Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices

Michael D Dake,Osamu Iida,Michael R Jaff,Marc Bosiers,Hiroyoshi Yokoi,Thomas Zeller,Gary M Ansel,Marc Schermerhorn,Erin E O’Leary,Andrew Holden,Alan T Saunders,Aaron E Lottes

doi:10.1007/s00270-019-02324-4

Abstract

PurposePatient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.MethodsData from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan–Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.ResultsIn the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality.ConclusionAnalyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality.Level of EvidenceZilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.

Highlights

An endovascular-first approach is commonly used to treat symptomatic femoropopliteal peripheral artery disease (PAD) [1, 2]
In the randomized controlled trial (RCT), there were 336 patients treated with the drug-eluting stent (DES) and 143 patients treated with percutaneous transluminal angioplasty (PTA) or bare metal stent (BMS)
Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality

Summary

Introduction

An endovascular-first approach is commonly used to treat symptomatic femoropopliteal peripheral artery disease (PAD) [1, 2]. A meta-analysis that grouped both drug-eluting stents (DES) and drug-coated balloons (DCB) together indicated a higher incidence of late all-cause mortality for paclitaxel-based devices compared to uncoated PTA or BMS at 2 years up to 5 years [12]. This difference in mortality was attributed directly to paclitaxel no etiology was postulated for the increased rate. To evaluate the long-term mortality rate of the DES, the patient-level data from the Zilver PTX RCT were analyzed based on treatment received, and the results for patients treated with the DES were compared to patients treated only with PTA and/or BMS. Supporting evidence from the Japan Zilver PTX and Zilver BMS postmarket studies (PMS) provides long-term mortality information from a broader patient population

Methods

Results

Conclusion