Transcript PPT
Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer Agnes Y. Y. Lee, MD, MSc; Pieter W. Kamphuisen, MD, PhD; Guy Meyer, MD; Rupert Bauersachs, MD; Mette S. Janas, MD, PhD; Mikala F. Jarner, MSc; Alok A. Khorana, MD; for the CATCH Investigators Amy Patel, PGY-3 March 17, 2016 Objective • To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute, symptomatic VTE in patients with active cancer. Background • Venous thromboembolism common cause of M&M in cancer patients. • LMWH recommended over VKA based on a single, large RCT > 10 years ago Study Population • Age > 18 years old w/ cancer and acute DVT and/or PE • Active cancer with histologic confirmation – Diagnosed within the last 6 months, recurrent, regionally advanced or mets – Treatment in previous 6 months – ECOG 0, 1, or 2 Study Population • Exclusion criteria – CrCl < 20, contraindication to anticoagulation, known hypersensitivity, hx of HIT or therapeutic anticoagulation > 72 hours, or on AC at time of VTE, life expectancy < 6 months, “unlikely to comply,” or participating in another study, women of childbearing age or fertile men not using contraception Randominazation • Within 72 hours of VTE • All had imaging for DVT and PE • Stratified by tumor extent, geographic region, and history of VTE Interventions • Tinzaparin 175 IU/kg once daily SC x 6 months • Warfarin 6 months with a 5-10 day bridge with tinzaparin until therapeutic INR for 2 days. • Warfarin group had INR tested q2 weeks • Temporary interruption for no more than 3 weeks for platelets < 50K, bleeding event, or procedures Outcomes • Primary outcomes – symptomatic DVT, nonfatal PE, fatal PE on autopsy, incidental proximal DVT or PE found on staging imaging. • Safety outcomes – major bleeding, clinically relevant nonmajor bleeding, all-cause mortality. Follow up • Visits at 7, 14, 30, every 30 days. • Weekly phone visits Results • 900 patients from 32 countries with a 91% completion of scheduled follow up • Balanced groups • Majority had solid tumors (90%) • Time in therapeutic INR in warfarin group was 47%. Baseline Characteristics Results Discussion • Study states that LMWH did not significantly reduce composite recurrent VTE. • Not associated with reductions in mortality or major bleeding • Reduced risk of non major bleeding Study Strengths/Weaknesses • Strength – International study (as opposed to prior trial that was N. America and Europe) – Shares similar characteristics to the other trial • Weakness – Tinzaparin not used in US – TTR on 47%? – No NOAC Discussion • Change in cancer treatments over 10 years may account for changes • Not powered to analyze differences between cancer types • Open-label design, no sham testing of INR in Tinzaparin group or sham injections in VKA group. Study Conclusions • Full dose Tinzaparin vs. VKA was not associated with reduced mortality, major bleeding or recurrent VTE, but was associated with a lower rate of nonmajor bleeding. Questions?