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

Lichtenberg, Michael; Kolks, Oliver; Hailer, Birgit; Stahlhoff, Wilhelm-Friedrich; Tiefenbacher, Christiane; Nolte-Ernsting, C.; Arjumand, Jawed; Wittenberg, G.

doi:10.1583/13-4637r.1

Cited by 17 publications

(13 citation statements)

References 20 publications

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“…Two large prospective multicenter trials (4-EVER and PEACE I) have been carried out to examine the safety and efficacy of implantation of 4F stents in patients with symptomatic femoropopliteal occlusive disease. 1,2 The access related complication rates were 3.3% in the 4-EVER trial and 2.0% in the current study, and all of the complications could be managed by non-surgical treatments. 1 These rates are lower than most of the published rates on 6F devices.…”

Section: Discussionmentioning

confidence: 51%

“…10,11 The 12 month patency and revascularization rates of these two studies are similar to the rates of the PEACE I trial. 2,10,11 More importantly, these results are not worse than the reported 12 month outcomes of the 6F stents. 12e18 Neointimal hyperplasia is the major cause of ISR.…”

Section: Discussionmentioning

confidence: 84%

“…1,2 Moreover, the treated lesions were longer in the PEACE I trial (111.5 AE 71.4 mm) than they were in the 4-EVER trial (71.0 AE 45.9 mm) and the current study (80.9 AE 64.1 mm). 1,2 Two other smaller 4F studies should be mentioned; in one of them only patients with TASC-D lesions were enrolled, while only those having long segment femoropopliteal stenosis (!120 mm) were enrolled in the other. 10,11 The 12 month patency and revascularization rates of these two studies are similar to the rates of the PEACE I trial.…”

Section: Discussionmentioning

confidence: 99%

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Safety, Clinical Outcome, and Fracture Rate of Femoropopliteal Stenting Using a 4F Compatible Delivery System

Sarkadi

Bérczi

Kollár

et al. 2015

European Journal of Vascular and Endovascular Surgery

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Section: Discussionmentioning

confidence: 51%

Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 99%

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Safety, Clinical Outcome, and Fracture Rate of Femoropopliteal Stenting Using a 4F Compatible Delivery System

Sarkadi

Bérczi

Kollár

et al. 2015

European Journal of Vascular and Endovascular Surgery

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“…The use of the Pulsar-18 self-expanding (SE) nitinol stent for endovascular intervention of femoropopliteal disease was investigated in the PEACE I all-comers registry. 14 Patients with a mean lesion length of 111.5 mm showed promising primary patency and freedom from target lesion revascularization (fTLR) rates after 6 and 12 months. These very positive data of this all-comers registry led us to perform a prospective all-comers registry to analyze the patency rate and fTLR rate of this nitinol stent in patients with long SFA lesions.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions

Lichtenberg

Hailer

Kaeunicke

et al. 2014

Clin Med Insights Cardiol

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PURPOSETo evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months.METHODSThis registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months’ follow-up. No drug-eluting devices were allowed in this registry.RESULTSAverage lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly (P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes (P = 0.18) and renal insufficiency (P = 0.3) was not significantly lower as compared to the overall primary patency.CONCLUSIONSIn this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

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“…Acute patency is being achieved with balloons, stents and atherectomy, but how these devices impact long-term results needs to be identified. Finally, the efficacy of drug-eluting balloons added to the use of these devices needs further study (15)(16)(17)(18).…”

mentioning

confidence: 99%

Focal Stenting Versus “Metal Jacket” for Long Subintimal Recanalization of the Femoropopliteal Artery

Niazi

2015

JACC: Cardiovascular Interventions

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L ong chronic total occlusions are a formidable challenge for endovascular recanalization. Patients with critical limb ischemia are at a greater risk of developing advanced disease along with chronic total occlusions requiring revascularization to avoid amputation (1). Over the years, different endovascular techniques have been used to cross long chronic total occlusions. Subintimal recanalization was serendipitously discovered and first reported by Bolia et al. (2) in 1989, when the atherosclerotic plaque, occluding the lumen, was crossed by circumventing the plaque via the subintimal space using a wire and catheter. This technique is also known as percutaneous intentional extraluminal recanalization (PIER) (3). Histological analysis of vessels that had undergone subintimal recanalization demonstrated that the dissection plane was between the internal elastic lamina and the occlusive plaque (4). The space is dilated with a balloon that communicates with the true lumen distal to the occlusion, thereby establishing flow. Despite establishing flow and high limb salvage rates, the nemesis has been the high rate of restenosis with subintimal recanalization. Primary patencies ranging from 45% to 70% at 1 year, with further decrements over time (5,6). The availability of nitinol stents, in conjunction with this new channel technique created by subintimal recanalization, has improved long-term patency. The excitement of the first-generation nitinol stents quickly waned when data showed poor longterm patency, especially when multiple stents were used to treat long lesions or when stent fractures happened (7). Second-generation stents became available in longer lengths to reduce the use of multiple stents. Stent design has evolved to reduce the incidence of fractures but has not completely prevented them (8). These stents have demonstrated superiority in long-term patency when compared with balloon angioplasty in complex long lesions (9). The endovascular approach has to overcome 3 main challenges when confronting chronic total occlusions: 1) crossing the lesion; 2) establishing a lumen; and 3) long-term patency. In this issue of JACC: Cardiovascular Interventions, Hong et al. (10) have retrospectively evaluated patency, utilizing spot stenting versus long stenting, after an intentional subintimal approach for long chronic total occlusions of the femoropopliteal arteries. Of 163 patients with chronic total occlusions, 196 limbs were recanalized successfully. Of these, 129 limbs (66%) with spot stenting were compared with 67 limbs (34%) with long stenting. Restenosis of 29% in the spot-stenting group and 45% in the longstenting group (p ¼ 0.001) with a median follow-up of 1.7 years was noted. Multivariate analysis showed long stenting, nonuse of clopidogrel or of cilostazol, distal runoff vessels #1, small stent diameter, lower post-procedural ankle-brachial index, and stent coverage of the popliteal artery (especially whenextending to the tibial plateau or below) increased the risk of restenosis. Because this was a retros...

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

Cited by 17 publications

References 20 publications

Safety, Clinical Outcome, and Fracture Rate of Femoropopliteal Stenting Using a 4F Compatible Delivery System

Safety, Clinical Outcome, and Fracture Rate of Femoropopliteal Stenting Using a 4F Compatible Delivery System

Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions

Focal Stenting Versus “Metal Jacket” for Long Subintimal Recanalization of the Femoropopliteal Artery

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