Comparison Between Interwoven Nitinol and Drug Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease

Abstract

WHAT THIS PAPER ADDS This analysis compares the efficiency of interwoven nitinol stents with drug eluting stents for treatment of atherosclerotic lesions in the femoropopliteal artery with regard to clinically driven target lesion re-intervention at 12 months. Inverse probability treatment weighting was used to remove biased estimates given by data collection from non-randomly assigned treatment. The data do not provide conclusive evidence to favour one stent over the other including calcified lesions or popliteal artery involvement. Randomised controlled comparisons of different stent platforms with longer term follow up are needed to individualise treatment for patients with symptomatic femoropopliteal lesions. Objectives: Information on performance of different stent platforms in endovascular revascularisation of femoropopliteal lesions is controversial and scarce. Methods: Interwoven nitinol (INS, Supera) were compared with drug eluting (DES, Zilver PTx) stents with primary intervention for femoropopliteal lesions. The primary endpoint was time to clinically driven target lesion revascularisation (CD-TLR) within 12 months. Secondary endpoints were time to death, amputation and composite of death, amputation and CD-TLR. Due to the retrospective analysis, inverse probability treatment weighted (IPTW) Cox models were calculated to reach more similar patient populations with weights for the average treatment effect of the population. The two sensitivity analyses were propensity score matching and adjustment for covariates. Results: At 12 months, the cumulative incidence of CD-TLR in the INS group (13%) and DES group (18%) did not differ (HR 1.36, 95% CI 0.56e3.31). A significant interaction between stents used and grade of calcification was observed (p ¼ .006). HR for CD-TLR was 6.4 (95% CI 1.3e32.5) in none to mildly calcified favouring INS, and 0.3 (95% CI 0.1e1.3) for moderate to severely calcified lesions favouring DES. Stent efficiency did not differ comparing treatment of popliteal lesions (HR 0.80; 95% CI 0.21e3.13). Sensitivity analyses confirmed the primary efficacy outcome for either adjusted (HR 1.16; 95% CI 0.51e2.62) or matched analysis (HR 1.35; 95% CI 0.50e3.62)). Interaction of stents with calcification grade was lost for adjusted (HR 0.28; 95% CI 0.06e 1.19) and matched analysis (HR 0.53; 95% CI 0.10e2.91). Conclusion: Both stents (INS and DES) showed comparable results regarding CD-TLR in femoropopliteal lesions, so that one stent could not be favoured over the other, even for calcified or popliteal artery lesions.

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

“…8,11 In a retrospective single-center comparison of participants with an average lesion length of 120 mm (severe calcification 39%/40%, critical limb ischemia 27%/29%), polymer-free DES led to comparable results regarding 12 month cdTLR as interwoven nitinol stents (18% vs 13%, p=0.50). 25 However, 12 and 24 month freedom from cdTLR with the POLARIS stent was comparable with that reported from polymer-free DES (92% at 12 months and 86% at 24 months; mean lesion length 70 mm, 33% CTOs, 37% severe calcifications) 14 and from polymer-coated DES (95.5% at 12 months and 87.3% at 24 months; mean lesion length 87 mm, 31% CTOs, 40% severe calcifications). 16,26 Post hoc comparison of time to cdTLR concerning lesion length in our study gives an indication of less effectiveness of the POLARIS stent in long lesions, which, however, needs further examination.…”

Timing of endovascular repair impacts long-term outcomes of uncomplicated acute type B aortic dissection

“…Inverse probability treatment weighting (IPTW) was used to account for selection bias and to balance baseline covariates between groups. 22 To calculate weights, a propensity score was first generated for each patient from a logistic regression model with the subacute group as the response variable and 25 baseline patient characteristics as covariates (Table I). Based on the propensity score, a stabilized weight was then calculated.…”

One Year on: Test Your Knowledge from December 2019

“…Primary endpoint was time to clinically driven target lesion revascularisation (CD-TLR) within 12 months. Which of the following is correct?15 A. cumulative incidence of CD-TLR was similar in the two groups B. cumulative incidence of CD-TLR was higher in the INS group C. DES were better in highly calcified lesions D. DES were better in moderately calcified lesions E. None of the above 16. A study investigated the effectiveness of color duplex ultrasound (CDU) plus contrast-enhanced ultrasound (CEUS) versus computed tomography angiography (CTA) for surveillance in patients with isolated mesenteric artery dissection (IMAD).…”