Author + information
- Received May 13, 2015
- Revision received June 26, 2015
- Accepted June 30, 2015
- Published online September 15, 2015.
- Sripal Bangalore, MD, MHA∗∗ (, )
- Yu Guo, MA∗,
- Zaza Samadashvili, MD†,
- Saul Blecker, MD, MHS∗,
- Jinfeng Xu, PhD∗ and
- Edward L. Hannan, PhD, MS†
- ∗New York University School of Medicine, New York, New York
- †School of Public Health, State University of New York at Albany, Albany, New York
- ↵∗Reprint requests and correspondence:
Dr. Sripal Bangalore, New York University School of Medicine, The Leon H. Charney Division of Cardiology, 550 First Avenue, New York, New York 10016.
Background Randomized trials of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) routinely exclude patients with chronic kidney disease (CKD).
Objectives This study evaluated outcomes of PCI versus CABG in patients with CKD.
Methods Patients with CKD who underwent PCI using everolimus-eluting stents were propensity-score matched to patients who underwent isolated CABG for multivessel coronary disease in New York. The primary outcome was all-cause mortality. Secondary outcomes were myocardial infarction (MI), stroke, and repeat revascularization.
Results Of 11,305 patients with CKD, 5,920 patients were propensity-score matched. In the short term, PCI was associated with a lower risk of death (hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.35 to 0.87), stroke (HR: 0.22; 95% CI: 0.12 to 0.42), and repeat revascularization (HR: 0.48; 95% CI: 0.23 to 0.98) compared with CABG. In the longer term, PCI was associated with a similar risk of death (HR: 1.07; 95% CI: 0.92 to 1.24), higher risk of MI (HR: 1.76; 95% CI: 1.40 to 2.23), a lower risk of stroke (HR: 0.56; 95% CI: 0.41 to 0.76), and a higher risk of repeat revascularization (HR: 2.42; 95% CI: 2.05 to 2.85). In the subgroup with complete revascularization with PCI, the increased risk of MI was no longer statistically significant (HR: 1.18; 95% CI: 0.67 to 2.09). In the 243 matched pairs of patients with end-stage renal disease on hemodialysis, PCI was associated with significantly higher risk of death (HR: 2.02; 95% CI: 1.40 to 2.93) and repeat revascularization (HR: 2.44; 95% CI: 1.50 to 3.96) compared with CABG.
Conclusions In patients with CKD, CABG is associated with higher short-term risk of death, stroke, and repeat revascularization, whereas PCI with everolimus-eluting stents is associated with a higher long-term risk of repeat revascularization and perhaps MI, with no long-term mortality difference. In the subgroup on dialysis, the results favored CABG over PCI.
The chronic kidney disease (CKD) population has grown exponentially over the past decade and is projected to grow consistently in the next decade due to an increase in the incidence of obesity and diabetes and a decrease in mortality rates (1). Cardiovascular disease is the leading cause of morbidity and mortality in patients with CKD (1,2). However, there is a “treatment risk paradox,” in that these high-risk patients have lower rates of medical therapy, referral for stress testing, cardiac catheterization, and revascularization compared with low-risk patients (2). Moreover, the majority of cardiovascular clinical trials routinely exclude this high-risk group of patients (3). The evidence-based management of these patients, therefore, relies on extrapolating the results from clinical trials in non-CKD cohorts and applying them to patients with CKD. However, it is not known whether this extrapolation is accurate.
In patients with obstructive coronary artery disease (CAD), percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery are both treatment options. Although a number of clinical trials have been performed to evaluate the efficacy and safety of PCI versus CABG, patients with CKD have generally been excluded. The 2014 European Society of Cardiology and the European Association for Cardio-Thoracic Surgery Guidelines on myocardial revascularization recommend CABG over PCI (Class IIa) in patients with moderate to severe CKD and multivessel disease when the surgical risk profile is acceptable and life expectancy is more than 1 year (4). The American College of Cardiology/American Heart Association guidelines also recommend CABG to improve survival in patients with end-stage renal disease and 3-vessel CAD or proximal left anterior descending artery plus 1 other major vessel (5). Most of these recommendations stem from observational studies of CABG versus PCI using older-generation stents. In the absence of randomized trials comparing CABG and PCI with second-generation drug-eluting stents (DES) in patients with CKD, we used data from the New York State registries to compare outcomes for CABG and PCI in patients with CKD.
Patients with CKD who underwent either PCI with everolimus-eluting stents (EES) or isolated CABG surgery for multivessel CAD between January 1, 2008, and December 31, 2011, in New York State were included in the study. Patients were identified using the New York State Percutaneous Coronary Intervention Reporting System and the Cardiac Surgery Reporting System registries. These are mandatory reporting systems for all PCI and CABG procedures performed in nonfederal hospitals in New York State. Data are entered by trained data coordinators at participating hospitals. Audits of samples of medical records are conducted regularly to ensure data quality.
Patient inclusion and exclusion criteria
The inclusion criteria were the following: 1) patients with CKD, defined as those with an estimated glomerular filtration rate (eGFR) (calculated using the MDRD [Modification of Diet in Renal Disease] study equation) <60 ml/min/1.73 m2; 2) patients with multivessel disease, defined as severe stenosis (≥70%) in at least 2 major epicardial coronary arteries; and 3) patients undergoing PCI with implantation of EES or those undergoing isolated CABG.
The exclusion criteria were the following: 1) previous cardiac surgery (CABG or valve surgery), because such patients are unlikely to undergo repeat surgery; 2) myocardial infarction (MI) within 24 h preceding the index procedure, because these patients preferentially undergo PCI; 3) severe left main CAD (degree of stenosis ≥50%), because these patients preferentially undergo CABG; 4) PCI with a stent other than an EES or using a combination of stents; 5) revascularization within 1 year before the index procedure; and 6) unstable hemodynamics or in cardiogenic shock.
The Percutaneous Coronary Intervention Reporting System and Cardiac Surgery Reporting System registries collect data on in-hospital events and are linked across time and with each other to capture subsequent revascularization procedures. In addition, the registries were linked with the New York State Vital Statistics registry to obtain information on mortality and with the Statewide Planning and Research Cooperative System registry to obtain follow-up information for patients admitted with MI and stroke. The Statewide Planning and Research Cooperative System registry collects comprehensive information on discharges from all nonfederal hospitals in New York State and contains information on patient diagnoses, procedures, admission and discharge dates, and discharge disposition for hospital discharges, ambulatory surgery, and emergency department admissions. Data are edited monthly to identify errors, audit reports are generated after monthly updates, and related data are verified using 2 data sources for consistency (6).
The primary outcome of the study was long-term all-cause death. Secondary outcomes were MI, stroke, and repeat revascularization, which were tabulated separately. Short-term (within 30 days) and longer-term outcomes were evaluated. MI included both procedural MI (defined as new Q waves in both the Percutaneous Coronary Intervention Reporting System and the Cardiac Surgery Reporting System) and spontaneous MI (defined as an emergency admission with a principal diagnosis of MI or a principal diagnosis of cardiogenic shock with a secondary diagnosis of MI). Similarly, stroke was identified either as a complication at the time of the index procedure or at readmission (principal diagnosis of stroke). Repeat revascularization was identified as any unstaged revascularization after the index procedure. Staged revascularization was defined as a nontarget vessel revascularization within 90 days of the index procedure that was coded as intended to be staged in the index procedure and at the time of the staged procedure.
To adjust for differences in measured baseline characteristics between the PCI and CABG groups and to assemble a cohort of patients with similar baseline characteristics, propensity-score matching was used. The propensity score is a conditional probability of having a particular exposure (EES vs. CABG), given a set of baseline-measured covariates (7,8). A nonparsimonious multivariable logistic regression model (9), using EES use as the dependent variable and all of the baseline characteristics outlined in Table 1 as covariates, was used to estimate the propensity scores. Matching was performed using a 1:1 matching protocol without replacement (Greedy matching algorithm), using a caliper width equal to 0.2 of the SD of the logit of the propensity score. Absolute standardized differences were estimated for all baseline covariates before and after matching to assess pre-match and post-match imbalances (10). Absolute standardized differences <10% for a given covariate indicate a relatively small imbalance (10). The risks of outcomes were analyzed in the matched cohort using a Cox proportional regression model after stratifying the matched pairs.
Pre-specified subgroup analyses were performed on the basis of anatomy: 1) 3-vessel disease versus 2-vessel disease; and 2) complete versus incomplete revascularization in the PCI cohort. For the subgroup analysis, only the corresponding matched pairs in a subgroup were chosen to maintain the baseline balance between EES and CABG groups. In addition, a pre-specified analysis was performed of the cohort of patients on dialysis. Subgroup analysis using corresponding matched pairs of patients on dialysis yielded a small sample size. Therefore, separate propensity-score matching was performed by first choosing patients on dialysis from the unmatched cohort of patients and then matching them on their baseline measure covariates, as described earlier. In addition, in the cohort not on dialysis (separate propensity-score matching), subgroup analyses were performed to evaluate the outcomes on the basis of eGFR categories of 45 to 60, 30 to 45, 15 to 30, and <15 ml/min. However, the number of patients in the eGFR <15 and eGFR 15 to 30 categories was small, and this group was combined with the eGFR 30 to 45 category.
All reported p values are 2-sided and are not adjusted for multiple testing. All analyses were performed with SAS version 9.3 (SAS Institute, Cary, North Carolina). The event rates presented are Kaplan-Meier estimates.
We identified 11,305 patients with CKD and multivessel disease who fulfilled the entry criteria (Table 1, Online Table 1). Of the patients, 5,058 (45.0%) underwent PCI with EES and 6,247 patients (55.0%) underwent CABG. The cohort included 48.0% with diabetes and 8.2% on dialysis (Table 1). Using propensity-score matching, 2,960 PCI patients were matched with 2,960 CABG patients with similar propensity scores. After matching, the absolute standardized difference was <10.0% for all variables, indicating an adequate match and no significant baseline difference between the 2 groups (Table 1). The C statistic for the model was 0.81. All outcomes presented in the following sections are for the matched cohort.
Short-term (within 30 days) outcomes
In the 5,920 patients in the matched cohort, PCI was associated with a 45.0% lower risk of death (1.0% vs. 1.7%; hazard ratio [HR]: 0.55; 95% confidence interval [CI]: 0.35 to 0.87; p = 0.01), a 78.0% lower risk of stroke (0.4% vs. 1.7%; HR: 0.22; 95% CI: 0.12 to 0.42; p < 0.0001), and a 52.0% lower risk of repeat revascularization (0.4% vs. 0.8%; HR: 0.48; 95% CI: 0.23 to 0.98; p = 0.04) with no significant difference in MI when compared with CABG (Table 2).
Primary outcome (death)
PCI was associated with a similar risk of death (22.7% vs. 20.5%; HR: 1.07; 95% CI: 0.92 to 1.24; p = 0.40) compared with CABG at a mean follow-up of 2.9 years (2.7 years for EES and 3.2 years for CABG) (Figure 1, Table 2). This was consistent across anatomic subgroups on the basis of the number of diseased vessels and completeness of revascularization (pinteraction >0.05) (Table 3). In addition, in the cohort not on dialysis, subgroup analysis on the basis of eGFR categories yielded largely similar results (pinteraction >0.05) (Table 4).
PCI was associated with a higher risk of MI (10.7% vs. 7.0%; HR: 1.76; 95% CI: 1.40 to 2.23; p < 0.0001) compared with CABG (Figure 2, Table 2). This was driven by patients with 3 diseased vessels (HR: 2.75; 95% CI: 1.55 to 4.87; p = 0.0005), but not those with 2 diseased vessels (HR: 1.26; 95% CI: 0.76 to 2.09; p = 0.37) (pinteraction = 0.04), and by patients who underwent incomplete revascularization (HR: 1.91; 95% CI: 1.48 to 2.47; p < 0.0001), but not those who underwent complete revascularization (HR: 1.18; 95% CI: 0.67 to 2.09; p = 0.56), although the test for interaction for the latter was not significant (pinteraction = 0.13) (Table 3). In addition, in the cohort not on dialysis, subgroup analysis on the basis of eGFR categories yielded largely similar results (pinteraction = 0.94) (Table 4).
PCI was associated with a lower risk of stroke (4.5% vs. 6.4%; HR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0002) compared with CABG (Figure 3, Table 2). In addition, in the cohort not on dialysis, subgroup analysis on the basis of eGFR categories yielded largely similar results (Table 4).
PCI was associated with a higher risk of repeat revascularization (26.1% vs. 13.1%; HR: 2.42; 95% CI: 2.05 to 2.85; p < 0.0001) compared with CABG (Figure 4, Table 2). The results of the test for interaction was borderline significant (pinteraction = 0.05) for the magnitude of effect size, rather than the direction, both for the number of diseased vessels and for the completeness of revascularization. Thus, the risk of repeat revascularization with PCI (vs. CABG) was significantly higher in those with 3-vessel disease (vs. 2-vessel disease) and in those with incomplete revascularization (vs. complete revascularization) (Table 3). In addition, in the cohort not on dialysis, subgroup analysis on the basis of eGFR categories yielded largely similar results (Table 4).
Patients on dialysis
A separate propensity score matching was performed in patients on dialysis who would otherwise satisfy all of the inclusion and exclusion criteria. Propensity-score matching identified 486 patients on dialysis with similar baseline characteristics. In the matched cohort of patients on dialysis, PCI was associated with a significantly higher long-term risk of death (54.3% vs. 39.1%; HR: 2.02; 95% CI: 1.40 to 2.93; p = 0.0002), a numerically higher risk of MI (31.9% vs. 16.7%; HR: 1.68; 95% CI: 0.99 to 2.85; p = 0.05), a significantly higher risk of repeat revascularization (48.3% vs. 25.0%; HR: 2.44; 95% CI: 1.50 to 3.96; p = 0.0003), and no difference in stroke compared with CABG (Table 5).
The results of this study of 5,920 subjects with CKD and multivessel disease showed that PCI using the latest-generation stents (EES) was associated with lower short-term risk (death, stroke, and repeat revascularization), similar long-term risk of death, a higher risk of MI (in those with incomplete revascularization), and a lower risk of stroke, but a higher risk of repeat revascularization compared with CABG (Central Illustration). However, in the subgroup on dialysis, the results favored CABG over PCI, with an increase in death and repeat revascularization with PCI.
Revascularization in patients with CKD
Patients with CKD are at high risk of cardiovascular disease and have an increased risk of death from CAD. Although the major concern in patients with CAD and CKD is to prevent/avoid acute kidney injury (during PCI or CABG), CKD patients are 5 to 10 times more likely to die (mainly of cardiovascular causes) than experience the development of end-stage renal disease requiring dialysis (10,11). In a longitudinal follow-up of a large managed-care organization, Keith et al. (11) reported that the rate of end-stage renal disease was only 1.3%, whereas patients were more likely to die, with a mortality rate of 24.3%.
CAD in CKD patients tends to present with unique challenges, including earlier onset, more rapid progression, and stronger association with calcification and vascular stiffness. As such, revascularization with PCI or CABG poses challenges. Compared with patients without CKD, patients with CKD have increased rates of repeat revascularization after PCI with bare-metal stents (12–15), although these rates have improved considerably compared with balloon angioplasty alone (16). With the advent of DES, the incidence of restenosis after PCI has further decreased compared with bare-metal stents in the nondialysis CKD population (17), as well as for patients on dialysis (18–23). However, most of the evidence is from nonrandomized studies (11). In addition, both PCI and CABG are associated with an increased risk of acute kidney injury, with some studies showing a 2- to 3-fold higher risk with CABG in the short term than with PCI (24).
The question of PCI versus CABG in patients with multivessel disease and CKD is not readily answered by randomized trials because the majority of randomized trials of PCI versus CABG have either excluded patients with CKD or included only a small subgroup of such patients. In the SYNTAX study (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries) of CABG versus PCI using paclitaxel-eluting stents (25), only 264 patients with renal insufficiency (eGFR <60) were included. In this small subgroup of patients, CABG was superior to PCI for the reduction of cardiovascular events (15.6% vs. 27.4%; p < 0.05), driven by a decrease in repeat revascularization (5.0% vs. 14.9%; p < 0.05), with no difference in death (9.9% vs. 11.8%) (26). Compared with the first-generation DES used in the SYNTAX study, second-generation DES (such as EES) have thinner struts and thinner and more biocompatible polymer properties that reduce inflammation, promote faster vessel healing, and reduce the risk of restenosis and stent thrombosis. As such, data from an all-comers population from randomized, controlled trials (27), observational registries (28), and meta-analyses of randomized trials (27,29) indicate a reduction in death, MI, and stent thrombosis with newer-generation stents compared with older-generation stents. Data on the CKD cohort suggest similar low rates of repeat revascularization with EES, even compared with the cohort with no CKD (30). In the BEST (Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease) study (31), PCI with EES was associated with increased risk of MI and repeat revascularization, without any mortality difference compared with CABG, largely similar to our report on the overall cohort from the New York State registries (32). However, the BEST study did not report on the CKD subgroup.
The results of this study with data from 5,920 propensity score–matched patients therefore offer important insights into the outcomes of patients who underwent PCI with the latest-generation DES (EES) or CABG. For the overall CKD cohort, PCI using EES was associated with lower short-term risk (death, stroke, and repeat revascularization) compared with CABG, consistent with the results of previous studies. In addition, the primary outcome of death in the longer term was also not statistically different between PCI and CABG. PCI was associated with a higher risk of MI (in those with incomplete revascularization) and repeat revascularization compared with CABG. The higher risk of MI in those with incomplete revascularization with PCI is an important outcome because patients on dialysis who present with an MI have high mortality from a cardiac cause and poor long-term survival (33). In a recent analysis of 1,786 propensity score–matched patients with CKD from Ontario, Canada, CABG was associated with improved survival compared with PCI using DES (34). However, the study did not report outcomes with second-generation DES. Our study has 3.3× the sample size of the Ontario analysis and restricts the comparison to second-generation DES (EES). Consequently, it offers important additional insights and is also the largest series comparing CABG with second-generation DES. Although there was excess stroke occurrence with CABG compared with PCI in the current study, consistent with previous data, more recent trials have shown the risk of stroke to be similar to that for CABG and PCI (31), likely due to increased use of off-pump surgery and avoidance of aortic cross-clamping.
In our study, the results favored CABG over PCI in the subgroup on dialysis, with increases in death, repeat revascularization, and numerically higher MIs with PCI. The results for the dialysis cohort are consistent with data from the CREDO-Kyoto PCI/CABG registry analysis of 388 patients on dialysis, in which CABG was associated with a lower risk of cardiac death, MI, and repeat revascularization compared with PCI using bare-metal stents or first-generation DES, although there was no difference in all-cause death between the 2 groups (35). However, other studies comparing CABG with PCI using first-generation DES (N = 104 patients) have shown a lower risk of both all-cause death and cardiac death with CABG in patients on hemodialysis (36). The results are also consistent with the analysis by Shroff et al. (37), where short-term mortality was higher after CABG, but long-term survival was superior. However, the study by Shroff et al. (37) did not directly compare CABG with PCI, and PCI was performed mainly using first-generation DES. Patients with CKD, especially patients on dialysis, have an increased prevalence of medial calcification (38). This impairs the response to PCI, with increased prevalence of underexpanded stents, reduced efficacy of the antiproliferative drugs eluted from the stent, and impaired endothelialization, resulting in a propensity for restenosis and stent thrombosis. The newer-generation DES, and especially EES, have thinner struts as well as thinner, more biocompatible and thromboresistant polymers (39). Although stenting results in “spot” treatment, the risk of restenosis and stent thrombosis in the stented segment contributes to a proportion of long-term events with PCI. EES, with all of the favorable properties mentioned earlier, likely reduce future stent-associated events and can potentially bridge the outcomes gap between PCI and CABG.
Although the present study compared PCI and CABG, it is not known whether revascularization is superior to optimal medical therapy alone in patients with CKD because patients with CKD were excluded or formed a small proportion of enrolled patients in contemporary trials of revascularization versus optimal medical therapy. The ISCHEMIA CKD (ISCHEMIA-Chronic Kidney Disease) trial (NCT01985360) will address the question of invasive versus conservative management in patients with advanced CKD and will provide valuable insights into this question.
In our analysis, although propensity-score matching adjusts for baseline imbalances, the analysis does not control for unmeasured confounders. We did not have data on medication use for the 2 cohorts. The analysis compared CABG with PCI using EES, and hence, the results may not be generalizable to other second-generation DES. Moreover, the cohort on dialysis was a small subgroup of patients and the analysis is likely underpowered. Although there was no difference in mortality between PCI and CABG for the overall CKD cohort, a difference may appear at longer-term follow-up. The registries do not collect data on the method used to measure serum creatinine, nor whether the method was standardized to isotope dilution mass spectrometry. However, this is unlikely to differentially affect the PCI and CABG outcomes. Similarly, although the Modification of Diet in Renal Disease formula was used to calculate the eGFR, the choice of formula is unlikely to differentially affect the PCI and CABG outcomes. The follow-up outcomes were derived from registries in New York State, and patients who had outcomes outside of New York State would likely have been missed. However, a previous study evaluated the percentage of deaths missed because of the previously mentioned limitation and found it to be small (40) and unlikely to differentially affect the PCI and CABG outcomes. We excluded patients with left main artery disease. In the timeframe of this study, PCI for left main artery disease was a Class III indication by the American College of Cardiology/American Heart Association guideline committee. As such, only 159 patients with left main disease underwent PCI, whereas the majority (2,715 patients) underwent CABG. Given the small numbers and likely selection bias in those who underwent PCI in deference to the Class III recommendations (likely patients with extensive comorbidities who were poor surgical candidates), we did not perform additional analyses of this cohort. In addition, the follow-up durations differed in the EES and CABG groups due to slower uptake of EES when the stent was first approved. However, we used time-to-event analysis and therefore incorporated the follow-up duration.
In this largest series of comparison of PCI with a second-generation DES versus CABG in patients with CKD, CABG was associated with a higher short-term risk of death, stroke, and repeat revascularization, whereas PCI with EES was associated with a higher long-term risk of repeat revascularization and perhaps MI (in patients who underwent incomplete revascularization). However, in patients on dialysis, the results favored CABG over PCI. These associations should be considered when choosing between PCI and CABG in patients with CKD and should be tested in future clinical trials.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: In patients with CKD, CABG was associated with a higher 30-day risk of death, stroke, and repeat revascularization compared with PCI with EES, whereas stenting was associated with a higher long-term risk of repeat revascularization and MI when revascularization was incomplete.
TRANSLATIONAL OUTLOOK: Further studies are needed to determine predictors of outcomes in patients with CKD undergoing myocardial revascularization to guide referrals for CABG or PCI.
This study was funded by Abbott Vascular. Academic authors who were not governed by the funding sponsors independently performed the design, data analysis, interpretation, preparation, review, and approval of the manuscript. The funding source had no role in the design, conduct of this analysis, interpretation of the data, or preparation or approval of this paper. Dr. Bangalore has served as an ad-hoc consultant/speaker for Abbott Vascular; has received research grants from Abbott Vascular and the National Heart, Lung, and Blood Institute; and has received honoraria from Abbott Vascular. Dr. Blecker is supported by the Agency for Healthcare Research and Quality (AHRQ) grant K08 HS23683. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- coronary artery bypass graft
- coronary artery disease
- confidence interval
- chronic kidney disease
- drug-eluting stent(s)
- everolimus-eluting stent(s)
- estimated glomerular filtration rate
- hazard ratio
- myocardial infarction
- percutaneous coronary intervention
- Received May 13, 2015.
- Revision received June 26, 2015.
- Accepted June 30, 2015.
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