Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials
Abstract Background Rivaroxaban, a direct factor Xa inhibitor, has seldom been used in patients with coronary artery disease. In this analysis, we aimed to systematically compare the efficacy and safety of rivaroxaban in addition to the anti-platelet regimen in patients with coronary artery disease....
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| Format: | Article |
| Language: | English |
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BMC
2018-05-01
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| Series: | BMC Pharmacology and Toxicology |
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| Online Access: | http://link.springer.com/article/10.1186/s40360-018-0209-2 |
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| author | Jun Yuan |
| author_facet | Jun Yuan |
| author_sort | Jun Yuan |
| collection | DOAJ |
| description | Abstract Background Rivaroxaban, a direct factor Xa inhibitor, has seldom been used in patients with coronary artery disease. In this analysis, we aimed to systematically compare the efficacy and safety of rivaroxaban in addition to the anti-platelet regimen in patients with coronary artery disease. Methods Online databases (MEDLINE, EMBASE, Cochrane database, www.ClinicalTrials.gov and Google scholar were searched for randomized controlled trials which were exclusively based on patients with coronary artery disease; and which compared efficacy (cardiovascular outcomes) and safety (bleeding outcomes) outcomes with the addition of rivaroxaban to the other anti-platelet agents. Analysis was carried out by the RevMan 5.3 software whereby odds ratios (OR) and 95% confidence intervals (CI) were generated following data input. Results Four trials with a total number of 40,148 patients were included (23,231 participants were treated with rivaroxaban whereas 16,919 participants were treated with placebo) in this analysis. Patients’ enrollment period varied from years 2006 to 2016. The current results showed addition of rivaroxaban to significantly lower composite endpoints (OR: 0.81, 95% CI: 0.74–0.88; P = 0.00001). In addition, all-cause death, cardiac death, myocardial infarction, and stent thrombosis were also significantly reduced (OR: 0.82, 95% CI: 0.72–0.92; P = 0.0009), (OR: 0.80, 95% CI: 0.69–0.92; P = 0.002), (OR: 0.87, 95% CI: 0.77–0.98; P = 0.03) and (OR: 0.73, 95% CI: 0.55–0.97; P = 0.03) respectively. However, stroke was not significantly different. However, TIMI defined minor and major bleeding were significantly higher with rivaroxaban (OR: 2.27, 95% CI: 1.47–3.49; P = 0.0002) and (OR: 3.44, 95% CI: 1.13–10.52; P = 0.03) respectively. In addition, intracranial hemorrhage and bleeding which was defined according to the International Society on Thrombosis and Hemostasis criteria were also significantly higher with rivaroxaban (OR: 1.63, 95% CI: 1.04–2.56; P = 0.03) and (OR: 1.80, 95% CI: 1.45–2.22; P = 0.00001) respectively. Nevertheless, fatal bleeding was not significantly different. Conclusions Addition of rivaroxaban to the anti-platelet regimen was effective in patients with coronary artery disease, but the safety outcomes were doubtful. Further future trials will be able to completely solve this issue. |
| first_indexed | 2024-12-22T15:39:18Z |
| format | Article |
| id | doaj.art-ac743355a612444880232dfc18fdeee8 |
| institution | Directory Open Access Journal |
| issn | 2050-6511 |
| language | English |
| last_indexed | 2024-12-22T15:39:18Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj.art-ac743355a612444880232dfc18fdeee82022-12-21T18:21:11ZengBMCBMC Pharmacology and Toxicology2050-65112018-05-011911910.1186/s40360-018-0209-2Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trialsJun Yuan0Department of Cardiology, The People’s Hospital of Guangxi Zhuang Autonomous RegionAbstract Background Rivaroxaban, a direct factor Xa inhibitor, has seldom been used in patients with coronary artery disease. In this analysis, we aimed to systematically compare the efficacy and safety of rivaroxaban in addition to the anti-platelet regimen in patients with coronary artery disease. Methods Online databases (MEDLINE, EMBASE, Cochrane database, www.ClinicalTrials.gov and Google scholar were searched for randomized controlled trials which were exclusively based on patients with coronary artery disease; and which compared efficacy (cardiovascular outcomes) and safety (bleeding outcomes) outcomes with the addition of rivaroxaban to the other anti-platelet agents. Analysis was carried out by the RevMan 5.3 software whereby odds ratios (OR) and 95% confidence intervals (CI) were generated following data input. Results Four trials with a total number of 40,148 patients were included (23,231 participants were treated with rivaroxaban whereas 16,919 participants were treated with placebo) in this analysis. Patients’ enrollment period varied from years 2006 to 2016. The current results showed addition of rivaroxaban to significantly lower composite endpoints (OR: 0.81, 95% CI: 0.74–0.88; P = 0.00001). In addition, all-cause death, cardiac death, myocardial infarction, and stent thrombosis were also significantly reduced (OR: 0.82, 95% CI: 0.72–0.92; P = 0.0009), (OR: 0.80, 95% CI: 0.69–0.92; P = 0.002), (OR: 0.87, 95% CI: 0.77–0.98; P = 0.03) and (OR: 0.73, 95% CI: 0.55–0.97; P = 0.03) respectively. However, stroke was not significantly different. However, TIMI defined minor and major bleeding were significantly higher with rivaroxaban (OR: 2.27, 95% CI: 1.47–3.49; P = 0.0002) and (OR: 3.44, 95% CI: 1.13–10.52; P = 0.03) respectively. In addition, intracranial hemorrhage and bleeding which was defined according to the International Society on Thrombosis and Hemostasis criteria were also significantly higher with rivaroxaban (OR: 1.63, 95% CI: 1.04–2.56; P = 0.03) and (OR: 1.80, 95% CI: 1.45–2.22; P = 0.00001) respectively. Nevertheless, fatal bleeding was not significantly different. Conclusions Addition of rivaroxaban to the anti-platelet regimen was effective in patients with coronary artery disease, but the safety outcomes were doubtful. Further future trials will be able to completely solve this issue.http://link.springer.com/article/10.1186/s40360-018-0209-2RivaroxabanCoronary artery diseaseDual anti-platelet therapyStent thrombosisMinor bleedingMajor bleeding |
| spellingShingle | Jun Yuan Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials BMC Pharmacology and Toxicology Rivaroxaban Coronary artery disease Dual anti-platelet therapy Stent thrombosis Minor bleeding Major bleeding |
| title | Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials |
| title_full | Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials |
| title_fullStr | Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials |
| title_full_unstemmed | Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials |
| title_short | Efficacy and safety of adding rivaroxaban to the anti-platelet regimen in patients with coronary artery disease: a systematic review and meta-analysis of randomized controlled trials |
| title_sort | efficacy and safety of adding rivaroxaban to the anti platelet regimen in patients with coronary artery disease a systematic review and meta analysis of randomized controlled trials |
| topic | Rivaroxaban Coronary artery disease Dual anti-platelet therapy Stent thrombosis Minor bleeding Major bleeding |
| url | http://link.springer.com/article/10.1186/s40360-018-0209-2 |
| work_keys_str_mv | AT junyuan efficacyandsafetyofaddingrivaroxabantotheantiplateletregimeninpatientswithcoronaryarterydiseaseasystematicreviewandmetaanalysisofrandomizedcontrolledtrials |