Real-World MARIS Registry Supports Stenting for SFA Disease

September 22, 2014—The Journal of Endovascular Therapy announced the publication of a study by Hans Krankenberg, MD, et al, that sought to investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants (2014;2:463–471). The registry evaluated the Maris nitinol stent that was developed by Invatec, which Medtronic, Inc. acquired in 2010.

As summarized in the Journal of Endovascular Therapy, patients presenting with symptomatic SFA stenosis > 70% were consecutively enrolled in the 13-center MARIS prospective registry of the Maris device.

The investigators advised that there was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age, 67.4 ± 9.2 years) had 1,050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5 ± 9.6 cm (range, 0.5–44; median, 8); more than a third of the lesions (450; 42.9%) were total occlusions. The primary endpoint was the need for clinically driven TLR at 12 months.

The MARIS investigators reported that acute technical success was achieved in 1,042 lesions (99.2%). At 12 months, restenosis occurred in 187 lesions (23.7%) and reocclusion in 79 (10%). The primary endpoint of TLR at 12 months was reached by 136 patients (17.2%). The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender (odds ratio [OR], 0.5; 95% confidence interval [CI], 0.3 to 0.7; P < .001] and lesion length > 20 cm versus 10 cm (OR, 2.7; 95% CI, 1.1 to 6.6; P = .029) and 10 to 20 cm versus 10 cm (OR, 1.9; 95% CI, 1.0 to 4.1; P = .047).

The MARIS investigators concluded that stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

The press release from the Journal of Endovascular Therapy advised that in an accompanying commentary in the publication, Mark G. Davies, MD, asserts that the “real-world” study group is actually representative of a narrower set of patients, largely because the median lesion length was less than 10 cm—a length that has previously shown good success with intervention (2014;21;472­–­473). Dr. Davies notes that, although the study validates that SFA stenting is producing satisfactory patency results, patient quality of life and functionality measures might better represent success.

He cautioned, “Finally, we need to address the need for any intervention in a claudicant. In an era of reduced resources, we still must weight the benefit of best medical therapy over any intervention for claudication, especially in those with Rutherford category 1 or 2 disease. The CLEVER trial (Claudication: Exercise Versus Endoluminal Revascularization) results remind us that optimal medical therapy can be as effective as percutaneous therapy, and the jury is still out on whether intervention or optimum medical intervention is first line for iliac disease.”