TEL AVIV, Israel, Oct. 7, 2019 /PRNewswire/ -- Vascular Graft Solutions reports the presentation of Clinical data from two prospective trials of the VEST external stent for vein grafts during CABG which was presented at the 2019 European Cardio-Thoracic Surgery (EACTS) annual meeting (3-5 October, Lisbon, Portugal). The results showed low MACCE rates up to 3 years after CABG, excellent patency rates of vein grafts and significant reduction in the progression of vein graft disease.
On Friday, October 4th, Prof. David Taggart from John Radcliffe hospital (Oxford, UK) presented the results of the VEST III trial at the late breaking clinical trials session. The VEST III is a randomized controlled trial that enrolled 184 patients in 14 centers in Germany, Austria, Israel and the UK. At 2 years, the trial met its primary and secondary endpoints showing superior perfect patency rates (Fitzgibbon I) of externally stented vein grafts compared to the control group (66.4% vs 53.6%, p value = 0.02) and a highly significant reduction of 25% (p value <0.001) in both intimal area and thickness assessed by intravascular ultrasound.
"The results of the VEST III trial confirm our previous observations regarding the bio-mechanical effects of external stenting," said Prof. David Taggart. "This is another milestone in our ongoing efforts to improve coronary surgery and patients' quality of life. As the principle investigator of the first in man VEST I trial in 2011, and who has closely followed the evolution of this technology in the last 10 years, it is very satisfying to see how the combined effort of surgeons, scientists and innovators has led to a technology with high clinical impact."
On Saturday, October 5th, Prof. Luca Weltert from the European hospital (Rome, Italy) presented interim results from a prospective investigator's led all comers study that evaluated the angiographic and clinical outcomes in 51 patients. The majority of patient underwent off pump CABG (77%) and all vein grafts were supported with VEST external stent. CT angiography was performed at 1 year and patients were prospectively followed every 6 months for MACCE. Although average age in the study cohort was 73.5 with 32% of patients having prior PCI, at average follow up of 3 years, MACCE rates were 2% with only one patient requires revascularization to a de-novo coronary lesion. At 1 year, CT angiography demonstrated 100% patency of the VEST externally supported vein grafts.
"It is very encouraging to see that "real world" data supports the evidence from randomized trials," said Prof. Luca Weltert. "Very often, we see big gaps between clinical results of randomized cohorts, which are highly selective in nature, and the results in our day to day practice. Our interim follow up data shows that at 3 years, clinical and angiographic results are superior compared to those observed in published randomized trials."
Rotem Katzenellenbogen, VP Business Development VGS
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SOURCE Vascular Grafts Solutions