Risk of bleeding for dual antiplatelet therapy using ticagrelor or prasugrel vs clopidogrel in real-world acute coronary syndrome patients undergoing percutaneous intervention in England
This population–based cohort study emulating a tRCT (targeted randomized control trial) had evaluated the incidence and hazard rates of bleeding by various DAPT regimens in realworld ACS and STEMI patients undergoing PCI in England.
Compared to less potent DAPT*, more potent DAPT† increased the risk of bleeding without decreasing ischemic/CV events or mortality.
Up to one-fifth of patients switched their first DAPT prescription.
- Up to one-third of patients did not adhere to DAPT
- Patients receiving more potent DAPT had slightly higher non-adherence rates.
Authors highlighted that, the current findings should be carefully considered alongside RCT evidence while making recommendations about DAPT, as more potent DAPT might increase bleeding risk without reduction in CV events.
WHY THIS MATTERS
RCTs have shown that, in patients with ACS undergoing PCI, DAPT using prasugrel or ticagrelor‡ was found to be more efficacious in lowering the CV events§.
These RCTs, however, were primarily focused to evaluate ischemic events.
The increased bleeding risk associated with DAPT using ticagrelor and prasugrel was not adequately assessed.
This retrospective, population-based cohort study (ISRCTN76607611) emulating a tRCT, was
carried out¶ using routinely collected clinical data from the CPRD and HES databases.
Study population: Patients with ACS undergoing emergency PCI
- ACS: Bleeding risk compared between aspirin + clopidogrel (AC, reference) vs aspirin + ticagrelor (AT)
- STEMI: Bleeding risk compared between AC (reference) INTERVENTION ARMS vs AT, and AC vs aspirin + prasugrel (AP)
- Primary endpoint: Time to first bleeding event#
- Secondary endpoints: CPRD and HES-recorded bleeding||, ACM, CV mortality, mortality from bleeding, MI, stroke, additional coronary intervention, and MACCE
A total of 4,689 and 2,587 patients were included in ACS and STEMI groups, respectively.
Patients who received AT or AP vs AC were: Younger, had a higher percentage of men and
smokers with fewer comorbid conditions
RATES OF ANY BLEEDING BY ANTIPLATELET REGIMENS
CUMULATIVE BLEEDING RATES IN PATIENTS WITH ACS AND STEMI
In patients with ACS and STEMI, DAPT using ticagrelor or prasugrel was associated with increased hazard rates of any bleeding, without reduction in ischemic events and mortality.
For HR (95% CI) values, please click on the hyperlink
- Residual confounding and selection bias could have an impact on tRCT.
- Few eligible patients were excluded from the study, and this mighthave caused biasness in the results for both ischemic and bleedingevents.
For additional details, please refer the source publication Pufulete M, et al.
† With ticagrelor or prasugrel
‡ When compared to less potent DAPT using clopidogrel
§ Despite the incidence of higher bleeding
¶ April 2010 – Jan 2017
# Either CPRD-or HES-recorded
|| Requiring hospital admission
** CPRD and HES-recorded bleeding
†† Although both AP and AT resulted in 62% and 54% increase in CPRD bleeding, respectively
‡‡ Treatment switches/discontinuation: stopping aspirin/second antiplatelet/starting different antiplatelet
AC, aspirin + clopidogrel; ACM, all-cause mortality; ACS, acute coronary syndrome; AP, aspirin + prasugrel; AT, aspirin + ticagrelor; CI, cumulative incidence; CPRD, Clinical Practice Research Datalink; CV, cardiovascular; DAPT, dual antiplatelet therapy; HES, Hospital Episode Statistics; MACCE, major adverse cardiovascular and cerebrovascular events; MI, myocardial infraction; PCI, percutaneous coronary intervention; RCT, randomized control trial; HR, hazard ratio; STEMI, ST-elevated myocardial infraction; tRCT, targeted randomized control trial.
Pufulete M, Harris J, Pouwels K, Reeves BC, Lasserson D, Loke YK, et al. Real-world bleeding in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and prescribed different combinations of dual antiplatelet therapy (DAPT) in England: A population-based cohort study emulating a 'target trial'. Open Heart. 2022;9(2):e001999. doi: 10.1136/ openhrt-2022-001999. PMID: 35961692.
MAT-IN-2301958 - 09/2023
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