Death After Paclitaxel-Coated Balloons and Stents in the Leg — Should Patients Worry?

A meta-analysis demonstrated a time- and dose-related elevated risk for death after exposure to paclitaxel.

Drug-coated balloons (DCB) and drug-eluting stents (DES) using paclitaxel are approved for peripheral intervention in the leg (in addition to coronary arteries). The devices are effective for reducing restenosis, but some small and underpowered studies have suggested an increased risk of late mortality. In a meta-analysis to assess all-cause mortality, investigators pooled the results of 28 randomized, controlled trials with 4663 patients undergoing femoropopliteal interventions with paclitaxel DCB or DES versus other non–drug-eluting strategies.

At 1 year, intervention and control groups showed no differences in all-cause death. However, after 2 years (12 studies) and 4 to 5 years (3 studies) of follow-up, a higher rate of all-cause death w…

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI

Leadership Positions in Professional SocietiesHeart Valve Collaboratory (Scientific Committee Member, Chair of the Publications Committee)