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Published on: May 28, 2019
Bleeding Events After ST-segment Elevation Myocardial Infarction in Patients Randomized to an All-comer Clinical
Golnaz Sadjadieh1, Thomas Engstrøm2, Dan Eik Høfsten1
1Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.
Insights
Clinical trial nonparticipants with ST-elevation myocardial infarction (STEMI) experienced higher bleeding rates within 30 days. These bleeds, often linked to cardiac arrest, anemia, or Killip class >2, were more common in real-world STEMI patients than trial participants.
Area of Science:
- Cardiology
- Clinical Research
- Public Health
Background:
- Clinical trials may not represent real-world bleeding incidences in ST-segment elevation myocardial infarction (STEMI) patients.
- Understanding bleeding risks in unselected STEMI populations is crucial for patient care.
Purpose of the Study:
- To investigate 1-year bleeding and mortality rates in an unselected STEMI population.
- To compare bleeding incidences between participants and non-participants of the DANAMI-3 clinical trial.
Main Methods:
- Retrospective analysis of hospital charts for 2,490 consecutive STEMI patients undergoing primary percutaneous coronary intervention.
- Bleeding events classified using Thrombolysis in Myocardial Infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria.
- Comparison of bleeding rates between DANAMI-3 trial participants and non-participants.
Main Results:
- Overall Thrombolysis in Myocardial Infarction minor and/or major bleeding (TMMB) occurred in 4.4% (0-30 days) and 2.1% (31-365 days).
- DANAMI-3 non-participants had significantly higher 30-day bleeding rates (7.2%) compared to participants (2.9%).
- Patients with cardiac arrest, Killip class >2, and anemia accounted for 70% of 30-day TMMBs and were more frequent among non-participants.
Conclusions:
- Clinical trial non-participants in STEMI populations exhibit higher early bleeding rates.
- Specific patient factors (cardiac arrest, anemia, Killip class >2) significantly contribute to bleeding events.
- Real-world bleeding incidences in unselected STEMI patients differ from clinical trial data.
Abstract:
Most studies reporting bleedings in patients with ST-segment elevation myocardial infarction (STEMI) are reports from clinical trials, which may be unrepresentative of incidences in real-life. In this study, we investigated 1-year bleeding and mortality incidences in an unselected STEMI population, and compared participants with nonparticipants of a randomized all-comer clinical trial (The Third DANish Study of Optimal Acute Treatment of Patients with STEMI (DANAMI-3)). Hospital charts were read and bleedings classified according to thrombolysis in myocardial infarction (TIMI) and Bleeding Academic Research Consortium (BARC) criteria in 2,490 consecutive STEMI patients who underwent primary percutaneous coronary intervention in a single, large, and tertiary heart center. Thrombolysis in myocardial infarction minor and/or major bleeding (TMMB) occurred in 4.4% day 0 to 30 and 2.1% day 31 to 365. DANAMI-3 nonparticipants (n = 887) had significantly higher 30-day bleeding rates than DANAMI-3-participants (n = 1,603) (7.2% vs 2.9%, p <0.0001), but not thereafter (p = 0.8). DANAMI-3 nonparticipation was significantly associated with 30-day TMMB (hazard ratio, 1.8, 95% confidence interval, 1.2 to 2.8, p = 0.007), but this did not persist after adjusting for resuscitated cardiac arrest, Killip-class>2 and anemia. Patients with cardiac arrest, Killip-class>2, and anemia accounted for 70.0% of 30-day TMMBs, and the majority of these patients were DANAMI-3 nonparticipants. TMMB day 0 to 30 was associated with increased 30-day mortality (hazard ratio 3.1, 95% confidence interval 1.9 to 5.2, p <0.0001) but not thereafter (p = 0.9). In conclusion, we found that clinical trial (DANAMI-3) nonparticipants had significantly more TMMBs within 30 days than participants. Patients with resuscitated cardiac arrest, anemia, and Killip-class>2 were accountable for a high rate of TMMBs. Bleeding incidences from clinical trials cannot be translated to an unselected STEMI population.
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