Comparison of Carbon-impregnated and Standard ePTFE Prostheses in Extra-anatomical Anterior Tibial Artery Bypass: A Prospective Randomized Multicenter Study

Flow diagram of the study acc. to CONSORT statement: randomization and analysis groups (C, carbon PTFE; St, standard PTFE; ITT, intention-to-treat; PP, per protocol; AT, as-treated; m, month; LTFU, lost-to-follow-up/did not reach defined study endpoints).

Pre-operative angiographic run-off status of the anterior tibial artery and plantar arch in the carbon and standard PTFE group (n=265; ITT-analysis; Arcus, plantar arch; patent, patent-no relevant stenosis; stenosed, patent-but relevant stenosed; occluded, distal occlusion; values below 2% not numbered; Fisher's exact test p>0.05 for all groups and subgroups).

Life table curves for primary patency rate acc. to Rutherford et al.⁴⁴, carbon- vs. standard-PTFE vascular grafts; ITT analysis (log-rank test χ²=1.65, 1 d.f.; p=0.20); standard-error<5% at all times; table indicates number of patients (n) at risk at begin of each intervall.

Life table curves for secondary patency rate acc. to Rutherford et al.⁴⁴, carbon- vs. standard-PTFE vascular grafts; ITT analysis (log-rank test χ²=2.46, 1 d.f.; p=0.12); standard-error<5% at all times; table indicates number of patients (n) at risk at begin of each interval.

Life table curves for limb salvage rate acc. to Rutherford et al.⁴⁴, carbon- vs. standard-PTFE vascular grafts; ITT analysis (log-rank test χ²=1.96, 1 d.f.; p=0.16); standard-error<5.3% at all times; table indicates number of patients (n) at risk at begin of each interval.