To research the safety and efficacy of an early platelet function testing (PFT)-guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVS)

To research the safety and efficacy of an early platelet function testing (PFT)-guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVS). control group (day 19) and 1 possible ST (sudden cardiovascular death) in Lercanidipine the de-escalation group (day 86), both despite prasugrel treatment and in a background of high on-treatment platelet reactivity assessed at day 14 after randomization (ADP-induced platelet aggregation values of 108 U and 59 U, respectively). A PFT-guided DAPT de-escalation strategy could potentially be a safe and effective strategy in ACS patients with BVS implantation but the level of platelet inhibition may be of particular importance. This hypothesis-generating post-hoc analysis requires verification in larger studies with upcoming BVS platforms. acute coronary syndrome, bioresorbable vascular scaffold, high platelet reactivity, optimum platelet reactivity, low platelet reactivity Table 1 Baseline clinical characteristics left ventricular ejection fraction (%), adenosine diphosphate, angiotensin-converting-enzyme Table 2 Angiographic and procedural characteristics ST-segment elevation Bmpr2 myocardial infarction, non-ST-segment elevation myocardial infarction, percutaneous coronary intervention, thrombolysis in myocardial infarction, American Heart Association, American College of Cardiology The primary combined endpoint Lercanidipine (cardiovascular death, myocardial infarction, stroke or bleeding??grade 2 according to BARC criteria) occurred in 6 patients (8.8%) in the de-escalation group (n?=?68) and in 10 patients (12.0%) in the control group (n?=?83) (HR 0.72, 95% CI 0.26C1.98, p?=?0.52) (Fig.?2). A Cox Lercanidipine proportional hazards model that included presence (in n?=?151 patients) vs. absence (in n?=?2459 patients) of a BVS as a dichotomic adjustable showed zero interaction of BVS implantation with treatment effects for the principal endpoint between research organizations (p-value for interaction?=?0.82). Open up in another home window Fig. 2 KaplanCMeier curves for the principal endpoint (net medical benefit). Bleeding Academics Research Consortium, Risk ratio, 95% self-confidence interval The occurrence of the main element supplementary endpoint of BARC??2 or more bleedings was 5.9% (4 events) in the guided de escalation group versus 8.4% (7 occasions) in the control group [HR 0.69 (95% CI 0.20C2.67); p?=?0.55]. The cumulative occurrence of all blood loss events (BARC course 1 to 5) was 10.3% (7 occasions) in the guided de escalation group versus 9.6% (8 occasions) in the control group [HR 1.09 (95% CI 0.39C2.99); p?=?0.87]. Mixed ischemic occasions (cardiovascular loss of life, myocardial infarction, and heart stroke) happened in 2 individuals (2.9%) in the guided de-escalation group and in 4 individuals (4.8%) in the control group [HR 0.61 (95% CI 0.11C3.32); p?=?0.56], suggesting that early de-escalation didn’t result in an elevated ischemic risk. Further information on results across research groups are reported in Table?3. Table 3 Clinical outcomes at 12 months Bleeding Academic Research Consortium The overall frequency of definite ST at 1?year in the TROPICAL-ACS subset of patients with BVS implantation was Lercanidipine 0.7%. We observed only one early scaffold thrombosis (ST) event in the control group in a 57-year-old male patient that 18?days after hospital discharge presented with clinical Lercanidipine symptoms of a ST segment elevation myocardial infarction. Despite being treated with 10?mg/d of prasugrel, the patient exhibited HPR (ADPtest of 108 U on prasugrel and assessed at day 14 after discharge). Per study protocol, antiplatelet treatment remained unchanged for this patient in the control group. Further on, there was one possible ST (sudden CVD) in the guided de-escalation group at day 86 after randomization. This was a 58-year-old male, who presented with a NSTEMI during the index ACS-PCI procedure. This patient exhibited HPR as well (ADPtest of 59 U on clopidogrel assessed at day 14 after discharge) and according to the study protocol the patient was switched to 10?mg/days prasugrel thereafter. Discussion To the best of our knowledge.