European Heart Journal Advance Access originally published online on April 19, 2006
European Heart Journal 2006 27(10):1146-1152; doi:10.1093/eurheartj/ehi886
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Pre-hospital thrombolysis delivered by paramedics is associated with reduced time delay and mortality in ambulance-transported real-life patients with ST-elevation myocardial infarction
1 Department of Cardiology, University Hospital of Uppsala, 751 85 Uppsala Sweden
2 Department of Cardiology, University Hospital of Linköping, Stockholm Sweden
3 Uppsala Clinical Research Center, University Hospital of Uppsala, Uppsala Sweden
4 Department of Cardiology, South Hospital, Stockholm Sweden
Received 27 September 2005; revised 3 March 2006; accepted 23 March 2006; online publish-ahead-of-print 19 April 2006.
* Corresponding author. Tel: +46 18 6114043; fax: +46 18 506638. E-mail address: erik.bjorklund{at}akademiska.se
See page 1131 for the editorial comment on this article (doi:10.1093/eurheartj/ehi740)
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Abstract |
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Aims There are sparse data on the impact of pre-hospital thrombolysis (PHT) in real-life patients. We therefore evaluated treatment delays and outcome in a large cohort of ambulance-transported real-life patients with ST-elevation myocardial infarction (STEMI) according to PHT delivered by paramedics or in-hospital thrombolysis.
Methods and results Prospective cohort study used data from the Swedish Register of Cardiac intensive care on patients admitted to the coronary care units of 75 Swedish hospitals in 2001–2004. Ambulance-transported thrombolytic-treated patients younger than age 80 with a diagnosis of acute myocardial infarction were included. Patients with PHT (n=1690) were younger, had a lower prevalence of co-morbid conditions, fewer complications, and a higher ejection fraction (EF) than in-hospital-treated patients (n=3685). Median time from symptom onset to treatment was 113 min for PHT and 165 min for in-hospital thrombolysis. One-year mortality was 7.2 vs. 11.8% for PHT and in-hospital thrombolysis, respectively. In a multivariable analysis, after adjusting for baseline characteristics and rescue angioplasty, PHT was associated with lower 1-year mortality (odds ratio 0.71, 0.55–0.92, P=0.008).
Conclusion When compared with regular in-hospital thrombolysis, pre-hospital diagnosis and thrombolysis with trained paramedics in the ambulances are associated with reduced time to thrombolysis by almost 1 h and reduced adjusted 1-year mortality by 30% in real-life STEMI patients.
Key Words: Acute myocardial infarction • Pre-hospital thrombolysis • Treatment delay • Mortality
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Introduction |
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Time to thrombolysis remains a key modifiable determinant of mortality in ST-elevation myocardial infarction (STEMI).1,2 Despite many years of medical advances, the time from symptom onset to thrombolysis has remained at large unchanged, with a median of 2.5–3 h.3 A pre-hospital treatment strategy when compared with in-hospital thrombolysis has been shown to reduce time to thrombolysis with around 1 h and in-hospital mortality by 17% in a meta-analysis of randomized trials.4
In a recent randomized trial comparing pre-hospital thrombolysis (PHT) with primary percutaneous coronary intervention (PCI), there was no statistical difference in 30-day mortality or re-infarction according to the treatment strategy.5 In addition, in patients randomized within 2 h of symptom onset, PHT showed a tendency towards lower 30-day mortality when compared with primary PCI.6
There are sparse data on time delays and outcome in real-life patients treated with PHT delivered by paramedics when compared with in-hospital thrombolysis. One recent registry study in France7 reported that PHT provided by physicians in the ambulances showed a tendency towards lower 1-year mortality when compared with in-hospital thrombolysis and primary PCI. However, there was no information on time from symptom onset to therapy, according to treatment modalities. In addition, one-third of the patients with in-hospital thrombolysis were admitted to the hospitals without ambulance transport and thus not directly comparable with the PHT-treated group of patients.
We therefore evaluated treatment delays and short- and long-term outcome in a large cohort of ambulance-transported real-life STEMI patients in Sweden in relation to PHT delivered by paramedics or regular in-hospital thrombolysis during 2001–2004.
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Methods |
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Study population
We used data obtained from the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA) between 1 January 2001 and 30 November 2004. Collection of information in the registry on ambulance transportation started in 2001, and during the registration period, 75 of 80 hospitals in Sweden were contributing data to the registry.
We included all ambulance-transported patients younger than age 80 with a final diagnosis of acute myocardial infarction (AMI), treated with thrombolysis and with information on time to thrombolysis. We included only ambulance-transported patients to allow an equal comparison of patients treated with and without PHT. Older patients were excluded because of the increased risk of concomitant disease that might not be covered by the registered variables. Only patients with their first recorded admission for AMI during the registration period were used, to avoid double counting of patients. The criteria for the diagnosis of AMI were standardized and identical for all participating hospitals using the WHO criteria.8 The biochemical criterion was in accordance with the consensus document.9
A more general implementation of PHT started in 1999 in Sweden. The ambulances in Sweden are staffed with paramedics who are trained to send a pre-hospital electrocardiogram (ECG) in patients with chest pain to the corresponding hospital's coronary care units (CCUs) using telemedicine and to check inclusion and exclusion criteria for thrombolysis according to the standardized protocols. A physician on call evaluates the ECG and checks the inclusion and exclusion criteria together with the paramedics over the phone and decides whether to start thrombolytic treatment if the patient is judged eligible.10
Data collection
RIKS-HIA contains details of all patients admitted to the CCU of participating hospitals. Information is reported on case record forms, including 100 variables, and has been described elsewhere.11 Briefly, the register includes information on demographic data, ambulance transportation (yes/no), time of symptom onset, time of arrival at emergency department and at the CCU, time of start of thrombolytic treatment, previous cardiac disease, medication at entry, pre-hospital or in-hospital thrombolysis, echocardiography, treatments and major complications and procedures during hospital stay, and discharge medications and diagnosis. In addition, since 2002, the registry has started to collect data on time of ambulance arrival on scene and time of pre-hospital ECG transmission.
Source data verification is continuously performed, and in 1972 randomly selected computer forms from 38 hospitals, comprising 161 280 variables, there was 95% overall agreement between the registered information and the source data in the patients' records.
One-year and 30-day mortality data were obtained by merging the RIKS-HIA database with the National Cause of Death Register, which includes the vital status of all Swedish citizens. Complete follow-up was available until 31 December 2004.
Previous history of stroke, congestive heart failure (CHF), peripheral artery disease, and chronic pulmonary disease were obtained by merging with the National Patient Register, which includes diagnoses of all patients hospitalized in Sweden from 1987 and forward.
All patients for whom data were entered into the RIKS-HIA database were informed of their participation in the registry and the long-term follow-up. The RIKS-HIA registry and its merging with other registries were approved by the National Board of Health and Welfare and the Swedish Data Inspection Board.
Statistical analysis
Baseline characteristics were summarized as medians (with 25th–75th percentile) or percentages. The PHT stratum was compared with the in-hospital-treated stratum by the 
2 test for categorical variables and by the Mann–Whitney U test for continuous variables. A propensity score was calculated for each patient to estimate the probability of receiving PHT given the characteristics at baseline.12 Adjustment for the propensity score aimed to balance the groups with regard to differences in baseline characteristics, based on treatment with PHT. Multiple logistic regression analysis was performed to calculate the propensity score, including 20 covariates listed in Table 1 with the exception of cardiopulmonary resuscitation (CPR) before admission and smoking status. Smoking status was not included in the model, as it increased the missing cases by 175, and when added to the model, the results were at large unchanged. The relationship between the two-patient strata and 1-year mortality was evaluated in two models of multiple logistic regression analyses. Model 1 included the propensity score, CPR before admission, and rescue angioplasty. Model 1 was also used to evaluate the 30-day mortality. In model 2, only patients who survived the first 14 days were included and revascularization within 14 days was added to the model (instead of rescue angioplasty). In all statistical analyses, a P-value of less than 0.05 (two-sided test) was considered significant. All statistical analyses were done using SPSS version 12.0 software (SPSS Inc.).
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Results |
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Patients and baseline characteristics
A total of 13 158 patients younger than age 80, treated with thrombolysis (n=9212) or primary PCI (n=3946), were admitted with their first recorded AMI between January 2001 and November 2004 (Figure 1). All PHT patients (n=2095) and 4081 patients with in-hospital thrombolysis had information on ambulance transportation and were transported with ambulance. Of these, 1690 PHT and 3685 in-hospital-treated patients had complete data on time from symptom onset to thrombolysis and thus met the inclusion criteria (see Methods) in the present study. The corresponding numbers of patients with 1-year follow-up were 1294 and 3162, respectively.
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There were large variations in the proportion of pre-hospital-treated patients at different hospitals (median 22.6%, 10th–90th percentile, 1.5–51.6%), reflecting different treatment traditions (Figure 2). In addition, a decrease in the use of in-hospital thrombolysis [2001 (n=1249) and 2004 (n=523)] was observed during the registration period because of a marked increase in primary PCI, whereas the rate of PHT remained stable [2001 (n=391) and 2004 (n=396)].
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The PHT patients when compared with the in-hospital-treated patients were generally at lower baseline risk. Thus, they were younger, less often female, less likely to have comorbid conditions, and had lesser medications indicative of coronary heart disease and heart failure (Table 1). The baseline characteristics of the PHT population were similar during the study period.
Time delays
The median time from symptom onset to treatment was 113 min in the PHT group and 165 min in the in-hospital group (Table 2), corresponding to 53 and 33% of the patients in each group being treated within 2 h, respectively. Thus, PHT reduced the median time to thrombolysis by 52 min and was similar for each year during the registration period. For patients treated within 6 h from symptom onset, the median symptom duration was 103 and 141 min, respectively.
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In an analysis restricted to patients with information on time of ambulance arrival on scene, there was no statistical difference between the two regimens in time from symptom onset to ambulance arrival (Table 2).
Treatments, complications, and procedures
There were fewer complications at the CCU indicative of CHF in PHT than in-hospital-treated patients, whereas there was no statistical difference in cerebral bleedings. Multiple logistic regression analyses revealed PHT to be strongly associated with lower odds of development of heart failure (pulmonary rales and/or intravenous diuretics and/or continuous positive airway pressure therapy) at the CCU [odds ratio (OR) 0.69, 0.59–0.80, P<0.001] and cardiogenic shock on CCU admission (OR 0.61, 0.48–0.76, P<0.001), after adjusting for baseline characteristics.
Information on left ventricular ejection fraction (LVEF) was available in 58 and 50% of the PHT and in-hospital-treated survivors. When compared with in-hospital-treated group, LVEF was higher in the PHT group (Table 3). Also, when evaluated in patients without previous MI and CHF, LVEF showed a similar distribution according to the treatment groups.
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Early invasive procedures were more frequently performed in PHT patients and to the same extent when investigated in the quartile of hospitals that had the highest proportion (>40%) of PHT-treated patients. The use of guideline-recommended medications at discharge was somewhat more common in the PHT group.
Outcome
At 30 days, the crude mortality in the whole study population and at 1 year was 5.4 vs. 8.3% (P<0.001) and 7.2 vs. 11.8% (P<0.001) (OR 0.57, 0.46–0.73) in PHT and in-hospital-treated patients, respectively (Table 4). When stratified according to time to treatment, a stepwise increase in 1-year mortality was observed in in-hospital-treated and partly in PHT (not the first 2 h) patients (Figure 3).
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There was also a gradual increase in 1-year mortality according to decreasing LVEF in hospital survivors without previous MI and CHF (1.7, 2.2, 7.7, and 16.3%).
In a multivariable analysis adjusting for the propensity score, CPR before admission, and rescue angioplasty (model 1), PHT compared with in-hospital treatment was associated with lower 1-year mortality (OR 0.71, 0.55–0.92, P=0.008) (Table 4) and tended to be with 30-day mortality (OR 0.79, 0.61–1.03, P=0.08). This lower adjusted 1-year mortality was still present when the analysis was restricted to patients without streptokinase therapy treated within 6 h of symptom onset (OR 0.73, 0.54–0.98, P=0.04). In addition, when evaluating patients who survived the first 14 days and adjustment for revascularization within 14 days was done (model 2), PHT was associated with a lower adjusted 1-year mortality (OR 0.64, 0.42–0.96, P=0.03).
In the individual propensity score quartiles, the adjusted ORs for 1-year mortality was between 0.53 and 0.89 (Table 4).
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Discussion |
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This study evaluates the use of pre-hospital and in-hospital thrombolyses in real-life patients during the last 4 years from a nationwide perspective. For the first time, we could demonstrate that PHT delivered by paramedics vs. regular in-hospital thrombolysis among ambulance-transported real-life patients was associated with a 52 min reduction in time to treatment and a significantly lower adjusted long-term mortality.
Time delays
The observed reduced time of 52 min from symptom onset to therapy was in the same range, 0.5–1 h, as in the randomized trials.4,13,14 This was achieved in a system with only paramedics in the ambulances, but no physicians. Thus, a system with paramedics, who transmit a pre-hospital ECG using telemedicine to a physician in the hospital for decision-making and then administrating thrombolysis, seems as efficient in reducing treatment delay as a system with physician-staffed ambulances.14 Moreover, in the recently performed ASSENT-3 PLUS trial, the median time to thrombolysis was even longer in study sites with physician- vs. paramedic-staffed ambulances (120 vs. 108 min).15 Although the randomization procedure might have delayed the treatment by 
10 min when compared with a real-life situation, the result from the present study (median symptom duration of 103 min for PHT patients treated within 6 h) indicates also an even shorter time to treatment compared with a physician-based pre-hospital process of care. One reason for a longer treatment delay with a pre-hospital physician might be the limited numbers of ambulances staffed with physicians, as indicated by a longer time from patient call to a physician-staffed ambulance arrival on scene in the ASSENT-3 PLUS trial.15
This paramedic-based system of pre-hospital diagnosis and PHT also appeared to be safe with no statistical difference in the rate of cerebral bleedings when compared with in-hospital thrombolysis.
An in-hospital delay of 40 min in the present study represented 75% of the total time saved by PHT vs. in-hospital treatment, consistent with the GREAT study in which 67% of the time saved corresponded to in-hospital delay.16 An in-hospital treatment delay of 40 min compares well with a recent large US registry.17 In contrast, shorter in-hospital delays have been reported in some randomized trials of PHT, probably because the conduct of the studies led to a marked shortening of time to thrombolysis in the hospital.13,14
Outcome
One problem in quantifying time-dependent mortality benefit of thrombolytic therapy has been that patients with large infarcts and a worse prognosis tend to seek help earlier,16,18 thus confounding mortality analyses of non-randomized comparisons between pre-hospital and in-hospital thrombolyses.18 Our data appeared to be partly consistent with these previous findings, as there was a higher mortality among PHT patients who were treated during the first hour compared with the second hour from symptom onset. In contrast, there was a stepwise increase in mortality according to the longer symptom duration among in-hospital-treated and PHT patients who were treated after the first hour. In addition, it did not appear to be a selection bias with more early presenting patients who were treated with PHT, at least not in the subgroup with information on time from symptom onset to ambulance arrival (Table 2). Finally, the lower rates of complications at the CCU indicating severe heart failure in PHT-treated patients compared with in-hospital-treated patients as in a previous registry,7 but in contrast to another,18 seem also to some extent to contradict these previous observations. The fact that there were lower rates of complications at the CCU among PHT patients in our study might be explained by two factors. First, it may partly reflect a selection bias with a reluctance to treat critically ill patients with thrombolytics in the ambulance. This is supported by younger patients with a lower prevalence of comorbidity in the PHT group, indicating a selection bias at presentation. Secondly, the earlier administration of reperfusion treatment may prevent the development of severe heart failure, as in the randomized CAPTIM study.5 This is supported by a higher EF in the PHT group in patients without previous MI and CHF, indicating a larger amount of myocardial salvage. Also, this accords with the strong independent reverse association between PHT and admission cardiogenic shock and heart failure at the CCU after adjustments for baseline characteristics.
The observed adjusted mortality benefit of PHT was statistically significant at 1 year, but not at 30 days. This finding indicates an increasing benefit of PHT when compared with in-hospital thrombolysis during 1 year of follow-up in accordance with the GREAT study.16 One plausible explanation for this could be a higher extent of myocardial salvage, shown to be highly dependent on time from symptom onset to thrombolysis.19 Accordingly, a higher LVEF was observed in the PHT group.
After adjustments for baseline risk factors and rescue angioplasty, PHT was independently associated with a lower mortality at 1 year, with an OR that compared reasonably well with a previous meta-analysis of randomized PHT trials that evaluated in-hospital mortality,4 in which the corresponding reduction in treatment delay was similar to our study. The fact that the OR in the present study was slightly lower might be explained by the longer follow-up period of 1 year. In addition, when adjusting for other potential confounders such as revascularization within 14 days and when excluding patients treated with streptokinase and with symptom duration more than 6 h, PHT was independently associated with a reduced mortality.
Implications
The encouraging observations concerning PHT in this registry together with previous findings that early PHT (within 2–3 h) compared favourably with primary PCI6,7 underline the need to expand the pre-hospital-treated population in real-life. For example, more than 800 patients had a pre-hospital ECG, but were nevertheless treated with thrombolysis in the hospital. Furthermore, patients admitted at on-call time had a lower probability to receive PHT, indicating that less-experienced physicians on call might be less likely to decide to start thrombolysis in the ambulance. Patients with higher risk characteristics at baseline were also less likely to be treated pre-hospitally, consistent with findings from a previous registry.7 One reason for this could be that the physician on call might hesitate to initiate treatment of older patients in the ambulance, given the increased risk of cerebral bleedings. Finally, it is also an important issue to obtain a higher proportion of patients with chest pain and suspected AMI to alert emergency services for subsequent ambulance transportation, which is mandatory for pre-hospital diagnosis and treatment. In our study, about 60% of the in-hospital-treated used an ambulance, whereas in a US registry, only about 50% of the AMI patients did so.20
Limitations
A major limitation of the present study is the non-randomized assignment of treatment strategy and the possibility that unknown differences in baseline characteristics contributed to the results. To address this concern, we used statistical methods to reduce the problems of bias inbuilt in observational studies.12 Nevertheless, heart rate, systolic blood pressure, and Killip class at presentation, which are strongly associated with mortality in STEMI,21 could not be used for mortality adjustment, as the first two of these variables are not recorded in the registry and the Killip class is registered at the CCU, after treatment with PHT and before treatment with in-hospital thrombolysis. On the contrary, the present study has the strength that it reflects the results achieved in the real world, including patients from more than 90% of the hospitals within Sweden, outside the constraining limits of a randomized trial. Another limitation is that 405 of 2095 (19.3%) with PHT and 396 of 4081 (9.7%) with in-hospital thrombolysis of the eligible patients had missing data regarding time to treatment and were excluded. However, patients with missing data had at large similar baseline characteristics as the included patients in relation with treatment modality, whereas 30-day (as well as 1 year) mortality was higher (6.2% PHT and 14.1% in-hospital), especially among the excluded in-hospital-treated patients. Thus, the mortality benefit associated with PHT was infact even larger when these patients were included as well. For all other variables except ambulance transportation and LVEF (probably related to running in problems), there were few missing values, at most 3%.
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Conclusions |
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This nationwide registry of real-life patients shows that pre-hospital diagnosis and treatment are associated with reduced time to thrombolysis by almost 1 h and reduced adjusted long-term mortality by 30%. Importantly, pre-hospital diagnosis established by a physician at the hospital using telemedicine and subsequent PHT delivered by paramedics in the ambulances seem as efficient in reducing time delays as physician-staffed ambulances. Further efforts are needed to expand the pre-hospital-treated population in real-life.
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Acknowledgement |
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This study was supported by grants from the Swedish Heart and Lung Foundation.
Conflict of interest: none declared.
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References |
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