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• W1989935089 endingPage "1942" @default.
• W1989935089 startingPage "1934" @default.
• W1989935089 abstract "HomeStrokeVol. 33, No. 7Anticoagulants and Antiplatelet Agents in Acute Ischemic Stroke Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBAnticoagulants and Antiplatelet Agents in Acute Ischemic StrokeReport of the Joint Stroke Guideline Development Committee of the American Academy of Neurology and the American Stroke Association (a Division of the American Heart Association) B.M. Coull, L.S. Williams, L.B. Goldstein, J.F. Meschia, D. Heitzman, S. Chaturvedi, K.C. Johnston, S. Starkman, L.B. Morgenstern, J.L. Wilterdink, S.R. Levine and J.L. Saver B.M. CoullB.M. Coull From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , L.S. WilliamsL.S. Williams From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , L.B. GoldsteinL.B. Goldstein From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , J.F. MeschiaJ.F. Meschia From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , D. HeitzmanD. Heitzman From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , S. ChaturvediS. Chaturvedi From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , K.C. JohnstonK.C. Johnston From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , S. StarkmanS. Starkman From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , L.B. MorgensternL.B. Morgenstern From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , J.L. WilterdinkJ.L. Wilterdink From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author , S.R. LevineS.R. Levine From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author and J.L. SaverJ.L. Saver From the Department of Neurology (B.M.C.), Arizona Health Science Center, Tucson, Ariz; Department of Neurology (L.S.W.), Indiana University School of Medicine, Research Scientist, Regenstrief Institute for Health Care, Indianapolis, Ind; Department of Neurology (L.B.G.), Duke Center for Cerebrovascular Disease, Duke Center for Clinical Health Policy Research, and Durham VA Medical Center, Durham, NC; Department of Neurology (J.F.M.), Mayo Clinic/Jacksonville, Fla; Texas Neurology, PC (D.H.), Dallas, Tex; Department of Neurology (S.C.), Wayne State University, Detroit, Mich; Departments of Neurology and Health (K.C.J.), Evaluation Sciences, University of Virginia, Charlottesville; Departments of Emergency Medicine and Neurology (S.S.), UCLA, and Department of Neurology (J.L.S.), UCLA School of Medicine, Los Angeles, Calif; Departments of Neurology & Epidemiology (L.B.M.), University of Texas, Houston; Department of Clinical Neurosciences (J.L.W.), Brown Medical School, Providence, RI; and Department of Neurology (S.R.L.), Mount Sinai School of Medicine, New York, NY. Search for more papers by this author Originally published1 Jul 2002https://doi.org/10.1161/01.STR.0000028456.18614.93Stroke. 2002;33:1934–1942Stroke remains a common and costly problem worldwide, but substantial advances have been made in recent decades in understanding stroke mechanisms, risk factors, and therapies. Because thrombosis plays an important role in the pathogenesis of ischemic stroke, drugs that interfere with hemostasis and clot formation such as anticoagulants and platelet antiaggregants commonly are used in the management of cerebrovascular disease. Considerable evidence supports the use of certain antithrombotic drugs in stroke prevention. However, because of limited supportive data, the use of these agents in patients with acute ischemic stroke remains controversial.In this report, we examine the published evidence relevant to the effects of anticoagulants and antiplatelet agents on acute ischemic stroke mortality, morbidity, and recurrence rates as well as associated ancillary benefits and risks of those treatments on the rates of deep vein thrombosis, pulmonary embolus, and cardiovascular complications. As part of these analyses, we also sought to determine whether there was evidence supporting differential efficacy of these drugs according to ischemic stroke subtypes.MethodsTo prepare this report, experienced neurologists with a special interest in stroke diagnosis and management were appointed by the Quality Standards Subcommittee (QSS) and the Therapeutics and Technology Assessment (TTA) Subcommittee of the American Academy of Neurology, and the Stroke Council and Science Advisory and Coordinating Committee (SACC) of the American Heart Association (AHA). The QSS, TTA, Stroke Council and SACC are each charged with the responsibility of preparing evidence-based reports pertaining to medical practice issues including stroke.To facilitate the process of joint guideline development, a Steering Committee, chaired by representatives of the AAN and the American Stroke Association of the AHA, was appointed to discuss potential topics of wide interest to the stroke community. Choosing the role of anticoagulants and antiplatelet agents in acute ischemic stroke as the first topic, a Joint Writing Committee was appointed with equal representation from each organization.The Joint Writing Committee first conducted a structured literature review with the assistance of a professional medical research librarian based at the University of Minnesota (see Acknowledgment). The literature review was based on MEDLINE searches from 1966 through February 2001. In addition, Current Contents and International Pharmaceutical Abstracts databases were searched from 1985 to February 2001. The search strategy, available online at www.aan.com, included controlled clinical trials and large-scale cohort studies.The committee also searched the Cochrane Database for pertinent randomized clinical trials and systematic reviews. Cochrane Reviews typically consist of formal meta-analyses of published and unpublished trials, not all of which are indexed in MEDLINE. These reviews were used to identify any relevant studies that may not have been found in the other searches. In addition, to help ensure that all pertinent studies were considered, a letter requesting relevant articles was sent to an international group of stroke experts who, in the opinion of the Joint Writing Committee, were considered authorities in the field of antithrombotic treatment of acute ischemic stroke (see Acknowledgment).The treatments selected by the Joint Writing Committee for review included unfractionated heparin, low molecular weight (LMW) heparin, heparinoids, aspirin, ticlopidine, clopidogrel, dipyridamole, hirudin, and glycoprotein IIb/IIIa antagonists. Reports of thrombolytics and fibrinogenolytics identified in the search were excluded because they are neither antiplatelet agents nor anticoagulants. Prostacyclin and pentoxifylline were also excluded because they have major vascular effects other than antiplatelet actions. Case reports, studies of primary intracranial hemorrhages, studies that included only patients with TIA, and studies of dural sinus or cerebral vein thrombosis were also excluded.To be considered for analysis, a study had to be a controlled clinical trial that tested an anticoagulant or antiplatelet agent in patients with ischemic stroke. In addition, the drug must have been given within 48 hours of symptom onset. Clinical endpoints had to be clearly defined before the study started. Studies that included patients in whom treatment could be delayed after 48 hours were considered only if results were also separately reported on a well defined subgroup of patients treated within 48 hours of symptom onset. A number of excellent and comprehensive articles on acute stroke management have been published recently, such as the recommendations from the European Stroke Initiative,1 but these reports did not meet our criteria for inclusion because they were based on reviews of other studies and expert opinion rather than primary source clinical trials.Each study considered was rated using the evidence classification system of the QSS and approved by the AAN and AHA (Appendix A). This evidence-based classification scheme excludes review articles, letters, comments, editorials, and articles based solely on expert opinion.Abstracts of all identified articles were independently reviewed by two members of the committee, and accepted articles were read and independently abstracted by two committee members according to the Data Abstraction Form, available online at www.aan.com. This form was designed to address the key questions listed in table 1. These key questions were designed to critically assess the major issues involved in the efficacy of anticoagulants and antiplatelet agents in the outcome of patients with acute ischemic stroke. For each of these questions, the quality of the evidence was rated and recommendations formulated and assigned a grade of A, B, or C based on the quality of evidence as outlined in Appendix A. Key QuestionsDVT/PE = deep vein thrombosis/pulmonary emboli.1. Do antithrombotic agents reduce stroke-related morbidity and mortality?2. Do antithrombotic agents reduce early stroke recurrence?3. Do antithrombotic agents vary in efficacy according to stroke subtype?4. Do antithrombotic agents reduce systemic thrombotic complications such as DVT/PE?5. What are the risks of hemorrhage associated with antithrombotic treatment?6. Do antithrombotic agents alter acute cardiovascular complications?ResultsThe structured literature search yielded 2372 abstracts. There were no disagreements among the reviewers regarding inclusion or exclusion of individual studies. This review process yielded 310 articles to be read in full and reviewed by the committee members in detail. Of the total reviewed, only 10 articles satisfied all inclusion criteria.2–11 Despite the apparently common use of anticoagulation for progressing stroke or vertebrobasilar stroke, we found no Class I or II evidence addressing these specific clinical situations. None of the included studies that fulfilled the prespecified inclusion criteria and addressed the review’s key questions (see table 1) examined the use of hirudin, dipyridamole, ticlopidine, or clopidogrel in the setting of acute ischemic stroke. Table 2 summarizes the results. Summary of ResultsPlatelet antiaggregants and anticoagulants within 48 hours of acute ischemic strokeTreatmentBenefit dataRisk data* Compared with placebo/no aspirin.† Compared with no subcutaneous heparin (50% on ASA, 50% on no ASA).‡ Compared with no subcutaneous heparin.¶ Compared with placebo.§ Compared with aspirin.CAST = The Chinese Acute Stroke Trial; IST = The International Stroke Trial; MAST = The Multicentre Acute Stroke Trial–Italy; PE = pulmonary emboli; DVT = deep vein thrombosis; LMW = low molecular weight; TOAST = Trial of the Heparinoid ORG 10172 in Acute Stroke.AspirinPrevention of early recurrent ischemic stroke (CAST, IST)* Small benefit in reducing death and dependence (CAST, IST, MAST)Small increase in intracerebral hemorrhage or hemorrhagic transformation (CAST, IST, MAST)* Small increase in transfused or fatal extracranial hemorrhage (IST, CAST)*IV unfractionated heparinInadequate dataInadequate dataSQ unfractionated heparinSmall benefit in reducing early recurrent stroke outweighed by small increase in CNS hemorrhage (IST)† No benefit in reducing morbidity, mortality (IST)† Reduces PE and DVT (IST†, McCarthy and Turner6)‡Increase in symptomatic CNS hemorrhage (8/1000 treated, IST)† Increase in fatal or transfused systemic hemorrhage (9/1000 treated, IST)†LMW heparins/heparinoidsBenefit in reducing 6-month morbidity (nadroparin, Kay et al5)¶ No benefit in reducing 3-month morbidity (TOAST)¶ Reduces DVT (TOAST)¶Variable increase in systemic and CNS hemorrhage across studies (Kay et al.,5 TOAST,¶ Berge10§)Key questions1. Do antithrombotic agents reduce stroke mortality and stroke-related morbidity?Neither stroke-related mortality nor all-cause mortality was used as the primary endpoint in any of the studies included in this document. Stroke-related impairment was difficult to compare among the studies because different outcome scales were used and the interval after onset of the stroke at which stroke-related morbidity was assessed varied. The therapeutic agents used in the studies in which mortality and/or stroke-related impairment could be assessed included platelet antiaggregants,2,4,8 unfractionated heparin,4,6,7 and LMW heparin/heparinoids.3,5,10Platelet antiaggregants. Two large prospective, randomized, placebo-controlled trials included aspirin given within 48 hours of stroke onset.2,4 The Chinese Acute Stroke Trial (CAST) was a randomized, double-blind, placebo-controlled trial of aspirin at 160 mg/day started within 48 hours of onset of suspected acute ischemic stroke2 (Class I). A total of 21,106 patients were randomized at 413 hospitals at a mean of 25 hours after the onset of symptoms. Aspirin reduced early mortality rate (3.3 vs 3.9%; p = 0.04). However, the beneficial effects of aspirin did not reach significance for the primary endpoint of the combined proportion of patients who were dead or dependent at hospital discharge (30.5 vs 31.6%; p = 0.08).The International Stroke Trial (IST) was another large prospective, randomized, but open-label trial of aspirin and unfractionated heparin (Class II).4 A total of 19,436 patients were randomized at specialist and nonspecialist hospitals in 36 countries. Half of the patients were randomized to aspirin at 300 mg/day, and the remaining patients were randomized to a group instructed to avoid aspirin. In a factorial design, half of the patients in each group either received subcutaneous, unfractionated heparin or were instructed to avoid heparin. The treatment assignments persisted for up to 14 days, after which time the clinicians were encouraged to consider treating all patients with aspirin. Trends favoring aspirin in the proportion of patients who were dead at 14 days were not significant (heparin 9%, aspirin 9%; no heparin 9.3%, no aspirin 9.4%). The differences in proportion dead or dependent at 6 months also did not reach statistical significance (heparin 62.9%, aspirin 62.1%; no heparin 62.9%, no aspirin 63.5%). A combined analysis of the results of these two trials shows that aspirin (160 mg or 325 mg daily) had a small but statistically significant reduction of 9 (±3) fewer deaths or nonfatal strokes per 1000 treated patients (absolute risk reduction = 0.9%; number needed to treat = 111).12The Multicenter Acute Stroke Trial–Italy was a placebo-controlled, unblinded, randomized trial that included 465 patients who received either aspirin alone (n = 153), aspirin plus IV streptokinase (n = 156), or neither aspirin nor streptokinase (n = 156) within 6 hours of stroke onset (Class II). The streptokinase arm was associated with increased 10-day mortality. This study found no effect of aspirin (either alone or in combination with streptokinase) in reducing 10-day mortality rate (aspirin, 10% vs control, 13%), 6-month disability (aspirin, 42% vs control, 39%), or the combined endpoint.8 However, because only 153 patients received aspirin alone, this study was likely underpowered to determine whether aspirin alone reduced mortality and morbidity rates after stroke.A secondary analysis of a Phase II, randomized, double-blind, placebo-controlled, dose-escalation trial of abciximab, a platelet glycoprotein IIb/IIIa inhibitor, was relevant to the above question. This drug was given within 24 hours of acute ischemic stroke (abciximab-treated patients, n = 54; placebo-treated patients, n = 20). The study found a trend toward a higher rate of excellent recovery among patients who received abciximab (modified Rankin scale <1: 35% vs 20%; Barthel >98: 50% vs 40%), but the trial was not powered to detect clinically relevant differences in functional outcome assessments (Class I).9 Three-month mortality rate was not statistically different between the groups (placebo, 15% and abciximab, 17%).Unfractionated heparin. Available data demonstrate no reduction in mortality or morbidity rates with unfractionated heparin given subcutaneously to patients with acute stroke.4,6 In the IST trial,4 one-fourth of the patients were randomized to subcutaneous unfractionated heparin at 5000 IU twice daily and another one-fourth to 12,500 IU twice daily, whereas the remaining half were instructed to avoid unfractionated heparin. Thus, in the factorial design, half of the patients in each group either received aspirin or were instructed to avoid aspirin (Class II).Randomized, controlled trials of dose-adjusted IV unfractionated heparin in acute stroke that specifically address long-term, stroke-related morbidity and mortality have not been reported. One study published in 1986 reported a prospective, double-blind trial of dose-adjusted IV unfractionated heparin (Class I) in 225 patients with partial stable carotid and vertebrobasilar distribution stroke.7 This trial showed that there was no difference in death at 7 days between patients who were treated with unfractionated heparin (1/112 [0.89%]) and those treated with placebo (2/113 [1.77%]). Functional activity at 7 days, 3 months, and 1 year also was not significantly different between groups. At 6 months, the proportion of patients who were dead or dependent was identical for the group that received unfractionated heparin and the group that avoided heparin (62.9% in each). Mortality at one year was significantly increased in the unfractionated heparin-treated group compared with the placebo group (heparin, 17 vs control, 8; p <0.05).7Low molecular weight heparins/heparinoids. LMW heparins or heparinoids have antifactor Xa activity and a decreased tendency to induce thrombocytopenia compared with unfractionated heparin. A double-blind trial randomized 308 patients from four Hong Kong hospitals into three groups: placebo, nadroparin calcium at 4100 anti-Xa IU once daily, or 4100 anti-Xa IU twice daily (Class I).5 There was no reduction in death (7, 8, and 8 in the high, low, and placebo groups) or dependence at 3 months between the groups given nadroparin as compared with those given placebo (53% in high, 60% in low, and 64% in placebo groups). After 6 months, t" @default.
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• W1989935089 title "Anticoagulants and Antiplatelet Agents in Acute Ischemic Stroke" @default.
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