Brief communication: high incidence of venous thrombotic events among patients with Wegener granulomatosis: the Wegener's Clinical Occurrence of Thrombosis (WeCLOT) Study.
BACKGROUND
Venous thrombotic events (VTEs) have been observed in Wegener granulomatosis, but the incidence rate is not known.


OBJECTIVE
To measure the incidence of VTEs in patients with Wegener granulomatosis.


METHODS
Prospective, observational cohort study.


METHODS
A multicenter, randomized, double-blind, placebo-controlled treatment trial for Wegener granulomatosis.


METHODS
180 patients with Wegener granulomatosis enrolled during periods of active disease.


METHODS
Venous thrombotic events (deep venous thromboses or pulmonary emboli) were documented and confirmed prospectively. Incidence rates were calculated on the basis of time to first VTE.


RESULTS
Thirteen patients had VTEs before enrollment. During 228 person-years of prospective follow-up, 16 VTEs occurred in 167 patients with no history of VTE. Median time from enrollment to VTE for patients with an event was 2.1 months. The incidence of VTE among patients with Wegener granulomatosis was 7.0 per 100 person-years (95% CI, 4.0 to 11.4).


CONCLUSIONS
Although prospectively recorded, screening for VTEs did not occur.


CONCLUSIONS
The incidence rate of VTEs in Wegener granulomatosis is high when compared with available rates in the general population, patients with lupus, and patients with rheumatoid arthritis. These results have important implications for clinical care of patients with Wegener granulomatosis.
Merkel
Peter A
PA
Boston University School of Medicine, Vasculitis Center, E-5, 715 Albany Street, Boston, MA 02118, USA. pmerkel@bu.edu
Lo
Grace H
GH
Holbrook
Janet T
JT
Tibbs
Andrea K
AK
Allen
Nancy B
NB
Davis
John C
JC
Hoffman
Gary S
GS
McCune
W Joseph
WJ
St Clair
E William
EW
Specks
Ulrich
U
Spiera
Robert
R
Petri
Michelle
M
Stone
John H
JH
D004311:Double-Blind Method; D005260:Female; D014890:Granulomatosis with Polyangiitis / Q000150:complications*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D020246:Venous Thrombosis / Q000453:epidemiology* / Q000209:etiology