Registries are an important method of analysing research questions that cannot be ethically or feasibly answered with randomised controlled studies. This section provides summaries of the most important findings from registries of unstable angina and acute myocardial infarction.
The registries described here were conducted at a range of different scales, from small registries of individual metropolitan areas (Vienna STEMI, São Paulo STEMI Network, and the Minneapolis registry) to larger registries with national (NRMI and FAST-MI) or international (GRACE) scope. All have been instrumental in transforming the care of patients with cardiovascular disease.
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Pre-hospital thrombolysis vs. PPCI – a regional Australian experience
The Hunter New England Local Health District developed a system of care for STEMI patients based on their individual estimated travel time to the nearest cath. lab. If the total travel time was more than 60 minutes, pre-hospital thrombolysis was administered. If the travel time was thought to be shorter than 60 minutes, or if fibrinolysis was contraindicated, PPCI was the reperfusion therapy of choice. Patients with successful reperfusion after thrombolysis were not required to be transferred to the cath lab immediately, but rather at the earliest possible convenience provided they remained clinically stable.
The analysis summarised here is based on 484 consecutive, non-randomised STEMI patients treated between August 2008 and August 2013 at the John Hunter Hospital, Newcastle, Australia. 150 patients received pre-hospital thrombolysis and 334 underwent PPCI.
All-cause mortality at 12 months was the primary efficacy endpoint. Safety was assessed based on bleeding.
The median time from FMC to reperfusion therapy was 35 min (IQR, 28-43 min) for the pre-hospital thrombolysis group and 130 min (IQR, 100-150 min) for the PPCI group.
There were no significant differences in mortality at 12 months between the two types of reperfusion therapies. 6.7% (10/150) of the pre-hospital thrombolysis patients and 7.2% (24/334) of the PPCI patients died within 12 months (RR, 0.93; 95% CI: 0.45-1.9; p=0.84). 1.3% of patients in the pre-hospital thrombolysis group had a major bleeding event. No patients in the PPCI group had a major bleed.
Using a time-based approach to make a choice regarding type of reperfusion therapy has been shown to be safe and effective.
- Khan AA, et al. Pre-hospital thrombolysis in ST-segment elevation myocardial infarction: a regional Australian experience. Med J Australia 2016;205(3):121-125.
The purpose of this study was to determine whether the implementation of therapeutic guidelines effectively improves in-hospital mortality after an acute ST-elevation myocardial infarction (STEMI) in a metropolitan area, in this case Vienna, Austria.
This was based on (1) the then-recommended time intervals, and (2) the varying clinical status of individuals presenting with myocardial infarction. For this purpose, uniformity among catheterisation laboratories was created by the implementation of a central triage network via the Viennese Ambulance System (VAS) in conjunction with recommendations to initiate TT, either in-hospital or before arrival at the hospital, if PPCI could not be offered in a timely fashion, particularly in patients who had experienced symptoms <2 hours. At the same time, a prospective registry was established for control and quality assurance purposes.
In 2002, Vienna, a city with 1.8 million inhabitants, had only 1 catheterisation laboratory (at the Department of Cardiology, University of Vienna) which offered a 24-hour PPCI service on a routine basis (on-call) for patients with acute STEMI. This situation was profoundly reorganised by the implementation of (1) central triage for STEMI patients by the Viennese Ambulance System (VAS); (2) a second catheterisation laboratory open at night (Monday to Friday) by use of a rotation principle between 4 non-academic hospitals (on weekends [Friday afternoon to Monday morning], only 1 catheterisation centre was active during this preliminary network); and (3) pre-hospital or in-hospital TT if acute PPCI was unlikely to be offered within the recommended time intervals.
CHANGES IN REPERFUSION STRATEGIES
Implementation of guidelines resulted in an increased number of patients treated with one of the two reperfusion strategies (from 66% to 86.7%). Accordingly, the proportion of patients not receiving reperfusion therapy dropped from 34% to 13.4%. Management of patients via PPCI increased from 16% to almost 60%, whereas the use of TT decreased from 50% to 26.7% in the participating centres.
TREATMENT STRATEGIES SEGMENTED BY TIME-TO-TREATMENT
Adapted from Kalla et al. Circulation 2006; 113: 2398–2405.
PCI could only be offered to 14.6% of patients within the first 2 hours after symptom onset, whereas thrombolysis was offered to 50.5% of patients within the first 2 hours after symptom onset.
In-hospital mortality rates were lowest in patients treated within 2 hours of symptom onset. Although the differences were not statistically significant, there was a trend in favour of thrombolysis over PCI (PCI 7.8%, thrombolysis 5.1%; p=0.37). However, as time from symptom onset increased, there appeared to be an increasing survival benefit with PCI over thrombolysis.
- Implementation of guidelines for the treatment of acute STEMI by the organisation of a cooperating network within a large metropolitan area was associated with a significant improvement in clinical outcomes.
- Kalla et al. Circulation 2006; 113: 2398–2405.
Bosnia & Herzegovina
A STEMI network in Bosnia and Herzegovina was established in 2010 and is made up of six PCI-capable centres. Despite the increase in number of patients treated with PPCI after the network was implemented, the overall use of reperfusion therapy remains low, with as many as 41% of patients receiving no reperfusion therapy.
Barriers to rapid reperfusion
Pre-hospital barriers are related to infrastructure and patient education/delays. The main in-hospital barriers to treating STEMI patients in Bosnia and Herzegovina with PPCI is the lack of personnel – there is only a staggering 24 interventional cardiologists for nearly 4 million inhabitants – and a decline in insurance reimbursement. Post-procedure phase barriers are due to a lack of skilled medical staff to care specifically for PCI patients.
Dilic et al. have put out a call-to-action to address each barrier level in STEMI patient care, namely, patient education and campaigns (pre-hospital), increase use of fibrinolysis (tenecteplase) and possibly pharmaco-invasive strategy (in-hospital), and keeping health care professionals caring for STEMI patients up-to-date with technology and the latest evidence-based practices (post-procedure phase).
Overall, these systematic changes may improve access to reperfusion therapy throughout the Bosnia and Herzegovina.
- Dilic M, et al. Primary percutaneous coronary intervention network in Bosnia and Herzegovina: Where are we now and how to improve PCI network. Int J Cardiol 2016;217:S49-S51.
Acute myocardial infarction is responsible for the majority of deaths in São Paulo, Brazil. The emergency services as well as access to hospitals are rather scarce in the peripheries, being more concentrated in the central areas of the city, and this can cause delays in diagnosis and treatment of myocardial infarction.
The São-Paulo STEMI Network study was a pilot investigation to monitor clinical outcomes of patients with ST-elevation acute myocardial infarction (STEMI) presenting via ambulance or emergency departments that were part of the STEMI Network.
The STEMI Network is a structured network involving a tertiary hospital, Hospital São Paulo, 126 ambulances of the Emergency Mobile Health Care Service (abbreviation in Portuguese: SAMU) covering the entire São Paulo municipal area, and 4 municipal emergency departments. The aim of the STEMI Network was to standardise treatment and reduce delays for STEMI patients.
In 2010, the STEMI Network was implemented in São Paulo to standardise treatment for STEMI patients, with steps taken to ensure the following:
- Rapid clinical diagnosis
- Immediate ECG for any patient with chest pain (including reading support from an ECG central office if necessary)
- Immediate definition of management (primary percutaneous coronary intervention [PCI] for anticipated transfers to catheterisation laboratory 90 min)
- Immediate use of therapeutic adjuvants
- Immediate transfer to a tertiary hospital, even if stable
Sao Paolo STEMI network: organisation
Sao Paulo STEMI network: results
From January 2010 until June 2011, the STEMI Network study assessed 205 consecutive patients, with no exclusions, who underwent the entire process, i.e. diagnosis to transfer to the tertiary hospital with a catheterisation laboratory.
As expected, due to the distances between the centres involved in the STEMI Network and the logistical problems of transferring patients in São Paulo, only 38 patients (18.5%) were transferred for primary PCI, although it was only actually performed in 22 patients; of the remaining 16 patients, 13 had no intervention and 3 did not undergo cardiac catheterisation. The rest of the patients (81.5%, n=167) that were not referred for primary PCI received a thrombolytic agent, in almost all cases tenecteplase. Of these patients, 25.7% underwent rescue PCI and the others underwent elective cardiac catheterisation with stent implantation if necessary.
There were 14 in-hospital deaths (6.8%), almost all involving elderly patients or patients with low cardiac output.
A specific comparison of mortality in the emergency department of Hospital Ermelino Matarazzo before and after the implementation of the STEMI Network was performed:
- In 2009, before the implementation of the STEMI Network, mortality for 88 STEMI patients was 26.1%
- In 2010-2011, after the implementation of the STEMI Network, mortality for 65 patients that initiated treatment at the Hospital Ermelino Matarazzo and completed it at the Hospital São Paulo was only 6.1%
São Paulo STEMI network: mortality before & after establishing STEMI network
- The results of the STEMI Network confirm that implementation of an organised STEMI network can improve patient outcomes, and in particular, reduce in-hospital mortality.
- Caluza AC, et al. ST-Elevation myocardial infarction network: systematization in 205 cases reduced clinical events in the public health care system. Arq Bras Cardiol 2012;99(5):1040-1048.
The French registries of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 and 2010 are registries of the French Society of Cardiology.1-3 Along with their earlier counterparts, USIK 1995 and USIC 2000,4,5 these registries were one-month, nationwide surveys of patients with acute myocardial infarction (MI), with the aim of providing cardiologists and health authorities national and regional data on acute MI management and outcomes every 5 years.
The 4 registries, in 1995, 2000, 2005 and 2010, included data from a total of 6,707 patients with ST-segment elevation myocardial infarction (STEMI) admitted to intensive care or coronary care units within 48 h of symptom onset during a specified month-long period.6 The characteristics, management and outcomes, including 30-day mortality, of patients were recorded.
- A total of 6707 patients were enrolled in four nationwide surveys and during the 15-year period, a 2.9% decline was observed in the mean age of patients with STEMI, declining from 66.2 years to 63.3 years.
- The age distribution also changed, with the proportion of STEMI patients that were <60 years old increasing for men (from 38.1% to 49.0%) and women (from 11.8% to 25.5%).
Age characteristics of STEMI patients in the 4 French national registries
- The duration of patient admission pathways decreased over the 15 years of the registries, with the median time from symptom onset to admission decreasing from 240 min in 1995 to 175 min in 2010. The mean time between symptom onset and first call also decreased.
Improvement in admission pathway times for STEMI patients in the 4 French national registries (1995-2010)
- The use of reperfusion therapy has increased over the past 20 years, with an increase in primary percutaneous coronary intervention (PPCI) from 11.9% to 76.0% of patients, but a decrease in fibrinolysis from 37.5% to 6.0%.
Management of STEMI patients in the 5 French national registries: reperfusion therapy
- Early use (within 48 h) of some adjunctive therapies, including statins, beta blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB), anti-platelet agents, glycoprotein IIb/IIIa inhibitors and low-molecular-weight heparins, increased. In contrast, the use of unfractionated heparin decreased.
- Thirty-day mortality decreased from 13.7% in 1995 to 4.4% in 2010, with decreases unrelated to the use and type of reperfusion therapy.9
Improvements in 30-day mortality of STEMI patients in the 4 French national registries (1995-2010)
- FAST-MI data has shown that 6-month mortality in patients with STEMI has decreased considerably over the past 20 years.9
Improving treatments and STEMI care has had a huge impact on mortality over the years
FAST-MI 5-year survival analysis: real-life data supports a pharmaco-invasive strategy
The French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) investigators used a subpopulation of the FAST-MI 2005 cohort to investigate a prolonged follow-up window of 5 years based on reperfusion strategy in patients with STEMI.
- The study population included patients who had a symptom onset-to-call time of ≤12 hours with persisting ST-segment elevation or new left bundle-branch block on the initial ECG.
STREAM-like population subset
- A 5-year all-cause mortality analysis was also done in a “STREAM-like” subgroup population, defined as, “the subgroup of patients with time from onset to call ≤180 minutes and treated with either fibrinolysis or primary PCI beyond 90 minutes of first call.”
- STREAM used a 60-minute threshold from diagnostic ECG to expected PPCI. However, time from diagnostic ECG to reperfusion was not recorded in the FAST-MI 2005 registry. Therefore, time from call to reperfusion was used with an adjusted time frame of >90 minutes. The additional allotted time compensates for emergency medical response time.
- Given that the data is based on real-life setting, and not a randomised trial, the baseline characteristics of the overall study population were not uniform across all intervention therapies. However, the Global Registry of Acute Coronary Events (GRACE) scores were similar among patients who received fibrinolysis or intended PPCI.
- One difference that should be noted among the baseline characteristics is that patients who received fibrinolysis tended to call earlier after symptom onset than patients treated with PPCI.
Entire study population (N=1492) by reperfusion category
5-year cumulative survival curves
The real-life data from the FAST-MI 2005 registry favours pharmacoinvasive therapy, particularly pre-hospital, over PPCI for both the entire study population and the STREAM-like population.
FAST-MI update: 5-year cumulative survival in STEMI patients by reperfusion therapy
- Over the last 15 years, improvements in STEMI treatment (including increased use of reperfusion therapy, particularly PPCI, increased use of adjunctive therapies, and shorter patient admission pathways) as well as the changing demographics of the patient population (particularly the increase in the proportion of younger patients without a history of cardiovascular disease) has resulted in a decrease in 30-day mortality.
- When timely PPCI is unavailable within recommended timelines, FAST-MI data support the current recommendation of performing a coronary angiogram within 3–24 hours after successful fibrinolysis.8
- 5-year survival:
- There is no significant difference in 5-year survival rates for STEMI patients as analysed by reperfusion strategy – fibrinolysis (both pre- and in-hospital combined) vs PPCI.
- Pre-hospital fibrinolysis is associated with a significantly better 5-year survival rate for STEMI patients compared to PPCI.
- Therefore, a pharmaco-invasive approach may be an effective and safe alternative to PPCI.8
- Reperfusion strategies that are available vary from region to region and can be influenced by a number of factors such as access to PPCI facilities, facility hours, infrastructure, traffic/road conditions and weather.
- The emergency medical system is France is very well established and includes physicians, which undoubtedly contributed not only to the high prehospital fibrinolysis rate, but also to the early initiation of treatment.
- The 5-year survival analysis of the FAST-MI 2005 cohort data shows, in a real-life, country-wide setting, a pharmaco-invasive strategy seem to be an effective and safe alternative to PPCI for STEMI patients without contraindications to the components of pharmaco-invasive reperfusion strategy.
- PCI-related delay might have contributed to the favourable outcomes observed in the fibrinolysis group.
- It is difficult to emulate the high rate of pre-hospital fibrinolysis and set-up in many countries/regions.
- Danchin N, et al. Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome: results from the French Nationwide USIC 2000 Registry. Circulation 2004;110:1909e15.
- Danchin N, et al. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the French registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation 2008;118:268e76.
- Hanssen M, et al. French Registry in Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart 2012;98:699-705.
- Danchin N, et al. Management of acute myocardial infarction in intensive care units in 1995: a nationwide French survey of practice and early hospital results. J Am Coll Cardiol 1997;30:1598e605.
- Hanania G, et al. Management and in-hospital outcome of patients with acute myocardial infarction admitted to intensive care units at the turn of the century: results from the French nationwide USIC 2000 registry. Heart 2004;90:1404e10.
- Puymirat E, et al. Association of changes in clinical characteristics and management with improvement in survival among patients with ST-elevation myocardial infarction. JAMA 2012;308:998-1006.
- Danchin N et al. Five-year survival in patients with ST-segment elevation myocardial infarction according to modalities of reperfusion therapy: The French registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 cohort. Circulation 2014;129:1629-1636.
- ElGuindy AM. STREAM and FAST-MI - Pharmacoinvasive therapy: A continued role for fibrinolysis in the primary PCI era. Glob Cardiol Sci Pract 2014;2014(2):56-60.
- Puymirat E, et al. Acute myocardial infarction: Changes in patient characteristics, management, and 6-month outcomes over a period of 20 years in the FAST-MI program (French Registry of Acute ST-Elevation or Non ST-Elevation Myocardial Infarction). Circulation 2017;136(20):1908-1919.
STEMI INDIA was founded in 2012 with the goal of improving the management and care of STEMI patients by providing educating, training and support to those involved in STEMI care in India.
The STEMI INDIA model is a proponent of the pharmaco-invasive strategy in order to shorten the time to reperfusion for many patients who live outside of urban areas and who do not have access to PPCI within the guideline recommended time window. The STEMI INDIA model is a hub-and-spoke based system, with a centralised PCI-capable facility serving as the hub and smaller, regional hospitals serving as the spokes. The “spoke” hospitals are connected electronically and through EMS to the hubs.
A STEMI INDIA pilot study was conducted in the state of Tamil Nadu in southeast India. The study consisted of four hub hospitals located in Chennai, Vellore, and Coimbatore. The primary and secondary outcomes were proportion of STEMI patients undergoing coronary angiography/PCI, and 1-year mortality, respectively.
STEMI INDIA co-founder Dr. Thomas Alexander reports that the pilot study in Tamil Nadu was a success and has piqued the interest of other regions in India. Furthermore, he states this pilot study “could serve as a model STEMI system of care for low- and middle-income countries.”
- Alexander T. STEMI in India. Eur Heart J 2016;37(31): 2449-2453.
The Global Registry of Acute Coronary Events (GRACE) is an international observational registry collecting data on the characteristics, management and outcomes of patients with acute coronary syndromes (ACS), including myocardial infarction (ST-segment elevation myocardial infarction [STEMI] and non-STEMI) and unstable angina. The aim of GRACE is to narrow the gap between evidence and clinical practice, by providing clinicians with a useable, reliable risk-prediction tool and quarterly reports containing regional and international data on the full spectrum of patients with ACS.
Data from all non-transfer patients presenting between 1999 and 2006 to GRACE hospitals with new or presumed ST-elevation myocardial infarction (STEMI) and/or left bundle branch block (LBBB) within 12 h of symptom onset, were analysed (n=10,954 patients). In particular, demographic factors, comorbid conditions, timing and type of reperfusion treatment, and in-hospital and 6-month outcomes were reported.
Between April 1999 and June 2006, there was an increasing trend in the use of primary percutaneous coronary intervention (PPCI) from 15% to 44% (p <0.001), while use of thrombolytic therapy decreased (from 41% to 16%; p <0.01). These findings mirror results from the NRMI registry in the United States.
The median time to fibrinolysis was reduced from 40 min in 1999 to 34 min in 2006 (p <0.001), but the delay to PPCI remained unchanged.
In 2006, 33% of patients still did not receive reperfusion therapy (although this was an improvement on the 40% reported in 1999).
Change in use of reperfusion therapy from 1999 to 2006
GRACE data was also used to derive the GRACE risk score, for predicting in-hospital and 6-month death and death or MI due to ACS (MI). The GRACE risk score is now endorsed in guidelines produced by the European Society of Cardiology (ESC), the American College of Cardiologists and the American Heart Association (ACC/AHA) and the National Institute for Health and Clinical Excellence (NICE) in the UK. For further information, or to download the risk calculator, visit: www.outcomes-umassmed.org
- GRACE is the largest international observational registry to include data from the complete spectrum of ACS patients to date.
- The GRACE risk score calculator is recommended in international guidelines.
- The global effort to improve reperfusion therapy for acute MI is having an impact; nevertheless there are still substantial opportunities for improvement.
- Eagle KA, et al. Trends in acute reperfusion therapy for ST-segment elevation myocardial infarction from 1999 to 2006: we are getting better but we have got a long way to go. Eur Heart J 2008;29:609-617.
- Fox KA, et al. The Global Registry of Acute Coronary Events, 1999 to 2009 - GRACE. Heart 2010;96:1095-1101.
EPICOR (long-tErm follow-uP of anti-thrombotic management patterns In acute CORonary) is an international cohort study which aims to evaluate international patterns of pre- and in-hospital care of patients with acute coronary syndromes (ACS).
The study enrolled 10,568 consecutive ACS survivors from September 2010 to March 2011 from over 550 hospitals throughout Europe and Latin America. Differences in treatment strategy were analysed.
The main findings in STEMI patients (n=4943) is summarised here.
In STEMI patients, the global median time from symptom onset to:
- FMC or pre-hospital ECG was 1.5 hours.
- PPCI was 4.1 hours.
Globally, 75.5% of STEMI patients underwent reperfusion therapy (56.2% PPCI and 19.3% fibrinolysis). Although the overall rate of reperfusion is acceptable, rates varied by region. For example, more than a third of STEMI patients in Latin American did not receive reperfusion therapy at all (see figure). Furthermore, the results show a need to improve pre-hospital care. Only 49.3% of STEMI patients received pre-hospital care (ECG and/or anti-thrombolytic therapy). Only 2% of STEMI patients received pre-hospital fibrinolysis. The investigators note that the low use of pre-hospital fibrinolytic therapy may be attributed to the high rates of PPCI in some regions. However, this does not explain the low use of pre-hospital fibrinolysis in Latin America where fibrinolysis tends to be the dominant method of reperfusion. The investigators further encourage an increase in the use of pre-hospital ECG which in turn can lead to earlier diagnoses and reduce symptom-onset-to-treatment times, in patients treated with fibrinolysis and PPCI alike.
STEMI management strategies by region
- Bueno H, et al. Opportunities for improvement in anti-thrombotic therapy and other strategies for the management of acute coronary syndromes: Insights from EPICOR, an international study of current practice patterns. Eur Heart J Acute Cardiovasc Care 2016;5(1):3-12.
The National Registry of Myocardial Infarction (NRMI) was a large, prospective US registry, running from 1990 to 2006, which collected data on reperfusion therapy, including door-to-needle (D2N) and door-to-balloon (D2B) times, and outcomes of more than 2.5 million patients with acute myocardial infarction, of which 1,374,232 patients had ST-elevation myocardial infarction (STEMI).
Patients were selected if they had a diagnosis of acute ST-elevation myocardial infarction and/or left bundle branch block on initial ECG and <12 h after onset of symptoms, and also if they received reperfusion therapy – either primary percutaneous coronary intervention (PPCI) or thrombolysis – at a NRMI hospital.
NRMI: Selection criteria
A key finding of the NRMI has been the documentation of changes in the use and type of reperfusion therapy for patients with ST-segment elevation myocardial infarction (STEMI) and changes in door-to-needle (D2N) times for fibrinolysis and door-to-balloon (D2B) times for primary percutaneous coronary intervention (PPCI).
Over the duration of the study, the proportion of STEMI patients eligible for but not receiving reperfusion therapy decreased significantly, from 44.9% in 1990 to 28.1% in 2006 (p <0.001).
In 1990, the predominant reperfusion therapy was fibrinolysis (52.5%), with primary PCI used in only a very small proportion of patients (2.6%). However, by 2006, primary PCI had overtaken fibrinolysis as the predominant form of reperfusion therapy (43.2% versus 27.6%). These findings mirror results from the international GRACE registry.
NRMI: Trends in reperfusion for reperfusion-eligible STEMI patients, 1990 to 2006
Among eligible STEMI patients that were treated with fibrinolysis, the D2N time decreased from 59 min in 1990 to 29 min in 2006 (p <0.001 for trend). This corresponded to a decrease in in-hospital mortality for patients treated with fibrinolysis from 7.0% in 1994 to 6.0% in 2006 (p <0.001 for trend). The relative improvement in mortality attributable to reductions in D2N was estimated to be between 14.3 and 16.3%.
Among eligible STEMI patients that were treated with primary PCI, the D2B time decreased from 120 min in 1994 to 87 min in 2006 (p <0.001 for trend). For non-transfer patients, D2B time decreased from 111 to 79 min, whereas for patients transferred from other hospitals or emergency departments, D2B time decreased from 226 to 139 min. This corresponded to a decrease in in-hospital mortality for patients treated with pPCI from 8.6% in 1994 to 3.3% in 2006. The relative improvement in mortality attributable to reductions in D2B was estimated to be between 5.8% and 7.5%.
NRMI: Trends in door-to-needle (D2N) times, 1990 to 2006, and door-to-balloon (D2B) times, 1994 to 2006
NRMI: Changes in in-hospital mortality for STEMI patients receiving thrombolysis or PPCI (1994 to 2006)
- The rate of overall reperfusion for patients diagnosed with ST-elevation myocardial infarction increased from 1990 to 2006, with proportionally more patients receiving PPCI than thrombolysis in 2006.
- There were significant reductions in D2N and D2B times for STEMI patients eligible for reperfusion therapy over the duration of the NRMI, which resulted in a significant improvement in in-hospital mortality for all reperfusion strategies.
- French WJ, et al. Transforming quality of care and improving outcomes after acute MI. Lessons from the National Registry of Myocardial Infarction. JAMA 2012;308:771-772.
- Gibson CM, et al. Trends in reperfusion strategies, door-to-needle and door-to-balloon times, and in-hospital mortality among patients with ST-segment elevation myocardial infarction enrolled in the National Registry of Myocardial Infarction from 1990 to 2006. Am Heart J 2008;156:1035-1044.
- Pinto DS, et al. Hospital delays in reperfusion for ST-elevation myocardial infarction. Implications when selecting a reperfusion strategy. Circulation 2006;114:2019-2025.
The National Cardiovascular Data Registry is comprised of ten different registries, each covering a specific cardiovascular-related clinical area. ACTION® (Acute Coronary Treatment and Intervention Outcomes Network) – GWTG™ (Get with the Guidelines) is a hospital quality programme focusing on acute myocardial infarction and its treatment.1
As of 2014, more than 71,000 STEMI patients were enrolled from more than 900 participating hospitals.1
Of the STEMI patients treated within ACTION® – GWTG™ hospitals between 2011 and 2014:
- The majority of patients receive timely PPCI (within 90 minutes of first presentation) if they arrive directly at a PCI-capable facility.
- Less than a third of patients who are transferred to a PCI-capable facility for PPCI receive timely reperfusion.
- Just under half of all patients receiving fibrinolysis did so within 30 minutes of initial presentation (see Table 1).1
Table 1: Proportion of STEMI patients receiving timely reperfusion within the ACTION® – GWTG™ hospital programme (2011-2014)1
Several analyses have been conducted using ACTION® – GWTG™ registry data. Some of the most recent STEMI analyses are summarised here.
Fibrinolysis and inter-hospital transfer2
Among patients with STEMI who require inter-hospital transfer, it is unclear how reperfusion strategy selection and outcomes vary with inter-hospital drive times. Using the ACTION® – GWTG™ data, this study aims to assess the association of estimated inter-hospital drive times with reperfusion strategy selection among transferred patients with STEMI in the United States.
22,481 patients eligible for PPCI or fibrinolysis who were transferred from 1,771 STEMI-referring centres to 366 STEMI-receiving centres within the registry between 1 July 2008 and 31 March 2012 were identified.
- The median estimated inter-hospital drive time was 57 minutes (interquartile range [IQR], 36-88 minutes).
- As the estimated drive time increased, the proportion of patients achieving a first DTB time within 120 minutes was lower and the proportion of patients receiving fibrinolysis was higher (Table 2).
Table 2: Proportion of patients who received primary percutaneous coronary intervention stratified by the estimated inter-hospital drive time
- When the estimated drive time exceeded 30 minutes, only 42.6% of transfer patients treated with PPCI achieved the first DTB time within 120 minutes.
- Only 52.7% of eligible patients with a drive time exceeding 60 minutes received fibrinolysis.
- Among 15,437 patients with estimated drive times of 30 to 120 minutes who were eligible for fibrinolysis or PPCI, 5,296 (34.3%) received pre-transfer fibrinolysis, with a median DTN time of 34 minutes (IQR, 23-53 minutes).
- After fibrinolysis, the median time to transfer to the STEMI receiving centre was 49 minutes (IQR, 34-69 minutes), and 97.1% underwent follow-up angiography.
- Patients treated with fibrinolysis vs PPCI had no significant mortality difference (3.7% vs 3.9%; adjusted odds ratio, 1.13; 95%CI, 0.94-1.36) but had marginally significant higher risk of bleeding (10.7% vs 9.5%; adjusted odds ratio, 1.17; 95%CI, 1.02-1.33).
In the United States, neither fibrinolysis nor PPCI is being optimally used to achieve guideline-recommended reperfusion targets. For patients who are unlikely to receive timely PPCI, pre-transfer fibrinolysis followed by early transfer for angiography may be a reperfusion option when the potential benefits of timely reperfusion outweigh bleeding risk.
Pre-hospital electrocardiogram and distance patients must travel to PCI-centre on total reperfusion time3
- More than 29,500 STEMI patients were transported by ambulance to a PCI-capable facility within the ACTION® – GWTG™ registry from July 2008 through September 2012.
- A retrospective cohort study found that more than two thirds (67% or n=19,690) of these patients received a pre-hospital ECG while the remaining 33% did not.
- Analysis showed use of pre-hospital ECG was associated with a 10-minute reduction in time from first medical contact to balloon time. Furthermore, association was not affected by the distance between the patient’s home and the PCI-capable facility.
Race and STEMI4
Using registry data to look at racial trends in STEMI with respect to patient characteristics and treatment strategy, investigators found that black STEMI patients tended to be younger, more likely to be current smokers, had a higher prevalence of diabetes mellitus and hypertension, were more likely to have had prior stroke, a higher heart rate upon admission and higher initial Cr levels, and were more educated than white STEMI patients but have a lower household income and tended to live in non-rural communities (p<0.0001 for all values for both males and females). White male STEMI patients were more likely to have dyslipidaemia than black male STEMI patients (p<0.0001).
Although there were significant differences in patient baseline characteristics, the rates of invasive or interventional procedures were similar. Black patients had less CABG, less overall revascularisation and were not as likely to be referred to discharge therapy and counselling compared to their white counterparts. Despite these differences, there were no significant differences in the rates of death or major bleeding between the two patient groups.
- Masoudi FA, et al. Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries. JACC 2017. doi: 10.1016/j.jacc.2016.12.005.
- Vora AN, et al. Fibrinolysis use among patients requiring inter-hospital transfer for ST-segment elevation myocardial infarction care a report from the US national cardiovascular data registry. JAMA Intern Med 2015;175(2):207-215.
- Mumma BE, Kontos MC, Peng SA, Diercks DB. Association Between Prehospital ECG Use and Patient Home Distance from the PCI Center on Total Reperfusion Time in STEMI Patients: A Retrospective Analysis from the NCDR. Am Heart J 2014;167(6):915-920.
- Anstey, DE, Li, S, Thomas, L, et al; Race and Sex Differences in Management and Outcomes of Patients After ST-Elevation and Non-ST-Elevation Myocardial Infarct: Results From the NCDR. Clinical Cardiology 2016;39(10):585-595.
In rural settings, direct transfer of patients with ST-elevation myocardial infarction (STEMI) for percutaneous coronary intervention (PCI) is often subject to prolonged delays. This prospective study, conducted in Minneapolis, assessed the safety and efficacy of a pharmaco-invasive reperfusion strategy with half-dose fibrinolytic and direct transfer for immediate PCI compared with primary PCI.
Between April 2003 and December 2009, 2,634 consecutive STEMI patients were enrolled into the “Level 1 MI” database of the Minneapolis Heart Institute at Abbot-North-western (MHI-ANW) Hospital, in Minneapolis (which uses a standardised protocol to transfer STEMI patients from regional hospitals up to 210 miles from the PCI centre by means of a pharmaco-invasive strategy or for primary PCI). Patients were grouped into those presenting directly to the PCI centre (n=600), a Zone 1 hospital within 60 miles of the PCI centre (n=1,195), or a Zone 2 hospital located more than 60 miles from the PCI centre (n=839). The groups were further subdivided in the Zone 1 and 2 hospitals into those patients receiving a pharmaco-invasive strategy and those transferred directly for primary PCI.
All patients received aspirin, clopidogrel, unfractionated heparin and a beta-blocker on presentation in the emergency room. Patients presenting to Zone 2 hospitals (or Zone 1, if timely transfer for primary PCI was not possible) received half-dose thrombolytic (usually tenecteplase) before being transferred for immediate PCI.
Minneapolis STEMI registry
Patients presenting directly to the PCI hospital (Group A) had a median door-to-balloon time of 62 (44, 83) min. Patients transferred from Zone 1 hospitals for PCI had a median door-to-balloon time of 94 (80, 116) min, and those transferred from Zone 2 hospitals for PCI had a medial door-to-balloon time of 122 (100,147) min. The median door-to-needle time for patients receiving pharmaco-invasive treatment was 29 (20, 42) min.
Minneapolis STEMI registry: Time to treatment
D2B, door-to-balloon time (first presentation at the hospital to PPCI)
D2N, door-to-needle time (first presentation at the hospital to administration of thrombolytic)
Despite the significantly longer door-to-balloon times for patients from Zone 2, there were no significant differences in 30-day mortality, stroke, recurrent ischaemia/myocardial infarction, or TIMI major bleeding in the comparison between Group A patients who directly underwent PPCI and Group D patients, transferred from hospitals in Zone 2 (60 miles away from the PCI centre), who received a pharmaco-invasive strategy. There was also no significant difference in any of the above factors when the patients treated with PPCI (Groups A and B) were compared with those treated with the pharmaco-invasive strategy (Groups C and D).
Minneapolis STEMI registry outcomes: group A (PPCI) vs group D (Ph-INV)
Patients in Group E, who were transferred for PPCI had a median door-to-balloon time of 133 min, and a higher in-hospital and 30-day mortality compared to patients in Group D (Zone 2 patients receiving pharmaco-invasive treatment).
A pharmaco-invasive strategy using half-dose thrombolytic may be an effective and safe reperfusion strategy for STEMI patients in rural or isolated settings with delayed transfer times to a PCI centre, when performed within an organised regional network.
- Larson DM, et al. Safety and efficacy of a pharmaco-invasive reperfusion strategy in rural ST-elevation myocardial infarction patients with expected delays due to long-distance transfers. Eur Heart J 2012;33:1232-1240.