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

Haine, Axel; Schmid, Martin J; Schindewolf, Marc; Lenz, Armando; Bernhard, Sarah M.; Drexel, Heinz; Baumgartner, Iris; Dopheide, Jörn F. (2019). Comparison Between Interwoven Nitinol and Drug Eluting Stents for Endovascular Treatment of Femoropopliteal Artery Disease. European journal of vascular and endovascular surgery EJVES, 58(6), pp. 865-873. Elsevier 10.1016/j.ejvs.2019.09.002

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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 0.56-3.31). A significant interaction between stents used and grade of calcification was observed (p = .006). HR for CD-TLR was 6.4 (95% CI 1.3-32.5) in none to mildly calcified favouring INS, and 0.3 (95% CI 0.1-1.3) for moderate to severely calcified lesions favouring DES. Stent efficiency did not differ comparing treatment of popliteal lesions (HR 0.80; 95% CI 0.21-3.13). Sensitivity analyses confirmed the primary efficacy outcome for either adjusted (HR 1.16; 95% CI 0.51-2.62) or matched analysis (HR 1.35; 95% CI 0.50-3.62)). Interaction of stents with calcification grade was lost for adjusted (HR 0.28; 95% CI 0.06-1.19) and matched analysis (HR 0.53; 95% CI 0.10-2.91). 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Haine, Axel; Schindewolf, Marc; Lenz, Armando; Bernhard, Sarah Maike; Drexel, Heinz; Baumgartner, Iris and Dopheide, Jörn Fredrik

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1078-5884

Publisher:

Elsevier

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

07 Nov 2019 12:00

Last Modified:

19 Dec 2019 13:17

Publisher DOI:

10.1016/j.ejvs.2019.09.002

PubMed ID:

31668949

Uncontrolled Keywords:

drug eluting stents femoropopliteal segment lower extremity revascularisation patency peripheral artery disease self expanding interwoven nitinol stent

BORIS DOI:

10.7892/boris.134602

URI:

https://boris.unibe.ch/id/eprint/134602

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