Frequency and impact of bleeding in elective coronary stent clinical trials--utility of three commonly used definitions
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Lisa M Fleming1, Victor Novack, Lena Novack
1Department of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. lisa.fleming04@gmail.com
Insights
Bleeding after percutaneous coronary intervention (PCI) increases mortality risk. Different bleeding definitions impact clinical trial results, highlighting the need for standardized criteria in low-risk patients undergoing PCI with drug-eluting stents (DES).
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Bleeding events are common following percutaneous coronary intervention (PCI).
- Increased mortality is associated with bleeding in acute coronary syndrome (ACS) patients on anti-thrombotic therapy.
- Bleeding has not been a traditional endpoint in low-risk PCI trials, limiting understanding of definition impact.
Purpose of the Study:
- To evaluate the impact of different bleeding definitions on mortality and myocardial infarction (MI) in low-risk PCI patients.
- To assess the variability in identifying clinically significant bleeding events using ACUITY, TIMI, and GUSTO criteria.
- To determine the association between bleeding events and adverse outcomes after PCI with drug-eluting stents (DES).
Main Methods:
- Pooled patient-level data from sirolimus and zotarolimus drug-eluting stent (DES) clinical trials were analyzed.
- Bleeding events were identified using three common definitions: ACUITY, TIMI, and GUSTO.
- The impact of bleeding on all-cause death or MI at 12 months post-PCI was assessed.
Main Results:
- Bleeding rates varied by definition: GUSTO (2.3%), TIMI (2.1%), and ACUITY (1.9%).
- GUSTO criteria captured all bleeding events, while ACUITY and TIMI missed 18.6% and 6.8% respectively.
- Patients experiencing bleeding had a significantly higher risk of death or MI at 12 months (HR 1.95).
Conclusions:
- Significant variability exists in the utility and inclusiveness of common bleeding definitions for low-risk PCI patients.
- Elective PCI patients who experience bleeding have an elevated one-year risk of death or MI.
- Standardized bleeding definitions are crucial for consistent clinical trial outcomes in PCI with DES.
Background:
Bleeding events are common after percutaneous coronary intervention (PCI) and have been shown to increase mortality in studies of acute coronary syndrome (ACS) and anti-thrombotic therapy. Despite this evidence, bleeding has not been included as a traditional major endpoint in clinical trials of low-risk populations enrolled in PCI clinical trials. Thus, the impact of specific bleeding definitions has not been evaluated fully among these patients.
Methods And Results:
Using patient-level pooled data from sirolimus and zotarolimus drug-eluting stent clinical trials, we identified bleeding events using three common definitions of bleeding, ACUITY, TIMI, and GUSTO, and assessed the impact on mortality and MI at 12 months after PCI. The GUSTO, ACUITY, and TIMI classifications identified bleeding rates of 2.3%, 1.9%, and 2.1%, respectively. The GUSTO criteria classified all 118 suspected bleeding events. There were 22 (18.6%) and 8 (6.8%) suspected bleeding events that did not meet ACUITY and TIMI criteria, respectively. The combined endpoint of all-cause death or myocardial infarction (MI) at 12 months was significantly higher for patients with a bleeding event compared with those who did not bleed [hazard ratio 1.95 (95% CI 1.06-3.60)].
Conclusion:
There is a substantial variability in the utility and inclusiveness of three widely used bleeding definitions in identifying clinically significant bleeding events in clinical trials of low risk patients undergoing PCI with DES. Patients with bleeding after elective PCI have an increased one-year risk of death or MI compared to those patients who do not bleed.
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