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Discrepancies in identification of bleeding events after percutaneous coronary intervention
Marianne McCollum1, Kathleen A Stringer, Ann K Wittkowsky
1Department of Clinical Pharmacy, School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, Colorado 80262, USA. marianne.mccollum@uchsc.edu
Insights
Discrepant bleeding criteria, Thrombolysis in Myocardial Infarction (TIMI) and investigator-developed, lead to differing rates and lengths of hospital stay (LOS) after percutaneous coronary intervention (PCI). Consensus criteria are needed for accurate clinical trial and practice comparisons.
Area of Science:
- Cardiology
- Clinical Research
- Medical Device Evaluation
Background:
- Percutaneous coronary intervention (PCI) is a common procedure for treating coronary artery disease.
- Assessing bleeding events is crucial for evaluating the safety of PCI and antithrombotic therapies.
- Current bleeding criteria, such as the Thrombolysis in Myocardial Infarction (TIMI) criteria, may not fully capture all bleeding complications.
Purpose of the Study:
- To compare the agreement between Thrombolysis in Myocardial Infarction (TIMI) criteria and investigator-developed criteria for identifying bleeding events post-PCI.
- To evaluate length of hospital stay (LOS) as a surrogate marker for bleeding severity using these different criteria.
Main Methods:
- Retrospective chart review of 422 patients undergoing PCI at two university-affiliated medical centers.
- Bleeding events within one week post-PCI were assessed using both TIMI and investigator-developed criteria.
- Agreement between criteria was quantified using the kappa statistic; LOS was compared between groups.
Main Results:
- A poor level of agreement (kappa = 0.09) was found between TIMI and investigator-developed bleeding criteria.
- Bleeding event rates differed significantly: 5% by TIMI criteria vs. 54% by investigator criteria.
- Discrepancies in criteria led to a difference of 66 fewer hospital days when TIMI criteria were applied to bleeding events not meeting TIMI criteria.
Conclusions:
- The use of TIMI criteria versus investigator-developed criteria results in significantly different bleeding event rates and lengths of hospital stay.
- This discrepancy complicates the accurate comparison of bleeding rates and consequences across clinical trials and in routine practice.
- The development of consensus bleeding criteria is essential for standardized clinical evaluations, particularly for antithrombotic agents.
Study Objective:
To evaluate the level of agreement between two sets of criteria, the Thrombolysis in Myocardial Infarction (TIMI) criteria and investigator-developed criteria, for identifying bleeding events in patients who had undergone a percutaneous coronary intervention (PCI) and to measure length of hospital stay (LOS) as a surrogate marker of bleeding severity.
Design:
Retrospective chart review.
Setting:
Two university-affiliated medical centers.
Patients:
Four hundred twenty-two consecutive patients who had undergone PCI from December 1, 2001-June 30, 2002.
Measurements And Main Results:
Data were collected on the number of bleeding events that occurred within 1 week after PCI (limited to one event/patient) and on LOS. Bleeding was assessed by TIMI criteria and by investigator-developed criteria. Bleeding according to TIMI criteria included intracranial hemorrhage, spontaneous hematuria or hematemesis, or decreases in hemoglobin level. Bleeding according to investigator-developed criteria included intracranial, retroperitoneal, intraocular, or clinically overt bleeding without a specified decrease in hemoglobin level. Agreement between criteria was assessed by means of the kappa statistic. Of the 422 patients, 23 (5%) experienced TIMI-defined bleeding events and 229 (54%) investigator-defined bleeding events. A kappa value of 0.09 (95% confidence interval 0.06-0.13) indicated a poor level of agreement between the two sets of bleeding criteria. The effect of this discrepancy on LOS was 66 fewer days of care when TIMI criteria were applied versus investigator-developed criteria in the 206 patients who experienced bleeding events that met investigator criteria (total LOS 645 days) but not TIMI criteria (total LOS 579 days).
Conclusion:
Bleeding assessment with use of TIMI criteria versus investigator-developed criteria yielded discrepant bleeding event rates and LOS, making it difficult to accurately compare bleeding rates and consequences across clinical trials and in practice. Consensus bleeding criteria are needed for applications in clinical evaluations of antithrombotic agents.
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