RESTORE II Supports Bolton Medical's Relay for Elective Endografting of Thoracic Aneurysms and Dissections

June 9, 2016—Results from the RESTORE II registry were published by Burkhart Zipfel, MD, et al in the Journal of Vascular Surgery (JVS, 2016;63:1466–1475). RESTORE II assessed the safety, performance, and efficacy of the Relay thoracic stent graft (Bolton Medical, a WerfenLife company) in the treatment of patients who require elective thoracic endovascular aortic repair, including aneurysms and dissections.

As noted in JVS, RESTORE II is a multicenter, prospective, international cohort study involving 21 centers in 12 countries worldwide. All consecutively included patients in the registry underwent elective thoracic endovascular aortic repair with a Relay uncovered thoracic stent graft or a Relay NBS covered thoracic stent graft (including off-the-shelf and custom-made devices) to repair thoracic aortic aneurysms or dissections. Demographic, clinical, and aortic parameters were Web-based registers. Safety and efficacy data were collected for a follow-up period of 24 months.

RESTORE was a precedent registry involving European sites that used Relay first-generation devices.

The investigators concluded that the worldwide results of the RESTORE II registry show the safety and effectiveness of Relay and Relay NBS stent grafts for elective endovascular thoracic aortic repair. Additionally, the device presents a lower rate of perioperative complications compared with the RESTORE registry.

In RESTORE II, a total of 173 patients were enrolled in the registry from October 2010 to September 2014 (aneurysm, n = 99; dissection, n = 74). Overall technical success of the intervention reached 97.1%, irrespective of the etiology and geographic origin of patients. Baseline clinical heterogeneity was observed between devices concerning the etiology of the disease and certain comorbidities and/or risk factor distribution (diabetes, hypertension, myocardial infarction, angina pectoris). An average of 1.36 stent graft components were used per patient, with mean intended treatment length of 197 ± 87.7/188.7 ± 103.1 mm and mean access site diameter of 10.3 ± 8.2/9.7 ± 1.7 mm in aneurysms/dissections, respectively.

The investigators found that the rate of all-cause 30-day mortality in RESTORE II was lower than in the RESTORE registry (4% vs 7.2%). Additionally, perioperative neurologic complications (paraplegia/paraparesis [2.9% vs 2%] and stroke [0.6% vs 1.6%]) were infrequent compared to RESTORE.

Freedom from all-cause mortality at 2 years was 93.6% in RESTORE II and at the final completion angiography, device-associated complications were detected in 4.6% of the patients, versus 5.3% in RESTORE; the endoleak rate was 6.4% (type I, 5.8%; type II, 1.7%), reported the investigators in JVS.