While primary outcomes were largely unmoved, compelling evidence was presented supporting the use of implantable cardioverter defibrillators (ICDs) in heart failure (HF) patients, continuous positive airway pressure (CPAP) to improve patient quality of life, drug-eluting stents (DES) in reducing the need for repeat revascularizations, and stem cell therapy for patients with severe heart enlargement.
Results of seven important trials were featured at the 2016 European Society of Cardiology (ESC) Congress, held the last week of August in Rome, Italy. Among the key findings:
- ICDs: A Danish study, published in the New England Journal of Medicine (NEJM), assessed the efficacy of ICDs in patients with non-ischemic HF. The results suggest that ICD implantation might benefit younger patients and, among ICD patients generally, reduce the risk of sudden cardiac death (secondary endpoint). The trial involved 1,116 patients with left ventricular systolic dysfunction, half receiving an ICD and the remainder usual care, with a follow-up median of 68 months. The primary outcome (all-cause mortality) occurred in 21.6 percent of the ICD group versus 23.4 percent of the control group—not statistically significant.
- CPAP: Results of the Sleep Apnea Cardiovascular Endpoints (SAVE) trial, also published in NEJM, found CPAP therapy plus usual care is no better than usual care alone for the secondary prevention of cardiovascular (CV) events in patients with established coronary artery disease (CAD) and CV disease, and moderate to severe obstructive sleep apnea. However, the use of CPAP improved daytime sleepiness and health-related quality-of-life measures. The 1:1 randomized trial involved 2,687 patients, with a follow-up mean of 3.7 years. The primary outcome (CV death, myocardial infarction, stroke, hospitalization for HF, unstable angina or transient ischemic attack) occurred in 17 percent of the CPAP + usual care group versus 15.4 percent of the control group—not statistically significant. Mean use of CPAP was 3.3 hours per night. Additional studies are needed to assess the benefit of extending that to 4 hours or more.
- DES: Findings of the Norwegian Coronary Stent (NORSTENT) trial, published in NEJM, suggest DES is superior to bare metal stents (BMS) in terms of reducing repeat revascularizations (16.5 percent versus 19. 8 percent) and modestly reducing the incidence of stent thrombosis (0.8 percent versus 1.2 percent), but BMS can safely be used in select patients. Similar rates of long-term death and myocardial infarction, the primary outcomes, were observed in the two groups (9,013 patients total)—half receiving percutaneous coronary intervention for obstructive CAD with DES and the other half with BMS. Twenty-seven percent of patients had ST-elevation myocardial infarction (STEMI) and 31 percent had non-STEMI; clopidogrel was used for nine months post-procedure.
- Remote monitoring of HF patients: A pair of studies involving patients with cardiovascular implantable electronic devices (CIEDs) indicate remote monitoring is just as effective as usual care, as measured by rates of mortality and hospitalizations. The Remote Management of Heart Failure Using Implantable Electronic Devices (REM-HF) trial had 1,650 British participants with a cardiac resynchronization therapy (CRT) pacemaker, CRT defibrillators (CRT-D) or ICD. Remote monitoring patients had data automatically downloaded weekly, and results were used to discuss medications, lifestyle or visits. Follow-up was 2.8 years. The assumption that more data improves outcomes was proven untrue. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) trial randomized 900 HF patients with CRT-D with wireless transmission capabilities to receive remote monitoring alternating with in-office visits. Median follow-up was 24 months. Secondary cost savings due to a reduction in office visits was noted.
- Stem cell therapies: A pair of trials examined the safety and efficacy of stem cell therapies. The Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial, involving 271 patients with HF in Europe and Israel evaluated over 39 weeks, found a therapy using bone-marrow stem cells did not significantly improve the primary outcome (all-cause mortality, worsening HF event, QOL score, six-minute walk, left ventricular volume and ejection fraction) over a sham procedure. However, a positive effect was seen in a subgroup of patients with severe heart enlargement at baseline. The second, single-blind study of 22 patients with chronic non-ischemic cardiomyopathy found that a single dose of mesenchymal stromal cells (MSC) delivered intravenously offered no significant cardiac structural or functional improvements. This was a “first” study and will lead to additional research of IV MSC.