European Heart Journal Advance Access originally published online on October 23, 2008
European Heart Journal 2008 29(23):2835-2842; doi:10.1093/eurheartj/ehn462
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Pre-hospital thrombolysis in perspective
Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris and Université Paris 5 René Descartes, Paris, France
Received 21 November 2007; revised 23 September 2008; accepted 29 September 2008; online publish-ahead-of-print 23 October 2008.
* Corresponding author: Division of Coronary Artery Disease and Intensive Care, HEGP, 20 rue Leblanc, 75015 Paris, France. Tel: +33 156 09 25 71, Fax: +33 156 09 25 72, Email: nicolas.danchin{at}egp.aphp.fr
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Abstract |
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Top
Abstract
IntroductionAims: To review existing evidence on the role of pre-hospital fibrinolysis in patients with ST-elevation myocardial infarction (MI).
Methods and results: Overview of current guidelines and data from trials and registries on the best perfusion approach for acute MI with ST-elevation. Despite advances in the treatment of ST-elevation MI, the mortality rate before any therapy is administered is high, with half of all fatalities occurring within 2 h of symptom onset. Current treatment options, including the timely use of pre-hospital fibrinolysis, have reduced the overall 1 month mortality. Mortality can be further improved when patient characteristics, risk factors and time delays to treatment are considered.
Conclusion: Time factors are essential in the success of fibrinolysis, and subsequent coronary intervention seems beneficial.
Key Words: Pre-hospital thrombolysis • ST-elevation myocardial infarction • Primary PCI • Registry • Randomized trial
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Introduction |
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Annually, approximately 500 000 ST-elevation myocardial infarction (STEMI) events are reported in the USA.1 Predictors of death include age, size and site of infarction, concurrent medical conditions, a past history of MI, low blood pressure, Killip class on admission, and extent of the ischaemia.2 The increase in the availability of percutaneous coronary intervention (PCI) facilities and the simplification of pre-hospital thrombolysis (PHT) through the administration of single-bolus fibrinolytics have transformed the management of STEMI patients and reduced the overall 1 month mortality for those who receive a timely treatment. Treatment options may also be combined, providing facilitated PCI and rescue PCI. Many factors influence the choice and outcome of reperfusion, but to obtain the best possible result, symptom recognition, emergency care guidelines, and subsequent management plans need to be standardized and implemented. The main problem in designing a therapeutic protocol is the discrepancy between trial and registry data, and the translation of strategies from the ideal to the real world. This article reviews current data on reperfusion therapy for acute STEMI.
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Current guidelines |
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All guidelines are based on the results of RCTs comparing primary PCI (PPCI) and thrombolysis, as well as on observational data from registries. As most guidelines were published a few years ago, the most recent data have obviously not been taken into account. All agree that time is critical and reperfusion should be initiated as soon as possible.3–5
The American Heart Association (AHA) and the American College of Cardiology (ACC) favour the use of PHT over PCI, placing the emphasis on the time factor rather than on the method of reperfusion. AHA/ACC guidelines state that PHT should be performed only following the confirmation of STEMI on a 12-lead ECG, interpreted by a physician on site or after transmission to a specialist. A reperfusion checklist should also be completed to ensure that the patient has no contraindications to thrombolytics and to identify high-risk patients who would benefit more from PPCI. PHT should be performed within 30 min of the arrival of the emergency services. If PHT cannot be administered and the patient is subsequently transported to a hospital that has no PCI facility, the door-to-needle time (arrival at the hospital to the administration of thrombolytic, DN) should be <30 min. If, however, the hospital can offer PCI, the door-to-balloon time (arrival to PCI, DB) should be <90 min.1,3 The recent update of the ACC/AHA guidelines3 insists that patients presenting to a hospital with PCI capability should be treated with PPCI within 90 min of first medical contact (level of evidence A). In patients presenting to a hospital without PCI capability and who cannot be transferred to a hospital centre and undergo PCI within 90 min of first medical contact, fibrinolytic therapy should be administered within 30 min of hospital presentation unless contraindicated (level of evidence B). The goal is to organize systems of care such that the total ischaemic time be <120 min. The goals for each management step are the following: time from symptom onset to first call to emergency medical service (EMS): 5 min, with 1 min EMS dispatch; EMS on scene within 8 min, ECG on scene and consider pre-hospital fibrinolytic therapy by EMS if capable and time to lytic therapy <30 min; if transportation to a hospital without PCI capability, DN time <30 min; if transportation to a hospital with PCI capability, EMS-to-balloon time <90 min (if patient self-transport: DB time <90 min).
In its most recent guidelines,4 the European Society of Cardiology (ESC) recommends reperfusion by PPCI, if performed by an experienced operator within 120 min of the first medical contact or within 90 min of first medical contact if the patients present within 2 h of the onset of symptoms and have a large myocardial area at risk and a low bleeding risk. PPCI should be used in patients with contraindications to thrombolysis and is the preferred treatment for patients in shock. Otherwise, thrombolysis should be administered as soon as possible. If thrombolysis fails (based on the lack of sufficient ST-segment resolution), rescue PCI should be performed within a reasonable time delay (up to 12 h after symptom onset). If thrombolysis is successful (>50% ST-segment resolution at 60–90 min, reperfusion arrhythmias, disappearance of chest pain), coronary angiography is recommended in the absence of contraindications. To avoid an early PCI during the pro-thrombotic period following fibrinolysis, on the one hand, and to minimize the risk of re-occlusion, on the other hand, a time window of 3–24 h following successful fibrinolysis is recommended.4 In contrast, facilitated PCI (using thrombolytics or GP IIb/IIIa inhibitors before primary angioplasty) is not recommended.
The National Institute for Clinical Excellence supports reperfusion with fibrinolytics, recommending PHT using the newer agents, reteplase and tenecteplase, whose bolus application simplifies administration. Time is crucial here too and therapy should be initiated within 12 h of symptom onset.6
The European Resuscitation Council guidelines state: thrombolysis is indicated in the absence of contraindications if PCI is not possible within 90 min, or if symptom duration is <3 h and delay to PCI >60 min. PCI is indicated if available within 90 min (60 min if presenting within 3 h of symptom onset) if thrombolytics are contraindicated, the patient is in cardiogenic shock, severe left ventricular failure, or presents later than 3 h.7
All guidelines stress that a network for STEMI management should be developed on a national and/or regional level, with continuous monitoring to show how reperfusion strategies work in real-life situations.
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Comparison of thrombolysis with percutaneous coronary intervention in randomized controlled trials |
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Randomized controlled trials (RCTs) have shown PPCI to be more effective than fibrinolysis for STEMI when performed by an experienced team within 90 min of first medical contact.8–10 Keeley et al. evaluated 23 trials comparing PPCI with thrombolysis using streptokinase or a fibrin-specific agent. Regardless of the thrombolytic agent, PPCI was more effective, even if transfer to centres with appropriate facilities was necessary.8,10 However, as documented in a meta-analysis of six randomized trials, PHT is significantly superior to in-hospital thrombolysis (IHT) in terms of hospital mortality and it saved 45 min compared with IHT, which could potentially preserve myocardial tissue and improve outcomes.11 This is especially important in regions and countries where PCI is not available either at all, or on a 24 h basis.
Only one trial, Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction (CAPTIM), compared PHT and PPCI. Patients who received thrombolysis within 2 h of symptom onset showed a strong trend towards lower 30 day mortality than those who had undergone PPCI. Beyond 2 h, the difference between the groups was almost reversed in favour of PPCI.12
The findings from CAPTIM are consistent with those from PRAGUE-2, which showed that within 3 h of symptom onset, mortality rates were almost identical, but in patients randomized after 3 h, mortality following thrombolysis was much higher.13 The investigators concluded that if STEMI patients can be transferred within 20–30 min, they should receive PPCI. If this cannot be performed within 60 min, thrombolysis can be administered up to 3 h after onset. Beyond 3 h, thrombolysis should not be used, and patients should be transferred for PPCI. Likewise, in the Primary Coronary Angioplasty vs. Thrombolysis (PCAT)-2 Trialists Collaborative Group meta-analysis,14 30 day mortality doubled in the fibrinolysis group as the time delay increased from 1 to >6 h. The re-infarction rate was also higher in this group and increased with the time delay (not observed in the PPCI group). Thus, the time delay to reperfusion remains central to the choice of strategy.14
Another important point is the role of subsequent PCI after PHT. In CAPTIM, 70% of patients in the thrombolysis group underwent PCI before day 30, with 26% requiring rescue PCI. Therefore, the actual comparison in this trial was between PPCI and PHT followed by PCI if thrombolysis failed.12 Furthermore, the role of systematic PCI within 24 h of thrombolysis was tested in the Grupo de Analisis de la Cardiopatia Isquemica Aguda (GRACIA-1) trial15 and in the CARESS-in-AMI trial.16 In both instances, the policy of systematic PCI following thrombolysis yielded better results than conservative management. The WEST (Which Early ST-elevation myocardial infarction Therapy) study extended this concept and compared tenecteplase alone with tenecteplase and mandatory PCI within 24 h and PPCI with a loading dose of clopidogrel. The results suggested that rapidly applied pharmacological reperfusion with follow-up (rescue and routine) PCI within 24 h produced equivalent results to PPCI.17
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Registry data |
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Inclusion and exclusion criteria of RCTs imply that only ideal situations are represented. Registry data provide a more realistic view of treatment strategies and outcomes in unselected populations. Consequently, results of registries and trials often differ. Björklund et al. demonstrated a 1 year mortality of 8.8% for STEMI patients treated with fibrinolytics in a RCT, in contrast to 20.3% for patients not included in the trial but treated at a trial hospital, and 19.0% for patients treated in a non-trial hospital (P < 0.001 for both). Thus, less critically ill patients are preferentially selected for inclusion in RCTs.18
French registries
The first nationwide French registry, in 1995, showed equivalent results for 1 year mortality with intravenous thrombolysis and PPCI. However, PHT and IHT were not analysed separately, as PHT was seldom used in France at that time.19 In the USIC 2000 Registry, reperfusion was selected according to several criteria, including the time to reach a catheterization laboratory and the availability of the specialist team. In contrast to RCTs, the USIC 2000 results favoured PHT.20 This may have been influenced by the large proportion of patients who underwent rapid coronary angiography,20 similar to that found in CAPTIM,12 and much higher than in trials such as DANAMI-2,21 which found PCI to confer a higher survival advantage than IHT if performed within 2 h of symptom onset.
Vienna registry
The results of the Vienna STEMI registry, which included 1053 acute STEMI patients admitted to hospital, were similar to those of CAPTIM.12,22 PHT, when initiated within 2 h of symptom onset, showed a (not statistically significant) trend towards reduced mortality compared with PPCI. Only a small number of patients underwent PPCI within 2 h. As in other registries and CAPTIM, the advantage of PHT was lost as times to administration increased. Overall, PPCI was associated with an increased survival benefit over PHT. However, because 91% underwent coronary angiography (rescue or systematic) while in hospital, the results are not strictly those of PHT alone, rather a combination of thrombolysis and angiography with or without mechanical intervention. The conclusion reflected trial results: within 2 h of symptom onset, thrombolysis should be administered, preferably pre-hospital, if PPCI cannot be performed within 90 min of the first medical contact.22
Swedish registry
In the large RIKS-HIA (Register of Information and Knowledge about Swedish Heart Intensive Care Admissions), PHT had better outcomes than IHT, but patients who received PPCI had lower mortality and re-infarction rates and shorter hospital stays.23 However, only a few months before, the same group reported the results of thrombolysis in the same patients treated in the ambulance before hospital admission.24 In this latter group, mean age was comparable with the age of patients treated with PPCI. Interestingly, comparing 30 day and 1 year results between the ambulance-managed PHT patients and the primary angioplasty group shows that both reperfusion methods yield very similar mortality figures: 5.4 vs. 4.9% at 30 days and 7.2 vs. 7.6% at 1 year, respectively (Table 1).23,24
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Time delay to reperfusion appeared very important in the thrombolysis groups, as mortality increased sharply beyond 2 h. The difference was less dramatic for PPCI (Table 2). Overall, time delay was central to the benefit incurred by any type of reperfusion, but loss of benefit with increasing delay was less pronounced with PPCI. Therefore, the authors concluded that, within 2 h of symptom onset, patients should receive PHT only if PPCI is not available within 4 h.24 This conclusion, however, did not take into account the results of PHT in ambulance-transported patients.
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US registry: National Registry of Myocardial Infarction
The National Registry of Myocardial Infarction (NRMI) registries studied the impact of the difference in time delays between the administration of thrombolysis and PPCI in 192 509 patients. Overall, PPCI yielded more favourable results than thrombolysis, but increasing DB minus DN times were associated with increasing mortality rates (P < 0.001).9,25 The time point at which PCI lost its survival advantage over fibrinolysis varied considerably between various subgroups: from 40 min in patients <65 years with an anterior infarction, presenting within 2 h of symptom onset, to 179 min in patients >65 years with a non-anterior infarct, presenting after 2 h of symptom onset (Figure 1). The effect of thrombolysis was greatest in patients presenting with a large infarction, short duration of symptoms, and low bleeding risk. The prolonged time window gained for PCI in the elderly appeared related to the increased risk of intracerebral haemorrhage with fibrinolysis.9,25,26
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International GRACE registry
The Global Registry of Acute Coronary Events (GRACE) followed 44 372 STEMI and non-STEMI patients from 1999 until 2005, looking for improvement in outcomes when evidence-based treatment guidelines were followed.27 The proportion of STEMI patients eligible for any kind of reperfusion therapy did not change significantly over the study period, but the proportion undergoing PPCI increased by 37%, whereas pharmacological reperfusion decreased by 22%. Correspondingly, in-hospital mortality and cardiogenic shock decreased (Table 3). However, recommended adjuvant pharmacological treatment increased markedly throughout the study. The decrease in mortality can be attributed to increased experience in invasive treatment strategies and more efficient pre-hospital management, but also to the effect of improved adjuvant therapies.27 The GRACE registry therefore shows that the implementation of guidelines is central to the provision of improved patient care.
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Practical considerations |
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Time factors
It is indisputable and logical that shorter times to reperfusion are associated with more favourable outcomes.5,9,14,25 But the argument for and against the use of thrombolysis over PPCI in the first 2 h following symptom onset still prevails. Some data, including CAPTIM and the USIC registry, have shown that PHT may be superior if administered within the first 2 h12,20; some have shown PPCI to be superior regardless of the time of administration14; and others that only certain high-risk subgroups benefit from early thrombolysis.28
The success of reperfusion in STEMI is dependent on the time of administration.25 However, registry data show that the 30 min DN and 90 min DB time goals are extremely difficult to achieve.1 DB times are often much longer in clinical practice than in RCTs, as transfer of patients for PCI, local factors (weather, location, staff, etc), or poor management strategies can lead to long delays.10,29 An analysis of the NRMI 3/4 data demonstrated that only 4.2% of patients undergoing PPCI achieve a DB time <90 min.29 This calls for continued efforts to improve time delays. This task, however, appears extremely difficult, as shown in the most recent data from the GRACE registry, which failed to document any improvement in time delays for PPCI between 2000 and 2005.30
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Pre-hospital thrombolysis: advantages and limitations |
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PHT constitutes one of the means to shorten time delays before the administration of reperfusion therapy. However, it poses several organizational problems that can find different answers according to each regional/national system of care.
A number of barriers may exist and limit the actual use of PHT. Among those, the strict selection criteria for the administration of PHT by nurses or technicians account for the lack of use of PHT in a high percentage of patients (in a recent study in the UK, 
60% of patients receiving thrombolysis did not fulfil the selection criteria for PHT).31 Likewise, the perception of PHT by technicians or nurses is a balance between positive views (transfer of potentially life-saving techniques from physicians to technicians/nurses) and more negative views (PHT may be seen as a potentially harmful technique, and the pay that is given to paramedics may be judged insufficient in regard to the increased responsibility that goes with the use of PHT).32
Finally, there remains a discussion on the optimal system of pre-hospital care, with the on-site involvement of physicians or with the involvement of paramedics without physicians. A study of 641 consecutive STEMI patients in Finland found that the clinical results achieved with an EMS with the on-site involvement of physicians were superior to those of an EMS with only paramedics on site.33
Obviously, the system of care chosen is likely to have a definite impact on the percentage of STEMI patients in whom PHT can be delivered. In the recent French registry of MI in 2005, PHT was used in 19% of the STEMI patients admitted to intensive care units within 48 h of pain onset, representing two-thirds of those treated with intravenous thrombolysis.34 From a practical standpoint, emergency ambulances in France are physician-staffed and PHT is administered by physicians who decide on its use after the initial clinical and ECG work-up.20,35
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Combined pharmaco-invasive strategy |
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One of the main advantages of PCI over thrombolysis is to limit the risk of re-infarction. Lately, the potential benefit of a pharmaco-invasive strategy (i.e. thrombolysis followed by coronary angiography) has been investigated in several studies. Both the WEST and CARESS-in-AMI trials16,17 showed improved clinical results with a policy of systematic PCI following thrombolysis. Very recently, the Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) investigated the impact of immediate transfer for coronary angiography (within 6 h of the administration of thrombolysis) vs. a more conventional strategy (immediate transfer for patients with failed reperfusion only and elective PCI after 24 h for patients with successful thrombolysis) in patients with moderate-to-high-risk STEMI admitted to non-PCI hospitals.36 In the immediate transfer group, PCI was actually performed in 84% of the patients, compared with 62% of the patients in the conventional strategy group. The primary endpoint of the trial (death, re-infarction, congestive heart failure, severe recurrent ischaemia, or shock) was significantly reduced in the pharmaco-invasive arm, with a remarkable reduction in the rates of re-infarction and recurrent ischaemia. In the latest French registry, 96% of the patients treated with thrombolysis (two-thirds with pre-hospital administration) underwent coronary angiography and 84% underwent PCI during their hospital stay; this pharmaco-invasive strategy yielded results which were comparable with those of PPCI in terms of early and 1 year mortality. Most PCI procedures were performed within 24 h of the administration of lytic therapy. Thirty day mortality was lower in patients who underwent PCI after thrombolytic treatment (3.9 vs. 9.2%, P < 0.05).34 Put together, these results suggest that a combined pharmaco-invasive approach may be the best option in patients receiving thrombolytic therapy, at least for patients with larger infarcts.
Age
The difficulty in assessing treatment options in the elderly (
75 years) is that they are often excluded from trials.18 The Fibrinolytic Therapy Trialists' (FTT) overview of 5788 STEMI patients >75 years demonstrated that thrombolysis reduced 35 day mortality, with an absolute mortality reduction of 34 lives per 1000 patients treated. So, fibrinolytic therapy should not be denied to elderly patients; however, they have a much higher risk of mortality and adverse events when treated with thrombolysis compared with younger patients.37 Each case should therefore be considered individually, especially with regard to risk factors and time of presentation.38
A small randomized trial showed improved outcomes with PPCI vs. thrombolysis in elderly patients,39 and registry data are in keeping with these findings.40 In the NRMI registry, Pinto et al. reported that the survival advantage of PPCI was maintained over longer DB times in the elderly (here 65 years), probably because of the higher risk of intracerebral haemorrhage with fibrinolysis in the elderly.9
Overall, although thrombolysis can be used in elderly patients when truly appropriate, PPCI is definitely the preferred therapeutic option in this population.
Gender
One study within the USIC registries found that all reperfusion strategies were used less frequently in women, who also received less additional medications. In patients <67 years of age, in-hospital mortality was higher in women than in men, irrespective of the use of reperfusion therapy, whereas there were no differences in outcomes between men and women aged over 67 years.41 The same was also noticed in RIKS-HIA for women <70 years.23 The precise reasons for this are unclear and further studies need to be performed in this area. On the whole, there is no evidence that the respective efficacy of thrombolysis and PPCI is different in women and men.
Infarct location
Infarct location is another factor that affects the outcome in STEMI patients. In the NRMI studies, patients with non-anterior infarcts lost the survival advantage of PPCI over PHT after a shorter delay than those with an anterior infarct.9
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Appropriate management strategies in the light of current evidence |
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Each STEMI patient needs to be assessed for risk factors and potential treatment benefits of the reperfusion strategies available before a decision is made on one particular therapy. In the elderly, in spite of the lack of evidence from RCTs, PPCI seems to be the treatment of choice regardless of the time delay.42 Otherwise, although the guidelines recommend that PPCI is the first-choice treatment, time delays and other risk factors need to be considered. Thrombolysis, particularly in the pre-hospital setting and in younger patients, yields excellent results when the patients are seen very early, and may be the preferred therapeutic option when a fully operational catheterization team is not readily available. If thrombolysis is chosen, a bolus thrombolytic is recommended to simplify administration. Subsequent transfer of the patient to an institution with catheterization capabilities appears preferable, as evidence grows on the benefit of rapid PCI following thrombolysis.16
As first medical contact-to-balloon times are still much too long in many areas, it is crucial that local guidelines with continued monitoring of time delays are implemented. This is likely to improve outcomes.43 The first medical attendant (physician or paramedic) should be trained to perform a 12-lead ECG on the spot, which can be transmitted to a specialist for interpretation, and a decision should then be taken as regards the preferred reperfusion option, according to local factors and the availability of emergency interventional cardiology teams. Cardiologists and emergency departments should be involved in the decision-making process and need to work together as a synergistic network to improve STEMI management and time to reperfusion.44 Recent examples have documented the feasibility and efficacy of such organizational efforts: in two different regions in the USA, the implementation of a regional system of care devoted to patients with STEMI, based on geographical and timing algorithms, resulted in excellent clinical results, with no significant difference in mortality whatever be the distance from the place where the event occurred to the PCI centre.45,46
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Conclusion |
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The question these days is not so much, which treatment offers the greatest benefit from a theoretical standpoint, what is available within certain time boundaries, and how to improve the number of patients receiving reperfusion therapy. Although PPCI is the treatment of choice, it is often not possible to implement it within the required time window. In this case, thrombolysis should be considered with the availability of systematic or rescue PCI. In areas where PCI is not (immediately) available, thrombolysis remains the only treatment option and should be administered as soon as possible, preferably pre-hospital. The most recent data, from both randomized trials and registries, suggest that a pharmaco-invasive strategy should probably be the preferred option in patients treated with thrombolytic therapy. In this regard, an organized network of assessment, treatment, and transfer should be established and adapted to the local situation to manage STEMI patients optimally, with continuous monitoring of the clinical results achieved.
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Funding |
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This work was supported by a grant from Boehringer Ingelheim.
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Appendix |
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The references on which this paper is based were retrieved from the PubMed database. In all, 186 references on PHT, 330 references on door-to-treatment times, 341 references on STEMI management and registries, and 335 references on PCI, thrombolysis, and STEMI were examined. The 43 references that were felt most relevant and informative were retained.
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Acknowledgements |
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We are indebted to Emma Raderschadt for her technical assistance in preparing the manuscript.
Conflict of interest: N.D. has been an investigator in the CAPTIM trial and has been the principal investigator of the USIK 1995 and USIC 2000 registries, which were sponsored by sanofi-aventis, and of the FAST-MI registry, which was sponsored by Pfizer and Servier. He has received honoraria for participating in symposia sponsored by Boehringer Ingelheim, which manufactures tenecteplase.
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