Stent Placement versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery: A Prospective, Multi-centre, Randomized Trial
Background—Stenting has been shown to improve patency after femoral artery revascularization in comparison to balloon angioplasty (PTA). Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery (PA).
Methods and Results—This prospective, randomized, multi-centre trial compares primary nitinol stent (NS) placement to PTA in patients with peripheral artery disease Rutherford-Becker class (RC) 2-5 who had a de-novo lesion in the PA. The primary study endpoint was 1-year primary patency defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound. Secondary endpoints included target lesion revascularization (TLR) rate and changes in RC. Provisional stent placement was considered as TLR and loss of primary patency.Two-hundred-forty-six patients were included in this trial. The mean target lesion length was 42.3mm. One-hundred-ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the NS group (67.4%) than in the PTA group (44.9%, P=0.002). TLR rates were 14.7% and 44.1% (P=0.0001). However, when provisional NS placement was not considered as TLR and loss in patency no significant differences prevailed between the study groups (67.4% vs. 65.7%, P=0.92 for primary patency). Approximately 73% of patients in the PTA group and 77% in the NS group showed an improvement of at least one RC (P=0.31).
Conclusions—Primary NS of obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency, only if provisional stenting is considered as TLR. Provisional stenting, as part of a PTA strategy has equivalent 1-year patency, and should be preferred over primary stenting.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT00712309.
- Received February 6, 2013.
- Revision received April 21, 2013.
- Accepted April 29, 2013.