Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.
Aged
Angioplasty, Balloon
/ adverse effects
Cardiovascular Agents
/ administration & dosage
Coated Materials, Biocompatible
Female
Humans
Intermittent Claudication
/ diagnostic imaging
Male
Middle Aged
Paclitaxel
/ administration & dosage
Peripheral Arterial Disease
/ diagnostic imaging
Randomized Controlled Trials as Topic
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Vascular Access Devices
DCB
mortality
paclitaxel
primary patency
target lesion revascularization
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
04
06
2020
accepted:
03
07
2020
pubmed:
25
8
2020
medline:
29
6
2021
entrez:
25
8
2020
Statut:
ppublish
Résumé
Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality. To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm. In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.
Sections du résumé
BACKGROUND
Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.
OBJECTIVES
To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.
METHODS
The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.
RESULTS
The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.
CONCLUSIONS
In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.
Identifiants
pubmed: 32830913
doi: 10.1002/ccd.29152
pmc: PMC7693077
doi:
Substances chimiques
Cardiovascular Agents
0
Coated Materials, Biocompatible
0
Paclitaxel
P88XT4IS4D
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1087-1099Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
Références
N Engl J Med. 2004 Jan 15;350(3):221-31
pubmed: 14724301
Catheter Cardiovasc Interv. 2018 Jun;91(7):1320-1328
pubmed: 29332315
Catheter Cardiovasc Interv. 2020 Nov;96(5):1087-1099
pubmed: 32830913
Circ Cardiovasc Interv. 2019 Jun;12(6):e007702
pubmed: 31195825
Circulation. 2019 Oct;140(14):1145-1155
pubmed: 31567024
J Am Heart Assoc. 2018 Dec 18;7(24):e011245
pubmed: 30561254
Cardiovasc Intervent Radiol. 2020 Jan;43(1):8-19
pubmed: 31502026
J Endovasc Ther. 2020 Apr;27(2):175-185
pubmed: 32066315
J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034
pubmed: 29495982
Cardiovasc Intervent Radiol. 2020 Jan;43(1):2-7
pubmed: 31502025
J Am Coll Cardiol. 2019 May 28;73(20):2550-2563
pubmed: 30690141
J Vasc Surg. 2014 May;59(5):1291-9
pubmed: 24393280
Circulation. 2003 Aug 19;108(7):788-94
pubmed: 12900339
Eur Heart J. 2020 Oct 7;41(38):3732-3739
pubmed: 31593987
Cardiovasc Intervent Radiol. 2019 Jul;42(7):949-955
pubmed: 30843092
J Vasc Surg. 2019 Sep;70(3):981-995.e10
pubmed: 31126769
JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524
pubmed: 31575518
Lancet Oncol. 2004 May;5(5):283-91
pubmed: 15120665
JAMA Cardiol. 2019 Apr 1;4(4):332-340
pubmed: 30747949
Expert Opin Pharmacother. 2002 Jun;3(6):755-66
pubmed: 12036415
J Vasc Surg. 2020 Sep;72(3):968-976
pubmed: 31917036
J Endovasc Ther. 2018 Feb;25(1):109-117
pubmed: 29264999
Clin J Am Soc Nephrol. 2008 Jul;3(4):1084-9
pubmed: 18337552
JACC Cardiovasc Interv. 2011 May;4(5):530-42
pubmed: 21596326
Circulation. 2015 Feb 3;131(5):495-502
pubmed: 25472980
Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596
pubmed: 31926836
J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338
pubmed: 26476467
Circ Cardiovasc Interv. 2018 Jan;11(1):e005891
pubmed: 29326153