Thirty six-month follow-up data for 161 patients from RESILIENT, a randomised, multicentre trial which compared primary nitinol stent implantation with balloon angioplasty in moderate-length (up to 15cm) lesions in the superficial femoral and proximal popliteal arteries were published in the February issue of Journal of Endovascular Therapy. The current analysis demonstrated that there is sustained benefit of femoropopliteal stenting over angioplasty out to three years. However, an accompanying commentary asks if these results are enough to warrant a change in practice that could result in a dramatic increase in treatment costs.
For the long-term study, investigators John R Laird, UC Davis Health System, Sacramento, USA et al randomised 206 patients (143 men; mean age 67 years) with intermittent claudication in a 2:1 ratio to treatment with nitinol stents (Lifestent self-expanding stent from Bard Peripheral Vascular) or balloon angioplasty at 24 US and European centres. The cohort was followed for three years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment.
After 36 months, no significant difference was found between the stent and angioplasty groups in survival (90% vs. 91.7%, p‰Û_=‰Û_0.71) or in occurrence of major adverse events (75.2% vs. 75.2%, p‰Û_=‰Û_0.98). However, freedom from further intervention—target lesion revascularisation—was significantly better in the stent group (75.5%) compared to the angioplasty group (41.8%), p<0.0001.
There was no difference in quality of life between the angioplasty and stent groups at two and three years following intervention based upon the SF-8 questionnaire and WIQ. There was, however, a significant improvement in quality of life for both treatment groups compared to baseline at all study time intervals.
The 12-month freedom from target lesion revascularisation was 87.3% for the stent group vs. 45.2% for the angioplasty group (pplus provisional stenting. In this analysis, the difference between groups for freedom from target lesion revascularisation was less pronounced, although still favouring the primary stent (81.5% vs. 66.9%). Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond one year. The rate of stent fracture remained low, and stent fracture was infrequently associated with any adverse clinical sequelae. At 18 months, a 4.1% (12/291) stent fracture rate was documented.
These results led the authors to conclude that primary implantation of a nitinol stent is associated with better long-term results than balloon angioplasty. However, the author of an accompanying commentary points out that no significant difference in freedom from target lesion revascularisation was found between primary stent and angioplasty plus provisional stenting at the 36-month follow-up.
Do the results justify a more expensive primary stenting policy?
In the commentary, Mark G Davies, Methodist DeBakey Heart & Vascular Center, Department of Cardiovascular Surgery, The Methodist Hospital, Houston, USA writes: “Importantly, there was no difference in the outcomes of primary stenting and balloon angioplasty plus provisional stenting at the later time points: freedom from target lesion revascularisation at 36 months was 75.5% for the primary stent group compared to 70.1% for the angioplasty plus provisional stent group.”
He also states that “clinically-driven target lesion revascularisation and quality of life were not different between the primary stenting and angioplasty groups, which raised the question of the discrepancy between anatomical outcomes and the patient-centred outcomes in this patient population.”
Davies concludes that “while the study is positive and satisfies its hypothesis and goal, the clinical utility of the strategy adopted and the disappointing lack of difference in quality of life at two to three years must raise the question whether this dataset alone should mandate a change in practice and the dramatic increase in supply costs associated with a primary stenting policy.”