“No evidence of increased long-term mortality” with paclitaxel-eluting stent in new JACC analysis

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“Drug-eluting stents (DES) are important additions to the armamentarium of devices used for peripheral artery revascularization, associated with decreased rates of restenosis and target vessel revascularization”, Eric Secemsky (Boston, USA) and colleagues write in the Journal of the American College of Cardiology today.

They penned an editorial in response to the recent meta-analysis, published in The Journal of the American Heart Association (JAHA) and authored by Konstantinos Katsanos (Patras, Greece) and colleagues, which reported an association between peripheral paclitaxel-coated devices and increased long-term mortality. Secemsky et al write: “These findings have not been replicated in other data sources with extended follow-up.”

In their own analysis of patients admitted to US Centers for Medicare and Medicaid Services (CMS) with a principal diagnosis of peripheral arterial disease (PAD), Secemsky and colleagues did not find a statistically significant difference in mortality rates between those treated with a bare metal stent (BMS) and those with the Zilver PTX paclitaxel-coated balloon (Cook Medical). In fact, they conclude that they could find no evidence of increased long-term mortality following peripheral artery revascularisation with DES compared with BMS among CMS beneficiaries, which they suggest indicates “the safety of these devices in routine practice”.

The study investigators collected data from 1 December 2012 through to 30 September 2015. ICD-9-PCS codes were used to identify peripheral drug-eluting stent (DES) and BMS placement. For patients with repeated procedures, only the first procedure was included.

Plotting the temporal trends of BMS and DES overly quarterly time periods, Secemsky and colleagues found that the cumulative incidence of death had similar mortality through 4.1 years (51.7% for DES vs. 50.1% for BMS; log-rank=0.16), and that “this relationship persisted after stratification by critical limb ischaemia (CLI).”

Furthermore, there was no association between stent type and mortality after multivariable adjustment (hazard ratio [HR] for DES vs. BMS: 0.98; 95%CI 0.93–1.03; p=0.53). In addition, there was no adjusted relationship between stent type and death among patients with CLI (HR: 0.97; 95%CI 0.92-1.03; p=0.32) or ALI (HR: 0.99; 95%CI 0.81-1.21; p=0.95).

The authors write: “We observed a gradual uptake of DES use and found no difference in mortality between DES and BMS through the end of follow-up. This finding remained after multivariable adjustment, and among patients with CLI or acute limb ischaemia (ALI). Peripheral artery revascularisation has been challenged by high rates of restenosis and need for re-intervention. The first DES indicated for femoropopliteal artery revascularisation, the paclitaxel-eluting Zilver PTX, was approved in November 2012 after demonstrating improved patency at 12 months compared with balloon angioplasty and BMS. Follow-up data through five years have shown persistent efficacy over these other devices, supporting their routine use.”

However, the authors do acknowledge that the long-term safety of these devices has not been well-established, writing that this is “mainly due to their limited duration on the market”. Regarding the Katsanos et al meta-analysis, which they cite as the motivator for their current analysis, they caution: “Due to the significant implications of these findings and the increasing use of peripheral DES, investigation of this relationship [between mortality and paclitaxel dose] in other data sources is needed urgently.”

Listing the limitations of their study, Secemsky and co-authors write: “This analysis is limited by an inability to localise the lesion of interest, possible misclassification due to use of claims codes, lack of data on outpatient procedures and DCBs (no ICD-9-PCS code), the potential influence of unmeasured confounding, and the inability to determine specific causes of death. In addition, this CMS population was older and had more comorbidities, including CLI, compared with the Katsanos et al meta-analysis.”

The Vascular Leaders Forum is currently taking place in Washington DC, USA (1–2 March 2019), where participants are discussing the use of paclitaxel-coated and –eluting devices following the Katsanos et al publication. Follow updates from our live blog here.

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