Limited data are available on comparing the clinical outcomes of coronary artery bypass grafting (CABG) and drug-eluting stent (DES) implantation in patients with reduced left ventricular systolic function in the DES era. From January 2003 to December 2010, 953 patients with reduced left ventricular systolic function, defined as a left ventricular ejection fraction <50%, who had undergone percutaneous coronary intervention with DESs (n = 402) or CABG (n = 551) were enrolled in a retrospective, observational registry. Patients with acute myocardial infarction were excluded. Propensity score-matching analysis was also performed in 141 patient pairs. The primary outcome was all-cause death. The median follow-up duration was 32 months (interquartile range 15 to 61). All-cause death occurred in 81 patients (20.1%) in the DES group and 98 patient (17.8%) in the CABG group (p = 0.524). After propensity score matching, the long-term cumulative rate of death was not significantly different between the 2 groups (DES vs CABG 21.3% vs 19.1%; adjusted hazard ratio 1.23, 95% confidence interval 0.57 to 2.66, p = 0.603). However, the rate of major adverse cardiac and cerebrovascular events (35.5% vs 24.1%, adjusted hazard ratio 1.69, 95% confidence interval 1.04 to 2.77, p = 0.036) was higher in the DES group than the CABG group. This was driven by the higher incidence of repeat revascularization in the DES group (11.3% vs 4.3%, adjusted hazard ratio 3.65, 95% confidence interval 1.01 to 10.37, p = 0.018). In conclusion, DES implantation provides comparable long-term clinical outcomes, except for repeat revascularization, to CABG in patients with coronary artery disease and chronic left ventricular systolic dysfunction.
Left ventricular (LV) systolic dysfunction caused by severe coronary artery disease is an important predictor of hospital and late mortality. In the past, the use of coronary artery bypass grafting (CABG) has been the preferred revascularization strategy for patients with reduced LV systolic function. In the pre–drug-eluting stent (DES) era, a few previous studies have compared the clinical outcomes after percutaneous coronary intervention (PCI) or CABG for revascularization of coronary lesions in patients with LV systolic dysfunction. These studies demonstrated that the survival benefits of PCI were not inferior to those of CABG, despite the high incidence of repeat revascularization in patients with a low LV ejection fraction. The recent introduction of DESs has dramatically reduced the restenosis rate, broadening the indications for PCI to include high-risk patients and complex lesions. However, in the DES era, few studies have compared the clinical outcomes of CABG and DES implantation in patients with chronic reduced LV systolic function. Therefore, we investigated the long-term clinical outcomes of DES versus CABG in patients with coronary artery disease and chronic LV systolic dysfunction.
Methods
The present study was a retrospective, single-center, observational study comparing the outcomes of DES and CABG performed in patients with chronic LV systolic dysfunction. The institutional review board approved the present study, and informed consent was waived. The patients were recruited from the cardiovascular catheterization and surgery databases of Samsung Medical Center (Seoul, South Korea). Patients with a LV ejection fraction <50% who had undergone PCI with DES or CABG from January 2003 to December 2010 were included. The patients who presented with acute myocardial infarction within 4 weeks of PCI were excluded.
The LV ejection fraction was evaluated using echocardiography in all patients within 4 weeks before the procedure. The baseline clinical, laboratory, and angiographic characteristics were collected from the databases and medical records. The follow-up clinical status was documented by a review of the hospital records, telephone interviews, or interviewing the general practitioners.
DES or CABG was selected according to patient preference and the preference of their physician. Coronary interventions were performed according to current standard procedural guidelines. All patients undergoing PCI were prescribed aspirin (300 mg loading dose) and clopidogrel (300 to 600 mg loading dose) before PCI. The treatment strategy and the use of glycoprotein IIb/IIIa receptor inhibitors or intravascular ultrasonography were left to the operator’s discretion. DESs were used without restriction. After the procedure, aspirin was continued indefinitely, and clopidogrel was recommended for ≥12 months. In the CABG group, an arterial graft with off-pump coronary artery bypass was the preferred technique, when possible. We did not limit the use of aspirin or heparin before or after surgery.
All-cause death was defined as any death during or after the procedure. Recurrent myocardial infarction (MI) was defined as the recurrence of ischemic symptoms or electrocardiographic changes accompanied by elevated cardiac enzymes. Periprocedural MI was not considered recurrent MI in the present study. Cerebrovascular accident was defined as ischemic neurologic deficits that persisted >24 hours. Any coronary revascularization was defined as revascularization of either target or nontarget vessels using PCI or CABG. A significant lesion was defined as stenosis of ≥50% of the diameter of a vessel with a reference diameter of >2.0 mm by visual estimation. Complete revascularization was considered to have been accomplished when all vessels with a significant lesion were successfully revascularized.
The primary outcome was all-cause death during follow-up. The secondary outcomes included all-cause death, recurrent MI, cerebrovascular accident, coronary revascularization with PCI or CABG, and major adverse cardiac and cerebrovascular events, defined as a composite event of all-cause death, recurrent MI, cerebrovascular accident, and coronary revascularization during follow-up.
Continuous variables were compared using the t test or Wilcoxon rank sum test, where applicable. Categorical data were tested using the chi-square test or Fisher’s exact test, as appropriate. Survival curves were constructed using Kaplan-Meier estimates and compared using the log-rank test. The Cox proportional hazard model was used to compare the risk of adverse cardiac events between the DES and CABG groups. Propensity scores were estimated using multiple logistic regression analysis. A full nonparsimonious model was developed that included age; gender; diabetes mellitus; hypertension; dyslipidemia; smoking; chronic kidney disease; history of MI, PCI, CABG, or cerebrovascular accident; New York Heart Association functional classification III or greater; LV ejection fraction; N-terminal pro-B-type natriuretic peptide; clinical manifestations; aspirin use; use of renin-angiotensin system blockers, β blockers, and statins at discharge; European System for Cardiac Operative Risk Evaluation score; an artery with significant stenosis; number of coronary arteries narrowed; and complete revascularization ( Tables 1 and 2 ). The discrimination and calibration ability of the propensity score model were assessed using the c-statistic and Hosmer–Lemeshow statistic. Cox regression analysis using pairs matched by a greedy algorithm and the nearest available pair-matching method among patients with an individual propensity score was also performed to evaluate the reduction in outcomes risk. The covariate balance achieved by matching was assessed by calculating the absolute standardized differences in covariates between the DES and CABG groups. In the propensity score–matched population, continuous variables were compared using a paired t test or the Wilcoxon sign rank test, as appropriate. Categorical variables were compared using the McNemar or Bowker test of symmetry, as appropriate. The reduction in the risk of an adverse outcome was compared using a stratified Cox regression model adjusted by the synergy between PCI with Taxus and cardiac surgery (SYNTAX) score. The cumulative incidence rates of individual clinical outcomes and composite outcomes were estimated using the Kaplan-Meier method and compared using the paired Prentice-Wilcoxon test. Statistical analyses were performed using Statistical Analysis Systems, version 9.2 (SAS Institute, Cary, North Carolina). All tests were 2 tailed, and p <0.05 was considered statistically significant.
Variable | Total Population | Propensity-Matched Population | ||||
---|---|---|---|---|---|---|
DES (n = 402) | CABG (n = 551) | p Value | DES (n = 141) | CABG (n = 141) | p Value | |
Age (yrs) | 67 (59–74) | 65 (57–70) | <0.001 | 66 (58–74) | 65 (59–70) | 0.247 |
Men | 293 (72.9) | 439 (79.7) | 0.014 | 101 (71.6) | 111 (78.7) | 0.194 |
Diabetes mellitus | 197 (49.0) | 278 (50.5) | 0.659 | 78 (55.3) | 78 (55.3) | 1.000 |
Hypertension | 251 (62.4) | 318 (57.7) | 0.142 | 86 (61.0) | 82 (58.2) | 0.716 |
Dyslipidemia ∗ | 98 (24.4) | 163 (29.6) | 0.075 | 39 (27.7) | 40 (28.4) | 0.999 |
Smoker | 127 (31.6) | 217 (39.4) | 0.013 | 52 (36.9) | 52 (36.9) | 0.999 |
CKD † | 68 (16.9) | 52 (9.4) | 0.001 | 26 (18.4) | 20 (14.2) | 0.417 |
Previous MI | 107 (26.6) | 174 (31.6) | 0.097 | 53 (37.6) | 47 (33.3) | 0.544 |
Previous PCI | 123 (30.6) | 110 (20.0) | <0.001 | 50 (35.5) | 50 (35.5) | 1.000 |
Previous CABG | 30 (7.5) | 9 (1.6) | <0.001 | 7 (5.0) | 8 (5.7) | 0.999 |
Previous CVA | 42 (10.4) | 115 (20.9) | <0.001 | 19 (13.5) | 14 (9.9) | 0.424 |
NYHA classification ≥III | 79 (19.7) | 123 (22.3) | 0.319 | 28 (19.9) | 24 (17.0) | 0.539 |
LV ejection fraction (%) | 41 (34–47) | 40 (34–45) | 0.001 | 41 (34–47) | 40 (34–45) | 0.218 |
N-terminal pro-B-type natriuretic peptide (pg/ml) | 1,324 (512–2,301) | 1,135 (554–2,494) | 0.068 | 1,324 (869–2,384) | 1,135 (478–2,883) | 0.416 |
Clinical manifestation | 0.971 | 0.378 | ||||
Stable angina pectoris | 214 (53.2) | 289 (52.5) | 72 (51.1) | 78 (55.3) | ||
Unstable angina pectoris | 159 (39.6) | 222 (40.3) | 54 (38.3) | 55 (39.0) | ||
Silent myocardial ischemia | 29 (7.2) | 40 (7.3) | 15 (10.6) | 8 (5.7) | ||
Medication at discharge | ||||||
Aspirin | 370 (92.0) | 505 (91.7) | 0.829 | 127 (90.1) | 127 (90.1) | 0.999 |
Renin-angiotensin system blockers | 287 (71.4) | 205 (37.2) | <0.001 | 87 (61.7) | 91 (64.5) | 0.683 |
β Blocker | 220 (54.7) | 330 (59.9) | 0.111 | 81 (57.5) | 77 (54.6) | 0.716 |
Statins | 277 (68.9) | 461 (83.7) | <0.001 | 98 (69.5) | 109 (77.3) | 0.215 |
EuroSCORE | 5 (3–7) | 4 (3–6) | 0.016 | 5 (3–7) | 5 (3–6) | 0.241 |
∗ Defined as history of dyslipidemia or total cholesterol level >240 mg/dl.
† Defined as an estimated glomerular filtration rate of <60 ml/min/1.73 m 2 .
Variable | Total Population | Propensity-Matched Population | ||||
---|---|---|---|---|---|---|
DES (n = 402) | CABG (n = 551) | p Value | DES (n = 141) | CABG (n = 141) | p Value | |
Coronary artery with significant stenosis | ||||||
Left main | 26 (6.5) | 100 (18.1) | <0.001 | 10 (7.1) | 4 (2.8) | 0.181 |
Left anterior descending | 339 (84.3) | 501 (90.9) | 0.002 | 117 (83.0) | 123 (87.2) | 0.429 |
Left circumflex | 262 (65.2) | 465 (84.4) | <0.001 | 95 (67.4) | 103 (73.1) | 0.350 |
Right | 261 (64.9) | 458 (83.1) | <0.001 | 90 (63.8) | 90 (63.8) | 1.000 |
Narrowed coronary arteries (n) | <0.001 | 0.599 | ||||
Left main, isolated | 1 (0.2) | 5 (0.9) | 1 (0.7) | 0 | ||
1 | 89 (22.1) | 38 (6.9) | 29 (20.6) | 26 (18.4) | ||
2 | 159 (39.6) | 138 (25.0) | 59 (41.8) | 55 (39.0) | ||
3 | 153 (38.1) | 370 (67.2) | 52 (36.9) | 60 (42.6) | ||
SYNTAX score | 17 (11–23) | 34 (23–36) | <0.001 | 19 (12–23) | 28 (18–35) | <0.001 |
Complete revascularization | 268 (66.7) | 541 (98.2) | <0.001 | 130 (92.2) | 134 (95.0) | 0.330 |