Extensive investigations of treatment strategies for patients with STEMIs have led to many improvements in care.
Yet optimal treatment strategies for patients aged ≥75 years with STEMIs are much less clear, and many knowledge gaps remain.
Age ≥75 years is an independent predictor of 30-day mortality in STEMI.
Although this higher mortality risk generally would dictate more aggressive treatments, recent data have shown, for example, that <1/2 of patients aged ≥80 years with STEMIs are treated with any reperfusion therapies at all.
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Pre hospital reduced-dose fibrinolysis followed by pci
1. University of Texas Health Science Center and
Memorial Hermann
Heart and Vascular Institute, Houston, Texas.
Am J Cardiol 2014;113:60e63
2. Introduction
• Extensive investigations of treatment strategies for patients
with STEMIs have led to many improvements in care.
• Yet optimal treatment strategies for patients aged ≥75
years with STEMIs are much less clear, and many
knowledge gaps remain.
• Age ≥75 years is an independent predictor of 30-day
mortality in STEMI.
• Although this higher mortality risk generally would dictate
more aggressive treatments, recent data have shown, for
example, that <1/2 of patients aged ≥80 years with STEMIs
are treated with any reperfusion therapies at all.
3. • Field evaluation for STEMI using 12-lead
electrocardiograms obtained on the scene by
EMS personnel and transmitted for overread
by emergency center physicians.
• Eligible patients with STEMIs receive pre
hospital, reduced-dose fibrinolytic agents
along with aspirin, clopidogrel, and heparin
and are transported to our STEMI center for
urgent percutaneous coronary intervention
(PCI). This is termed the FAST-PCI strategy.
4. • Patients with STEMIs evaluated by EMS units
not equipped with fibrinolytic kits, and those
who are not eligible for fibrinolysis, receive
aspirin, clopidogrel, and heparin followed by
transport for urgent PCI (the primary PCI
[PPCI] strategy.
• The purpose of this retrospective study was to
examine differences in outcomes for patients
aged ≥75 years treated in this coordinated
STEMI system of care according to FAST-PCI or
PPCI strategy.
5. Methods
• The prehospital evaluation and treatment protocol
• Field evaluation of STEMI using 12-lead electrocardiograms
obtained and transmitted by EMS personnel, with overread by
emergency department physicians.
• Eligible patients with STEMIs are given reduced dose reteplase (10
U intravenously), aspirin (325 mg orally), clopidogrel (600 mg
orally), and heparin (60 U/kg, up to 4,000 U intravenously).
• Patients with STEMIs who are not eligible for fibrinolysis receive
aspirin, clopidogrel, and heparin at the same dosages.
• Glycoprotein IIb/IIIa inhibitors are used according to local practices
or at the discretion of the treating physician.
6. • From March 2006 to February 2013- 1,303 patients
with STEMIs
• Of these, 214 (16.4%) were ≥75 years of age and
formed the basis of this study.
• In the subset of 214 patients aged ≥75 years, the FAST-
PCI strategy was used in 120 (56%) and PPCI in 94
(44%).
• Analyzed demographics, clinical features, laboratory
data, angiographic data, and outcomes of the 2
strategies.
7. • The primary end point comparison was 30-day mortality.
• Secondary end points included stroke, reinfarction, and
major bleeding.
• A composite end point of mortality, stroke, reinfarction, or
major bleeding was also analyzed.
• Ischemic time was defined as the time from pain onset to
first device activation (first balloon inflation or thrombus
aspiration).
• Stroke was defined as the development of new neurologic
deficit not present on initial screening examination,
neurologist diagnosis of stroke, or new intracranial bleeding
diagnosed by CT or MRI.
8. • Reinfarction was defined as new significant Q waves in 2 contiguous
leads different from the initial STEMI, reelevation of creatine
kinase-MB to normal or higher (or by another 50%, if already
normal or higher), and reelevation of creatine kinase-MB to >3 or
>5 times the upper limit of normal after angioplasty or surgery,
respectively.
• Major bleeding was defined as bleeding resulting in hemodynamic
instability requiring intervention and assessed using Global
Utilization of Streptokinase and Tissue Plasminogen Activator for
Occluded Coronary Arteries (GUSTO) trial criteria.
• Patients were followed up for events after hospital discharge by
telephone call, outpatient visit, or both at 30 days after the index
STEMI.
11. Discussion
• Our main finding is that FAST-PCI decreased 30-day mortality compared with PPCI
in patients aged ≥75 years with STEMIs treated within a coordinated STEMI system
of care.
• There were no apparent bleeding, stroke, or reinfarction penalties.
• These results are similar to what we found previously for in-hospital outcomes in
the overall STEMI population including all ages.
• The combination of prehospital reduced-dose fibrinolysis followed by urgent PCI
offers potential benefits of smaller infarct size and lower mortality compared with
PPCI alone.
• The likely mechanism is shortened time to initial treatment and thus earlier infarct
artery patency, ultimately reducing ischemic times.
• Because ischemic time is a better measure of infarct size and mortality,
minimization of this ischemic time is the supreme goal of coordinated STEMI
systems of care
12. • The population ≥75 years in age has not been studied as extensively
as others with acute coronary syndromes.
• Fibrinolytic agents are administered only cautiously because
intracranial hemorrhage and nonhemorrhagic strokes are possible
complications of treatment, especially in those with certain risk
factors such as uncontrolled hypertension, low body weight, and
female gender.
• This concern has led to the belief that PPCI may offer advantages
over full-dose intravenous fibrinolysis in elderly patients.
• Unfortunately, the 2 largest trials testing this hypothesis, the
Primary Angioplasty Versus Thrombolytic Therapy for Acute
Myocardial Infarction in the Elderly (Senior PAMI) trial (481
patients) and the Tratamiento del Infarto Agudo de Miocardio en
Ancianos (TRIANA) trial (266 patients) were terminated early
because of slow enrollment.
13. • Although neither trial demonstrated superiority of PPCI
over full-dose intravenous fibrinolysis with the enrollment
numbers obtained, numerically, the results seemed to favor
PPCI.
• A pooled analysis of available randomized patients aged
>75 years with STEMIs (n ¼ 834) included within the
TRIANA report indicated only a nonsignificant reduction in
mortality for PPCI over full-dose intravenous fibrinolysis
(10.7% vs 13.8%, odds ratio 0.74, 95% confidence interval,
0.49 to 1.13, p ¼ 0.16).
• However, this pooled analysis did suggest a benefit of PPCI
over full-dose fibrinolysis for the larger composite end
point of mortality, reinfarction, and disabling stroke (14.9%
vs 21.5%, odds ratio 0.64, 95% confidence interval 0.45 to
0.91, p ¼ 0.013).
14. • More recently, the Strategic Reperfusion Early After Myocardial Infarction
(STREAM) study, which included 255 patients aged ≥75 years from a total
of 1,892 patients, initially compared prehospital full-dose fibrinolysis with
PPCI in patients with STEMIs.
• At an interim safety analysis, intracranial hemorrhage rates were noted to
be higher in the full-dose fibrinolysis group (1.0% vs 0.2%, p ¼ 0.04).
• A protocol change was then adopted to use only half-dose fibrinolysis in
patients aged ≥75 years, and after that, the intracranial hemorrhage rates
were equivalent (0.5% vs 0.3%, p ¼ 0.45).
• There were no cases of intracranial hemorrhage in patients aged ≥75 years
(0 of 97 patients) after the protocol change, compared with 3 cases of
intracranial hemorrhage in 37 patients in this age group before the
change.
• The primary composite end point of death, shock, congestive heart failure,
or reinfarction at 30 days was equivalent in the 2 groups (all ages), 12.4%
for prehospital fibrinolysis and 14.3% for PPCI (p ¼ 0.21).
15. • The total ischemic time was shorter in the prehospital fibrinolysis group
compared with the PPCI group (median 100 vs 178 minutes, p <0.001).
• However, in STREAM, this ischemic time was measured from the onset of
symptoms until the initiation of therapy.
• For the prehospital fibrinolysis group it was administration of the agent
that was used as the initiation measure, and first device activation was
used for the PPCI group.
• In our study, we used time from symptom onset to first device activation
as the ischemic time measure in the 2 groups so as to have consistent
comparisons.
• The frequency of completely occluded arteries at angiography before PCI
in STREAM was lower for prehospital fibrinolysis compared with PPCI
(16.0% vs 59.5%, p <0.001).
• We noted comparable differences, and this again suggests that 1
mechanism of benefit to prehospital reduced-dose fibrinolysis is earlier
patency of the infarct artery.
16. limitations
• Patients were not assigned randomly to treatment strategy but
rather were assigned on the basis of eligibility, EMS vehicle status
(equipped or not), and sequential timing (because of the nature of
fibrinolytic supply interruption). This might have led to selection
bias.
• Only simple comparative analyses were performed, because the
group sizes were too small to permit more sophisticated
comparisons.
• Nevertheless, the same operators and the same system were at
work for the 2 groups, reducing the impact of such differences.
• Adverse event rates were low in the 2 groups examined, although
numerically, there were more strokes and more major bleeding
events in the FAST-PCI than in the PPCI group.
17. • With larger sample sizes, these differences may or may
not have become significant.
• It is also unknown but likely that aggressive adherence
to bleeding avoidance strategies, including the use of a
radial artery approach, would have reduced the
frequency of bleeding events in the 2 groups, thus
making it even more difficult to compare small values.
• In general, enrolling large numbers of patients aged
≥75 years with STEMIs in randomized controlled trials
is difficult because of the presence of many high-risk
features.
• Registry analyses and meta-analyses of smaller studies
may be the only way to obtain data on this population.
18. Conclusion
• For patients aged ≥75 years with STEMIs, a FAST-
PCI strategy in a coordinated system of care was
associated with reduced 30-day mortality, earlier
infarct artery patency, and lower incidence of
cardiogenic shock at arrival compared with PPCI,
without apparent bleeding, stroke, or reinfarction
penalties.
• Larger studies and clinical trials if possible are
needed to further investigate this approach.
Editor's Notes
In late 2009, the manufacturer suspended delivery of reteplase, causing our institution to interrupt the FAST-PCI strategy and continue from that point with a completely PPCI protocol for all patients with STEMIs.
Patients with STEMIs are still identified in the field, either at the scene or in local referral hospitals.
Adjunctive agents including aspirin, clopidogrel, and heparin are still administered and patient transport is initiated, all in a similar manner as when the FAST-PCI and PPCI protocols were in place.
Urgent PCI upon hospital arrival also is performed in a similar manner and by the same operators as before.
FAST-PCI patients had a 30-day mortality rate approximately 1/4 that of PPCI patients (4.2% vs 18.1%, p <0.01).
Secondary end points (stroke, reinfarction, and major bleeding) individually were not significantly different between the 2 groups.
The composite end point of mortality, stroke, reinfarction, or major bleeding was lower in the FAST-PCI than in the PPCI cohort (11.7% vs 22.3%, p ¼ 0.04).
Most of the outcome events in the PPCI cohort were deaths, whereas in the FAST-PCI cohort, events were equally distributed among deaths, strokes, and major bleeding.