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Sergio Leonardi , L. Kristin Newby, E. Magnus Ohman , Paul W. Armstrong.

Implementation of ESC/ACC Definition of Myocardial Infarction in Contemporary, Large RCTs: A Systematic Review. Sergio Leonardi , L. Kristin Newby, E. Magnus Ohman , Paul W. Armstrong. November 16 th 2010 Chicago, IL – AHA Scientific Sessions. Disclosures Information.

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Sergio Leonardi , L. Kristin Newby, E. Magnus Ohman , Paul W. Armstrong.

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  1. Implementation of ESC/ACC Definition of Myocardial Infarction in Contemporary, Large RCTs: A Systematic Review Sergio Leonardi, L. Kristin Newby, E. Magnus Ohman, Paul W. Armstrong. November 16th 2010 Chicago, IL – AHA Scientific Sessions

  2. Disclosures Information None of the authors have relevant financial disclosures

  3. Background • Myocardial Infarction (MI) is a key endpoint in RCTs evaluating new therapies • However heterogeneity in MI definition may affect comparisons across RCTs as well as meta-analyses • The 2000 ESC/ACC MI definition 1 consensus recommendations were aimed at resolving this • 1: Antman E, Bassand J-P, Klein W, et al. Myocardial infarction redefined -- A consensus document of The Joint European Society of Cardiology/American College of Cardiology committee for the redefinition of myocardial infarction: The Joint European Society of Cardiology/ American College of Cardiology Committee. J Am CollCardiol2000;36:959-69. • Hence, we explored the extent to which they are applied in contemporary, large, cardiovascular RCTs

  4. Methods – Search Criteria • We performed a systematic review of CV RCTs with • > 500 patients • where MI was part of the primary endpoint • initiated after the 2000 ESC/ACC MI redefinition publication • Search terms included: • Acute Coronary Syndrome • Myocardial Infarction • Coronary Artery Disease • Percutaneous Coronary Intervention • Coronary Artery By-pass Grafting

  5. Metrics of Guideline Recommendations Adherence • We evaluated: • % RCTs referencing the 2000 ESC/ACC consensus document & • % of RCTs referencing any consensus document endorsed by the ACC, AHA, or ESC • Adherence to 2000 ESC/ACC consensus document was captured using 3 of its key recommendations • Use of troponin to define endpoint MI • Separate reporting of spontaneous and procedural MI • Enzymatic infarct size reporting (i.e., AUC or peak biomarker value)

  6. Flowchart for Study Screening Process • Time Period Explored : • Sep 1, 2000 to May 5, 2010 • Exclusion if any of the following: • 1. ≤ 500 pts enrolled • 2. MI not part of the primary EP • 3. Started before Sep 2000

  7. Summary of RCTs Evaluated • 2,729 RCTs screened  134 (5%) met inclusion criteria • Of these 55 (41%) RCTs had primary results including 297,467 pts, 13,526 end-point MIs and a median FU of 9 months (IQR: 1-15.6 months) • 9 additional RCTs had design paper published but not primary results (from which MI def’n can be assessed) • MIs contributed a median40.3% (IQR: 22.9, 61.2) of events in the primary composites, a % that decreased with increasing number of components

  8. Relationship Between Proportion MI Events Within Primary Endpoint and Number of Components Proportion of MI events within the primary EP 2 Comp (n=7 RCTs) 3 Comp (n=28 RCTs) 4 Comp (n=11 RCTs) >4 Comp (n=8 RCTs)

  9. Index Event At Enrollment into RCTs

  10. Referencing of Consensus Documents in RCTs • 55 RCTs with primary results + 9 Only Design = 64 RCTs evaluable. Overall, 31.2% of RCTs (20/64) sourced a consensus document

  11. Use of Troponin to Define Endpoint MI • 12 RCTs (18.7%) had no MI definition published  52 residual RCTs evaluable for troponin use • 38.5% (20/52) used Troponin to define MI [66.7% (12/18) among those that referenced a consensus document] • Only 1 used troponin for procedural MI • 2 used troponin only if CK-MB not available • No RCT specified the 99th percentile as the MI decision limit

  12. Separate Reporting and Infarct Size • Only 1/55 RCT (1.8%) reported separately spontaneous and procedural MI in the primary results • NO RCTs reported infarct size, either by area under the curve of biomarker release or peak values

  13. Conclusions • MI contributes substantially to primary outcome measures in contemporary large RCTs • However, there is surprisingly little implementation of ESC/ACC recommendations for MI definition and reporting • Appropriate strategies for uniform implementation of the MI endpoint in cardiovascular RCTs appear urgently required

  14. Supplementary Slide 1 Contribution of MI to Primary Endpoint in RCTs by Revascularization Groups • Group 1: Interventional RCTs All patients underwent a coronary revascularization (PCI/CABG) either as part of the randomized intervention or as inclusion criterion  Rate of coronary revascularization ≈ 100% • Group 2: ACS RCTs A coronary revascularization could be performed as part of the index enrolling ACS but not required Median Revascularization rate 62.8% • Group 3:Other RCTs Broad group of RCTs were a coronary revascularization was possible, but not expected Median Revascularization rate 3.8 %

  15. Supplementary Slide 2 MI Events in RCTs by Revascularization Groups Proportion of MI events within the primary EP Interventional RCTs (N=31 RCTs) ACS RCTs (N=13 RCTs) Other RCTs (n=11 RCTs)

  16. Use of Troponin to Define MI According to Revascularization Group

  17. Supplementary Slide 3 Adjust. MI Rate in RCTs by Revascularization Groups MI %* N of components Interventional RCTs (N=31 RCTs) ACS RCTs (N=13 RCTs) Other RCTs (n=11 RCTs)

  18. Supplementary Slide 4 Key features of MI definition in the 10 largest RCTs studied

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