Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Metho...Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Methods: The REPLACE-2(randomised evaluation of PCI linking Angiomax to reduced clinical events) database of patients undergoing PCI was used. Various definitions of myocardial infarction, bleeding and revascularisation were modelled by logistic regression assessing their relationship with 12-month mortality. Estimates from these models were used to calculate the “attributable fraction”for late mortality associated with each definition. Results: The most liberal definition of myocardial infarction was associated with an attributable risk of 13.7%(95%CI 3.4%to 23.0%). The most stringent definition was associated with an attributable risk of 4.6%(95%CI 0.6%to 8.6%). Restrictive definitions of bleeding such as TIMI(thrombolysis in myocardial infarction) major bleeding are associated with a high odds ratio of risk(6.1, 95%CI 2.1 to 17.7, p=0.001) but low attributable fraction(3.5%, 95%CI 0.9%to 6.8%). Conclusions: Stringent end point definitions may under-represent the clinical significance of adverse outcomes after PCI. Considering both the proportional and absolute risk associated with definitions may be a more useful method for evaluating clinical trial end points. This analysis supports the current definitions of ischaemic events but suggests that more liberal definitions of bleeding events may also be relevant to late mortality.展开更多
Background: Restenosis after percutaneous coronary intervention(PCI) has been thought to present in a stable manner as exertional angina. However, the presentation of in-stent restenosis(ISR) is not well-studied. We h...Background: Restenosis after percutaneous coronary intervention(PCI) has been thought to present in a stable manner as exertional angina. However, the presentation of in-stent restenosis(ISR) is not well-studied. We hypothesized that a substantial proportion of bare metal ISR presents as acute coronary syndromes. We aimed to characterize the severity of the clinical presentation of ISR. Methods: We searched our PCI database for all cases of PCI for bare metal ISR occurring between May 1999 and September 2003. Multivessel interventions were excluded. In-stent restenosis presentation was classified into three categories:(1) myocardial infarction(MI),(2) unstable angina requiring hospitalization before angiography, and(3) exertional angina. Routine angiographic screening after initial stent placement was not performed, so ISR episodes were clinical, rather than angiographic, ISR. Results: We identified 1186 cases of bare metal ISR in 984 patients. Median age was 63, 72%were male, and 36%had diabetes. Of the ISR episodes, 9.5%presented as acute MI(7.3%as non-ST-segment elevation MI and 2.2%as ST-segment elevation MI), 26.4%as unstable angina requiring hospitalization before angiography, and 64.1%as exertional angina. Conclusions: More than one third of bare metal ISR episodes presented as MI or unstable angina requiring hospitalization. The acuity of the clinical presentation of bare metal ISR appears to be more severe than has been previously thought. Aggressive efforts, such as drug-eluting stents to decrease the incidence of unstable angina due to bare metal ISR, are warranted.展开更多
文摘Objectives: To explore the relative and absolute risks associated with various definitions for myocardial infarction, bleeding and revascularisation within the context of percutaneous coronary intervention(PCI). Methods: The REPLACE-2(randomised evaluation of PCI linking Angiomax to reduced clinical events) database of patients undergoing PCI was used. Various definitions of myocardial infarction, bleeding and revascularisation were modelled by logistic regression assessing their relationship with 12-month mortality. Estimates from these models were used to calculate the “attributable fraction”for late mortality associated with each definition. Results: The most liberal definition of myocardial infarction was associated with an attributable risk of 13.7%(95%CI 3.4%to 23.0%). The most stringent definition was associated with an attributable risk of 4.6%(95%CI 0.6%to 8.6%). Restrictive definitions of bleeding such as TIMI(thrombolysis in myocardial infarction) major bleeding are associated with a high odds ratio of risk(6.1, 95%CI 2.1 to 17.7, p=0.001) but low attributable fraction(3.5%, 95%CI 0.9%to 6.8%). Conclusions: Stringent end point definitions may under-represent the clinical significance of adverse outcomes after PCI. Considering both the proportional and absolute risk associated with definitions may be a more useful method for evaluating clinical trial end points. This analysis supports the current definitions of ischaemic events but suggests that more liberal definitions of bleeding events may also be relevant to late mortality.
文摘Background: Restenosis after percutaneous coronary intervention(PCI) has been thought to present in a stable manner as exertional angina. However, the presentation of in-stent restenosis(ISR) is not well-studied. We hypothesized that a substantial proportion of bare metal ISR presents as acute coronary syndromes. We aimed to characterize the severity of the clinical presentation of ISR. Methods: We searched our PCI database for all cases of PCI for bare metal ISR occurring between May 1999 and September 2003. Multivessel interventions were excluded. In-stent restenosis presentation was classified into three categories:(1) myocardial infarction(MI),(2) unstable angina requiring hospitalization before angiography, and(3) exertional angina. Routine angiographic screening after initial stent placement was not performed, so ISR episodes were clinical, rather than angiographic, ISR. Results: We identified 1186 cases of bare metal ISR in 984 patients. Median age was 63, 72%were male, and 36%had diabetes. Of the ISR episodes, 9.5%presented as acute MI(7.3%as non-ST-segment elevation MI and 2.2%as ST-segment elevation MI), 26.4%as unstable angina requiring hospitalization before angiography, and 64.1%as exertional angina. Conclusions: More than one third of bare metal ISR episodes presented as MI or unstable angina requiring hospitalization. The acuity of the clinical presentation of bare metal ISR appears to be more severe than has been previously thought. Aggressive efforts, such as drug-eluting stents to decrease the incidence of unstable angina due to bare metal ISR, are warranted.
