David Safley presented the three-year health related quality of life data from the STROLL clinical trial during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) 2013 Annual Meeting in Las Vegas, USA.
The results from this analysis showed that patients with peripheral artery disease in the superficial femoral artery treated with the Smart Vascular Stent System experienced clinically meaningful improvements in quality of life, including reduced pain in the affected leg(s), improved social function and increased walking distance, that were maintained over the three year study follow-up period.
The quality of life analysis included the 250 patients studied in the STROLL clinical trial, a multicentre, prospective trial, which assessed the safety and efficacy of the Smart stent. Patients enrolled in the trial had Rutherford Class 2-4 symptoms and were treated with standard percutaneous transluminal angioplasty with placement of one or more stents.
“These new findings show the quality of life benefit was very large and sustained over at least three years in patients with superficial femoral artery disease treated with Smart stent,” said Safley, consulting cardiologist, Saint Luke’s Mid America Heart Institute, and associate professor of Medicine at the University of Missouri School of Medicine, Kansas City, who presented the data at VIVA on behalf of the STROLL trial investigators. “Currently there are limited published reports evaluating the impact and durability of these types of treatments on patient-reported outcomes beyond one year, which makes these findings noteworthy to clinicians evaluating treatment options for peripheral arterial disease patients.”
The analysis evaluated health status and quality of life using validated patient assessment scales, including the Short Form 12 and EQ-5D (generic health status), the Peripheral Artery Questionnaire (PAQ) and Walking Impairment Questionnaire for peripheral arterial disease (specific health status). Quality of life was assessed on all patients at baseline, one, six, 12, 24, and 36 months.
At one month follow-up, there was significant improvement on the PAQ summary scale (mean change 31.4 points, p‹0.001 vs. baseline; minimum clinically important difference = 8 points) as well as most other disease-specific and generic scales. Additionally, there was significant improvement on the PAQ summary scale as well as most other scales that were sustained through the three year follow-up (mean change 28 points, p‹0.001).
“When coupled with the positive two year clinical outcomes reported earlier this year, which demonstrated minimal or no recurrence of lower extremity stenosis or occlusion in more than 80% of treated patients, with high patency and low target lesion revascularisation rates, these impressive results further validate the use of the Smart stent in the treatment of these patients,” said William A Gray, director of Endovascular Services, Cardiovascular Research Foundation, New York. “We will continue to build on this robust data set with the presentation of the STROLL Trial three year clinical data at a future medical congress.”