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

2021 ◽  
pp. 152660282110457
Author(s):  
Osamu Iida ◽  
Kazushi Urasawa ◽  
Yoshisato Shibata ◽  
Yoshito Yamamoto ◽  
Hiroshi Ando ◽  
...  
Keyword(s):  
Japanese Patients ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Lesion Length ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
Occlusive Lesion ◽  
Grade 3 ◽  
Peripheral Arterial

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.

Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results

2021 ◽  
pp. 152660282110570
Author(s):  
Jean-Baptiste Dexpert ◽  
Daniel Hayoz ◽  
Rolf P. Engelberger ◽  
Caroline Krieger ◽  
Marie-Antoinette Rey Meyer ◽  
...  
Keyword(s):  
De Novo ◽  
Arterial Disease ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Stent Restenosis ◽  
Stent Length ◽  
Peripheral Arterial ◽  
Vessel Preparation

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

Sex-related differences in Japanese patients with peripheral arterial disease

2011 ◽  
Vol 219 (2) ◽  
pp. 846-850 ◽  
Author(s):  
Hisao Kumakura ◽  
Hiroyoshi Kanai ◽  
Yoshihiro Araki ◽  
Shu Kasama ◽  
Hiroyuki Sumino ◽  
...  
Keyword(s):  
Peripheral Arterial Disease ◽  
Japanese Patients ◽  
Arterial Disease ◽  
Peripheral Arterial

scholarly journals Case Report: ENDOVASCULAR STENTING IN PERIPHERAL ARTERIAL DISEASE OF LOWER EXTREMITY

2017 ◽  
Vol 52 (2) ◽  
pp. 140
Author(s):  
Yudi Her Oktaviono
Keyword(s):  
Peripheral Arterial Disease ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Focal Lesions ◽  
First Choice ◽  
History Of ◽  
Arterial Insufficiency ◽  
Artery Disease ◽  
Peripheral Arterial

Peripheral arterial disease (PAD) is usually caused by multilevel atherosclerotic disease, typically in patients with a history of cigarette smoking, diabetes mellitus, or both. Intermittent claudication (IC), an early manifestation of PAD, commonly leads to reduced quality of life for patients who are limited in their ambulation. Percutaneous intervention for peripheral artery disease has evolved from balloon angioplasty for simple focal lesions to multimodality techniques that enable treatment of severe arterial insufficiency. Especially for high-grade stenoses or short arterial occlusions, percutaneous transluminal angioplasty (PTA) should be the method of first choice followed by the best surgical procedure later on. To achieve good long-term efficacy, a close follow-up including objective tests of both the arterial lesion and hemodynamic status, surveillance of secondary preventive measures and risk factor control is mandatory.

Comparison of Results in Endovascular Interventions for Infrainguinal Lesions: Claudication versus Critical Limb Ischemia

2005 ◽  
Vol 71 (6) ◽  
pp. 474-480 ◽  
Author(s):  
Susan M. Trocciola ◽  
Rabih Chaer ◽  
Rajeev Dayal ◽  
Stephanie C. Lin ◽  
Naveen Kumar ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Clinical Success ◽  
Ankle Brachial Index ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Transluminal Angioplasty ◽  
Primary Patency ◽  
Endovascular Interventions

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively ( P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12-month patency with limited morbidity.

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