Final Six Late-Breaking Endovascular Clinical Trial Results Announced at VIVA 16

ESPRIT I TRIAL: 3-YEAR RESULTS OF THE EVALUATION OF THE ESPRIT BIORESORBABLE VASCULAR SCAFFOLD IN THE TREATMENT OF PATIENTS WITH OCCLUSIVE VASCULAR DISEASE OF THE SFA OR COMMON OR EXTERNAL ILIAC ARTERIES 
Presenter: Michael R. Jaff, DO

The purpose of the ESPRIT I clinical investigation was to evaluate the safety and performance of the Esprit everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular) in subjects with symptomatic claudi­cation from occlusive vascular disease of the superficial femoral artery (SFA) or common or external iliac arteries. The trial was a prospective, single-arm, open-labeled, mul­ticenter clinical investigation in which 35 subjects were enrolled at seven clinical sites in Europe.

Clinical assessment and peak systolic velocity ratio assessed by duplex ultrasound was performed at 1, 6, and 12 months and at 2 and 3 years. Angiographic follow-up was performed at 12 months. Thirty-five study scaffolds and one non-study stent were placed in 35 patients who had lesion length of 35.5 mm and reference vessel diameter of 4.9 mm. Acute device success was 100%. The 3-year results confirm earlier data demonstrating the safety and feasibility of treatment with the Esprit bioresorbable vascular scaffold for SFA and iliac lesions, with no new events occurring between 2 and 3 years.

12-MONTH RESULTS FROM THE DANCE TRIAL ATHERECTOMY COHORT 
Presenter: Chris Owens, MD, MSc

The DANCE study is a 281-patient, multicenter, single-arm trial examining the local drug delivery of dexametha­sone into the adventitial and perivascular tissues via the Bullfrog microinfusion device (Mercator MedSystems). The hypothesis was that dexamethasone would safely reduce restenosis rates in patients with atherosclerotic obstructive lesions of the superficial femoral and/or popli­teal arteries. Two revascularization treatment options were evaluated: atherectomy and percutaneous transluminal angioplasty. The primary efficacy endpoint is primary patency at 12 months.

This hypoth­esis was supported by demonstrating reduction of circulating biomarkers of inflammation and the achieved clinical outcomes. By placing the drug directly into the vessel wall outside the external elastic lamina, traditional barriers to intima-based delivery methods are overcome. The trial enrolled 157 patients who received primary atherectomy revascularization and 124 patients who received PTA without atherectomy. The trial had angiographic, ultrasound, and clinical core laboratory adjudication of lesion characteristics, surveillance, and clinical events. The atherectomy group has completed 1-year follow-up, and the intent-to-treat population had 1-year primary patency rate of 79.5%. The per-protocol population had a primary patency rate of 83.8% at 365 days and 80.2% at 395 days.

USE OF AN ePTFE BALLOON-EXPANDABLE COVERED STENT FOR OBSTRUCTIVE LESIONS IN THE ILIAC ARTERY: 9-MONTH RESULTS FROM THE PROSPECTIVE, MULTICENTER BOLSTER TRIAL 
Presenter: John Laird, MD

Patients were enrolled in 17 sites in the United States, Europe, and New Zealand. The LifeStream balloon-expandable covered stent (Bard Peripheral Vascular) comprises an electropolished, 316-L stainless steel balloon-expandable stent encapsulated between two layers of expanded polytetrafluoroethylene. It is premounted on a noncompliant balloon on a 0.035-inch guidewire–compatible delivery catheter. Radiopaque markers on the balloon shaft indicate the ends of the covered stent.

In BOLSTER, the LifeStream covered stent was success­fully deployed in 98.3% of cases, with an acute procedural success rate of 97.4%. At 9 months, 11.6% of evaluated patients met the primary composite endpoint. The primary patency rate was 89.1%, and the rate of freedom from target lesion revascularization was 96.7% at 270 days. The BOLSTER trial is ongoing, with duplex ultrasound imaging follow-up to continue through 3 years.

CAROTID STENT FRACTURES ARE NOT ASSOCIATED WITH DEATH, STROKE, MYOCARDIAL INFARCTION AND STENT RESTENOSIS: RESULTS FROM THE ACT 1 MULTICENTER RANDOMIZED TRIAL 
Presenter: Ido Weinberg, MD

The objective of this study was to report the stent frac­ture rate as well as its association with carotid in-stent restenosis and clinically meaningful adverse outcomes in ACT-1. ACT-1 is the largest prospective, multicenter random­ized trial of standard-risk asymptomatic patients with severe carotid artery stenosis randomized to carotid artery stenting (CAS) or carotid endarterectomy  (Abbott Vascular). All patients were required to undergo duplex ultrasound surveillance at 30 days and annually thereafter. After 771 patients had been random­ized, all subsequent randomized patients were required to also undergo annual radiographic analysis for stent fracture.

The primary endpoint was the composite of death or myocardial infarction during the 30 days after the proce­dure and ipsilateral stroke during the 365 days after the procedure. Stent fracture was reported in 51 patients. Adverse clinical outcomes up to 5 years occurred in 47 CAS patients enrolled in ACT 1. Neither stent fracture nor restenosis was associated with the primary end­point to 5 years. ACT-1 demonstrates that carotid stent fracture rate was low and was not associated major adverse clinical events or with in-stent restenosis.

NOVEL NITINOL STENT FOR LONG LESIONS IN THE SUPERFICIAL FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY: 24-MONTH RESULTS FROM THE TIGRIS RANDOMIZED TRIAL 
Presenter: John Laird, MD

The TIGRIS trial is a prospective, multicenter, random­ized controlled noninferiority clinical study. Patients were randomized 3:1 to treatment with either the Tigris stent or LifeStent (Bard Peripheral Vascular). There were 33 enrollment sites in the United States and three in Europe; 274 patients were enrolled on an intention-to-treat basis, and 267 patients were per protocol.

The Kaplan-Meier estimates for 24-month primary patency and freedom from target lesion revasculariza­tion are 63% and 76.6% for the Tigris stent, respectively, versus 67.4% and 80.6% for LifeStent. There were no stent fractures observed at 12-month follow-up with the Tigris stent, whereas the LifeStent fracture rate was 28.8%. The challenging, head-to-head, real-world, long-lesion trial met its endpoints and demonstrated Tigris' safety and efficacy. The high LifeStent fracture rate was notable. The novel design of the Tigris stent matches the demands of high-flexion areas.

PRISM: ASSESSING THE SAFETY AND TECHNICAL EFFECTIVENESS OF THE PENUMBRA INDIGO ASPIRATION SYSTEM WHEN USED AS A FRONT-LINE TOOL AND AS SALVAGE THERAPY FOR THE TREATMENT OF THROMBOEMBOLISM IN THE PERIPHERAL VASCULATURE 
Presenter: Richard R. Saxon, MD, FSIR

A total of 85 patients were enrolled in PRISM. In 43 patients, aspiration thromboembolectomy with the Indigo aspiration system (Penumbra, Inc.) was used as the initial therapy. In an additional 42 patients, thrombolysis or other mechanical intervention was attempted before the study device was used. Vessel patency was determined via angiogram before and after the various treatments and at completion of all therapies using the thrombolysis in myocardial infarction (TIMI) scale to evaluate efficacy.

Overall, complete restoration of flow was achieved in 77.6% of patients. Mechanical aspiration thromboembolectomy using the Indigo system is effective for revascularization of peripheral arterial occlusions. The study device was equally effective as a front-line, primary therapy and as a salvage therapy after other endovascular techniques had failed.

About VIVA Physicians
VIVA Physicians strive to be the premier educators in the field of vascular medicine and intervention. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field of vascular medicine with a spirit of collegiality by synergizing their collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.  

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