2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association
This article has multiple corrections.
Abstract
Correction
This article has two related Corrections:
Abstract
Background and Purpose—
The purpose of these guidelines is to provide an up-to-date comprehensive set of recommendations for clinicians caring for adult patients with acute arterial ischemic stroke in a single document. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators. These guidelines supersede the 2013 guidelines and subsequent updates.
Methods—
Members of the writing group were appointed by the American Heart Association Stroke Council’s Scientific Statements Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained. Members were not allowed to participate in discussions or to vote on topics relevant to their relations with industry. The members of the writing group unanimously approved all recommendations except when relations with industry precluded members voting. Prerelease review of the draft guideline was performed by 4 expert peer reviewers and by the members of the Stroke Council’s Scientific Statements Oversight Committee and Stroke Council Leadership Committee. These guidelines use the American College of Cardiology/American Heart Association 2015 Class of Recommendations and Levels of Evidence and the new American Heart Association guidelines format.
Results—
These guidelines detail prehospital care, urgent and emergency evaluation and treatment with intravenous and intra-arterial therapies, and in-hospital management, including secondary prevention measures that are appropriately instituted within the first 2 weeks. The guidelines support the overarching concept of stroke systems of care in both the prehospital and hospital settings.
Conclusions—
These guidelines are based on the best evidence currently available. In many instances, however, only limited data exist demonstrating the urgent need for continued research on treatment of acute ischemic stroke.
New high-quality evidence has produced major changes in the evidence-based treatment of patients with acute ischemic stroke (AIS) since the publication of the most recent “Guidelines for the Early Management of Patients With Acute Ischemic Stroke” in 2013.1 Much of this new evidence has been incorporated into American Heart Association (AHA) focused updates, guidelines, or scientific statements on specific topics relating to the management of patients with AIS since 2013. The purpose of these guidelines is to provide an up-to-date comprehensive set of recommendations for clinicians caring for adult patients with acute arterial ischemic stroke in a single document. These guidelines address prehospital care, urgent and emergency evaluation and treatment with intravenous (IV) and intra-arterial therapies, and in-hospital management, including secondary prevention measures that are often begun during the initial hospitalization. We have restricted our recommendations to adults and to secondary prevention measures that are appropriately instituted within the first 2 weeks. We have not included recommendations for cerebral venous sinus thrombosis because they were covered in a 2011 scientific statement and there is no new evidence that would change those conclusions.2
An independent evidence review committee was commissioned to perform a systematic review of a limited number of clinical questions identified in conjunction with the writing group, the results of which were considered by the writing group for incorporation into this guideline. The systematic reviews “Accuracy of Prediction Instruments for Diagnosing Large Vessel Occlusion in Individuals With Suspected Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke”3 and “Effect of Dysphagia Screening Strategies on Clinical Outcomes After Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke”4 are published in conjunction with this guideline.
These guidelines use the American College of Cardiology (ACC)/AHA 2015 Class of Recommendations (COR) and Levels of Evidence (LOE) (Table 1) and the new AHA guidelines format. New or revised recommendations that supersede previous guideline recommendations are accompanied by 250-word knowledge bytes and data supplement tables summarizing the key studies supporting the recommendations in place of extensive text. Existing recommendations that are unchanged are reiterated with reference to the previous publication. These previous publications and their abbreviations used in this document are listed in Table 2. When there is no new pertinent evidence, for these unchanged recommendations, no knowledge byte or data supplement is provided. For some unchanged recommendations, there are new pertinent data that support the existing recommendation, and these are provided. Additional abbreviations used in this guideline are listed in Table 3.
| Document Title | Publication Year | Abbreviation Used in This Document |
|---|---|---|
| “Recommendations for the Implementation of Telemedicine Within Stroke Systems of Care: A Policy Statement From the American Heart Association”5 | 2009 | N/A |
| “Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association”1 | 2013 | 2013 AIS Guidelines |
| “Interactions Within Stroke Systems of Care: A Policy Statement From the American Heart Association/American Stroke Association”6 | 2013 | 2013 Stroke Systems of Care |
| “2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society”8 | 2014 | N/A |
| “Recommendations for the Management of Cerebral and Cerebellar Infarction With Swelling: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association”9 | 2014 | 2014 Cerebral Edema |
| “Palliative and End-of-Life Care in Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association”10 | 2014 | 2014 Palliative Care |
| “Clinical Performance Measures for Adults Hospitalized With Acute Ischemic Stroke: Performance Measures for Healthcare Professionals From the American Heart Association/American Stroke Association”12 | 2014 | N/A |
| “Part 15: First Aid: 2015 American Heart Association and American Red Cross Guidelines Update for First Aid”13 | 2015 | 2015 CPR/ECC |
| “2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association”14 | 2015 | 2015 Endovascular |
| “Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association”15 | 2015 | 2015 IV Alteplase |
| “Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association”16 | 2016 | 2016 Rehab Guidelines |
ACC indicates American College of Cardiology; AHA, American Heart Association; AIS, acute ischemic stroke; CPR, cardiopulmonary resuscitation; ECC, emergency cardiovascular care; HRS, Heart Rhythm Society; IV, intravenous; and N/A, not applicable.
| ACC | American College of Cardiology |
| AHA | American Heart Association |
| AIS | Acute ischemic stroke |
| ARD | Absolute risk difference |
| ASCVD | Atherosclerotic cardiovascular disease |
| ASPECTS | Alberta Stroke Program Early Computed Tomography Score |
| BP | Blood pressure |
| CEA | Carotid endarterectomy |
| CeAD | Cervical artery dissection |
| CI | Confidence interval |
| CMB | Cerebral microbleed |
| COR | Class of recommendation |
| CS | Conscious sedation |
| CT | Computed tomography |
| CTA | Computed tomographic angiography |
| CTP | Computed tomographic perfusion |
| DTN | Door-to-needle |
| DVT | Deep vein thrombosis |
| DW-MRI | Diffusion-weighted magnetic resonance imaging |
| ED | Emergency department |
| EMS | Emergency medical services |
| EVT | Endovascular therapy |
| GA | General anesthesia |
| GWTG | Get With The Guidelines |
| HBO | Hyperbaric oxygen |
| HR | Hazard ratio |
| ICH | Intracerebral hemorrhage |
| IPC | Intermittent pneumatic compression |
| IV | Intravenous |
| LDL-C | Low-density lipoprotein cholesterol |
| LMWH | Low-molecular-weight heparin |
| LOE | Level of evidence |
| LVO | Large vessel occlusion |
| M1 | Middle cerebral artery segment 1 |
| M2 | Middle cerebral artery segment 2 |
| M3 | Middle cerebral artery segment 3 |
| MCA | Middle cerebral artery |
| MI | Myocardial infarction |
| MRA | Magnetic resonance angiography |
| MRI | Magnetic resonance imaging |
| mRS | Modified Rankin Scale |
| mTICI | Modified Thrombolysis in Cerebral Infarction |
| NCCT | Noncontrast computed tomography |
| NIHSS | National Institutes of Health Stroke Scale |
| NINDS | National Institute of Neurological Disorders and Stroke |
| OR | Odds ratio |
| OSA | Obstructive sleep apnea |
| RCT | Randomized clinical trial |
| RR | Relative risk |
| rtPA | recombinant tissue-type plasminogen activator |
| sICH | Symptomatic intracerebral hemorrhage |
| TIA | Transient ischemic attack |
| UFH | Unfractionated heparin |
Members of the writing group were appointed by the AHA Stroke Council’s Scientific Statements Oversight Committee, representing various areas of medical expertise. Strict adherence to the AHA conflict of interest policy was maintained throughout the writing and consensus process. Members were not allowed to participate in discussions or to vote on topics relevant to their relationships with industry. Writing group members accepted topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations. Draft recommendations and supporting evidence were discussed by the writing group, and the revised recommendations for each topic were reviewed by a designated writing group member. The full writing group then evaluated the complete guidelines. The members of the writing group unanimously approved all recommendations except when relationships with industry precluded members voting. Prerelease review of the draft guideline was performed by 4 expert peer reviewers and by the members of the Stroke Council’s Scientific Statements Oversight Committee and Stroke Council Leadership Committee.
1. Prehospital Stroke Management and Systems of Care
1.1. Prehospital Systems
1.2. EMS Assessment and Management
1.3. EMS Systems
1.5. Hospital Stroke Teams
1.6. Telemedicine
1.7. Organization and Integration of Components
1.8. Establishment of Data Repositories
1.9. Stroke System Care Quality Improvement Process
2. Emergency Evaluation and Treatment
2.1. Stroke Scales
2.2. Brain Imaging
2.3. Other Diagnostic Tests
3. General Supportive Care and Emergency Treatment
3.1. Airway, Breathing, and Oxygenation
3.2. Blood Pressure
3.3. Temperature
3.4. Blood Glucose
3.5. IV Alteplase
3.6. Other IV Thrombolytics and Sonothrombolysis
3.7. Mechanical Thrombectomy
3.8. Other EVTs
3.9. Antiplatelet Treatment
3.10. Anticoagulants
3.11. Volume Expansion/Hemodilution, Vasodilators, and Hemodynamic Augmentation
3.12. Neuroprotective Agents
3.13. Emergency CEA/Carotid Angioplasty and Stenting Without Intracranial Clot
3.14. Other
4. In-Hospital Management of AIS: General Supportive Care
4.1. Stroke Units
4.2. Supplemental Oxygen
4.3. Blood Pressure
4.4. Temperature
4.5. Glucose
4.6. Dysphagia Screening
4.7. Nutrition
4.8. Deep Vein Thrombosis Prophylaxis
4.9. Depression Screening
4.10. Other
4.11. Rehabilitation
5. In-Hospital Management of AIS: Treatment of Acute Complications
5.1. Cerebellar and Cerebral Edema
5.2. Seizures
Additional reference support for this guideline is provided in online Data Supplement 1.200,202,216,217,220,221,224,226,227,229,322,323,325,326,336-402,404-421
| Tested Item | Title | Responses and Scores |
|---|---|---|
| 1A | Level of consciousness | 0—Alert |
| 1—Drowsy | ||
| 2—Obtunded | ||
| 3—Coma/unresponsive | ||
| 1B | Orientation questions (2) | 0—Answers both correctly |
| 1—Answers 1 correctly | ||
| 2—Answers neither correctly | ||
| 1C | Response to commands (2) | 0—Performs both tasks correctly |
| 1—Performs 1 task correctly | ||
| 2—Performs neither | ||
| 2 | Gaze | 0—Normal horizontal movements |
| 1—Partial gaze palsy | ||
| 2—Complete gaze palsy | ||
| 3 | Visual fields | 0—No visual field defect |
| 1—Partial hemianopia | ||
| 2—Complete hemianopia | ||
| 3—Bilateral hemianopia | ||
| 4 | Facial movement | 0—Normal |
| 1—Minor facial weakness | ||
| 2—Partial facial weakness | ||
| 3—Complete unilateral palsy | ||
| 5 | Motor function (arm) | 0—No drift |
| a. Left | 1—Drift before 10 s | |
| b. Right | 2—Falls before 10 s | |
| 3—No effort against gravity | ||
| 4—No movement | ||
| 6 | Motor function (leg) | 0—No drift |
| a. Left | 1—Drift before 5 s | |
| b. Right | 2—Falls before 5 s | |
| 3—No effort against gravity | ||
| 4—No movement | ||
| 7 | Limb ataxia | 0—No ataxia |
| 1—Ataxia in 1 limb | ||
| 2—Ataxia in 2 limbs | ||
| 8 | Sensory | 0—No sensory loss |
| 1—Mild sensory loss | ||
| 2—Severe sensory loss | ||
| 9 | Language | 0—Normal |
| 1—Mild aphasia | ||
| 2—Severe aphasia | ||
| 3—Mute or global aphasia | ||
| 10 | Articulation | 0—Normal |
| 1—Mild dysarthria | ||
| 2—Severe dysarthria | ||
| 11 | Extinction or inattention | 0—Absent |
| 1—Mild loss (1 sensory modality lost) | ||
| 2—Severe loss (2 modalities lost) |
Adapted from Lyden et al.62 Copyright © 1994, American Heart Association, Inc.
| Class IIb, LOE C-EO |
| Patient otherwise eligible for acute reperfusion therapy except that BP is >185/110 mm Hg: |
| Labetalol 10–20 mg IV over 1–2 min, may repeat 1 time; or |
| Nicardipine 5 mg/h IV, titrate up by 2.5 mg/h every 5–15 min, maximum 15 mg/h; when desired BP reached, adjust to maintain proper BP limits; or |
| Clevidipine 1–2 mg/h IV, titrate by doubling the dose every 2–5 min until desired BP reached; maximum 21 mg/h |
| Other agents (eg, hydralazine, enalaprilat) may also be considered |
| If BP is not maintained ≤185/110 mm Hg, do not administer alteplase |
| Management of BP during and after alteplase or other acute reperfusion therapy to maintain BP ≤180/105 mm Hg: |
| Monitor BP every 15 min for 2 h from the start of alteplase therapy, then every 30 min for 6 h, and then every hour for 16 h |
| If systolic BP >180–230 mm Hg or diastolic BP >105–120 mm Hg: |
| Labetalol 10 mg IV followed by continuous IV infusion 2–8 mg/min; or |
| Nicardipine 5 mg/h IV, titrate up to desired effect by 2.5 mg/h every 5–15 min, maximum 15 mg/h; or |
| Clevidipine 1–2 mg/h IV, titrate by doubling the dose every 2–5 min until desired BP reached; maximum 21 mg/h |
| If BP not controlled or diastolic BP >140 mm Hg, consider IV sodium nitroprusside |
AIS indicates acute ischemic stroke; BP, blood pressure; IV, intravenous; and LOE, Level of Evidence.
*
Different treatment options may be appropriate in patients who have comorbid conditions that may benefit from acute reductions in BP such as acute coronary event, acute heart failure, aortic dissection, or preeclampsia/eclampsia.
Data derived from Jauch et al.1
| Indications (Class I) | |
| Within 3 h* | IV alteplase (0.9 mg/kg, maximum dose 90 mg over 60 min with initial 10% of dose given as bolus over 1 min) is recommended for selected patients who may be treated within 3 h of ischemic stroke symptom onset or patient last known well or at baseline state. Physicians should review the criteria outlined in this table to determine patient eligibility.† (Class I; LOE A) |
| Age | For otherwise medically eligible patients ≥18 y of age, IV alteplase administration within 3 h is equally recommended for patients <80 and >80 y of age.† (Class I; LOE A) |
| Severity | For severe stroke symptoms, IV alteplase is indicated within 3 h from symptom onset of ischemic stroke. Despite increased risk of hemorrhagic transformation, there is still proven clinical benefit for patients with severe stroke symptoms.† (Class I; LOE A) |
| For patients with mild but disabling stroke symptoms, IV alteplase is indicated within 3 h from symptom onset of ischemic stroke. There should be no exclusion for patients with mild but nonetheless disabling stroke symptoms, in the opinion of the treating physician, from treatment with IV alteplase because there is proven clinical benefit for those patients.† (Class I; LOE B-R)‡ | |
| 3–4.5 h* | IV alteplase (0.9 mg/kg, maximum dose 90 mg over 60 min with initial 10% of dose given as bolus over 1 min) is also recommended for selected patients who can be treated within 3 and 4.5 h of ischemic stroke symptom onset or patient last known well. Physicians should review the criteria outlined in this table to determine patient eligibility.† (Class I; LOE B-R)‡ |
| Age Diabetes mellitus Prior stroke Severity OACs Imaging | IV alteplase treatment in the 3- to 4.5-h time window is recommended for those patients ≤80 y of age, without a history of both diabetes mellitus and prior stroke, NIHSS score ≤25, not taking any OACs, and without imaging evidence of ischemic injury involving more than one third of the MCA territory.† (Class I; LOE B-R)‡ |
| Urgency | Treatment should be initiated as quickly as possible within the above listed time frames because time to treatment is strongly associated with outcomes.† (Class I; LOE A) |
| BP | IV alteplase is recommended in patients whose BP can be lowered safely (to <185/110 mm Hg) with antihypertensive agents, with the physician assessing the stability of the BP before starting IV alteplase.† (Class I; LOE B-NR)‡ |
| Blood glucose | IV alteplase is recommended in otherwise eligible patients with initial glucose levels >50 mg/dL.† (Class I; LOE A) |
| CT | IV alteplase administration is recommended in the setting of early ischemic changes on NCCT of mild to moderate extent (other than frank hypodensity).† (Class I; LOE A) |
| Prior antiplatelet therapy | IV alteplase is recommended for patients taking antiplatelet drug monotherapy before stroke on the basis of evidence that the benefit of alteplase outweighs a possible small increased risk of sICH.† (Class I; LOE A) |
| IV alteplase is recommended for patients taking antiplatelet drug combination therapy (eg, aspirin and clopidogrel) before stroke on the basis of evidence that the benefit of alteplase outweighs a probable increased risk of sICH.† (Class I; LOE B-NR)‡ | |
| End-stage renal disease | In patients with end-stage renal disease on hemodialysis and normal aPTT, IV alteplase is recommended.† (Class I; LOE C-LD)‡ However, those with elevated aPTT may have elevated risk for hemorrhagic complications. |
| Contraindications (Class III) | |
| Time of onset | IV alteplase is not recommended in ischemic stroke patients who have an unclear time and/ or unwitnessed symptom onset and in whom the time last known to be at baseline state is >3 or 4.5 h.† (Class III: No Benefit; LOE B-NR)‡§ |
| IV alteplase is not recommended in ischemic stroke patients who awoke with stroke with time last known to be at baseline state >3 or 4.5 h.† (Class III: No Benefit; LOE B-NR)‡§ | |
| CT | IV alteplase should not be administered to a patient whose CT reveals an acute intracranial hemorrhage.† (Class III: Harm; LOE C-EO)‡§ |
| There remains insufficient evidence to identify a threshold of hypoattenuation severity or extent that affects treatment response to alteplase. However, administering IV alteplase to patients whose CT brain imaging exhibits extensive regions of clear hypoattenuation is not recommended. These patients have a poor prognosis despite IV alteplase, and severe hypoattenuation defined as obvious hypodensity represents irreversible injury.† (Class III: No Benefit; LOE A)§ | |
| Ischemic stroke within 3 mo | Use of IV alteplase in patients presenting with AIS who have had a prior ischemic stroke within 3 mo may be harmful.† (Class III: Harm; LOE B-NR)‡§ |
| Severe head trauma within 3 mo | In AIS patients with recent severe head trauma (within 3 mo), IV alteplase is contraindicated.† (Class III: Harm; LOE C-EO)‡§ |
| Given the possibility of bleeding complications from the underlying severe head trauma, IV alteplase should not be administered in posttraumatic infarction that occurs during the acute in-hospital phase.† (Class III: Harm; LOE C-EO)‡§(Recommendation wording modified to match Class III stratifications.) | |
| Intracranial/intraspinal surgery within 3 mo | For patients with AIS and a history of intracranial/spinal surgery within the prior 3 mo, IV alteplase is potentially harmful.† (Class III: Harm; LOE C-EO)‡§ |
| History of intracranial hemorrhage | IV alteplase administration in patients who have a history of intracranial hemorrhage is potentially harmful.† (Class III: Harm; LOE C-EO)‡§ |
| Subarachnoid hemorrhage | IV alteplase is contraindicated in patients presenting with symptoms and signs most consistent with an SAH.† (Class III: Harm; LOE C-EO)‡§ |
| GI malignancy or GI bleed within 21 d | Patients with a structural GI malignancy or recent bleeding event within 21 d of their stroke event should be considered high risk, and IV alteplase administration is potentially harmful.† (Class III: Harm; LOE C-EO)‡§ |
| Coagulopathy | The safety and efficacy of IV alteplase for acute stroke patients with platelets <100 000/mm3, INR >1.7, aPTT >40 s, or PT >15 s are unknown, and IV alteplase should not be administered.† (Class III: Harm; LOE C-EO)‡§(In patients without history of thrombocytopenia, treatment with IV alteplase can be initiated before availability of platelet count but should be discontinued if platelet count is <100 000/mm3. In patients without recent use of OACs or heparin, treatment with IV alteplase can be initiated before availability of coagulation test results but should be discontinued if INR is >1.7 or PT is abnormally elevated by local laboratory standards.) (Recommendation wording modified to match Class III stratifications.) |
| LMWH | IV alteplase should not be administered to patients who have received a treatment dose of LMWH within the previous 24 h.† (Class III: Harm; LOE B-NR)‖(Recommendation wording modified to match Class III stratifications.) |
| Thrombin inhibitors or factor Xa inhibitors | The use of IV alteplase in patients taking direct thrombin inhibitors or direct factor Xa inhibitors has not been firmly established but may be harmful.† (Class III: Harm; LOE C-EO)‡§ IV alteplase should not be administered to patients taking direct thrombin inhibitors or direct factor Xa inhibitors unless laboratory tests such as aPTT, INR, platelet count, ecarin clotting time, thrombin time, or appropriate direct factor Xa activity assays are normal or the patient has not received a dose of these agents for >48 h (assuming normal renal metabolizing function).(Alteplase could be considered when appropriate laboratory tests such as aPTT, INR, ecarin clotting time, thrombin time, or direct factor Xa activity assays are normal or when the patient has not taken a dose of these ACs for >48 h and renal function is normal.)(Recommendation wording modified to match Class III stratifications.) |
| Glycoprotein IIb/IIIa receptor inhibitors | Antiplatelet agents that inhibit the glycoprotein IIb/IIIa receptor should not be administered concurrently with IV alteplase outside a clinical trial.† (Class III: Harm; LOE B-R)‡§(Recommendation wording modified to match Class III stratifications.) |
| Infective endocarditis | For patients with AIS and symptoms consistent with infective endocarditis, treatment with IV alteplase should not be administered because of the increased risk of intracranial hemorrhage.† (Class III: Harm; LOE C-LD)‡§(Recommendation wording modified to match Class III stratifications.) |
| Aortic arch dissection | IV alteplase in AIS known or suspected to be associated with aortic arch dissection is potentially harmful and should not be administered.† (Class III: Harm; LOE C-EO)‡§(Recommendation wording modified to match Class III stratifications.) |
| Intra-axial intracranial neoplasm | IV alteplase treatment for patients with AIS who harbor an intra-axial intracranial neoplasm is potentially harmful.† (Class III: Harm; LOE C-EO)‡§ |
| Additional recommendations for treatment with IV alteplase for patients with AIS (Class II) | |
| Extended 3- to 4.5-h window | For patients >80 y of age presenting in the 3- to 4.5-h window, IV alteplase is safe and can be as effective as in younger patients.† (Class IIa; LOE B-NR)‡ |
| For patients taking warfarin and with an INR ≤1.7 who present in the 3- to 4.5-h window, IV alteplase appears safe and may be beneficial.† (Class IIb; LOE B-NR)‡ | |
| In AIS patients with prior stroke and diabetes mellitus presenting in the 3- to 4.5- h window, IV alteplase may be as effective as treatment in the 0- to 3-h window and may be a reasonable option.† (Class IIb; LOE B-NR)‡ | |
| Severity 0- to 3-h window | Within 3 h from symptom onset, treatment of patients with mild ischemic stroke symptoms that are judged as nondisabling may be considered. Treatment risks should be weighed against possible benefits; however, more study is needed to further define the risk-to-benefit ratio.† (Class IIb; LOE C-LD)‡ |
| Severity 3- to 4.5-h window | For otherwise eligible patients with mild stroke presenting in the 3- to 4.5-h window, IV alteplase may be as effective as treatment in the 0- to 3-h window and may be a reasonable option. Treatment risks should be weighed against possible benefits. (Class IIb; LOE B-NR)‖ |
| The benefit of IV alteplase between 3 and 4.5 h from symptom onset for patients with very severe stroke symptoms (NIHSS > 25) is uncertain.† (Class IIb; LOE C-LD) | |
| Preexisting disability | Preexisting disability does not seem to independently increase the risk of sICH after IV alteplase, but it may be associated with less neurological improvement and higher mortality. Thrombolytic therapy with IV alteplase for acute stroke patients with preexisting disability (mRS score ≥2) may be reasonable, but decisions should take into account relevant factors, including quality of life, social support, place of residence, need for a caregiver, patients’ and families’ preferences, and goals of care.† (Class IIb; LOE B-NR)‡ |
| Patients with preexisting dementia may benefit from IV alteplase. Individual considerations such as life expectancy and premorbid level of function are important to determine whether alteplase may offer a clinically meaningful benefit.† (Class IIb; LOE B-NR)‡ | |
| Early improvement | IV alteplase treatment is reasonable for patients who present with moderate to severe ischemic stroke and demonstrate early improvement but remain moderately impaired and potentially disabled in the judgment of the examiner.† (Class IIa; LOE A) |
| Seizure at onset | IV alteplase is reasonable in patients with a seizure at the time of onset of acute stroke if evidence suggests that residual impairments are secondary to stroke and not a postictal phenomenon.† (Class IIa; LOE C-LD)‡ |
| Blood glucose | Treatment with IV alteplase in patients with AIS who present with initial glucose levels <50 or >400 mg/dL that are subsequently normalized and who are otherwise eligible may be reasonable. (Recommendation modified from 2015 IV Alteplase to conform to text of 2015 IV Alteplase. [Class IIb; LOE C-LD])‡ |
| Coagulopathy | The safety and efficacy of IV alteplase for acute stroke patients with a clinical history of potential bleeding diathesis or coagulopathy are unknown. IV alteplase may be considered on a case-by-case basis.† (Class IIb; LOE C-EO)‡ |
| IV alteplase may be reasonable in patients who have a history of warfarin use and an INR ≤1.7 and/or a PT <15 s.† (Class IIb; LOE B-NR)‡ | |
| Dural puncture | IV alteplase may be considered for patients who present with AIS, even in instances when they may have undergone a lumbar dural puncture in the preceding 7 d.† (Class IIb; LOE C-EO)‡ |
| Arterial puncture | The safety and efficacy of administering IV alteplase to acute stroke patients who have had an arterial puncture of a noncompressible blood vessel in the 7 d preceding stroke symptoms are uncertain.† (Class IIb; LOE C-LD)‡ |
| Recent major trauma | In AIS patients with recent major trauma (within 14 d) not involving the head, IV alteplase may be carefully considered, with the risks of bleeding from injuries related to the trauma weighed against the severity and potential disability from the ischemic stroke. (Recommendation modified from 2015 IV Alteplase to specify that it does not apply to head trauma. [Class IIb; LOE C-LD])‡ |
| Recent major surgery | Use of IV alteplase in carefully selected patients presenting with AIS who have undergone a major surgery in the preceding 14 d may be considered, but the potential increased risk of surgical-site hemorrhage should be weighed against the anticipated benefits of reduced stroke related neurological deficits.† (Class IIb; LOE C-LD)‡ |
| GI and genitourinary bleeding | Reported literature details a low bleeding risk with IV alteplase administration in the setting of past GI/genitourinary bleeding. Administration of IV alteplase in this patient population may be reasonable.† (Class IIb; LOE C-LD‡(Note: Alteplase administration within 21 d of a GI bleeding event is not recommended; see Contraindications.) |
| Menstruation | IV alteplase is probably indicated in women who are menstruating who present with AIS and do not have a history of menorrhagia. However, women should be warned that alteplase treatment could increase the degree of menstrual flow.† (Class IIa; LOE C-EO) |
| Because the potential benefits of IV alteplase probably outweigh the risks of serious bleeding in patients with recent or active history of menorrhagia without clinically significant anemia or hypotension, IV alteplase administration may be considered.† (Class IIb; LOE C-LD)‡ | |
| When there is a history of recent or active vaginal bleeding causing clinically significant anemia, then emergency consultation with a gynecologist is probably indicated before a decision about IV alteplase is made.† (Class IIa; LOE C-EO)‡ | |
| Extracranial cervical dissections | IV alteplase in AIS known or suspected to be associated with extracranial cervical arterial dissection is reasonably safe within 4.5 h and probably recommended.† (Class IIa; LOE C-LD)‡ |
| Intracranial arterial dissection | IV alteplase usefulness and hemorrhagic risk in AIS known or suspected to be associated with intracranial arterial dissection remain unknown, uncertain, and not well established.† (Class IIb; LOE C-LD)‡ |
| Unruptured intracranial aneurysm | For patients presenting with AIS who are known to harbor a small or moderate-sized (<10 mm) unruptured and unsecured intracranial aneurysm, administration of IV alteplase is reasonable and probably recommended.† (Class IIa; LOE C-LD)‡ |
| Usefulness and risk of IV alteplase in patients with AIS who harbor a giant unruptured and unsecured intracranial aneurysm are not well established.† (Class IIb; LOE C-LD)‡ | |
| Intracranial vascular malformations | For patients presenting with AIS who are known to harbor an unruptured and untreated intracranial vascular malformation the usefulness and risks of administration of IV alteplase are not well established.† (Class IIb; LOE C-LD)‡ |
| Because of the increased risk of ICH in this population of patients, IV alteplase may be considered in patients with stroke with severe neurological deficits and a high likelihood of morbidity and mortality to outweigh the anticipated risk of ICH secondary to thrombolysis.† (Class IIb; LOE C-LD)‡ | |
| CMBs | In otherwise eligible patients who have previously had a small number (1–10) of CMBs demonstrated on MRI, administration of IV alteplase is reasonable. (Class IIa; Level B-NR)‖ |
| In otherwise eligible patients who have previously had a high burden of CMBs (>10) demonstrated on MRI, treatment with IV alteplase may be associated with an increased risk of sICH, and the benefits of treatment are uncertain. Treatment may be reasonable if there is the potential for substantial benefit. (Class IIb; Level B-NR)‖ | |
| Extra-axial intracranial neoplasms | IV alteplase treatment is probably recommended for patients with AIS who harbor an extra-axial intracranial neoplasm.† (Class IIa; LOE C-EO)‡ |
| Acute MI | For patients presenting with concurrent AIS and acute MI, treatment with IV alteplase at the dose appropriate for cerebral ischemia, followed by percutaneous coronary angioplasty and stenting if indicated, is reasonable.† (Class IIa; LOE C-EO)‡ |
| Recent MI | For patients presenting with AIS and a history of recent MI in the past 3 mo, treating the ischemic stroke with IV alteplase is reasonable if the recent MI was non-STEMI.† (Class IIa; LOE C-LD)‡ |
| For patients presenting with AIS and a history of recent MI in the past 3 mo, treating the ischemic stroke with IV alteplase is reasonable if the recent MI was a STEMI involving the right or inferior myocardium.† (Class IIa; LOE C-LD)‡ | |
| For patients presenting with AIS and a history of recent MI in the past 3 mo, treating the ischemic stroke with IV alteplase may reasonable if the recent MI was a STEMI involving the left anterior myocardium.† (Class IIb; LOE C-LD)‡ | |
| Other cardiac diseases | For patients with major AIS likely to produce severe disability and acute pericarditis, treatment with IV alteplase may be reasonable† (Class IIb; LOE C-EO)‡; urgent consultation with a cardiologist is recommended in this situation. |
| For patients presenting with moderate AIS likely to produce mild disability and acute pericarditis, treatment with IV alteplase is of uncertain net benefit.† (Class IIb; LOE C-EO)‡ | |
| For patients with major AIS likely to produce severe disability and known left atrial or ventricular thrombus, treatment with IV alteplase may be reasonable.† (Class IIb; LOE C-LD)‡ | |
| For patients presenting with moderate AIS likely to produce mild disability and known left atrial or ventricular thrombus, treatment with IV alteplase is of uncertain net benefit.† (Class IIb; LOE C-LD)‡ | |
| For patients with major AIS likely to produce severe disability and cardiac myxoma, treatment with IV alteplase may be reasonable.† (Class IIb; LOE C-LD)‡ | |
| For patients presenting with major AIS likely to produce severe disability and papillary fibroelastoma, treatment with IV alteplase may be reasonable.† (Class IIb; LOE C-LD)‡ | |
| Procedural stroke | IV alteplase is reasonable for the treatment of AIS complications of cardiac or cerebral angiographic procedures, depending on the usual eligibility criteria.† (Class IIa; LOE A)‡ |
| Systemic malignancy | The safety and efficacy of alteplase in patients with current malignancy are not well established.† (Class IIb; LOE C-LD)‡ Patients with systemic malignancy and reasonable (>6 mo) life expectancy may benefit from IV alteplase if other contraindications such as coagulation abnormalities, recent surgery, or systemic bleeding do not coexist. |
| Pregnancy | IV alteplase administration may be considered in pregnancy when the anticipated benefits of treating moderate or severe stroke outweigh the anticipated increased risks of uterine bleeding.† (Class IIb; LOE C-LD)‡ |
| The safety and efficacy of IV alteplase in the early postpartum period (<14 d after delivery) have not been well established.† (Class IIb; LOE C-LD)‡ | |
| Ophthalmological conditions | Use of IV alteplase in patients presenting with AIS who have a history of diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions is reasonable to recommend, but the potential increased risk of visual loss should be weighed against the anticipated benefits of reduced stroke-related neurological deficits.† (Class IIa; LOE B-NR)‡ |
| Sickle cell disease | IV alteplase for adults presenting with an AIS with known sickle cell disease can be beneficial. (Class IIa; LOE B-NR)‖ |
| Illicit drug use | Treating clinicians should be aware that illicit drug use may be a contributing factor to incident stroke. IV alteplase is reasonable in instances of illicit drug use–associated AIS in patients with no other exclusions.† (Class IIa; LOE C-LD)‡ |
| Stroke mimics | The risk of symptomatic intracranial hemorrhage in the stroke mimic population is quite low; thus, starting IV alteplase is probably recommended in preference over delaying treatment to pursue additional diagnostic studies.† (Class IIa; LOE B-NR) |
Clinicians should also be informed of the indications and contraindications from local regulatory agencies (for current information from the US Food and Drug Administration refer to http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf).
For a detailed discussion of this topic and evidence supporting these recommendations, refer to the American Heart Association (AHA) scientific statement on the rationale for inclusion and exclusion criteria for IV alteplase in AIS.15
AC indicates anticoagulants; ACC, American College of Cardiology; AIS, acute ischemic stroke; AHA, American Heart Association; aPTT, activated partial thromboplastin time; BP, blood pressure; CMB, cerebral microbleed; CT, computed tomography; GI, gastrointestinal; ICH, intracerebral hemorrhage; INR, international normalized ratio; IV, intravenous; LMWH, low-molecular-weight heparin; LOE, level of evidence; MCA, middle cerebral artery; MI, myocardial infarction; MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NCCT, noncontrast computed tomography; NIHSS, National Institutes of Health Stroke Scale; OAC, oral anticoagulant; PT, prothromboplastin time; sICH, symptomatic intracerebral hemorrhage; and STEMI, ST-segment–elevation myocardial infarction.
*
When uncertain, the time of onset time should be considered the time when the patient was last known to be normal or at baseline neurological condition.
†
Recommendation unchanged or reworded for clarity from 2015 IV Alteplase. See Table LXXXIII in online Data Supplement 1 for original wording.
‡
LOE amended to conform with ACC/AHA 2015 Recommendation Classification System.
§
COR amended to conform with ACC/AHA 2015 Recommendation Classification System.
‖
See also the text of these guidelines for additional information on these recommendations.
| Infuse 0.9 mg/kg (maximum dose 90 mg) over 60 min, with 10% of the dose given as a bolus over 1 min. |
| Admit the patient to an intensive care or stroke unit for monitoring. |
| If the patient develops severe headache, acute hypertension, nausea, or vomiting or has a worsening neurological examination, discontinue the infusion (if IV alteplase is being administered) and obtain emergency head CT scan. |
| Measure BP and perform neurological assessments every 15 min during and after IV alteplase infusion for 2 h, then every 30 min for 6 h, then hourly until 24 h after IV alteplase treatment. |
| Increase the frequency of BP measurements if SBP is >180 mm Hg or if DBP is >105 mm Hg; administer antihypertensive medications to maintain BP at or below these levels (Table 5). |
| Delay placement of nasogastric tubes, indwelling bladder catheters, or intra-arterial pressure catheters if the patient can be safely managed without them. |
| Obtain a follow-up CT or MRI scan at 24 h after IV alteplase before starting anticoagulants or antiplatelet agents. |
AIS indicates acute ischemic stroke; BP, blood pressure; CT, computed tomography; DBP, diastolic blood pressure; IV, intravenous; MRI, magnetic resonance imaging; and SBP, systolic blood pressure.
Reprinted from Jauch et al.1 Copyright © 2013, American Heart Association, Inc.
| Class IIb, LOE C-EO |
|---|
| Stop alteplase infusion |
| CBC, PT (INR), aPTT, fibrinogen level, and type and cross-match |
| Emergent nonenhanced head CT |
| Cryoprecipitate (includes factor VIII): 10 U infused over 10–30 min (onset in 1 h, peaks in 12 h); administer additional dose for fibrinogen level of <200 mg/dL |
| Tranexamic acid 1000 mg IV infused over 10 min OR ε-aminocaproic acid 4–5 g over 1 h, followed by 1 g IV until bleeding is controlled (peak onset in 3 h) |
| Hematology and neurosurgery consultations |
| Supportive therapy, including BP management, ICP, CPP, MAP, temperature, and glucose control |
AIS indicates acute ischemic stroke; aPTT, activated partial thromboplastin time; BP, blood pressure; CBC, complete blood count; CPP, cerebral perfusion pressure; CT, computed tomography; ICP, intracranial pressure; INR, international normalized ratio; IV, intravenous; LOE, Level of Evidence; MAP, mean arterial pressure; and PT, prothrombin time.
| Class IIb, LOE C-EO |
|---|
| Maintain airway |
| Endotracheal intubation may not be necessary if edema is limited to anterior tongue and lips. |
| Edema involving larynx, palate, floor of mouth, or oropharynx with rapid progression (within 30 min) poses higher risk of requiring intubation. |
| Awake fiberoptic intubation is optimal. Nasal-tracheal intubation may be required but poses risk of epistaxis post-IV alteplase. Cricothyroidotomy is rarely needed and also problematic after IV alteplase. |
| Discontinue IV alteplase infusion and hold ACEIs |
| Administer IV methylprednisolone 125 mg |
| Administer IV diphenhydramine 50 mg |
| Administer ranitidine 50 mg IV or famotidine 20 mg IV |
| If there is further increase in angioedema, administer epinephrine (0.1%) 0.3 mL subcutaneously or by nebulizer 0.5 mL |
| Icatibant, a selective bradykinin B2 receptor antagonist, 3 mL (30 mg) subcutaneously in abdominal area; additional injection of 30 mg may be administered at intervals of 6 h not to exceed total of 3 injections in 24 h; and plasma-derived C1 esterase inhibitor (20 IU/kg) has been successfully used in hereditary angioedema and ACEI-related angioedema |
| Supportive care |
Supplemental Material
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The image is taken from an article in this issue, “Late Window Paradox” by Albers et al (Stroke. 2018;49:768–771. doi: 10.1161/STROKEAHA.117.020200). The image is Figure 2.
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© 2018 American Heart Association, Inc.
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Published online: 24 January 2018
Published in print: March 2018
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Disclosures
| Writing Group Member | Employment | Research Grant | Other Research Support | Speakers’ Bureau/Honoraria | Expert Witness | Ownership Interest | Consultant/Advisory Board | Other |
|---|---|---|---|---|---|---|---|---|
| William J. Powers | University of North Carolina, Chapel Hill | NIH (coinvestigator on grant to develop MR CMRO2 measurement)*; NIH (coinvestigator on clinical trial of dental health to prevent stroke)* | None | None | Cleveland Clinic*; Wake Forest University*; Ozarks Medical Center* | None | None | None |
| Alejandro A. Rabinstein | Mayo Clinic | None | None | None | None | None | None | None |
| Teri Ackerson | Saint Luke’s Health System, AHA/ASA | None | None | None | None | None | None | None |
| Opeolu M. Adeoye | University of Cincinnati | NIH/NINDS* | None | None | None | Sense Diagnostics, LLC† | None | None |
| Nicholas C. Bambakidis | University Hospitals, Cleveland Medical Center | None | None | None | None | None | None | None |
| Kyra Becker | University of Washington School of Medicine Harborview Medical Center | None | None | None | Various law firms† | None | Icon† | None |
| José Biller | Loyola University Chicago | Accorda (DSMB committee member)* | None | None | None | None | None | Journal of Stroke and Cerebrovascular Disease (family)†; Up-to-Date (Editorial Board member)*; editor (self; Journal of Stroke and Cerebrovascular Disease, unpaid)* |
| Michael Brown | Michigan State University College of Human Medicine, Emergency Medicine | None | None | None | Wicker Smith O’Hara McCoy & Ford PA*; Anthony T. Martino, Clark, Martino, PA* | None | None | None |
| Bart M. Demaerschalk | Mayo Clinic Neurology, Mayo Clinic Hospital | None | None | None | None | None | None | None |
| Brian Hoh | University of Florida | None | None | None | None | None | None | None |
| Edward C. Jauch | Medical University of South Carolina | Genentech (Executive Committee for PRISMS Study)*; Ischemia Care (Biomarker research study)*; NIH (PI StrokeNet hub)† | None | None | Defense* | Jan Medical* | None | None |
| Chelsea S. Kidwell | University of Arizona | None | None | None | None | None | None | None |
| Thabele M. Leslie-Mazwi | Massachusetts General Hospital | None | None | None | None | None | None | None |
| Bruce Ovbiagele | Medical University of South Carolina | NIH (U01 NS079179, U54 HG007479)† | None | None | None | None | None | None |
| Phillip A. Scott | University of Michigan, Department of Emergency Medicine | NIH/NINDS (PI for NINDS Regional Coordinating Stroke Center grant RCC-17)† | None | None | Medical legal consultant, defense and plaintiff* | None | None | None |
| Kevin N. Sheth | Yale University School of Medicine | None | Remedy (grant for PI on Clinical Trial)†; Bard (grant for PI on Clinical Trial)†; Stryker (Adjudication Committee)* | None | Defense and Plaintiff* | None | None | None |
| Andrew M. Southerland | University of Virginia | HRSA GO1RH27869-01-00 (investigator, research salary support)†; American Academy of Neurology (PI, project support)*; American Board of Psychiatry and Neurology (Faculty Fellowship, research and salary support)†; NHLBI, NINDS (U01 HL088942) (Cardiothoracic Surgical Trials Network)† | None | AHA/ASA* | Legal expert review* | US provisional patent application serial No. 61/867,477* | None | Neurology® journal* |
| Deborah V. Summers | St. Luke’s Health System | None | None | None | None | None | None | None |
| David L. Tirschwell | University of Washington–Harborview Medical Center | None | None | None | None | None | St. Jude/Abbott* | None |
This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be “significant” if (a) the person receives $10 000 or more during any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
*
Modest.
†
Significant.
| Reviewer | Employment | Research Grant | Other Research Support | Speakers’ Bureau/Honoraria | Expert Witness | Ownership Interest | Consultant/Advisory Board | Other |
|---|---|---|---|---|---|---|---|---|
| Karen L. Furie | Rhode Island Hospital | None | None | None | None | None | None | None |
| Steven J. Kittner | Veterans Affairs Maryland Health Care System; University of Maryland | None | None | None | None | None | None | None |
| Lawrence R. Wechsler | University of Pittsburgh | None | None | None | None | None | None | None |
| Babu G. Welch | UT Southwestern Medical Center | None | None | Stryker Neurovascular* | None | None | Stryker Neurovascular* | None |
This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be “significant” if (a) the person receives $10 000 or more during any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
*
Modest.
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