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ACS Real-World Studies

Several major studies have been launched to assess real-world outcomes in patients with ACS. These include:

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Real World Evidence and Claims Databases – a Guide for Healthcare Professionals
Prof. Craig I. Coleman gives an appreciation of the methodology used to perform Real World Evidence studies, particularly those investigating the effectiveness and safety, of non-vitamin K antagonist oral anticoagulants (or NOACs) in non-valvular atrial fibrillation patients. He also provides some key insights on what real world evidence and specifically claims databases can - and cannot - tell us. Approval number: PP-XAR-ALL-0036-2

  • Objective: to track the outcomes of patients presenting with ACS
  • Large observational registry launched in 1999
  • Involves over 100,000 patients who have presented to 247 hospitals in 30 countries, including those in North America, South America, Europe, Asia and Australia
  • Incorporates the data from the first 10–20 consecutive cases that presented with qualifying symptoms plus evidence of coronary artery disease each month at each centre, with 6-month follow-up for these patients1
  • GRACE provides data on:
    • Patient demographics
    • Presenting symptoms
    • Management
    • Outcomes
    • Guideline compliance rates2
    • Risk factors for adverse or fatal outcomes3,4
  • The GRACE ACS risk model score,5 which has been validated extensively, was incorporated into the 2007 European Society of Cardiology guidelines for the treatment of patients with NSTEMI6
  • An updated version of the GRACE risk score (version 2.0) appears to offer improved discrimination and ease of use than the previous score, while performing equally well both acutely and over the longer term.7 GRACE 2.0 has been validated in different patient populations7-9 and has been incorporated into the 2015 European Society of Cardiology guidelines for the treatment of patients with NSTEMI10

 

For more information visit:
Centre for Outcomes Research (Accessed 9 November 2020)
GRACE risk score calculator (Accessed 9 November 2020)

 

Related key publications:

Luo J, Dai L, Li J et al. Risk evaluation of new-onset atrial fibrillation complicating ST-segment elevation myocardial infarction: a comparison between GRACE and CHA2DS2-VASc scores. Clin Interv Aging 2018;13:1099–1109.

 

Akyuz S, Yazici S, Bozbeyoglu E et al. Validity of the updated GRACE risk predictor (version 2.0) in patients with non-ST-elevation acute coronary syndrome. Rev Port Cardiol 2016;35:25–31.

Fox KAA, Fitzgerald G, Puymirat E et al. Should patients with acute coronary disease be stratified for management according to their risk? Derivation, external validation and outcomes using the updated GRACE risk score. BMJ Open 2014;4:e004425.

Fox KAA, Dabbous OH, Goldberg RJ et al. Prediction of risk of death and myocardial infarction in the six months after presentation with acute coronary syndrome: prospective multinational observational study (GRACE). BMJ 2006;333:1091.

Eagle KA, Lim MJ, Dabbous OH et al. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA 2004;291:2727–2733.

Granger CB, Goldberg RJ, Dabbous O et al. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med 2003;163:2345–2353.

 

Publications utilizing GRACE registry data
GRACE bibliography (Accessed 9 November 202009/11/2020)

 

  • Objectives: to document the current presentation of ACS in Europe and to determine the adherence to current European Society of Cardiology guidelines for the management of the different kinds of ACS:
    • Acute reperfusion treatment (STEMI)
    • Invasive versus conservative treatment (NSTEMI/unstable angina)
    • Adjunctive medical treatment (all ACS)
  • The first Euro Heart Survey ACS Registry collected data on 10,484 patients with ACS between September 2000 and May 2001. The survey assessed a number of in-hospital and 30-day outcomes for these patients, including:
    • Correlation between initial and final diagnoses
    • Diagnostic and therapeutic modalities
    • In-hospital complications
    • Post-discharge event rates and mortality rates11
  • The second Euro Heart Survey ACS Registry collected data on 6385 patients with ACS between March and October 2004. The survey enabled the assessment of temporal trends in the diagnosis, management and outcomes of ACS (in-hospital and 30-day follow-up), as well as comparing with the results with those from the initial survey12
  • The third Euro Heart Survey ACS Registry collected data on 21,582 consecutive patients between October 2006 and October 2008. After 1 year of follow-up, the immediate, in-hospital and 1-year outcome of patients with ACS were assessed, which included the following factors:
    • Gender disparities in the management and outcomes in patients presenting with acute MI13
    • Performance measures (such as appropriate and timely therapy use) in STEMI and their result on patient outcomes14
    • Validation of the Killip classification in patients presenting with ACS15
    • The determinants of stroke and its impact on the outcomes of patients with presenting with an ACS event16
    • Patient demographics, subsequent intervention/therapy use and clinical outcome17

 

Related key publications:

Mandelzweig L, Battler A, Boyko V et al. The second Euro Heart Survey on acute coronary syndromes: characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean basin in 2004. Eur Heart J 2006;27:2285–2293.

Hasdai D, Behar S, Wallentin L et al. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J 2002;23:1190–1201.

 

  • ACTION Registry–Get With The Guidelines (GWTG) is an ongoing national registry created in 2007 by the merger of the National Cardiovascular Data Registry (NCDR) ACTION Registry from the American College of Cardiology (ACC) Foundation and the GWTG-CAD Program from the American Heart Association (AHA). The ACTION registry was renamed to the Chest Pain – MI registry on 26 June 201818
  • Objectives: to record information on:
    • Treatment patterns
    • Clinical outcomes
    • Drug safety
  • Overall quality of care (measured by adherence to ACC/AHA clinical guidelines) provided to patients with STEMI and NSTEMI
  • Includes detailed clinical information on >147,000 patients with STEMI or NSTEMI in 383 participating US hospitals19
  • The registry has determined:
    • The extent to which numerous factors, such as age20 and gender,21 can influence patient outcomes
    • Ethnic differences in treatment patterns in patients presenting with STEMI22
    • The bleeding risk of patients presenting with MI who were treated with anticoagulant therapy23
  • Models of in-hospital bleeding24,25 in-hospital mortality26 and long-term mortality27 have also been developed by the ACTION Registry–GWTG group
  • Recent data analyses from specific patient groups have shown:
    • Hospital survivors of acute MI aged ≥65 years who experienced cardiogenic shock had a higher risk of death and/or hospitalization in the first year after discharge28
    • High mortality (25%) was reported for STEMI patients presenting with cardiac arrest during hospitalization, despite high use of primary percutaneous coronary intervention29
    • There are significant differences in contemporary patterns of care across varying risk profiles of mortality and major bleeding in NSTEMI patients, with patients at high risk for major bleeding continuing to receive excess doses of antithrombotic therapy30
    • MI with non-obstructive coronary arteries (MINOCA), which is more prevalent in younger and female patients versus older or male patients, has a better prognosis than MI with coronary artery disease (CAD). MINOCA was associated with reduced mortality risk compared with MI with CAD. The elevated risk of post-MI death among women versus men was restricted to patients with MI with CAD31

 

For more information visit:
National Cardiovascular Data Registry (Accessed 9 November 2020)

 

Related key publications:
Basra SS, Wang TY, Simon DN et al. Ticagrelor use in acute myocardial infarction: insights from the National Cardiovascular Data Registry. J Am Heart Assoc 2018;7:e008125.

Bradley SM, Hess GP, Stewart P et al. Implications of the PEGASUS-TIMI 54 trial for US clinical practice. Open Heart 2017;4:e000580.

Desai NR, Kennedy KF, Cohen DJ et al. Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry®-Get With The Guidelines (GWTG)®. Am Heart J 2017;194:16–24.

Pokorney SD, Miller AL, Chen AY et al. Reassessment of cardiac function and implantable cardioverter-defibrillator use among Medicare patients with low ejection fraction after myocardial infarction. Circulation 2017;135:38–47.

Smilowitz NR, Mahajan AM, Roe MT et al. Mortality of myocardial infarction by sex, age, and obstructive coronary artery disease status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines). Circ Cardiovasc Qual Outcomes 2017;10:e003443.

Vora AN, Wang TY, Li S et al. Selection of stent type in patients with atrial fibrillation presenting with acute myocardial infarction: an analysis from the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry-Get With The Guidelines. J Am Heart Assoc 2017;6:e005280.

Yu T, Tian C, Song J et al. ACTION (acute coronary treatment and intervention outcomes network) registry-GWTG (get with the guidelines) risk score predicts long-term mortality in acute myocardial infarction. Oncotarget 2017;8:102559–102572.

Mathews R, Fonarow GC, Li S et al. Comparison of performance on Hospital Compare process measures and patient outcomes between hospitals that do and do not participate in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines. Am Heart J 2016;175:1–8.

Pandey A, McGuire DK, de Lemos JA et al. Revascularization trends in patients with diabetes mellitus and multivessel coronary artery disease presenting with non-ST elevation myocardial infarction: insights from the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (NCDR ACTION Registry-GWTG). Circ Cardiovasc Qual Outcomes 2016;9:197–205.

Shah RU, de Lemos JA, Wang TY et al. Post-hospital outcomes of patients with acute myocardial infarction with cardiogenic shock: findings from the NCDR. J Am Coll Cardiol 2016;67:739–747.

Sutton NR, Li S, Thomas L et al. The association of left ventricular ejection fraction with clinical outcomes after myocardial infarction: findings from the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry-Get With The Guidelines (GWTG) Medicare-linked database. Am Heart J 2016;178:65–73.

Kontos MC, Scirica BM, Chen AY et al. NCDR. Cardiac arrest and clinical characteristics, treatments and outcomes among patients hospitalized with ST-elevation myocardial infarction in contemporary practice: A report from the National Cardiovascular Data Registry. Am Heart J 2015;169:515–522.

Shavelle DM, Chen AY, Matthews RV et al. Predictors of reperfusion delay in patients with ST elevation myocardial infarction self-transported to the hospital (from the American Heart Association's Mission: Lifeline Program). Am J Cardiol 2014;113:798–802.

Desai NR, Peterson ED, Chen AY et al. Balancing the risk of mortality and major bleeding in the treatment of NSTEMI patients – a report from the National Cardiovascular Data Registry. Am Heart J 2013;166:1043-1049.

Kadakia MB, Desai NR, Alexander KP et al. Use of anticoagulant agents and risk of bleeding among patients admitted with myocardial infarction: a report from the NCDR ACTION Registry–GWTG (National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines). JACC Cardiovasc Interv 2010;3:1166–1177.

Peterson ED, Roe MT, Chen AY et al. The NCDR ACTION Registry-GWTG: transforming contemporary acute myocardial infarction clinical care. Heart 2010;96:1798–1802.

References
  • Fox KA, Eagle KA, Gore JM et al. The Global Registry of Acute Coronary Events, 1999 to 2009-GRACE. Heart 2010;96:1095-1101. Return to content
  • Eagle KA, Goodman SG, Avezum Á et al. Practice variation and missed opportunities for reperfusion in ST-segment-elevation myocardial infarction: findings from the Global Registry of Acute Coronary Events (GRACE). Lancet 2002;359:373–377. Return to content
  • Goldberg RJ, Currie K, White K et al. Six-month outcomes in a multinational registry of patients hospitalized with an acute coronary syndrome (the Global Registry of Acute Coronary Events [GRACE]). Am J Cardiol 2004;93:288–293. Return to content
  • Mehta RH, Dabbous OH, Granger CB et al. Comparison of outcomes of patients with acute coronary syndromes with and without atrial fibrillation. Am J Cardiol 2003;92:1031–1036. Return to content
  • Eagle KA, Lim MJ, Dabbous OH et al. A validated prediction model for all forms of acute coronary syndrome: estimating the risk of 6-month postdischarge death in an international registry. JAMA 2004;291:2727–2733. Return to content
  • Bassand JP, Hamm CW, Ardissino D et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J 2007;28:1598–1660. Return to content
  • Fox KAA, Fitzgerald G, Puymirat E et al. Should patients with acute coronary disease be stratified for management according to their risk? Derivation, external validation and outcomes using the updated GRACE risk score. BMJ Open 2014;4:e004425. Return to content
  • Akyuz S, Yazici S, Bozbeyoglu E et al. Validity of the updated GRACE risk predictor (version 2.0) in patients with non-ST-elevation acute coronary syndrome. Rev Port Cardiol 2016;35:25–31. Return to content
  • Luo J, Dai L, Li J et al. Risk evaluation of new-onset atrial fibrillation complicating ST-segment elevation myocardial infarction: a comparison between GRACE and CHA2DS2-VASc scores. Clin Interv Aging 2018;13:1099–1109. Return to content
  • Roffi M, Patrono C, Collet JP et al. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: task force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2016;37:267–315. Return to content
  • Hasdai D, Behar S, Wallentin L et al. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J 2002;23:1190–1201. Return to content
  • Mandelzweig L, Battler A, Boyko V et al. The second Euro Heart Survey on acute coronary syndromes: characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J 2006;27:2285–2293. Return to content
  • Schiele F, Bueno H, Hochadel M et al. Gender disparities in the management and in-hospital outcomes acute myocardial infarction: temporal changes between 2006 and 2008. Insights from the Euro Heart Survey ACS III registry. American Heart Association Scientific Sessions 2011. Orlando, FL, USA, 12–16 November 2011. Abstract 12712. Return to content
  • Schiele F, Hochadel M, Tubaro M et al. Reperfusion strategy in Europe: temporal trends in performance measures for reperfusion therapy in ST-elevation myocardial infarction. Eur Heart J 2010;31:2614–2624. Return to content
  • Papp A, Bueno H, Gierlotka M et al. Value of Killip classification first described in 1967 for risk stratification of STEMI and NSTE-ACS in the new millennium: lessons from The Euro Heart Survey ACS Registry. American College of Cardiology 2011 60th Annual Scientific Session. New Orleans, LA, USA, 2–5 April 2011. Abstract E1062. Return to content
  • Papp A, Wojakowski W, Gierlotka M et al. Determinants of stroke and its impact on outcome of ACS in clinical practice in Europe: lessons from the Euro Heart Survey ACS Registry. American College of Cardiology 2011 60th Annual Scientific Session. New Orleans, LA, USA, 2–5 April 2011. Abstract E1139-315. Return to content
  • Gitt A, Hochadel M, Wojakowski W et al. Improvement of early invasive treatment for NSTE-ACS over time in clinical practice in Europe: lessons from The Euro Heart Survey ACS Registry. American College of Cardiology 2011 60th Annual Scientific Session. New Orleans, LA, USA, 2–5 April 2011. Abstract 1104-328. Return to content
  • American College of Cardiology. Press release: American College of Cardiology launches NCDR Chest-Pain - MI Registry. 2018. Available at: https://www.acc.org/about-acc/press-releases/2018/06/26/09/37/american-college-of-cardiology-launches-ncdr-chest-pain-mi-registry [accessed 19 November 2020]. American College of Cardiology. Press release: American College of Cardiology launches NCDR Chest-Pain - MI Registry. 2018. Available at: https://www.acc.org/about-acc/press-releases/2018/06/26/09/37/american-college-of-cardiology-launches-ncdr-chest-pain-mi-registry [accessed 19 November 2020]. Return to content
  • Alexander KP, Wang TY, Li S et al. Randomized trial of targeted performance feedback to facilitate quality improvement in acute myocardial infarction care. Circ Cardiovasc Qual Outcomes 2011;4:129–135. Return to content
  • Forman DE, Chen AY, Wiviott SD et al. Comparison of outcomes in patients aged <75, 75 to 84, and >=85 years with ST-elevation myocardial infarction (from the ACTION Registry-GWTG). Am J Cardiol 2010;106:1382–1388. Return to content
  • Diercks DB, Owen KP, Kontos MC et al. Gender differences in time to presentation for myocardial infarction before and after a national women's cardiovascular awareness campaign: a temporal analysis from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress ADverse Outcomes with Early Implementation (CRUSADE) and the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network-Get with the Guidelines (NCDR ACTION Registry-GWTG). Am Heart J 2010;160:80–87. Return to content
  • Guzman LA, Li S, Wang TY et al. Differences in treatment patterns and outcomes between Hispanics and non-Hispanic Whites treated for ST-segment elevation myocardial infarction: results from the NCDR ACTION Registry-GWTG. J Am Coll Cardiol 2012;59:630–631. Return to content
  • Kadakia MB, Desai NR, Alexander KP et al. Use of anticoagulant agents and risk of bleeding among patients admitted with myocardial infarction: a report from the NCDR ACTION Registry - GWTG (National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry - Get With The Guidelines). JACC Cardiovasc Interv 2010;3:1166–1177. Return to content
  • Mathews R, Peterson ED, Chen AY et al. In-hospital major bleeding during ST-elevation and non-ST-elevation myocardial infarction care: derivation and validation of a model from the ACTION Registry(R)-GWTG. Am J Cardiol 2011;107:1136–1143. Return to content
  • Desai NR, Kennedy KF, Cohen DJ et al. Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry(R)-Get With The Guidelines (GWTG)(R). Am Heart J 2017;194:16–24. Return to content
  • Chin CT, Chen AY, Wang TY et al. Risk adjustment for in-hospital mortality of contemporary patients with acute myocardial infarction: The Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry-Get With The Guidelines (GWTG) acute myocardial infarction mortality model and risk score. Am Heart J 2011;161:113–122. Return to content
  • Yu T, Tian C, Song J et al. ACTION (acute coronary treatment and intervention outcomes network) registry-GWTG (get with the guidelines) risk score predicts long-term mortality in acute myocardial infarction. Oncotarget 2017;8:102559–102572. Return to content
  • Shah RU, de Lemos JA, Wang TY et al. Post-hospital outcomes of patients with acute myocardial infarction with cardiogenic shock: findings from the NCDR. J Am Coll Cardiol 2016;67:739–747. Return to content
  • Kontos MC, Scirica BM, Chen AY et al. Cardiac arrest and clinical characteristics, treatments and outcomes among patients hospitalized with ST-elevation myocardial infarction in contemporary practice: A report from the National Cardiovascular Data Registry. Am Heart J 2015;169:515–522. Return to content
  • Desai NR, Peterson ED, Chen AY et al. Balancing the risk of mortality and major bleeding in the treatment of NSTEMI patients - a report from the National Cardiovascular Data Registry. Am Heart J 2013;166:1043–1049. Return to content
  • Smilowitz NR, Mahajan AM, Roe MT et al. Mortality of myocardial infarction by sex, age, and obstructive coronary artery disease status in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines). Circ Cardiovasc Qual Outcomes 2017;10:e003443. Return to content