Avinger announced on 13 October 2015 interim six-month results for its VISION clinical trial. VISION is designed to evaluate the safety and effectiveness of the Pantheris system to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
VISION results were presented by Arne Schwindt, St Franziskus Hospital in Münster, Germany, at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 medical meeting. Six-month results presented at TCT were from an interim analysis of 93 patients out of the 130 patients treated per protocol in the study. Data from this interim cohort was the basis for the 510(k) application Avinger submitted to the FDA on 12 August 2015. The company anticipates that six-month data from all 130 patients will be presented at a major medical meeting in November.
VISION results demonstrate successful achievement of all primary and secondary safety and effectiveness endpoints. The primary safety endpoint, related to incidence of major adverse events, was 21.5% in the 93-patient interim cohort, measuring below the pre-defined study limit of 43.2%. The safety results include zero Pantheris-related dissections or perforations across all lesions treated. Importantly, the interim cohort, representing 72% all of patients treated, demonstrates a promising target lesion revascularisation rate through six-month follow-up of 10.8%. As previously reported, the primary efficacy endpoint of residual stenosis less than or equal to 50% following Pantheris treatment alone was achieved in 96.3% (158/164) of lesions, significantly outperforming the pre-defined study goal of 87%.
Commenting on the VISION trial results, principal investigator Schwindt stated, “I have been impressed with the Pantheris technology, especially the amount of additional information and precision available during the intervention. The high efficacy and low target lesion revascularisation results through six months further confirm my belief that the precision offered through real time optical coherence tomography visualisation at the point of therapy will have a lasting effect on patient outcomes. This new tool will make atherectomy a safer and more effective procedure for patients with peripheral arterial disease.”
Additional metrics from the VISION trial point to the standalone therapeutic capability of Pantheris with 55% of lesions being treated with Pantheris alone. Importantly, placement of a stent following treatment with Pantheris was minimised to 4% across all lesions treated (n=7).
On average, following treatment using Pantheris with or without adjunctive therapy, arterial stenosis was reduced from 78.7±15.2% pre-treatment to 22.2 ± 9.8% post-treatment, which represents a 70.5% reduction in stenosis. These results correlate with statistically significant improvements in both ankle-brachial index and Rutherford classification at six months.
In addition to positive clinical outcomes, histologic analysis of the VISION trial atherectomy specimens highlights the tremendous precision that real-time optical coherence tomography guidance enables during directional atherectomy. Across all lesions treated, the average percent area of adventitia in tissue removed was 1.0%. This result confirms that real-time imaging provides the feedback necessary for physicians to treat peripheral arterial disease without damaging normal arterial structures such as adventitia, which has been shown to potentiate restenosis. Histologic results are expected to be a key differentiator in the VISION trial. These findings will be used to further support the Avinger hypothesis that minimising arterial wall disruption during therapy promotes reduced adjunctive treatments, improved long-term arterial patency, and ultimately minimises the need for reintervention.
“These interim results from the VISION trial are a testament to the game-changing lumivascular technology and years of dedication by both our physician partners and the Avinger team,” said John B Simpson, founder and executive chairman of Avinger. “As the study results demonstrate, the VISION investigators were able to achieve unprecedented levels of control and precision in the Pantheris atherectomy procedures, which I believe will radically improve outcomes for patients suffering from peripheral arterial disease.”
VISION is a non-randomised, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the Pantheris system to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The study enrolled 134 patients and includes follow-up data collection review by independent third parties at thirty days and six months.
Pantheris is the first-ever image-guided atherectomy device using real-time intravascular visualisation technology. Pantheris is the subject of the VISION IDE trial, a study designed to evaluate the safety and efficacy of Pantheris for directional atherectomy in the peripheral arteries, while allowing physicians to use high resolution optical coherence tomography intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.