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Multicenter Study
. 2017 Nov;40(11):1669-1677.
doi: 10.1007/s00270-017-1673-6. Epub 2017 May 9.

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan

Yukihisa Ogawa  1 , Hiroyoshi Yokoi  2 , Takao Ohki  3 , Kimihiko Kichikawa  4 , Masato Nakamura  5 , Kimihiro Komori  6 , Shinsuke Nanto  7 , Erin E O'Leary  8 , Aaron E Lottes  8 , Alan T Saunders  8 , Michael D Dake  9
Affiliations
Multicenter Study

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan

Yukihisa Ogawa et al. Cardiovasc Intervent Radiol. 2017 Nov.

Abstract

Purpose: Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF.

Methods: This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency.

Results: Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively.

Conclusion: This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF.

Level of evidence: Level 3, Post-Market Surveillance Study.

Keywords: Chronic renal failure; Drug-eluting stent; Femoropopliteal artery; Paclitaxel-eluting stent; Peripheral artery disease.

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Conflict of interest statement

Conflict of interest

Dr. Yokoi has received speakers’ fees from Cook Medical. Dr. Ohki has received research fees for clinical trials. Drs. O’Leary and Lottes and Mr. Saunders are paid employees of Cook Research Incorporated, a contract research organization and Cook Group Company. Dr. Dake is a member of the scientific advisory board for W.L. Gore and Associates and has received consulting fees from Cook Medical and Novate Medical. All other authors have reported that they have no conflicts relevant to the contents of this paper to disclose.

Ethical Approval and Informed Consent

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, informed consent processes were determined by each institution’s ethical committee policy to specify whether informed consent was necessary or outcome data could be abstracted while protecting patient’s rights without requiring individual patient consent.

Figures

Fig. 1
Fig. 1
Patient flowchart. Of the 905 patients enrolled in the study, 321 patients were in the CRF group and 584 patients were in the non-CRF group. At 2 years, 224 patients in the CRF group and 486 patients in the non-CRF group remained in the study; death (all-cause), withdrawals, and lost to follow-up through 2 years are shown
Fig. 2
Fig. 2
Freedom from TLR. Kaplan–Meier curves of freedom from clinically driven target lesion revascularization (TLR) for patients in the non-CRF group (black line) versus patients in the CRF group (red line). Freedom from TLR was 84.9% in the non-CRF group versus 81.4% in the CRF group through 2 years (p = 0.24, log-rank test)
Fig. 3
Fig. 3
Primary patency. Kaplan–Meier curves of primary patency for patients in the non-CRF group (black line) versus patients in the CRF group (red line). Primary patency was 70.3% in the non-CRF group versus 70.7% in the CRF group through 2 years (p = 0.95, log-rank test)
Fig. 4
Fig. 4
Post-treatment clinical benefit. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia (i.e., claudication, rest pain, ulcer, or tissue loss) after the initial study treatment. Kaplan–Meier curves of clinical benefit for patients in the non-CRF group (black line) versus patients in the CRF group (red line). Clinical benefit was 82.5% in the non-CRF group versus 74.1% in the CRF group through 2 years (p < 0.01, log-rank test)
Fig. 5
Fig. 5
Rutherford classification. Rutherford classification significantly improved for both groups from pre-procedure (p < 0.001). The incidence of CLI was reduced through 1 and 2 years in both groups
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