Research ExplorerPublicationsSafety and Effectiveness of Paclitaxel Drug-Coated Devices i...

Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD

Standard

Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. / Hess, Connie N; Patel, Manesh R; Bauersachs, Rupert; Anand, Sonia; Debus, Sebastian; Mark R, Nehler; Fanelli, Fabrizio; Yeh, Robert W; Secemsky, Eric A; Beckmann, Joshua A ; Mauri, Laura; Govsyeyev, Nicholas; Capell, Warren H; Brackin, Taylor; Berkowitz, Scott D; Muehlhofer, Eva; Haskell, Lloyd P; Hiatt, William R; Bonaca, Marc P.

In: J AM COLL CARDIOL, Vol. 78, No. 18, 02.11.2021, p. 1768-1778.

Research output: SCORING: Contribution to journal › Other (editorial matter etc.) › Research

Harvard

Hess, CN, Patel, MR, Bauersachs, R, Anand, S, Debus, S, Mark R, N, Fanelli, F, Yeh, RW, Secemsky, EA, Beckmann, JA, Mauri, L, Govsyeyev, N, Capell, WH, Brackin, T, Berkowitz, SD, Muehlhofer, E, Haskell, LP, Hiatt, WR & Bonaca, MP 2021, 'Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD', J AM COLL CARDIOL, vol. 78, no. 18, pp. 1768-1778. https://doi.org/10.1016/j.jacc.2021.08.052

APA

Hess, C. N., Patel, M. R., Bauersachs, R., Anand, S., Debus, S., Mark R, N., Fanelli, F., Yeh, R. W., Secemsky, E. A., Beckmann, J. A., Mauri, L., Govsyeyev, N., Capell, W. H., Brackin, T., Berkowitz, S. D., Muehlhofer, E., Haskell, L. P., Hiatt, W. R., & Bonaca, M. P. (2021). Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J AM COLL CARDIOL, 78(18), 1768-1778. https://doi.org/10.1016/j.jacc.2021.08.052

Vancouver

Hess CN, Patel MR, Bauersachs R, Anand S, Debus S, Mark R N et al. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J AM COLL CARDIOL. 2021 Nov 2;78(18):1768-1778. https://doi.org/10.1016/j.jacc.2021.08.052

Bibtex

@article{62b5f741ae3644eb859e36d8a6e398e7,
title = "Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD",
abstract = "Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality.Objectives: This study assessed DCD safety and effectiveness in LER for PAD.Methods: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models.Results: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 0.57) were observed.Conclusions: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).",
keywords = "Antineoplastic Agents, Phytogenic/therapeutic use, Cardiovascular Diseases/diagnosis, Chronic Limb-Threatening Ischemia/diagnosis, Drug-Eluting Stents, Endovascular Procedures/adverse effects, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Outcome Assessment, Health Care, Paclitaxel/therapeutic use, Peripheral Arterial Disease/diagnosis, Postoperative Complications/diagnosis, Proportional Hazards Models",
author = "Hess, {Connie N} and Patel, {Manesh R} and Rupert Bauersachs and Sonia Anand and Sebastian Debus and {Mark R}, Nehler and Fabrizio Fanelli and Yeh, {Robert W} and Secemsky, {Eric A} and Beckmann, {Joshua A} and Laura Mauri and Nicholas Govsyeyev and Capell, {Warren H} and Taylor Brackin and Berkowitz, {Scott D} and Eva Muehlhofer and Haskell, {Lloyd P} and Hiatt, {William R} and Bonaca, {Marc P}",
year = "2021",
month = nov,
day = "2",
doi = "10.1016/j.jacc.2021.08.052",
language = "English",
volume = "78",
pages = "1768--1778",
journal = "J AM COLL CARDIOL",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "18",

}

RIS

TY - JOUR

T1 - Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD

AU - Hess, Connie N

AU - Patel, Manesh R

AU - Bauersachs, Rupert

AU - Anand, Sonia

AU - Debus, Sebastian

AU - Mark R, Nehler

AU - Fanelli, Fabrizio

AU - Yeh, Robert W

AU - Secemsky, Eric A

AU - Beckmann, Joshua A

AU - Mauri, Laura

AU - Govsyeyev, Nicholas

AU - Capell, Warren H

AU - Brackin, Taylor

AU - Berkowitz, Scott D

AU - Muehlhofer, Eva

AU - Haskell, Lloyd P

AU - Hiatt, William R

AU - Bonaca, Marc P

PY - 2021/11/2

Y1 - 2021/11/2

N2 - Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality.Objectives: This study assessed DCD safety and effectiveness in LER for PAD.Methods: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models.Results: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 0.57) were observed.Conclusions: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).

AB - Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality.Objectives: This study assessed DCD safety and effectiveness in LER for PAD.Methods: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models.Results: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (Pinteraction = 0.88) and safety of rivaroxaban with respect to bleeding (Pinteraction = 0.57) were observed.Conclusions: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216).

KW - Antineoplastic Agents, Phytogenic/therapeutic use

KW - Cardiovascular Diseases/diagnosis

KW - Chronic Limb-Threatening Ischemia/diagnosis

KW - Drug-Eluting Stents

KW - Endovascular Procedures/adverse effects

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Outcome Assessment, Health Care

KW - Paclitaxel/therapeutic use

KW - Peripheral Arterial Disease/diagnosis

KW - Postoperative Complications/diagnosis

KW - Proportional Hazards Models

UR - https://pubmed.ncbi.nlm.nih.gov/34711335/

U2 - 10.1016/j.jacc.2021.08.052

DO - 10.1016/j.jacc.2021.08.052

M3 - Other (editorial matter etc.)

C2 - 34711335

VL - 78

SP - 1768

EP - 1778

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 18

ER -