Results Published From the Pivotal Trial of Bolton Medical's Relay TEVAR Device
May 23, 2017—The initial and midterm results of the pivotal trial for the Relay thoracic stent graft (Bolton Medical) for thoracic endovascular aortic repair (TEVAR) of thoracic aortic lesions were published by Mark A. Farber, MD, et al in Journal of Vascular Surgery (2017;65:1556–1566).
This prospective, nonrandomized, multicenter, investigational device exemption study was conducted at 27 investigational sites in the United States. Between January 2007 and May 2010, 120 TEVAR patients were treated with the Relay device. An additional 13 patients were enrolled during the continued access phase through September 2012.
The study investigators compared TEVAR outcomes with a prospectively and retrospectively enrolled surgical cohort composed of 60 patients enrolled under similar inclusion/exclusion criteria. Follow-up examinations were performed at 1 month, 6 months, and yearly thereafter for 5 years. Major adverse events (MAEs) included stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, wound healing complications, and aneurysm-related mortality.
As summarized in Journal of Vascular Surgery, stent grafts were successfully delivered and deployed in 129 of 133 patients (97%). At 30 days, a lower rate of mortality was observed in the TEVAR arm (5.3% vs 10%; P = .23), and TEVAR was associated with a significantly lower rate of MAEs (20.3% vs 48.3%; P < .001), primarily driven by a lower frequency of respiratory failure (5.5% vs 21.6%; P = .007) and procedural bleeding.
The freedom from aneurysm-related mortality through 5 years was similar at 91.3% for the TEVAR cohort and 89.4% for the surgical cohort (P = .406), with 5-year freedom from all-cause mortality at 57.1% and 50.2% (P = .289), respectively.
Freedom from MAEs through 5 years was significantly higher in the TEVAR cohort (65.7% vs 44.7%; P = .001). Six TEVAR patients (4.5%) experienced core laboratory–reported type I or III endoleaks, and secondary procedures were performed in 10 patients (7.5%), with seven procedures to correct endoleaks and one surgical conversion.
Endograft migration occurred in three patients (2.3%), and wireform fractures were assessed in two patients (1.5%). Aneurysm sac size decreased or remained stable in 113 patients (85%) during the 5-year follow-up. There were no instances of rupture or endograft occlusion.
Additionally, the investigators found that a 38-patient subset treated with the newer RelayPlus delivery system had a significantly reduced MAE rate (15.8% vs 35.8%; P = .035) and fewer perioperative strokes (2.6% vs 12.6%; P = .108).
Data from the Relay TEVAR clinical trial demonstrate the safety and effectiveness of the Relay device compared with surgical controls, indicating continued device durability with a low rate of device-related complications through 5 years, concluded the investigators in Journal of Vascular Surgery.