Abstract

Introduction: Findings from the recent EXCLAIM study demonstrate that selected acutely ill medical patients with reduced mobility benefit from extended-duration enoxaparin venous thromboembolism (VTE) prophylaxis (

Blood
2007
;
110
:
1862
). However, it is unknown whether the EXCLAIM population is representative of acutely ill medical patients admitted to hospitals worldwide. In this subanalysis, we assessed whether the EXCLAIM population was representative of the medical patients enrolled in the multinational IMPROVE (
Chest
2007
;
132
:
936
–45
) and ENDORSE (
Lancet
2008
;
371
:
387
–94
) registries known to be at risk for VTE.

Methods: Using patient data from IMPROVE and ENDORSE, we applied the EXCLAIM eligibility criteria to a representative, multinational population of acutely ill medical patients at risk for VTE. The IMPROVE and ENDORSE studies assessed VTE-risk and prophylaxis use of enrolled patients according to the 2004 American College of Chest Physicians (ACCP) guidelines (

Chest
2004
;
126
:
338S
–400S
). ACCP criteria for VTE risk were met in 46% (6,907/15,156) of IMPROVE and 43% (15,487/36,351) of ENDORSE study patients (
Chest
2007
;
132
:
936
–45
;
Lancet
2008
;
371
:
387
–94
). The EXCLAIM eligibility criteria required patients to be confined to total bed rest (level 1 immobility), or bed rest with bathroom privileges (level 2 immobility) and have at least 1 of 3 predefined risk factors for VTE (i.e., age > 75 years; history of VTE; active or prior cancer).

Results: EXCLAIM eligibility criteria were met in 30% (2,072/6,907) IMPROVE and 36% (5,535/15,487) ENDORSE medical patients considered at risk for VTE by ACCP. During hospitalization, ACCP-recommended prophylaxis was provided to 69% (1,426/2,072) and 46% (2,548/5,535) of EXCLAIM-eligible patients enrolled in IMPROVE and ENDORSE, respectively. Following discharge from hospital (median length of stay 5 days for US, 8 days for non-US), only 9% (153/1,719) of EXCLAIM-eligible patients in the IMPROVE study received any type of ACCP-recommended VTE prophylaxis.

Conclusions: Evidence from the EXCLAIM study demonstrated that the benefit-to-risk ratio in selected hospitalized medical patients favors the use of prolonged VTE prophylaxis. This population corresponds to one in three of the representative hospitalized patients with acute medical illness enrolled in IMPROVE and ENDORSE. Data on prophylaxis use from the IMPROVE registry suggest that only 9% of such patients are currently receiving optimal VTE prophylaxis following hospital discharge.

Disclosures: Anderson:sanofi-aventis: Consultancy, Honoraria, Research Funding; The Medicines Company: Consultancy, Honoraria, Research Funding; Millennium Pharmaceuticals: Consultancy, Honoraria; GSK: Consultancy, Honoraria; Johnson & Johnson: Consultancy, Honoraria. Hull:sanofi-aventis: Consultancy, Honoraria, Research Funding; Leo Pharma: Honoraria; GSK: Honoraria; Bayer: Honoraria; Pfizer: Honoraria. Schellong:sanofi-aventis: Consultancy, Honoraria. Deslandes:sanofi- aventis: Employment. Tapson:sanofi-aventis: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Research Funding; Genentech: Honoraria. Samama:sanofi-aventis: Consultancy, Honoraria; Eli Lilly: Consultancy; Pfizer: Consultancy; Boehringer-Ingelheim: Consultancy; BMS: Consultancy, Honoraria; GSK: Honoraria; Bayer: Honoraria. Turpie:sanofi-aventis: Consultancy, Honoraria; Bayer: Consultancy; Boehringer-Ingelheim: Consultancy; BMS: Consultancy; Daiichi: Consultancy; GSK: Consultancy; Johnson & Johnson: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Takeda: Consultancy. Yusen:sanofi-aventis: Consultancy, Honoraria, Research Funding. Cohen:AstraZeneca: Consultancy, Research Funding; Bayer: Consultancy, Research Funding; Boehringer-Ingelheim: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Daiichi: Consultancy, Research Funding; GSK: Consultancy, Research Funding; Johnson & Johnson: Consultancy, Research Funding; Mitsubishi Pharma: Consultancy, Research Funding; Organon: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; sanofi-aventis: Consultancy, Research Funding; Schering Plough: Consultancy, Research Funding; Takeda: Consultancy, Research Funding. Monreal:sanofi-aventis: Honoraria.

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