ESC Congress 2016 - 17

Your FREE access to ESC Congress content all year long www.escardio.org/365 Despite the technical capacity of these devices to provide an almost continuous stream of information to clinicians, the additional work and training required to make use of this information does not translate into significant improvements for patients. Cardiopoietic Regenerative Therapy in Patients With Ischemic Heart Failure Written by Phil Vinall Cardiopoietic stem cells did not reduce mortality in patients with advanced ischemic heart failure (IHF) in the CHART-I multisite/multinational clinical trial. CHART-1 was a Phase 3 randomized, double-blind, sham-controlled study conducted at 39 centers in Europe and Israel to evaluate the efficacy and safety of cardiopoietic stem cells (C3BS-CQR-1, Celyad, Mont St Guibert, BE) compared with a sham procedure, in patients with symptomatic IHF despite optimal therapy. The results of CHART-1 were presented by Jozef Bartunek, MD, PhD, OLV Hospital Aalst, Cardiovascular Center, Aalst, Belgium [NCT01768702]. Men and women aged ≥ 18 to < 80 years with symptomatic IHF (NYHA class ≥ II at inclusion and NYHA class III/IV or INTERMACS class ≥ 4 within the last 12 months) and reduced left ventricular ejection fraction (LVEF; < 35%) who had been hospitalized for HF or who's HF had worsened within 12 months were eligible for enrollment. Participants were also required to be on guideline HF therapy. Eligible participants were randomized to either a single dose of 600 million endomyocardial cardiopoietic stem cells (n = 120) or a sham procedure (n = 151). Cardiopoietic stem cells were administered with a dedicated transendocardial catheter designed to increase cell retention (C-Cathez, Celyad, Mont St Guibert, BE). The primary efficacy endpoint was the composite of all-cause mortality, number of worsening HF events, change in any of the following: Minnesota Living with HF Questionnaire Score, 6-minute walk test, echocardiographic derived LV end systolic volume and LVEF. Safety was assessed using all-cause mortality, aborted sudden death, cardiac transplantation, myocardial infarction, stroke, hospitalizations, and incidence of adverse events. Study participants had a mean age of 62 years, with a mean LVEF of about 28%; most (> 89%) were men and most were NYHA class II with a mean of about 45 months between the diagnosis of HF and screening. Over 89% of patients were already being treated with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a ß-blocker; 89% were also taking a diuretic. ESC CONGRESS 2016 IN REVIEW There was no benefit with cardiopoietic stem cell administration with respect to the primary efficacy outcome at 39 weeks (Mann-Whitney Estimator 0.54; 95% CI, 0.47 to 0.61; P = .27). Similar results were noted on each of the components of the primary outcome. The number of deaths in the 2 groups was similar (10 in the active treatment group versus 14 in the control group). There was a higher incidence of sudden cardiac death and aborted sudden death in the sham control compared with the active arm (HR, 0.16; 95% CI, 0.02 to 1.23; P = .04). Exploratory analyses suggested a benefit of cell therapy in a subset of patients with baseline left ventricular end diastolic volume between 200 mL and 370 mL (MannWhitney Estimator 0.61; 95% CI, 0.52 to 0.70; P = .015) and those who received ≤ 19 injections. As key clinical insight, Dr Bartunek suggested that optimized treatment intensity together with disease severity-targeted patient selection should be considered for future trials. Additional information: Bartunek J, Davison B, Sherman W, et al. Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design. Eur J Heart Fail. 2016;18(2):160-168. Six Months of DAPT Noninferior to 18 Months of Treatment Written by Phil Vinall The NIPPON trial results, presented by Masato Nakamura, MD, PhD, Toho University, Ohashi Medical Center, Tokyo, Japan, cautiously suggest that 6 months of dual antiplatelet treatment (DAPT) is noninferior to 18 months of DAPT treatment in terms of net adverse clinical and cerebrovascular events. Although previous trials yielded inconsistent and contradictory findings, prolonged DAPT is thought to be associated with higher bleeding risk concomitant with a lower risk of major adverse cardiovascular events (MACE). The NIPPON trial [NCT01514227] was a prospective, multicenter, randomized trial to compare the net clinical benefits between short DAPT (6 months) and prolonged DAPT (18 months) after NOBORI stent deployment. NOBORI is a drug-eluting stent with bioabsorbable polymer and abluminal coating. Subjects were > 20 to < 80 years of age undergoing percutaneous intervention, with an ejection fraction ≥ 30% and no active bleeding or history of bleeding. Participants were allocated to 18-month DAPT (n = 1391) or 6-month DAPT (n = 1381). The primary outcome was net adverse clinical and cerebrovascular events (NACCE) defined as the composite of all-cause death, myocardial infarction (MI), stroke, or major bleeding (from the Official Peer-Reviewed Highlights From ESC Congress 2016 17 http://www.escardio.org/365

Table of Contents for the Digital Edition of ESC Congress 2016