Data from the AMDS PERSEVERE and PROTECT trials—both assessing the use of the Ascyrus medical dissection stent (AMDS, Artivion)—were presented in late-breaking science presentations at the 39th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (8–11 October, Copenhagen, Denmark).
The AMDS PERSEVERE trial presentation highlighted positive 30-day data focused on a subset of patients with visceral and renal malperfusion. The results demonstrate resolution of visceral malperfusion in 83% and renal malperfusion in 74% of affected subjects following AMDS implantation.
Real-world results from the AMDS PROTECT trial further confirm the statistically significant positive clinical outcomes demonstrated in the PERSEVERE IDE study.
Michael Moon (University of Alberta, Edmonton, Canada), steering committee member of the PERSEVERE trial and co-principal investigator of the PROTECT trial, said: “The latest data from these two ongoing long-term studies of AMDS continue to highlight how this critical technology is improving outcomes for some of our sickest patients.”
“We were thrilled to command such a strong presence at EACTS with data from our AMDS clinical trials featured in two late-breaking science sessions,” said Pat Mackin, chairman, president, and chief executive officer of Artivion. “These results further validate the strength of our best-in-class portfolio and reinforce our commitment to advancing innovation in the treatment of aortic disease.”
The PERSEVERE trial is a prospective, multicentre, non-randomised clinical trial to determine if patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis.
The trial is designed to support the company’s forthcoming application to the US Food and Drug Administration (FDA) for premarket approval of the AMDS. The trial consists of 93 participants in the USA, who have experienced an acute DeBakey Type I aortic dissection complicated by malperfusion.
Each participant will be followed for up to five years. Thirty-day trial data met combined safety and primary efficacy endpoints, demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction, and distal anastomotic new entry (DANE) tears following AMDS implantation. The secondary endpoint relates to remodelling of the aorta.
Results from the PERSEVERE study focus on the assessment of downstream benefits of AMDS, specifically visceral and renal malperfusion resolution at 30-days following AMDS implantation in the 40 study participants presenting with clinical malperfusion of those organs.
Eighty-three per cent of patients with preoperative visceral malperfusion did not develop any significant gastrointestinal events including bowel ischaemia, ileus, bleeding, abdominal pain, the need for laparotomy, or artery stenting.
Seventy-four per cent of patients with preoperative renal malperfusion did not develop renal failure requiring dialysis or the need for artery stenting, and all had radiographic resolution.
Importantly, the analysis evaluated patients with and without preoperative symptomatic malperfusion and found no meaningful difference in clinical outcomes between the two groups, underscoring the consistent performance of AMDS, even in higher-risk patients.
The AMDS PROTECT trial is a real-world, observational, prospective and retrospective, non-randomised, non-interventional study to investigate the performance and clinical benefits of AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural haematomas.
The registry has enrolled 302 participants in Europe and Canada. The current presentation reports on 141 of 300 participants who have reached the three- to six-month follow-up.
Three to six-month results of European and Canadian multicentre PROTECT registry focused on real-world usage of AMDS across 141 patients. The real-world results from this registry demonstrate excellent outcomes consistent with those of the PERSEVERE and DARTS studies, namely no occurrences of paralysis/paraparesis, aortic rupture, or myocardial infarction and 95.3–100% of patients experienced positive remodelling with true lumen diameter increasing or stable in zones 1, 2, and 3.
