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• W2123818091 abstract "Thromboprophylaxis for catheter‐related thrombosis in cancer patients remains controversial. Indeed, two systematic reviews were recently published on thromboprophylaxis in cancer patients with central venous catheters [1Cunningham M.S. White B. Hollywood D. O’Donnell J. Primary thromboprohylaxis for cancer patients with central venous catheters – a reappraisal of the evidence.Br J Cancer. 2006; 94: 189-94Crossref PubMed Scopus (48) Google Scholar, 2Chan A. Lannucci A. Dager W.E. Systemic anticoagulant prophylaxis for central catheter‐associated venous thrombosis in cancer patients.Ann Pharmacother. 2007; 41: 635-41Crossref PubMed Scopus (15) Google Scholar]. Our meta‐analysis expands and updates this literature by incorporating data from two further multi‐center, randomized trials. We searched MEDLINE (from 1950 to 2007 week 4), EMBASE (from 1980 to 2007 week 5), the Cochrane Register of Controlled Trials (first quarter of 2007) and all Evidence‐Based Medicine Reviews (fourth quarter of 2006) while applying a randomized, controlled trial (RCT) filter [3Dickersin K. Scherer R. Lefebvre C. Identifying relevant studies for systematic reviews.BMJ. 1994; 309: 1286-91Crossref PubMed Scopus (1426) Google Scholar]. The search concepts included: thrombosis, deep vein thrombosis (DVT), catheterization, cannulation, neoplasms, medical oncology and hematologic neoplasms. Our primary outcome measure was symptomatic catheter‐related thrombosis defined as upper extremity DVT or catheter occlusions. Thrombosis was defined as mural thrombus with partial or total occlusion of a vessel in which a catheter was present or had been present within the prior 30 days, confirmed by imaging techniques. Asymptomatic thromboses detected by screening tests were excluded. Our secondary outcomes were: death, major bleeding and minor bleeding. For all eligible studies, two reviewers independently assessed trial quality and extracted the data using a standardized form. Subsequently, the methodological quality of randomized studies was evaluated by a validated scale [4Jadad A.R. Moore R.A. Carroll D. Jenkinson C. Reynolds D.J. Gavaghan D.J. McQuay H.J. Assessing the quality of reports of randomized clinical trials: is blinding necessary.Control Clin Trials. 1996; 17: 1-12Abstract Full Text PDF PubMed Scopus (13573) Google Scholar] and examination of allocation concealment [5Schulz K.F. Chalmers I. Hayes R.J. Altman D.G. Empirical evidence of bias.JAMA. 1995; 273: 408-12Crossref PubMed Google Scholar]. Relative risk (RR) was the primary measurement with 95% CIs, and pooled measurements were calculated using a random‐effects model within Review Manager software (The Nordic Cochrane Centre, Copenhagen, Denmark). A RR <1 would suggest that thromboprophylaxis reduced the risk of the outcome measured while a RR >1 would suggest the converse. Heterogeneity was assessed using the Cochrane Q/χ2 test and the I2 test. A total of 510 citations were identified by our systematic search. Six articles and one abstract met our predefined inclusion criteria [6Monreal M. Alastrue A. Rull M. Mira X. Muxart J. Rosell R. Abad A. Upper extremity deep vein thrombosis in cancer patients with venous access devices. Prophylaxis with a low molecular weight heparin (Fragmin).Thromb Haemost. 1996; 75: 251-3Crossref PubMed Scopus (386) Google Scholar, 7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar, 8Bern M.M. Lokich J.J. Wallach S.R. Bothe Jr, A. Benotti P.N. Arkin C.F. Greco F.A. Huberman M. Moore C. Very low doses of warfarin can prevent thrombosis in central venous catheters. A randomized prospective trial.Ann Intern Med. 1990; 112: 423-8Crossref PubMed Scopus (796) Google Scholar, 9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 10Heaton D.C. Han D.Y. Inder A. Minidose (1 mg) warfarin as prophylaxis for central vein catheter thrombosis.Intern Med J. 2002; 32: 84-8Crossref PubMed Scopus (141) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar, 12Young A.M. Begum G. Billingham J. Hughes A.I. Kerr D.J. Rea D. Stanley A. Sweeney A. Wheatley K. Wilde J. WARP – A multicentre prospective randomized controlled trial of thrombosis prophylaxis with warfarin in cancer patients with central venous catheters.J Clin Oncol. 2005; 23Crossref Google Scholar]. Of the seven RCTs included in this review, three studies investigated the use of low‐molecular‐weight heparin (LMWH) [6Monreal M. Alastrue A. Rull M. Mira X. Muxart J. Rosell R. Abad A. Upper extremity deep vein thrombosis in cancer patients with venous access devices. Prophylaxis with a low molecular weight heparin (Fragmin).Thromb Haemost. 1996; 75: 251-3Crossref PubMed Scopus (386) Google Scholar, 7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar] while the other four studies investigated low‐dose warfarin [8Bern M.M. Lokich J.J. Wallach S.R. Bothe Jr, A. Benotti P.N. Arkin C.F. Greco F.A. Huberman M. Moore C. Very low doses of warfarin can prevent thrombosis in central venous catheters. A randomized prospective trial.Ann Intern Med. 1990; 112: 423-8Crossref PubMed Scopus (796) Google Scholar, 9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 10Heaton D.C. Han D.Y. Inder A. Minidose (1 mg) warfarin as prophylaxis for central vein catheter thrombosis.Intern Med J. 2002; 32: 84-8Crossref PubMed Scopus (141) Google Scholar, 12Young A.M. Begum G. Billingham J. Hughes A.I. Kerr D.J. Rea D. Stanley A. Sweeney A. Wheatley K. Wilde J. WARP – A multicentre prospective randomized controlled trial of thrombosis prophylaxis with warfarin in cancer patients with central venous catheters.J Clin Oncol. 2005; 23Crossref Google Scholar]. Three studies were double‐blinded and received a score of >3 on the Jadad scale [7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar, 9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar]; however, only two of the studies reported adequate allocation concealment [9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar]. Seven studies including 2131 patients assessed the use of thromboprophylaxis for catheter‐related thrombosis prevention in cancer patients. Three studies that assessed the use of LMWH were included in the analysis, with a total of 856 patients [6Monreal M. Alastrue A. Rull M. Mira X. Muxart J. Rosell R. Abad A. Upper extremity deep vein thrombosis in cancer patients with venous access devices. Prophylaxis with a low molecular weight heparin (Fragmin).Thromb Haemost. 1996; 75: 251-3Crossref PubMed Scopus (386) Google Scholar, 7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar]. Two studies compared different prophylactic doses of daltaparin (2500 and 5000 IU s.c.) with no treatment and placebo, respectively [6Monreal M. Alastrue A. Rull M. Mira X. Muxart J. Rosell R. Abad A. Upper extremity deep vein thrombosis in cancer patients with venous access devices. Prophylaxis with a low molecular weight heparin (Fragmin).Thromb Haemost. 1996; 75: 251-3Crossref PubMed Scopus (386) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar]. One study compared a prophylactic dose of enoxaparin (40 mg s.c.) with placebo [7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar]. There were 1275 patients from the four RCTs that investigated warfarin included in the analysis [8Bern M.M. Lokich J.J. Wallach S.R. Bothe Jr, A. Benotti P.N. Arkin C.F. Greco F.A. Huberman M. Moore C. Very low doses of warfarin can prevent thrombosis in central venous catheters. A randomized prospective trial.Ann Intern Med. 1990; 112: 423-8Crossref PubMed Scopus (796) Google Scholar, 9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 10Heaton D.C. Han D.Y. Inder A. Minidose (1 mg) warfarin as prophylaxis for central vein catheter thrombosis.Intern Med J. 2002; 32: 84-8Crossref PubMed Scopus (141) Google Scholar, 12Young A.M. Begum G. Billingham J. Hughes A.I. Kerr D.J. Rea D. Stanley A. Sweeney A. Wheatley K. Wilde J. WARP – A multicentre prospective randomized controlled trial of thrombosis prophylaxis with warfarin in cancer patients with central venous catheters.J Clin Oncol. 2005; 23Crossref Google Scholar]. Three RCTs compared warfarin 1 mg day–1 with either no treatment or placebo [9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar]. One study compared a mixture of dose‐adjusted warfarin (INR between 1.5 and 2.0; 20.5% of patients) and 1 mg warfarin (79.5% of patients) with placebo [12Young A.M. Begum G. Billingham J. Hughes A.I. Kerr D.J. Rea D. Stanley A. Sweeney A. Wheatley K. Wilde J. WARP – A multicentre prospective randomized controlled trial of thrombosis prophylaxis with warfarin in cancer patients with central venous catheters.J Clin Oncol. 2005; 23Crossref Google Scholar]. Baseline characteristics were comparable among studies. The pooled RR of symptomatic catheter‐related thrombosis from the seven RCTs that assessed thromboprophylaxis was 0.71 (95% CI 0.42–1.20; Fig. 1). The pooled estimates of thromboprophylaxis with LMWH and warfarin were 0.43 (95% CI 0.12–1.56) and 0.82 (95% CI 0.46–1.47), respectively. Six out of seven studies reported on overall mortality. No statistically significant mortality benefit was found with either LMWH (RR 1.51; 95% CI 0.49–4.70) or warfarin (RR 0.95; 95% CI 0.62–1.46). Two studies reported on major bleeding, with Karthaus et al. [11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar] reporting a RR of 0.49 (95% CI 0.03–7.83) and Couban et al. [9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar] reporting a RR of 0.14 (95% CI 0.001–2.63). Minor bleeding was not more frequent in patients given thromboprophylaxis with either LMWH (pooled RR 1.32; 95% CI 0.87–2.02) or low‐dose warfarin (pooled RR 0.93; 95% CI 0.31–2.77). Heterogeneity for all analyses was non‐significant or low to moderate, as demonstrated by the χ2 and I2 tests. Our systematic review demonstrates that the use of thromboprophylaxis does not significantly reduce symptomatic catheter‐related thrombosis in patients with cancer. Unfortunately, the three most recent trials may have been underpowered in order to detect important differences in catheter‐related thrombosis, because the rate of symptomatic catheter‐related thrombosis was much lower than anticipated [7Verso M. Agnelli G. Bertoglio S. Di Somma F.C.D. Paoletti F. Ageno W. Bazzan M. Parise P. Quintavalla R. Naglieri E. Santoro A. Imberti D. Soraru M. Mosca S. Enoxaparin for the prevention of venous thromboembolism associated with central vein catheter: a double‐blind, placebo‐controlled, randomized study in cancer patients.J Clin Oncol. 2005; 23: 4057-62Crossref PubMed Scopus (272) Google Scholar, 9Couban S. Goodyear M. Burnell M. Dolan S. Wasi P. Barnes D. MacLeod D. Burton E. Andreou P. Anderson D.R. Randomized placebo‐controlled study of low‐dose warfarin for the prevention of central venous catheter‐associated thrombosis in patients with cancer.J Clin Oncol. 2005; 23: 4063-9Crossref PubMed Scopus (284) Google Scholar, 11Karthaus M. Kretzschmar A. Kroning H. Biakhov M. Irwin D. Marschner N. Slabber C. Fountzilas G. Garin A. Abecasis N.G.F. Baronius W. Steger G.G. Südhoff T. Giorgetti C. Reichardt P. Dalteparin for prevention of catheter‐related complications in cancer patients with central venous catheters: final results of a double‐blind, placebo‐controlled phase III trial.Ann Oncol. 2006; 17: 289-96Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar]. The lower catheter‐related thrombosis rates as compared with older studies are probably a consequence of the type of central catheter employed and/or maintenance techniques (i.e. routine flushing of catheters). It is important to note the limitations of this review. Firstly, there is a wide range in both incidence and definition of catheter‐related thrombosis. Consequently, we limited our primary analyses to symptomatic catheter‐related thrombosis. Including asymptomatic and symptomatic events might have increased the power required to detect a difference between the groups. Secondly, observational studies were excluded from our review as their conclusions are similar to our findings. Pucheu et al. [13Pucheu A. Leduc B. Sillet‐Bach I. Payen C. Assaf W. Pucheu M. Experimental prevention of deep venous thrombosis with low‐molecular‐weight heparin using implantable infusion devices.Ann Cardiol Angeiol. 1996; 45: 59-63PubMed Google Scholar] failed to demonstrate a statistically significant benefit of daltaparin compared with historical controls. Uncontrolled cohort studies by Boraks et al. [14Boraks P. Seale J. Price J. Bass G. Ethell M. Keeling D. Mahendra P. Baglin T. Marcus R. Prevention of central venous catheter associated thrombosis using minidose warfarin in patients with haematological malignancies.Br J Haematol. 1998; 101: 483-6Crossref PubMed Scopus (162) Google Scholar] and Nightingale et al. [15Nightingale C.E. Norman A. Cunningham D. Young J. Webb A. Filshie J. A prospective analysis of 949 long‐term central venous access catheters for ambulatory chemotherapy in patients with gastrointestinal malignancy.Eur J Cancer. 1997; 33: 398-403Abstract Full Text PDF PubMed Scopus (96) Google Scholar] suggest incidence rates of symptomatic catheter‐related thrombosis while on warfarin (4.6% and 4.4%, respectively) similar to the incidence rates detected in the placebo groups of recently completed randomized trials. Further, a recent large cohort study by Fagnani et al. [16Fagnani D. Franchi R. Porta C. Bertolini A. Duro M. Ardizzoia A. Filipazzi V. Isa L. Vergani C. Milani M. Cimminiello C on behalf of POLONORD groupThrombosis‐related complications and mortality in cancer patients with central venous devices: an observational study on the effect of antithrombotic prophylaxis.Ann Onc. 2007; 18: 551-5Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar] did not find a difference in catheter‐related thrombosis (odds ratio 1.29; 95% CI 0.64–2.6) in patients receiving continuous antithrombotic prophylaxis (mainly low‐dose warfarin). Third, given the low number of trials in each analysis, the statistical tests for heterogeneity are likely to be underpowered in order to detect important differences. Fourth, sensitivity and subgroup analyses were planned a priori but were limited by the small number of studies. Finally, we could not assess for publication bias because of the limited numbers of studies. In conclusion, our review suggests that thromboprophylaxis with either LMWH or low‐dose warfarin does not prevent symptomatic catheter‐related thrombosis in patients with cancer and cannot be routinely recommended. The authors state that they have no conflict of interest. P. Wells is the recipient of a Canada Research Chair. M. Carrier is the recipient of a Canadian Institute for Health Research Fellowship. J. Tay is a University of Ottawa Centre for Transfusion Research Fellow supported by the Canadian Blood Services. D. Fergusson is the recipient of a Canadian Institute for Health Research New Investigator Research Award." @default.
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• W2123818091 title "Thromboprophylaxis for catheter‐related thrombosis in patients with cancer: a systematic review of the randomized, controlled trials" @default.
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