ESC Congress 2016 - 21

Your FREE access to ESC Congress content all year long www.escardio.org/365 LDL-C Targeting for ACS Reduces More CV Events Than Standard Treatment Written by Maria Vinall Nobuhisa Hagiwara, MD, Tokyo Women's Medical University, Tokyo, Japan, reported the results of Heart Institute of Japan-PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome trial [HIJ- PROPER; UMIN-CTR000002742], which showed that there was no significant benefit with adding ezetimibe to background pitavastatin therapy in patients with acute coronary syndromes (ACS). HIJ-PROPER was a prospective, randomized, openlabel, blinded endpoint, multicenter trial designed to test the hypothesis that LDL-C lowering (to < 70 mg/dL) with a standard dose of pitavastatin + ezetimibe would reduce cardiovascular (CV) events more than pitavastatin monotherapy in patients with ACS and dyslipidemia. This study included 1734 patients (aged ≥ 20 years) with ACS and dyslipidemia who were hospitalized for STEMI, NSTEMI, or unstable angina (UA) within the 10 days prior to randomization. Patients randomized to combination therapy received 2 mg of pitavastatin and 10 mg of ezetimibe as a starting dose, targeting an LDL-C level of < 70 mg/dL while the monotherapy group targeted a LDL-C level of 90-100 mg/dL with 2 mg of pitavastatin (patients already receiving a statin discontinued their current medication and were switched to 2 mg of pitavastatin as a starting dose). In both groups, the pitavastatin dose was adjusted daily to produce the appropriate LDL-C target level. The composite primary endpoint consisted of all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke, UA, or revascularization with either percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG). Secondary endpoints included CV events (nonfatal MI, nonfatal stroke, UA, ischemia-driven revascularization with either PCI or CABG), all-cause death, heart failure, inflammatory markers, and adverse events (including new occurrence of malignant tumor). Patients were followed for a minimum of 3 years. At baseline, participants were a mean age of 65.6 years and had a mean body mass index of 24.3 kg/m2; 75.5% were men and 83.3% were statin naïve. Index ACS events were STEMI (51.0%), NSTEMI (10.5%), and UA (38.5%). Hypertension was present in 68% of patients and diabetes in 30%. The mean LDL-C at study entry was 135 mg/dL (SD ± 30) and mean sitosterol (a cholesterol absorption marker) was 2.50 µg/mL. The index revascularization for ACS was PCI in 94.5% of individuals. ESC CONGRESS 2016 IN REVIEW Patients treated with pitavastatin and ezetimibe had significantly lower LDL-C (67.5 mg/dL vs 87.2 mg/dL; P < .001), total cholesterol (142.7 mg/dL vs 165.3 mng/dL; P < .001), and triglyceride values (125.2 mg/dL vs 144.2 mg/dL; P < .001) after 1 year compared with those receiving pitavastatin monotherapy. However, the reduction in the composite primary endpoint events among patients receiving intensive LDL-C lowering with the combination of pitavastatin and ezetimibe was not significantly different from the reductions achieved with pitavastatin alone in patients with ACS and dyslipidemia at 3 years (32.8% vs 36.9; HR, 0.89; 95% CI, 0.76 to 1.04; P = .152). There were no significant differences between groups for the secondary outcomes (CV death, nonfatal MI, or nonfatal stroke) and safety outcomes were similar between the 2 arms. There were no differences between the 2 therapeutic approaches for the major pre-specified subgroups of age, diabetes status, prior lipid-lowering therapy, or median LDL-C mg/dL. However, among patients with higher baseline levels of sitosterol (≥ 2.2 µg/mL), the combination of pitavastatin and ezetimibe reduced CV events more than pitavastatin alone (HR, 0.71; 95% CI, 0.56 to 0.91; P = .006). Based on this, Prof Hagiwara suggested that sitosterol may offer a potential therapeutic target for the treatment of dyslipidemia in patients with ACS. OPTICARE: Examining the Effects of Added Counseling to Standard Cardiac Rehabilitation in Patients With ACS Written by Maria Vinall Ron T. Van Domburg, MD, Erasmus Medical Center, Rotterdam, The Netherlands, presented the results from the OPTICARE trial, which examined the effects of 2 alternative cardiac rehabilitation (CR) programs for patients with recent acute coronary syndrome (ACS). The alternative treatments did not improve results on the primary outcome of Systematic Coronary Risk Evaluation (SCORE); however, some benefit was seen for cholesterol levels, smoking status, and quality of life among more motivated patients. OPTICARE was a single-center, open, multidisciplinary, randomized, controlled, superiority trial with additional interventions up to 1 year after the start of CR and an additional 6-month follow-up. The objective was to compare the effect of 2 extended CR programs Official Peer-Reviewed Highlights From ESC Congress 2016 21 http://www.escardio.org/365

Table of Contents for the Digital Edition of ESC Congress 2016