MURRAY HILL, N.J., June 15 C. R. Bard, Inc. today announced the publication of RESILIENT trial results by Circulation: Cardiovascular Interventions showing the Bard LIFESTENT® Vascular Stent improved patency and reduced revascularization rates in patients with moderate-length lesions in the superficial femoral artery (SFA) and proximal popliteal artery compared to patients treated with percutaneous transluminal angioplasty (PTA).
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The LIFESTENT® Vascular Stent is the only stent approved by the U.S. Food and Drug Administration and commercially available for use in the SFA and proximal popliteal artery, which are both arteries above the knee. The narrowing of these arteries is responsible for the symptoms associated with peripheral artery disease (P.A.D.).
P.A.D. affects more than eight million people in the U.S. and, if not treated, P.A.D. can limit the ability to walk and exercise, as well as place patients at risk for limb loss. P.A.D. patients also have a greater chance of heart attack, stroke and death.
In the prospective, randomized, controlled, multi-center trial, 206 patients who required treatment for lesions up to 15cm received either PTA alone or PTA and a LIFESTENT® Vascular Stent. At six months post procedure, freedom from target lesion revascularization (TLR) was significantly better for the LIFESTENT® Vascular Stent group (98.5 percent) compared to the PTA group (52.6 percent). Similarly, freedom from TLR at 12 months remained significantly better for patients treated with a LIFESTENT® Vascular Stent (87.3 percent) compared to patients treated with PTA (45.1 percent).
"This trial provides compelling evidence that the self-expanding nitinol stent can keep the arteries open and reduce the need for additional procedures better than balloon angioplasty alone," said John Laird, MD, medical director, University of California, Davis, Vascular Center, and co-principal investigator for the RESILIENT trial. "These data suggest this stent will improve the outcomes clinicians can expect when treating lesions in the SFA and proximal popliteal artery."
Primary patency, a combination of ultrasound confirmed patency and absence of TLR, was significantly better for patients who received stents. Patients treated with the LIFESTENT® Vascular Stent were more than two times as likely to maintain primary patency compared to PTA patients at six months (94.2 percent vs. 47.4 percent) and 12 months post procedure (81.3 percent vs. 36.7 percent).
Additionally, there was no statistically significant difference between the major adverse clinical events (MACE) rates for the treatment groups. Freedom from MACE at six months for the stent group was 93.1 percent and for the angioplasty group was 92.8 percent (p =0.95). At 12 months, freedom from MACE was 85.8 percent for the stent group and 86.6 percent for the angioplasty group (p=0.88).
"The RESILIENT trial shows the LIFESTENT® Vascular Stent is a safe device both in terms of major adverse clinical events as well as stent fracture rates," said Barry Katzen, MD, FACR, FACC, founder and medical director of Baptist Cardiac & Vascular Institute.
The rate of stent fracture was 3.1 percent at 12 months, and stent fracture was not associated with any adverse clinical events. The low fracture rate with the LIFESTENT® Vascular Stent suggests the flexible helical design may afford some degree of fracture resistance.
C. R. Bard, Inc., (www.crbard.com) headquartered in Murray Hill, N.J., is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.
SOURCE C.R. Bard, Inc.
