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.

Journal of the American Heart Association
Konstantinos KatsanosDimitrios Karnabatidis

Abstract

Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta-analysis of RCT s investigating paclitaxel-coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCT s with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCT s with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCT s with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; -number-needed-to-harm, 29 patients [95% CI , 19-59]). All-cause death up to 5 years (3 RCT s with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI , 1.27-2...Continue Reading

References

Feb 15, 2008·The New England Journal of Medicine·Gunnar TepeUlrich Speck
Apr 22, 2009·Journal of the Royal Statistical Society. Series A, (Statistics in Society)·Julian P T HigginsDavid J Spiegelhalter
Jul 23, 2009·BMJ : British Medical Journal·David MoherUNKNOWN PRISMA Group
Jan 1, 2010·BMC Medical Research Methodology·Jørn WetterslevChristian Gluud
Sep 15, 2010·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Anikó PósaMariann Gyöngyösi
Mar 23, 2011·Journal of Vascular and Interventional Radiology : JVIR·Michael D DakeAnthony O Ragheb
Oct 20, 2011·BMJ : British Medical Journal·Julian P T HigginsUNKNOWN Cochrane Statistical Methods Group
May 24, 2012·Circulation. Cardiovascular Interventions·Ulrich SpeckBruno Scheller
Oct 11, 2012·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Fabrizio FanelliFilippo Maria Salvatori
Nov 30, 2012·Circulation. Cardiovascular Interventions·Michael WerkEnrique Lopez Hänninen
May 25, 2013·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Saami K YazdaniRenu Virmani
Apr 12, 2014·Cardiovascular and Interventional Radiology·Konstantinos KatsanosFabrizio Fanelli
Jan 24, 2015·European Journal of Clinical Investigation·Vivian G NgAlexandra J Lansky
Jan 27, 2015·JACC. Cardiovascular Interventions·Gunnar TepeThomas Zeller
Mar 17, 2015·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Dierk ScheinertGunnar Tepe
Jun 25, 2015·The New England Journal of Medicine·Kenneth RosenfieldUNKNOWN LEVANT 2 Investigators
Oct 20, 2015·Journal of the American College of Cardiology·John R LairdUNKNOWN IN.PACT SFA Trial Investigators
Nov 10, 2015·JAMA : the Journal of the American Medical Association·Farzin FakhryM G Myriam Hunink
Jan 15, 2016·Journal of the American College of Cardiology·Milan MilojevicDavid R Holmes
Feb 17, 2017·International Journal of Epidemiology·Neil Pearce, Debbie A Lawlor
Mar 8, 2017·BMC Medical Research Methodology·Jørn WetterslevChristian Gluud
Jun 1, 2017·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Yvonne BausbackUNKNOWN RANGER SFA Investigators
Jun 1, 2017·Advanced Drug Delivery Reviews·Ian SchornGeorge Papandreou

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Citations

Feb 6, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Bimmer E Claessen, George D Dangas
Mar 7, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Mahesh Anantha-NarayananCarlos Mena-Hurtado
Mar 26, 2019·Circulation·Sanjay Misra, Michael D Dake
May 17, 2019·Journal of the American Heart Association·Rajesh V SwaminathanManesh R Patel
Jun 11, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Andrew HoldenThomas Zeller
Jul 20, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Kazuhiro DanRon Waksman
Aug 10, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Ashish KumarMariam Shariff
Jun 6, 2019·The Journal of Cardiovascular Surgery·Frank J Veith
May 7, 2019·The Journal of Cardiovascular Surgery·John Phillips
May 8, 2019·The Journal of Cardiovascular Surgery·Marco FerroneJuan F Granada
Sep 9, 2019·Current Treatment Options in Cardiovascular Medicine·Anna K Krawisz, Eric A Secemsky
Jan 11, 2020·Expert Opinion on Drug Delivery·Thomas NestelbergerRaban Jeger
Nov 7, 2019·Cardiovascular and Interventional Radiology·Yoshimitsu SogaStefan Müller-Hülsbeck
Oct 23, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Fabrizio FanelliVittorio Miele
Oct 15, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Tjun Y TangTze T Chong
Jan 18, 2020·Circulation. Cardiovascular Interventions·J Antonio Gutierrez, Rajesh V Swaminathan
Jan 18, 2020·European Heart Journal·Iris Baumgartner, Marc Schindewolf
Jan 29, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Gunnar TepeMarianne Brodmann
Dec 7, 2019·Cardiovascular and Interventional Radiology·Thijs WakkieHans van Overhagen
Feb 6, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Frank BunchCraig Walker
Jun 1, 2019·Expert Review of Medical Devices·Stavros SpiliopoulosElias Brountzos
Nov 20, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Bernardo CorteseJuan F Granada
Feb 12, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Zhanjiang CaoWeiwei Wu
Feb 19, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Krystal DinhRamon L Varcoe
Feb 12, 2020·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Alexandra LanskyWilliam Wijns
Feb 28, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Gilberto MelnickGrzegorz L Kaluza
Mar 4, 2020·International Urology and Nephrology·Zhong Hong LiewAlwin Hwai Liang Loh
Feb 26, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Gunnar TepeThomas Zeller
Mar 20, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Rami El-MokdadBernardo Cortese
Feb 14, 2020·International Angiology : a Journal of the International Union of Angiology·Marta Spychalska-ZwolińskaJacek Budzyński
Nov 7, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Ulf TeichgräberUNKNOWN Collaborators
May 2, 2020·European Heart Journal·Francesco Liistro, Carlo Di Mario
May 5, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Damianos G KokkinidisEhrin J Armstrong
May 15, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Dmitriy N FeldmanChristopher J White

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Methods Mentioned

BETA
percutaneous transluminal angioplasty
amputations
coronary artery bypass

Clinical Trials Mentioned

ISRCTN47846578
NCT00120406
NCT00156624
NCT01175850
NCT01566461
NCT00472472
NCT00930813
NCT01412541
NCT01858363
NCT01970579

Software Mentioned

R
Cochrane Collaboration
R meta
meta

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