A Randomised Trial of Subcutaneous Low Molecular Weight Heparin (CY 216) Compared with lntravenous Unfractionated Heparin in the Treatment of Deep Vein Thrombosis

Ninet, J.; Bachet, P.; Prandoni, Paolo; Ruol, A; Vigo, M; Barret, A; Mericq, Olivier; Boneu, B; Janvier, G.; Duroux, P; Girard, P.; Laprevote-Heully, M. C.; Sourou, P; Robert, Dominique; Chagny, M; Gg, Nenci; Agnelli, Giancarlo; D'Addato, M; Palumbo, H; Bensaid, J; Gouffault, J; Leborgne, P; Hellocco, A Le; Ducreux, J.C.; Tempelhoff, G.-F. von; E, Salaplanell; Rosendo-Carrera, A.; Torres-Gomez, A; Blettery, B; Bachmann, Fédor; Gaux, Jean‐Claude; Muntlak, H; Caulin, C; Bergmann, Jean‐François

doi:10.1055/s-0038-1647660

Cited by 138 publications

(12 citation statements)

References 6 publications

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“…14,23 All but 1 study 16 blinded outcome assessors. Only 2 studies blinded data analysts, 16,21 and only 2 studies blinded patients and caregivers.…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

“…Only 2 studies blinded data analysts, 16,21 and only 2 studies blinded patients and caregivers. 15,23 Eight studies clearly used ITT analysis. 12,15,16,21,23,24,26,28 Although follow-up was 89% for 1 study 14 and 92% for another, 23 it was 100% for the remaining studies.…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

“…In 3 studies, the subgroups of patients with cancer had small and imbalanced arms with respect to the number of patient randomized to each treatment (ie, the number of patients in the LMWH and UFH arms for the 3 studies were 6 and 12, 7 and 2, 7 and 2, respectively). 13,23,27 The methodologic quality for death and recurrent VTE outcomes, respectively, was moderate and low for patients with cancer and low for both outcomes among patients without cancer (summary of findings tables are available from the authors on request).…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

“…Patients with cancer, as noted earlier, constituted subgroups in all studies that were included. [12][13][14][15][16]21,[23][24][25][26][27][28][29] The 13 studies recruited a total of 1016 patients with cancer and 4797 patients without cancer. None of the studies specified the type(s) of cancer of participants.…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

“…In collaborative European multicenter study, the long-term anticoagulation was either subcutaneous UFH or oral anticoagulation, depending on the participating center's usual regimen. 23 …”

Section: Data Synthesis and Analysismentioning

confidence: 99%

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Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Akl

Rohilla

Barba³

et al. 2008

Cancer

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BACKGROUND.The authors compared the relative efficacy and safety of low‐ molecular‐weight heparin (LMWH) and unfractionated heparin (UFH) for the initial treatment of venous thromboembolism (VTE) between patients with and without cancer.METHODS.By using Cochrane methodology for systematic reviews, separate meta‐analyses were conducted for subgroups of patients with and without cancer, and relative risks (RRs) were compared for statistical significance. The methodologic quality for each outcome was assessed by using the Grading of Recommendations Assessment, Development, and Evaluation approach.RESULTS.LMWH reduced mortality significantly compared with UFH in patients with cancer (RR of 0.71; 95% confidence interval [95% CI], 0.52‐0.98 [moderate‐quality evidence]) but not in patients without cancer (RR of 0.97; 95% CI, 0.65‐1.46 [low‐quality evidence]). However, the difference in the RR for the 2 subgroups did not reach statistical significance (P = .113). The difference between LMWH and UFH in the effect on recurrent VTE was not statistically significant in the subgroup with cancer (RR of 0.78; 95% CI, 0.29‐2.08 [low‐quality evidence]), in the subgroup without cancer (RR of 0.94; 95% CI, 0.60‐1.46 [low‐quality evidence]), or between the 2 subgroups (P = .367). No data were available for bleeding outcomes, thrombocytopenia, or postphlebitic syndrome.CONCLUSIONS.The current results indicated that LMWH most likely is superior to UFH in reducing mortality in the initial treatment of VTE for patients with cancer. There is a need for more and better designed trials to confirm these findings. Cancer 2008. © 2008 American Cancer Society.

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“…14,23 All but 1 study 16 blinded outcome assessors. Only 2 studies blinded data analysts, 16,21 and only 2 studies blinded patients and caregivers.…”

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

Section: Methodologic Quality Of Included Studiesmentioning

confidence: 99%

Section: Data Synthesis and Analysismentioning

confidence: 99%

“…In collaborative European multicenter study, the long-term anticoagulation was either subcutaneous UFH or oral anticoagulation, depending on the participating center's usual regimen. 23 …”

Section: Data Synthesis and Analysismentioning

confidence: 99%

See 3 more Smart Citations

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Akl

Rohilla

Barba³

et al. 2008

Cancer

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A Meta-analysis Comparing Low-Molecular-Weight Heparins With Unfractionated Heparin in the Treatment of Venous Thromboembolism

Dolovich¹,

Ginsberg²,

Douketis³

et al. 2000

Arch Intern Med

447

201

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Low-molecular-weight heparins are at least as effective as UFH in preventing recurrent VTE. It is unlikely that LMWHs are superior in the treatment of VTE, but they do show a statistically significant decrease in total mortality. No differences were seen in the development of recurrent VTE dependent on treatment setting. There were no apparent differences between once-daily and twice-daily therapy or among products. Inpatient therapy may be associated with less major bleeding; therefore, if LMWHs are given in the outpatient setting, patients should be rigorously monitored.

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Subcutaneous Adjusted-Dose Unfractionated Heparin vs Fixed-Dose Low-Molecular-Weight Heparin in the Initial Treatment of Venous Thromboembolism

Prandoni

Carnovali²,

Marchiori³

et al. 2004

Arch Intern Med

108

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A Randomised Trial of Subcutaneous Low Molecular Weight Heparin (CY 216) Compared with lntravenous Unfractionated Heparin in the Treatment of Deep Vein Thrombosis

Cited by 138 publications

References 6 publications

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

A Meta-analysis Comparing Low-Molecular-Weight Heparins With Unfractionated Heparin in the Treatment of Venous Thromboembolism

Subcutaneous Adjusted-Dose Unfractionated Heparin vs Fixed-Dose Low-Molecular-Weight Heparin in the Initial Treatment of Venous Thromboembolism

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