Background: We present the results of a patient-level meta-analysis of the two currently completed and core-lab adjudicated prospective trials of Jetstream atherectomy system (Boston Scientific) in femoropopliteal in-stent restenosis (FP-ISR) and compare the findings to a published, prespecified 6-month performance goal of target-lesion revascularization (TLR) with angioplasty alone.
Methods: The JETSTREAM-ISR (n = 29 patients; n = 32 lesions) was a two-center feasibility study that evaluated Jetstream atherectomy in FP-ISR. The JET-ISR (n = 60 patients; n = 60 lesions) was a 10-center investigational device exemption study that evaluated the same. Both trials were investigator-initiated, prospective, single-arm designs, with core lab assessments of stent-device interaction and with nearly identical inclusion/exclusion criteria and data definitions. The primary endpoint was TLR, which was analyzed using proportional and Kaplan-Meier analyses.
Results: A total of 92 lesions were treated in 89 patients. Kaplan-Meier freedom from TLR at 6 months was 78.5% (95% confidence interval, 69.9-87.1). Proportional TLR was 21.2% (18/85 limbs). The performance goal of TLR (bailout stent included as TLR) was set at 37.9% at 6 months with balloon angioplasty alone. TLR rate derived from the meta-analysis was significantly lower than the TLR rate set for the historic control accounting for the 95% confidence interval lower bound (P<.01). There was no device-stent interaction and no amputation. Distal embolization occurred in 11/92 (12.0%) (filters used in 76.1% of all cases) and bailout stenting was performed in 8.7%.
Conclusion: In this meta-analysis, Jetstream atherectomy in treating FP-ISR had a high freedom from TLR despite no adjunctive drug-coated balloon use. Randomized trials are needed to confirm these findings.
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