Efficacy and safety of low molecular weight heparin in patients with mechanical heart valves: systematic review and meta‐analysis

Introduction Ibrutinib is an oral covalent inhibitor of Bruton's tyrosine kinase approved for the treatment of patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma and Waldenstrӧm’s macroglobulinemia. Ibrutinib has an increased risk of atrial fibrillation but the mechanism is unknown, and hypertension may play a role in the pathogenesis of this adverse drug reaction. Methods We aimed to review the risk of hypertension and atrial fibrillation as adverse events associated with ibrutinib through a systematic review with meta-analysis of randomized controlled trials (RCTs) retrieved in December 2018 on MEDLINE, EMBASE, CENTRAL and ClinicalTrials.gov. The data were pooled using random-effects meta-analyses using the risk ratio (RR) with the 95% confidence interval (95%CI). The confidence on the pooled estimates was ascertained through the grading of recommendations assessment, development, and evaluation (GRADE) approach. Results There were 8 eligible RCTs (2580 patients), all reporting safety data of interest. Ibrutinib was associated with a significant increase in the risk of hypertension with a RR of 2.82 (95%CI 1.52–5.23) with moderate quality evidence. Ibrutinib increased significantly the risk of atrial fibrillation with a RR of 4.69 (95%CI 2.17–7.64) with high quality evidence. Conclusions Ibrutinib was associated with significantly increased risks of both hypertension and atrial fibrillation.

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“…Results and conclusion here presented are weakened by limitations inherent to meta-analysis and individual studies [45, 46].…”

Section: Discussionmentioning

confidence: 87%

Ibrutinib increases the risk of hypertension and atrial fibrillation: Systematic review and meta-analysis

et al. 2019

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“…The inclusion of studies published after 2006 and the differences in either the inclusion criteria or the inclusion of studies presenting data pertaining to short-term outcomes that were difficult to distinguish from either the mediumterm or the long-term results [49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65] distinguished the systematic review completed in 2006 [3] from our study. Significant differences in the inclusion criteria were also noted relative to the meta-analysis completed in 2014 [66], which included studies that utilized bridging therapy for non-cardiac surgery (such as tooth extraction and pregnant women receiving long-term anticoagulation). Additionally, there were only four studies comparing OAC with LMWH; two did not include events.…”

Section: Discussionmentioning

confidence: 99%

Early postoperative bridging anticoagulation after mechanical heart valve replacement: a systematic review and meta‐analysis

Passaglia

Barros

Sousa

2015

Journal of Thrombosis and Haemostasis

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To cite this article: Passaglia LG, de Barros GM, de Sousa MR. Early postoperative bridging anticoagulation after mechanical heart valve replacement: a systematic review and meta-analysis. J Thromb Haemost 2015; 13: 1557-67.Summary. Objective: To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve implantation. Methods: Five literature databases were searched to assess the rates of bleeding and thromboembolic events among patients receiving oral anticoagulation (OAC), both with and without bridging anticoagulation therapy with unfractionated heparin (UFH) or subcutaneous low molecular weight heparin (LMWH). The studies' results were pooled via a mixed effects meta-analysis. Heterogeneity (I 2 ) and publication bias were both evaluated. Results: Twenty-three studies including 9534 patients were included. The bleeding rates were 1.8% (95% confidence interval CI 1.0-3.3) in the group receiving OAC, 2.2% (95% CI 0.9-5.3) in the OAC + UFH group, and 5.5% (95% CI 2.9-10.4) in the OAC + LMWH group (P = 0.042). The thromboembolic event rate was 2.1% (95% CI 1.5-2.9) in the group receiving OAC, as compared with 1.1% (95% CI 0.7-1.8) when the bridging therapy groups were combined as follows: OAC + UFH and OAC + LMWH (P = 0.035). Most of the analyses showed moderate heterogeneity and negative test results for publication bias. Conclusions: Bridging therapy following cardiac valve surgery was associated with a lower thromboembolic event rate, although the difference was small, with considerable overlap of the CIs. Direct comparisons are missing. Bridging therapy with UFH appears to be safe; however, this observation has a risk of bias. Early bridging therapy with LMWH appears to be associated with consistently high bleeding rates across multiple analyses. On the basis of the quality of the included studies, more trials are necessary to establish the clinical relevance of bridging therapy and the safety of LMWH.

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“…[ 15 ] A meaningful meta-analysis study also has been conducted on the focus of this issue by pooling nine studies with 1042 patients and demonstrated that the use of LMWH seem to be as effective and safe as UFH/VKA for the VTE prophylaxis in patients with MHVs. [ 16 ] Meanwhile, unlike warfarin, LMWH (nadroparin) is not metabolized by hepatic cytochrome P-450 microsomal enzymes owing to relatively low molecular weight of 3500 to 5000 Da. [ 11 ] Thus, the efficiency of nadroparin with normal dosage will not be affected by impaired hepatic function.…”

Section: Discussionmentioning

confidence: 99%

The optimal anticoagulant therapy for mechanical heart valves in a gallbladder cancer patient with hepatic metastases

Yan

Chen

et al. 2018

Medicine

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Rationale:Developing an optimal anticoagulant strategy poses a challenging task in patients with mechanical heart valves (MHVs) throughout their lifetime. We report an optimal anticoagulant therapy in a cancer patient with hepatic metastases after MHV replacement.Patient concerns:A 68-year-old female with MHVs suffered from gallbladder cancer with hepatic metastases. Her international normalized ratio (INR) fluctuated owing to the declined hepatic function.Diagnoses:Gallbladder cancer and hepatic metastases, with a history of mechanic aortic valve replacement and mitral valve replacement.Interventions:Warfarin was discontinued and Vitamin K1 was immediately administrated via intravenous infusion. low-molecular-weight heparin (LMWH) was regarded as a preferable option, and nadroparin at the dosage of 4100IU daily was administered.Outcomes:No adverse event occurred during the patient's hospitalization and two-week follow up after discharge.Lessons:LMWH may represent a reasonable alternative regarding the inhibition of thrombus and bleeding in MHVs carriers with cancer and hepatic metastases.

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Efficacy and safety of low molecular weight heparin in patients with mechanical heart valves: systematic review and meta‐analysis

Cited by 28 publications

References 50 publications

Ibrutinib increases the risk of hypertension and atrial fibrillation: Systematic review and meta-analysis

Ibrutinib increases the risk of hypertension and atrial fibrillation: Systematic review and meta-analysis

Early postoperative bridging anticoagulation after mechanical heart valve replacement: a systematic review and meta‐analysis

The optimal anticoagulant therapy for mechanical heart valves in a gallbladder cancer patient with hepatic metastases

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