RT Journal Article
SR Electronic
T1 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’
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e001999
DO 10.1136/openhrt-2022-001999
VO 9
IS 2
A1 Maria Pufulete
A1 Jessica Harris
A1 Koen Pouwels
A1 Barney C Reeves
A1 Daniel Lasserson
A1 Yoon K Loke
A1 Andrew Mumford
A1 Kalaivani Mahadevan
A1 Thomas W Johnson
YR 2022
UL http://openheart.bmj.com/content/9/2/e001999.abstract
AB Objective To estimate the incidence and HRs for bleeding for different dual antiplatelet therapies (DAPT) in a real-world population with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in England.Design A retrospective, population-based cohort study emulating a target randomised controlled trial (tRCT).Data sources Linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES).Setting Primary and secondary care.Participants Patients ≥18 years old with ACS undergoing emergency PCI.Interventions Aspirin and clopidogrel (AC, reference) versus aspirin and prasugrel (AP) or aspirin and ticagrelor (AT); AP evaluated only in patients with ST-elevation myocardial infarction (STEMI).Main outcome measures Primary: any bleeding up to 12 months after the index event (HES- or CPRD- recorded). Secondary: HES-recorded bleeding, CPRD-recorded bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular and cerebrovascular events (MACCE).Results In ACS, the rates of any bleeding for AC and AT were 89 per 1000 person years and 134 per 1000 person years, respectively. In STEMI, rates for AC, AP and AT were 93 per 1000 person years, 138 per 1000 person years and 143 per 100 person years, respectively. In ACS, compared with AC, AT increased the hazard of any bleeding (HR: 1.47, 95% CI 1.19 to 1.82) but did not reduce MACCE (HR: 1.06, 95% CI 0.89 to 1.27). In STEMI, compared with AC, AP and AT increased the hazard of any bleeding (HR: 1.77, 95% CI 1.21 to 2.59 and HR: 1.50, 95% CI 1.10 to 2.05, respectively) but did not reduce MACCE (HR: 1.10, 95% CI 0.80 to 1.51 and HR: 1.21, 95% CI 0.94 to 1.51, respectively). Non-adherence to the prescribed DAPT regimen was 28% in AC (29% in STEMI only), 31% in AP (STEMI only) and 33% in AT (32% in STEMI only).Conclusions In a real-world population with ACS, DAPT with ticagrelor or prasugrel are associated with increased bleeding compared with DAPT with clopidogrel.Trial registration number ISRCTN76607611.No data are available.