Trial reportOpen heart2025
Parsimonious versus extensive bleeding score: can we simplify risk stratification after percutaneous coronary intervention and reduce bleeding events by de-escalation of the antiplatelet strategy?
Trial report in Open heart, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01813435 (GLOBAL LEADERS), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation
Who cites it
2 citing papers in PubMed.
- Modern Era in Personalized Medicine of Dual Antiplatelet Therapy After Myocardial Revascularization.Journal of clinical medicine · 2026Review
- Design and rationale of the South-East Netherlands Heart Registry (ZON-HR).Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsDue to the multitude of risk factors outlined in the guidelines, personalised dual antiplatelet therapy (DAPT) guidance after percutaneous coronary intervention (PCI) is complex. A simplified method was created to facilitate the use of risk stratification. We aimed to compare the predictive and prognostic value of the 'Zuidoost Nederland Hart Registratie' (ZON-HR) classification for bleeding risk with the PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent DAPT (PRECISE-DAPT) score and to determine the effect of ticagrelor monotherapy versus DAPT in patients with or without high bleeding risk (HBR).
methodsA post hoc analysis of the GLOBAL LEADERS trial was performed to compare the predictive value of the ZON-HR classification with the PRECISE-DAPT score. Also, the outcomes stratified by either method were compared and the interaction of HBR on the treatment effect was determined.
resultsThe required parameters for the ZON-HR classification (3.7% HBR) and PRECISE-DAPT score (16.6% HBR) were available in 99.9% and 93% of the patients, respectively. The ZON-HR classification had a lower sensitivity (0.09 vs 0.26) and a higher specificity (0.97 vs 0.84), positive predictive value (0.13 vs 0.08) and accuracy (0.92 vs 0.82). Regression analysis showed that both methods predicted hazard for bleeding risk with HRs of 1.87 (95% CI: 1.59 to 2.18) and 2.67 (95% CI: 2.10 to 3.41) for the PRECISE-DAPT score and ZON-HR classification, respectively. The omission of aspirin reduced bleeding events only in acute coronary syndrome (ACS) patients without HBR (HR: 0.74, 95% CI: 0.61 to 0.90, p value for interaction of HBR: 0.04).
conclusionsStratification for bleeding risk according to the ZON-HR classification was feasible in almost all patients and showed to be more conservative than the PRECISE-DAPT score with a consistent prognostic accuracy. The benefit of aspirin omission was the largest in ACS patients without HBR. TRIAL REGISTRATION NUMBER: NCT01813435.
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