ABSTRACT
Objective:
To investigate the effect of
platelet reactivity and other clinical factors on the postoperative 1-year adverse clinical events in
patients who underwent selective
percutaneous coronary intervention (PCI) anticoagulated with bivalirudin.
Methods:
This is a multicenter, retrospective and
observational study, enrolling 632
patients at high
risk of
bleeding adjudicated by
operators who underwent selective PCI anticoagulated with bivalirudin and had preoperative
thrombelastography (TEG) test results in Fuwai
Hospital, Northern Theater
General Hospital and Xinxiang Central
Hospital between January 2017 and August 2018.
Platelet reactivity was tested by TEG and
adenosine-induced maximal amplitude (MAADP) was recorded. According to MAADP
patients were divided into three groups low on-
treatment platelet reactivity (LTPR) group (MAADP<31 mm, n=229), normal on-
treatment platelet reactivity (NTPR) group (31 mm≤MAADP≤47 mm, n=207) and high on-
treatment platelet reactivity (HTPR) group (MAADP>47 mm, n=196). The endpoints consisted of major adverse cardiovascular and cerebrovascular events (MACCE) and
bleeding events. The definition of MACCE was the composite of all-cause
mortality,
myocardial infarction, intrastent
thrombosis,
stroke and revascularization.
Bleeding events were defined by
bleeding academic
research consortium (BARC) type 2, 3 and 5
bleeding. Using multivariate Cox regression to analyze the factors of MACCE and
bleeding events in
patients underwent selective PCI anticoagulated with bivalirudin.
Results:
A total of 632
patients were finally enrolled in the study with age of (68.3±10.0) years and there were 423 (66.9%)
males. All of 632
patients finished one-year follow-up, and 48 (7.6%)
patients occurred MACCE and 11 (1.7%)
patients occurred
bleeding events. There was not statistically significant difference in the
incidence of MACCE (8.3% (19/229) vs. 6.3% (13/207) vs.8.2% (16/196), P=0.68) and
bleeding events (1.8% (4/229) vs. 2.9% (6/207) vs. 0.5% (1/196), P=0.17) in LTPR, NTPR and HTPR group. Multivariate Cox regression showed that HTPR was not the independent factor of MACCE (HR=1.25, 95%CI 0.67-2.30, P=0.49), and the
history of peripheral vessel
disease was the independent
risk factor of MACCE (HR=2.47, 95%CI 1.19-5.11, P=0.02). LTPR was not the independent factor of
bleeding events (HR=1.35, 95%CI 0.39-4.66, P=0.64), and the independent factors of
bleeding events were
history of peripheral vessel
disease (HR=3.95, 95%CI 1.03-15.22, P=0.05) and
hemoglobin (HR=0.96, 95%CI 0.93-0.99, P=0.01).
Conclusions:
In
patients undergoing selective PCI anticoagulated with bivalirudin, there is no significant
association between
platelet reactivity and postoperative 1-year MACCE or
bleeding events.
History of peripheral vessel
disease is an independent
risk factor of MACCE, and
history of peripheral vessel
disease and decreased
hemoglobin are independent
risk factors of
bleeding events.