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## Complete Summary

#### GUIDELINE TITLE

Thrombolytic therapy and balloon angioplasty in acute ST elevation
myocardial infarction (STEMI).

#### BIBLIOGRAPHIC SOURCE(S)

Finnish Medical Society Duodecim. Thrombolytic therapy and balloon
angioplasty in acute ST elevation myocardial infarction (STEMI). In: EBM
Guidelines. Evidence-Based Medicine \[Internet\]. Helsinki, Finland:
Wiley Interscience. John Wiley & Sons; 2006 Apr 28 \[various\].

#### GUIDELINE STATUS

**Note**: This guideline has been updated. The National Guideline
Clearinghouse (NGC) is working to update this summary.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [February 28, 2008, Heparin Sodium
    Injection](http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2):
    The U.S. Food and Drug Administration (FDA) informed the public that
    Baxter Healthcare Corporation has voluntarily recalled all of their
    multi-dose and single-use vials of heparin sodium for injection and
    their heparin lock flush solutions. Alternate heparin manufacturers
    are expected to be able to increase heparin production sufficiently
    to supply the U.S. market. There have been reports of serious
    adverse events including allergic or hypersensitivity-type
    reactions, with symptoms of oral swelling, nausea, vomiting,
    sweating, shortness of breath, and cases of severe hypotension.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Acute ST elevation myocardial infarction (STEMI)

#### GUIDELINE CATEGORY

Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Cardiology\
Emergency Medicine\
Internal Medicine

#### INTENDED USERS

Health Care Providers\
Physicians

#### GUIDELINE OBJECTIVE(S)

Evidence-Based Medicine Guidelines collect, summarize, and update the
core clinical knowledge essential in general practice. The guidelines
also describe the scientific evidence underlying the given
recommendations.

#### TARGET POPULATION

Patients with acute ST elevation myocardial infarction (STEMI)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Evaluation/Management/Treatment**

**Procedure Prior to Treatment**

1.  Evaluate appropriateness of administering thrombolytic therapy
    (clinical picture, pain, electrocardiogram \[ECG\] results, no
    contraindications)

2.  Continuous ECG monitoring

3.  Glyceryl trinitrate and oxygen

4.  Aspirin

5.  Intravenous cannulas with sodium chloride (NaCl) infusion

6.  Blood samples (haemoglobin, leucocytes, sodium, potassium,
    creatinine, creatinine kinase, or creatinine kinase-MB)

7.  Beta-blocker

8.  Nitrate infusion if indicated

**Thrombolytic Treatment**

1.  Thrombolysis with streptokinase or a tissue plasminogen activator
    (tPA) (tenecteplase, reteplase, or alteplase)

2.  Heparin with tPA thrombolysis

**Other Management/Treatments**

1.  Transfer to hospital

2.  Treatment of complications

3.  Assessment of coronary artery patency

4.  Percutaneous transluminal coronary angioplasty (PTCA)

#### MAJOR OUTCOMES CONSIDERED

-   Rates of acute ST-segment elevation myocardial infarction

-   Treatment outcomes

    -   Coronary artery patency

    -   Re-occlusion rates

    -   30-day prognosis

    -   Mortality rates

    -   Complication rates

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The evidence reviewed was collected from the Cochrane database of
systematic reviews and the Database of Abstracts of Reviews of
Effectiveness (DARE). In addition, the Cochrane Library and medical
journals were searched specifically for original publications.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

A.  Strong research-based evidence. Multiple relevant, high-quality
    scientific studies with homogenic results.

B.  Moderate research-based evidence. At least one relevant,
    high-quality study or multiple adequate studies.

C.  Limited research-based evidence. At least one adequate scientific
    study.

D.  No research-based evidence. Expert panel evaluation of other
    information.

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Note**: This guideline has been updated. The National Guideline
Clearinghouse (NGC) is working to update this summary. The
recommendations that follow are based on the previous version of the
guideline.

The levels of evidence \[A-D\] supporting the recommendations are
defined at the end of the \"Major Recommendations\" field.

**Basic Rules**

-   The earlier the thrombolytic therapy is started, the better the
    chances of achieving reperfusion. Time is more crucial than the
    agent used. \"One hundred minutes from the onset of pain\" (Boersma
    et al., 1996) \[**A**\].

-   All patients fulfilling the criteria should be offered treatment.
    Delays must be prevented at all treatment phases. Treating an
    imminent major acute myocardial infarction (MI) with thrombolytic
    therapy is as urgent as the treatment of multiple trauma!

-   Pharmacological reperfusion therapy consists of the administration
    of a fibrinolytic and antithrombotic agent.

-   If pharmacological reperfusion therapy is contraindicated, or has
    failed, an attempt should be made to recanalize the artery with
    balloon angioplasty

-   Electrocardiogram (ECG) recordings of acute ischaemic chest pain
    must be repeated if the first one is non-diagnostic.

**Indications**

-   All the criteria 1 to 4 must be met.

    1.  Clinical picture of imminent MI (note that the main symptom
        instead of pain is sometimes dyspnoea and acute left ventricular
        failure).

    2.  Pain lasting more than 20 minutes but less than 6 hours.
        Treatment might be indicated even if the symptoms have lasted
        for longer, especially if the pain and ST segment elevation
        persist. Treatment outcome worsens sharply when treatment delay
        exceeds four hours, and thrombolytic treatment administered 12
        hours after the onset of pain is rarely of any benefit.

    3.  ECG shows new signs of imminent myocardial damage:

        -   [\>]{.underline}2 mm ST segment elevation at the J point in
            at least two chest leads or

        -   [\>]{.underline}1 mm ST segment elevation in at least two
            limb leads or

        -   New left bundle branch block (that prevents the evaluation
            of ECG) or

        -   Reciprocal ST segment depression (V1-V3,4) due to posterior
            wall damage

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    ```
    4.  No contraindications

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```
-   If previous ECGs are available, check that the changes are new. Most
    interpretation errors occur with early repolarisation (ST segment
    elevations in chest leads V1-V4) and myocarditis (See Finnish
    Medical Society Duodecim guideline \"Myocarditis.\").

-   A small Q wave does not prevent thrombolysis, although it indicates
    that myocardial damage has already occurred.

-   Thrombolytic therapy is particularly important for patients with
    high ST segment elevations in chest leads and no deep Q waves. If
    recanalization is not achieved with pharmacological reperfusion
    therapy, these patients warrant rescue angioplasty.

**Possible Indications**

-   There is no consensus on whether a true posterior wall infarction
    manifesting with reciprocal ST segment depression (V1-V3, 4) should
    be treated with thrombolysis, because anterior ischaemia may cause
    similar changes. If the clinical picture is suggestive of an acute
    MI, thrombolysis may be considered. It is acceptable not to attempt
    reperfusion in a small inferior MI, particularly if the patient is
    at risk of bleeding. This should be considered especially in cases
    where the ST segment changes reverse quickly after the
    administration of nitrates, aspirin, and beta-blockers. A posterior
    infarction is often associated with a more extensive
    inferior-posterior infarction with accompanying inferior ST segment
    elevation (II, III, aVF) and/or ST segment elevation in V4R
    suggestive of right ventricular involvement. If a posterior
    infarction is associated with a lateral infarction, ST segment
    elevation will be seen in the lateral leads (aVL, I, V6).

-   If the ECG is distorted by a bundle branch block or paced rhythm,
    the need for thrombolysis must be based on the clinical picture.

-   Thrombolysis is of no benefit in a non-Q wave infarction (ST
    depression + increased serum markers) or in unstable angina, where
    the pain is caused by a partially occluded artery blocked by a
    platelet-rich clot originating from a plaque rupture. Medication to
    inhibit platelet aggregation is recommended for these patients
    (aspirin, clopidogrel, glycoprotein \[GP\] IIb/IIIa inhibitors) (See
    the Finnish Medical Society Duodecim guideline \"Unstable Angina
    Pectoris.\").

-   T-wave inversion, in a patient with a diseased left anterior
    descending artery (LAD), is usually indicative of a recanalized
    coronary artery. Due to the risk of reocclusion, angiography should
    be carried out during the same admission.

**Contraindications**

-   If fibrinolytic therapy is contraindicated or has failed (Van de
    Werf et al., 2003), the patient must be referred urgently to a
    hospital where the occluded artery can be opened with angioplasty.

**Absolute Contraindications**

-   Strong suspicion of dissection of the aorta

-   Pericardial effusion

-   Active gastrointestinal or other internal bleeding

-   Brain tumour, arteriovenous malformation, or aneurysm

-   Ischaemic stroke in preceding 6 months (a verified transient
    ischemic attack \[TIA\] is an exception)

-   Previous intracerebral haemorrhage or subarachnoid haemorrhage

-   Intracranial procedure or recent head trauma

-   Severe known bleeding disorder: coagulation abnormality,
    thrombocytopenia, etc.

**Relative Contraindications**

-   Fibrinolytic treatment should be considered even if the patient has
    relative contraindications if the onset of pain is within three
    hours, a large (anterior) infarction is imminent, and no deep
    Q-waves have developed yet. The relative contraindications are:

    -   Recent intestinal bleeding, for example an ulcer

    -   Recent surgery or significant trauma within preceding 2 to 4
        weeks

        -   At least 4 weeks safety period after, e.g., brain or eye
            surgery

    -   Hypertension (i.e. systolic over 180 to 200, diastolic over 100
        to 110 mmHg)

    -   Other life-threatening illness, for example, hepatic cirrhosis,
        renal insufficiency, etc.

    -   Anticoagulant therapy increases the risk of intracerebral
        haemorrhage. If the patient is at risk of bleeding, vitamin K
        should be administered.

        -   Patients on anticoagulant therapy require extra vigilance
            when possible fibrinolytic therapy is considered (balloon
            angioplasty is the primary choice). Administration of
            vitamin K is too late when a massive bleeding has already
            occurred.

-   Other factors increasing the risk of bleeding should also be taken
    into account (e.g., anaemia, thrombocytopenia, known haemophilia
    \[also von Willebrand\], advanced age, septic illness, cancer).

**Procedures Before Treatment**

1.  Continuous ECG monitoring, readiness to defibrillate

2.  Administer glyceryl trinitrate---two sublingual tablets or two doses
    of a spray---and oxygen: observe ST segment changes. (If the changes
    are reversible, reconsider the need for the thrombolytic treatment.)

3.  Aspirin 250 milligrams orally (not if the patient is on warfarin or
    allergic to aspirin)

4.  Insert two intravenous (i.v.) cannulas and start an infusion of NaCl
    (0.45% or 0.9%).

5.  Take the following blood samples (preferably from the i.v. cannula
    before connecting the infusion): haemoglobin, leucocytes, sodium
    (Na), potassium (K), creatinine, creatinine kinase (CK), CK-MB or
    other serum marker of myocardial necrosis. (Do not wait for the
    results.)

6.  Beta-blocker (atenolol, metoprolol) may be given 5 mg i.v. over 5
    minutes; repeat after 10 minutes if heart rate is over 50-60
    beats/minute and there are no other contraindications (severe heart
    failure, asthma).

7.  If blood pressure is high (\>160/100), it should be reduced with a
    nitrate infusion.

**Carrying Out Thrombolytic Treatment**

-   Thrombolysis is usually carried out using tissue plasminogen
    activator (tPA) (tenecteplase, reteplase, or alteplase), but
    streptokinase may also be used (not recommended for elderly
    patients). The price difference is considerable but the effect on
    mortality is small. Streptokinase therapy is more difficult to carry
    out as it requires vigorous monitoring of blood pressure and
    continuous infusion. Heparin is not used together with
    streptokinase, but with tPA it is mandatory.

-   Every effort must be made to minimize treatment delays whilst taking
    the contraindications into consideration.

**Special Indications for Streptokinase Administration**

-   Increased risk of intracerebral haemorrhage (age over 75 years, high
    blood pressure, previous cerebral infarction) and

-   A small infarction

**Special Indications for tPA Administration**

-   Streptokinase allergy

-   Previous streptokinase treatment (5 days to 2 years)

-   Hypotension

-   Large anterior wall damage (Granger et al., 1994; Barbagelata et
    al., 1997) \[**A**\]

-   New thrombus after streptokinase therapy (in 10 to 15% of patients,
    usually within a few hours to days after thrombolysis)

**Reteplase Regimen**

-   Give two bolus injections (10 + 10 U) of reteplase (Rapilysin®) at a
    30-minute interval.

-   Heparinization (DARE-988072, 1999; Antman et al., 2002) \[**B**\]
    (e.g., enoxaparin \[Klexane®\] 30 mg bolus intravenously at the
    beginning of thrombolysis, 1 mg/kg subcutaneously at the end of
    thrombolysis, and 1 mg/kg twice a day \[b.d.\] subcutaneously during
    the next 3 days). For a patient over 75 years of age, no intravenous
    bolus is given and the dose of subcutaneous enoxaparin is 0.75 mg/kg
    b.d. Any warfarin treatment should be discontinued.

**Tenecteplase Regimen**

-   Give tenecteplase (Metalyse®) according to body weight (Table below;
    maximum dose is 10,000 units = 50 mg)

-   Give as a single bolus over 10 seconds.

-   Heparinization as described above

  -----------------------------------------------------------------------------
  **Table.                                           
  Administration                                     
  of                                                 
  Tenecteplase**                                     
  ---------------- ---------------- ---------------- --------------------------
  **Patient\'s     **Tenecteplase   **Tenecteplase   **Amount of reconstituted
  weight (kg)**    (U)**            (mg)**           solution (mL)**

  \<60             6,000            30               6

  60-69            7,000            35               7

  70-79            8,000            40               8

  80-89            9,000            45               9

  90-              10,000           50               10
  -----------------------------------------------------------------------------

**Alteplase Regimen**

1.  Dilute the two 50 mg bottles of alteplase (Actilyse®).

2.  Using a syringe, give 15 mL (15 mg) by intravenous injection over 1
    to 2 minutes.

3.  This is followed by intravenous infusion of:

    -   0.75 mg/kg over the next 30 minutes (maximum 50 mg = 50 mL) and
        then

    -   0.5 mg/kg over the next 60 minutes (maximum 35 mg) (Granger et
        al., 1994; Barbagelata et al., 1997) \[**A**\]

    -   The total duration of the treatment is 90 minutes. An infusion
        pump must be used for the administration.

    -   Heparinization (DARE-988072, 1999; Antman et al., 2002)
        \[**B**\] as described above for reteplase treatment.

**Streptokinase Regimen**

1.  Rapid infusion of 200 to 300 mL of 0.9% NaCl if the patient is
    hypotensive. Give prophylactically, unless the patient has pulmonary
    oedema.

2.  Streptokinase (Streptase®) 1.5 million U over 30 to 60 minutes as a
    continuous infusion. Initially without adjunct heparin; heparin may
    be introduced 6 to 12 hours later. If the patient has previously
    received streptokinase, tPA should be administered.

    -   Streptokinase 1.5 million units dry substance is dissolved first
        into 5 mL 0.9% NaCl, or into another suitable diluent, and then
        further into 100 mL of 0.9% NaCl.

-   Streptokinase infusion often causes hypotension. Should hypotension
    occur, elevate the patient\'s legs and discontinue any nitrate
    infusions. If hypotension persists, slow down or discontinue the
    streptokinase infusion. If necessary, infuse 0.9% NaCl or, in very
    severe hypotension, dopamine.

-   Reperfusion, like acute infarction itself, is often accompanied by
    arrhythmias (ventricular ectopic beats, idioventricular rhythm).
    Isolated ventricular ectopic beats or short runs of ventricular
    tachyarrhythmias can be observed only. Lidocaine or electric
    cardioversion (30-100 J) is indicated in long-lasting ventricular
    tachyarrhythmias and when haemodynamic complications become
    apparent.

**Transfer to Hospital**

-   If the patient\'s haemodynamic status is stable, he/she can be
    transported to a hospital during the administration of the
    thrombolytic therapy. A competent paramedic crew is sufficient if
    the patient\'s condition is stable; otherwise a doctor should
    accompany the patient.

-   The patient should be monitored continuously and a defibrillator
    must be ready for use. Adrenaline (epinephrine), atropine, and
    lidocaine (for a bolus and infusion) must be readily available.

-   A patient with an MI can be treated on a general ward, with adequate
    facilities, if invasive treatment is not an option

**Prediction, Prevention, Monitoring, and Treatment Guidelines of
Bleeding Complications**

-   Intracranial haemorrhage is a rare (1 to 2%) but the most serious
    complication of thrombolytic therapy. The risk increases if the
    contraindications are not observed. The incidence of intestinal and
    other haemorrhage is higher (5 to 10%) than that of intracranial
    haemorrhage, but they are treatable. Bleeding usually occurs 24
    hours after the administration of the fibrinolytic agent.

-   A bleed may be anticipated by monitoring the blood pressure,
    thrombocyte count, and haematocrit (e.g., every 6 hours during the
    first 24 hours after thrombolytic therapy). Vitamin K should be
    considered for patients who have previously received anticoagulants
    and are at risk of bleeding.

-   Signs of an intracranial haemorrhage include impaired level of
    consciousness or symptoms affecting one side only. A bleed is
    confirmed with a computed tomography (CT) scan. Treatment may
    include the involvement of a neurosurgeon in order to evacuate the
    haematoma. Internal bleeding will cause a decrease in blood pressure
    and haematocrit.

-   Treatment of bleeding complications consists of the administration
    of blood cells, fresh frozen plasma, and vitamin K.

    -   Vitamin K corrects clotting factors with a delay of 6 to 12
        hours.

    -   Frozen plasma will normalize international normalized ration
        (INR) quickly.

        -   Reversal of anticoagulation with frozen plasma requires
            large infusion volumes: reasonable only if there is a need
            for volume correction.

    -   Protamine has only a weak effect on low-molecular weight heparin
        and is not much used.

    -   Tranexamic acid will only prevent fibrinolysis, which usually
        has already taken place at this stage. Tranexamic acid is
        thrombogenic and often only harmful when used in connection with
        bleeding complications.

    -   The effect of aspirin on platelets will persist for 3 to 5 days.

**Assessment of Coronary Artery Patency**

-   Intravenous administration of a fibrinolytic agent opens an occluded
    vessel in 50 to 60% of cases. The outcome is dependent on timing
    related factors and the success rate might be as high as 80% if the
    time from onset of pain was \<2 hours

-   Chest pain improves.

-   ST segments normalize rapidly.

-   Reperfusion arrhythmias

-   Early but short lasting rise in serum markers (8 to 12 hours).

**Primary Percutaneous Transluminal Coronary Angioplasty (PTCA)**

-   Whenever possible primary angioplasty should always be considered
    instead of pharmacological reperfusion therapy (Grines et al., 2003;
    Keeley, Boura, & Grines, 2003) \[**A**\]; treatment outcome is
    better and the costs are lower (Keeley, Boura, & Grines, 2003).

    -   Primary angioplasty has been shown in several studies to be more
        effective than pharmacological reperfusion therapy in the
        treatment of STEMI (Grines et al., 2003; Keeley, Boura, &
        Grines, 2003) \[**A**\]. Adequate flow rates are achieved in as
        many as 90% of cases.

    -   The availability of angioplasty treatment and the provision of
        24-hour cardiologist cover remain problems in many countries.
        Primary angioplasty is currently often only considered for high
        risk patients.

    -   According to the Danish Multicentre Randomized Trial on
        Thrombolytic Therapy versus Acute Coronary Angioplasty in Acute
        Myocardial Infarction (DANAMI2) study, treatment outcome after
        angioplasty is superior to that achieved with thrombolysis
        provided that the angioplasty can be carried out within a 150 km
        radius. It is likely that the use of angioplasty, therefore, as
        a treatment for acute STEMI will increase as the facilities of
        treating centres improve.

-   Angioplasty is a superior treatment form if the time interval
    between the onset of pain and treatment is long.

-   Primary angioplasty may also be considered if pharmacological
    reperfusion therapy is for some reason contraindicated, or it has
    failed.

-   According to the current guidelines, primary angioplasty may be
    considered for high risk patients with:

    -   Extensive infarction + contraindication to thrombolysis

    -   Extensive anterior infarction

    -   Inferior infarction with significant right ventricular
        involvement

    -   Acute pump failure

    -   Cardiogenic shock

-   If the patency of the artery was not achieved with pharmacological
    reperfusion therapy, a \"rescue angioplasty\" may be considered. The
    results of angioplasty carried out after pharmacological reperfusion
    therapy are not as good as those of primary angioplasty, but with
    modern equipment the procedure does, however, improve the patient\'s
    prognosis.

-   Platelet glycoprotein IIb/IIIa receptor antagonists reduce the risk
    of death and myocardial infarctions as well as the need for urgent
    reintervention in association with percutaneous coronary angioplasty
    (Bosch & Marrugat, 2001; Vorchheimer, Badimon, & Fuster, 1999)
    \[**A**\].

-   After implantation of a stent, the antithrombotic agent to be used
    is aspirin, which should be combined with clopidogrel for 3 to 6
    months to prevent thrombosis and restenosis. With drug-eluting
    stents the combination therapy is continued up to 12 months. The
    epithelialization of drug-eluting stents is slow, and an
    uninterrupted aspirin-clopidogrel treatment is particularly
    important during the first few months after implantation (Iakovou et
    al., 2005)

    -   Combination therapy increases the risk of bleeding in patients
        with a history of cerebral infarction.

**Thrombolysis As First Aid**

-   The delay in treatment is shortened if the members of the emergency
    services start thrombolytic therapy. Motivated and trained personnel
    of an emergency service unit are able to interpret ECGs and make the
    diagnosis of an MI even better than an untrained doctor.

-   Legal implications must be considered if a non-medical person
    initiates a potentially dangerous treatment. Therefore, the aim
    should be for a consulting physician to make the decision on
    initiating thrombolysis. Telemetry ECG makes such consultation
    possible.

-   The hallmarks of the diagnosis are typical chest pain and ECG
    changes. Risk stratification should always be carefully carried out
    to avoid adverse treatment decisions. The current contraindications
    are not difficult to comply with.

-   An international recommendation has been issued for the
    administration of pre-hospital thrombolysis, which should be
    adjusted to local conditions. The American Heart Association (AHA)
    recommendation is available on the Internet
    ([www.americanheart.org](http://www.americanheart.org/presenter.jhtml?identifier=3032316)).
    Tenecteplase (single bolus) is the easiest to administer, while
    streptokinase is the most difficult.

**Related Evidence**

-   Low molecular weight heparins (LMWHs) and unfractionated heparin
    have similar efficacy in preventing death but LMWH caused fewer
    complications (Magee et al., 2003) \[**A**\].

-   Coronary artery bypass grafting improves the physical functioning
    and prognosis in patients with moderate to severe left ventricular
    dysfunction and concomitant, performance limiting coronary heart
    disease (Baker et. al., 1994) \[**C**\].

-   The medium and long-term outcomes after balloon angioplasty are
    favourable with a low mortality and myocardial infarction rate and a
    low rate of later restenosis (after 6 months) (de Feyter et
    al., 1994) \[**C**\].

-   Angioplasty may lead to greater reduction in angina than is achieved
    with medical treatment, but the patient cohorts are too small as yet
    to allow for estimating the effect of angioplasty on the incidence
    of infarctions, deaths, or revascularisation (Bucher et al., 2000)
    \[**C**\].

**Definitions**:

**Levels of Evidence**

A.  Strong research-based evidence. Multiple relevant, high-quality
    scientific studies with homogenic results.

B.  Moderate research-based evidence. At least one relevant,
    high-quality study or multiple adequate studies.

C.  Limited research-based evidence. At least one adequate scientific
    study.

D.  No research-based evidence. Expert panel evaluation of other
    information.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=9641)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

Concise summaries of scientific evidence attached to the individual
guidelines are the unique feature of the Evidence-Based Medicine
Guidelines. The evidence summaries allow the clinician to judge how
well-founded the treatment recommendations are. The type of supporting
evidence is identified and graded for select recommendations (see the
\"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate and timely treatment of acute ST elevation myocardial
infarction

#### POTENTIAL HARMS

-   Streptokinase infusion often causes hypotension.

-   Intracranial haemorrhage is a rare (1-2%) but the most serious
    complication of thrombolytic therapy. The risk increases if the
    contraindications are not observed. The incidence of intestinal and
    other haemorrhage is higher (5-10%) than that of intracranial
    haemorrhage, but they are treatable. Bleeding usually occurs 24
    hours after the administration of the fibrinolytic agent.

-   Combination therapy increases the risk of bleeding in patients with
    a history of cerebral infarction.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

**Contraindications to Thrombolytic Therapy**

**Absolute**

-   Strong suspicion of dissection of the aorta

-   Pericardial effusion

-   Active gastrointestinal or other internal bleeding

-   Brain tumour, arteriovenous malformation, or aneurysm

-   Ischaemic stroke in preceding 6 months (a verified transient
    ischemic attack \[TIA\] is an exception)

-   Previous intracerebral haemorrhage or subarachnoid haemorrhage

-   Intracranial procedure or recent head trauma

-   Severe known bleeding disorder: coagulation abnormality,
    thrombocytopenia, etc.

**Relative**

-   Fibrinolytic treatment should be considered even if the patient has
    relative contraindications if the onset of pain is within three
    hours, a large (anterior) infarction is imminent and no deep Q-waves
    have developed yet. The relative contraindications are:

    -   Recent intestinal bleeding, for example an ulcer

    -   Recent surgery or significant trauma within preceding 2 to 4
        weeks

        -   At least 4 weeks safety period after, e.g., brain or eye
            surgery

    -   Hypertension (i.e., systolic over 180 to 200, diastolic over 100
        to 110 mmHg)

    -   Other life-threatening illness, for example hepatic cirrhosis,
        renal insufficiency, etc.

    -   Anticoagulant therapy increases the risk of intracerebral
        haemorrhage. If the patient is at risk of bleeding, vitamin K
        should be administered.

    -   Other factors increasing the risk of bleeding should also be
        taken into account (e.g., anaemia, thrombocytopenia, known
        haemophilia \[also von Willebrand\] advanced age, septic
        illness, cancer).

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Finnish Medical Society Duodecim. Thrombolytic therapy and balloon
angioplasty in acute ST elevation myocardial infarction (STEMI). In: EBM
Guidelines. Evidence-Based Medicine \[Internet\]. Helsinki, Finland:
Wiley Interscience. John Wiley & Sons; 2006 Apr 28 \[various\].

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2004 Sep 14 (revised 2006 Apr 28)

#### GUIDELINE DEVELOPER(S)

Finnish Medical Society Duodecim - Professional Association

#### SOURCE(S) OF FUNDING

Finnish Medical Society Duodecim

#### GUIDELINE COMMITTEE

Editorial Team of EBM Guidelines

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Author*: Editors

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

**Note**: This guideline has been updated. The National Guideline
Clearinghouse (NGC) is working to update this summary.

#### GUIDELINE AVAILABILITY

This guideline is included in \"EBM Guidelines. Evidence-Based
Medicine\" available from Duodecim Medical Publications, Ltd, PO Box
713, 00101 Helsinki, Finland; e-mail: <info@ebm-guidelines.com>; Web
site: [www.ebm-guidelines.com](http://www.ebm-guidelines.com/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on August 31, 2005. This NGC
summary was updated by ECRI on November 8, 2005, and again on August 7,
2006. This summary was updated by ECRI Institute on June 22, 2007
following the U.S. Food and Drug Administration (FDA) advisory on
heparin sodium injection. This summary was updated by ECRI Institute on
March 14, 2008 following the updated FDA advisory on heparin sodium
injection.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/10/2008