Temporal Trend of In-hospital Major Bleeding in Non ST-Elevation ACS
Temporal Trend of In-hospital Major Bleeding in Non ST-Elevation ACS
Background Although randomized controlled trials support the use of intensive medical and invasive therapies for non-ST segment elevation acute coronary syndromes (NSTE-ACS), major bleeding is a serious treatment complication. We sought to determine the temporal trend of in-hospital major bleeding among patients with NSTE-ACS, in relation to the evolving management pattern.
Methods We identified 14 111 NSTE-ACS patients enrolled in 4 successive, prospective, multicenter registries (ACS I, 1999–2001; ACS II, 2002–2003; GRACE, 2004–2007; and CANRACE, 2008) in Canada between 1999 and 2008. We collected data on patient characteristics, use of cardiac medications and procedures on standardized case report forms. In all registries, major bleeding was defined a priori as life threatening or fatal bleeding, bleeding requiring transfusion of ≥2 U of packed red cells, or resulting in an absolute decrease in hemoglobin of >30g/L.
Results A total of 14 111 patients had a final diagnosis of NSTE-ACS and were included in this study (3294 in the ACS-I registry, 1956 in the ACS-II registry, 7543 in GRACE, and 1318 in CANRACE). Over time, there was a substantial increase in the use of dual anti-platelet (aspirin and thienopyridine) therapy (P for trend <.001), and in rates of in-hospital cardiac catheterization and percutaneous coronary intervention (both Ps for trend <.001). Overall, major bleeding was relatively infrequent (1.7%). There was no significant increase in the unadjusted rates of major bleeding over time (P for trend = .19). In multivariable analysis adjusting for GRACE risk score and intensive treatment, enrolment period was not an independent predictor of bleeding (P for trend = .98). There was no interaction between the enrolment period and the use of intensive medical and invasive management.
Conclusion Despite more widespread use of dual anti-platelet therapies and invasive cardiac procedures in the management of NSTE-ACS, the rate of major bleeding remains relatively low and has not increased significantly over time. Our findings suggest that physicians selectively target treatment for their patients, and these evidence-based therapies can be safely administered to ACS patients in clinical practice.
Strategies entailing the use of potent anti-platelet and anti-thrombotic regimens, coupled with early invasive management in high-risk patients, have been shown to improve clinical outcomes in non-ST elevation acute coronary syndrome (NSTE-ACS). Accordingly, these treatment strategies have been adopted in treatment guidelines and have become the standard of care for patients with NSTE-ACS. However, these proven therapies increase the risk of major bleeding and blood transfusions, which are associated with adverse clinical events, including recurrent ischemia, stroke, and death. Therefore, recent efforts have focused on identifying patients at risk of bleeding, and strategies to reduce this complication.
The adoption of intensive treatment strategies into real life practices might lead to an increase in rates of bleeding, especially since these randomized controlled trials enroll selected patients who may be at lower risk of bleeding. Nevertheless, there are limited contemporary data on the temporal changes in bleeding rates among unselected NSTE-ACS patients. Accordingly, the objectives of this study are to evaluate the temporal trend of in-hospital major bleeding and its relation to treatment in patients with NSTE-ACS in routine clinical practice.
Abstract and Introduction
Abstract
Background Although randomized controlled trials support the use of intensive medical and invasive therapies for non-ST segment elevation acute coronary syndromes (NSTE-ACS), major bleeding is a serious treatment complication. We sought to determine the temporal trend of in-hospital major bleeding among patients with NSTE-ACS, in relation to the evolving management pattern.
Methods We identified 14 111 NSTE-ACS patients enrolled in 4 successive, prospective, multicenter registries (ACS I, 1999–2001; ACS II, 2002–2003; GRACE, 2004–2007; and CANRACE, 2008) in Canada between 1999 and 2008. We collected data on patient characteristics, use of cardiac medications and procedures on standardized case report forms. In all registries, major bleeding was defined a priori as life threatening or fatal bleeding, bleeding requiring transfusion of ≥2 U of packed red cells, or resulting in an absolute decrease in hemoglobin of >30g/L.
Results A total of 14 111 patients had a final diagnosis of NSTE-ACS and were included in this study (3294 in the ACS-I registry, 1956 in the ACS-II registry, 7543 in GRACE, and 1318 in CANRACE). Over time, there was a substantial increase in the use of dual anti-platelet (aspirin and thienopyridine) therapy (P for trend <.001), and in rates of in-hospital cardiac catheterization and percutaneous coronary intervention (both Ps for trend <.001). Overall, major bleeding was relatively infrequent (1.7%). There was no significant increase in the unadjusted rates of major bleeding over time (P for trend = .19). In multivariable analysis adjusting for GRACE risk score and intensive treatment, enrolment period was not an independent predictor of bleeding (P for trend = .98). There was no interaction between the enrolment period and the use of intensive medical and invasive management.
Conclusion Despite more widespread use of dual anti-platelet therapies and invasive cardiac procedures in the management of NSTE-ACS, the rate of major bleeding remains relatively low and has not increased significantly over time. Our findings suggest that physicians selectively target treatment for their patients, and these evidence-based therapies can be safely administered to ACS patients in clinical practice.
Introduction
Strategies entailing the use of potent anti-platelet and anti-thrombotic regimens, coupled with early invasive management in high-risk patients, have been shown to improve clinical outcomes in non-ST elevation acute coronary syndrome (NSTE-ACS). Accordingly, these treatment strategies have been adopted in treatment guidelines and have become the standard of care for patients with NSTE-ACS. However, these proven therapies increase the risk of major bleeding and blood transfusions, which are associated with adverse clinical events, including recurrent ischemia, stroke, and death. Therefore, recent efforts have focused on identifying patients at risk of bleeding, and strategies to reduce this complication.
The adoption of intensive treatment strategies into real life practices might lead to an increase in rates of bleeding, especially since these randomized controlled trials enroll selected patients who may be at lower risk of bleeding. Nevertheless, there are limited contemporary data on the temporal changes in bleeding rates among unselected NSTE-ACS patients. Accordingly, the objectives of this study are to evaluate the temporal trend of in-hospital major bleeding and its relation to treatment in patients with NSTE-ACS in routine clinical practice.
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