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<span class="hide tagmanagervalue" data-attribute="articleDOI" data-value="10.1001/jama.2022.0948" data-type="string"></span>
<span class="hide tagmanagervalue" data-attribute="articleTitle"
data-value="Association of Recent Use of Non–Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase" data-type="string"></span>
<span class="hide tagmanagervalue" data-attribute="articleType" data-value="Original Investigation" data-type="string"></span>
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<div class="meta-article-type thm-col">Original Investigation </div>
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<div class="meta-date">February 10, 2022</div>
<div class="meta-article-title-wrap">
<h1 class="meta-article-title ">Association of Recent Use of Non–Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase</h1>
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<div class="meta-authors">
<span class="meta-authors--limited"><span class="wi-fullname brand-fg"><a href="/searchresults?author=Wayneho+Kam&q=Wayneho+Kam" rel="nofollow" target="_blank">Wayneho Kam, MD<sup>1</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=DaJuanicia+N.+Holmes&q=DaJuanicia+N.+Holmes" rel="nofollow" target="_blank">DaJuanicia N. Holmes, MS<sup>2</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Adrian+F.+Hernandez&q=Adrian+F.+Hernandez" rel="nofollow" target="_blank">Adrian F. Hernandez, MD<sup>2,3</sup></a></span>;
<a class="meta-authors--etal td-u">et al</a></span>
<span class="meta-authors--remaining"><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jeffrey+L.+Saver&q=Jeffrey+L.+Saver" rel="nofollow" target="_blank">Jeffrey L. Saver, MD<sup>4</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Gregg+C.+Fonarow&q=Gregg+C.+Fonarow" rel="nofollow" target="_blank">Gregg C. Fonarow, MD<sup>5</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Eric+E.+Smith&q=Eric+E.+Smith" rel="nofollow" target="_blank">Eric E. Smith, MD, MPH<sup>6</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Deepak+L.+Bhatt&q=Deepak+L.+Bhatt" rel="nofollow" target="_blank">Deepak L. Bhatt, MD, MPH<sup>7</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Lee+H.+Schwamm&q=Lee+H.+Schwamm" rel="nofollow" target="_blank">Lee H. Schwamm, MD<sup>8</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Mathew+J.+Reeves&q=Mathew+J.+Reeves" rel="nofollow" target="_blank">Mathew J. Reeves, PhD<sup>9</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Roland+A.+Matsouaka&q=Roland+A.+Matsouaka" rel="nofollow" target="_blank">Roland A. Matsouaka, PhD<sup>2,10</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Yosef+M.+Khan&q=Yosef+M.+Khan" rel="nofollow" target="_blank">Yosef M. Khan, MD, MPH, PhD<sup>11</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Martin+Unverdorben&q=Martin+Unverdorben" rel="nofollow" target="_blank">Martin Unverdorben, MD, PhD<sup>12</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Mary+C.+Birmingham&q=Mary+C.+Birmingham" rel="nofollow" target="_blank">Mary C. Birmingham, PharmD<sup>13</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Patrick+D.+Lyden&q=Patrick+D.+Lyden" rel="nofollow" target="_blank">Patrick D. Lyden, MD<sup>14</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Andrew+W.+Asimos&q=Andrew+W.+Asimos" rel="nofollow" target="_blank">Andrew W. Asimos, MD<sup>15</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Dorothea+Altschul&q=Dorothea+Altschul" rel="nofollow" target="_blank">Dorothea Altschul, MD<sup>16</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Timothy+L.+Schoonover&q=Timothy+L.+Schoonover" rel="nofollow" target="_blank">Timothy L. Schoonover, DO<sup>17</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Mouhammad+A.+Jumaa&q=Mouhammad+A.+Jumaa" rel="nofollow" target="_blank">Mouhammad A. Jumaa, MD<sup>18</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Jason+T.+Nomura&q=Jason+T.+Nomura" rel="nofollow" target="_blank">Jason T. Nomura, MD<sup>19</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Muhammad+Fareed+K.+Suri&q=Muhammad+Fareed+K.+Suri" rel="nofollow" target="_blank">Muhammad Fareed K. Suri, MD<sup>20</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=S.+Arthur+Moore&q=S.+Arthur+Moore" rel="nofollow" target="_blank">S. Arthur Moore, MD<sup>21</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Eugene+F.+Lafranchise&q=Eugene+F.+Lafranchise" rel="nofollow" target="_blank">Eugene F. Lafranchise, MD<sup>22</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=DaiWai+Olson&q=DaiWai+Olson" rel="nofollow" target="_blank">DaiWai Olson, PhD, RN<sup>23</sup></a></span><span class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Eric+D.+Peterson&q=Eric+D.+Peterson" rel="nofollow" target="_blank">Eric D. Peterson, MD, MPH<sup>24</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Ying+Xian&q=Ying+Xian" rel="nofollow" target="_blank">Ying Xian, MD, PhD<sup>23</sup></a></span></span>
</div>
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<div class="meta-author-name"><sup>1</sup>Department of Neurology, Duke University Medical Center, Durham, North Carolina</div>
</li>
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<div class="meta-author-name"><sup>2</sup>Duke Clinical Research Institute, Duke University, Durham, North Carolina</div>
</li>
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<div class="meta-author-name"><sup>3</sup>Division of Cardiology, Duke University Medical Center, Durham, North Carolina</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>4</sup>Department of Neurology, University of California, Los Angeles</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>5</sup>Division of Cardiology, University of California, Los Angeles</div>
</li>
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<div class="meta-author-name"><sup>6</sup>Department of Clinical Neurosciences and the Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>7</sup>Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>8</sup>Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>9</sup>Department of Epidemiology and Biostatistics, Michigan State University, East Lansing</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>10</sup>Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>11</sup>Health Informatics and Analytics, Center for Health Metrics and Evaluation, American Heart Association, Dallas, Texas</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>12</sup>Daiichi Sankyo Inc, Basking Ridge, New Jersey</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>13</sup>Janssen Scientific Affairs LLC, Titusville, New Jersey</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>14</sup>Zilkha Neurogenetic Institute of the Keck School of Medicine, University of Southern California, Los Angeles</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>15</sup>Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>16</sup>Valley Hospital, Ridgewood, New Jersey</div>
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<div class="meta-author-name"><sup>17</sup>Dayton Center for Neurological Disorders, Centerville, Ohio</div>
</li>
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<div class="meta-author-name"><sup>18</sup>Department of Neurology, ProMedica Toledo Hospital, University of Toledo, Toledo, Ohio</div>
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<div class="meta-author-name"><sup>19</sup>Department of Emergency Medicine, ChristianaCare, Newark, Delaware</div>
</li>
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<div class="meta-author-name"><sup>20</sup>CentraCare, St Cloud, Minnesota</div>
</li>
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<div class="meta-author-name"><sup>21</sup>Fort Sanders Regional Medical Center, Knoxville, Tennessee</div>
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<div class="meta-author-name"><sup>22</sup>Ascension Saint Thomas Hospital, Nashville, Tennessee</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>23</sup>Department of Neurology, University of Texas Southwestern Medical Center, Dallas</div>
</li>
<li class="meta-author-affiliation">
<div class="meta-author-name"><sup>24</sup>Division of Cardiology, University of Texas Southwestern Medical Center, Dallas</div>
</li>
</ul>
</div>
</div>
<div class="meta-citation-wrap">
<span class="meta-citation-journal-name">JAMA. </span><span class="meta-citation"> 2022;327(8):760-771. doi:10.1001/jama.2022.0948</span>
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<p><strong>Question</strong> <span>Is the recent use of non–vitamin K antagonist oral anticoagulants (NOACs) associated with increased risk of intracranial hemorrhage among patients with acute ischemic stroke treated with
intravenous alteplase?</span></p>
<p><strong>Findings</strong> <span>This US retrospective cohort study included 163 038 patients with acute ischemic stroke treated with alteplase. Among patients with use of NOACs within 7 days of hospital arrival vs patients with
no use of anticoagulants, intracranial hemorrhage occurred in 3.7% vs 3.2%, respectively, a difference that was not statistically significant after multivariable adjustment.</span></p>
<p><strong>Meaning</strong> <span>Recent use of NOACs was not significantly associated with increased risk of intracranial hemorrhage among patients with acute ischemic stroke treated with alteplase.</span></p>
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<p><strong>Importance</strong> <span>Current guidelines recommend against use of intravenous alteplase in patients with acute ischemic stroke who are taking non–vitamin K antagonist oral anticoagulants (NOACs).</span></p>
<p><strong>Objective</strong> <span>To evaluate the safety and functional outcomes of intravenous alteplase among patients who were taking NOACs prior to stroke and compare outcomes with patients who were not taking long-term
anticoagulants.</span></p>
<p><strong>Design, Setting, and Participants</strong> <span>A retrospective cohort study of 163 038 patients with acute ischemic stroke either taking NOACs or not taking anticoagulants prior to stroke and treated with intravenous
alteplase within 4.5 hours of symptom onset at 1752 US hospitals participating in the Get With The Guidelines–Stroke program between April 2015 and March 2020, with complementary data from the Addressing Real-world Anticoagulant
Management Issues in Stroke registry.</span></p>
<p><strong>Exposures</strong> <span>Prestroke treatment with NOACs within 7 days prior to alteplase treatment.</span></p>
<p><strong>Main Outcomes and Measures</strong> <span>The primary outcome was symptomatic intracranial hemorrhage occurring within 36 hours after intravenous alteplase administration. There were 4 secondary safety outcomes,
including inpatient mortality, and 7 secondary functional outcomes assessed at hospital discharge, including the proportion of patients discharged home.</span></p>
<p><strong>Results</strong> <span>Of 163 038 patients treated with intravenous alteplase (median age, 70 [IQR, 59 to 81] years; 49.1% women), 2207 (1.4%) were taking NOACs and 160 831 (98.6%) were not taking anticoagulants prior
to their stroke. Patients taking NOACs were older (median age, 75 [IQR, 64 to 82] years vs 70 [IQR, 58 to 81] years for those not taking anticoagulants), had a higher prevalence of cardiovascular comorbidities, and experienced more
severe strokes (median National Institutes of Health Stroke Scale score, 10 [IQR, 5 to 17] vs 7 [IQR, 4 to 14]) (all standardized differences >10). The unadjusted rate of symptomatic intracranial hemorrhage was 3.7% (95% CI, 2.9%
to 4.5%) for patients taking NOACs vs 3.2% (95% CI, 3.1% to 3.3%) for patients not taking anticoagulants. After adjusting for baseline clinical factors, the risk of symptomatic intracranial hemorrhage was not significantly different
between groups (adjusted odds ratio [OR], 0.88 [95% CI, 0.70 to 1.10]; adjusted risk difference [RD], −0.51% [95% CI, −1.36% to 0.34%]). There were no significant differences in the secondary safety outcomes, including inpatient
mortality (6.3% for patients taking NOACs vs 4.9% for patients not taking anticoagulants; adjusted OR, 0.84 [95% CI, 0.69 to 1.01]; adjusted RD, −1.20% [95% CI, −2.39% to −0%]). Of the secondary functional outcomes, 4 of 7 showed
significant differences in favor of the NOAC group after adjustment, including the proportion of patients discharged home (45.9% vs 53.6% for patients not taking anticoagulants; adjusted OR, 1.17 [95% CI, 1.06 to 1.29]; adjusted RD,
3.84% [95% CI, 1.46% to 6.22%]).</span></p>
<p><strong>Conclusions and Relevance</strong> <span>Among patients with acute ischemic stroke treated with intravenous alteplase, use of NOACs within the preceding 7 days, compared with no use of anticoagulants, was not associated
with a significantly increased risk of intracranial hemorrhage.</span></p>
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<div class="comment-item--date-submitted">February 15, 2022</div>
<div class="comment-item--title thm-col fw-b sb-pc">Confounding Factors</div>
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<span class="author-name fw-b">Saeed Taheri, MD.</span> | New Lahijan Scientific Foundation
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<span class="comment-item--text-limited ellipsis">David J. Seiffge [1] has mentioned a number of potential selection biases associated with the study by Kam et al. [2]. There are also many potential confounding variables. The
authors employed multivariable logistic regression analysis but did not report coefficients for the many independent ('adjustment') variables in the model in the article or the supplementary material. It would be important to see
these results to understand all the factors possibly confounding the outcome, most notably other comorbidities, history of previous stroke, simultaneous use of antiplatelets (e.g. aspirin or dual agent therapy) or other anticoags.
An exploratory analysis of the outcome</span>
<span class="comment-item--text-remaining"> directed at finding sub-populations at highest risk of the outcomes would be desirable. For example is it safe to use thrombolysis in patients taking both aspirin (or dual antiplatelets)
and a NOAC vs. NOAC alone or antiplatelets alone and even vitamin K anticoagulation? We need to know which subpopulation is at highest risk and which ones might experience the most benefit. Another interesting analysis could have
been association of ICH with the hard outcomes of the study (i.e. mortality). <br>
<br> References:<br> 1. Seiffge DJ. Intravenous Thrombolytic Therapy for Treatment of Acute Ischemic Stroke in Patients Taking Non–Vitamin K Antagonist Oral Anticoagulants. JAMA. Published online February 10, 2022.
doi:10.1001/jama.2022.0068<br><br> 2. Kam W, Holmes DN, Hernandez AF, et al. Association of Recent Use of Non–Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated
With Alteplase. JAMA. Published online February 10, 2022. doi:10.1001/jama.2022.0948<br><br></span>
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<div class="comment-item--date-submitted">February 26, 2022</div>
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<span class="author-name fw-b">Qunfengking Wq433121, Dr.</span> | Wuhan University
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<div class="comment-item--text"> If guidelines recommend against use of rTPA in patients previously using NOACs, how can there still 2207 (1.4%) who were taking NOACs in this RCT? </div>
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TRENDING
* Highlights From the International Stroke Conference 2022—Thrombectomy and
Alteplase, Access to Stroke Centers, and Warfarin vs Direct Oral
Anticoagulants
News
February 23, 2022
* Intravenous Thrombolytic Therapy for Treatment of Acute Ischemic Stroke in
Patients Taking NOACs
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February 22, 2022
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Original Investigation
February 10, 2022
ASSOCIATION OF RECENT USE OF NON–VITAMIN K ANTAGONIST ORAL ANTICOAGULANTS WITH
INTRACRANIAL HEMORRHAGE AMONG PATIENTS WITH ACUTE ISCHEMIC STROKE TREATED WITH
ALTEPLASE
Wayneho Kam, MD1; DaJuanicia N. Holmes, MS2; Adrian F. Hernandez, MD2,3; et al
Jeffrey L. Saver, MD4; Gregg C. Fonarow, MD5; Eric E. Smith, MD, MPH6; Deepak
L. Bhatt, MD, MPH7; Lee H. Schwamm, MD8; Mathew J. Reeves, PhD9; Roland
A. Matsouaka, PhD2,10; Yosef M. Khan, MD, MPH, PhD11; Martin Unverdorben, MD,
PhD12; Mary C. Birmingham, PharmD13; Patrick D. Lyden, MD14; Andrew
W. Asimos, MD15; Dorothea Altschul, MD16; Timothy L. Schoonover, DO17; Mouhammad
A. Jumaa, MD18; Jason T. Nomura, MD19; Muhammad Fareed K. Suri, MD20; S.
Arthur Moore, MD21; Eugene F. Lafranchise, MD22; DaiWai Olson, PhD, RN23; Eric
D. Peterson, MD, MPH24; Ying Xian, MD, PhD23
Author Affiliations Article Information
* 1Department of Neurology, Duke University Medical Center, Durham, North
Carolina
* 2Duke Clinical Research Institute, Duke University, Durham, North Carolina
* 3Division of Cardiology, Duke University Medical Center, Durham, North
Carolina
* 4Department of Neurology, University of California, Los Angeles
* 5Division of Cardiology, University of California, Los Angeles
* 6Department of Clinical Neurosciences and the Hotchkiss Brain Institute,
University of Calgary, Calgary, Alberta, Canada
* 7Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical
School, Boston, Massachusetts
* 8Department of Neurology, Massachusetts General Hospital and Harvard Medical
School, Boston
* 9Department of Epidemiology and Biostatistics, Michigan State University,
East Lansing
* 10Department of Biostatistics and Bioinformatics, Duke University, Durham,
North Carolina
* 11Health Informatics and Analytics, Center for Health Metrics and Evaluation,
American Heart Association, Dallas, Texas
* 12Daiichi Sankyo Inc, Basking Ridge, New Jersey
* 13Janssen Scientific Affairs LLC, Titusville, New Jersey
* 14Zilkha Neurogenetic Institute of the Keck School of Medicine, University of
Southern California, Los Angeles
* 15Department of Emergency Medicine, Carolinas Medical Center, Charlotte,
North Carolina
* 16Valley Hospital, Ridgewood, New Jersey
* 17Dayton Center for Neurological Disorders, Centerville, Ohio
* 18Department of Neurology, ProMedica Toledo Hospital, University of Toledo,
Toledo, Ohio
* 19Department of Emergency Medicine, ChristianaCare, Newark, Delaware
* 20CentraCare, St Cloud, Minnesota
* 21Fort Sanders Regional Medical Center, Knoxville, Tennessee
* 22Ascension Saint Thomas Hospital, Nashville, Tennessee
* 23Department of Neurology, University of Texas Southwestern Medical Center,
Dallas
* 24Division of Cardiology, University of Texas Southwestern Medical Center,
Dallas
JAMA. 2022;327(8):760-771. doi:10.1001/jama.2022.0948
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* Editorial
Intravenous Thrombolytic Therapy for Treatment of Acute Ischemic Stroke in
Patients Taking NOACs
David J. Seiffge, MD
* Medical News & Perspectives
Highlights From the International Stroke Conference 2022—Thrombectomy and
Alteplase, Access to Stroke Centers, and Warfarin vs Direct Oral
Anticoagulants
Melissa Suran, PhD, MSJ
* Preliminary Communication
Intra-arterial Alteplase After Successful Thrombectomy and Functional
Outcomes in Large Vessel Occlusion Stroke
Arturo Renú, MD; Mónica Millán, MD; Luis San Román, MD; Jordi Blasco, MD;
Joan Martí-Fàbregas, MD; Mikel Terceño, MD; Sergio Amaro, MD;
Joaquín Serena, MD; Xabier Urra, MD; Carlos Laredo, PhD; Roger Barranco, MD;
Pol Camps-Renom, MD; Federico Zarco, MD; Laura Oleaga, MD; Pere Cardona, MD;
Carlos Castaño, MD; Juan Macho, MD; Elisa Cuadrado-Godía, MD; Elio Vivas, MD;
Antonio López-Rueda, MD; Leopoldo Guimaraens, MD; Anna Ramos-Pachón, MD;
Jaume Roquer, MD; Marian Muchada, MD; Alejandro Tomasello, MD;
Antonio Dávalos, MD; Ferran Torres, MD; Ángel Chamorro, MD; CHOICE
Investigators; Laura Llull; Martha Vargas; Victor Obach; Salvatore Rudilosso;
Alejandro Rodríguez-Vázquez; Daniel Santana; Napoleón Macías; Elena Serrano;
Javier Moreno; Natalia Pérez de la Ossa; Laura Dorado; Maria Hernández-Pérez;
Meritxell Gomis; Lucia Muñoz; P. Rodríguez-Molinos; Martí Boix;
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Álvarez-Cienfuegos; M. Comas; B. Martínez; E. Nogué; Oscar Chirife;
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Angel de Miquel; Sónia Aixut; Anna Maria Ferrer; R. Marín;
Luis Prats-Sánchez; Raquel Delgado-Mederos; A Martínez-Domeño; Joan Branera;
R. Guerrero; J, Villalba; A, Rodríguez; N. Berga; Elena Jiménez-Xarrié;
G. Romeral; Ángel Ois; Jordi Jiménez; C. Avellaneda; N, Cayuela;
Ana Rodríguez; Eva Giralt; M Espona; J. Saldaña; David Hernández; Marc Ribó;
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Full Text
Key Points
Question Is the recent use of non–vitamin K antagonist oral anticoagulants
(NOACs) associated with increased risk of intracranial hemorrhage among patients
with acute ischemic stroke treated with intravenous alteplase?
Findings This US retrospective cohort study included 163 038 patients with
acute ischemic stroke treated with alteplase. Among patients with use of NOACs
within 7 days of hospital arrival vs patients with no use of anticoagulants,
intracranial hemorrhage occurred in 3.7% vs 3.2%, respectively, a difference
that was not statistically significant after multivariable adjustment.
Meaning Recent use of NOACs was not significantly associated with increased
risk of intracranial hemorrhage among patients with acute ischemic stroke
treated with alteplase.
Abstract
Importance Current guidelines recommend against use of intravenous alteplase in
patients with acute ischemic stroke who are taking non–vitamin K antagonist oral
anticoagulants (NOACs).
Objective To evaluate the safety and functional outcomes of intravenous
alteplase among patients who were taking NOACs prior to stroke and compare
outcomes with patients who were not taking long-term anticoagulants.
Design, Setting, and Participants A retrospective cohort study of 163 038
patients with acute ischemic stroke either taking NOACs or not taking
anticoagulants prior to stroke and treated with intravenous alteplase within 4.5
hours of symptom onset at 1752 US hospitals participating in the Get With The
Guidelines–Stroke program between April 2015 and March 2020, with complementary
data from the Addressing Real-world Anticoagulant Management Issues in Stroke
registry.
Exposures Prestroke treatment with NOACs within 7 days prior to alteplase
treatment.
Main Outcomes and Measures The primary outcome was symptomatic intracranial
hemorrhage occurring within 36 hours after intravenous alteplase administration.
There were 4 secondary safety outcomes, including inpatient mortality, and 7
secondary functional outcomes assessed at hospital discharge, including the
proportion of patients discharged home.
Results Of 163 038 patients treated with intravenous alteplase (median age, 70
[IQR, 59 to 81] years; 49.1% women), 2207 (1.4%) were taking NOACs and 160 831
(98.6%) were not taking anticoagulants prior to their stroke. Patients taking
NOACs were older (median age, 75 [IQR, 64 to 82] years vs 70 [IQR, 58 to 81]
years for those not taking anticoagulants), had a higher prevalence of
cardiovascular comorbidities, and experienced more severe strokes (median
National Institutes of Health Stroke Scale score, 10 [IQR, 5 to 17] vs 7 [IQR, 4
to 14]) (all standardized differences >10). The unadjusted rate of symptomatic
intracranial hemorrhage was 3.7% (95% CI, 2.9% to 4.5%) for patients taking
NOACs vs 3.2% (95% CI, 3.1% to 3.3%) for patients not taking anticoagulants.
After adjusting for baseline clinical factors, the risk of symptomatic
intracranial hemorrhage was not significantly different between groups (adjusted
odds ratio [OR], 0.88 [95% CI, 0.70 to 1.10]; adjusted risk difference [RD],
−0.51% [95% CI, −1.36% to 0.34%]). There were no significant differences in the
secondary safety outcomes, including inpatient mortality (6.3% for patients
taking NOACs vs 4.9% for patients not taking anticoagulants; adjusted OR, 0.84
[95% CI, 0.69 to 1.01]; adjusted RD, −1.20% [95% CI, −2.39% to −0%]). Of the
secondary functional outcomes, 4 of 7 showed significant differences in favor of
the NOAC group after adjustment, including the proportion of patients discharged
home (45.9% vs 53.6% for patients not taking anticoagulants; adjusted OR, 1.17
[95% CI, 1.06 to 1.29]; adjusted RD, 3.84% [95% CI, 1.46% to 6.22%]).
Conclusions and Relevance Among patients with acute ischemic stroke treated
with intravenous alteplase, use of NOACs within the preceding 7 days, compared
with no use of anticoagulants, was not associated with a significantly increased
risk of intracranial hemorrhage.
* Editorial
Intravenous Thrombolytic Therapy for Treatment of Acute Ischemic Stroke in
Patients Taking NOACs
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2 Comments for this article
EXPAND ALL
February 15, 2022
Confounding Factors
Saeed Taheri, MD. | New Lahijan Scientific Foundation
David J. Seiffge [1] has mentioned a number of potential selection biases
associated with the study by Kam et al. [2]. There are also many potential
confounding variables. The authors employed multivariable logistic regression
analysis but did not report coefficients for the many independent ('adjustment')
variables in the model in the article or the supplementary material. It would be
important to see these results to understand all the factors possibly
confounding the outcome, most notably other comorbidities, history of previous
stroke, simultaneous use of antiplatelets (e.g. aspirin or dual agent therapy)
or other anticoags. An exploratory analysis of the outcome directed at finding
sub-populations at highest risk of the outcomes would be desirable. For example
is it safe to use thrombolysis in patients taking both aspirin (or dual
antiplatelets) and a NOAC vs. NOAC alone or antiplatelets alone and even vitamin
K anticoagulation? We need to know which subpopulation is at highest risk and
which ones might experience the most benefit. Another interesting analysis could
have been association of ICH with the hard outcomes of the study (i.e.
mortality).
References:
1. Seiffge DJ. Intravenous Thrombolytic Therapy for Treatment of Acute Ischemic
Stroke in Patients Taking Non–Vitamin K Antagonist Oral Anticoagulants. JAMA.
Published online February 10, 2022. doi:10.1001/jama.2022.0068
2. Kam W, Holmes DN, Hernandez AF, et al. Association of Recent Use of
Non–Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among
Patients With Acute Ischemic Stroke Treated With Alteplase. JAMA. Published
online February 10, 2022. doi:10.1001/jama.2022.0948
CONFLICT OF INTEREST: None Reported
READ MORE
February 26, 2022
Question
Qunfengking Wq433121, Dr. | Wuhan University
If guidelines recommend against use of rTPA in patients previously using NOACs,
how can there still 2207 (1.4%) who were taking NOACs in this RCT?
CONFLICT OF INTEREST: None Reported
READ MORE ABOUT
Anticoagulation Emergency Medicine Cerebrovascular Disease Cerebrovascular
Infarction Neurology Stroke Bleeding and Transfusion Cerebrovascular Hemorrhage
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CITATION
Kam W, Holmes DN, Hernandez AF, et al. Association of Recent Use of Non–Vitamin
K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients
With Acute Ischemic Stroke Treated With Alteplase. JAMA. 2022;327(8):760–771.
doi:10.1001/jama.2022.0948
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