We reviewed our database of 312 patients with pulmonary embolism who received thrombolysis in five clinical trials. At baseline, none had a history of stroke, internal bleeding within 6 months, ...surgery within 10 days, or occult blood in stool. Sixty-six major bleeding episodes occurred within 72 hours of administering thrombolysis in 61 (20%) patients: bleeding at the catheterization site (34 cases), gross hematuria (9), intracranial hemorrhage (5), and 18 other bleeding episodes that led to at least a 10% hematocrit decrease. Patients with a major bleeding complication were on average older than patients with no hemorrhagic complication (mean age 62.9 ± 1.9 years vs 56.2 ± 1.1 years;
p = 0.005). In an adjusted analysis, there was a fourfold increased risk of bleeding among patients older than 70 years compared with patients younger than 50 years (relative risk RR 3.9; 95% confidence interval CI 1.7 to 8.9). By using age as a continuous variable, we found a 4% (RR 1.04; 95% CI 1.02 to 1.06) increase in risk of bleeding for each incremental year of age. In addition, patients with higher body mass index had an increased risk of bleeding. Patients who had undergone catheterization had a five times greater risk of bleeding (RR 5.2; 95% CI 1.5 to 17.8). In summary, increasing age, larger body mass index, and catheterization predisposed to bleeding complications after pulmonary embolism thrombolysis. (Am Heart J 1997;134:69-72.)
Activated protein C resistance caused by factor V Leiden mutation is the most common inherited cause of an underlying predisposition to pulmonary embolism (PE) and deep venous thrombosis (DVT). We ...studied the frequency of the factor V Leiden mutation in 50 women who had PE and/or DVT during or after pregnancy or during oral contraceptive use. Ten (20%; 95% Cl 10% to 34%) of the 50 women were heterozygous for the mutation. First-trimester PE or DVT developed in 6 (60%; 95% Cl, 26% to 88%) of the 10 women with the mutation compared with 3 (8%; 95% Cl 2% to 20%) of 40 women without the mutation (
p = 0.0009). These data indicate that the factor V Leiden mutation is an important risk factor for PE or DVT during pregnancy (especially the first trimester), after pregnancy, or during oral contraceptive use.
Summary Background Information about the variation in the risk for venous thromboembolism (VTE) and in prophylaxis practices around the world is scarce. The ENDORSE (Epidemiologic International Day ...for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting) study is a multinational cross-sectional survey designed to assess the prevalence of VTE risk in the acute hospital care setting, and to determine the proportion of at-risk patients who receive effective prophylaxis. Methods All hospital inpatients aged 40 years or over admitted to a medical ward, or those aged 18 years or over admitted to a surgical ward, in 358 hospitals across 32 countries were assessed for risk of VTE on the basis of hospital chart review. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and to determine whether patients were receiving recommended prophylaxis. Findings 68 183 patients were enrolled; 30 827 (45%) were categorised as surgical, and 37 356 (55%) as medical. On the basis of ACCP criteria, 35 329 (51·8%; 95% CI 51·4–52·2; between-country range 35·6–72·6) patients were judged to be at risk for VTE, including 19 842 (64·4%; 63·8–64·9; 44·1–80·2) surgical patients and 15 487 (41·5%; 41·0–42·0; 21·1–71·2) medical patients. Of the surgical patients at risk, 11 613 (58·5%; 57·8–59·2; 0·2–92·1) received ACCP-recommended VTE prophylaxis, compared with 6119 (39·5%; 38·7–40·3; 3·1–70·4) at-risk medical patients. Interpretation A large proportion of hospitalised patients are at risk for VTE, but there is a low rate of appropriate prophylaxis. Our data reinforce the rationale for the use of hospital-wide strategies to assess patients' VTE risk and to implement measures that ensure that at-risk patients receive appropriate prophylaxis.
Four-factor prothrombin complex concentrates (PCCs), which contain factor II, FVII, FIX, and FX, have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers. The ...purpose of this study was to determine whether a three-factor PCC, which contains little FVII, has a similar effect.
We performed an open-label, single-center, parallel-group study comparing the effect of a three-factor PCC (Profilnine SD) with that of a four-factor PCC (Beriplex P/N) on the pharmacodynamics of rivaroxaban in 35 healthy volunteers. After receiving 4 days of rivaroxaban 20 mg twice daily to obtain supratherapeutic steady-state concentrations, volunteers were randomized to receive a single 50 IU kg(-1) bolus dose of four-factor PCC, three-factor PCC or saline 4 h after the morning dose of rivaroxaban on day 5, and the effects of these interventions on prothrombin time and thrombin generation were determined. Within 30 min, four-factor PCC reduced mean prothrombin time by 2.5-3.5 s, whereas three-factor PCC produced only a 0.6-1.0-s reduction. In contrast, three-factor PCC reversed rivaroxaban-induced changes in thrombin generation more than four-factor PCC.
This study demonstrates the potential of both three-factor and four-factor PCCs to at least partially reverse the anticoagulant effects of rivaroxaban in healthy adults. The discrepant effects of the PCC preparations may reflect differences in the procoagulant components present in each.
Abstract Background Venous thromboembolism prophylaxis is suboptimal in the US despite long-standing evidence-based recommendations. The aim of this subset analysis of the Epidemiologic International ...Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) study was to identify characteristics of hospitals with high guideline-recommended prophylaxis use. Methods Between September and November 2006, charts from eligible patients aged ≥40 years with an acute medical illness or age ≥18 years and undergoing a surgical procedure were reviewed from randomly selected US acute-care hospitals. Hospitals were ranked based on the proportion of at-risk patients who received American College of Chest Physicians–recommended types of prophylaxis. Hospital characteristics were compared to determine factors related to more frequent prophylaxis use. Hospitals were followed up 1 year after the chart audit. Results Overall, 9257 patients were evaluated from 81 hospitals. Appropriate types of prophylaxis were prescribed to more at-risk patients in hospitals in the highest quartile compared with the lowest quartile of prophylaxis use (74% vs 36%). All quartiles had a similar percentage of at-risk patients (61%-65%). Significantly more hospitals in the highest quartile had residency training programs (43% vs 5%), a larger median number of beds (277 vs 140), and had adopted hospital-wide prophylaxis protocols (76% vs 40%). In the follow-up survey, more hospitals overall had adopted hospital-wide written guidelines for venous thromboembolism prevention. Conclusions These findings support the value of hospital-wide protocols and local audits for VTE prevention, as recommended by several national quality-of-care groups.
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