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Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting
  1. Pascal Vranckx1,2,
  2. Vasim Farooq3,
  3. Scot Garg3,
  4. Gerrit-Anne Van Es2,
  5. Sigmund Silber4,
  6. Stephan Windecker5,
  7. Gregg W Stone6,
  8. Patrick W Serruys3
  1. 1Department of Cardiac Intensive Care and Interventional Cardiology, Hartcentrum Hasselt, Hasselt, Belgium
  2. 2Cardialysis, Clinical Research Management and Core Laboratories, Rotterdam, The Netherlands
  3. 3Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands
  4. 4Department of Cardiology, Kardiologische Praxis und Praxisklinik, Munich, Germany
  5. 5Department of Interventional Cardiology, Bern University Hospital, Bern, Switzerland
  6. 6Columbia University Medical Center, New-York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA
  1. Correspondence to Professor Patrick W Serruys, Ba583a, Thoraxcenter, Erasmus MC,'s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands; p.w.j.c.serruys{at}erasmusmc.nl

Abstract

Objective To assess the differential implications of cardiac biomarker type on peri-procedural myocardial infarction (PMI) reporting.

Setting The Resolute ‘All-Comers’ stent trial.

Interventions Blood samples for creatine kinase (CK), CK-myoband (CK-MB) mass or cardiac troponin (cTn) (optional) were collected before and at 6, 12 and 18 h after the assigned percutaneous coronary intervention or at discharge. PMIs were adjudicated using either the 2007 universal definition of MI (type-4a) or the extended historical definition of MI.

Patients 2121/2292 patients (92.5%) had an analysable dataset for either biomarker. 890/2121 patients (42%) presented with an acute coronary syndrome (ACS). 267/890 patients (30%) were within 24 h of an ST-segment elevation MI.

Main outcome measures Type-4a MI was diagnosed in 208/2121 patients (9.8%) when cTn was used (CK-MB mass if cTn not available), and in 93/2121 of patients (4.4%) when CK-MB mass was used (cTn if CK-MB mass not available). With the extended historical CK-based definition of MI, PMI was diagnosed in 65/2121 patients (3.1%). Adjudication of type-4a MI in patients with an ACS was problematic with <10% of the potential type-4a MI being confirmed as an event, as compared with approximately 95% in stable patients undergoing elective PCI. Type-4a MI was not associated with the subsequent hazard for cardiac mortality (p=0.6).

Conclusions The percentage of adjudicated PMI events is driven by the MI-definition criteria and biomarker type. Type-4a MI may not be a reliable component of the primary composite end point in coronary stent investigations which recruit patients with ACS.

Trial registration number http://www.ClinicalTrials.gov; Unique identifier: NCT00617084.

  • PCI
  • myocardial infarction
  • cardiac biomarkers
  • outcome
  • adjudication
  • allied specialities
  • intensive care
  • coronary artery disease
  • atherosclerosis
  • coronary physiology
  • coronary hemodynamics
  • heart failure
  • cardiogenic shock
  • myocardial ischaemia and infarction (IHD)
  • acute coronary syndrome
  • EBM
  • CT scanning
  • chronic total occlusion (CTO)
  • MRI
  • coronary angioplasty (PCI)
  • coronary stenting
  • coronary intervention
  • percutaneous valve therapy
  • coronary angioplasty
  • stents
  • stent interventions
  • invasive cardiology

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Footnotes

  • See Editorial, p 1397.

  • Funding Funding for Resolute-AC and its analysis was provided by grants from Medtronic Cardiovascular, Santa Rosa, California, USA.

  • Competing interests GWS reports consulting fees from Abbott Vascular, Boston Scientific and Medtronic; SW reports grants support through his institution from Abbott Vascular, Boston Scientific, Biosensors, Cordis and Medtronic. No other potential conflict of interest relevant to this article was reported.

  • Patient consent Obtained.

  • Ethics approval Ethics approval was provided by the institutional review board of participating sites.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement I am unable to share data beyond the ones used in this analysis owing to data sharing agreements in place with the sponsor and Cardialysis. Data are stored in a central database (Med Net Solutions INC, Minnetonka, USA) and maintained by a contract research organisation (Cardialysis BV, Rotterdam, The Netherlands).

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