One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study)

Ohki, Takao; Yokoi, Hiroyoshi; Jaff, Michael R.; Popma, Jeffrey J.; Piegari, Guy; Kanaoka, Yuji; Angle, John F.; Feiring, Andrew J.; Nelson, Brian; Glickman, Marc H.; Guimarães, Marcelo; Hall, Patrick; Johnson, Sarah A.; Jordan, William D.; Khoudoud, Omran; Leung, Daniel A.; McGarvey, Joseph F.X.; McKinsey, James F.; Nowygrod, Roman; Shammas, Nicolas W.; Carey, Daniel; Iyengar, Srinivas; Isenbarger, Daniel W.; Ali, Vaqar; Ashchi, Majdi; Rivera, Ernesto; Moursi, Mohammed M.; Bachinsky, William; Metzger, Christopher; Aronow, Herbert D.; Wiechmann, Bret N.; Callicutt, Christopher S.; Gordon, Ian L.; Chaille, Peter; Espinoza, Andrey; Sharafuddin, Melhem J.; Shah, Rakesh; Bunch, Frank; Harlin, Stuart A.; Iwabuchi, Masashi; Ando, Kenji; Kichikawa, Kimihiko; Muramatsu, Toshiya; Urasawa, Kazushi; Yokoi, Yoshiaki; Uematsu, Masaaki; Lo, Ping‐Han; Huang, Chi‐Hung; Kao, Hsien‐Li; Jae, HwanJun

doi:10.1016/j.jvs.2015.08.093

Cited by 20 publications

(15 citation statements)

References 23 publications

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“… 32 ) Ohki et al reported two stent fractures in the overall OSPREY study (0.5% of 383 stents examined) with no fractures reported in the Asian sub-group (60 patients) through 12 months. 16 ) In the present study, three stent fractures were reported at 12 months. Two fractures were classified by the core laboratory as type 1 and one as type 4; the type 4 fracture was noted early in the trial (30-day follow), and occurred in a stent that was elongated at the time of deployment.…”

Section: Discussionsupporting

confidence: 49%

“… 26 ) Ohki and colleagues reported the one-year outcomes from the Asian patient subset (50 Japanese and 10 Taiwanese and Korean patients) of the prospective, multicenter OSPREY study (Misago stent). 16 ) Clinically-driven TLR in the Asian sub-group at 12 months was 11.7%, compared to a 10.6% rate of TVR/TLR in the RELIABLE trial.…”

Section: Discussionmentioning

confidence: 87%

“… 30 , 31 ) Studies using more flexible stents designed to accommodate to the tortuous anatomy of the SFA, have shown reductions in stent fractures compared to first-generation stents with fracture rates ranging from 0–8%. 10 , 13 , 14 , 16 , 17 ) Laird et al reported nine stent fractures in the RESILIENT trial at 12 months (3.1% of 291 stents examined); the angiographic core laboratory determined that four of the nine stent fractures were single-strut, type 1 fractures and five were full longitudinal, type 4 fractures. 10 ) Schulte et al reported 15 fractures in the MISAGO 2 study (3.1% of 484 stents examined); 13 fractures were classified as type 1 and two as type 2.…”

Section: Discussionmentioning

confidence: 99%

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Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study

Nakamura

Jaff

Settlage

et al. 2018

Annals of Vascular Diseases

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Objective: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA).Materials and Methods: Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months. Secondary endpoints, including primary patency, freedom from TVR/target-lesion revascularization (TLR), improvements in clinical parameters, and major adverse events (MAEs) were evaluated through 36 months.Results: The mean overall lesion length was 80.7±38.9 mm (mean stented length: 98.8±46.1 mm). Freedom from TLF was 81.2% (p<0.001 compared to OPG) with a Kaplan–Meier estimate of 84.2% [95% confidence interval (95%CI) 73.3%, 90.9%] at 12 months. Primary patency was 71.0% at 12 months and 67.8% at 36 months. A total of 94.7% of patients improved by at least one Rutherford category and 70.2% of patients improved ankle–brachial indices ≧0.10 from baseline to 36 months. Freedom from TVR/TLR (Kaplan–Meier) was 90% at 12 months and 79.5% at 36 months. Four MAEs were reported; none were found to be device or procedure related.Conclusion: A self-expanding stent was used safely to treat stenotic and occlusive lesions of the SFA in a Japanese patient population. The composite endpoint, freedom from TLF, was superior to an historical control at one year, with low rates of revascularization and good functional and clinical outcomes through three years.

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Section: Discussionsupporting

confidence: 49%

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

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Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study

Nakamura

Jaff

Settlage

et al. 2018

Annals of Vascular Diseases

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“…However, the indication of this strategy could be reconsidered with the appearance of new devices, such as a more flexible stent, drug-eluting stent, drug-eluting balloon catheter, or stent-graft. 23 – 27 ) Ohki et al reported clinical outcomes of the Misago stent (a nickel–titanium bare-metal stent featuring a linkless structure that may reduce the rate of fracture) for the treatment of SFA disease. 23 ) The stent was implanted in 261 TASC II-A or -B SFA lesions, and overall 12-month primary patency rate and freedom from target lesion revascularization were 82.9% and 87.0%, respectively.…”

Section: Discussionmentioning

confidence: 99%

“… 23 – 27 ) Ohki et al reported clinical outcomes of the Misago stent (a nickel–titanium bare-metal stent featuring a linkless structure that may reduce the rate of fracture) for the treatment of SFA disease. 23 ) The stent was implanted in 261 TASC II-A or -B SFA lesions, and overall 12-month primary patency rate and freedom from target lesion revascularization were 82.9% and 87.0%, respectively. Dake et al reported 5-year results of the Paclitaxel eluting stents (Zilver PTX) in the femoropopliteal artery.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of Popliteal-To-Distal Bypass Combined with Femoropopliteal Artery Endovascular Treatment for Critical Limb Ischemia

Tsuji

Kitano

Sugimoto

2017

Annals of Vascular Diseases

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Objective: The aim of this study was to evaluate outcomes of combined popliteal-to-distal bypass and endovascular treatment (EVT) for femoropopliteal lesions in patients with critical limb ischemia (CLI). Patients and Methods: We reviewed data of 14 CLI patients who were treated by popliteal-to-distal bypass combined with femoropopliteal EVT. The femoropopliteal lesions included 3 TASC II-A, 8 TASC II-B, and 3TASC II-C but no TASC II-D, and balloon dilatation was performed in 9 cases and a stent was placed in 5 cases. The saphenous vein graft was used in all bypasses, and the target arteries were the dorsalis pedis artery in 12 cases and the posterior tibial artery in 2 cases. Results: At 12 and 24 months, primary patency rates were both 79%, primary assisted and secondary patency rates were both 93%, limb salvage rates were both 93%, and survival rates were 92% and 84%, respectively. Restenosis after femoropopliteal EVT occurred in 2 cases, and both were successfully revised by additional endovascular balloon dilatation. Conclusion: Combined popliteal-to-distal bypass and femoropopliteal EVT might be a useful therapeutic option for appropriately selected CLI patients. Intensive follow-up for endovascular treated lesions and vein graft is mandatory.

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Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Kichikawa

Ichihashi

Yokoi³

et al. 2018

Cardiovasc Intervent Radiol

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Purpose A prospective, multicenter post-market surveillance study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions. Methods There were no exclusion criteria, and consecutive symptomatic patients with femoropopliteal lesions treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for > 50% diameter stenosis after recurrent clinical symptoms of peripheral arterial disease. Clinical benefit was defined as freedom from persistent or deteriorating ischemic symptoms. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. Results In this study, 905 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including a high incidence of diabetes (58.8%) and chronic kidney disease (43.6%). Additionally, 21.4% of patients were classified with critical limb ischemia. Lesions were complex, with an average length of 14.6 ± 9.6 cm (range 0.5–40 cm), 41.5% total occlusions, and 18.7% in-stent restenosis. In total, 1861 DES were placed in 1080 lesions. Two-year follow-up was obtained for > 90% of eligible patients. Freedom from TLR was 83.7%, and clinical benefit was 80.0% through 2 years. The 2-year primary patency rate was 70.3%. Rutherford classification significantly improved ( p < 0.01), with approximately 80% of patients classified as Rutherford class 0 or 1 at 2 years. Conclusion Despite more challenging lesion characteristics, 2-year results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the efficacy of the Zilver PTX DES in a complicated femoropopliteal lesion (Zilver PTX Post-Market Study in Japan; NCT02254837). Level of Evidence Post-market surveillance study, Level III.

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One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study)

Abstract: OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials.

Cited by 20 publications

References 23 publications

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study

Outcomes of Popliteal-To-Distal Bypass Combined with Femoropopliteal Artery Endovascular Treatment for Critical Limb Ischemia

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

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