October 23, 2013 — Vascular Interventional Advances (VIVA) Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announced 15 trial results at the recent VIVA 13 meeting. The trial results offered new information on advances in the treatment of vascular diseases.
Below are summaries and results of the initial trial presentations:
The DURABILITY II evaluated the safety and efficacy of a single EverFlex self-expanding nitinol stent. At the 30-day follow-up assessment, 88.6 percent (39/44) and 90 percent (45/50) had an improvement of at least one renal cell carcinoma (RCC) level in the DAART arm and DCB arm, respectively. Compared to baseline, 88 percent of patients in the DAART arm and 89 percent of patients in the DCB arm showed an improvement in ABI at the 30-day follow-up visit. Acute results of the DAART treatment show a high technical success rate and acceptable periprocedural complications.
Re-ROUTE provided additional clinical data regarding the safety and technical success of Boston Scientific’s OffRoad re-entry catheter system for subintimal recanalization of chronic total occlusions (CTOs) in the femoropopliteal arteries. Effectiveness was based on device technical success, defined as placement of a guidewire in the true lumen distal to a CTO. The site reported technical success rate was 84.8 percent (78/92), which exceeded the pre-specified performance goal. The Re-ROUTE results demonstrate that the OffRoad system is a safe and effective treatment option for recanalization of femoropopliteal CTOs.
Ovation evaluated the safety and effectiveness outcomes of the ultra-low profile, 14 French outer diameter (OD) Ovation abdominal stent graft system for endovascular repair of abdominal aortic aneurysms (AAA). The two-year outcomes with the Ovation stent graft demonstrated excellent safety and effectiveness in patients with AAA. These results were similarly impressive in patients with challenging anatomical characteristics who would be ineligible for treatment with other approved stent grafts. The ability of the Ovation stent graft to treat a broad range of aortoiliac anatomies may help to expand the patient population eligible for endovascular aneurysm repair (EVAR).
Hercules, a prospective, multicenter renal stent trial, confirmed long-term safety and efficacy of Abbott Vascular’s RX Herculink Elite renal stent system in patients with uncontrolled hypertension (HTN) and renal artery stenosis (RAS). At baseline, the mean systolic blood pressure (SBP) was 162 mmHg, 71 percent of patients were receiving three or more antihypertensive medications and 61.5 percent of subjects had impaired renal function (estimated glomerular filtration rate: eGFR < 60 mL/min per 1.73 m2). Post-procedure, the mean SBP significantly decreased (mean SBP 141 mmHg, paired t test, p < 0.0001). This was sustained through three years (mean 146 mmHg, paired t test, p < 0.0001) with no change in the number of antihypertensive medications and without episodes of renal failure. At three years, freedom from clinically-driven target lesion revascularization (CD-TLR) was 91.8 percent.
ESPRIT 1 evaluated the safety and performance of the Abbott Vascular Esprit bioresorbable vascular scaffold (BVS) in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral artery (SFA) or common or external iliac arteries. Angiography and duplex ultrasound showed widely patent arteries after treatment with Esprit BVS, sustained to six months with a restenosis rate of 0 percent on duplex. The imaging results show no indication of acute or delayed scaffold recoil.
STROLL assessed health related quality of life (HRQoL) over a three-year follow-up period of patients treated with Cordis’ S.M.A.R.T. nitinol self-expandable stent system for obstructive SFA disease. The results showed that patients with peripheral artery disease (PAD) in the SFA treated with the S.M.A.R.T. stent experienced clinically meaningful improvements in HRQoL — such as social function, walking distance and speed — that were maintained for at least three years.
ANCHOR assessed EndoAnchor safety and efficacy to augment proximal fixation and sealing in primary EVAR (“Primaries”) or therapeutically for type Ia endoleaks/migration after a prior EVAR (“Revisions”). EndoAnchors were associated with excellent early results when high-risk anatomy was encountered in initial EVAR procedures. EndoAnchors were successful in repairing most proximal neck problems in EVAR revisions.
Zilver PTX 4-Year
Zilver PTX 4-Year compared the safety and effectiveness of the Zilver PTX stent to balloon angioplasty (PTA) and bare-metal stenting (BMS) in the SFA. The one-year primary endpoints were met and showed non-inferior EFS and superior patency for the Zilver PTX group compared to the PTA control group. The randomized comparison of provisional stenting with Zilver PTX versus Zilver BMS also showed significant benefit of the paclitaxel coating.
For more information: www.vivapvd.com