Hiroyoshi Yokoi1, Takao Ohki2, Kimihiko Kichikawa3, Masato Nakamura4, Kimihiro Komori5, Shinsuke Nanto6, Erin E O'Leary7, Aaron E Lottes7, Scott A Snyder7, Michael D Dake8. 1. Department of Cardiovascular Medicine, Fukuoka Sanno Hospital, Fukuoka, Japan. Electronic address: hiroyokoi@circus.ocn.ne.jp. 2. Department of Surgery, Jikei University Hospital, Tokyo, Japan. 3. Department of Radiology, Nara Medical University, Kashihara, Japan. 4. Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center, Tokyo, Japan. 5. Division of Vascular Surgery, Division of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. 6. Nishinomiya Hospital Affairs, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan. 7. Cook Research Incorporated, West Lafayette, Indiana. 8. Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California.
Abstract
OBJECTIVES: This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. BACKGROUND: The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. METHODS: There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) 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 PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. RESULTS: In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. CONCLUSIONS: Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837).
OBJECTIVES: This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. BACKGROUND: The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. METHODS: There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) 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 PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. RESULTS: In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. CONCLUSIONS: Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837).
Authors: Michael D Dake; Gary M Ansel; Michael R Jaff; Takao Ohki; Richard R Saxon; H Bob Smouse; Lindsay S Machan; Scott A Snyder; Erin E O'Leary; Anthony O Ragheb; Thomas Zeller Journal: Circulation Date: 2016-03-11 Impact factor: 29.690
Authors: Michael D Dake; Gary M Ansel; Marc Bosiers; Andrew Holden; Osamu Iida; Michael R Jaff; Aaron E Lottes; Erin E O'Leary; Alan T Saunders; Marc Schermerhorn; Hiroyoshi Yokoi; Thomas Zeller Journal: Cardiovasc Intervent Radiol Date: 2019-09-09 Impact factor: 2.740