Feasibility Study Supports Boston Scientific's JetStream XC to Treat In-Stent Restenosis

May 3, 2016—Results from the JETSTREAM-ISR feasibility study were published by Nicolas W. Shammas, MD, et al, in the Journal of Endovascular Therapy (JEVT; 2016;23:339–346). The study evaluated outcomes and stent–device interaction with the JetStream XC (Boston Scientific Corporation), a rotational cutter with aspiration capacity, in treating in-stent restenosis (ISR) of the femoropopliteal segment. 

The investigators concluded that atherectomy with the JetStream XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no stent–device interaction, and low target lesion revascularization (TLR) rates.

As summarized in JEVT, the study evaluated the JetStream XC atherectomy device in a prospective cohort of 29 patients (mean age, 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs. Lesion length was 17.4 ± 13.1 cm. The primary effectiveness outcome was acute success (≤ 30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven TLR at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory.

The investigators reported that treated length was 19.5 ± 12.9 cm, and acute success was obtained in 91% (29/32) of limbs. Acute device success (< 50% residual narrowing after atherectomy alone) was 76% (22/29) of limbs. Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 50% (16/32) of limbs.

Macrodebris was observed in 12% (2/16) of filters. Distal embolization requiring treatment occurred in 9.4% (3/32; two with no filter) of limbs. Other nonprocedure-related adverse events were one death (nonvascular) and one case of major bleeding. There were no new stent fractures or deformities (n = 24) after atherectomy. 

At 6- and 12-month follow-up on 27 patients (29 limbs), TLR rates were 14% (4/29) and 41% (12/29), respectively. Patency (duplex-derived peak systolic velocity ratio < 2.4) was 72% at 6 months. A multicenter trial is needed to confirm these results, advised the investigators in JEVT.