Abstract
Aim
In the ARTEMIS study fondaparinux 2.5mg reduced the overall incidence of venous thromboembolism (VTE) by 47% in general medical patients when compared to placebo. Our aim was to identify which medical patient populations with an acute medical illness or risk factor for VTE benefited from fondaparinux prophylaxis.
Method
A total of 849 patients were enrolled in 35 centres in 8 countries. Patients were randomised to receive placebo or fondaparinux 2.5mg subcutaneously once daily for 6 to 14 days. 644 (76%) patients were available for assessment of the primary outcome, occurrence of documented VTE between day 1 and day 15. We performed a subgroup analysis of the incidence of VTE in the placebo and fondaparinux 2.5mg treatment groups. The medical illness subgroups analysed were those predefined in the original study: acute heart failure only, respiratory disease only, infectious/inflammatory disease only and more than one disease.
Results
Conclusion
Fondaparinux 2.5mg is superior to placebo in preventing VTE in patients with acute medical illness. Similar point estimates and overlapping confidence intervals indicate that the results are consistent within all the predefined medical illness.
| Population variable . | Placebo . | Fondaparinux 2.5mg . | Relative risk reduction . | 95% CI * . | P Value . | ||
|---|---|---|---|---|---|---|---|
| . | n/N . | % . | n/N . | % . | . | . | . |
| *exact CI for RRR based on standardized statistics and inverting a 2-sided test | |||||||
| Acute heart failure (NYHA III/IV) | 10/82 | 12.2 | 7/78 | 9.0 | 26.4% | [−78.9%;69.7%] | 0.61 |
| Acute respiratory disease only | 4/73 | 5.5 | 1/63 | 1.6 | 71.0% | [−86.6%;97.7%] | 0.37 |
| Acute infectious/inflammatory disease only | 10/88 | 11.4 | 4/77 | 5.2 | 54.3% | [−33.1%;85.0%] | 0.17 |
| More than one disease | 10/80 | 12.5 | 6/103 | 5.8 | 53.4% | [−21.4%;83.4%] | 0.12 |
| Population variable . | Placebo . | Fondaparinux 2.5mg . | Relative risk reduction . | 95% CI * . | P Value . | ||
|---|---|---|---|---|---|---|---|
| . | n/N . | % . | n/N . | % . | . | . | . |
| *exact CI for RRR based on standardized statistics and inverting a 2-sided test | |||||||
| Acute heart failure (NYHA III/IV) | 10/82 | 12.2 | 7/78 | 9.0 | 26.4% | [−78.9%;69.7%] | 0.61 |
| Acute respiratory disease only | 4/73 | 5.5 | 1/63 | 1.6 | 71.0% | [−86.6%;97.7%] | 0.37 |
| Acute infectious/inflammatory disease only | 10/88 | 11.4 | 4/77 | 5.2 | 54.3% | [−33.1%;85.0%] | 0.17 |
| More than one disease | 10/80 | 12.5 | 6/103 | 5.8 | 53.4% | [−21.4%;83.4%] | 0.12 |
Author notes
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