Abstract
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.
| Original language | English |
|---|---|
| Article number | e001999 |
| Journal | Open Heart |
| Volume | 9 |
| Issue number | 2 |
| Early online date | 12 Aug 2022 |
| DOIs | |
| Publication status | Published - 12 Aug 2022 |
Bibliographical note
Funding Information:This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA 14/192/89). The British Heart Foundation and NIHR Bristol Biomedical Research Unit for Cardiovascular Disease funded some staff time (MP, JH and BCR). DSL is partly funded by the NIHR Applied Research Collaboration West Midlands. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.
Funding Information:
Clinical Practice Research Datalink (CPRD) is a database of primary care electronic health record data covering roughly 7% of the UK population. CPRD is linked with Hospital Episode Statistics (HES), which covers hospital admissions for all English patients whose treatment is funded by the UK National Health Service. The study protocol was approved by the Independent Scientific Advisory Committee of the CPRD (protocol number: 16_126R).
Publisher Copyright:
© 2022 Author(s) (or their employer(s)). Re-use permitted under CC BY. Published by BMJ.
Structured keywords
- BTC (Bristol Trials Centre)
Keywords
- Dual antiplatelet therapy (DAPT)
- acute coronary syndrome (ACS)
- percutaneous coronary intervention (PCI)
- bleeding
- Clinical Practice Research Datalink (CPRD)
- Hospital Episode Statistics (HES)