Faculty Collaboration Database

Increased risk of venous thromboembolism with a sirolimus-based immunosuppression regimen in lung transplantation. J Heart Lung Transplant 2011 Feb;30(2):175-81

Date

10/16/2010

Pubmed ID

20947384

DOI

10.1016/j.healun.2010.08.010

Scopus ID

2-s2.0-78650961986 (requires institutional sign-in at Scopus site)   60 Citations

Abstract

BACKGROUND: Sirolimus (rapamycin) is a potent anti-proliferative agent with immunosuppressive properties that is increasingly being used in solid-organ and hematopoietic stem cell transplantation. In addition, this drug is being investigated for treatment of a broad range of disorders, including cardiovascular disease, malignancies, tuberous sclerosis, and lymphangeioleiomyomatosis. In this study, we found an increased risk of venous thromboembolism (VTE) in lung transplant recipients treated with a sirolimus (SIR)-based immunosuppressive regimen.

METHODS: One hundred eighty-one lung transplant recipients were enrolled in a prospective, multicenter, randomized, open-label trial comparing a tacrolimus (TAC)/SIR/prednisone immunosuppression regimen with a TAC/azathioprine (AZA)/prednisone immunosuppressive regimen. The differences in rates of VTE were examined.

RESULTS: There was a significantly higher occurrence of VTE in the SIR cohort [15 of 87 (17.2%)] compared with the AZA cohort [3 of 94 (3.2%)] (stratified log-rank statistic = 7.44, p < 0.01). When adjusted for pre-transplant diagnosis and stratified by transplant center, this difference remained essentially unchanged (hazard ratio for SIR vs AZA = 5.2, 95% confidence interval 1.4 to 19.5, p = 0.01).

CONCLUSION: Clinicians prescribing SIR should maintain a high level of vigilance for VTE, particularly among patients with other risk factors for this complication.

Author List

Ahya VN, McShane PJ, Baz MA, Valentine VG, Arcasoy SM, Love RB, Seethamraju H, Garrity E, Alex CG, Bag R, DeOliveira NC, Vigneswaran WT, Charbeneau J, Krishnan JA, Durazo-Arvizu R, Norwick L, Bhorade S

MESH terms used to index this publication - Major topics in bold

Azathioprine
Drug Therapy, Combination
Female
Graft Rejection
Humans
Immunosuppressive Agents
Incidence
Lung Transplantation
Male
Middle Aged
Prednisone
Prospective Studies
Risk Factors
Sirolimus
Tacrolimus
Venous Thromboembolism