Abstract
Objectives
Optimal medical therapy in patients with heart failure and coronary artery disease is associated with improved outcomes. However, whether this association is influenced by the performance of coronary artery bypass grafting is less well established. Thus, the aim of this study was to determine the possible relationship between coronary artery bypass grafting and optimal medical therapy and its effect on the outcomes of patients with ischemic cardiomyopathy.
Methods
The Surgical Treatment for Ischemic Heart Failure trial randomized 1212 patients with coronary artery disease and left ventricular ejection fraction 35% or less to coronary artery bypass grafting with medical therapy or medical therapy alone with a median follow-up over 9.8 years. For the purpose of this study, optimal medical therapy was collected at baseline and 4 months, and defined as the combination of 4 drugs: angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, beta-blocker, statin, and 1 antiplatelet drug.
Results
At baseline and 4 months, 58.7% and 73.3% of patients were receiving optimal medical therapy, respectively. These patients had no differences in important parameters such as left ventricular ejection fraction and left ventricular volumes. In a multivariable Cox model, optimal medical therapy at baseline was associated with a lower all-cause mortality (hazard ratio, 0.78; 95% confidence interval, 0.66-0.91; P = .001). When landmarked at 4 months, optimal medical therapy was also associated with a lower all-cause mortality (hazard ratio, 0.82; 95% confidence interval, 0.62-0.99; P = .04). There was no interaction between the benefit of optimal medical therapy and treatment allocation.
Conclusions
Optimal medical therapy was associated with improved long-term survival and lower cardiovascular mortality in patients with ischemic cardiomyopathy and should be strongly recommended.
Graphical abstract
Graphical Abstract
Key Words
Abbreviations and Acronyms:
ACEI (angiotensin-converting enzyme inhibitor), ARB (angiotensin receptor blocker), CABG (coronary artery bypass grafting), CAD (coronary artery disease), CV (cardiovascular), HF (heart failure), KCCQ (Kansas City Cardiomyopathy Questionnaire), LV (left ventricular), LVEF (left ventricular ejection fraction), MI (myocardial infarction), NYHA (New York Heart Association), OMT (optimal medical therapy), PCI (percutaneous coronary intervention), STICH (Surgical Treatment for Ischemic Heart Failure)
All-cause mortality by OMT and non-OMT, and with randomization to treatment allocation.
Central Message
OMT in a multivariable Cox model was associated with a lower all-cause mortality in patients with ischemic cardiomyopathy from the STICH trial.
Perspective
We evaluate the effects of OMT on long-term survival in patients with ischemic cardiomyopathy from the STICH trial. In a multivariable Cox model, despite the differences between OMT and non-OMT groups at baseline, receiving OMT was associated with a lower all-cause and CV mortality.
Evidence supports the use of optimal medical therapy (OMT) for all patients with heart failure (HF) and coronary artery disease (CAD) to relieve symptoms, reduce incident myocardial infarction (MI), and improve survival. Medical therapy in HF
1
includes a combination of an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) and a beta-blocker. Aldosterone antagonists are indicated in patients in New York Heart Association (NYHA) functional class II or greater. In patients with HF and CAD, a statin and at least 1 antiplatelet drug are recommended.- Writing Committee Members
- Yancy C.W.
- Jessup M.
- Bozkurt B.
- Butler J.
- Casey Jr., D.E.
- et al.
2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines.
Circulation. 2013; 128: e240-e327
Despite the benefits of medical therapy, there is a low use of OMT in this high-risk group of patients. Moreover, in systematic literature review of postrevascularization trials, a marked underreporting of medical therapy was noted in cardiovascular (CV) interventional trials.
2
In a recent study of medical therapy in contemporary coronary revascularization trials, medication adherence was reported to be only 40% at 1 year and 38% at 5 years.3
The underuse of OMT is likely multifactorial. It may reflect healthcare system issues, medication nonadherence, drug intolerance, medical comorbidities, or even the misconception of the importance of maintaining OMT in these high-risk patients.4
,5
Finally, there is paucity of data on the association between OMT and long-term outcomes in patients with HF after revascularization, and even less is known about the impact of CABG on this association.
6
, 7
, 8
, 9
The Surgical Treatment for Ischemic Heart Failure (STICH) trial randomized eligible patients with HF and CAD to coronary artery bypass grafting (CABG) plus medical therapy versus medical therapy alone therapy. CABG was associated with a significantly lower rate of death from any cause, death from CV causes, and death from any cause or hospitalization for CV causes.
10
The STICH trial population provides a unique opportunity to evaluate the importance of OMT in these patients. Accordingly, the purpose of this study was to evaluate the association of OMT with all-cause mortality and CV events in patients with ischemic cardiomyopathy and to determine the influence of revascularization with CABG on this association (Video 1).
Materials and Methods
The design of the STICH trial has been described previously.
11
STICH was a prospective, multicenter, randomized controlled trial sponsored by the National Heart, Lung, and Blood Institute that recruited 1212 patients with CAD and left ventricular (LV) ejection fraction 35% or less from 99 sites in 22 countries between 2002 and 2007, and before the results were reported, the protocol was amended to extend the follow-up period by an additional 5 years for all patients.Unless contraindicated, medications (medical therapy) were adjusted to optimal doses within 30 days after randomization. Statin, diuretic, and digitalis use were individualized to patient-specific indications. A lead cardiologist at each site was responsible for ensuring high-quality medical treatment trying to achieve OMT for both medical therapy only and CABG groups. In principle, every patient in STICH had to have OMT, but for reasons that we are unable to determine, some patients did not receive OMT as defined in this article.
Medication status was recorded at baseline, at 4, 8, and 12 months, and every 6 months thereafter, with a median follow-up of 9.8 years. The STICH Trial demonstrated a significantly lower all-cause mortality and CV mortality among patients who underwent CABG in addition to OMT compared with those who received medical therapy alone.
12
Detailed inclusion and exclusion criteria have been previously described.11
The National Heart, Lung, and Blood Institute and the ethics committee at each participating institution approved the study protocol. All patients provided written informed consent. There is no additional Institutional Review Board review required for this analysis, because this is a post hoc analysis based on the existing STICH database, that is, no new data are collected and consent had been obtained from every patient in the STICH trial.For the purpose of this study, OMT was defined as a combination of 4 drugs: ACEI/ARB, beta-blocker, statin, and at least 1 antiplatelet drug (clopidogrel or aspirin) at baseline. By the time STICH was designed, aldosterone antagonists were only reasonable in selected patients with moderately severe to severe symptoms of HF and reduced left ventricular ejection fraction (LVEF),
11
so this drug was not suggested in all patients at baseline and not incorporated in the OMT definition for this analysis.Because of drug adjustments within 30 days after randomization, OMT was expected to increase from baseline to 4 months, reaching a stable standard of treatment. To better evaluate the effects of OMT, a landmark analysis using medical therapy at baseline and at 4 months was conducted and included in this investigation.
Statistical Analysis
All statistical analyses were conducted under the intention-to-treat principle. Baseline characteristics were summarized by OMT and randomized treatment. Categorical variables were presented as counts (percentages), and continuous variables were summarized as median (25th, 75th, percentiles) or mean (standard deviation). Comparisons for categorical variables were performed using Pearson's chi-square or Kruskal–Wallis tests for continuous variables. Baseline OMT status was the primary item in this analysis; however, OMT status at 4 months was analyzed as a landmark in Table E1. Kaplan–Meier estimates were used to depict the clinical outcome of mortality. Survival curves were compared using log-rank test and stratified by OMT and randomized treatment.
A multivariable Cox proportional hazards model was used to develop an association model for all-cause mortality. Stepwise selection was performed using a significance level for entry and retention of 0.10 and 0.05, respectively. Candidate variables included age, body mass index, weight, blood pressure, heart rate, hemoglobin, Duke index score, creatinine, smoking status, diabetes, sex, hyperlipidemia, hypertension, angina class, peripheral vascular disease, prior stroke, prior CABG, prior percutaneous coronary intervention (PCI), prior MI, ethnicity, race, chronic renal disease, depression, left main stenosis greater than 50%, mitral regurgitation, and proximal left anterior descending coronary artery stenosis 75% or less. For continuous variables, nonlinear transformations such as restricted cubic-spline were considered. Proportional hazards assumption was checked and met.
Significant baseline risk factors, OMT status, and randomized treatment were included in the Cox model. An interaction term between OMT status and randomized treatment was considered. All statistical analyses were conducted using SAS software v9.4 (SAS Institute, Inc, Cary, NC).
Results
Demographics and Baseline Parameters
Information on the medication status was available for all patients. At baseline, 58.7% of the patients were receiving OMT. Patients receiving OMT had less atrial fibrillation (18.2% vs 8.7%, P < .01) and better renal function (median glomerular filtration rate, 90.4 vs 87.0 mL.min−1.1.73 m−2; P = .019). In addition, patients receiving OMT had more dyslipidemia (64.8% vs 54.8%, P < .01).
Baseline Left Ventricular Function, Volumes, and Coronary Anatomy
There were no differences in OMT versus non-OMT groups in LV function and end-systolic and end-diastolic volume indices. There was also no difference in the degree of mitral regurgitation. The rates of triple-vessel disease, left main stenosis 50% or greater, and proximal left anterior descending stenosis 75% or greater were not significantly different. Table 1 includes details of baseline LV function, volume index, and coronary anatomy measured at baseline.
Table 1Baseline left ventricular function and coronary anatomy
| OMT | Non-OMT | P value | |
|---|---|---|---|
| N = 712 | N = 500 | ||
| LV function | |||
| Baseline EF (%) | 28.0 (22.0, 34.0) | 27.0 (22.0, 33.0) | .144 |
| Baseline ESVI (mL/m2) | 78.9 (59.7, 103.3) | 77.1 (59.3, 100.9) | .633 |
| Baseline EDVI (mL/m2) | 111.9 (90.6, 138.3) | 111.9 (89.1, 139.2) | .902 |
| Mitral regurgitation, % | .988 | ||
| None or trace | 256 (36.0%) | 179 (35.9%) | |
| Mild | 325 (45.7%) | 229 (46.0%) | |
| Moderate | 106 (14.9%) | 75 (15.1%) | |
| Severe | 24 (3.4%) | 15 (3.0%) | |
| Vessels with ≥75% stenosis, n | .464 | ||
| None, % | 11 (1.5%) | 14 (2.8%) | |
| 1% | 170 (23.9%) | 112 (22.4%) | |
| 2% | 273 (38.3%) | 189 (37.9%) | |
| 3% | 258 (36.2%) | 184 (36.9%) | |
| Multivessel disease, % | 531 (74.6%) | 373 (74.7%) | >.995 |
| Left main stenosis ≥50% | 19 (2.7%) | 13 (2.6%) | >.995 |
| Proximal LAD ≥75%, % | 463 (65.0%) | 363 (72.7%) | .005 |
OMT, Optimal medical therapy; LVEF, left ventricular ejection fraction; ESVI, end-systolic volume index; EDVI, end-diastolic volume index; LAD, left anterior descending artery.
∗ For categorical variables, frequencies and percentages are provided; P values are from chi-square exact tests. For continuous variables, medians (25th, 75th percentiles) are provided; P values are from Kruskal–Wallis tests.
Symptoms and Quality of Life
At baseline, patients receiving OMT had a lower Canadian Cardiovascular Society angina score (Table 2). The percentage of patients with advanced HF class (by highest NYHA class during the 3-month period before randomization) was higher in the non-OMT group (P < .001) at baseline. Health status–related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score was higher in the OMT group at baseline (62.6 ± 22.8 vs 58.3 ± 22.4, P < .001).
Table 2Baseline characteristics by baseline optimal medical therapy status
| OMT | Non-OMT | P value | |
|---|---|---|---|
| N = 712 | N = 500 | ||
| Demographics, % | |||
| Age (y) | 59.4 (53.6, 66.5) | 59.9 (53.6, 68.0) | .362 |
| Male | 628 (88.2%) | 436 (87.2%) | .594 |
| BMI (m2/kg) | 26.8 (24.2, 29.8) | 26.8 (23.7, 29.8) | .459 |
| Weight (kg) | 78.0 (69.0, 88.7) | 78.0 (67.0, 88.0) | .390 |
| Region | <.001 | ||
| United States | 70 (9.8%) | 50 (10.0%) | |
| Canada | 78 (11.0%) | 45 (9.0%) | |
| Europe | 157 (22.1%) | 198 (39.6%) | |
| Australia/New Zealand/Asia | 132 (18.5%) | 107 (21.4%) | |
| South America | 42 (5.9%) | 14 (2.8%) | |
| Poland | 233 (32.7%) | 86 (17.2%) | |
| Medical history, % | |||
| Dyslipidemia | 460 (64.8%) | 270 (54.0%) | <.001 |
| Diabetes | 284 (39.9%) | 194 (38.8%) | .720 |
| Prior stroke | 50 (7.0%) | 42 (8.4%) | .380 |
| Current smoker | 143 (20.1%) | 109 (21.8%) | .473 |
| Prior PVD | 108 (15.2%) | 76 (15.2%) | 1.000 |
| Hemoglobin (g/dL) | 13.9 (12.7, 14.9) | 13.9 (12.7, 15.0) | .836 |
| Chronic renal insufficiency | 56 (7.9%) | 38 (7.6%) | .913 |
| Creatinine (mg/dL) | 1.1 (0.9, 1.2) | 1.1 (1.0, 1.3) | .023 |
| GFR (mL/min/1.73 m2) | 90.4 (73.2, 106.1) | 87.0 (70.8, 102.0) | .019 |
| Atrial fibrillation/flutter | 62 (8.7%) | 91 (18.2%) | <.001 |
| Prior PCI | 105 (14.7%) | 51 (10.2%) | .023 |
| Prior CABG | 16 (2.2%) | 20 (4.0%) | .087 |
| KCCQ - Overall Summary score | 64.0 (47.0, 80.0) | 58.0 (43.0, 77.0) | <.001 |
| CCS angina class, % | |||
| Current angina class | .043 | ||
| No angina | 260 (36.5%) | 182 (36.4%) | |
| I | 128 (18.0%) | 59 (11.8%) | |
| II | 293 (41.2%) | 232 (46.4%) | |
| III | 26 (3.7%) | 22 (4.4%) | |
| IV | 5 (0.7%) | 5 (1.0%) | |
| Highest NYHA HF class, % | |||
| Current NYHA | <.001 | ||
| I | 100 (14.0%) | 39 (7.8%) | |
| II | 396 (55.6%) | 230 (46.0%) | |
| III | 198 (27.8%) | 214 (42.8%) | |
| IV | 18 (2.5%) | 17 (3.4%) | |
OMT, Optimal medical therapy; BMI, body mass index; PVD, peripheral vascular disease; GFR, glomerular filtration rate; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; KCCQ, Kansas City Cardiomyopathy Questionnaire; CCS, Canadian Cardiovascular Society; NYHA, New York Heart Association; HF, heart failure.
∗ For categorical variables, counts (percentages) are provided; continuous variables were summarized as mean (standard deviation); categorical variables P values are from chi-square exact tests. Continuous variables P values are from Kruskal–Wallis tests.
Medical Therapy
A lower prevalence of OMT was observed at baseline in both groups (CABG + medical therapy and medical therapy alone), achieving a higher level at 4 months, remaining stable for the first 5 years, and decreasing at extended follow-up (Figure 1). The reasons why some patients were not receiving OMT were not collected and therefore were not available for this analysis.
Figure 1OMT over time in CABG + medical therapy and medical therapy alone groups. OMT, Optimal medical therapy; MED, medical therapy; CABG, coronary artery bypass grafting.
Clinical Outcomes Landmarked at Baseline
Over a median follow-up of 9.8 years, OMT was associated with a significantly lower all-cause mortality compared with non-OMT (58.8% vs 67.6%, P < .001), lower CV mortality (40.3% vs 51.4%, P < .001), and lower HF death (11.2% vs 15.6%, P < .001). Sudden death was not different (21.5% vs 23.4%, P = .058) (Figure 2, A and B; Table 3).
Figure 2A, Kaplan–Meier rates of all-cause mortality by OMT 58.8% versus non-OMT 67.6%, P < .001 at baseline. B, CV mortality by OMT 40.3% versus non-OMT 51.4%, P < .001 at baseline. C, All-cause mortality by OMT and non-OMT with randomization to CABG/OMT 55.0% versus CABG/non-OMT 63.8%; medical therapy/OMT 62.4% versus medical therapy/non-OMT 72.0% P < .001. D, CV mortality by OMT and non-OMT with randomization to CABG/OMT 36.3% versus CABG/non-OMT 45.9%; medical therapy/OMT 44.1% versus medical therapy/non-OMT 57.8% P < .001. OMT, Optimal medical therapy; CV, cardiovascular; CABG, coronary artery bypass grafting; MED, medical therapy.
Figure 3Kaplan–Meier rates of all-cause mortality by OMT 58.8% versus non-OMT 67.6%, P < .001 at baseline in patients with CAD and EF 35% or less. OMT, Optimal medical therapy; STICH, Surgical Treatment for Ischemic Heart Failure; CAD, coronary artery disease; EF, ejection fraction.
Table 3Clinical event rates by baseline optimal medical therapy status
| OMT (n = 712) | Non-OMT (n = 500) | Log-rank P value | |||
|---|---|---|---|---|---|
| No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | ||
| All-cause mortality | 419 (58.8%) | 59.9 (56.1-63.8) | 338 (67.6%) | 69.2 (64.8-73.5) | <.001 |
| CV mortality | 287 (40.3%) | 45.0 (40.9-49.2) | 257 (51.4%) | 57.7 (52.8-62.7) | <.001 |
| Sudden cardiac death | 153 (21.5%) | 16.3 (13.1-20.2) | 117 (23.4%) | 31.7 (26.9-37.2) | .054 |
| HF death | 80 (11.2%) | 16.3 (13.1-20.2) | 78 (15.6%) | 26.5 (21.2-32.8) | <.001 |
OMT, Optimal medical therapy; CI, confidence interval; CV, cardiovascular; HF, heart failure.
When patients were analyzed according to the treatment assigned by randomization (CABG + medical therapy vs medical therapy alone) and OMT versus non-OMT, a benefit of OMT was associated with all-cause mortality for both groups (55.0% vs 63.8% for CABG + medical therapy and 62.4% vs 72.0% medical therapy alone P < .001). The benefit was observed in both treatment groups for all other clinical end points (Figure 2, C and D; Table 4).
Table 4Clinical event rates by baseline optimal medical therapy status and randomized arms
| Clinical event | CABG/OMT (n = 342) | CABG/non-OMT (n = 268) | Medical therapy/OMT (n = 370) | Medical therapy/non-OMT (n = 232) | Log-rank P value | ||||
|---|---|---|---|---|---|---|---|---|---|
| No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | No. of events (%) | 10-y Kaplan–Meier rate (95% CI), % | ||
| All-cause mortality | 188/342 (55.0%) | 55.6 (50.1, 61.2) | 171/268 (63.8%) | 65.1 (59.1, 71.1) | 231/370 (62.4%) | 63.9 (58.6, 69.2) | 167/232 (72.0%) | 73.9 (67.5, 79.9) | <.001 |
| CV mortality | 124/342 (36.3%) | 39.3 (33.8, 45.3) | 123/268 (45.9%) | 51.9 (45.3, 58.9) | 163/370 (44.1%) | 50.3 (44.5, 56.4) | 134/232 (57.8%) | 64.1 (57.0, 71.2) | <.001 |
| Sudden cardiac death | 65/342 (19.0%) | 27.5 (22.0, 34.1) | 51/268 (19.0%) | 27.7 (21.5, 35.4) | 88/370 (23.8%) | 40.3 (33.4, 47.9) | 66/232 (28.4%) | 50.2 (40.8, 60.4) | <.001 |
| HF death | 33/342 (9.6%) | 14.6 (10.4, 20.3) | 33/268 (12.3%) | 22.4 (16.0, 31.0) | 47/370 (12.7%) | 24.9 (17.4, 35.0) | 45/232 (19.4%) | 38.8 (26.9, 53.7) | <.001 |
CABG, Coronary artery bypass grafting; CI, confidence interval; CV, cardiovascular; HF, heart failure; OMT, optimal medical therapy.
Analysis Landmarked at 4 Months, After Adjustments to Optimal Doses and Therapy
At 4 months, OMT increased to 73.3% of the patients (Figure 1). There were 129 patients (78 in the CABG group and 51 in the medical therapy group) who did not have a month 4 medication visit, including 78 patients who died between baseline and 4 months. Thus, this analysis included 1083 patients who were alive at 4 months.
The clinical characteristics of the patients landmarked at 4 months are listed in Tables E1 and E2. Patients in the OMT versus non-OMT group at 4 months were younger (59.5 vs 62.4 years P < .001), had higher systolic pressure (121.9 vs 119.3 mm Hg, P = .0035), and had higher diastolic blood pressure (76.0 vs 74.2 mm Hg). They also had less atrial fibrillation/flutter (8.3% vs 27.8%, P < .001). There were no differences in other important parameters, including gender, diabetes, hyperlipidemia, hypertension, renal function, previous MI, and randomized treatment.
At 4 months, the percentage of patients receiving OMT had more class I angina by the Canadian Cardiovascular Society, but less patients were asymptomatic. In the OMT group, there was a lower percentage of patients with advanced HF by the highest NYHA class during the 3-month period before randomization (Table E1). Health status–related quality of life measured by the KCCQ score was similar in both groups, measured at baseline.
Cox Model Results for All-Cause Mortality
A multivariable model for all-cause mortality was created after adjustments for all significant baseline covariates (Table E5). When OMT was landmarked at baseline, we observed that OMT was associated with a reduction in all-cause death compared with non-OMT (hazard ratio [HR], 0.78; confidence interval [CI], 0.66-0.91; P = .001) (Figure 3). When analyzing by treatment randomization, OMT versus non-OMT, in the medical therapy alone group, the reduction in all-cause mortality did not reach statistical significance (HR, 0.86; CI, 0.69-1.07), whereas in the CABG group, a reduction in mortality was observed with OMT (HR, 0.70; CI, 0.56-0.87), but there was no interaction (P = .189).
When landmarked at 4 months, OMT was also associated with a lower all-cause mortality (HR, 0.82; 95% CI, 0.62-0.99; P = .04) (Figure E1). When analyzed by treatment allocation to CABG + medical therapy versus medical therapy alone, both CABG (relative risk, 0.76; 95% CI, 0.64-0.89; P = .001) and medical therapy alone were associated with lower all-cause mortality (relative risk, 0.82; 95% CI, 0.69-0.99; P = .040).
Discussion
STICH is a prospective randomized trial in CABG-eligible patients with HF that compares CABG plus medical therapy with medical therapy alone, associating contemporary OMT for HF and CAD with robust and high-quality data.
In this study, we analyzed the association of OMT with all-cause mortality in patients with ischemic cardiomyopathy randomized to CABG + medical therapy or medical therapy alone. Despite the differences in clinical characteristics between OMT or non-OMT groups, Cox analysis showed an association of OMT with lower all-cause death when landmarked at baseline and 4 months. There was no interaction between the benefit of OMT and the treatment allocation. This observation reinforces the importance of OMT in ischemic myocardiopathy, irrespective of surgical treatment.
Clinical Characteristics at Baseline and 4 Months
Apart from LV function and NYHA, baseline characteristics of the patients in STICH were similar to those in other CAD studies, such as the Coronary Artery Surgery Study, CABG Patch, Syntax, and patients with HF such as Candesartan in Heart Failure-Assessment of Mortality and Morbidity and Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure.
10
, 11
, 12
, 13
The 160 patients in the Coronary Artery Surgery Study trial with low ejection fraction included those with LVEF greater than 0.34 but less than 0.50 at baseline. Patients were younger, with a mean age of 51 years.13
The Syntax trial, which excluded LV dysfunction, in a comparison of PCI and CABG had similar baseline characteristics. The Candesartan in Heart Failure-Assessment of Mortality and Morbidity trial14
compared candesartan with placebo in patients with LVEF less than 40. The mean age was 65 years, and the mean LVEF was 29%. Previous MI occurred in less than 60% of the patients. Only 20% of patients were receiving spironolactone.- Young J.B.
- Dunlap M.E.
- Pfeffer M.A.
- Probstfield J.L.
- Cohen-Solal A.
- Dietz R.
- et al.
Mortality and morbidity reduction with Candesartan in patients with chronic heart failure and left ventricular systolic dysfunction: results of the CHARM low-left ventricular ejection fraction trials.
Circulation. 2004; 110: 2618-2626
In this post hoc analysis, we observed that important prognostic baseline and 4-month cardiac characteristics associated with in-hospital and long-term mortality, such as LVEF, end-diastolic volume index, and end-systolic volume index, and other characteristics, such as diabetes, were similar in both groups. However, at baseline, patients receiving OMT had slightly better renal function, less atrial fibrillation, a lower angina score by the Canadian Cardiovascular Society, and a lower NYHA HF score. At 4 months, age was higher and AF was more prevalent in the non-OMT group and systolic and diastolic blood pressures were higher in the OMT group. Renal function was similar between groups. In addition, a higher health status–related quality of life as measured by the KCCQ overall score was associated with OMT. This finding might be partially influenced by the beneficial effects of OMT in these patients, reducing symptoms and improving quality of life.
Atrial fibrillation was more prevalent in the non-OMT group, which may explain the greater use of anticoagulation and consequently lesser use of antiplatelets, one of the drugs of the OMT definition. Renal dysfunction may be associated with reduced use of ACEI/ARBs seen at baseline, but this dysfunction was not seen at 4 months. Elevated doses of ACEI/ARB may cause creatinine elevation but are indicated for renal dysfunction. Lower use of OMT may help explain the greater symptoms of angina and HF (NYHA), and lower quality of life.
At 4 months, after adjustments to optimal doses and therapy at 4 months, OMT increased to 73.3% of all patients. This adjustment may be related to therapy optimization and the initial postoperative period. The baseline characteristics in both groups were still not similar; however, important characteristics including diabetes, LVEF, end-systolic volume index, and end-diastolic volume index were similar in both groups, including renal function. Patients were older and AF was more prevalent in the non-OMT group. Systolic and diastolic blood pressures were higher in the OMT group.
Medications
Medication use was collected at every follow-up visit, and we had data from all patients. The prevalence of OMT in our study is higher than in other contemporary randomization CABG trials
15
and higher than in large observational studies.16
The 4-month prevalence of OMT (73.3%) in our study is also higher than in other contemporary randomization CABG trials15
and higher than in large observational studies.16
In contemporary coronary revascularization randomized trials, without HF, the prevalence of OMT, according to definition, decreased from 67% at 1 year to 53% at 5 years, or 40% at 1 year to 38% at 5 years, if a 2 or 4 medication definition was used.3
There was an even lower use in patients undergoing CABG compared with PCI.In our study, the prevalence of OMT was similar between CABG + medical therapy and medical therapy alone group at baseline and 4 months, and during follow-up, reducing the bias between randomization allocation.
Optimal Medical Therapy in Coronary Artery Disease and Heart Failure Studies
In the SYNTAX trial of patients with complex CAD with preserved LV function, the OMT prescription (defined by at least 1 antiplatelet drug, statin, beta-blocker, and ACEI) was only 41% overall at discharge (50.2% in the PCI group and 31.2% in the CABG group) and even less at 5 years (PCI 40% and CABG 36%).
17
Despite the differences in OMT rates between CABG and PCI, OMT use was an independent predictor of reduced mortality and in the major adverse cardiovascular and cerebrovascular event composite end point. In the CARE registry, patients with non–ST-segment-elevation MI undergoing coronary revascularization (PCI or CABG), the use of OMT (antiplatelet, lipid-lowering, and beta-blocker therapy) had benefits in major cardiac adverse event survival. Cox regression analysis identified OMT as the more powerful predictor of major adverse cardiac event-free survival than the choice of revascularization strategy.- Iqbal J.
- Zhang Y.J.
- Holmes D.R.
- Morice M.C.
- Mack M.J.
- Kappetein A.P.
- et al.
Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX) trial at the 5-year follow-up.
Circulation. 2015; 131: 1269-1277
18
In a patient-level pooled analysis of Freedom, BARI 2D, and Courage, CAD and OMT were evaluated in 5034 diabetic patients.
19
Only 15% had LVEF less than 50%, 77% had multivessel CAD, and 28% had proximal left anterior descending artery involvement. There was no information about the percentage of patients receiving OMT. They found that CABG plus OMT was superior to OMT alone for major adverse cardiovascular and cerebrovascular event reduction (HR, 0.79; 95% CI, 0.64-0.97; P = .022).The specific reason for our patients not receiving OMT was not collected. This issue was studied in the contemporary registry of outpatients with chronic heart failure with reduced ejection fraction in the United States, the Change the Management of Patients with Heart Failure,
20
which included 3518 patients. Among these patients, 27%, 33%, and 67% did not receive ACEI/ARB/angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist therapy, respectively. Older age, lower blood pressure, more severe functional class, renal insufficiency, and recent HF hospitalization were associated with lower medication use. At 4 months postoperatively, patients not receiving OMT had a number of these characteristics, but adjustment for these differences did not fully explain the better outcomes in patients with OMT.We observed an increase in OMT after baseline to 4 months. This is in part explained by optimization after initial evaluation and follow-up. The registry Get with The Guidelines-HF from 2008 to 2013
21
included 158,922 patients hospital with HF. At discharge, ACEI and ARB were prescribed in 91.2% of those eligible but not receiving it before admission, and beta-blockers were prescribed in 94.1%, demonstrating that optimization of the treatment occurred during hospitalization.Clinical Outcomes
OMT was associated with a lower all-cause mortality, CV mortality, and HF death. This benefit was observed early in the trial and maintained during 9.8 years of follow-up. When analyzed by randomization allocation, CABG + medical therapy or medical therapy, the benefit of OMT was associated with a lower all-cause mortality in both groups. The best results were observed in the CABG + medical therapy with OMT group. The worst outcome was associated with the medical therapy alone with non-OMT group. The CABG + medical therapy group with non-OMT had a survival similar to medical therapy with OMT, suggesting a synergistic effect of CABG and OMT on survival.
In this post hoc analysis, our Cox model identified known important risk factors associated with higher long-term all-cause mortality, including age, higher creatinine level, gender, diabetes, prior MI, peripheral vascular disease, stroke, higher end-systolic volume index, more severe mitral regurgitation, and higher NYHA class. We created a multivariable model for mortality adjusted for all significant baseline covariates and still found that both OMT and CABG were significantly associated with lower all-cause mortality over 9.8 years of follow-up.
Study Limitations
This analysis has several limitations, including its post hoc nature and possible baseline differences between groups. The underuse of OMT may be related to lack of tolerance, comorbidities, or medical issues, which by themselves are risk factors for poor outcomes or nonadherence.
We do not have information about medication dose, because it was ordered at the physician's discretion. Drug adherence was assessed by self-reporting during follow-up without external validation. However, self-reporting adherence has been shown to be a valuable tool,
22
and good drug compliance was an inclusion criterion in the STICH trial.Aldosterone and eplerenone were not included in the OMT definition, because they were only indicated for moderate to severe or severe HF at the time of the STICH design. In our data set, these medications were not specifically listed but included with potassium-sparing diuretics, which could be other diuretics as well. The 4-month landmark analysis creates a nonrandomization population, because many deaths were excluded before 4 months, so these data should be interpreted with caution.
Conclusions
This is a post hoc analysis of long-term outcomes of OMT in patients with ischemic cardiomyopathy randomized to CABG + medical therapy compared with medical therapy alone with a median follow-up of 9.8 years. Despite differences between the OMT and non-OMT groups, in a multivariate Cox model, patients receiving OMT landmarked at baseline or after 4 months had an improved long-term survival. There was no interaction between the benefit of OMT and the treatment allocation.
Conflict of Interest Statement
The authors reported no conflicts of interest.
The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
Supplementary Data
- Video 1
Findings and implications of this article. Video available at: https://www.jtcvs.org/article/S0022-5223(20)33449-8/fulltext.
- Video 1
Findings and implications of this article. Video available at: https://www.jtcvs.org/article/S0022-5223(20)33449-8/fulltext.
Appendix E1
Figure E1A, Kaplan–Meier rates of all-cause mortality by OMT 55.3% versus non-OMT 67.5%, P < .001. B, CV mortality by OMT 38.2% versus non-OMT 46.0%, P < .001. C, All-cause mortality by CABG/OMT 50.5% versus CABG/non-OMT 61.6%; medical therapy/OMT 59.8% versus medical therapy/non-OMT 73.4% P < .001. D, CV mortality by CABG/OMT 34.2% versus CABG/non-OMT 34.2%; medical therapy/OMT 41.9% versus medical therapy/non-OMT 58.0% P < .001 with randomization to CABG + medical therapy or medical therapy alone. OMT, Optimal medical therapy; CV, cardiovascular; CABG, coronary artery bypass grafting; MED, medical therapy.
Table E1Population characteristics at 4 months according to optimal medical therapy status
| OMT | Non-OMT | P value | |
|---|---|---|---|
| N = 794 (73.3%) | N = 289 (26.6%) | ||
| Demographics, % | |||
| Age (y) | 59.5 ± 8.8 | 62.4 ± 10.0 | <.001 |
| Male | 691 (87.0%) | 257 (88.9%) | .467 |
| Race | .137 | ||
| White | 563 (70.9%) | 191 (66.1%) | |
| Black or African American | 17 (2.1%) | 10 (3.5%) | |
| Asian | 121 (15.2%) | 60 (20.8%) | |
| Other | 91 (11.5%) | 27 (9.3%) | |
| Multiracial | 2 (0.3%) | 1 (0.3%) | |
| Medical history, % | |||
| Diastolic blood Pressure (mm Hg) | 76.0 ± 10.8 | 74.2 ± 11.3 | .030 |
| Systolic blood Pressure (mm Hg) | 121.9 ± 17.8 | 119.3 ± 16.6 | .035 |
| Pulse (beats/min) | 73.8 ± 13.0 | 76.2 ± 18.7 | .206 |
| BMI (m2/kg) | 27.5 ± 4.7 | 27.0 ± 4.9 | .093 |
| Hypertension | 487 (61.3%) | 166 (57.4%) | .262 |
| Dyslipidemia | 500 (63.1%) | 163 (56.6%) | .057 |
| Diabetes | 309 (38.9%) | 127 (43.9%) | .142 |
| Prior stroke | 54 (6.8%) | 25 (8.7%) | .294 |
| Current smoker | 159 (20.0%) | 62 (21.5%) | .609 |
| Prior PVD | 115 (14.5%) | 49 (17.0%) | .338 |
| Chronic renal Insufficiency | 51 (6.4%) | 27 (9.4%) | .110 |
| GFR (mL/min/1.73 m2) | 88.0 ± 23.2 | 84.5 ± 25.4 | .079 |
| Atrial fibrillation flutter | 66 (8.3%) | 66 (22.8%) | <.001 |
| Prior PCI | 108 (13.6%) | 37 (12.8%) | .763 |
| Prior CABG | 21 (2.6%) | 8 (2.8%) | 1.000 |
| KCCQ - Overall Summary Score | 61.7 ± 22.2 | 60.6 ± 22.9 | .510 |
| CCS angina class, % | |||
| Angina Class | .016 | ||
| No angina | 275 (34.6%) | 121 (41.9%) | |
| I | 144 (18.1%) | 32 (11.1%) | |
| II | 344 (43.3%) | 119 (41.2%) | |
| III | 25 (3.1%) | 15 (5.2%) | |
| IV | 6 (0.8%) | 2 (0.7%) | |
| NYHA HF class, % | |||
| NYHA | <.001 | ||
| I | 114 (14.4%) | 14 (4.8%) | |
| II | 415 (52.3%) | 153 (52.9%) | |
| III | 250 (31.5%) | 110 (38.1%) | |
| IV | 15 (1.9%) | 12 (4.2%) | |
OMT, Optimal medical therapy; BMI, body mass index; PVD, peripheral vascular disease; GFR, glomerular filtration rate; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; KCCQ, Kansas City Cardiomyopathy Questionnaire; CCS, Canadian Cardiovascular Society; NYHA, New York Heart Association; HF, heart failure.
∗ For categorical variables, counts (percentages) are provided; continuous variables were summarized as mean (standard deviation); categorical variables P values are from chi-square exact tests. Continuous variables P values are from Kruskal–Wallis tests.
Table E2Baseline left ventricular function and coronary anatomy
| OMT | Non-OMT | P value | |
|---|---|---|---|
| N = 794 (73.3%) | N = 289 (26.6%) | ||
| LV function | |||
| Baseline EF (%) | 28.5 ± 8.8 | 28.3 ± 8.4 | .699 |
| Baseline ESVI (mL/m2) | 84.2 ± 34.5 | 80.3 ± 31.5 | .263 |
| Baseline EDVI (mL/m2) | 116.1 ± 37.5 | 112.5 ± 33.0 | .420 |
| Mitral regurgitation | |||
| Mitral regurgitation | .218 | ||
| None or trace | 284 (35.9%) | 111 (38.4%) | |
| Mild | 374 (47.2%) | 118 (40.8%) | |
| Moderate | 109 (13.8%) | 51 (17.6%) | |
| Severe | 25 (3.2%) | 9 (3.1%) | |
| Coronary anatomy | |||
| No. of vessels ≥75% stenosis | .796 | ||
| None | 17 (2.1%) | 6 (2.1%) | |
| 1 | 186 (23.4%) | 73 (25.3%) | |
| 2 | 306 (38.5%) | 102 (35.3%) | |
| 3 | 285 (35.9%) | 108 (37.4%) | |
| Multivessel disease | 591 (74.4%) | 210 (72.7%) | .584 |
| Left main stenosis ≥50% | 21 (2.6%) | 10 (3.5%) | .536 |
| Proximal LAD ≥75% | 525 (66.1%) | 201 (69.6%) | .307 |
Clinical values are the best available data reported by the participating sites. OMT, Optimal medical therapy; LVEF, left ventricular ejection fraction; ESVI, end-systolic volume index; EDVI, end-diastolic volume index; LAD, left anterior descending artery.
Table E3Clinical event rates landmarked at 4 months
| OMT (n = 794) | Non-OMT (n = 289) | Log-rank P value | |||
|---|---|---|---|---|---|
| Events | 10-y Kaplan–Meier rate (95% CI), % | Events | 10-y Kaplan–Meier rate (95% CI), % | ||
| All-cause death | 55.3% | 58.3 (54.4-62.1) | 67.5% | 70.1 (64.1-75.9) | <.001 |
| CV death | 38.2% | 43.5 (39.6-47.6) | 46.0% | 55.4 (48.4-62.6) | .002 |
| HF death | 11.5% | 19.8 (14.5-26.9) | 18.7% | 29.8 (21.1-41.1) | .007 |
| Sudden death | 20.0% | 29.5 (25.4-34.1) | 18.7% | 31.0 (23.7-39.9) | .835 |
OMT, Optimal medical therapy; CI, confidence interval; CV, cardiovascular; HF, heart failure.
Table E4Clinical event rates by optimal medical therapy status and randomized arms landmarked at 4 months
| CABG | Medical therapy | Log-rank P value | |||||||
|---|---|---|---|---|---|---|---|---|---|
| OMT (n = 386) | Non-OMT (n = 146) | OMT (n = 408) | Non-OMT (n = 143) | ||||||
| Events | 10-y Kaplan–Meier rate (95% CI) | Events | 10-y Kaplan–Meier rate (95% CI) | Events | 10-y Kaplan–Meier rate (95% CI) | Events | 10-y Kaplan–Meier rate (95% CI) | ||
| All-cause death | 50.5% | 53.0 (47.6-58.6) | 61.6% | 64.3 (55.7-72.8) | 59.8% | 63.4 (58.0-68.7) | 73.4% | 75.8 (67.7-83.3) | <.001 |
| CV death | 34.2% | 38.9 (33.5-44.9) | 34.2% | 41.6 (32.9-51.6) | 41.9% | 48.0 (42.4-53.8) | 58.0% | 67.5 (57.9-76.9) | <.001 |
| HF death | 9.6% | 16.4 (10.0-26.3) | 14.4% | 20.2 (12.3-32.2) | 13.2% | 23.5 (16.5-32.8) | 23.1% | 41.3 (25.6-61.8) | <.001 |
| Sudden death | 18.4% | 24.0 (19.0-30.2) | 13.0% | 18.2 (11.2-28.8) | 21.6% | 35.9 (29.5-43.3) | 24.5% | 47.9 (35.0-62.6) | <.001 |
CABG, Coronary artery bypass grafting; OMT, optimal medical therapy; CI, confidence interval; CV, cardiovascular; HF, heart failure.
Table E5Cox model results for all-cause death
| Covariate | HR (95% LCL, UCL) | Chi-square | P value |
|---|---|---|---|
| Effect of age >60 y, per 5 y | 1.15 (1.08, 1.23) | 17.2 | <.001 |
| Effect of weight, per 5 kg | 0.97 (0.94, 0.99) | 6.5 | .011 |
| Effect of SBP, per 10 mm Hg | 1.05 (1, 1.09) | 4.5 | .034 |
| Male | 1.59 (1.21, 2.1) | 10.9 | <.001 |
| Atrial fibrillation/flutter | 1.27 (1.01, 1.59) | 4.1 | .042 |
| Diabetes | 1.29 (1.11, 1.52) | 10.2 | .001 |
| Prior MI | 1.21 (1, 1.47) | 4.0 | .045 |
| Prior PVD | 1.38 (1.13, 1.69) | 10.0 | .002 |
| Prior stroke | 1.39 (1.07, 1.81) | 6.1 | .014 |
| Creatinine | 22.3 | <.001 | |
| Effect of creatinine less than 1.1, per 0.1 mg/dL | 1.09 (1.01, 1.16) | ||
| Effect of creatinine over 1.1, per 0.1 mg/dL | 1.02 (1.01, 1.03) | ||
| Effect of Duke Index Score up to 65, by 10 points | 1.07 (1.01, 1.13) | 5.4 | .020 |
| Effect of baseline ESVI per 10 mL/m2 | 1.08 (1.06, 1.11) | 48.2 | <.001 |
| Mitral regurgitation | 16.2 | <.001 | |
| Mild vs none | 1.31 (1.10, 1.56) | ||
| Moderate/severe vs none | 1.53 (1.23, 1.91) | ||
| NYHA | 6.4 | .040 | |
| II vs I | 1.20 (0.92, 1.57) | ||
| III or IV vs I | 1.39 (1.05, 1.84) | ||
| Treatment | |||
| OMT vs no OMT | 0.78 (0.66, 0.91) | 10.2 | .001 |
| CABG vs medical therapy | 0.83 (0.71, 0.97) | 5.9 | .015 |
| Interaction | .189 | ||
| OMT vs no OMT/medical therapy | 0.86 (0.69, 1.07) | ||
| OMT vs no OMT/CABG | 0.70 (0.56, 0.87) |
Adjusted for baseline covariates with interaction of OMT at baseline by treatment. HR, Hazard ratio; LCL, lower confidence limit; UCL, upper confidence limit; SBP, systolic blood pressure; MI, myocardial infarction; PVD, peripheral vascular disease; ESVI, end-systolic volume index; NYHA, New York Heart Association; OMT, optimal medical therapy; CABG, coronary artery bypass grafting.
∗ Effects were nonlinear with respect to outcome. Two linear splines were created. Only statistically significant effects were kept in the model.
† Categorical variables were kept in the model if the overall effect was significant.
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Article Info
Publication History
Published online: January 06, 2021
Accepted:
December 14,
2020
Received in revised form:
December 2,
2020
Received:
July 26,
2020
Footnotes
This work was supported by Grants U01HL69015 , U01HL69013 , and RO1HL105853 from the National Institutes of Health and National Heart, Lung, and Blood Institute . This work is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or National Institutes of Health.
There is no additional Institutional Review Board approval required for this analysis because this is a post hoc analysis based on the existing STICH database, that is, no new data are collected and consent had been obtained from every patient in the STICH trial.
Clinical Trial Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00023595.
Working Group: Rafal Dabrowski, MD, PhD,h Ljubomir Djokovic, MD,i Mark Drazner, MD,j Haissam Haddad, MD,k Imtiaz S. Ali, MD,l Matyas Keltai, MD,m Ajay Naik, MD,n George Sopko, MD,o Krzysztof Golba, MD,p Bert Andersson, MD,q Peter Carson, MD,r and Tomasz Kukulski, MDs
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© 2021 by The American Association for Thoracic Surgery
ScienceDirect
Access this article on ScienceDirectLinked Article
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- PreviewIschemic cardiomyopathy (ICM) is a leading cause of morbidity and mortality across the globe, with a rapidly growing number of affected patients in the US and a poor prognosis overall.1 Median survival is not substantially greater than 5 years in patients with ICM and reduced ejection fraction (EF).2 Although primary prevention of coronary artery disease (CAD) is the sole hope of effectively lessening the societal burden of this disease, effective secondary prevention can preserve some quality and quantity of life in patients diagnosed with ICM.
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- PreviewIn their post hoc analysis of data obtained from the Surgical Treatment for Ischemic Heart Failure (STICH) trial, Farsky and colleagues1 substantiate the benefit of optimal medical therapy (OMT) on long-term survival after surgical coronary revascularization in patients suffering from ischemic cardiomyopathy. This finding is particularly important given the surprisingly low adherence to OMT and attenuated long-term survival rates in these high-risk patients.
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