Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study.
Drug-eluting balloon
Long-term benefit
Mortality
PAD
Paclitaxel
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
25 Jan 2024
25 Jan 2024
Historique:
received:
23
09
2023
accepted:
07
12
2023
medline:
26
1
2024
pubmed:
26
1
2024
entrez:
25
1
2024
Statut:
aheadofprint
Résumé
This follow-up study was designed as a reopen of the completed Freeway Stent Study and collected mortality and clinical outcome data for at least 5 years after enrollment to evaluate long-term patient safety and treatment efficacy. The primary study enrolled 204 patients with stenosis or occlusion in the superficial femoral artery and proximal popliteal artery. Patients were randomized to primary nitinol stenting followed by standard PTA or primary nitinol stenting followed by FREEWAY™ paclitaxel-eluting balloon PTA. Previous patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected. No increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032. The safety results presented support the recent conclusions that the use of paclitaxel technology does not lead to an increase in mortality. At the same time, the efficacy results clearly demonstrate that the potential benefits of drug-eluting balloon treatment are maintained over a 5-year period.
Identifiants
pubmed: 38273128
doi: 10.1007/s00270-023-03646-0
pii: 10.1007/s00270-023-03646-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Fusaro M, Cassese S, Ndrepepa G, et al. Paclitaxel-coated balloon or primary bare nitinol stent for revascularization of femoropopliteal artery: a meta-analysis of randomized trials versus uncoated balloon and an adjusted indirect comparison. Int J Cardiol. 2013;168(4):4002–9. https://doi.org/10.1016/j.ijcard.2013.06.081 .
doi: 10.1016/j.ijcard.2013.06.081
pubmed: 23890909
Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries. Circulation. 2008;118(13):1358–65. https://doi.org/10.1161/CIRCULATIONAHA.107.735985 .
doi: 10.1161/CIRCULATIONAHA.107.735985
pubmed: 18779447
Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. New Engl J Med. 2008;358(7):689–99. https://doi.org/10.1056/NEJMoa0706356 .
doi: 10.1056/NEJMoa0706356
pubmed: 18272892
Tepe G, Laird J, Schneider P. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12-month results from the IN. PACT SFA randomized trial. J Vas Surg. 2015;61(4):1098. https://doi.org/10.1016/j.jvs.2015.03.002 .
Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel coated balloon for femoropopliteal artery disease. New Engl J Med. 2015;373(2):145–53. https://doi.org/10.1056/NEJMoa1406235 .
doi: 10.1056/NEJMoa1406235
pubmed: 26106946
Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-inhuman randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovas Intervent. 2014;7(1):10–9. https://doi.org/10.1016/j.jcin.2013.05.022 .
doi: 10.1016/j.jcin.2013.05.022
Katsanos K, Spiliopoulos S, Kitrou P, et al. 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(24): e011245. https://doi.org/10.1161/JAHA.118.011245 .
doi: 10.1161/JAHA.118.011245
pubmed: 30561254
pmcid: 6405619
US Food and Drug Administration Update: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality—letter to health care providers. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm . Published January 17, 2019.
US Food and Drug Administration Update: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality—letter to health care providers. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm . Published March 15, 2019
US Food and Drug Administration Update: Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality—letter to health care providers. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm . Published August 7, 2019
FDA Executive Summary 19–20 June 2019; Accessed 11.05.2023 https://fda.report/media/127698/CSDP-06.19.19-FDA-Exec-Summary.pdf
Beckman JA, White CJ. Paclitaxel coated balloons and eluting stents: is there a mortality risk in patients with peripheral artery disease? Circulation. 2019;140:1342–51. https://doi.org/10.1161/CIRCULATIONAHA.119.041099 .
doi: 10.1161/CIRCULATIONAHA.119.041099
pubmed: 31177820
Rocha-Singh KJ, Duval S, Jaff MR, et al. Mortality and paclitaxel-coated devices: an individual patient data meta-analysis. Circulation. 2020;141:1859–69. https://doi.org/10.1161/CIRCULATIONAHA.119.044697 .
doi: 10.1161/CIRCULATIONAHA.119.044697
pubmed: 32370548
pmcid: 8029645
Secemsky EA, Kundi H, Weinberg I, et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol. 2019;4:332–40. https://doi.org/10.1001/jamacardio.2019.0325 .
doi: 10.1001/jamacardio.2019.0325
pubmed: 30747949
pmcid: 6484791
Behrendt CA, Sedrakyan A, Peters F, et al. Editor’s Choice—Long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: a propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020;59:587–96. https://doi.org/10.1016/j.ejvs.2019.12.034 .
doi: 10.1016/j.ejvs.2019.12.034
pubmed: 31926836
Freisinger E, Koeppe J, Gerss J, et al. Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis. Eur Heart J. 2019;41(38):3732–9. https://doi.org/10.1093/eurheartj/ehz698 .
doi: 10.1093/eurheartj/ehz698
pmcid: 7666867
Nordanstig J, James S, Andersson M, et al. Mortality with paclitaxel-coated devices in peripheral artery disease. J Vasc Surg. 2021;73(6):2205. https://doi.org/10.1016/j.jvs.2021.03.012 .
doi: 10.1016/j.jvs.2021.03.012
Hess C, Patel M, Bauersachs R, et al. Safety and effectiveness of paclitaxel drug-coated devices in peripheral artery revascularization. J Am Coll Cardiol. 2021;78(18):1768–78. https://doi.org/10.1016/j.jacc.2021.08.052 .
doi: 10.1016/j.jacc.2021.08.052
pubmed: 34711335
Tacke J, Müller-Hülsbeck S, Schröder H, et al. The randomized freeway stent study: drug-eluting balloons outperform standard balloon angioplasty for postdilatation of nitinol stents in the SFA and PI segment. Cardiovasc Intervent Radiol. 2019;42:1513–21. https://doi.org/10.1007/s00270-019-02309-3 .
doi: 10.1007/s00270-019-02309-3
pubmed: 31432220
pmcid: 6775030
Laird J, Schneider P, Jaff M, et al. Long-term clinical effectiveness of a drug-coated balloon for the treatment of femoropopliteal lesions: five-year outcomes from the IN. PACT SFA randomized trial. Circ Cardiovasc Interv 2019;12(6):e007702. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007702
Tepe G, Schnorr B, Albrecht T, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. J Am Coll Cardiol Intv 2015; 8 (1PartA);102–8. https://doi.org/10.1016/j.jcin.2014.07.023
Ouriel K, Adelman M, Rosenfield K, et al. Safety of paclitaxel-coated balloon angioplasty for femoropopliteal peripheral artery disease. J Am Coll Cardiol Intv. 2019;12(24):2515–24. https://doi.org/10.1016/j.jcin.2019.08.025 .
doi: 10.1016/j.jcin.2019.08.025
Xu Y, Liu J, Zhang J, et al. Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial. J Vasc Surg. 2021;74(3):756–62. https://doi.org/10.1016/j.jvs.2021.01.041 .
doi: 10.1016/j.jvs.2021.01.041
pubmed: 33600928
Teichgräber U, Lehmann T, Ingwersen M, et al. Long-term effectiveness and safety of femoropopliteal drug-coated balloon angioplasty: 5-year results of the randomized Controlled EffPac trial. Cardiovasc Intervent Radiol. 2022;45(12):1774–83. https://doi.org/10.1007/s00270-022-03265-1 .
doi: 10.1007/s00270-022-03265-1
pubmed: 36088609
pmcid: 9705448
Lyden S, Faries P, Niazi K, et al. No mortality signal with stellarex low-dose paclitaxel DCB: ILLUMENATE Pivotal 4-Year outcomes. J Endovasc Ther. 2022;29(6):929–36. https://doi.org/10.1177/15266028211068769 .
doi: 10.1177/15266028211068769
pubmed: 35000470
Holden A, Varcoe R, Jaff M, et al. Paclitaxel and mortality: the dose argument is critical. J Endovasc Ther. 2019;26(4):467–70. https://doi.org/10.1177/1526602819857241 .
doi: 10.1177/1526602819857241
pubmed: 31179816
Donas K, Sohr A, Pitoulias G, et al. Long-term mortality of matched patients with intermittent claudication treated by high-dose paclitaxel-coated balloon versus plain balloon angioplasty: a real-world study. Cardiovasc Intervent Radiol. 2020;43:2–7. https://doi.org/10.1007/s00270-019-02329-z .
doi: 10.1007/s00270-019-02329-z
pubmed: 31502025
FDA Letter to Health Care Providers: UPDATE: paclitaxel-coated devices to treat peripheral arterial disease unlikely to increase risk of mortality. July 11, 2023. Accessible via: https://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality
Müller-Hülsbeck S, Fanelli F, Haage P, et al. Re-analysis of old data and new outcomes data do not support a link between paclitaxel coated balloons and paclitaxel eluting stents and mortality: these devices should be used in PAD (Peripheral Arterial Disease) treatment in femoropopliteal disease on the basis of their published efficacy. Cardiovasc Intervent Radiol. 2023; 1–4. https://doi.org/10.1007/s00270-023-03507-w