Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD
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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, Jahrgang 78, Nr. 18, 02.11.2021, S. 1768-1778.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › Andere (Vorworte u.ä.) › Forschung
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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 -