Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Feb 16;10(4):e018149.
doi: 10.1161/JAHA.120.018149. Epub 2021 Feb 6.

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration

Jorge Antonio Gutierrez  1   2   3 , Sunil V Rao  1   2   3 , William Schuyler Jones  2   3 , Eric A Secemsky  4   5 , Aaron W Aday  6 , Lin Gu  1 , Ryan D Schulteis  1 , Mitchell W Krucoff  1   2   3 , Roseann White  7 , Ehrin J Armstrong  8 , Subhash Banerjee  9   10 , Shirling Tsai  9   10 , Manesh R Patel  2   3 , Rajesh V Swaminathan  1   2   3
Affiliations

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration

Jorge Antonio Gutierrez et al. J Am Heart Assoc. .

Abstract

BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long-term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision (ICD-10) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability-weighted estimates, was used to evaluate the association between PCDs and long-term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non-PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non-PCD groups, respectively. The adjusted hazard for all-cause mortality for patients treated with a PCD versus non-PCD was 1.06 (95% CI, 0.95-1.18, P=0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non-PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long-term, all-cause mortality associated with PCD use. Cause-specific mortality rates were similar between treatment groups.

Keywords: paclitaxel; peripheral artery disease; peripheral endovascular intervention.

PubMed Disclaimer

Conflict of interest statement

Dr. Gutierrez discloses the following relationships: a Veterans Health Administration Career Development Award and consulting for Janssen Pharmaceuticals and Amgen Inc. Dr. Swaminathan discloses the following relationships: research support from ACIST Medical, site principal investigator for Cardiovascular Systems Inc., and consulting for Medtronic. Dr. Schuyler Jones discloses research support from Medtronic. Dr. Secemsky discloses the following relationships: research grants to Beth Israel Deaconess Medical Center, AstraZeneca, Becton Dickinson Bard Medical, Boston Scientific, Cook Medical, CSI, Medtronic, Philips, and University of California San Francisco and consulting for Becton Dickinson Bard Medical, Cook Medical, CSI, Janssen, Medtronic, and Philips. Dr. Armstrong discloses the following relationships: consultant to Abbott Vascular, Boston Scientific, Cardiovascular Systems, Gore, Intact Vascular, Medtronic, Philips, and PQ Bypass. The remaining authors have no disclosures to report.

Figures

Figure 1
Figure 1. Kaplan–Meier curve for overall survival: drug coated vs. non–drug coated.
Figure 2
Figure 2. Kaplan–Meier curve for overall survival stratified by presentation (claudication and CLI).
CLI indicates critical limb ischemia.
Figure 3
Figure 3. Specific‐cause mortality: non–drug coated vs. drug coated.
CV, indicates cardiovascular; CVD, cerebrovascular; DM, diabetes mellitus–related complication; GI, gastrointestinal; GU, genitourinary.
See this image and copyright information in PMC

Comment in

References

    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;7:e011245. DOI: 10.1161/JAHA.118.011245 . - DOI - PMC - PubMed
    1. Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA, Beckman JA, Mustapha J, Rosenfield K, Yeh RW. Association of survival with femoropopliteal artery revascularization with drug‐coated devices. JAMA Cardiol. 2019;4:332–340. DOI: 10.1001/jamacardio.2019.0325 . - DOI - PMC - PubMed
    1. Long CA, Zepel L, Greiner MA, Hammill BG, Patel MR, Jones WS. Use and 1‐year outcomes with conventional and drug‐coated balloon angioplasty in patients with lower extremity peripheral artery disease. Am Heart J. 2019;217:42–51. DOI: 10.1016/j.ahj.2019.07.014 . - DOI - PubMed
    1. Velarde KE, Romesser JM, Johnson MR, Clegg DO, Efimova O, Oostema SJ, Scehnet JS, DuVall SL, Huang GD. An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system. Contemp Clin Trials Commun. 2018;11:107–112. DOI: 10.1016/j.conctc.2018.07.001 . - DOI - PMC - PubMed
    1. Maynard C, Trivedi R, Nelson K, Fihn SD. Disability rating, age at death, and cause of death in U.S. veterans with service‐connected conditions. Mil Med. 2018;183:e371–e376. - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources