Background:
Proton pump inhibitors
(PPIs) are used to prevent gastrointestinal hemorrhage in patients with coronary
treatment undergoing dual antiplatelet therapy (DAPT).
Methods:
A
systematic review was performed to compare the outcomes between DAPT and DAPT +
PPI in acute coronary syndrome (ACS) patients or patients who took percutaneous
coronary intervention (PCI) with coronary stent implantation (PCI patients), and
to estimate, for the first time, the sample size needed for reliable results via
trial sequential analysis (TSA). The PubMed, EMBASE, the Cochrane Library and Web of Science databases were searched for articles authored from the onset until
November 1, 2022, for randomized controlled trials (RCTs) comparing outcomes in
ACS or PCI patients who undertook DAPT or DAPT + PPI. The primary outcomes were
the incidence rate of gastrointestinal events and major adverse cardiovascular
events (MACEs).
Results:
The initial web search retrieved 786 literature
references. Eventually, eight articles published between 2009 and 2020 were
incorporated into the systematic review and meta-analysis. The combined results
established a non-significant variation in MACEs incidences between the DAPT group and DAPT + PPI group [risk ratio (RR) = 0.93, 95% confidence
interval (CI) = 0.81–1.06,
p
= 0.27,
= 0%];
conversely, the incidence of gastrointestinal events was significantly decreased
in the DAPT + PPI group in comparison with the DAPT group (RR = 0.33, 95% CI =
0.24–0.45,
p
0.00001,
= 0%). TSA of
MACEs and gastrointestinal events revealed that meta-analysis included adequate
trials (required sample size = 6874) in the pool to
achieve 80% study power.
Conclusions:
Based on our results, DAPT + PPI
can significantly reduce gastrointestinal outcomes without affecting
cardiovascular outcomes in PCI and ACS patients compared to DAPT.