JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study

J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.

Abstract

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment.

Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). 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 target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory.

Results: Treated length was 19.5 ± 12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months.

Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.

Keywords: embolization; femoropopliteal segment; in-stent restenosis; popliteal artery; protection filter; rotational atherectomy; stent; superficial femoral artery; target lesion revascularization.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atherectomy / adverse effects
  • Atherectomy / methods*
  • Constriction, Pathologic
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Feasibility Studies
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Recurrence
  • Stents*
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • United States
  • Vascular Patency

Associated data

  • ClinicalTrials.gov/NCT01722877