New Oral Anticoagulants in Patients With Cancer

Abstract

Effectiveness of new oral anticoagulants (NOAC) in patients with cancer is not clearly defined. There remain concerns of doubtful benefit and chances of potential harm with newer agents. In this meta-analysis, we evaluated the efficacy and safety of NOAC in patients with cancer. PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 01, 2001 through February 28, 2013. Randomized controlled trials reporting efficacy and safety data of NOACs (rivaroxaban, dabigatran, and apixaban) with control (low-molecular-weight heparin/vitamin K antagonists/placebo) for patients with cancer were included. Primary efficacy outcome was venous thromboembolism (VTE) or VTE-related death, and primary safety outcome was clinically relevant bleeding. We used random-effects models. Six trials randomized 19,832 patients, and 1197 patients had cancer. Risk of VTE or VTE-related death was not significantly different with NOAC versus control [odds ratio (OR), 0.80; 95% confidence interval (CI), 0.39-1.65] in patients with cancer. Separate analysis for individual effects showed similar results for rivaroxaban (OR, 1.08; 95% CI, 0.60-1.94) and dabigatran (OR, 0.91; 95% CI, 0.21-3.91). Clinically relevant bleeding was not higher with NOAC compared with control (OR, 1.49; 95% CI, 0.82-2.71); individual effect of rivaroxaban showed similar results. No statistically significant difference of efficacy and safety with NOAC was found between patients with and without cancer. Rivaroxaban might be equally effective and safe as vitamin K antagonist in patients with cancer. Dabigatran is as effective as comparator; however, safety profile of dabigatran is unknown. Randomized trials of new anticoagulants specific to the cancer population are necessary, and NOAC also need to be evaluated against low-molecular-weight heparin.

Comparative effectiveness of direct oral anticoagulants and warfarin in patients with cancer and atrial fibrillation

“…[3][4][5][6] In the studies of DOACs vs warfarin for VTE, subset analysis of cancer patients was not preplanned, although it appears that DOACs were safe in the small group for which information is available. [29][30][31] Until results of randomized control trials specifically designed to look at the safety and efficacy of DOACs in cancer patients are available, clinicians have to rely on robust observational data. Based on our findings, all of the DOACs appear to be safe compared with warfarin from the standpoint of rate of severe bleeding.…”

Extended Therapy of Venous Thrombosis by Oral Anticoagulants: Focus at Safety

“…Все препараты из названной груп-пы в рамках выполненных клинических исследований III фазы оказались не менее эффективны и более безопас-ны при лечении ВТЭО по сравнению с традиционной схемой применения НМГ и АВК [18]. Последующие мета-анализы показали, что группа НОАК характеризуется пониженным риском развития больших кровотечений по сравнению с АВК, в особенности при терапии ВТЭО [19]. Аналогичное преимущество было продемонстрировано в отношении риска развития внутричерепных кровоизлия-ний и летальных кровотечений [20,21].…”

Venous Thromboembolism in the Elderly

“…Recently, the American College of Chest Physicians (ACCP) updated their antithrombotic guidelines as well and recommended the use of NOACs over VKAs for initial and long-term management of VTE patients without cancer [92••]. Data regarding the use of NOACs in cancerrelated VTE is less convincing [93].…”