Abstract
Background:
Studies evaluating long-term (≥5 years) outcome of percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease (ULMCAD) are still limited, despite concerns for late adverse events after drug-eluting stents implantation.
Methods and Results:
We identified 1,004 patients with ULMCAD (PCI: n=364, CABG: n=640) among 15,939 patients with first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG registry cohort-2. The primary outcome measure in the current analysis was a composite of death, myocardial infarction, and stroke (death/MI/stroke). The cumulative 5-year incidence of and the adjusted risk for death/MI/stroke were significantly higher in the PCI group than in the CABG group (34.5% vs. 24.1%, log-rank P<0.001, adjusted hazard ratio (HR): 1.48 [95% confidence interval (CI): 1.07–2.05, P=0.02]). The adjusted risks for all-cause death was not significantly different between the 2 groups. Regarding the stratified analysis by the SYNTAX score, the adjusted risk for death/MI/stroke was not significantly different between the 2 groups in patients with low (<23) or intermediate (23–33) SYNTAX score, whereas it was significantly higher in the PCI group than in the CABG group in patients with high (≤33) SYNTAX score.
Conclusions:
CABG as compared with PCI was associated with better long-term outcome in patients with ULMCAD, especially those with high anatomical complexity. (Circ J 2015; 79: 1282–1289)
Several studies have reported favorable short- and mid-term outcomes of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) in patients with unprotected left main coronary artery disease (ULMCAD), leading to the update of clinical guidelines in which PCI is regarded as an acceptable alternative to coronary artery bypass grafting (CABG) in selected patients with ULMCAD.1–8
On the other hand, late adverse events beyond 1 year after DES implantation, such as very late stent thrombosis (VLST) and late target-lesion revascularization (TLR), are reported to be a continuous hazards up to 5 years after DES implantation and still a major concern after PCI using DES.9–11
Studies evaluating long-term (≥5 years) outcome of PCI compared with CABG in patients with ULMCAD are still limited.12–15
We previously reported 3-year outcome in patients with ULMCAD from the Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/CABG registry cohort-2, demonstrating that (1) 3-year clinical outcome of PCI was comparable with that of CABG in terms of serious cardiovascular events in patients with ULMCAD and (2) the risk for serious cardiovascular events was not significantly different between PCI and CABG in patients with low or intermediate SYNTAX score, but was markedly higher after PCI as compared with CABG in patients with high SYNTAX score.16
In the current report, we extended the follow-up to evaluate longer-term (≥5 years) outcome of PCI compared with CABG in patients with ULMCAD in real-world clinical practice.
Editorial p 1201
Methods
Study Population
As previously described in detail, the CREDO-Kyoto PCI/CABG registry cohort-2 is a physician-initiated non-company sponsored multicenter registry enrolling consecutive patients undergoing their first coronary revascularization in 26 centers in Japan between January 2005 and December 2007.16–18
The relevant ethics committees in all 26 participating centers (Appendix S1) approved the research protocol. Because of the retrospective enrollment, the requirement for written informed consent from the patients was waived; however, we excluded patients who refused participation in the study when contacted for follow-up. This strategy is concordant with the guidelines of the Japanese Ministry of Health, Labor and Welfare.
Among the 15,939 patients enrolled in the registry, the study population for the current analysis consisted of 1,004 patients with ULMCAD (PCI: 364 patients, CABG: 640 patients), excluding those patients refusing study participation (n=99), concomitant non-coronary surgery (n=609), acute myocardial infarction (MI) presentation (n=4,892), and without ULMCAD (n=9,336) (Figure 1).
Definitions and Endpoints
The primary outcome measure in the current study was a composite of death, MI, and stroke. The secondary outcome measures included cardiac death, sudden cardiac death, non-cardiac death, MI, stroke, hospitalization for heart failure, major bleeding, any coronary revascularization, and ischemia-driven coronary revascularization. Death was regarded as cardiac in origin unless an obvious non-cardiac cause could be identified. Any death during the index hospitalization for coronary revascularization was regarded as cardiac death. MI was defined according to the definition in the Arterial Revascularization Therapy Study.19
Stroke was defined as ischemic or hemorrhagic stroke either occurring during the index hospitalization or requiring hospitalization with symptoms lasting >24 h. Hospitalization for heart failure was defined as hospitalization for worsening heart failure requiring intravenous drug therapy. Bleeding was defined according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries (GUSTO) classification;20
GUSTO moderate or severe bleeding was adjudicated as a bleeding event. Any coronary revascularization was defined as either PCI or CABG for any reason. Scheduled staged coronary revascularization procedures performed within 3 months of the initial procedure were not regarded as follow-up events, but were included in the index procedure. Detailed definitions of baseline clinical characteristics and endpoints were reported previously.16,17,21,22
Data Collection for Baseline Characteristics and Follow-up Events
Experienced clinical research coordinators from an independent clinical research organization (Research Institute for Production Development, Kyoto, Japan;
Appendix S2) collected baseline clinical, angiographic and procedural characteristics from hospital charts or hospital databases according to prespecified definitions. Collection of follow-up information was mainly conducted through review of inpatient and outpatient hospital charts by the clinical research coordinators, and additional follow-up information was collected through contact with patients, relatives and/or referring physicians by mail with questions regarding vital status, subsequent hospitalizations, and status of antiplatelet therapy. Death, MI, and stroke were adjudicated by the clinical event committee (Appendix S3). Median follow-up duration for the surviving patients was 1,959 (inter-quartile range [IQR]: 1,695–2,200) days. Complete 1-, 3-, and 5-year clinical follow-up information was obtained for 97.9%, 96.3%, and 72.5% of patients, respectively.
Statistical Analysis
Categorical variables were presented as number and percentage and compared with the chi-square test. Continuous variables were expressed as mean±standard deviation (SD) or median with IQR. Continuous variables were compared using Student’s t-test or the Wilcoxon rank sum test based on their distributions. Cumulative incidence was estimated by the Kaplan-Meier method and differences were assessed with the log-rank test. The effects of PCI relative to CABG for individual endpoints were expressed as hazard ratios (HR) with 95% confidence intervals (CI). We estimated the HR by Cox proportional hazard models adjusting for 30 clinically relevant factors listed in
Table 1. Continuous variables were dichotomized by clinically meaningful reference values or median values. Proportional hazard assumptions for potential independent risk-adjusting variables were assessed on the plots of log (time) vs. log [−log (survival)] stratified by the variable, and the assumptions were verified to be acceptable for all the variables. We incorporated the 26 participating centers in the Cox proportional hazard models as the stratification variable.
Table 1.
Comparison of the Baseline Characteristics of the PCI and CABG Groups
| |
PCI (n=364) |
CABG (n=640) |
P value |
| Clinical characteristics |
| Age (years) |
71.4±10.1 |
69.4±9.2 |
0.001 |
| ≥75 years* |
151 (41%) |
208 (33%) |
0.005 |
| Male* |
258 (71%) |
490 (77%) |
0.048 |
| Body mass index <25.0* |
270 (74%) |
467 (73%) |
0.68 |
| Unstable angina |
51 (14%) |
71 (11%) |
0.18 |
| Hypertension* |
312 (86%) |
542 (85%) |
0.66 |
| Diabetes mellitus* |
154 (42%) |
291 (45%) |
0.33 |
| On insulin therapy |
34 (9.3%) |
93 (15%) |
0.02 |
| Current smoking* |
78 (21%) |
157 (25%) |
0.26 |
| LDL cholesterol (mg/dl) |
117±34 |
112±36 |
0.06 |
| Heart failure* |
76 (21%) |
131 (20%) |
0.88 |
| Ejection fraction ≤40% |
34 (12%) |
56 (9.5%) |
0.30 |
| Mitral regurgitation grade 3/4* |
25 (6.9%) |
17 (2.7%) |
0.002 |
| Prior MI* |
70 (19%) |
105 (16%) |
0.26 |
| Prior stroke (symptomatic)* |
54 (15%) |
75 (12%) |
0.16 |
| Peripheral vascular disease* |
45 (12%) |
76 (12%) |
0.82 |
| eGFR <30, without hemodialysis* |
19 (5.2%) |
38 (5.9%) |
0.63 |
| Hemodialysis* |
25 (6.9%) |
44 (6.9%) |
0.997 |
| Anemia (hemoglobin <11.0 g/dl)* |
72 (20%) |
128 (20%) |
0.93 |
| Thrombocytopenia (platelets <10×104)* |
3 (0.8%) |
19 (3.0%) |
0.02 |
| Chronic obstructive pulmonary disease* |
12 (3.3%) |
17 (2.7%) |
0.56 |
| Liver cirrhosis* |
9 (2.5%) |
19 (3.0%) |
0.64 |
| Malignancy* |
58 (16%) |
69 (11%) |
0.02 |
| Procedural characteristics |
| No. of target lesions or anastomoses |
2.00±1.03 |
3.09±1.04 |
<0.001 |
| Target of proximal LAD* |
174 (48%) |
451 (70%) |
<0.001 |
| Target of chronic total occlusion* |
45 (12%) |
166 (26%) |
<0.001 |
| Emergency procedure |
34 (9.3%) |
50 (7.8%) |
0.40 |
| Extent of coronary artery disease |
|
|
<0.001 |
| Isolated ULMCA disease |
31 (8.5%) |
57 (8.9%) |
|
| ULMCA+1-vessel disease |
89 (24.5%) |
108 (16.9%) |
|
| ULMCA+2-vessel disease |
131 (36.0%) |
182 (28.4%) |
|
| ULMCA+3-vessel disease |
113 (31.0%) |
293 (45.8%) |
|
| SYNTAX score |
26.5 (21–34) |
30 (22–40) |
<0.001 |
| Low <23 |
122 (34.2%) |
154 (26.8%) |
<0.001 |
| Intermediate 23–32 |
131 (36.7%) |
177 (30.8%) |
|
| High ≥33 |
104 (29.1%) |
243 (42.3%) |
|
| Total no. of stents |
2.79±1.70 |
– |
– |
| Total stent length (mm) |
58.8±41.1 |
– |
– |
| Stent use |
356 (98%) |
– |
– |
| DES use |
276 (78%) |
– |
– |
| ITA use |
– |
629 (98%) |
– |
| Off pump |
– |
414 (65%) |
– |
| Baseline medications |
| Antiplatelet therapy |
| Thienopyridine |
361 (99%) |
72 (11%) |
<0.001 |
| Ticlopidine |
315 (87%) |
67 (94%) |
0.07 |
| Clopidogrel |
46 (13%) |
4 (5.6%) |
|
| Aspirin |
360 (99%) |
632 (99%) |
0.83 |
| Cilostazol* |
45 (12%) |
41 (6.4%) |
0.002 |
| Other medications |
| Statins* |
184 (51%) |
199 (31%) |
<0.001 |
| β-blockers* |
109 (30%) |
174 (27%) |
0.35 |
| ACEI/ARB* |
190 (52%) |
211 (33%) |
<0.001 |
| Nitrates* |
170 (47%) |
230 (36%) |
0.001 |
| Calcium-channel blockers* |
170 (47%) |
332 (52%) |
0.12 |
| Nicorandil* |
94 (26%) |
277 (43%) |
<0.001 |
| Warfarin* |
30 (8.2%) |
244 (38%) |
<0.001 |
| Proton-pump inhibitors* |
92 (25%) |
263 (41%) |
<0.001 |
| Histamine type-2 receptor blockers* |
77 (21%) |
204 (32%) |
<0.001 |
*Risk-adjusting variables selected for Cox proportional hazard models. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; CABG, coronary artery bypass grafting; DES, drug-eluting stents; eGFR, estimated glomerular filtration rate; ITA, internal thoracic artery; LAD, left anterior descending coronary artery; MI, myocardial infarction; PCI, percutaneous coronary intervention; SYNTAX, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery; ULMCA, unprotected left main coronary artery.
The unadjusted and adjusted risks of PCI relative to CABG for the primary outcome measure were evaluated in each SYNTAX score category as a subgroup analysis. In addition to the modes of coronary revascularization (PCI vs. CABG), variables with P<0.05 in the previously described full model were included in the multivariable models for the subgroup analysis, reflecting our preference for parsimonious models to avoid over-fitting.
All statistical analyses were conducted using JMP 8.0 software (SAS Institute Inc, Cary, NC, USA) and SAS 9.2 (SAS Institute Inc). All reported P values were 2-tailed, and P<0.05 was considered statistically significant.
Results
Baseline Characteristics
The study population reflected real-world clinical practice, including large proportions of patients with advanced age, diabetes mellitus, past history of heart failure, prior stroke, and renal insufficiency (Table 1). Compared with the CABG group, the PCI group included more elderly patients and those with malignancy and severe mitral regurgitation. Patients with diabetes on insulin therapy and thrombocytopenia were more common in the CABG group than in the PCI group (Table 1).
Regarding the lesion characteristics, approximately two-thirds of the patients in the entire cohort had multivessel coronary artery disease in addition to ULMCAD. The CABG group included more patients with complex coronary anatomy represented by the SYNTAX score (mean SYNTAX score: 26.5 vs. 30, P<0.001) and greater numbers of target lesions or anastomoses (2.00±1.03 vs. 3.09±1.04, P<0.001) (Table 1). In the PCI group, the majority of patients received stents (98%) and 78% of patients received at least 1 DES. DES were used for ULMCAD in 69% of patients. In the CABG group, the vast majority of patients received at least 1 internal thoracic artery bypass graft (98%), and the prevalence of off-pump CABG was high (65%).
The patients in the PCI group more often experienced evidence-based medicine such as statins and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker compared with those in the CABG group (Table 1).
Long-Term Clinical Outcome: PCI vs. CABG
The cumulative 5-year incidence of death/MI/stroke (primary outcome measure) in the PCI group was significantly higher than that in the CABG group (34.5% vs. 24.1%, log-rank P<0.001) (Figure 2, Table 2). After adjusting for confounders, the risk for death/MI/stroke remained significantly higher in the PCI group than in the CABG group (adjusted HR: 1.48, 95% CI: 1.07–2.05, P=0.02) (Table 2). Regarding survival outcome, the adjusted risk for all-cause death was not significantly different between the 2 groups (adjusted HR: 1.32, 95% CI: 0.90–1.93, P=0.16), although the cumulative 5-year incidence of all-cause death was significantly higher in the PCI group than in the CABG group (25.3% vs. 18.0%, log-rank P=0.001) (Figure 2, Table 2). The cumulative 5-year incidences of and the adjusted risks for cardiac death, MI, and any coronary revascularization were significantly higher in the PCI group than in the CABG group (adjusted HR: 2.00 [95% CI: 1.10–3.63, P=0.02], adjusted HR: 2.25 [95% CI: 1.04–4.88, P=0.04], and adjusted HR: 4.31 [95% CI: 2.97–6.26, P<0.001], respectively) (Table 2). The adjusted risk for hospitalization for heart failure was not significantly different between the 2 groups (HR: 1.43, 95% CI: 0.82–2.49, P=0.21). The risk for major bleeding beyond 30 days after procedure was also not significantly different between the 2 groups (HR: 1.18, 95% CI: 0.71–1.96, P=0.52), although the overall risk for major bleeding, including bleeding events during the perioperative period, was significantly higher in the CABG group than in the PCI group (HR: 0.20, 95% CI: 0.14–0.29, P<0.001) (Table 2).
Table 2.
Crude and Adjusted 5-Year Clinical Outcomes: PCI vs. CABG
| Endpoint |
PCI (n=364) |
CABG (n=640) |
Crude HR
(95% CI) |
P value |
Adjusted HR
(95% CI) |
P value |
No. of events
(Incidence) |
No. of events
(Incidence) |
| All-cause death |
88 (25.3%) |
109 (18.0%) |
1.54 (1.18–2.00) |
0.001 |
1.32 (0.90–1.93) |
0.16 |
| Cardiac death |
44 (13.2%) |
41 (7.2%) |
1.99 (1.34–2.95) |
<0.001 |
2.00 (1.10–3.63) |
0.02 |
| Sudden cardiac death |
15 (4.9%) |
9 (1.6%) |
2.71 (1.34–5.67) |
0.004 |
– |
– |
| Non-cardiac death |
44 (13.9%) |
68 (11.7%) |
1.26 (0.88–1.79) |
0.20 |
0.98 (0.58–1.66) |
0.95 |
| MI |
25 (7.7%) |
19 (3.3%) |
2.53 (1.42–4.57) |
0.001 |
2.25 (1.04–4.88) |
0.04 |
| Stroke |
27 (8.6%) |
42 (7.1%) |
1.32 (0.84–2.05) |
0.22 |
0.92 (0.48–1.79) |
0.81 |
| Hospitalization for heart failure |
43 (13.4%) |
51 (9.0%) |
1.65 (1.12–2.42) |
0.01 |
1.43 (0.82–2.49) |
0.21 |
| Major bleeding |
56 (17.0%) |
350 (54.9%) |
0.25 (0.19–0.33) |
<0.001 |
0.20 (0.14–0.29) |
<0.001 |
Major bleeding beyond 30 days
after procedure |
41 (13.1%) |
62 (10.7%) |
1.32 (0.90–1.91) |
0.15 |
1.18 (0.71–1.96) |
0.52 |
| Any coronary revascularization |
148 (45.7%) |
84 (14.3%) |
3.81 (2.94–4.97) |
<0.001 |
4.31 (2.97–6.26) |
<0.001 |
Ischemia-driven coronary
revascularization |
74 (23.8%) |
35 (6.2%) |
4.18 (2.86–6.20) |
<0.001 |
4.53 (2.67–7.68) |
<0.001 |
| Death/MI/stroke |
121 (34.5%) |
147 (24.1%) |
1.66 (1.32–2.07) |
<0.001 |
1.48 (1.07–2.05) |
0.02 |
CI, confidence interval; HR, hazard ratio. Other abbreviations as in Table 1.
The SYNTAX scores were available for 931 patients (92.7%). The median SYNTAX score was significantly higher in the CABG group than in the PCI group (30 vs. 26.5, P<0.001) (Table 1).
The cumulative 5-year incidence of the primary outcome measure (death/MI/stroke) was not significantly different between the 2 groups in patients with low (<23) SYNTAX score (31.9% vs. 24.1%, log-rank P=0.16) (Figure 3). In patients with intermediate (23–33) and high (≥33) SYNTAX score, however, the measure was significantly higher in the PCI group than in the CABG group (35.8% vs. 21.8%, log-rank P<0.001, and 37.3% vs. 27.5%, log-rank P=0.009, respectively) (Figure 3). After adjusting for confounders, the risk for death/MI/stroke was not significantly different between the 2 groups for patients with low and intermediate SYNTAX scores (adjusted HR: 1.76 [95% CI: 0.99–3.10, P=0.0504], and adjusted HR: 1.53 [95% CI: 0.88–2.66, P=0.14], respectively), whereas it was significantly higher in the PCI group than in the CABG group for patients with high SYNTAX score (adjusted HR: 2.09, 95% CI: 1.26–3.46, P=0.004).
Discussion
The main findings of the current analysis were as follows: (1) CABG as compared with PCI was associated with better long-term outcome in patients with ULMCAD in real-world clinical practice, and (2) consistent with our previous 3-year report and the SYNTAX randomized trial, the long-term risk for serious cardiovascular events was not significantly different between PCI and CABG in patients with low or intermediate SYNTAX scores, but was markedly higher after PCI as compared with CABG in patients with high SYNTAX score.
Extended 5-year follow-up in the current study made it possible to demonstrate an advantage of CABG over PCI in terms of the long-term outcome of patients with ULMCAD in real-world clinical practice, which could not be demonstrated in our previous 3-year follow-up results. In fact, late adverse events occurring beyond 1 year after DES implantation, such as VLST and late TLR, are major concerns of DES, and have been reported to continue occurring for up to 5 years at least.9–11
However, studies evaluating long-term (≥5 years) outcomes of PCI compared with CABG in patients with ULMCAD are still limited.12–15
The long-term risks for both MI and repeat coronary revascularization were significantly lower after CABG than after PCI in the current study. Subgroup analysis of ULMCAD patients in the SYNTAX randomized trial recently reported comparable 5-year cardiovascular outcomes for PCI and CABG.13
The randomized control trial is the gold standard for comparing treatments, but generally enrolls selective patients without high risk profiles. On the other hand, observational study reflects real-world clinical practice, where there are many patients considered high risk such as the elderly, diabetics, and those with surgical ineligibility. The MAIN-COMPARE registry and several other studies reported comparable long-term cardiovascular outcomes for PCI and CABG, except for excess risk with PCI for repeat revascularization in patients with ULMCAD.12,14,15
Consistent with the current study result, however, the RERIC and REAL investigators reported the long-term risks for death and MI as significantly lower after CABG than after PCI in patients with ULMCAD.23
The reason for this discrepancy between studies might be the different characteristics of the patient populations in each study, especially differences in the proportions of high-risk patients with such as the elderly, diabetics, and those with a past history of heart failure, or complex multivessel disease.
Consistent with both our previous 3-year follow-up results and the 5-year follow-up results from the SYNTAX randomized trial, the current 5-year follow-up study in real-world clinical practice confirmed the utility of the SYNTAX score for risk stratification and selection of mode of revascularization procedure, supporting the current updated clinical guidelines for ULMCAD.5–7,13,16
Therefore, in ULMCAD patients with relatively less anatomical complexity, represented by a low or intermediate SYNTAX score, PCI using DES is a reasonable alternative to CABG in real-world clinical practice. On the other hand, CABG still remains the preferable treatment for ULMCAD patients with high anatomical complexity (ie, high SYNTAX score or complex multivessel disease), because the clinical outcome after CABG is not affected by anatomical complexity.
Study Limitations
First and most importantly, the observational study design precludes drawing definitive conclusions regarding the superiority of either PCI or CABG, because of selection bias and unmeasured confounders, despite appropriate statistical adjustment for potential confounders. Second, the number of patients enrolled was still small, although longer-term follow-up made it possible to demonstrate an advantage of CABG over PCI in the entire cohort. Finally, because patient demographics, practice patterns, and clinical outcomes in patients undergoing PCI and CABG in Japan may be different from those outside Japan, generalizing these results to populations outside Japan should be done with caution.
Conclusions
CABG as compared with PCI was associated with better long-term outcome for patients with ULMCAD, especially those with high anatomical complexity.
Acknowledgments
We appreciate the support and collaboration of the co-investigators participating in the CREDO-Kyoto PCI/CABG Registry Cohort-2. We are indebted to the outstanding effort of the clinical research coordinators for data collection.
Disclosures
Conflict of Interest: None of the authors has any conflict of interest to disclose.
Funding Sources: This study was supported by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Supplementary Files
Supplementary File 1
Appendix S1
Appendix S2
Appendix S3
Please find supplementary file(s);
http://dx.doi.org/10.1253/circj.CJ-15-0034
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