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).

Highlights

  • The objective of this review is to assess the frequency of primary obstruction events (PrO) during one-year followup after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (Group S/ TH) or remote superficial femoral artery endarterectomy (Group RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD)

  • Data of SilverHawk/TurboHawk atherectomy device (S/TH)’ impact on PrO, and other adverse effects were limited to single-arm studies, it is necessary to compare S/TH and RSFAE for preventing PrO in patients with СSFAOD

  • As a result of meta-analysis, we gained new knowledge: the cumulative evidence is conclusive that (1) the addition of excisional atherectomy with the SilverHawk/ TurboHawkTM atherectomy device instead of RSFAE significantly reduces the PrO during a one-year follow-up among patients with СSFAOD. (2) It is necessary to conduct well-planned randomized studies with sufficient statistical power to determine the usefulness of the compared methods for improving PrO during a oneyear follow-up in patients with СSFAOD

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Summary

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). When the TurboHawk catheter is used in the case of hard, complex calcified lesions, it should be accompanied by the SpiderFXTM Embolic Protection Device to eliminate the distal embolization risk.[2] The objective of this review is to assess the frequency of primary obstruction events (PrO) during one-year followup after performing excisional atherectomy with the SilverHawk/TurboHawk atherectomy device (Group S/ TH) or remote superficial femoral artery endarterectomy (Group RSFAE) in patients with the chronic superficial femoral artery occlusive disease (СSFAOD). Hypothesis: S/TH is an effective method of treatment of patients with СSFAOD (compare with RSFAE)

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