Content area
Abstract
Abstract
Background
Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown.
Methods
We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores.
Results
A total of 700 patients underwent randomization — 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P=0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, −1.6 percentage points; 95% CI, −3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, −1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months.
Conclusions
Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure. (Funded by the National Institute for Health and Care Research Health Technology Assessment Program; REVIVED-BCIS2 ClinicalTrials.gov number, NCT01920048.)
Details
; Clayton, Tim; Peter D O’Kane; Greenwood, John P
; Weerackody, Roshan; Ryan, Matthew
; Morgan, Holly P; Dodd, Matthew; Evans, Richard; Canter, Ruth; Arnold, Sophie; Dixon, Lana J; Edwards, Richard J; De Silva, Kalpa; Spratt, James C; Conway, Dwayne; Cotton, James; McEntegart, Margaret; Chiribiri, Amedeo; Saramago, Pedro; Gershlick, Anthony; Shah, Ajay M; Clark, Andrew L; Petrie, Mark C 1 1 From the National Institute for Health and Care Research Biomedical Research Centre and the British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Medicine and Sciences, King’s College London (D.P., M.R., H.P.M., A.C., A.M.S.), Guy’s and St. Thomas’ NHS Foundation Trust (D.P., S.A., K.D.S.), the London School of Hygiene and Tropical Medicine (T.C., M.D., R.E., R.C.), Barts Health NHS Trust (R.W.), St. George’s University Hospitals NHS Foundation Trust (J.C.S.), and King’s College Hospital NHS Foundation Trust (A.M.S.), London, University Hospitals Dorset NHS Foundation Trust, Bournemouth (P.D.O.), Leeds Teaching Hospitals NHS Trust, Leeds (J.P.G.), Belfast Health and Social Care NHS Trust, Belfast (L.J.D.), Newcastle Hospitals NHS Foundation Trust, Newcastle (R.J.E.), University Hospitals Bristol NHS Foundation Trust, Bristol (K.D.S.), Mid Yorkshire Hospitals NHS Trust, Wakefield (D.C.), Royal Wolverhampton NHS Trust, Wolverhampton (J.C.), the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (M.M., M.C.P.), the University of York, York (P.S.), University Hospitals of Leicester NHS Trust, Leicester (A.G.), and Hull University Teaching Hospitals NHS Trust, Hull (A.L.C.) — all in the United Kingdom.