Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial.

Kansal, Aman

Huang, Zhen

Rockhold, Frank W

Baumgartner, Iris

Berger, Jeffrey S

Blomster, Juuso I

Fowkes, F Gerry

Katona, Brian

Mahaffey, Kenneth W

Norgren, Lars

Hiatt, William R

Patel, Manesh R

Jones, W Schuyler

2019-10-14T21:01:15Z

2019-10-14T21:01:15Z

2019-10-04

2019-10-14T21:01:14Z

BACKGROUND:The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure. METHODS:EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group. RESULTS:Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation. CONCLUSIONS:The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.

1941-7640

1941-7632

https://hdl.handle.net/10161/19415

eng

Ovid Technologies (Wolters Kluwer Health)

Circulation. Cardiovascular interventions

10.1161/circinterventions.119.008069

amputation

hemoglobins

incidence

lower extremity

peripheral arterial disease

Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial.

Journal article

Rockhold, Frank W|0000-0003-3732-4765

Patel, Manesh R|0000-0001-6477-9728

Jones, W Schuyler|0000-0002-7288-9596

e008069

10

School of Medicine

Duke

Duke Clinical Research Institute

Institutes and Centers

Biostatistics & Bioinformatics

Basic Science Departments

Published

12