PEACE I All-Comers Registry: Patency Evaluation After Implantation of the 4-French Pulsar-18 Self-Expanding Nitinol Stent in Femoropopliteal Lesions. (June 2014)

• Record Type: Journal Article
• Authors: Lichtenberg, Michael; Kolks, Oliver; Hailer, Birgit; Stahlhoff, Wilhelm-Friedrich; Tiefenbacher, Christiane; Nolte-Ernsting, Claus; Arjumand, Jawed; Wittenberg, Guenther
• Is Part Of: Journal of endovascular therapy. Volume 21:Number 3(2014)
• Page Start: 373
• Page End: 380
• Publication Date: 2014-06
• Subjects: peripheral artery disease -- superficial femoral artery -- popliteal artery -- self-expanding stent -- 4-French device -- patency -- restenosis -- target lesion revascularization; Blood-vessels -- Endoscopic surgery -- Periodicals; Angioscopy -- Periodicals; Intravenous catheterization -- Periodicals; Peripheral vascular diseases -- Treatment -- Periodicals; Vascular Surgical Procedures -- Periodicals; Angioscopy -- Periodicals; Catheterization, Peripheral -- Periodicals; Peripheral Vascular Diseases -- therapy -- Periodicals; Angioscopie; Maladies vasculaires périphériques; 617.413
• DOI: 10.1583/13-4637R.1
• Languages: English
• ISSNs: 1526-6028

Abstract

Purpose: To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry. Methods: Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2–5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months. Results: The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions. Conclusions: In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.