Lawrence A Garcia1, Kenneth R Rosenfield2, Christopher D Metzger3, Frank Zidar4, Ashish Pershad5, Jeffrey J Popma6, Margo Zaugg7, Michael R Jaff8. 1. Division of Cardiology and Vascular Medicine, St. Elizabeth Medical Center, Tufts University School of Medicine, Boston, Massachusetts. 2. Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. 3. Interventional Cardiology, Wellmont CVA Heart Institute, Kingsport, Tennessee. 4. Coronary and Vascular Interventions, Austin Heart Hospital, Austin, Texas. 5. Department of Interventional Cardiology, Banner Good Samaritan Medical Center, Phoenix, Arizona. 6. Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 7. Abbott Vascular, Inc, Santa Clara, California. 8. Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.
Abstract
IMPORTANCE: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG). RESULTS: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period. DISCUSSION: The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation.
IMPORTANCE: Long-term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease METHODS: The subjects were enrolled in an open single arm study comparing the outcomes to an FDA mandated objective performance goal (OPG). RESULTS: About 325 patients (264 intention-to-treat and 64 roll-in subjects) were enrolled. Mean follow-up period was 887+/- 352 days. Treated lesion lengths were 7.8 cm ± 4.3 cm in the trial with chronic total occlusions comprising 24.6% (65/264) of subjects. Freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months was 89%, at 24 and 36 months it was 84% and 82% respectively. The difference in the 12 month CD-TLR was 7% at 36 months. The difference of clinically driven-TLR at 36 months in those subjects who received their stents deployed nominally in length, compressed or elongated (between -10% and +10% nominal length) had an impact on the CD-TLR. At 2 and 3 years, freedom from CD-TLR in minimal compression was 86.7%, and was 90.0% for moderate compression. In those stents deployed with minimal, moderate, or severe elongation (10-20%, 20-40%, or >40%, respectively) freedom from CD-TLR of 84.1%, 87.4%, and 77.0% respectively at 12 months. At 2 and 3 years, freedom from CD-TLR for moderate elongation was 81.8% and 78.2%, and for severe elongation was 63.4% and 42.3%, respectively. Fractures were distinctly uncommon with this stent with a single facture event in the 36 month follow-up period. DISCUSSION: The interwoven nitinol design stent is a stent that achieves an excellent primary patency but further maintains the durability of the stent through 36 months. Optimal stent deployment remains critical to the performance of this stent device and requires optimal vessel preparation.
Authors: Raja Chakraborty; Payel Chatterjee; Jui M Dave; Allison C Ostriker; Daniel M Greif; Eva M Rzucidlo; Kathleen A Martin Journal: JVS Vasc Sci Date: 2021-05-15
Authors: Soo Buem Cho; Ho Cheol Choi; EunJin Bae; Tae Jin Park; Hye Jin Baek; Sung Eun Park; Kyeong Hwa Ryu; Jin Il Moon; Bo Hwa Choi; Kyungsoo Bae; Kyung Nyeo Jeon Journal: Medicine (Baltimore) Date: 2017-12 Impact factor: 1.817