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SVS PSO Surveillance of Paclitaxel Mortality

Society for Vascular Surgery Patient Safety Organization Surveillance of Paclitaxel Mortality in the Vascular Quality InitiativeAuthors: Daniel Bertges, MD, Jens Eldrup-Jorgensen, MD, Fred Resnic, MD, et.al.

In December, 2018, a meta-analysis of randomized trials of paclitaxel devices for the treatment of femoral-popliteal disease reported higher 2 and 5 year mortality in patients treated with paclitaxel devices.1  These findings were subsequently validated by an FDA analysis – a potentially concerning signal of increased long-term mortality in study subjects treated with paclitaxel-coated products compared to patients treated with uncoated devices prompting 3 letters of notification to providers.  For further information please see the 3 prior FDA communications and the executive summary of the June 2019 Circulatory System Devices Panel Meeting.2-5

In response to this mortality signal, the Society for Vascular Surgery Patient Safety Organization has conducted surveillance of mortality in the Vascular Quality Initiative Peripheral Vascular Intervention registry. The analysis was conducted in collaboration with Dr. Fred Resnic at the Lahey Clinic using Data Extraction and Longitudinal Trend Analysis (DELTA), a risk adjusted software application designed for signal detection in clinical registries. Full details about the study are available at clinicaltrials.gov under the identifier NCT04110288.

This report summarizes the first results of our surveillance program. We compared paclitaxel drug coated balloons to plain balloon angioplasty and paclitaxel drug eluting stents to bare metal stents.  At present, there is no mortality signal discernment in real world data using the VQI registry (Table). Kaplan Meier life table analysis is shown in Figures 1 and 2.

In an effort to provide VQI members with the most recent data, we plan to update the analysis on a biannual basis moving forward which will benefit from a larger sample size and longer follow-up. Please contact us (daniel.bertges@uvmhealth.org or jorgej@mmc.org) or PSO staff (jwadzinski@svspso.org or c.bosela@svspso.org) with any comments or questions.

DELTA, Data Extraction and Longitudinal Trend Analysis; HR, hazard ratio; CI, confidence interval; SES, self-expanding stent

Figure 1.   Kaplan‐Meier Survival Plot for estimated two‐year freedom from death due to any cause for paclitaxel drug coated balloon (green) as compared with plain balloon treatment (blue).

Figure 2.  Kaplan‐Meier Survival Plot for estimated two‐year freedom from death due to any cause for paclitaxel eluting stent (green) as compared with bare metal stent treatment (blue).


1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245
2. https://www.fda.gov/medical-devices/letters-health-care-providers/treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting-stents
3. https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting
4. https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel
5. https://www.fda.gov/media/127698/download

Daniel Bertges, MD
Associate Professor of Surgery
University of Vermont Medical Center
Chair, SVS VQI PVI Committee

Jens Eldrup-Jorgensen, MD
Professor of Surgery
Tufts University School of Medicine
Maine Medical Center
Medical Director, SVS PSO




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