Author + information
- Divaka Perera, MA, MDa,∗ (, )
- Tim Clayton, MScb,
- Mark C. Petrie, MBChB, MDc,
- John P. Greenwood, MBChB, PhDd,
- Peter D. O’Kane, MBBS, MDe,
- Richard Evans, BAb,
- Mark Sculpher, MA, PhDf,
- Theresa Mcdonagh, MBBS, MDg,
- Anthony Gershlick, MBBSh,
- Mark de Belder, MA, MDi,
- Simon Redwood, MBBS, MDa,
- Gerald Carr-White, MBBS, PhDa,
- Michael Marber, MBBS, PhDa,
- on behalf of the REVIVED investigators
- aNational Institute for Health Research Biomedical Research Centre and British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, King’s College London, London, United Kingdom
- bClinical Trials Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom
- cInstitute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom
- dLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, United Kingdom
- eRoyal Bournemouth and Christchurch Hospital, United Kingdom
- fCentre for Health Economics, University of York, United Kingdom
- gKing’s College Hospital, London, United Kingdom
- hBiomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom
- iThe James Cook Hospital, Middlesbrough, United Kingdom
- ↵∗Address for correspondence:
Prof. Divaka Perera, Cardiovascular Division, Rayne Institute, 4th Floor Lambeth Wing, St Thomas’ Hospital, Westminster Bridge Road, London SE1 7EH, United Kingdom.
Objectives Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone.
Background Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit.
Methods REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard.
Results A total of 400 patients have been enrolled to date.
Conclusions International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711)
- heart failure
- ischemic cardiomyopathy
- left ventricular dysfunction
- myocardial viability
- percutaneous coronary intervention
The prevalence of heart failure (HF) due to left ventricular (LV) systolic dysfunction is increasing (1), and ischemic cardiomyopathy (ICM) accounts for approximately 60% of all cases of HF (2,3). Pathophysiologically, ICM encompasses a spectrum of sequelae of coronary disease including myocardial infarction (MI), which leads to irreversible fibrosis, and hibernation, a potentially reversible adaptation to repetitive ischemia, which often co-exist in a given patient and can both lead to adverse remodeling and LV dysfunction. “Hibernation” was a word coined nearly 40 years ago to describe the reversal of remodeling and augmentation of systolic function following surgical coronary artery bypass grafting (CABG), noted in patients with chronic stable angina and severe LV dysfunction (4). Although subsequent observational studies of surgical revascularization appeared to confirm the existence of hibernation (5,6), until recently, this had not been adequately assessed in a randomized study.
The seminal STICH (Surgical Treatment for Ischemic Heart Failure) trial—the only randomized evaluation of CABG for ICM to date—enrolled patients with left ventricular ejection fraction (LVEF) ≤35%. At a median of 4.6 years, the primary outcome all-cause mortality, was not significantly different between patients treated with optimal medical therapy (OMT) alone compared with those assigned to CABG surgery (41% vs. 36%; hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.72 to 1.04; p = 0.12) (7). Mortality in the first 30 days was significantly higher in the surgical group (4% vs. 1%; HR: 3.12; 95% CI 1.33 to 7.32; p = 0.009). This finding is in keeping with the known association between mortality and LV dysfunction following CABG surgery (8). The early hazard of CABG may have negated the benefits of revascularization, which become gradually manifest in those who survive the complications of surgery. The STICHES (Surgical Treatment for Ischemic Heart Failure Extension Study) reported longer-term mortality data from the STICH trial. At median follow-up of approximately 10 years, 59% of patients assigned to CABG died versus 66% in the medical therapy group (HR: 0.84; 95% CI: 0.73 to 0.97; p = 0.02) (9). Death from cardiovascular causes and several pre-specified composite secondary endpoints also occurred less often in the CABG group. The critical balance between safety and efficacy is also borne out when examining the impact of age on treatment effect in STICH. Long-term survival benefit was most apparent in the youngest patients enrolled in the trial (in whom the risks of peri-procedural mortality and morbidity are lowest), and this benefit diminished with increasing age (10).
Given the lower procedural risks associated with percutaneous coronary intervention (PCI), it has the potential to allow the benefits of revascularization to be realized with fewer complications than CABG surgery, but this assertion is yet to be tested in a randomized trial. Table 1 summarizes randomized and observational studies of revascularization versus medical therapy published in the past 15 years and includes the proportion of patients treated with PCI. It should be noted that the risk of longer-term complications, such as restenosis and late stent thrombosis, in this population who tend to have complex coronary disease and multiple comorbidities, is largely unknown. Although numerous comparisons have been made between PCI and CABG in patients with symptomatic coronary disease, most of the large randomized trials excluded patients with impaired LV function. Less than 2% of all patients included in the largest randomized controlled trial comparing PCI with CABG—SYNTAX—had significant LV impairment (EF <30%) at baseline (11). We reported outcomes of PCI in 301 patients with severe ICM (mean EF 24%), showing 30-day, 6-month, and 4-year mortality rates of 1.3%, 6%, and 33%, respectively (12,13). These results appear to compare favorably with the surgical data, but, as these are not matched cohorts, further comparison is not possible. On the other hand, the degree of LV impairment is a known determinant of adverse outcome even in patients undergoing PCI (14); whether this modality of revascularization would offer incremental prognostic benefit—over and above contemporary HF medication and device therapy—is unclear. A recent meta-analysis of observational data suggests that CABG may offer superior outcomes compared with PCI, with either modality being preferable to medical therapy alone (15). The 2014 European Society of Cardiology (ESC) guidelines for revascularization make a Class IIb recommendation (with a Level of Evidence: C) for PCI, in the presence of viable myocardium, when surgery is not indicated (16). REVIVED-BCIS2 is the first randomized comparison of percutaneous revascularization with OMT versus OMT alone in patients with LV dysfunction and viable myocardium.
Trial Hypotheses and Outcome Measures
The principal hypothesis of REVIVED-BCIS2 is that PCI in combination with OMT will improve event-free survival in patients with ICM and viable myocardium compared with a strategy of OMT alone. The main secondary hypothesis is that PCI will improve LV systolic function in this cohort compared with OMT alone. The primary outcome is a composite endpoint of all-cause death or hospitalization due to HF over the entire duration of the trial. Patients will be followed up for at least 2 years from randomization (expected range: 2 to 8.5 years). The major secondary outcome is LVEF—assessed by echocardiography—6 and 12 months from randomization. Other outcome measures include cardiovascular death, all-cause death, hospitalization due to HF, acute MI, appropriate implantable cardioverter defibrillator (ICD) therapy, quality of life scores (Kansas City Cardiomyopathy Questionnaire and EuroQol EQ-5D-5L), New York Heart Association (NYHA) functional class, unplanned further revascularization, Canadian Cardiovascular Society (CCS) angina class, health resource use, serial troponin T or I levels, serial brain-type natriuretic peptide (BNP or NT-proBNP) levels, and the incidence of major bleeding. Definitions of outcome measures are detailed in Table 2.
Patients with all of the following characteristics will be eligible for inclusion: severe LV dysfunction (EF ≤35%), extensive coronary disease, and demonstrable viability in at least 4 dysfunctional myocardial segments (17) that can be revascularized by PCI. As this is a trial assessing the prognosis of patients with LV dysfunction, those with a spectrum of HF symptoms (NHYA functional class I to IV) will be enrolled.
LVEF is assessed by the biplane Simpson’s Rule/3D echocardiography or by magnetic resonance imaging (MRI). If there has been a recent clinical diagnosis of MI, the imaging study is performed at least 4 weeks after MI. Extensive coronary disease is defined as a British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) (18) of at least 6 (the maximum possible score is 12; a calculation tool is included in the Online Appendix). The BCIS-JS can be applied to patients with or without previous bypass grafts; for illustration, patients who do not have bypass grafts will have a BCIS-JS ≥6 if they have significant left main, proximal left anterior descending, or at least proximal 2-vessel disease. Myocardial viability is characterized using the AHA 17-segment model and can be assessed using any recognized modality including MRI, dobutamine stress echocardiography (DSE), single photon emission computerized tomography (SPECT), or positron emission tomography (PET).
Trial exclusion criteria are MI within 4 weeks of randomization (this is a clinical definition as adjudicated by recruiting centers); acutely decompensated HF requiring treatment with inotropes/ventilation/mechanical circulatory support (MCS) within 72 h of randomization; sustained ventricular tachycardia/fibrillation (VT/VF) or appropriate ICD discharges within 72 h of randomization; valve disease deemed by the local heart team to require imminent intervention; any contraindications to PCI; age <18 years (there is no upper age limit); estimated glomerular filtration rate <25 ml/min/1.73 m2, unless established on dialysis; pregnancy; previous enrollment in REVIVED-BCIS2 or current enrollment in other trial that may affect REVIVED-BCIS2 outcome data; and life expectancy <1 year due to noncardiac pathology.
It is anticipated that some eligible candidates—such as those with severe limiting angina—will be considered for revascularization on clinical grounds at the discretion of the responsible clinician and in accordance with the wishes of the patients. Similarly, in some cases, eligible patients may be offered coronary artery bypass surgery, including those thought to benefit from adjunctive surgical procedures—such as valve repair/replacement or LV reconstruction—or those whose coronary anatomy is considered by the local team to be more amenable to surgical than percutaneous revascularization. These patients will not be enrolled in the trial, but the screening log (see the following text) will capture such exclusions.
Trial Design, Conduct, and Organization
REVIVED-BCIS2 is a prospective randomized controlled trial, conducted across 30 to 35 centers in the United Kingdom. Once the principal investigator at each site confirms the eligibility of a patient and written informed consent is obtained, randomization is carried out via an online web-based system. Randomization of the treatment assignment is stratified by center using randomly permuted blocks of varying size, with 1:1 allocation between the PCI and OMT arms. Given the nature of PCI, this is an open-label trial, but researchers adjudicating and analyzing trial outcomes will be blinded to treatment assignment. Figure 1 summarizes recruitment and study flow.
The trial is sponsored by King’s College London, UK and funded by the UK Department of Health via the National Institute for Health Research (NIHR) (Health Technology Assessment project 10/57/67) with oversight by a trial steering committee (TSC) that meets pre-specified independence criteria (Figure 2). A data and safety monitoring committee (DSMC) has been convened—and a DSMC charter developed—that includes details of the meeting schedule and stopping guidelines. The DSMC is independent of the trial team and reports directly to the TSC. The Clinical Trials Unit (CTU) at the London School of Hygiene and Tropical Medicine coordinates and monitors all aspects of the trial. The trial is officially endorsed by the British Cardiovascular Intervention Society (BCIS) and hence is referred to as REVIVED-BCIS2.
The protocol and amendments have been reviewed and approved by the UK National Research Ethics Service (London-Westminster committee; REC reference 10/H0802/46). The trial is carried out in accordance with the declaration of Helsinki and in keeping with Good Clinical Practice Guidelines. Registration was completed before recruitment commenced (NCT01920048 and ISRCTN45979711). The first patient was randomized on August 28, 2013, and, at the time of this publication, 400 patients have been randomized. Figure 3 summarizes the study timeline. There has been 1 major amendment to the protocol, implemented in July 2014, when the first inclusion criterion was modified from “LVEF ≤30%” to “LVEF ≤35%” to facilitate comparison with relevant published data and guidelines. At this stage, “≥CCS class 3 angina” was removed from the list of exclusion criteria because of the difficulty in distinguishing angina from breathlessness in this particular population.
Assessment of LV function and viability
Suitability of patients on the basis of EF will be adjudicated by the participating centers based on the results of recent echocardiography or MRI studies. All patients will also have echocardiography performed at randomization (if the qualifying EF was based on a recent echocardiogram, this can be submitted as the baseline study) as well as 6 and 12 months later. Baseline, 6-month, and 12-month echocardiograms will be anonymized and submitted to an independent echocardiography core laboratory (at Guy’s and St. Thomas’ Hospital, London, United Kingdom), which will determine LV volumes and EF using a biplane Simpson’s method for evaluation of the major secondary outcome. The core laboratory will be blinded to treatment assignment as well as to the timing of the studies in relation to randomization. Core laboratory analysis will also include the degree of mitral regurgitation and segmental wall motion.
Myocardial viability testing is used to predict hibernation prospectively by identifying the extent of fibrosis, contractile reserve, membrane integrity, or metabolic activity (19). There has never been a randomized evaluation of the value of viability testing in the management of ICM, and observational series have reported seemingly conflicting results. A meta-analysis of more than 3,000 patients with ICM from 24 studies showed that mortality was lower following revascularization in patients with viable myocardium but that this benefit was not seen in the absence of viability (20). A more recent observational series of patients with ICM assessed by PET showed that revascularization was associated with lower mortality compared with OMT when the extent of viability exceeded more than 10% of the whole myocardium (21). However, analysis of a subgroup of patients in the STICH trial who underwent discretionary viability testing did not demonstrate an interaction between the response to revascularization and their viability classification (22). A pertinent consideration is the fact that the STICH substudy classified patients dichotomously as having viable hearts or not. However, a person with ICM usually has some regions that are clearly viable and others that are not, and, with PCI, it is possible to target revascularization to myocardial territories selected on this basis. Notwithstanding differences in sensitivity and specificity among imaging modalities, to ensure widespread applicability of trial results, segmental viability will be determined by any recognized modality in REVIVED. Imaging and intervention specialists at each participating center assess segmental viability and the feasibility of revascularizing the relevant segments to determine whether an individual patient will be eligible for randomization.
Percutaneous coronary intervention arm
PCI will be performed according to local protocols. Dual antiplatelet therapy should be given in all cases, with pre-loading and the post-PCI duration based on the patient’s risk of bleeding and local/national guidelines. In general, drug-eluting stents are recommended, but in patients who have an indication for long-term formal anticoagulation (e.g., for concurrent atrial fibrillation, LV thrombus, or venous thromboembolic disease), the choice of stent type should be based on their suitability for medium-term combined antiplatelet and anticoagulation therapy.
Completeness of revascularization
It is strongly recommended that PCI be attempted on all significant coronary lesions in major proximal coronary vessels (or side branches >2.5 mm in diameter) subtending viable myocardium. Lesion significance is defined as >70% diameter stenosis on angiography or for lesions between 50% and 70% diameter stenosis when accompanied by demonstrable reversible ischemia on invasive or noninvasive testing. Planned target lesions will need to be identified by the operator and recorded by the trial coordinator before the procedure. Patients who meet inclusion criteria and have chronic total occlusion (CTO) of coronary arteries subtending viable myocardial segments should be considered for REVIVED, provided that the PCI operators predict a high likelihood of reopening these vessels successfully. It is recommended that dedicated CTO operators—in units that have this degree of specialization—undertake such cases. The coronary disease burden at baseline and the completeness of final revascularization will be characterized by the BCIS-JS and Revascularization Index (RI), where RI = (JSpre − JSpost)/JSpre (18). The interaction between treatment effect and RI as well as the presence of a CTO will be the subject of a separate substudy.
A single-stage strategy should be used when possible. However, provisional staging could be considered in patients with renal dysfunction, complex coronary disease (including CTO), or if it is thought during PCI that deferring intervention to 1 or more vessels is in the patient’s best interests (e.g., because of unexpected high contrast volumes or procedural complications during PCI to the first vessel). Staging must be pre-specified at the index procedure. Urgent revascularization before the planned second-stage procedure will be considered a secondary endpoint.
Optimal medical therapy in both arms
To ensure that patients in both arms of the trial receive optimal medical and device therapy, there is a nominated HF lead at each participating center who is actively involved in patient selection and monitoring of therapy during the course of the trial. Furthermore, a trial Medical Therapy Committee has been established that will review available evidence and guidelines at least annually and refine recommendations to ensure that drug and device therapy given to all patients in the trial remains optimal and contemporary. Each site is provided with a standard operating procedure for delivering and monitoring OMT, which sets out classes of drugs appropriate for trial patients, including HF therapies—such as angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/− neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist (23)—and secondary prevention for atherosclerosis including statins and antiplatelet agents as well as recommended treatment targets including lipid profile, HbA1c, and resting heart rate. Formal anticoagulation for LV thrombus detected on imaging or as prophylaxis for severe LV dysfunction/dyskinesis is at the discretion of the treating physician. Initiation of these treatments, dose-titration, and relevant monitoring is per local HF protocols.
Eligible patients are initiated on medical therapy before randomization and, in patients presenting with de novo HF, assessment of LVEF is deferred if they are not on appropriate medical therapy at presentation. Optimization of medical and device therapy will continue in both groups even after randomization, throughout the course of the trial.
ICD implantation is not mandatory for inclusion in REVIVED, although many patients who fulfill trial eligibility criteria may also be candidates for primary prevention ICDs. Participating sites are encouraged to follow international guidelines (23) when deciding on ICD or resynchronization device therapy and to make and document the decision to implant—or not implant—a device before randomization.
In the STICH trial, the rate of all cause death or hospitalization for HF at 5 years was 54% in the medical therapy group, with approximately 50% of events occurring in the first year and a steady rate thereafter (7). These data are similar to the 1-year rates of death or HF hospitalization reported in registries of Western European populations (24). On this basis, the predicted occurrence of death or hospitalization for HF at 2 years is 36% in the OMT group. The primary outcome will be measured over the entire duration of the trial, with a minimum follow-up duration of 2 years. A trial of 700 (350 in each group), with 300 patients experiencing primary outcomes, would have over 85% power to detect a hazard ratio of 0.70 (a 30% relative reduction in the hazard) at 5% significance, allowing for up to 5% losses by the end of follow-up. The hazard ratio of 0.7 is considered clinically meaningful and in line with the magnitude of benefit observed across other treatment modalities in this population. For the major secondary endpoint, even one-half this sample size will provide 90% power to detect a minimum difference in EF of 4%, assuming a SD of 11%.
This trial will be a comparison of initial strategy, rather than technique; the projected event rates and hazard ratio allow for the fact that patients on OMT may undergo subsequent revascularization. As such, no additional adjustments have been made to the power calculation to account for unplanned revascularization in the OMT arm. In patients assigned to receive OMT, revascularization by PCI or CABG during the trial would only be recommended in 1 of the following circumstances: readmission with an acute coronary syndrome (diagnosed on the basis of typical ischemic symptoms as well as a rise in cardiac biomarker levels or dynamic ST-segment deviation on ECG), deterioration in exertional angina to ≥CCS class 3 symptoms, or the occurrence of resistant ventricular arrhythmias considered to be ischemic in etiology.
A detailed statistical analysis plan will be finalized before any data are analyzed by treatment assignment. Analysis of outcomes will be by treatment assignment, on an intention-to-treat basis. An unadjusted time-to-event analysis will be performed on the primary outcome using all follow-up data, with time-to-first-event (or censoring) times measured from randomization. Hazard ratios, together with associated confidence intervals, will be calculated from the Cox proportional hazards model. Cumulative event rates will be calculated and presented using Kaplan-Meier time-to-event curves. As a measure of absolute treatment difference, cumulative event rates will be compared at 2 years. Each individual component of the primary composite outcome, as well as other secondary time-to-event outcomes, will be analyzed using these methods. Losses to follow-up are expected to be minimal, and patients will be included up until the time they experience the event or are censored. Any categorical outcome measures compared at specific time points will be examined using risk ratios and risk differences, confidence intervals, and significance tests. Continuous variables will be analyzed and presented as mean treatment differences, confidence intervals, and p values derived from analysis of covariance models or unpaired t-tests as appropriate (with appropriate transformation if necessary).
Interim analyses by treatment assignment are not planned. A limited number of subgroups analyses will be performed, which will be detailed in the analysis plan. A risk model will be developed, based on interactions between variables and treatment in the Cox model, and used to examine whether the impact of treatment depends on a person’s underlying risk.
Health Economic Analysis
The Centre for Health Economics at the University of York, UK, will perform a formal health economic analysis. Data will be collected on use of health service resources including length of inpatient stays, outpatient visits, use of primary care resources, use of cardiovascular medication and devices, and subsequent cardiovascular procedures. Resource use will be valued in monetary terms using routine unit cost data relevant to the UK National Health Service (NHS). These will include NHS Reference Costs, British National Formulary drug prices, and the Personal Social Services Research Unit (PSSRU) survey of unit costs.
A formal cost effectiveness study of PCI in this population will be undertaken using a decision analytic framework, which will be a cohort model with states representing death and different levels of HF symptoms. Key features will include the quantification of health benefits in terms of quality-adjusted life years (QALYs) and the use of an NHS cost perspective. Standard decision rules will be used to assess cost effectiveness, and extensive sensitivity analysis will be undertaken (probabilistic and deterministic) to assess the implications of uncertainty in the available evidence for cost effectiveness. Heterogeneity in cost effectiveness among different subgroups of patients will be assessed using methods consistent with those applied to clinical outcomes.
Data Collection and Monitoring
Each patient’s demographic details, medical history, electrocardiogram, routine blood results, cardiac medication, LVEF, viability assessment, ICD interrogation result (if applicable), and BCIS-JS are recorded at baseline. LVEF will be reassessed at 6 and 12 months as detailed here. ICD interrogation, quality-of-life scores, BNP (or NT-pro BNP) level, troponin (T or I) level, and cardiac medication are recorded at 6, 12, and 24 months post-randomization. All major outcomes and serious adverse events are collected at 6, 12, and 24 months for all patients and yearly thereafter for patients who have been randomized more than 2 years before the end of the trial. Also, patients who undergo revascularization—by treatment assignment or as an unplanned procedure—have troponin levels checked before and after the procedure. Hospitalization and mortality will be tracked using national databases to ensure that any unreported major outcome events are identified. The DMSC will review serious adverse events and any other trial safety issues. The Clinical Trial Unit collects a snapshot of screening from each center twice a year. Recruiting centers capture details of all patients with extensive coronary artery disease and EF ≤35% during this representative period. These data will be used to generate a Consort-style flowchart, describing the total population screened as well as the frequency and causes of patients excluded from the trial.
Ischemic cardiomyopathy is the most common cause of HF and is associated with significant mortality and morbidity. Surgical revascularization has recently been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard in this group. PCI is an appealing alternative to surgery, which may allow a better balance between risk and benefit, but this assertion has never been formally tested. REVIVED is the first randomized controlled trial of PCI for severe ischemic LV dysfunction and will provide important data that will inform guidelines on revascularization in ICM.
COMPETENCY IN MEDICAL KNOWLEDGE: The void in evidence has led clinicians to adopt a spectrum of practice when managing ischemic cardiomyopathy. Some patients are offered CABG surgery or PCI; others are managed with medical therapy alone, whereas a significant proportion of patients with LV dysfunction are not even considered for coronary angiography. If REVIVED-BCIS2 finds that PCI improves event-free survival, this will provide the first randomized evidence for a new treatment option in this group of patients.
TRANSLATIONAL OUTLOOK: If PCI does improve outcomes in patients with LV dysfunction and severe coronary disease, several further questions will arise: For patients eligible for treatment by either modality, will PCI and CABG surgery offer comparable outcomes? Will the benefit of revascularization be limited to patients who have a minimum threshold of viable myocardium? What is the mechanism of improved outcome?
The authors acknowledge the assistance of Dr. Natalia Briceno in preparing Table 1.
The trial is sponsored by King’s College London, UK; and funded by the UK Department of Health via the National Institute for Health Research (NIHR) (Health Technology Assessment project 10/57/67). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- British Cardiovascular Intervention Society jeopardy score
- brain-type natriuretic peptide
- coronary artery bypass graft
- ejection fraction
- heart failure
- implantable cardioverter defibrillator
- ischemic cardiomyopathy
- left anterior descending
- left ventricular
- myocardial infarction
- magnetic resonance imaging
- optimal medical therapy
- percutaneous coronary intervention
- Received December 30, 2017.
- Accepted January 23, 2018.
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