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Ann Thorac Surg 2004;78:466-470
© 2004 The Society of Thoracic Surgeons
a Section of Cardiology, Veterans Affairs Hospital, White River Junction, Vermont, USA
b Section of Cardiology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA
g Section of Cardiothoracic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA
c Section of Clinical Research, Dartmouth Medical School, Hanover, New Hampshire, USA
d Section of Cardiothoracic Surgery, Eastern Maine Medical Center, Bangor, Maine, USA
e Section of Cardiothoracic Surgery, Maine Medical Center, Portland, Maine, USA
f Section of Cardiology, Catholic Medical Center, Manchester, New Hampshire, USA
Accepted for publication January 22, 2004.
* Address reprint requests to Dr O'Rourke, Medical Service-Cardiology, Veterans Affairs Medical Center, Hartland Rd, White River Junction, VT 05006, USA
e-mail: daniel.o'rourke{at}hitchcock.org
| Abstract |
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METHODS: In-hospital data were collected on 1,305 consecutive patients undergoing coronary revascularization (PCI, n = 341; CABG, n = 964) in northern New England from 1994 to 1996. Patient records were linked to the National Death Index to assess survival out to 3 years (mean 1.2 years). Logistic and Cox proportional hazards regression were used to calculate risk-adjusted odds ratios and hazard ratios.
RESULTS: Compared with CABG patients, those undergoing PCI were more often women, had more renal failure, more prior coronary revascularizations, were more likely to have two-vessel coronary artery disease and were more likely to undergo the procedure emergently. They were less likely to have a history of heart failure. After adjusting for differences in baseline characteristics, patients undergoing CABG had better intermediate survival than did PCI patients (hazard ratio 0.68; 95% confidence interval, 0.46 to 1.00; p = 0.05).
CONCLUSIONS: Patients with multivessel coronary artery disease and PVD undergoing CABG surgery have better intermediate survival out to 3 years than similar patients undergoing PCI. This information may be useful in counseling patients with PVD requiring coronary revascularization.
| Introduction |
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Because of the diffuse nature of the atherosclerotic process, patients with peripheral vascular disease (PVD) often have concomitant multivessel CAD [4]. Peripheral vascular disease is an important predictor of adverse outcomes after coronary revascularization. Patients with PVD have been found to have higher rates of adverse outcomes and poorer survival compared with patients without PVD [59]. Only one study has compared the outcomes of CABG versus PCI in patients with multivessel CAD and PVD [9]; a nonsignificant trend was found for improved survival with CABG (adjusted relative risk = 0.87, p = 0.40).
The question of whether surgical revascularization is superior to PCI for patients with PVD remains an open question. Therefore, we used our regional registry of consecutive coronary revascularizations to compare the in-hospital, 30-day, and intermediate survival out to 3 years among patients with PVD and multivessel CAD who underwent PCI or CABG in northern New England.
| Material and methods |
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Patients
Between January 1, 1994, and December 31, 1996, data were prospectively collected on 19,119 consecutive patients undergoing coronary revascularization (PCI = 9,832; CABG = 9,287). Patients with single-vessel CAD (7,489) and left main occlusion of at least 50% (2,474) were excluded because in most cases such patients are not candidates for both PCI and CABG. After these exclusions, 9,156 patients remained; 1,305 (14.3%) with PVD (PCI = 341; CABG = 964) became the study cohort. Data were collected on patient demographics, past medical history, comorbidities, primary indication for the intervention, therapy, cardiac anatomy and function, surgical indication and priority, procedural information, and outcomes as described previously [1013]. Peripheral vascular disease was defined as the presence of cerebrovascular disease including prior cerebrovascular accident, prior transient ischemic attack, carotid stenosis by history or carotid bruit; or lower extremity vascular disease including claudication, amputation, prior lower extremity bypass, absent pedal pulses, or lower extremity ulcers.
Outcome measures
The primary outcomes of interest included in-hospital, 30-day, and intermediate survival out to 3 years. In-hospital mortality was obtained from the Northern New England Cardiovascular Disease Study Group database. The National Death Index [14, 15] was searched to obtain data on 30-day and intermediate survival through December 31, 1996 (mean follow-up 1.2 years, range 0 to 3 years). These data were merged to the registry through a probabilistic match using some combination of name, social security number, date of birth, sex, date last known alive, and state of last known residence. The accuracy of the National Death Index is between 92% and 99%, depending on which patient identifiers are available [16, 17].
Statistical analysis
Comparisons of means and proportions were performed using standard statistical techniques. Multivariate models were used to adjust for difference in case-mix and severity of illness between patients undergoing PCI versus CABG. Patient and procedural characteristics associated with mortality (p < 0.01) in univariate analyses were included in a final multivariate model. The variables used to adjust for case-mix in the final model included: age, sex, surgical priority, three vessel coronary artery disease, prior CABG, congestive heart failure, ejection fraction, chronic obstructive pulmonary disease, dialysis-dependent renal failure, and diabetes. Logistic regression was used to determine the adjusted odds ratios (OR) for in-hospital and 30-day mortality and direct standardization was used to calculate adjusted rates. Cox proportional hazards regression was used to determine the adjusted hazard ratio (HR) for survival. All analyses were performed using Stata Statistical Software Release 6.0 (Stata Corporation, College Station, TX) and SAS 8.2 (SAS Institute, Cary, NC). Statistical significance was defined as a two-tailed p value less than 0.05.
| Results |
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| Comment |
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Short-term and intermediate-term outcome
The presence of PVD has been found to be an important predictor of both short-term and intermediate-term survival out to 3 years in patients undergoing coronary revascularization. Birkmeyer and colleagues [6] found that the adjusted in-hospital mortality for CABG was 73% higher for patients with PVD than for patients without PVD (OR = 1.73; 95% CI, 1.19 to 2.51), a finding similar to those of other investigators [13, 18, 19]. O'Connor and colleagues [13, 20] identified PVD as an important predictor of in-hospital outcome for both PCI and CABG. After more than 5 years of follow-up, Birkmeyer and colleagues [7] found a twofold increase in the mortality rate in patients with PVD compared with patients without PVD after bypass surgery (HR = 2.01; 95% CI, 1.57 to 2.58; p < 0.01). Eagle and coworkers [5] also found that PVD was an independent risk factor for long-term mortality in patients undergoing CABG, and that PVD was associated with an adverse long-term outcome (HR = 1.25; 95% CI, 1.15 to 1.36; p < 0.001).
Coronary artery bypass grafting versus percutaneous coronary intervention
Only one other study has compared survival after CABG to PCI in patients with PVD and multivessel CAD [9]. The BARI investigators reported on survival in a subgroup of 303 patients with PVD. The 5-year cumulative survival rates were similar between groups (80.3% CABG compared with 71.4% PCI, p = 0.11) and after adjusting for baseline characteristics no significant difference was found in survival between CABG and PCI (HR 0.87; 95% CI, 0.83 to 1.20; p = 0.40).
There are several possible explanations for our findings. Compared with PCI, CABG surgery offers more complete revascularization, which has been linked to survival [21]. Although we have no global measure of revascularization, in our CABG group the mean number of distal anastomoses was 3.6, whereas in the PCI group the mean number of vessels intervened on was 1.02, suggesting more complete revascularization with surgery. The durability of revascularization may be playing a role. The weak point of PCI is restenosis, which in the largely pre-stent era of this study was approximately 40%. Bypass grafts, particularly mammary grafts, have high long-term patency rates [22]. This advantage could result in less ischemia among CABG patients and possibly a lower incidence of life-threatening arrhythmic events. Some 40% of our patient population had diabetes, for which we have previously determined CABG is superior [23]. Because diabetes and PVD independently influence outcome after CABG, we sought to separate the independent effects of the two risk factors. We found that in patients with PVD and without diabetes, CABG was associated with improved survival compared with PCI (HR 0.63; 95% CI, 0.39 to 1.02; p = 0.063). Therefore, independent of diabetes, PVD was associated with improved survival in patients undergoing bypass surgery compared with PCI. Finally, more than twice as many patients who underwent PCI had a history of CABG, compared with the percentage of CABG patients who had a history of PCI. Therefore, we controlled for the variable prior CABG in our Cox model. After adjusting for differences in baseline characteristics, including prior CABG, we found that patients undergoing CABG had better intermediate survival out to 3 years than did patients undergoing PCI (HR 0.68; 95% CI, 0.46 to 1.00; p = 0.05). Perhaps part of the statistically significant survival benefit observed in the CABG group resulted from subsequent PCI for in-graft stenosis or new disease in the native circulation. Our database does not allow us to assess the proportion of CABG patients requiring reintervention or the proportion of PCI patients requiring subsequent CABG.
Why did the BARI results differ from ours? As the BARI investigators acknowledged, their study was underpowered to detect a difference between CABG and PCI survival. Interestingly, their nonsignificant HR (0.87) falls within the significant confidence intervals of our study (95% CI, 0.46 to 1.00). Although the details of revascularization in the BARI subgroup of PVD patients were not reported, in the overall study, 70% of PCI patients had multivessel intervention, compared with 21% in our study. Thus, more complete revascularization in BARI PCI patients may have resulted in survival more comparable to CABG.
Study limitations
Unlike BARI, patients in our study were not randomized to treatment. Our results may have been confounded by unmeasured differences in case-mix, although to the extent that this choice was based on measured patient characteristics this lack of randomization should not be a problem. We did not use an objective measure to define the presence of PVD. However, our clinical definition for PVD was similar to that adopted by the American College of Cardiology [24]. Finally, the practice of PCI is ever changing and we are now in the era of stents, IIb/IIIa inhibitors, and distal protection devices. To the extent that these practices improve vessel patency and curtail myocardial damage, they may result in improved survival after PCI, a possibility that merits further study.
Conclusions
In the mid-1990s, in northern New England, patients with PVD and multivessel CAD undergoing CABG had better intermediate survival out to 3 years than did patients undergoing PCI. If generalizable, this finding would be another important piece of information for patients with PVD and their physicians to consider when developing a strategy for coronary revascularization.
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