of run-off vessels, lesion length, Trans-Atlantic Inter-Society Consensus II (TASC II) II classification, and degree of calcification. Conclusion: The heparin-bonded Viabahn endoprosthesis demonstrates a good safety profile and acceptable patency rates through 2 years. Longer follow-up data is needed to draw robust conclusions through 5 years. Independent predictors of patency loss include younger age, female sex, and occlusive lesions, highlighting the importance of tailoring follow-up strategies to individual patient and lesion characteristics. Clinical Impact What does this study/review add to the existing literature and how will it influence future clinical practice? This Individual-Patient-Data meta-analysis includes 977 patients with 1023 treated limbs, representing, to our knowledge, the largest cohort reported in the literature. It provides a comprehensive assessment of the performance of the latest generation Viabahn endoprosthesis in the treatment of complex femoropopliteal lesions. By identifying key predictors of patency and analyzing relevant subgroups, this study offers valuable insights into which patients benefit most from this treatment.