Luigi Pacifico

Factors Associated With Adverse Outcomes in Outpatients Presenting With Pulmonary Embolism The Worcester Venous Thromboembolism Study

Background— Data from clinical trials suggest that short-term mortality in outpatients presenting with pulmonary embolism (PE) is low and that outpatient therapy may be appropriate. However, subjects enrolled in these studies may not be representative of patients seen in the community setting. Methods and Results— The medical records of residents from Worcester, Mass, with International Classification of Disease, Ninth Edition, codes consistent with potential venous thromboembolism during 1999, 2001, and 2003 were independently validated and reviewed by trained abstractors. A total of 305 patients presented with PE from the outpatient setting. The rates of recurrent PE, major bleeding, mortality, or occurrence of any 1 of these end points at 90 days were 1.4%, 9.5%, 11.1%, and 20.1%, respectively. Patients with a history of congestive heart failure, recent intensive care unit discharge, cancer, severe infection, systolic blood pressure <100 mm Hg, and male sex were at increased risk for the composite end point. Conclusions— In the present population-based study, morbidity and mortality after outpatient PE were much higher than what was observed in clinical studies. Our findings raise questions about broad-based outpatient treatment of PE in the community setting. In our study, comorbid conditions and recent illness were important determinants of adverse outcomes, suggesting that these variables should be carefully considered before embarking on outpatient therapy of PE.

Venous thromboembolism and bleeding in a community setting - The Worcester Venous Thromboembolism Study

Bleeding is the most frequent complication of antithrombotic therapy for venous thromboembolism (VTE). However, little attention has been paid to the impact of bleeding after VTE in the community setting. The purpose of this investigation was to describe the incidence rate of bleeding after VTE, to characterize patients most at risk for bleeding, and to assess the impact of bleeding on rates of recurrent VTE and all-cause mortality. The medical records of residents of the Worcester (MA, USA) metropolitan area diagnosed with ICD-9 codes consistent with potential VTE during 1999, 2001, and 2003 were individually validated and reviewed by trained data abstracters. Clinical characteristics, acute treatment, and outcomes (including VTE recurrence rates, bleeding rates, and mortality) over follow-up (up to 3 years maximum) were evaluated. Bleeding occurred in 228 (12%) of 1,897 patients with VTE during our follow-up. Of these, 115 (58.8%) had evidence of early bleeding occurring within 30 days of VTE diagnosis. Patient characteristics associated with bleeding included impaired renal function and recent trauma. Other than a history of prior VTE, the occurrence of bleeding was the strongest predictor of recurrent VTE (hazard ratio [HR] 2.18; 95% confidence interval [CI] 1.54-3.09) and was also a predictor of total mortality (HR 1.97; 95%CI 1.57-2.47). The occurrence of bleeding following VTE is associated with an increased risk of recurrent VTE and mortality. Future study of antithrombotic strategies for VTE should be informed by this finding. Advances that result in decreased bleeding rates may paradoxically decrease the risk of VTE recurrence.

Factors Associated With Adverse Outcomes in Outpatients Presenting With Pulmonary Embolism

Background— Data from clinical trials suggest that short-term mortality in outpatients presenting with pulmonary embolism (PE) is low and that outpatient therapy may be appropriate. However, subjects enrolled in these studies may not be representative of patients seen in the community setting. Methods and Results— The medical records of residents from Worcester, Mass, with International Classification of Disease, Ninth Edition, codes consistent with potential venous thromboembolism during 1999, 2001, and 2003 were independently validated and reviewed by trained abstractors. A total of 305 patients presented with PE from the outpatient setting. The rates of recurrent PE, major bleeding, mortality, or occurrence of any 1 of these end points at 90 days were 1.4%, 9.5%, 11.1%, and 20.1%, respectively. Patients with a history of congestive heart failure, recent intensive care unit discharge, cancer, severe infection, systolic blood pressure <100 mm Hg, and male sex were at increased risk for the composite end point. Conclusions— In the present population-based study, morbidity and mortality after outpatient PE were much higher than what was observed in clinical studies. Our findings raise questions about broad-based outpatient treatment of PE in the community setting. In our study, comorbid conditions and recent illness were important determinants of adverse outcomes, suggesting that these variables should be carefully considered before embarking on outpatient therapy of PE.

Factors Associated with Adverse Outcomes in Outpatients Presenting with Pulmonary Embolism: The Worcester VTE Study

Background— Data from clinical trials suggest that short-term mortality in outpatients presenting with pulmonary embolism (PE) is low and that outpatient therapy may be appropriate. However, subjects enrolled in these studies may not be representative of patients seen in the community setting. Methods and Results— The medical records of residents from Worcester, Mass, with International Classification of Disease, Ninth Edition, codes consistent with potential venous thromboembolism during 1999, 2001, and 2003 were independently validated and reviewed by trained abstractors. A total of 305 patients presented with PE from the outpatient setting. The rates of recurrent PE, major bleeding, mortality, or occurrence of any 1 of these end points at 90 days were 1.4%, 9.5%, 11.1%, and 20.1%, respectively. Patients with a history of congestive heart failure, recent intensive care unit discharge, cancer, severe infection, systolic blood pressure <100 mm Hg, and male sex were at increased risk for the composite end point. Conclusions— In the present population-based study, morbidity and mortality after outpatient PE were much higher than what was observed in clinical studies. Our findings raise questions about broad-based outpatient treatment of PE in the community setting. In our study, comorbid conditions and recent illness were important determinants of adverse outcomes, suggesting that these variables should be carefully considered before embarking on outpatient therapy of PE.