Estimation of contribution of changes in coronary care to improving survival, event rates and coronary heart disease mortality across the WHO MONICA Project populations: appendix to a paper published in the Lancet

Pharmacological treatment during AMI and in secondary prevention: the scientific evidence

February 2000

Diego Vanuzzo¹, Lorenza Pilotto¹, Laura Pilotto¹, Markku Mähönen² and Michael Hobbs³ for the WHO MONICA Project⁴

¹ Centre for Cardiovascular Diseases, A.S.S.4 "Medio Friuli", Udine, Italy
² Department of Epidemiology and Health Promotion (MONICA Data Centre), National Public Health Institute, KTL, Helsinki, Finland
³ Department of Public Health, University of Western Australia, Perth, Australia
⁴ Annex: Sites and key personnel of the WHO MONICA Project

Correspondence to: vanuzzod@tin.it

• Copyright notice
• Document identification:
  • URL:http://www.ktl.fi/publications/monica/carpfish/appenda/evidence.htm
  • URN:NBN:fi-fe976567

Contents

• 1. Introduction
• 2. Delimitations
• 3. Summary tables on drugs and procedures
• References
• Acknowledgements

1. Introduction

The WHO MONICA Project monitored coronary events from the mid 1980s to the mid 1990s, during which time major changes occurred in acute coronary care, in management of sub-acute coronary heart disease and in secondary prevention of coronary artery disease. Here we present a summary of advances in treatment and a reference list for evidence based coronary care. This exercise does not pretend to be thoroughly exhaustive but aims at demonstrating how the first evidences of a given treatment or procedure were translated into a wider evaluation in meta-analyses and into a real diffusion and acceptance by practicing cardiologists, while new, consistent information was being published. In the reference list we have considered randomized clinical trials and meta-analyses, and produced summary tables; other references, not RCTs or meta-analyses, but still useful in clarifying the issues, were footnoted to the summary tables. In addition, each table is followed by the well-known classification system proposed by the ACC/AHA guidelines and, as an example of diffusion and adoption, the classification proposed by the Italian Federation of Cardiology (ANMCO-SIC are the Italian acronyms).

About the ACC/AHA Guidelines we have considered the 1996 version [3] as well as the 1999 update published on the web sites of both the American College of Cardiology (http://www.acc.org) and the American Heart Association (http://www.americanheart.org),  and by the Journal of the American College of Cardiology in 1999 [83]. In our summary table we have added the 1999 revised text in red, when necessary.

We have analyzed drugs and procedures used during hospitalization, but with long-term follow-up only drugs used during hospitalization and at discharge, and drugs used in secondary prevention. In the list of drugs and procedures we have omitted intravenous magnesium as the ISIS-4 trial [47] on more than 58,000 patients did not confirm the results of previous smaller studies indicating a mortality reduction, and ISIS-4 dominated subsequent overviews of all the existing data.

From the overall review we derived Table 1 of reference [124]   which summarizes the evidence-based drugs ands procedures which demonstrated a consistent effect on mortality reduction during and after a myocardial infarction, as well as the dates in which they were published.

2. Delimitations

• Drugs and procedures used during hospitalization
• Drugs used during hospitalization and at discharge, with long term follow-up
• Drugs used after hospital discharge (secondary prevention)

3. Summary tables on drugs and procedures

• Thrombolytic therapy: Table 1.
• Primary angioplasty: Table 2.
• CABG during MI
  • Effect on mortality: Table 3a
  • CABG in Cardiogenic Shock: Table 3b
• Betablockers
  • Effect on mortality: Table 4a
  • Effect on mortality, meta-analyses: Table 4b
  • Effect on reinfarct: Table 4c
  • Effect on reinfarct, meta-analyses: Table 4d
• Calcium-antagonists: Table 5
• Nitrates: Table 6
• Antiplatelet therapy
  • in myocardial infarction: Table 7a
  • with glycoprotein iib/iiia inhibitors in Acute Coronary Syndromes/Unstable Angina: Table 7b
• IV Anticoagulants + ASA: Table 8
• Anticoagulants
  • Oral anticoagulants: Table 9a
  • Anticoagulants + ASA: Table 9b
• ACE-inhibitors: Table 10
• Antiarrhythmics (post infarct): Table 11
• Hypolipidemic (lipid-lowering) drugs (post infarct): Table 12
• Antioxidants: Table 13
• Postmenopausal estrogens: Table 14
• Drugs to stop smoking: Table 15

Classification systems referred to in the Tables

ACC/AHA guidelines for the treatment of patients with acute myocardial infarction (1996 and 1999) [3, 83]

• Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful, and effective.
• Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of procedure or treatment.
  • Class IIa: Weight of evidence/opinion is in favour of usefulness/efficacy.
  • Class IIb: Usefulness/efficacy is less well established by evidence/opinion.
• Class III: Conditions for which there is evidence and/or general agreement that a procedure or treatment is not useful/effective and in some cases may be harmful.

ANMCO-SIC clinical guidelines (1998) [7]

Guidelines on Acute Cardiac Ischemia – Acute Myocardial Infarction

• Type A evidence: the recommendation is based on the results of large randomized clinical trials
• Type B evidence: the recommendation is based on the results of meta-analyses, randomized clinical trials, but in small or non randomized populations.
• Type C evidence: the recommendation is based on a consensus reached by the authors of the guidelines

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Acknowledgements

The MONICA Centres are funded predominantly by regional and national governments, research councils, and research charities. Coordination is the responsibility of the World Health Organization (WHO), assisted by local fund raising for congresses and workshops. WHO also supports  the MONICA Data Centre (MDC) in Helsinki. Not covered by this general   description is the ongoing generous support of the MDC by the National  Public Health Institute of Finland, and a contribution to WHO from the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA for support of the MDC and the Quality Control Centre for Event Registration in Dundee. The completion of the MONICA Project is generously  assisted through a Concerted Action Grant from the European Community. Likewise appreciated are grants from ASTRA Hässle AB, Sweden, Hoechst AG, Germany, Hoffmann-La Roche AG, Switzerland, the Institut de Recherches Internationales Servier (IRIS), France, and Merck & Co. Inc., New Jersey, USA, to support data analysis and  preparation of publications.