Abstract
Background: Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications. Methods: We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS. Results: ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62). Conclusion: The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5pageSize=10page=1searchType=basic-searchoffset=3q=filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustriasort=.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 145-151 |
| Number of pages | 7 |
| Journal | Cerebrovascular Diseases |
| Volume | 43 |
| Issue number | 3-4 |
| DOIs | |
| State | Published - Apr 1 2017 |
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Keywords
- Asian ethnicity
- Blood pressure
- Cardiovascular disease
- Cerebrovascular disease
- Dual antithrombotic treatment or anticoagulant
- Elderly
- Lacune
- Low body mass index
- Sex
ASJC Scopus subject areas
- Neurology
- Clinical Neurology
- Cardiology and Cardiovascular Medicine
Cite this
The Intracranial-B2LEED3S Score and the Risk of Intracranial Hemorrhage in Ischemic Stroke Patients under Antiplatelet Treatment. / PERFORM and PRoFESS Committees and Investigators.
In: Cerebrovascular Diseases, Vol. 43, No. 3-4, 01.04.2017, p. 145-151.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The Intracranial-B2LEED3S Score and the Risk of Intracranial Hemorrhage in Ischemic Stroke Patients under Antiplatelet Treatment
AU - PERFORM and PRoFESS Committees and Investigators
AU - Amarenco, Pierre
AU - Sissani, Leila
AU - Labreuche, Julien
AU - Vicaut, Eric
AU - Bousser, Marie Germaine
AU - Chamorro, Angel
AU - Fisher, Marc
AU - Ford, Ian
AU - Fox, Kim M.
AU - Hennerici, Michael G.
AU - Mattle, Heinrich
AU - Rothwell, Peter M.
AU - Steg, Philippe Gabriel
AU - Diener, Hans Christoph
AU - Sacco, Ralph L
AU - Greving, Jacoba P.
AU - Algra, Ale
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Background: Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications. Methods: We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS. Results: ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62). Conclusion: The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5pageSize=10page=1searchType=basic-searchoffset=3q=filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustriasort=.
AB - Background: Chronic antiplatelet therapy in the post-acute phase of non-cardioembolic ischemic stroke is limited by the risk of intracranial hemorrhage (ICH) complications. Methods: We developed an ICH risk score based on the PERFORM trial cohort (n = 19,100), which included patients with a non-cardioembolic ischemic stroke or transient ischemic attack, and externally validated this score in one contemporary trial of very similar size and inclusion criteria, the PRoFESS trial (n = 20,332 patients). Outcome was ICH over 2 years. A Cox proportional-hazard regression analysis identified risk factors. Discrimination was quantified with c-statistics and calibration was assessed by comparing predicted and observed ICH risk in PERFORM and PRoFESS. Results: ICH occurred within 2 years in 263 (1.4%) patients in PERFORM trial and in 246 (1.2%) patients in PRoFESS trial. A 13-point score based on 9 items (Intracranial-B2LEED3S score - low body mass index, blood pressure, lacune, elderly, Asian ethnicity, coronary artery or cerebrovascular disease history, dual antithrombotic agent or oral anticoagulant, gender) was derived from the PERFORM trial. In PERFORM, the observed 2-year ICH risk varied from 0.75% in low-risk (score ≤2) to 2.44% in high-risk patients (score ≥5) with an acceptable calibration but a low discrimination both in PERFORM (c-statistic 0.64, 95% CI 0.61-0.68) and on external validation in PRoFESS (0.58, 95% CI 0.55-0.62). Conclusion: The Intracranial-B2LEED3S score helps identify patients who are at a high risk of bleeding. However, other variables need to be identified to improve the score (e.g., microbleeds) (Clinical Trial Registration Information ISRCTN66157730). URL: http://www.isrctn.com/ISRCTN66157730?totalResults=5pageSize=10page=1searchType=basic-searchoffset=3q=filters=conditionCategory%3ACirculatory+System%2CrecruitmentCountry%3ATaiwan%2CrecruitmentCountry%3AAustriasort=.
KW - Asian ethnicity
KW - Blood pressure
KW - Cardiovascular disease
KW - Cerebrovascular disease
KW - Dual antithrombotic treatment or anticoagulant
KW - Elderly
KW - Lacune
KW - Low body mass index
KW - Sex
UR - http://www.scopus.com/inward/record.url?scp=85010000869&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85010000869&partnerID=8YFLogxK
U2 - 10.1159/000453459
DO - 10.1159/000453459
M3 - Article
VL - 43
SP - 145
EP - 151
JO - Cerebrovascular Diseases
JF - Cerebrovascular Diseases
SN - 1015-9770
IS - 3-4
ER -