MATISSE PE study - description and results

Related trials

Treatments

Studied treatment

fondaparinux subcutaneously once daily
fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily, given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0

Control treatment

continuous intravenous infusion of unfractionated heparin
(ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0

Patients

patients with acute symptomatic pulmonary embolism

Inclusion criteria

patients 18 years of age or older who presented with acute symptomatic pulmonary embolism and who required antithrombotic therapy were potentially eligible for the study. Diagnostic criteria were an intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, a high-probability ventilation–perfusion lung scan, or a nondiagnostic lung scan with documentation of deep-vein thrombosis either by compression ultrasonography or by venography

Baseline characteristics

Age	62.5y
female (%)	27.2%

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Recurrent thromboembolic event

42 / 1103
56 / 1110
0,75 [0,51;1,12]

All cause death

57 / 1092
48 / 1092
1,19 [0,82;1,73]

Major bleeding

22 / 1092
26 / 1092
0,85 [0,48;1,48] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial
Recurrent thromboembolic event	42 / 1103 (3,8%)	56 / 1110 (5,0%)	0,75	[0,51;1,12]	entire study
Major bleeding	22 / 1092 (2,0%)	26 / 1092 (2,4%)	0,85	[0,48;1,48]
All cause death	57 / 1092 (5,2%)	48 / 1092 (4,4%)	1,19	[0,82;1,73]
The primary endpoint (if exists) appears in blod characters

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Recurrent thromboembolic event	3,81%	5,05%	-12,4‰
Major bleeding	2,01%	2,38%	-3,7‰
All cause death	5,22%	4,40%	8,2‰

Reference(s)

Trials register #

Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.. N Engl J Med 2003 Oct 30;349:1695-702

Pubmed | Hubmed | Fulltext

MATISSE PE study, 2003

Treatments

Patients

Method and design

Results

Reference(s)

Digital discoveries