In December 2018, a study-level meta-analysis published in JAHA indicated a link between the use of paclitaxel-delivery devices for peripheral artery disease and increased mortality. Subsequently, regulators, clinical trial investigators, and manufacturers of drug-coated balloons and drug-eluting stents have initiated reviews of patient-level data in order to determine whether a causal link could be established or denied.

Links to key primary source documents and Endovascular Today's ongoing coverage can be found below. This page will be updated as new data and reports emerge.

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December 5, 2018

Katsanos 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 [Journal of the American Heart Association]

Meta-Analysis Observes Increased Mortality Trend in Trials of Paclitaxel Coated SFA Devices, But No Definitive Cause [Endovascular Today]

December 13, 2018

Recruitment in BASIL-3 and SWEDEPAD Trials Paused After Report of 5-Year Mortality Risk With DCB/DES in SFA [Endovascular Today]

December 14, 2018

VIVA Physicians to Hold Forum on Drug Elution in Peripheral Artery Disease [Endovascular Today]

December 19, 2018

VIVA Physicians' Vascular Leaders Forum on Drug-Eluting Devices in PAD Scheduled [Endovascular Today]

January 17, 2019

Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers []

FDA Issues Letter on Potential Increased Mortality With Paclitaxel-Coated Devices in SFA [Endovascular Today]

January 24, 2019

LINC 2019: Patient-Level Data Presentations at LINC Aim to Disprove Causality Between Paclitaxel and Increased Mortality [Endovascular Today]

Full video [LINC Scientific Sessions]

January 25, 2019

Schneider et al: Mortality Not Correlated with Paclitaxel Exposure: An Independent Patient-level Meta-Analysis [Journal of the American College of Cardiology]

JACC Patient-Level Analysis of Medtronic DCB Studies Concludes That Mortality Is Not Correlated With Paclitaxel Exposure [Endovascular Today]

SCAI Issues Statement on the Association of Paclitaxel Devices and Mortality [Endovascular Today]

February 14, 2019

No Evidence of Paclitaxel-Related Increased Mortality Found in Medicare Database Analysis at 600 Days [Endovascular Today]

REAL PTX Data Show Similar Outcomes for DES and DCB With Bailout Stenting at 1 Year, Trend Favoring DES at 3 Years [Endovascular Today]

February 18, 2019

Medtronic Issues Statement Regarding Error in Its IN.PACT Global Postmarket Registry Data, Though Conclusions Still Supported [Endovascular Today]

February 20, 2019

Zilver PTX Trial 5-Year Mortality Data Corrected in Circulation [Endovascular Today]

March 2, 2019

Highlights From the VIVA Vascular Leaders Forum on Paclitaxel Safety [Endovascular Today]

March 5, 2019

On the Paclitaxel Meta-Analysis: A Conversation With Konstantinos Katsanos, MD [Endovascular Today]

March 6, 2019

SVS Establishes Task Force on Paclitaxel Safety [Endovascular Today]

March 6, 2019

Pooled Analysis of Four Trials Shows No Increase in 2-Year Mortality With Paclitaxel-Coated Balloons [Endovascular Today]

March 7, 2019

Medtronic Publishes Correction Letter and Revised Analysis of IN.PACT Global Postmarket Study in JACC [Endovascular Today]

March 14, 2019

No Long-Term Increased Mortality Seen in Medicare PAD Patients Treated With Peripheral DES [Endovascular Today]

March 15, 2019

FDA to Convene Advisory Committee Meeting After Preliminary Review Finds Signal of Increased Mortality With Paclitaxel-Eluting Devices [Endovascular Today]

March 20, 2019

UK Regulator Appoints Expert Advisory Group to Review Paclitaxel Devices in PAD [Endovascular Today]

March 21, 2019

Cook Medical Launches Paclitaxel Information and Resource Site [Cook Medical]

March 22, 2019

BD Issues Statement in Response to FDA’s Letter Announcing Long-Term Data Review of Paclitaxel Devices Used in PAD [Endovascular Today]

March 26, 2019

Cook Medical Letter to Physicians Addresses Paclitaxel Data [Endovascular Today]

March 29, 2019

CIRSE Position Statement Addresses the Use of Paclitaxel-Coated Devices in PAD [Endovascular Today]

April 17, 2019

Enrollment Resumes in the TRANSCEND Trial of Surmodics' SurVeil Paclitaxel-Coated Balloon [Endovascular Today]

April 18, 2019

Cook Medical Provides Patient-Level Paclitaxel Data From Zilver PTX Randomized Controlled Trial [Endovascular Today]

April 22, 2019

FDA Schedules Public Meeting on Paclitaxel Use in PAD [Endovascular Today]

May 9, 2019

FDA Paclitaxel Safety Panel Preview [Endovascular Today]

May 21, 2019

PCR Issues Statement Supporting Continued Use of Paclitaxel-Based DCBs [Endovascular Today]

May 31, 2019

SWEDEPAD Trials Explore Resumption of Enrollment [Endovascular Today]

May 31, 2019

Editorial Articles in JAHA Address Paclitaxel in PAD Studies [Endovascular Today]

June 6, 2019

UK MHRA Issues Recommendations on Use of Paclitaxel Devices in PAD [Endovascular Today]

June 17, 2019

JEVT Editorial Challenges Drug Dosing and Exposure Time Assumptions in Paclitaxel Mortality Meta-Analysis [Endovascular Today]

June 20, 2019

FDA Paclitaxel Advisory Meeting Day 1: Panel Addresses Updated Data, Signal Presence, Class Effect, Missing Data, Subgroups, and Causes of Death [Endovascular Today]

FDA Advisory Meeting Day 2: Panel Weighs the Future of Paclitaxel and Clinical Trials in PAD [Endovascular Today]

August 7, 2019

FDA Issues Updated Statement on the Use of Paclitaxel Devices to Treat PAD [Endovascular Today]

Medtronic Addresses FDA Update on Paclitaxel Devices to Treat PAD [Endovascular Today]

Cook Medical Responds to Updated FDA Recommendations on Paclitaxel Devices to Treat PAD [Endovascular Today]

August 9, 2019

BASIL-3 Study on Course to Resume Recruitment in September [Endovascular Today]

August 13, 2019

BD Issues Statement on FDA Recommendations Regarding Paclitaxel-Coated Devices [Endovascular Today]

August 28, 2019

Meta-Analysis Evaluates Mortality After Paclitaxel-Coated Device Use in Dialysis Access [Endovascular Today]

August 28, 2019

Computational Model Suggests a New Paradigm for Accelerated Treatment Optimization With Paclitaxel Devices [Endovascular Today]

September 9, 2019

New Long-Term Safety Data for Paclitaxel From Cook Medical's Zilver PTX Trial Presented at CIRSE [Endovascular Today]

October 8, 2019

Analysis of German Insurance Data Shows No Long-Term Increased Mortality With Paclitaxel-Based Devices [Endovascular Today]

October 21, 2019

Meta-Analysis Shows Heterogenity in Benefits and Risks With Paclitaxel-Coated Balloons for Femoropopliteal Disease [Endovascular Today]

November 5, 2019

Four-Year Data Presented From Medtronic's IN.PACT Global Study [Endovascular Today]

Five-Year Data Analysis Shows Benefit, No Increased Mortality With Cook Medical's Zilver PTX Across Different Patient Groups [Endovascular Today]


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Endovascular Today is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Our Editorial Advisory Board is composed of the top endovascular specialists, including interventional cardiologists, interventional radiologists, vascular surgeons, neurologists, and vascular medicine practitioners, and our publication is read by an audience of more than 22,000 members of the endovascular community.