ESC Congress 2016 - 18

clINIcAl TRIAl HIgHlIgHTs modified REPLACE-2 studies or BARC criteria) between 6 to 18 months after drug-eluting stent implantation. The noninferiority margin for the primary outcome was an absolute risk difference of -2.0%. The main secondary endpoints were the incidence of definite or probable stent thrombosis at 18 months after implantation, the incidence of death, MI, and cerebrovascular events at 18 months, and the incidence of major bleeding events at 18 months after implantation. There were no significant differences in baseline characteristics. About 80% of the participants were men; mean age was 67 years. The target lesion was in the left anterior descending artery in about 60% of patients; a single vessel was treated in ≥ 85% of patients; approximately 30% were treated in the setting of an acute coronary syndrome. Noninferiority after 6 months of DAPT was achieved in terms of the primary endpoint (1.45% in the 18-month DAPT group vs 1.92% in the 6-month DAPT group: absolute risk difference -0.46%; 95% CI, -1.48 to 0.51; P = .002; Figure 1). Time-to-event analyses during the complete 18 month follow up period and from 6 to 18 months found no significant increase in events with short-term versus long-term DAPT for the primary net clinical outcome of NACCE; however, there were numerically different rates in the short-term DAPT arm. Figure 1. Primary Endpoint (NACCE) 18 months DAPT n=1371 1.45 % 6 months DAPT n=1355 1.92 % Difference -0.46 Lower limit of 95% CI -1.48 Pre-specified non inferiority margin=-2.0 -4 -3 Newcombe score method Favor 6 months -2 -1 0 1.0 Favor 18 months DAPT Primary Non-Inferiority Endpoint Met DAPT, dual antiplatelet treatment; NACCE, net adverse clinical and cerebrovascular events. Reproduced with permission from M Nakamura, MD, PhD. There was a non-significant trend towards lower mortality (0.51% vs 0.74%; P = .48) and MI (0.07 vs 0.22%; P = .37) with 18 month compared with 6 month DAPT, respectively. Bleeding rates were not significantly different between the two arms. Results were consistent for NACCE in all subgroups. 18 October 2016 In terms of NACCE, noninferiority of 6 months of DAPT relative to 18 months of DAPT was achieved. These results should be interpreted with caution given the premature termination of enrollment, an open-label design with frequent crossover, and a wide noninferiority margin. Platelet Function Monitoring Does Not Improve Outcomes in Stented Elderly Patients: The ANTARCTIC Study Written by Toni Rizzo High platelet reactivity in patients with drug-eluting stents treated with clopidogrel is associated with increased rates of myocardial infarction (MI) and lower rates of bleeding [Stone GW et al. Lancet. 2013]. Previous randomized studies failed to show any benefit of platelet function monitoring to adjust therapy in low-risk percutaneous coronary intervention (PCI) patients treated with clopidogrel [Price MJ et al. JAMA. 2011; Collet JP et al. N Engl J Med. 2012]. However, the ARCTIC study [Collet JP et al. N Engl J Med. 2012] demonstrated a trend toward a reduction of bleeding in the platelet-monitoring group. These findings led to the ANTARCTIC study [Cayla G et al. Lancet. 2016], presented by Gilles Montalescot, MD, Pitié-Salpêtrière University Hospital, Paris, France. The objective of the multicenter, randomized ANTARCTIC study was to assess the effect of platelet function monitoring with treatment adjustment in elderly patients stented for an acute coronary syndrome (ACS). The investigators hypothesized that adjusting treatment to the platelet response might improve outcomes in these patients. Patients aged ≥ 75 years who underwent coronary stenting for ACS (n = 877) were randomized to an initial dose of prasugrel 5 mg and no platelet function monitoring (conventional group; n = 442) or to prasugrel 5 mg with platelet function monitoring and drug and dose adjustments (monitoring group; n = 435). Platelet function analysis (VerifyNow P2Y12) was performed 14 days after randomization. The prasugrel dose was increased to 10 mg/d in patients with P2Y12 reaction unit (PRU) ≥ 208 and kept at 5 mg/d in patients with PRU > 85 and < 208. Patients with PRU ≤ 85 were switched to clopidogrel 75 mg/d. A second analysis with dose adjustment was performed 14 days after the first analysis. The primary endpoint was net clinical benefit over www.escardio.org/ESCcongressinreview http://www.escardio.org/ESCcongressinreview

Table of Contents for the Digital Edition of ESC Congress 2016