Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials

Abstract

Purpose:

The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries.

Materials and Methods:

The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified.

Results:

A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category.

Conclusion:

J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

Keywords

drug-eluting balloon drug-coated balloon Jetstream vascular patency vessel preparation plaque modification peripheral artery disease superficial femoral artery

Get full access to this article

View all access options for this article.

References

Fowkes

Rudan

, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329–1340. doi:10.1016/S0140-6736(13)61249-0

Roberts

Niazi

Miller

, et al. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca⁺⁺ trial. Catheter Cardiovasc Interv. 2014;84:236–244. doi:10.1002/ccd.25384

Tepe

Laird

Schneider

, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131:495–502. doi:10.1161/CIRCULATIONAHA.114.011004

Iida

Soga

Urasawa

, et al. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan randomized trial. J Endovasc Ther. 2018;25:109–117. doi:10.1177/1526602817745565

Fanelli

Cannavale

Gazzetti

, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898–907. doi:10.1007/s00270-014-0904-3

Zeller

Langhoff

Rocha-Singh

, et al. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelve-month results of the DEFINITIVE AR study. Circ Cardiovasc Interv. 2017;10:e004848. doi:10.1161/CIRCINTERVENTIONS.116.004848. 9.

Maehara

Mintz

Shimshak

, et al. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention. 2015;11:96–103. doi:10.4244/EIJV11I1A17

Zeller

Krankenberg

Steinkamp

, et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009;16:653–662. doi:10.1583/09-2826.1

Gray

Garcia

Amin

, et al. Jetstream atherectomy system treatment of femoropopliteal arteries: results of the post-market JET registry. Cardiovasc Revasc Med. 2018;19:506–511. doi:10.1016/j.carrev.2017.12.015

10.

Moses

Carlier

Moussa

Lesion preparation prior to stenting. Rev Cardiovasc Med. 2004;5 Suppl 2:S16–S21.

11.

Shammas

NW.

An overview of optimal endovascular strategy in treating the femoropopliteal artery: mechanical, biological, and procedural factors. Int J Angiol. 2013;22:1–8. doi:10.1055/s-0032-1331840

12.

Tellez

Dattilo

Mustapha

, et al. Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention: early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis. EuroIntervention. 2014;10:1002–1008. doi:10.4244/EIJY14M10_03

13.

Caradu

Lakhlifi

Colacchio

, et al. Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. J Vasc Surg. 2019;70:981–995.e10. doi:10.1016/j.jvs.2019.01.080

14.

Cioppa

Stabile

Popusoi

, et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med. 2012;13:219–223. doi:10.1016/j.carrev.2012.04.007

15.

Shammas

Jones-Miller

, et al. Long-term outcomes with jetstream atherectomy with or without drug coated balloons in treating femoropopliteal arteries: a single center experience (JET-SCE). Cardiovasc Revasc Med. 2018;19:771–777. doi:10.1016/j.carrev.2018.02.003

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.02 MB