Vladimir Starodubtsev
1* , Andrey Karpenko
1, Evgeniy Lenko
1, Pavel Ignatenko
11 Siberian Federal Biomedical Research Center, Ministry for Public Health Care of Russian Federation, Novosibirsk, Russian Federation
Abstract
Introduction: The objective is to evaluate the frequency of primary obstruction events (PrO) during one-year follow-up after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (S/TH) or remote superficial femoral artery endarterectomy (RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD).
Methods: We included all randomized clinical trials (RCTs) and not-RCTs concerning the treatment of patients with СSFAOD after S/TH and RSFAE without duration.
Results: Twenty-nine items (1990-2017) were discovered; 27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis. The results of 2762 patients’ treatment were summed up in our analysis (1422 patients S/TH; 1340 patients RSFAE). All included reports were at low risk of bias. According to the criterion “frequency of PrO” during one-year follow-up, the pooled Hazard Ratios indicate significant favours of S/TH if compared it with RSFAE (HR= 0.66 (0.57 to 0.76, P < 0.00001), I2 = 9%).
Conclusion: Our study showed that S/TH with the SpiderFX device (distal embolic protection) are safe and effective treatment option for short lesion (<15 cm) in patients with СSFAOD. The usage of S/TH methods significantly reduced number of PrO if compared it with RSFAE. In long-segment lesion (>15 cm) in patients with СSFAOD, RSFAE may be considered better than an endovascular procedure. But still it is necessary to conduct well-planned randomized studies to determine effectiveness and safety of the compared methods (S/TH and RSFAE) in patients with long-segment lesion (>15 cm).