Artivion has announced presentation of interim results from the Ascyrus medical dissection stent (AMDS) PERSEVERE clinical trial in a late-breaking science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (4–7 October, Vienna, Austria).
Fernando Fleischman (Keck Hospital of the University of Southern California, Los Angeles, USA) delivered data from the PERSEVERE US investigational device exemption (IDE) trial in a late-breaking presentation titled, “Interim results of AMDS hybrid prosthesis in acute DeBakey Type I [ADTI] dissection with malperfusion”, including interim data on 52 study participants at 30 days post-implantation and an additional eight participants in total follow-up.
As Artivion details in a recent press release, these interim data demonstrate a clinically meaningful reduction of all-cause mortality and primary major adverse events (MAEs), with 79% of participants experiencing no target MAEs at 30 days (41 of 52 patients).
In PERSEVERE, rates of all-cause mortality (13.5%), new disabling stroke (9.6%), new onset renal failure requiring dialysis (7.7%) and myocardial infarction (0%) all compared favourably to ‘historical reference’ rates, according to Artivion.
The interim data also demonstrate “excellent” results for additional PERSEVERE endpoints, including a technical success rate of 98.3%; an unanticipated aortic reoperations rate of 1.7%; and no instances of distal anastomotic new entry (DANE) tears, distal stent-induced new entry (d-SINE), occlusion of supra-aortic vessels, or new postoperative paraplegia or paraparesis.
“The current standard of care to manage acute Type I aortic dissections is technically meticulous and often leads to distal anastomotic new entry tears, or DANE tears, which are associated with increased risk for re-intervention and mortality,” said Fleischman. “I am encouraged by the interim results of the PERSEVERE study, which indicate that the use of AMDS offers substantial clinical benefit—notably the absence of DANE tears and an improved all-cause mortality rate—for patients presenting with malperfusion and ADTI dissection at 30 days, while adding minimal time and complexity to the procedure.”
