Endospan today announced the one-year results of its TRIOMPHE investigational device exemption (IDE) study evaluating the Nexus aortic arch stent graft system. The data were presented at the Society of Thoracic Surgeons (STS) annual meeting (29 January–1 February, New Orleans, USA).
TRIOMPHE is a prospective, multicentre, three-arm trial designed to assess the safety and effectiveness of the Nexus system in patients with aortic arch pathologies (dissection, aneurysm, penetrating aortic ulcer [PAU]/intramural haematoma [IMH]). Endospan shares that the one-year results for the 94 high-surgical-risk patients in the three arms are “promising” for aortic arch treatment in zone 0, which is noted to be a difficult segment of the aorta to treat without high rates of comorbidities such as mortality or stroke.
“The 12-month data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease,” said Brad Leshnower (Emory University, Atlanta, USA), national cardiac surgery principal investigator. “The sustained low stroke and mortality rates in a very high-risk patient population is a significant achievement.”
The following highlights were shared at STS:
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TRIOMPHE (n=94) |
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30-day (0–30) |
One-year (31–365) |
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Lesion-related mortality |
6.4% (n=6) |
0.0% |
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Overall disabling stroke (bypass + Nexus) post |
7.4% (n=7) |
1.1% (n=1) |
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Bypass |
1.1% (n=1) |
– |
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Post Nexus |
6.4% (n=6) |
1% (n-1) |
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Renal failure |
0% |
0% |
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*All events are adjudicated by clinical events committee (CEC) |
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Further, core-lab analysis of stent graft sealing shows no type III or IV endoleaks and only three patients had a Ia or Ib endoleak, suggesting good sealing through 12 months.
“As a vascular surgeon, I am excited to see the one-year results from TRIOMPHE continue to mirror the positive results we have seen in the long-term data on NEXUS in Europe,” said Ross Milner (UChicago Medicine, Chicago, USA), national vascular surgery principal investigator. “It is rewarding to be involved in bringing a less invasive treatment option like Nexus to patients with complex aortic arch pathologies.”
Endospan advises that, in the USA, the Nexus is pending premarket approval (PMA) review by the US Food and Drug Administration (FDA), which includes a thorough, multistage, in-depth evaluation of the available safety and efficacy data. The company adds that, outside of the USA, device availability is subject to local regulations and guidelines.
