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

Ogawa, Yoshiaki; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O’Leary, Erin E.; Lottes, Aaron E.; Saunders, Alan T.; Dake, Michael D.

doi:10.1007/s00270-017-1673-6

Cited by 14 publications

(13 citation statements)

References 28 publications

(44 reference statements)

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“…The primary patency rate in the current study was 70.3% at 2 years, which also compares favorably to the 76.3% 2-year patency rate reported in the RCT [ 7 ], especially considering the real-world population in the current study. Positive results with the DES for patients with poor runoff vessels or chronic renal failure, which have been reported as risk factors for restenosis after BMS placement [ 2 ], are supportive of the DES usage in complicated situations [ 9 , 10 ].…”

Section: Discussionmentioning

confidence: 98%

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Kichikawa

Ichihashi

Yokoi³

et al. 2018

Cardiovasc Intervent Radiol

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Purpose A prospective, multicenter post-market surveillance study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions. Methods There were no exclusion criteria, and consecutive symptomatic patients with femoropopliteal lesions treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for > 50% diameter stenosis after recurrent clinical symptoms of peripheral arterial disease. Clinical benefit was defined as freedom from persistent or deteriorating ischemic symptoms. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. Results In this study, 905 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including a high incidence of diabetes (58.8%) and chronic kidney disease (43.6%). Additionally, 21.4% of patients were classified with critical limb ischemia. Lesions were complex, with an average length of 14.6 ± 9.6 cm (range 0.5–40 cm), 41.5% total occlusions, and 18.7% in-stent restenosis. In total, 1861 DES were placed in 1080 lesions. Two-year follow-up was obtained for > 90% of eligible patients. Freedom from TLR was 83.7%, and clinical benefit was 80.0% through 2 years. The 2-year primary patency rate was 70.3%. Rutherford classification significantly improved ( p < 0.01), with approximately 80% of patients classified as Rutherford class 0 or 1 at 2 years. Conclusion Despite more challenging lesion characteristics, 2-year results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the efficacy of the Zilver PTX DES in a complicated femoropopliteal lesion (Zilver PTX Post-Market Study in Japan; NCT02254837). Level of Evidence Post-market surveillance study, Level III.

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Section: Discussionmentioning

confidence: 98%

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Kichikawa

Ichihashi

Yokoi³

et al. 2018

Cardiovasc Intervent Radiol

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“…17,19 Okuno et al demonstrated independently worse clinical outcome after endovascular treatment of severely calcified at 12 months. 6,20 The INS is a stent promoted as specially designed for heavily calcified lesions, and its unique abilities 8,9 have been associated with the high primary patency rates (81%) and 12 month freedom from TLR (72%). 21,22 In contrast to expectations, in the initial primary analysis the two stents showed an opposite performance in none to mild and intermediate to severe calcified lesions.…”

Section: Discussionmentioning

confidence: 99%

“…18,23,24 On the other hand, DES demonstrated excellent results, with freedom from TLR above 90% at 12 months in patients with moderate to severely calcified lesions. 20 These contradictions remain unresolved and leave room for further clarification.…”

Section: Discussionmentioning

confidence: 99%

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

Haine

Schmid

Schindewolf

et al. 2019

European Journal of Vascular and Endovascular Surgery

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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.

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“…Table 1A (CKD vs. non-CKD) and 1B (ESRD vs. non-ESRD) list the baseline characteristics of the 16 studies included in this meta-analysis. The authors included observational studies comparing outcomes of lower extremity arterial interventions in patients with and without CKD/ESRD [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29]. There were a total of 44,138 patients with a mean follow-up of 48.9 ± 27.4 months and a maximum follow-up of 114 months.…”

Section: Study Characteristicsmentioning

confidence: 99%

Impact of Kidney Disease on Peripheral Arterial Interventions: A Systematic Review and Meta-Analysis

et al. 2020

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Background: There are limited data on outcomes of patients undergoing peripheral arterial disease (PAD) interventions who have comorbid CKD/ESRD versus those who do not have such comorbid condition. We performed a systematic review and meta-analysis to analyze outcomes in this patient population. Methods: Five databases were searched for studies comparing outcomes of lower extremity PAD interventions for claudication and critical limb ischemia (CLI) in patients with CKD/ESRD versus non-CKD/non-ESRD from January 2000 to June 2019. Results: Our study included 16 observational studies with 44,138 patients. Mean follow-up was 48.9 ± 27.4 months. Major amputation was higher with CKD/ESRD compared with non-CKD/non-ESRD (odds ratio [OR 1.97] [95% confidence interval [CI] 1.39-2.80], p = 0.001). Higher major amputations with CKD/ESRD versus non-CKD/ non-ESRD were only observed when indication for procedure was CLI (OR 2.27 [95% CI 1.53-3.36], p < 0.0001) but were similar for claudication (OR 1.15 [95% CI 0.53-2.49], p = 0.72). The risk of early mortality was high with CKD/ESRD patients undergoing PAD interventions compared with non-CKD/non-ESRD (OR 2.55 [95% CI 1.65-3.96], p < 0.0001), which when stratified based on indication, remained higher with CLI (OR 3.14 [95% CI 1.80-5.48], p < 0.0001) but was similar with claudication (OR 1.83 [95% CI 0.90-3.72], p = 0.1). Funnel plot of included studies showed moderate bias. Conclusions: Patients undergoing lower extremity PAD interventions for CLI who also have comorbid CKD/ESRD have an increased risk of experiencing major amputations and early mortality. Randomized trials to understand outcomes of PAD interventions in this at-risk population are essential.

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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

Cited by 14 publications

References 28 publications

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

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

Impact of Kidney Disease on Peripheral Arterial Interventions: A Systematic Review and Meta-Analysis

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