최근에 급성관상동맥증후군 또는 PCI 시행으로 P2Y12 inhibitor로 클로피도그렐을 복용 중이고 심방세동이 있는 환자에서 애픽사반만 추가한 것이 (애픽사반 + 위약 + 클로피도그렐)
In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor,
애픽사반 + 아스피린 + 클로피도그렐
와파린 + 아스피린 + 클로피도그렐
와파린 + 위약 + 클로피도그렐보다
출혈위험과 입원률이 더 적었고 허혈성 사건에 대해서는 차이가 없었습니다.
an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both.
화이자, BMS, 브로셔
In 2019, subsequent to the meta-analysis of the above trials, AUGUSTUS and ENTRUST-AF PCI were published and support the concept that NOAC plus a P2Y12 inhibitor is preferred to an OAC plus two antiplatelet agents in most cases:
● The AUGUSTUS trial used a two-by-two factorial design and randomly assigned 4614 patients with AF who had an ACS or had undergone PCI and were planning to take a P2Y12 inhibitor to apixaban or a VKA and to aspirin or matching placebo for six months. Patients taking long-term anticoagulant therapy for reasons other than AF were excluded. In more than 90 percent of patients, clopidogrel was the P2Y12 inhibitor chosen. The dose of apixaban was 5 mg twice daily and was adjusted to 2.5 mg twice daily according to the label criteria if a patient had two of three criteria, age was 80 years or greater, the weight was no more than 60 kg, or the creatinine level was 1.5 mg per deciliter or higher. The mean time from randomization to the index event was six days.
Comparison
s were made of apixaban versus warfarin and of aspirin versus placebo. One comparison of the four groups was made for the primary bleeding endpoint. Comparing apixaban with VKA:
• Major or clinically relevant nonmajor bleeding (the primary endpoint) was found in 10.5 percent of patients receiving apixaban compared with 14.7 percent of those receiving a VKA (HR 0.69, 95% CI 0.58-0.81).
Figure 2 (facing page). Kaplan–Meier Curves for
Primary Outcome of Major or Clinically Relevant
Nonmajor Bleeding.
Stated another way, the event rates (primary outcome) per 100 patient-years for VKA plus aspirin, apixaban plus aspirin, VKA plus placebo, and apixaban plus placebo were 49.1, 33.6, 26.7, and 16.8, respectively.
• The rate of death or hospitalization, a secondary endpoint, was lower with apixaban (23.5 versus 27.4 percent; HR 0.83, 95% CI 0.74-0.93)
Figure 3. Kaplan–Meier Curves for the Composite of Death or Hospitalization.
• There was no significant difference in the rate of ischemic events (the composite of death or hospitalization and the composite of death or ischemic events [stroke, MI, stent thrombosis (definite or probable)], or urgent revascularization) comparing apixaban with VKA or comparing aspirin with placebo, and no difference in the rate of stent thrombosis.
Comparing aspirin with placebo (ie, triple versus double therapy, pooling for type of anticoagulant):
• Major or clinically relevant nonmajor bleeding (the primary endpoint) was 16.1 percent of those receiving aspirin compared with 9.0 percent of those receiving placebo (HR 1.89, 95% CI 1.59-2.24).
Figure 2 (facing page). Kaplan–Meier Curves for
Primary Outcome of Major or Clinically Relevant
Nonmajor Bleeding.
• There was no significant difference in the rate of overall ischemic events (the composite of death or hospitalization and the composite of death or ischemic events [stroke, MI, stent thrombosis (definite or probable)], or urgent revascularization) comparing aspirin with placebo.
Figure 3. Kaplan–Meier Curves for the Composite of Death or Hospitalization.
• The study was underpowered for assessing differences in individual ischemic events. However, it should be mentioned that there was numerical twofold increase in stent thrombosis rates in patients with placebo compared with aspirin.
Figure 2 (facing page). Kaplan–Meier Curves for
Primary Outcome of Major or Clinically Relevant
Nonmajor Bleeding.
Figure 3. Kaplan–Meier Curves for the Composite of Death or Hospitalization.
REF. N Engl J Med 2019;380:1509-24.
UpToDate 2020.06.27
화이자, BMS 브로셔
