Non -favorable was not proven to death and ischemic events between P2Y12 inhibitor and dual antiplatelet therapy (DAPT) given for 12 months after home in patients with acute coronary syndromes (ACS).
DAPT consisting of aspirin plus a powerful P2Y12 inhibitor for 12 months is recommended for patients with ACS (myocardial infarction [MI] and unstable angina) after transdermal coronary intervention (PCI) with stent implantation.
Recent evidence suggests that aspirin withdrawal after 1 to 3 months DAPT, followed by P2Y12 inhibitor monotherapy can reduce bleeding while preventing recurrent ischemic events compared to 12 months DAPT. We conducted the Neo-Mindset test to investigate specifically whether P2Y12 inhibitor monotherapy could be used in the early phase, immediately after PCI and for all 12 months compared to DAPT for 12 months. “
Pedro Lemos, Main researcher, professor By Israeli Hospital Albert Einstein, Sao Paulo of Brazil
The randomized controlled Neo-Mindset test of the open label was held in 50 seats in Brazil. Patients with ACS who underwent successful PCIs with 1: 1 randomized 1: 1 within the first 4 days of hospitalization to stop aspirin and receive strong monotherapy with P2Y12 inhibitor (Ticagrelor or Prasugrel) or DAPT (aspirin plus a powerful P2y).
The first primary result was a complex death, Mi, stroke or urgent coronary coronary coronary target-Vessel, with an absolute risk difference of 2.5 percentage points defined as the predetermined margin of non-inferiority. The second primary result was significant or clinically relative non -mamjor bleeding, with superiority tests if the first primary result was non -inferior.
The population of analysis included 3,410 randomized patients with an average age of 59.6 years, with 29.3% being women.
The ischemic primary endpoint appeared in 7.0% of patients in the monotherapy group and 5.5% in the DAPT group (risk ratio [HR] 1.28; Confidence 95% [CI] 0.98 to 1.68), resulting in an absolute risk difference of +1,47 percentage points (95% CI -0.16 to 3.10), which did not meet the predetermined criteria for non -favorable (p = 0.11).
Significant or clinically relative non -major bleeding appeared in 2.0% of patients in the monotherapy group and 4.9% in the DAPT group (risk difference -2.97 percentage points, 95% CI -4.20 to -1.73).
The incidence of death of all the causes was 3.6% on the monotherapy group and 3.0% on the DAPT group (HR 1.24, 95% CI 0.85 to 1.79). Any bleeding occurred in 4.5% of patients in the monotherapy group and 9.0% in the DAPT group.
A milestone analysis in ischemic primary end point revealed a risk difference of +1.5 percentage points in the first 30 days and 0.0 percentage points from 30 days to 12 months for P2Y12 inhibitor monotherapy against DAPT. For the primary endpoint of bleeding, the risk difference was -0.8 percentage points in the first 30 days and -2.2 percentage points from 30 days to 12 months for monotherapy against DAPT.
In summary of the findings, Professor Lemos came to the conclusion: “We did not demonstrate the non -favors of aspirin -free monotherapy that began immediately after the PCI in terms of ischemic primary end point for 12 months. The results from the landmark analysis suggest that the excess ischemic risk with monotherapy occurred in the first 30 days, with comparable results later. Bleeding appeared to be lower in 30 days and 12 months with monotherapy vs DAPT. ”
