ESC Congress 2016 - 19

Your FREE access to ESC Congress content all year long www.escardio.org/365 12 months, defined as BARC bleeding type 2, 3, or 5, cardiovascular (CV) death, myocardial infarction (MI), urgent revascularization, stent thrombosis, or stroke. The key secondary endpoint was CV death, MI, urgent revascularization, stent thrombosis, or stroke. There was no significant difference between the groups in the primary endpoint, which occurred in 120 patients (28%) in the monitoring group compared with 123 patients (28%) in the conventional group (HR, 1.003; 95% CI, 0.78 to 1.29; P = .98. No significant difference was observed for the primary endpoint in a prespecified subgroup analysis. There also was no significant difference between the groups for the key secondary endpoint (HR, 1.06; 95% CI, 0.69 to 1.62; P = .80). The occurrence of BARC 2, 3, or 5 bleeding was similar between the 2 groups (HR, 1.04; 95% CI, 0.78 to 1.40; P = .77). No significant difference was observed between the groups in the other secondary endpoints of death (P = .22); CV death, MI, or stroke (P = .70); stent thrombosis (P = .98); TIMI major bleeding (P = .70); GUSTO severe or moderate bleeding (P = .51); or STEEPLE major bleeding (P = .82). Prof Montalescot concluded that platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an ACS does not improve their clinical outcomes. These results confirm the results of the ARCTIC trial, which showed that monitoring platelet function to individualize antiplatelet therapy, regardless of the risk level of the population or to the type of P2Y12 antagonist uses, does not improve prognosis. The SAVE Study: Quality of Life Improved, but No Reduction in Cardiovascular Events With CPAP Therapy Added to Usual Care Written by Phil Vinall R. Doug McEvoy, MD, Flinders University, Adelaide Institute for Sleep Health, Adelaide, Australia, presented findings from the SAVE study [McEvoy RD et al. N Engl J Med. 2016] indicating that the addition of continuous positive airway pressure (CPAP) to usual care did not reduce cardiovascular (CV) events in patients with CV disease and obstructive sleep apnea (OSA). The purpose of the SAVE study was to determine whether CPAP (REMstar Auto M or PR series devices, Philips Respironics) would reduce the incidence of major and minor CV events when added to standard care for patients with established coronary artery disease or cerebrovascular disease and a diagnosis of moderate-to-severe OSA. The diagnosis of moderate-to-severe OSA was defined as an ESC CONGRESS 2016 IN REVIEW oxygen desaturation index [ODI] ≥ 12 events/hr [Ganter D et al. Respirology. 2010]. Potential participants had to demonstrate minimum CPAP adherence during a 1-week runin period when a sham CPAP intervention was used. The study's primary endpoint was a composite of myocardial infarction, stroke, hospitalization for unstable angina, heart failure, or transient ischemic attack (TIA), and CV death. Secondary endpoints included ischemic CV events, major CV events, cardiac events, and cerebral events, as well as the individual components of the primary outcome, new-onset atrial fibrillation or diabetes mellitus, and all-cause mortality, plus symptoms of OSA and quality of life, among others. Because of challenges in achieving the originally intended sample size of 5000 patients, updated literature, and interim aggregate information accrued during the trial, the study investigators revised their sample size to 2500 participants and 533 endpoints among which it was estimated the trial would have 90% power to detect a 25% lower incidence of the primary endpoint with CPAP over a mean 4.5 years of follow-up. This was an international (89 centers in 7 countries), prospective, open-label, randomized controlled trial comparing outcomes in patients with OSA receiving CPAP plus usual care (n = 1346) or usual care alone (n = 1341). These 2687 participants comprised the final study population after demonstrating minimal compliance with CPAP during the run-in period (the non-compliance rate was 16%), and no major post-randomization protocol violations, monitoring irregularities, or withdrawal of consent. The baseline demographic/clinical characteristics were similar in the 2 groups: mean age 61 years; 81% men; 63% Asian; with a mean body mass index of 29 kg/m², mean ODI of 28 events/hr and a mean Epworth Sleepiness Scale (ESS) score of 7.4. About half of the subjects had a history of coronary artery disease and the other half had a history of cerebrovascular disease; more than half were past or current smokers (56%), while 78% had hypertension and a third were diabetic. After a mean duration of follow-up of 3.7 years, a total of 436 primary endpoints were confirmed. For the primary endpoint, there was no significant difference between treatments arms (17% among CPAP treated patients vs 15.4% among usual care; HR, 1.10; 95% CI, 0.91 to 1.32; P = .34). This result was consistent across major subgroups of patients stratified by region (China vs outside China), age, sex, severity of OSA, obesity, baseline CV disease or baseline presence of diabetes (all P-interaction ≥ .09). No significant differences were identified for any of the secondary endpoints except for a higher rate of total TIA hospital admission in the CPAP group (relative risk, 2.29; 95% CI, 1.05-4.99; P = .04), but this observation's Official Peer-Reviewed Highlights From ESC Congress 2016 19 http://www.escardio.org/365

Table of Contents for the Digital Edition of ESC Congress 2016