Unknown

Dataset Information

0

Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets: S2TOP-BLEED.


ABSTRACT:

Objective

To develop and externally validate a prediction model for major bleeding in patients with a TIA or ischemic stroke on antiplatelet agents.

Methods

We combined individual patient data from 6 randomized clinical trials (CAPRIE, ESPS-2, MATCH, CHARISMA, ESPRIT, and PRoFESS) investigating antiplatelet therapy after TIA or ischemic stroke. Cox regression analyses stratified by trial were performed to study the association between predictors and major bleeding. A risk prediction model was derived and validated in the PERFORM trial. Performance was assessed with the c statistic and calibration plots.

Results

Major bleeding occurred in 1,530 of the 43,112 patients during 94,833 person-years of follow-up. The observed 3-year risk of major bleeding was 4.6% (95% confidence interval [CI] 4.4%-4.9%). Predictors were male sex, smoking, type of antiplatelet agents (aspirin-clopidogrel), outcome on modified Rankin Scale ≥3, prior stroke, high blood pressure, lower body mass index, elderly, Asian ethnicity, and diabetes (S2TOP-BLEED). The S2TOP-BLEED score had a c statistic of 0.63 (95% CI 0.60-0.64) and showed good calibration in the development data. Major bleeding risk ranged from 2% in patients aged 45-54 years without additional risk factors to more than 10% in patients aged 75-84 years with multiple risk factors. In external validation, the model had a c statistic of 0.61 (95% CI 0.59-0.63) and slightly underestimated major bleeding risk.

Conclusions

The S2TOP-BLEED score can be used to estimate 3-year major bleeding risk in patients with a TIA or ischemic stroke who use antiplatelet agents, based on readily available characteristics. The discriminatory performance may be improved by identifying stronger predictors of major bleeding.

SUBMITTER: Hilkens NA 

PROVIDER: S-EPMC5683104 | biostudies-literature |

REPOSITORIES: biostudies-literature

Similar Datasets

| S-EPMC6885575 | biostudies-literature
| S-EPMC8459175 | biostudies-literature
| S-EPMC7928472 | biostudies-literature
| S-EPMC6794239 | biostudies-literature
| S-EPMC2818395 | biostudies-literature
| S-EPMC7188588 | biostudies-literature
| S-EPMC5390959 | biostudies-other
| S-EPMC6761671 | biostudies-other
| S-EPMC4802483 | biostudies-other
2016-04-01 | GSE66724 | GEO