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Vascular stent improved quality of life in patients with femoral artery disease
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Patients with peripheral arterial disease experienced significantly improved quality of life when treated with the S.M.A.R.T. vascular stent system, according to data presented at VIVA 2013.
In the multicenter, prospective STROLL trial, 250 patients with PAD in the superficial femoral artery received one or more S.M.A.R.T. stents (Cordis Corp.) in addition to percutaneous transluminal angioplasty. All participants had Rutherford class 2 to 4 symptoms. Investigators measured QOL at baseline and after 1, 6, 12, 24 and 36 months according to the Short Form-12 scale, EQ-5D scale, Peripheral Artery Questionnaire (PAQ) and Walking Impairment Questionnaire.
At 1 month, patients had significant improvements in PAQ summary scores (mean change, 31.4 points vs. baseline; P<.001), which persisted through the duration of follow-up (mean change at 3 years, 28 points; P<.001). Similar results were observed for most other incorporated QOL assessments.
“These new findings show the quality of life benefit was very large and sustained over at least 3 years in patients with superficial femoral artery disease treated with the S.M.A.R.T. stent,” David Safley, MD, consulting cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., said in a press release. “Currently, there are limited published reports evaluating the impact and durability of these types of treatments on patient-reported outcomes beyond 1 year, which makes these findings noteworthy to clinicians evaluating treatment options for PAD patients.”
The results from the STROLL trial follow 2-year clinical outcomes data from a trial earlier this year [KK1] in which more than 80% of S.M.A.R.T. stent recipients experienced no or minimal recurrence of stenosis or occlusion in the lower extremities, with low rates of target lesion revascularization and high patency, according to the release.
For more information:
Safley D. Late-breaking clinical trials. Presented at: VIVA Conference 2013; Oct. 8-11, 2013; Las Vegas.
Disclosure: Cardiology Today could not confirm disclosures at the time of publication.
Perspective
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Jay Giri, MD, MPH
Prior reports from the STROLL trial have added to the fairly robust body of literature supporting the use of self-expanding nitinol stents for the treatment of relatively short segment (< 15 cm) superficial femoral artery (SFA) disease. Firm conclusions regarding the S.M.A.R.T. stent in particular were difficult to draw, given the absence of a comparator therapy in STROLL.
The current study is unique in its focus on patient-centered quality of life (QOL) outcomes. The immediate and sustained positive results on several objective measures of QOL found in this cohort of patients treated with SFA stents is encouraging news for endovascular interventionists. Similar effects were noted in the NHLBI-sponsored CLEVER trial of aortoiliac disease, in which stenting was associated with significant improvements in several measures of QOL versus a supervised exercise-walking program. This was in spite of the failure of iliac stenting to show superiority with regards to the primary peak treadmill-walking endpoint in CLEVER. Especially in the emerging era of value-based care, the onus will be on interventionists to demonstrate objective benefits of endovascular therapies to justify their continued use and reimbursement.
Rigorous assessment and reporting of QOL in studies of lower extremity revascularization represent an important tool to demonstrate the usefulness of endovascular technologies in patient care. However, these conclusions may only be accepted by the medical community and policy-makers if studies are designed to evaluate true comparative effectiveness with a control arm.
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