evt | Article | September 2019
Nine Months Later… An Interview With Konstantinos Katsanos, MD
Dr. Katsanos's thoughts regarding the vascular community's reaction to his group's meta-analysis, the potential influence of follow-up and adjudication variables, non-SFA applications, and what comes next.
With Konstantinos Katsanos, MSc, MD, PhD, EBIR
Sponsored by Boston Scientific Corporation
evt | Article | October 2016 Europe Supplement
Sponsored by Cook Medical
evt | Article | United States November 2014 Supplement
Sponsored by Boston Scientific Corporation
evt | Article | September 2017 Europe Supplement
evt | News | February 3, 2016
Wound Healing and Quality-of-Life Outcomes Reported From the ACHILLES Trial
February 3, 2016—One-year wound healing outcomes and health-related quality-of-life (QoL) changes from the ACHILLES trial were published by Konstantinos Katsanos, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:259–267). ACHILLES is a prospective, randomized, controlled trial of infrapopliteal percutaneous transluminal balloon angioplasty (PTA) versus sirolimus-eluting stent (SES) placement in patients with ischemic peripheral arterial disease.
evt | News | January 30, 2019
evt | News | January 24, 2019
LINC 2019: Patient-Level Data Presentations at LINC Aim to Disprove Causality Between Paclitaxel and Increased Mortality
Attendees packed a special session to open LINC 2019 in Leipzig, Germany, to hear discussion of the recent meta-analysis published by Konstantinos Katsanos, MD, et al that suggested a link between the use of paclitaxel delivery devices and increased long-term mortality, as well as new data gathered by trialists and device manufacturers aiming to address these concerns.
evt | News | June 18, 2019
JEVT Editorial Challenges Drug Dosing and Exposure Time Assumptions in Paclitaxel Mortality Meta-Analysis
June 17, 2019—A recent editorial in the Journal of Endovascular Therapy (JEVT) challenges several key assumptions and findings of the recent meta-analysis by Konstantinos Katsanos, MD, et al published in December 2018 in the Journal of the American Heart Association (JAHA).
evt | News | December 6, 2018
Meta-Analysis Observes Increased Mortality Trend in Trials of Paclitaxel‐Coated SFA Devices, But No Definitive Cause
December 6, 2018—A systematic review and meta‐analysis of randomized controlled trials (RCTs) evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries concluded that there is an increased risk of death after application of these devices in this anatomy.
evt | News | March 20, 2019
UK Regulator Appoints Expert Advisory Group to Review Paclitaxel Devices in PAD
March 20, 2019—The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) announced the formation of an independent Expert Advisory Group (EAG) to review paclitaxel-coated balloon catheters and paclitaxel-eluting stents used to treat patients with peripheral artery disease (PAD), particularly in the femoropopliteal artery.
evt | News | January 31, 2019
JACC Patient-Level Analysis of Medtronic DCB Studies Concludes That Mortality Is Not Correlated With Paclitaxel Exposure
January 31, 2019—Peter A. Schneider, MD, et al conducted a patient-level analysis of data from several independently adjudicated prospective studies involving Medtronic drug-coated balloons (DCBs). The findings were published online ahead of print in Journal of the American College of Cardiology (JACC).
evt | News | June 6, 2019
UK MHRA Issues Recommendations on Use of Paclitaxel Devices in PAD
June 6, 2019—The United Kingdom Medicines & Healthcare Products Regulatory Agency (UK MHRA) announced that it has issued the agency's recommendations for ongoing use of paclitaxel drug-coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease (PAD).
evt | News | January 13, 2020
German Analysis Shows Long-Term Survival With Paclitaxel-Coated Devices Used for Femoropopliteal Artery Revascularization
January 13, 2020—The rapid adoption of the use of paclitaxel-coated devices to treat patients with chronic limb-threatening ischemia (CLTI) has resulted in higher long-term survival, better amputation-free survival, and lower rates of major cardiovascular events, concluded investigators of a retrospective, propensity score-matched cohort analysis of German health insurance claims.
evt | News | March 15, 2019
FDA to Convene Advisory Committee Meeting After Preliminary Review Finds Signal of Increased Mortality With Paclitaxel-Eluting Devices
March 15, 2019—The FDA has announced that its preliminary review of the long-term follow-up data on paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral artery disease (PAD) in the femoropopliteal artery has identified a potentially concerning signal of increased long-term mortality in study patients treated with paclitaxel-coated products compared to patients treated with uncoated devices.
evt | News | January 11, 2016
CE Mark Approved for Medtronic's In.Pact Admiral DCB to Treat AV Access in Hemodialysis Patients
January 11, 2016—Medtronic plc announced that the In.Pact Admiral drug-coated balloon (DCB) has received European CE Mark approval for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
evt | News | May 31, 2019
Editorial Articles in JAHA Address Paclitaxel in PAD Studies
May 31, 2019—A series of editorial articles and letters published online in Journal of the American Heart Association (JAHA) continue to evaluate the data and discuss the conclusions regarding long-term mortality with paclitaxel-eluting stents and paclitaxel-coated balloons in the superficial femoral artery.
evt | News | January 17, 2019
FDA Issues Letter on Potential Increased Mortality With Paclitaxel-Coated Devices in SFA
January 17, 2019—On its website, the FDA posted an advisory to peripheral interventionalists and vascular medicine physicians to inform them that the agency is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral artery disease (PAD) in the femoropopliteal artery.