Consistent Venous Thromboembolism Risk Reduction by Extended- Versus Standard-Duration Enoxaparin Prophylaxis in Subgroups of Acutely Ill Medical Patients in the EXCLAIM Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1863-1863 ◽  
Author(s):  
Victor F. Tapson ◽  
Russell D. Hull ◽  
Sebastian M. Schellong ◽  
Manuel Monreal ◽  
Meyer-Michel Samama ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Odds Ratio ◽  
Primary Diagnosis ◽  
Medical Patients ◽  
Once Daily ◽  
Standard Duration ◽  
Extended Duration ◽  
Level 1 ◽  
Reduced Mobility ◽  
Patient Subgroups

Abstract Introduction In the EXCLAIM study, extended-duration enoxaparin prophylaxis reduced the relative risk of VTE in acutely ill medical patients by 44% compared with placebo, following standard-duration prophylaxis (2.8% vs 4.9%; RR 0.56; 95% CI 0.39–0.80; p=0.0011). We assessed the benefits of extended-duration enoxaparin prophylaxis in subgroups of acutely ill medical patients with the most prominent primary diagnoses enrolled in EXCLAIM. Methods Patients enrolled in EXCLAIM had: recent reduced mobility (≤3 days) due to a medical illness, age ≥40 years, and anticipated level 1 (total bed rest or sedentary without bathroom privileges) or level 2 (level 1 with bathroom privileges) reduced mobility with further risk factors. Eligible patients received enoxaparin 40mg SC once-daily for 10±4 days, and were then double-blind randomized and received enoxaparin 40mg SC once-daily (n=2013) or placebo (n=2027) for a further 28±4 days. Asymptomatic DVT were diagnosed by bilateral compression ultrasound after completion of the randomized treatment. Suspected cases of symptomatic DVT or PE were confirmed by objective tests. Fatal PE were confirmed by autopsy where possible. Univariate logistic regressions were conducted to estimate treatment effects in patient subgroups. The primary safety endpoint was major bleeding. Results Baseline characteristics were similar between treatments within each primary diagnosis subgroup, and the considered primary diagnoses accounted for >80% of the enrolled population. The reduced VTE incidence associated with extended-duration enoxaparin prophylaxis was consistent across subgroups of patients with different primary diagnoses (Table). The incidence of major bleeding was generally higher in patients receiving extended-duration prophylaxis (Table). Table: VTE and major bleeding in patient subgroups receiving extended-duration vs standard-duration prophylaxis/placebo Primary diagnosis Incidence of VTE (%)* Odds Ratio [95% CI]** Incidence of Major Bleeding (%)*** Odds Ratio [95% CI] Extended Enox Standard Enox/Placebo Extended Enox Standard Enox/Placebo *N=3347 evaluable patients; **Alpha adjustment for an interim analysis; ***N=4040 treated patients Heart failure, NYHA class III or IV 3.1 4.7 0.64 [0.29–1.39] 0.0 0.2 N/A Acute respiratory insufficiency 2.2 3.7 0.60 [0.27–1.34] 0.6 0.2 3.15 [0.33–30.4] Post ischemic stroke 2.1 8.3 0.24 [0.06–0.91] 0.6 0.0 N/A Acute infection without septic shock 3.6 5.3 0.66 [0.36–1.22] 0.8 0.2 5.16 [0.60–44.3] Conclusion Extended enoxaparin prophylaxis consistently reduced VTE risk in acutely ill medical patients with the most prominent primary diagnoses compared with placebo following standard-duration prophylaxis. Major bleeding was generally higher in the extended-duration enoxaparin arm, but rates of bleeding were low. These findings are consistent with the primary findings of the EXCLAIM study which demonstrated the clinical benefit of the extended-duration enoxaparin regimen.

Extended-Duration Enoxaparin for Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients: An Evaluation of the EXCLAIM Study Based on a Recently Recommended Composite Efficacy Endpoint.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1870-1870 ◽  
Author(s):  
Sebastian M. Schellong ◽  
Russell D. Hull ◽  
Victor F. Tapson ◽  
Manuel Monreal ◽  
Meyer-Michel Samama ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Composite Endpoint ◽  
Medical Patients ◽  
Double Blind ◽  
Once Daily ◽  
All Cause Mortality ◽  
Standard Duration ◽  
Extended Duration ◽  
Level 1 ◽  
Reduced Mobility

Abstract Introduction The EXCLAIM study has shown that in acutely ill medical patients who have received a standard 10-day period of prophylaxis with enoxaparin, extended-duration prophylaxis with enoxaparin for 4 weeks reduces the relative risk of the primary composite endpoint of asymptomatic proximal deep-vein thrombosis (DVT), symptomatic DVT or pulmonary embolism (PE), and fatal PE by 44% compared with placebo (2.8% vs 4.9%; RR 0.56; 95% CI 0.39–0.80; p=0.0011). We assessed the consistency of these results using the composite efficacy endpoint recently proposed for venous thromboembolism (VTE) prophylaxis studies by the European Committee for Medicinal Products for Human Use (CHMP) which, in addition, takes all-cause mortality into account. Methods Patients enrolled in the EXCLAIM study had a recent reduced mobility (≤3 days) due to a medical illness, were aged 40 years or older, and had anticipated level 1 (total bed rest or sedentary without bathroom privileges) or level 2 (level 1 with bathroom privileges) reduced mobility with further risk factors. Eligible patients received enoxaparin 40mg SC once-daily for 10±4 days. Patients were then double-blind randomized and received either enoxaparin 40mg SC once-daily or placebo for a further 28±4 days. Asymptomatic DVT were diagnosed by bilateral compression ultrasound after completion of the randomized treatment period. Suspected cases of symptomatic DVT or PE were confirmed by objective tests. Fatal PE were confirmed by autopsy where possible. Data were analyzed using the CHMP-recommended composite efficacy endpoint of proximal DVT, adjudicated PE and all-cause mortality. Results Eligible patients enrolled at 370 sites in 20 countries received standard-duration prophylaxis with enoxaparin. Of these, 4114 patients were double-blind randomized and 4040 received extended-duration prophylaxis with enoxaparin (n=2013) and placebo (n=2027), respectively. Extended-duration enoxaparin reduced the relative risk of the CHMP composite endpoint by 26% compared with placebo (5.8% vs 7.9%; RR 0.74; 95% CI 0.58–0.95; p=0.018). Conclusion The significant reduction in the incidence of the primary efficacy endpoint associated with the use of extended-duration enoxaparin compared with placebo, following standard duration enoxaparin, was consistent when applying both the pre-defined EXCLAIM and the CHMP-recommended composite endpoints, the latter of which included all-cause mortality in addition to proximal DVT and adjudicated PE.

The Effects of the Degree of Mobility Reduction and Prespecified Risk Factors on Venous Thromboembolism Rates in Acutely Ill Medical Patients in the EXCLAIM Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1862-1862 ◽  
Author(s):  
Roger D. Yusen ◽  
Russell D. Hull ◽  
Sebastian M. Schellong ◽  
Victor F. Tapson ◽  
Manuel Monreal ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Major Bleeding ◽  
P Value ◽  
Medical Patients ◽  
Standard Duration ◽  
Extended Duration ◽  
Level 1 ◽  
Reduced Mobility ◽  
Level 2

Abstract Introduction EXCLAIM showed a 44% reduction of the relative risk of venous thromboembolism (VTE) with extended-duration enoxaparin prophylaxis compared with placebo, following standard-duration prophylaxis in acutely ill medical patients (2.8% vs 4.9%; RR 0.56; 95% CI 0.39–0.80; p=0.001). We retrospectively assessed the effects of degree of reduced mobility and prespecified risk factors on the incidence of VTE in EXCLAIM. Methods EXCLAIM eligibility required a recent (≤3 days) reduction in mobility due to acute medical illness, an anticipated level 1 (total bed rest/sedentary; no bathroom privileges) or level 2 (level 1 with bathroom privileges) decreased mobility, and age ≥40 years. During the latter part of the study, a protocol amendment required patients with level 2 mobility to have ≥1 of 3 additional prespecified risk factors (history of cancer, history of VTE, age >75 years). Enrolled patients received enoxaparin 40mg SC od for 10±4 days. Randomized patients received double-blind therapy (enoxaparin 40mg SC od or placebo) for 28±4 additional days. Patients were screened for deep vein thrombosis with bilateral proximal lower extremity compression ultrasound after randomized therapy. A blinded committee adjudicated cases of suspected VTE and major bleeding. Results Of patients evaluable for VTE (pre- and post-amendment; n=4995), 42% had level 1 mobility. 43% with level 2 mobility met the amended eligibility criteria. The incidence of VTE was 3.2%. Treatment effects on VTE incidence and major bleeding rates were consistent within mobility groups, regardless of the presence of prespecified risk factors (Table). In patients with level 1 mobility, those with ≥1 prespecified risk factors had a higher VTE incidence than those without (4.8% vs 2.6%; p=0.007). In patients with level 2 mobility, those with ≥1 risk factors had a higher VTE incidence than those without (4.6% vs 1.9%; p<0.0001). Table: Effect of level of reduced mobility and prespecified risk factors on incidence of VTE and major bleeding in patients receiving extended-duration prophylaxis or placebo, following standard-duration prophylaxis Level of mobility and number of prespecified risk factors Extended-duration enoxaparin Extended-duration placebo p-value for interaction* *Non-significant p-value denotes consistent treatment effect among subgroups; n=5963 for assessment of bleeding VTE (%) Level 1 - no risk factors 2.1 3.0 0.36 Level + ≥1 risk factor 2.7 6.8 Level 2 - no risk factors 1.9 2.0 Level 2 + ≥1 risk factor 3.5 5.6 Major bleeding (%) Level 1 - no risk factors 0.4 0.0 1.00 Level 1 + ≥1 risk factor 0.6 0.0 Level 2 - no risk factors 0.8 0.4 Level 2 + ≥1 risk factor 0.8 0.4 Conclusion After acutely ill medical patients with reduced mobility received standard-duration VTE prophylaxis, the presence of prespecified risk factors was associated with an increased incidence of VTE, independent of the level of reduced mobility. The treatment effects of extended-duration prophylaxis with enoxaparin compared with placebo were consistent among subgroups.

The Impact of Age on the Efficacy and Safety of Extended-Duration Thromboprophylaxis in Acutely Ill Medical Patients with Recent Immobility: A Sub-Group Analysis from the EXCLAIM Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 438-438 ◽  
Author(s):  
Roger D Yusen ◽  
Russell D Hull ◽  
Sebastian M Schellong ◽  
Victor F Tapson ◽  
Manuel Monreal ◽  
...  
Keyword(s):  
Placebo Group ◽  
Major Bleeding ◽  
Medical Patients ◽  
Efficacy And Safety ◽  
Double Blind ◽  
End Point ◽  
Standard Duration ◽  
Extended Duration ◽  
Level 1 ◽  
Level 2

Abstract Background: The EXtended CLinical prophylaxis in Acutely Ill Medical patients (EXCLAIM) trial was a randomized, double-blind, placebo-controlled, multicenter, international study that demonstrated a 38% relative risk reduction (RRR) for venous thromboembolism (VTE) with extended-duration enoxaparin prophylaxis compared with placebo (2.5% vs 4.0%; absolute difference [AD], −1.5% 95.8% CI −2.5 to −0.5%; P=0.002). Major bleeding occurred in 0.7% (20/2975) and 0.2% (7/2988) of patients who received enoxaparin and placebo, respectively (AD, 0.4% [CI 0.1% to 0.8%]; P=0.012). As age is a known independent risk factor for VTE, we conducted a pre-specified sub-analysis of the EXCLAIM trial to compare the efficacy and safety of extended-duration enoxaparin prophylaxis in patients &gt;75 years old with patients ≤75 years old. Methods: EXCLAIM eligibility required a recent (≤3 days) reduction in mobility due to acute medical illness, an anticipated level 1 (total bed rest/sedentary) or level 2 (level 1 with bathroom privileges) decreased mobility, and age ≥40 years. During the latter part of the study, a protocol amendment required patients with level 2 mobility to have ≥1 of 3 additional pre-specified risk factors (i.e., active or prior cancer, history of VTE, age &gt;75 years). Of the 7500 patients enrolled, 7415 received open-label enoxaparin 40 mg SC od for 10±4 days. Of these, 6085 were randomized to double-blind therapy (enoxaparin 40mg SC od or placebo) of 28±4 additional days duration. The incidence of VTE, the primary efficacy end point, was defined as the composite of symptomatic or asymptomatic proximal deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE), or fatal PE during the double-blind treatment period. Patients were screened for DVT with bilateral proximal lower extremity compression ultrasound at the end of randomized therapy. The incidence of major bleeding, the primary safety end point, was assessed through 48 hours after the last dose of study treatment. Results: Of the 5963 randomized patients that received at least one dose of double-blind therapy, 29.9% (1781) were &gt;75 years of age (mean age 81.5 years) and 70.1% (4182) were ≤75 years old (mean age 61.8 years). In patients &gt;75 years old, the incidence of VTE was 2.5% (18/725) in the enoxaparin group compared with 6.7% (50/743) in the placebo group (AD −4.2% [95.8% CI −6.5 to −2.0%]; P&lt;0.001). In patients ≤75 years old, the incidence of VTE was 2.4% (43/1760) with extended-duration enoxaparin treatment and 2.8% (50/1767) in the placebo group (AD −0.4%, 95.8% CI −1.5 to 0.7%; P=0.474). The incidence of major bleeding was low, but non-significantly higher with extended prophylaxis compared to placebo in patients &gt;75 years old (0.6% vs 0.2%; AD 0.3%, 95% CI −0.2 to 0.9%; P=0.282) and significantly higher in patients ≤75 years old (0.7% vs 0.2%; AD 0.5%, 95%CI 0.1 to 0.9%; P=0.041). Though the older group had a higher death rate compared to the younger group (3.2% vs 1.6%), the survival between the treatment groups was similar within the two age groups. Without extended prophylaxis (i.e., placebo group), patients &gt;75 years old had a significantly higher risk of VTE than those &lt;75 years old (6.7 % vs 2.8 %; AD 3.9%, 95.8% CI 1.9 to 5.9%; p&lt;0.001) during the first month after completing a standard 10±4 day course of enoxaparin VTE prophylaxis. Conclusions: Despite standard-duration prophylaxis with enoxaparin for 6 to 14 days, acutely ill patients &gt;75 years of age have a significantly higher risk of VTE in the following month, compared to patients ≤75 years of age. The risk-to-benefit ratio of extended-duration enoxaparin following standard-duration prophylaxis in acutely ill medical patients appears most favorable in patients &gt;75 years of age.

Should Patients with Deep Vein Thrombosis Alone be Treated as Those with Concomitant Asymptomatic Pulmonary Embolism? A Prospective Study

2002 ◽  
Vol 88 (12) ◽  
pp. 938-942 ◽  
Author(s):  
Harry Büller ◽  
Anthonie Lensing ◽  
Montserrat Bonet ◽  
Javier Roncales ◽  
Jordi Muchart ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Vitamin K Antagonists ◽  
Fixed Dose ◽  
Once Daily ◽  
Bleeding Rate ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryThe established initial treatment of patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) consists of the administration of subcutaneous, weight adjusted, low-molecular weight heparin (LMWH). However, the use of the same LMWH dosages for patients with either DVT or PE is not supported by data from comparative studies.1,000 consecutive patients with acute, proximal DVT were prospectively evaluated. All patients underwent a ventilation-perfusion lung scan on admission, and remained in hospital for at least 7 days. Patients with silent PE received once daily 10,000 to 15,000 IU subcutaneous LMWH dalteparin according to body weight for 7 days, and then vitamin K antagonists. Patients with DVT alone received LMWH in a fixed dose of 10,000 IU once daily for at least 5 days, and then vitamin K antagonists. The rate of both, major bleeding and symptomatic PE episodes during the 7-day study period was evaluated.Thirteen patients (1.3%) developed recurrent PE (1 died) and 16 patients (1.6%) had major bleeding (7 died). Recurrent PE was significantly more common in patients with silent PE (9 of 258 patients, 3.5%) than in those with DVT alone (4 of 742 patients, 0.5%. Odds ratio: 6.5; p <0.001). There were no significant differences in bleeding rate between patients with silent PE and those with DVT alone. However, the use of a fixed 10,000 IU dose in patients with DVT alone led to a significantly lower bleeding rate in patients weighing over 70 kg: 1 of 349 patients (0.3%) as compared to 9 of 393 patients (2.3%) in those weighing less than 70 kg (odds ratio: 0.12; p = 0.018).Fixed-dose 10,000 IU of LMWH dalteparin once daily proved to be both effective and safe in patients with DVT alone. The observed recurrence rate of 0.5% in these patients compares favourably with the 3.5% rate in patients with silent PE. Furthermore, this fixed-dosage was also safe. Patients weighing over 70 kg had a significant decrease in the rate of major bleeding, and no compensatory increase in the rate of recurrent PE.

Extended-duration thromboprophylaxis in acutely ill medical patients with recent reduced mobility: Methodology for the EXCLAIM study

2006 ◽  
Vol 22 (1) ◽  
pp. 31-38 ◽  
Author(s):  
Russell D. Hull ◽  
Sebastian M. Schellong ◽  
Victor F. Tapson ◽  
Manuel Monreal ◽  
Meyer-Michel Samama ◽  
...  
Keyword(s):  
Medical Patients ◽  
Extended Duration ◽  
Reduced Mobility

Venous Thromboembolism Risk in Stroke Patients Receiving Extended-Duration Enoxaparin Prophylaxis: Sub-Analysis of the EXCLAIM Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 433-433
Author(s):  
Alexander GG Turpie ◽  
Russell D Hull ◽  
Sebastian M Schellong ◽  
Victor F Tapson ◽  
Manuel Monreal ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Major Bleeding ◽  
Study Drug ◽  
Minor Bleeding ◽  
Medical Patients ◽  
Stroke Patients ◽  
Short Term ◽  
Vte Prophylaxis ◽  
Extended Duration

Abstract Background: Venous thromboembolism (VTE) is a common complication after acute ischemic stroke. Short-term (10 ± 4 days) prophylaxis reduces the risk of VTE in ischemic stroke patients (Lancet2007; 369:1347–1355), but the efficacy and safety of extended VTE prophylaxis in patients with stroke remains unknown. The EXCLAIM study demonstrated that extended-duration enoxaparin prophylaxis (28 ±4 days) reduced the risk for VTE compared with placebo (2.5% vs 4.0%, respectively: absolute difference − 1.5%, 95.8% confidence interval −2.5 to −0.5%; p= 0.002), in acutely ill medical patients with recent reduced mobility who had already received a short-term 10 ± 4 days prophylaxis regimen (J Thromb Haemost2007;5:Supp.1:O-S-001). In this analysis of the EXCLAIM study, we evaluated the benefit-to-risk ratio of extended-duration enoxaparin in a population of ischemic stroke patients at high risk for VTE. Methods: Acutely ill medical patients enrolled in EXCLAIM were aged ≥40 years and had recently reduced mobility (≤3 days). Of the 7500 patients enrolled, 7415 received enoxaparin 40mg subcutaneous (SC) once-daily for 10 ± 4 days. Of these, 6085 patients were randomized to receive double-blind therapy (enoxaparin 40mg SC once-daily or placebo) for a further 28 ± 4 days. The primary efficacy endpoint, VTE, defined as the composite of symptomatic or asymptomatic deep-vein thrombosis, symptomatic pulmonary embolism (PE), or fatal PE, was assessed at completion of the randomized treatment. The primary safety endpoint, major bleeding, was assessed through 48 hours after the last dose of randomized treatment. Secondary endpoints included symptomatic VTE and major and total (major plus minor) bleeding. Results: Of the 5,963 randomized patients who received at least 1 dose of study treatment, 389 (6.5%) had acute ischemic stroke. Of these, 198 received extended-duration enoxaparin prophylaxis and 191 received placebo. Key demographic variables were comparable in both groups. The VTE rate in the placebo group was higher in ischemic stroke patients, compared with those without (8.0% vs 3.7%). The incidence of VTE was significantly reduced in patients receiving extended-duration enoxaparin prophylaxis vs placebo (p&lt;0.05). Major bleeding was increased in patients receiving extended-duration enoxaparin prophylaxis vs patients receiving placebo, however this difference was not statistically significant (Table). Conclusion: Our findings support that acute ischemic stroke patients are at increased risk for VTE, compared with the general medical population. Acutely ill patients with ischemic stroke receiving extended-duration enoxaparin experienced a significantly reduced risk of VTE and a non-statistically significant increase in major bleeding compared with patients receiving placebo, after all patients completed a short-term 10 ± 4 days enoxaparin regimen. These findings warrant further studies of extended-duration VTE prophylaxis in patients with acute ischemic stroke. Table. Efficacy and safety outcomes in stroke patients receiving extended-duration enoxaparin prophylaxis vs placebo. Stroke patients, n=389 Parameter Extended-duration enoxaparin, n (%) Placebo, n (%) Relative risk (95.8% CI) P-value †Efficacy endpoints were assessed in all randomized patients who received at least 1 dose of study drug and had an evaluable ultrasound. ‡Safety endpoints were assessed in all randomized patients who received at least 1 dose of study drug. Efficacy † N=166 N=150 VTE 4 (2.4) 12 (8.0) 0.30 (0.10–0.91) 0.0236 Symptomatic VTE 0 (0.0) 2 (1.3) 0.1356 Safety ‡ N=198 N=191 Major bleeding 3 (1.5) 0 (0.0) 0.0881 Major and minor bleeding 12 (6.1) 5 (2.6) 2.32 (0.83–6.45) 0.0972

Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients

2013 ◽  
Vol 110 (12) ◽  
pp. 1152-1163 ◽  
Author(s):  
Russell D. Hull ◽  
Sebastian M. Schellong ◽  
Victor F. Tapson ◽  
Manuel Monreal ◽  
Meyer-Michel Samama ◽  
...  
Keyword(s):  
Bleeding Risk ◽  
Absolute Difference ◽  
Medical Patients ◽  
Open Label ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Extended Duration ◽  
Post Hoc ◽  
Reduced Mobility ◽  
The Impact

SummaryThe EXCLAIM study enrolled hospitalised acutely ill medical patients with age >40 years and recently-reduced mobility into a trial of extended-duration anticoagulant thromboprophylaxis. This post-hoc analysis evaluated the impact of age on patient outcomes. After completion of open-label therapy with enoxaparin 40 mg once-daily (10 ± 4 days), eligible patients underwent randomisation to receive double-blind therapy of enoxaparin (n=2,975) or placebo (n=2,988) for 28 ± 4 days. During follow-up, the venous thromboembolism (VTE) risk increased with age in both treatment groups. In patients with age >75 years, those who received extended-duration enoxaparin had lower incidence of VTE (2.5% vs 6.7%; absolute difference [AD] [95% confidence interval]: −4.2% [−6.5, −2.0]), proximal deep-vein thrombosis (2.5% vs 6.6%; AD −4.1 % [−6.2, −2.0]), and symptomatic VTE (0.3% vs 1.5%; AD −1.2% [−2.2, −0.3]), in comparison to those who received placebo. In patients with age ≤75 years, those who received enoxaparin had reduced VTE (2.4% vs 2.8%; AD −0.4% [−1.5, 0.7]) and symptomatic VTE (0.2% vs 0.7%; AD −0.6% [−1.0, −0.1]) in comparison to those who received placebo. In both age subgroups, patients who received enoxaparin had increased rates of major bleeding versus those who received placebo: age >75 years (0.6% vs 0.2%; AD +0.3% [−0.2, 0.9], respectively); age ≤75 years (0.7% vs 0.2%; AD +0.5% [0.1, 0.9]). Patients in both age subgroups that received enoxaparin had similar low bleeding rates (0.6% and 0.7%, respectively). VTE risk increased with age, though the bleeding risk did not. Patients with age >75 years had a more favourable benefit-to-harm profile than younger patients.

Sign in / Sign up

Export Citation Format

Share Document