P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS.

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial.

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).

Reference values of office central blood pressure, pulse wave velocity, and augmentation index recorded by means of the Mobil-O-Graph PWA monitor.

Assessment of central blood pressure (BP), pulse wave velocity (PWV), and augmentation index (AIx) measurements may improve cardiovascular risk stratification. This study aimed to establish reference office values for central BP, PWV, and AIx by means of a Mobil-O-Graph PWA monitor and to evaluate the impact of cardiovascular risk factors (CVRFs) on these measurements. We cross-sectionally evaluated clinical characteristics, central BP, PWV, AIx, and peripheral BP measurements among 867 apparently healthy individuals (age = 46.0 ± 15.5 years, 39% males) who were free of obesity, hypertension, active smoking, dyslipidemia, and diabetes (CVRF-No) and 5632 individuals (age = 57.0 ± 14.7 years, 44% males) with at least one of these major CVRFs (CVRF-Yes). Reference values for central BP, PWV, and AIx were provided for the CVRF-No and CVRF-Yes groups, stratified by age and sex. PWV and AIx exhibited curvilinear increases with age, and there was an interaction between age and sex for central systolic BP and PWV in both the CVRF-No and CVRF-Yes groups. The results of a multivariable analysis including the whole sample (n = 6499) showed that obesity had a direct association with central BP, while diabetes was directly related to PWV. In addition, alcohol intake was directly associated with central BP, while performance of physical activity was inversely related to AIx. In conclusion, values of office-measured central BP, PWV, and AIx obtained in an apparently healthy population and in a population with CVRFs are now available according to age and sex and may be useful to build thresholds for use in clinical practice.