Deep vein thrombosis landmark trials in treatment: Difference between revisions
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==Landmark Clinical Trials== | ==Landmark Clinical Trials== | ||
===Trials assessing treatment=== | ===Trials assessing treatment=== | ||
=== | ===Trials comparing Low-molecular-weight Heparin With subcutaneous unfractionated Heparin=== | ||
1. Compare subcutaneous [[LMWH]] with unfractionated heparin for treatment of [[VTE]] | 1. Compare subcutaneous [[LMWH]] with unfractionated heparin for treatment of [[VTE]] | ||
* '''Methods:''' A total of 720 patients (including those with [[PE]] and recurrent [[VTE]]) were randomly assigned to subcutaneous [[LMWH]] or fixed-dose unfractionated heparin. | * '''Methods:''' A total of 720 patients (including those with [[PE]] and recurrent [[VTE]]) were randomly assigned to subcutaneous [[LMWH]] or fixed-dose subcutaneous unfractionated heparin. | ||
* '''Results:''' Subcutaneous [[LMWH]] and unfractionated heparin groups had similar incidence of recurrent thromboembolic events (4.2% and 3.9%), mortality (3.3% and 3.3%) and major bleeding (0.8% and 1.1%) during 3-months of follow-up. | * '''Results:''' Subcutaneous [[LMWH]] and unfractionated heparin groups had similar incidence of recurrent thromboembolic events (4.2% and 3.9%), mortality (3.3% and 3.3%) and major bleeding (0.8% and 1.1%) during 3-months of follow-up. | ||
* '''Conclusions:''' Subcutaneous [[LMWH]] is as effective and safe as [[unfractionated heparin]] for treatment of [[VTE]]. | * '''Conclusions:''' Subcutaneous [[LMWH]] is as effective and safe as [[unfractionated heparin]] for treatment of [[VTE]]. | ||
2. Fixed-Dose Heparin (FIDO) trial | 2. Fixed-Dose Heparin (FIDO) trial | ||
* Objective: Compare subcutaneous [[unfractionated heparin]] with [[LMWH]] for treatment of [[VTE]] | * '''Objective:''' Compare subcutaneous [[unfractionated heparin]] with [[LMWH]] for treatment of [[VTE]] | ||
* Methods: Randomized, open-label, adjudicator-blinded, noninferiority trial of 708 patients with [[VTE]], who were randomized to [[unfractionated heparin]] at an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours and [[LMWH]] at a fixed dose of 100 U/kg every 12 hours. Both treatments were given as outpatients. | * '''Methods:''' Randomized, open-label, adjudicator-blinded, noninferiority trial of 708 patients with [[VTE]], who were randomized to [[unfractionated heparin]] at an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours and [[LMWH]] at a fixed dose of 100 U/kg every 12 hours. Both treatments were given as outpatients. | ||
* Results: The are of recurrent [[VTE]] (3.8% and 3.4%) and major bleeding (1.1% and 1.4%) was almost similar in the [[UFH]] and [[LMWH]] groups, respectively. | * '''Results:''' The are of recurrent [[VTE]] (3.8% and 3.4%) and major bleeding (1.1% and 1.4%) was almost similar in the [[UFH]] and [[LMWH]] groups, respectively. | ||
* Conclusions: Fixed dose subcutaneous [[UFH]] is as effective and safe as [[LMWH]] for treatment of [[VTE]] in an outpatient setting. | * '''Conclusions:''' Fixed dose subcutaneous [[UFH]] is as effective and safe as [[LMWH]] for treatment of [[VTE]] in an outpatient setting. | ||
3. Polish multi center trial | |||
* '''Methods:''' A total of 149 patients with [[DVT]] were randomly assigned to subcutaneous [[LMWH]] or subcutaneous [[UFH]] foe 10 days. | |||
* '''Results:''' One symptomatic nonfatal [[PE]], two rethromboses and one major leading was noted in the [[UFH]] group, compared to none in [[LMWH]] group. | |||
* '''Conculusions:''' Subcutaneous fixed-dose [[LMWH]] is as effective and safe as subcutaneous [[UFH]] in treatment of [[DVT]]. | |||
1. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990) <ref name="pmid1964751">{{cite journal |author=Bratt G, Aberg W, Johansson M, Törnebohm E, Granqvist S, Lockner D |title=Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT) |journal=Thromb. Haemost. |volume=64 |issue=4 |pages=506–10 |year=1990 |month=December |pmid=1964751 |doi= |url= |accessdate=2012-05-03}}</ref> | ===Trials comparing Low-molecular-weight Heparin With intravenous unfractionated Heparin=== | ||
1. Cochrane meta-analysis | |||
* Objective: To compare the effectiveness of [[LMWH]] with [[UFH]] for [[VTE]] treatment. | |||
* Methods: A [[cochrane collaboration]] meta-analysis of randomized controlled trials comparing the fixed dose subcutaneous [[LMWH]] with adjusted dose intravenous or subcutaneous [[UFH]] for treatment of [[VTE]] was performed. | |||
* Results: A total of 23 studies were included in the meta-analysis. Thrombotic complications (3.6% vs. 5.3%; OR, 0.70, 95% CI 0.57-0.85), major hemorrhages (1.1% vs. 1.9%; OR, 0.58, 95% CI 0.40-0.83) and mortality (4.3% vs. 5.8%; OR, 0.77, 95% CI 0.63-0.93) was significantly lower in subjects treated with [[LMWH]] compared with [[UFH]]. | |||
* Conclusions: Subcutaneous [[LMWH]] signficantly reduced the incidence of thrombotic complications, major bleeding and mortality in patients with acute [[VTE]]. It is more effective and safer than [[UFH]] for the initial treatment of [[VTE]]. | |||
2. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990) <ref name="pmid1964751">{{cite journal |author=Bratt G, Aberg W, Johansson M, Törnebohm E, Granqvist S, Lockner D |title=Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT) |journal=Thromb. Haemost. |volume=64 |issue=4 |pages=506–10 |year=1990 |month=December |pmid=1964751 |doi= |url= |accessdate=2012-05-03}}</ref> | |||
* '''Patient enrollment:''' 119 patients | * '''Patient enrollment:''' 119 patients | ||
*''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | *''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | ||
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*''' Conclusion:''' Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg. | *''' Conclusion:''' Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg. | ||
3. A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991) <ref name="pmid1646490">{{cite journal |author= |title=A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. A collaborative European multicentre study |journal=Thromb. Haemost. |volume=65 |issue=3 |pages=251–6 |year=1991 |month=March |pmid=1646490 |doi= |url= |accessdate=2012-05-02}}</ref> | |||
* '''Patient enrollment:''' 166 patients | * '''Patient enrollment:''' 166 patients | ||
*''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | *''' Purpose:''' To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis . | ||
Revision as of 04:20, 27 May 2012
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-In-Chief: Ujjwal Rastogi, MBBS [2]; Kashish Goel,M.D.
Landmark Clinical Trials
Trials assessing treatment
Trials comparing Low-molecular-weight Heparin With subcutaneous unfractionated Heparin
1. Compare subcutaneous LMWH with unfractionated heparin for treatment of VTE
- Methods: A total of 720 patients (including those with PE and recurrent VTE) were randomly assigned to subcutaneous LMWH or fixed-dose subcutaneous unfractionated heparin.
- Results: Subcutaneous LMWH and unfractionated heparin groups had similar incidence of recurrent thromboembolic events (4.2% and 3.9%), mortality (3.3% and 3.3%) and major bleeding (0.8% and 1.1%) during 3-months of follow-up.
- Conclusions: Subcutaneous LMWH is as effective and safe as unfractionated heparin for treatment of VTE.
2. Fixed-Dose Heparin (FIDO) trial
- Objective: Compare subcutaneous unfractionated heparin with LMWH for treatment of VTE
- Methods: Randomized, open-label, adjudicator-blinded, noninferiority trial of 708 patients with VTE, who were randomized to unfractionated heparin at an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours and LMWH at a fixed dose of 100 U/kg every 12 hours. Both treatments were given as outpatients.
- Results: The are of recurrent VTE (3.8% and 3.4%) and major bleeding (1.1% and 1.4%) was almost similar in the UFH and LMWH groups, respectively.
- Conclusions: Fixed dose subcutaneous UFH is as effective and safe as LMWH for treatment of VTE in an outpatient setting.
3. Polish multi center trial
- Methods: A total of 149 patients with DVT were randomly assigned to subcutaneous LMWH or subcutaneous UFH foe 10 days.
- Results: One symptomatic nonfatal PE, two rethromboses and one major leading was noted in the UFH group, compared to none in LMWH group.
- Conculusions: Subcutaneous fixed-dose LMWH is as effective and safe as subcutaneous UFH in treatment of DVT.
Trials comparing Low-molecular-weight Heparin With intravenous unfractionated Heparin
1. Cochrane meta-analysis
- Objective: To compare the effectiveness of LMWH with UFH for VTE treatment.
- Methods: A cochrane collaboration meta-analysis of randomized controlled trials comparing the fixed dose subcutaneous LMWH with adjusted dose intravenous or subcutaneous UFH for treatment of VTE was performed.
- Results: A total of 23 studies were included in the meta-analysis. Thrombotic complications (3.6% vs. 5.3%; OR, 0.70, 95% CI 0.57-0.85), major hemorrhages (1.1% vs. 1.9%; OR, 0.58, 95% CI 0.40-0.83) and mortality (4.3% vs. 5.8%; OR, 0.77, 95% CI 0.63-0.93) was significantly lower in subjects treated with LMWH compared with UFH.
- Conclusions: Subcutaneous LMWH signficantly reduced the incidence of thrombotic complications, major bleeding and mortality in patients with acute VTE. It is more effective and safer than UFH for the initial treatment of VTE.
2. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990) [1]
- Patient enrollment: 119 patients
- Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
- Result: Repeat phlebography after 5-7 days showed improvement in 34/45 patients (76%) in the Fragmin group and in 30/49 patients (61%) in the SH group and progress in 2/45 (4%) and 3/49 (6%), respectively. The mean Marder scores decreased from 18.7 +/- 12.1 to 15.7 +/- 12.7 in the Fragmin group and from 16.9 +/- 12.0 to 14.4 +/- 11.8 in the SH group (ns). Two patients in the SH group and none in the Fragmin group had major bleedings. After 22 +/- 7 months follow up 6 rethromboses had occurred in the SH group and 4 in the Fragmin group. Postthrombotic signs and symptoms were similar in both groups.
- Conclusion: Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg.
3. A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991) [2]
- Patient enrollment: 166 patients
- Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
- Result: Both "therapeutic efficacy" and "intention to-treat" analyses showed that subcutaneous CY 216 in fixed doses based only on body weight was more effective on the Arnesen and Marder phlebographic scores than continuous i.v. standard heparin with daily dose adjustment according to results of coagulation tests. There was no increase in the risks of pulmonary embolism, haemorrhage or clot extension.
References
- ↑ Bratt G, Aberg W, Johansson M, Törnebohm E, Granqvist S, Lockner D (1990). "Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT)". Thromb. Haemost. 64 (4): 506–10. PMID 1964751. Unknown parameter
|month=ignored (help);|access-date=requires|url=(help) - ↑ "A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. A collaborative European multicentre study". Thromb. Haemost. 65 (3): 251–6. 1991. PMID 1646490. Unknown parameter
|month=ignored (help);|access-date=requires|url=(help)