Universität zu Köln

Di Nisio, Marcello, Peinemann, Frank ORCID: 0000-0002-4727-1313, Porreca, Ettore and Rutjes, Anne W. S. (2015). Primary prophylaxis for venous thromboembolism in patients undergoing cardiac or thoracic surgery. Cochrane Database Syst Rev. (6). HOBOKEN: WILEY. ISSN 1361-6137

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Abstract

Background Cardiac and thoracic surgery are associated with an increased risk of venous thromboembolism (VTE). The safety and efficacy of primary thromboprophylaxis in patients undergoing these types of surgery is uncertain. Objectives To assess the effects of primary thromboprophylaxis on the incidence of symptomatic VTE and major bleeding in patients undergoing cardiac or thoracic surgery. Search methods The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched May 2014) and CENTRAL (2014, Issue 4). The authors searched the reference lists of relevant studies, conference proceedings, and clinical trial registries. Selection criteria Randomised controlled trials (RCTs) and quasi-RCTs comparing any oral or parenteral anticoagulant or mechanical intervention to no intervention or placebo, or comparing two different anticoagulants. Data collection and analysis We extracted data on methodological quality, participant characteristics, interventions, and outcomes including symptomatic VTE and major bleeding as the primary effectiveness and safety outcomes, respectively. Main results We identified 12 RCTs and one quasi-RCT (6923 participants), six for cardiac surgery (3359 participants) and seven for thoracic surgery (3564 participants). No study evaluated fondaparinux, the new oral direct thrombin, direct factor Xa inhibitors, or caval filters. All studies had major study design flaws and most lacked a placebo or no treatment control group. We typically graded the quality of the overall body of evidence for the various outcomes and comparisons as low, due to imprecise estimates of effect and risk of bias. We could not pool data because of the different comparisons and the lack of data. In cardiac surgery, 71 symptomatic VTEs occurred in 3040 participants from four studies. In a study of 2551 participants, representing 85% of the review population in cardiac surgery, the combination of unfractionated heparin with pneumatic compression stockings was associated with a 61% reduction of symptomatic VTE compared to unfractionated heparin alone (1.5% versus 4.0%; risk ratio (RR) 0.39; 95% confidence interval (CI) 0.23 to 0.64). Major bleeding was only reported in one study, which found a higher incidence with vitamin K antagonists compared to platelet inhibitors (11.3% versus 1.6%, RR 7.06; 95% CI 1.64 to 30.40). In thoracic surgery, 15 symptomatic VTEs occurred in 2890 participants from six studies. In the largest study evaluating unfractionated heparin versus an inactive control the rates of symptomatic VTE were 0.7% versus 0%, respectively, giving a RR of 6.71 (95% CI 0.40 to 112.65). There was insufficient evidence to determine if there was a difference in the risk of major bleeding from two studies evaluating fixed-dose versus weight-adjusted low molecular weight heparin (2.7% versus 8.1%, RR 0.33; 95% CI 0.07 to 1.60) and unfractionated heparin versus low molecular weight heparin (6% and 4%, RR 1.50; 95% CI 0.26 to 8.60). Authors' conclusions The evidence regarding the efficacy and safety of thromboprophylaxis in cardiac and thoracic surgery is limited. Data for important outcomes such as pulmonary embolism or major bleeding were often lacking. Given the uncertainties around the benefit-to-risk balance, no conclusions can be drawn and a case-by-case risk evaluation of VTE and bleeding remains preferable.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Di Nisio, Marcello UNSPECIFIED UNSPECIFIED UNSPECIFIED Peinemann, Frank UNSPECIFIED orcid.org/0000-0002-4727-1313 UNSPECIFIED Porreca, Ettore UNSPECIFIED UNSPECIFIED UNSPECIFIED Rutjes, Anne W. S. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-418542
DOI:	10.1002/14651858.CD009658.pub2
Journal or Publication Title:	Cochrane Database Syst Rev.
Number:	6
Date:	2015
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1361-6137
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DEEP-VEIN THROMBOSIS; LOW-DOSE ASPIRIN; AORTIC-VALVE-REPLACEMENT; ORAL ANTICOAGULANT-THERAPY; MOLECULAR-WEIGHT HEPARIN; RATIO SELF-MANAGEMENT; ARTERY BYPASS-SURGERY; PULMONARY-EMBOLISM; CARDIOPULMONARY BYPASS; MITRAL-VALVE Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41854