Author + information
- Received April 7, 2020
- Revision received June 2, 2020
- Accepted June 2, 2020
- Published online September 15, 2020.
- Jolanda Sabatino, MD, PhDa,b,
- Salvatore De Rosa, MD, PhDa,b,∗ (, )@SaDeRosa78,
- Alberto Polimeni, MD, PhDa,b,
- Sabato Sorrentino, MD, PhDa,b and
- Ciro Indolfi, MDa,b,∗∗ (, )@IndolfiCiro
- aDivision of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy
- bCardiovascular Research Center, Magna Graecia University, Catanzaro, Italy
Background Many patients with cancer have a hypercoagulable state and an increased risk of developing venous thromboembolism (VTE), arterial occlusion, and pulmonary emboli. Patients with cancer may also have an increased risk of bleeding with anticoagulant treatment. Recent trials have reported that direct oral anticoagulants (DOACs) are noninferior to the low-molecular-weight heparin, dalteparin, in preventing VTE, but have a higher bleeding rate.
Objectives This study compared the efficacy and risks of DOACs versus dalteparin in patients with cancer-related VTEs across all randomized controlled trials (RCTs).
Methods This study performed a systematic analysis of RCTs published in PubMed, SCOPUS, and Google Scholar from September 1, 2007 through March 31, 2020 that reported clinical outcomes of treatment with DOACs versus dalteparin in patients with cancer with acute VTE. Two investigators independently performed study selection and data extraction. Extracted data were recorded and exported to statistical software for all analyses (OpenMetaAnalyst).
Results This study included 4 randomized trials (N = 2,907). Compared with DOACs, dalteparin was associated with higher VTE recurrence (risk ratio [RR]: 1.55; 95% confidence interval [CI]: 1.19 to 2.03; p = 0.001), whereas clinically relevant nonmajor bleeding (CRNMB) was significantly less frequent with dalteparin than that with DOACs (RR: 0.68; 95% CI: 0.54 to 0.86; p = 0.001). The risk of CRNMB was largely observed with patients with gastrointestinal malignancies. No significant differences were observed in major bleeding (RR: 0.74; 95% CI: 0.52 to 1.06; p = 0.11).
Conclusions DOACs were noninferior to dalteparin in preventing VTE recurrence in patients with cancer without a significantly increased risk of major bleeding. However, DOACs were associated with higher rates of CRNMB compared with dalteparin, primarily in patients with gastrointestinal malignancies.
Drs. De Rosa and Indolfi have participated in clinical studies testing all 4 drugs DOACs object of the present work; and have participated in expert consensus meetings/panels for Bayer, Pfizer–Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi-Sankyo. Dr. Indolfi has received research grants from Boehringer Ingelheim and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: CardioOncology author instructions page.
- Received April 7, 2020.
- Revision received June 2, 2020.
- Accepted June 2, 2020.
- 2020 The Authors