Search Results

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.

SCAI Issues Statement on the Association of Paclitaxel Devices and Mortality

January 25, 2019—The Society for Cardiovascular Angiography and Interventions (SCAI) has issued a statement on the recent study of the association between paclitaxel-eluting devices and mortality.

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.

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).

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.

VIVA's Paclitaxel Analysis Finds Increased Mortality Risk, But No Dose Association; Lead Author Encourages Close Read

May 27, 2020—Earlier this month, VIVA Physicians announced the publication of an analysis of mortality and paclitaxel-coated devices by Krishna Rocha-Singh, MD, et al, which is available online ahead of print in Circulation.

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.

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).

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).

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.

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.

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.

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.

PCR Issues Statement Supporting Continued Use of Paclitaxel-Based DCBs

May 21, 2019—PCR has issued a statement addressing the controversy on the use of paclitaxel drug-coated balloons (DCBs) in peripheral interventions.