TY - JOUR
T1 - Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease
AU - Dani, Sourbha S.
AU - Majithia, Arjun
AU - Ssemaganda, Henry
AU - Robbins, Susan
AU - Bertges, Daniel J.
AU - Eldrup-Jorgensen, Jens
AU - Sedrakyan, Art
AU - Levy, Michael
AU - Siami, Flora S.
AU - Joynt Maddox, Karen E.
AU - Matheny, Michael
AU - Secemsky, Eric
AU - Resnic, Frederic
N1 - Funding Information:
This project was supported, in part, by a research grant from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology (NEST), an initiative funded by the U.S. Food and Drug Administration (FDA) through grant U01FD006292 . Its contents are solely the responsibility of the authors. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
Funding Information:
J.M. receives research support from the National Heart, Lung, and Blood Institute (R01HL143421), National Institute of Nursing Research (U01NR020555-01), and National Institute on Aging (R01AG060935, R01AG063759, and R21AG065526) and from Humana Inc. and serves on the Health Policy Advisory Council for the Centene Corporation (St. Louis, MO). E.S. has received research grants NIH/NHLBI K23HL150290, Food & Drug Administration, Harvard Medical School’s Shore Faculty Development Award, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips and honoraria for consulting/speaking from Abbott, Bayer, BD, Boston Scientific, Cook, CSI, Janssen, Medtronic, Philips, and VentureMed. The other authors have not identified a conflict of interest.
Funding Information:
This project was supported, in part, by a research grant from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology (NEST), an initiative funded by the U.S. Food and Drug Administration (FDA) through grant U01FD006292. Its contents are solely the responsibility of the authors. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
Publisher Copyright:
© 2023 SIR
PY - 2023/7
Y1 - 2023/7
N2 - Purpose: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. Materials and Methods: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. Results: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69–0.79]; P <.05, and HR, 0.89 [95% CI, 0.77–1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76–0.87]; P =.02, and HR, 0.77 [95% CI, 0.67–0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. Conclusions: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.
AB - Purpose: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database. Materials and Methods: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival. Results: A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69–0.79]; P <.05, and HR, 0.89 [95% CI, 0.77–1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76–0.87]; P =.02, and HR, 0.77 [95% CI, 0.67–0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. Conclusions: In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.
UR - http://www.scopus.com/inward/record.url?scp=85159062181&partnerID=8YFLogxK
U2 - 10.1016/j.jvir.2023.03.014
DO - 10.1016/j.jvir.2023.03.014
M3 - Article
C2 - 36972846
AN - SCOPUS:85159062181
SN - 1051-0443
VL - 34
SP - 1157-1165.e8
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 7
ER -