Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients

OBJECTIVES: This report compares long-term percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) survival among post-CABG patients included in the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial and prospective registry. BACKGROUND: Repeat CABG surgery is associated with a higher risk of mortality than first-time CABG. The AWESOME is the first randomized trial comparing CABG with PCI to include post-CABG patients. METHODS: Over a five-year period (1995 to 2000), patients at 16 hospitals were screened to identify a cohort of 2,431 individuals who had medically refractory myocardial ischemia and at least one of five high-risk factors. There were 454 patients in the randomized trial, of whom 142 had prior CABG. In the physician-directed registry of 1,650 patients, 719 had prior CABG. Of the 327 patient-choice registry patients, 119 had at least one prior CABG. The CABG and PCI survivals for the three groups were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI three-year survival rates were 73% and 76% respectively for the 142 randomized patients (75 and 67 patients) (log-rank = NS). In the physician-directed registry, 155 patients were assigned to reoperation and 357 to PCI (207 received medical therapy); 36-month survivals were 71% and 77% respectively (log-rank = NS). In the patient-choice registry, 32 patients chose reoperation and 74 chose PCI (13 received medical therapy); 36-month survivals were 65% and 86% respectively (log-rank test p = 0.01). CONCLUSIONS: Percutaneous coronary intervention is preferable to CABG for many post-CABG patients.     

Percutaneous coronary intervention versus coronary bypass graft surgery for diabetic patients with unstable angina and risk factors for adverse outcomes with bypass: outcome of diabetic patients in the AWESOME randomized trial and registry

OBJECTIVES: This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients. BACKGROUND: Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery. METHODS: Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests. RESULTS: The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant. CONCLUSIONS: We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.     

Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter,randomized trial

BACKGROUNDPercutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are being applied to high-risk populations, but previous randomized trials comparing revascularization methods have excluded a number of important high-risk groups.OBJECTIVESThis five-year, multicenter, randomized clinical trial was designed to compare long-term survival among patients with medically refractory myocardial ischemia and a high risk of adverse outcomes assigned to either a CABG or a PCI strategy, which could include stents.METHODSPatients from 16 Veterans Affairs Medical Centers were screened to identify myocardial ischemia refractory to medical management and the presence of one or more risk factors for adverse outcome with CABG, including prior open-heart surgery, age >70 years, left ventricular ejection fraction <0.35, myocardial infarction within seven days or intraaortic balloon pump required. Clinically eligible patients (n = 2,431) underwent coronary angiography; 781 were angiographically acceptable; 454 (58% of eligible) patients consented to random assignment between CABG and PCI.RESULTSA total of 232 patients was randomized to CABG and 222 to PCI. The 30-day survivals for CABG and PCI were 95% and 97%, respectively. Survival rates for CABG and PCI were 90% versus 94% at six months and 79% versus 80% at 36 months (log-rank test, p = 0.46).CONCLUSIONSPercutaneous coronary intervention is an alternative to CABG for patients with medically refractory myocardial ischemia and a high risk of adverse outcomes with CABG.     

Outcome of percutaneous coronary intervention versus coronary bypass grafting for patients with low left ventricular ejection fractions, unstable angina pectoris, and risk factors for adverse outcomes with bypass (the AWESOME Randomized Trial and Registry)

The recently concluded Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) was a randomized clinical trial of percutaneous coronary intervention versus coronary bypass graft surgery among patients with medically refractory ischemia who were at high risk for coronary bypass graft surgery because of > or =1 risk factors that included severely reduced left ventricular (LV) function, defined as LV ejection fraction <35%. This study reports the outcome of patients with LV ejection fraction <35% in the randomized clinical trial and the physician-directed and patient choice registries of the AWESOME study.     

Health-related quality of life after percutaneous coronary intervention versus coronary bypass surgery in high-risk patients with medically refractory ischemia

OBJECTIVES: We compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery. BACKGROUND: Mortality rates after PCI and CABG surgery are similar. Therefore, differences in HRQL outcomes may help in the selection of a revascularization procedure. METHODS: Patients were enrolled in a Veterans Affairs multicenter randomized trial comparing PCI versus CABG for patients with medically refractory ischemia and one or more risk factors for adverse outcome; 389 of 423 patients (92%) alive six months after randomization completed an Short Form-36 (SF-36) health status survey. Primary outcomes were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. Multivariable analyses were used to evaluate whether PCI or CABG surgery was associated with better PCS or MCS scores after adjusting for over 20 baseline variables. RESULTS: There were no significant differences in either PCS scores (38.7 vs. 37.3 for PCI and CABG, respectively; p = 0.23) or MCS scores (45.5 vs. 46.1, p = 0.58) between the treatment arms. In multivariable models, there remained no difference in HRQL for post-PCI versus post-CABG patients (for PCS, absolute difference = 0.56 +/- standard error of 1.14, p = 0.63; for MCS, absolute difference = -1.23 +/- 1.12, p = 0.27). We had 97% power to detect a four-point difference in scores, where four to seven points is a clinically important difference. CONCLUSIONS: High-risk patients with medically refractory ischemia randomized to PCI versus CABG surgery have equivalent six-month HRQL. Therefore, HRQL concerns should not drive decision-making regarding selection of a revascularization procedure for these patients.     

Percutaneous coronary intervention versus coronary artery bypass grafting in left main coronary artery disease: A review

The left main coronary artery is responsible for most of the irrigation of the left ventricle. Left main coronary artery disease (LMCAD) therefore leads to important morbidity and mortality. Coronary artery bypass grafting (CABG) is considered the standard treatment, however, percutaneous coronary intervention (PCI) has become a frequent alternative in the treatment of LMCAD. In the current review, four randomized clinical trials comparing PCI with CABG in patients with LMCAD, including new longer follow-up results, are reviewed. Major adverse cardiac and cerebrovascular event rates were similar between the two intervention groups in both the SYNTAX and PRECOMBAT trials, and favored the CABG group in the EXCEL and NOBLE trials. The composite of death, stroke and myocardial infarction was similar in all trials. Mortality rates were similar across all trials except for the EXCEL trial at five years, which favored CABG. Cardiac mortality was similar in all trials. Stroke rates were similar, apart from the SYNTAX trial, which favored PCI. CABG was more favorable concerning myocardial infarction in the NOBLE trial, but not in the other trials. Repeat revascularization was generally less frequent in the CABG group. Stent thrombosis and graft occlusion were less frequent with PCI in the EXCEL trial, with no differences in the other trials. Based on the overall similarity in the primary endpoint rates, as well as favorable short-term outcomes, it is plausible to state that PCI can be considered a good alternative to CABG, although the higher risk of repeat revascularization should be taken into consideration.     

Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II)

OBJECTIVES: The purpose of the present study is to report the five-year follow-up results of the ERACI II trial. BACKGROUND: Immediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG). METHODS: A total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up. RESULTS: At five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina. CONCLUSIONS: At five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE.     

Patient preferences for coronary artery bypass graft surgery or percutaneous intervention in multivessel coronary artery disease

Objectives: Determine if patients prefer multivessel percutaneous coronary intervention (mv‐PCI) over coronary artery bypass graft surgery (CABG) for treatment of symptomatic multivessel coronary artery disease (mv‐CAD) despite high 1‐year risk. Background: Patient risk perception and preference for CABG or mv‐PCI to treat medically refractory mv‐CAD are poorly understood. We hypothesize that patients prefer mv‐PCI instead of CABG even when quoted high mv‐PCI risk. Methods: 585 patients and 31 physicians were presented standardized questionnaires with a hypothetical scenario describing chest pain and medically refractory mv‐CAD. CABG or mv‐PCI was presented as treatment options. Risk scenarios included variable 1‐year risks of death, stroke, and repeat procedures for mv‐PCI and fixed risks for CABG. Participants indicated their preference of revascularization method based on the presented risks. We calculated the odds that patients or physicians would favor mv‐PCI over CABG across a range of quoted risks of death, stroke, and repeat procedures. Results: For nearly all quoted risks, patients preferred mv‐PCI over CABG, even when the risk of death was double the risk with CABG or the risk of repeat procedures was more than three times that for CABG (P < 0.0001). Compared to patients, physicians chose mv‐PCI less often than CABG as the risk of death and repeat procedures increased (P < 0.001 and P = 0.004, respectively). Conclusion: Patients favor mv‐PCI over CABG to treat mv‐CAD, even if 1‐year risks of death and repeat procedures far exceed risk with CABG. Physicians are more influenced by actual risk and prefer mv‐PCI less than patients despite similarly quoted 1‐year risks. © 2013 Wiley Periodicals, Inc.     

Outcomes of patients consented but not randomized in a trial of primary percutaneous coronary intervention in acute myocardial infarction (the CADILLAC registry)

Baseline features, management, and outcomes of patients who had acute myocardial infarction (AMI) and were excluded from randomized trials of primary percutaneous coronary intervention (PCI) have not been well described. We examined the baseline features and outcomes of patients who had AMI and were excluded due to angiographic ineligibility from a randomized trial of primary PCI. The CADILLAC trial evaluated 4 primary PCI strategies in patients who had AMI without cardiogenic shock. Of 2,681 patients who consented, 599 (22.3%) were subsequently excluded from randomization due to protocol-specified angiographic findings. These patients were enrolled in a formal in-hospital registry and were treated at the discretion of attending physicians. Registry versus randomized patients were older (median age 61.9 vs 59.0 years, p = 0.002), more frequently had 3-vessel disease (52.4% vs 15.6%, p = 0.0001), and more frequently had lower left ventricular ejection fraction (45% vs 50%, p = 0.002). Registry patients were treated with PCI (n = 234), coronary artery bypass grafting (n = 136), or medically only (n = 226). In-hospital mortality rate among all patients who consented was 2.2% and was higher among registry than among randomized patients (4.0% vs 1.6%, relative risk 2.45, p = 0.001). Within the registry, covariate-adjusted risk of mortality was lower among patients who were treated by PCI compared with those who were treated medically (odds ratio 0.21, p=0.03). In conclusion, angiographic ineligibility for randomization in a large, prospective, primary PCI trial was associated with numerous high-risk demographic characteristics and higher short-term mortality. Nonetheless, the overall survival of patients who were referred for primary PCI was excellent, and performance of primary PCI versus medical therapy was associated with increased survival among excluded patients.     

PCI versus CABG versus medical therapy in 2006

The decision to offer patients with myocardial ischemia a coronary artery bypass graft (CABG) surgery has been largely determined by extent of coronary artery disease (CAD) and left ventricular function, since the early 1970's. Based upon subset analyses, and long-term follow-up, of three moderate-sized trials of stable patients and two small trials of unstable angina (excluding recent myocardial infarction, MI) patients, the notion has persisted that patients with left main narrowing >50% or three-vessel stenoses >70%, or even two-vessel stenoses >70%, where one of the vessels is the proximal left anterior descending, derive a "survival benefit" relative to medical therapy (MED), from CABG (anatomic paradigm). The MED of the original CABG versus MED trials consisted of little more than anti-anginal medications, used on an as-needed basis. In the ensuing 3 decades, multiple large, well done, randomized clinical trials have established a survival benefit for 4 different forms of MED among a broad spectrum of CAD patients. Aspirin; lipid lowering, especially with statins; b-blockers; and angiotensin-converting-enzyme inhibitors and/or angiotensin receptor blocking agents; have all been shown to enhance survival, as well as reduce other objective adverse outcomes of CAD. The advances in MED, coupled with the small but significant mortality and morbidities of both CABG and percutaneous coronary intervention (PCI), are among the reasons to skeptically consider potential "survival benefit" of revascularization. A more common and far more easily justified reason to consider revascularization is to relieve "medically refractory" myocardial ischemia, particularly when the ischemia is accompanied by symptoms. Accordingly, documentation of medically refractory myocardial ischemia provides the answer to the first question of myocardial revascularization, "Is this patient likely to derive clinical benefit from revascularization, at this time?" It is only after this question has been answered that one needs to consider the relative advantages and disadvantages of PCI versus CABG (physiologic paradigm). Two of the relative advantages of PCI, namely speed of reperfusion, and relatively low morbidity, are among the reasons that most randomized trial data, and most clinical application of revascularization to patients with MI (ST-elevation MI [STEMI], and non-STEMI) have been by PCI. In contrast, for stable patients with medically refractory ischemia, anatomic considerations continue to be relevant to the choice between CABG and PCI. Specific advantages of CABG include: its potential to revascularize chronically occluded vessels with collaterals supplying viable myocardium; the fact that conduits protect territories rather than simply treating lesions; and the greater durability of conduits compared to bare-metal stents (drug-eluting stents may change the picture). Based on these principles, physiologic, rather than anatomic, considerations are most useful in determining whether to revascularize, and how urgently to revascularize (STEMI is an emergent indication and high-risk non-STEMI an urgent indication). Coronary anatomy, including both number of vessels and lesion characteristics, continues to help decide between CABG and PCI, and in formulating patient specific strategies.     

Balancing benefit against risk in the choice of therapy for coronary artery disease. Lesson from prospective, randomized, clinical trials of percutaneous coronary intervention and coronary artery bypass graft surgery

The ageing world population faces a coming pandemic of high-risk coronary artery disease (CAD). Patients with CAD have 3 therapeutic options, which are based on objective clinical outcome: medical therapy and risk factor modification (Medicine), and 2 forms of revascularization, coronary artery bypass graft surgery (CABG), and percutaneous coronary intervention (PCI). More than 50 large (>100 patients), multicenter, prospective, randomized clinical trials (RCT) have compared these treatment options in terms of clinical benefits and patient risks. The randomized trials which demonstrated hard outcome (survival, myocardial infarction, stroke) benefits from statins, angiotensin-converting enzyme inhibition and thienopyridines have all been completed subsequent to the publication of most Medicine versus revascularization trials. These medical therapies, plus aspirin, beta-blockers, and risk factor modification, should be made available to patients regardless of the decision to revascularize, or the decision by what means (CABG or PCI). This review integrates the information from these trials, comparing the clinical benefits against the risks inherent in the 3 therapeutic options. The results of our review show that: trials of medicine versus revascularization (either CABG or PCI) support the revascularization paradox, in that the patients at highest risk of adverse outcome, from myocardial ischemia, have a hard outcome benefit (survival, MI, or stroke) from revascularization. This paradox, first seen in the Medicine versus CABG trials of the 1970s, is evident in the trials comparing fibrinolysis and other medicines, with primary PCI for ST-elevation myocardial infarction (MI). The paradox is evident in the conservative versus invasive strategy trials of non-ST-elevation MI and unstable angina, where the benefit of revascularization occurs only in high-risk subsets. The paradox often results in sicker patients, who have more to gain from revascularization, being denied it because of the elevated perception of risk (comparable to a reperfusion paradox in ST-elevation MI, where patients most likely to benefit from thrombolytics are denied them because of the perception of risk). Trials that compared medicine with revascularization for the treatment of acute MI support the use of PCI as the preferred early stabilization strategy (90% of all PAMI trial patients). The majority of the PCI versus CABG trials enrolled populations that were at relatively low risk for ischemic clinical events. These trials demonstrated few hard outcome (survival, MI, or stroke) differences between CABG and PCI. On the basis of the results obtained the following conclusions may be drawn: medicines are the primary options for stable, low-risk CAD, and should be given to all CAD patients. Medically refractory is a useful high-risk marker of potential benefit from revascularization. CABG continues to be the complete revascularization option for patients with multivessel, multi-lesion CAD, in part because of its application to chronic occlusions. PCI is the acute stabilization method of choice for patients with on-going ischemia and acute MI, especially among patients with hemodynamic compromise, and/or major comorbidity.     

Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II study)

The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revascularization treated with PCI was significantly lower than those with complete revascularization treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p = 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p = 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p = 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p = 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved.     

Comparison of coronary artery bypass surgery with percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease.

OBJECTIVES: This study evaluated the clinical outcomes of consecutive, selected patients treated with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main coronary artery (ULMCA) disease. BACKGROUND: Although recent data suggest that PCI with DES provides better clinical outcomes compared to bare-metal stenting for ULMCA disease, there is a paucity of data comparing PCI with DES to CABG. METHODS: Since April 2003, when DES first became available at our institution, 123 patients underwent CABG, and 50 patients underwent PCI with DES for ULMCA disease. RESULTS: High-risk patients (Parsonnet score >15) comprised 46% of the CABG group and 64% of the PCI group (p = 0.04). The 30-day major adverse cardiac and cerebrovascular event (MACCE) rate for CABG and PCI was 17% and 2% (p < 0.01), respectively. The mean follow-up was 6.7 +/- 6.2 months in the CABG group and 5.6 +/- 3.9 months in the PCI group (p = 0.26). The estimated MACCE-free survival at six months and one year was 83% and 75% in the CABG group versus 89% and 83% in the PCI group (p = 0.20). By multivariable Cox regression, Parsonnet score, diabetes, and CABG were independent predictors of MACCE. CONCLUSIONS: Despite a higher percentage of high-risk patients, PCI with DES for ULMCA disease was not associated with an increase in immediate or medium-term complications compared with CABG. Our data suggest that a randomized comparison between the two revascularization strategies for ULMCA may be warranted.     

Revascularization for coronary artery disease in diabetes mellitus: Angioplasty,stents and coronary artery bypass grafting

Patients with diabetes mellitus (DM) are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. However, the unique pathophysiology of atherosclerosis in patients with DM modifies the response to arterial injury, with profound clinical consequences for patients undergoing percutaneous coronary intervention (PCI). Multiple studies have shown that DM is a strong risk factor for restenosis following successful balloon angioplasty or coronary stenting, with greater need for repeat revascularization and inferior clinical outcomes. Early data suggest that drug eluting stents reduce restenosis rates and the need for repeat revascularization irrespective of the diabetic state and with no significant reduction in hard clinical endpoints such as myocardial infarction and mortality. For many patients with 1- or 2-vessel coronary artery disease, there is little prognostic benefit from any intervention over optimal medical therapy. PCI with drug-eluting or bare metal stents is appropriate for patients who remain symptomatic with medical therapy. However, selection of the optimal myocardial revascularization strategy for patients with DM and multivessel coronary artery disease is crucial. Randomized trials comparing multivessel PCI with balloon angioplasty or bare metal stents to coronary artery bypass grafting (CABG) consistently demonstrated the superiority of CABG in patients with treated DM. In the setting of diabetes CABG had greater survival, fewer recurrent infarctions or need for re-intervention. Limited data suggests that CABG is superior to multivessel PCI even when drug-eluting stents are used. Several ongoing randomized trials are evaluating the long-term comparative efficacy of PCI with drug-eluting stents and CABG in patients with DM. Only further study will continue to unravel the mechanisms at play and optimal therapy in the face of the profoundly virulent atherosclerotic potential that accompanies diabetes mellitus.     

Estimating the number of coronary artery bypass graft and percutaneous coronary intervention procedures in Canada: A comparison of cardiac registry and Canadian Institute for Health Information data sources

BACKGROUND:

Provincial cardiac registries and the Canadian Institute for Health Information (CIHI) pan-Canadian administrative databases are invaluable tools for understanding Canadian cardiovascular health and health care. Both sources are used to enumerate cardiovascular procedures performed in Canada.

OBJECTIVE:

To examine the level of agreement between provincial cardiac registry data and CIHI data regarding procedural counts for coronary artery bypass grafts (CABGs) and percutaneous coronary interventions (PCIs).

METHODS:

CIHI staff obtained CABG and PCI counts from seven provinces that, in 2004, performed these procedures and had a cardiac registry (ie, British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Nova Scotia, and Newfoundland and Labrador). Structured mail questionnaires, and e-mail and telephone follow-ups elicited information from a designated registry respondent. The CIHI derived its counts of CABG and PCI procedures by applying the geographical boundaries, procedural definitions and analytical case criteria used by the cardiac registries to CIHI inpatient and day procedure databases. Steps were taken to reduce double-counting procedures when combining results from the two CIHI databases. Two measures were calculated: the absolute difference between registry and CIHI estimates, and the per cent agreement between estimates from the two sources.

RESULTS:

All seven cardiac registries identified as eligible for the study participated. Agreement was high between the two sources for CABG (98.8%). For PCI, the level of agreement was high (97.9%) when CIHI sources were supplemented with day procedure data from Alberta.

CONCLUSIONS:

The high level of agreement between cardiac registry and CIHI administrative data should increase confidence in estimates of CABG and PCI counts derived from these sources.     

Long-term prognosis after coronary revascularization in patients with end-stage renal disease on dialysis: comparison of percutaneous coronary intervention and coronary artery bypass grafting

OBJECTIVES: To investigate the optimal method of coronary revascularization in patients on dialysis. METHODS: We retrospectively analyzed 145 patients on dialysis who underwent percutaneous coronary intervention (PCI) (81 patients) or coronary artery bypass grafting (CABG) (64 patients). Survival and non-fatal cardiac event-free rates were compared between the two groups by the Kaplan-Meier method. The impact of independent predictors on survival and non-fatal cardiac event-free rates were examined by the Cox regression model. RESULTS: The number of diseased vessels was smaller and ejection fraction was greater in the PCI group compared with the CABG group (1.74 +/- 0.67 vs 2.56 +/- 0.61, p < 0.0001 and 61.1 +/- 14.3% vs 50.6 +/- 17.4%, p = 0.001). The 1-year and 5-year survival rates of the PCI group were significantly higher than those of the CABG group (93.8 +/- 2.7% and 66.6 +/- 5.7% vs 76.0 +/- 5.4% and 44.8 +/- 6.5%, p = 0.0065). However, CABG was not an independent predictor of death by multivariate analysis (p = 0.06). The 1-year and 5-year non-fatal cardiac event-free rates of the PCI group were significantly lower than those of the CABG group (63.7 +/- 5.4% and 34.7 +/- 5.8% vs 83.2 +/- 4.9% and 66.8 +/- 7.4%, p = 0.0003). PCI was an independent predictor of non-fatal cardiac event by multivariate analysis (p = 0.007). CONCLUSIONS: PCI was associated with a higher incidence of non-fatal cardiac events, but survival rate was better after PCI than after CABG. PCI is very important and acceptable as a method of coronary revascularization in patients on dialysis.     

A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: one- to eight-year outcomes

OBJECTIVES: We performed a meta-analysis of randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous transluminal coronary angioplasty (PTCA) for the treatment of coronary artery disease, incorporating new trials and examining long-term outcomes. BACKGROUND: Previous meta-analyses of trials comparing CABG with PTCA have reported short- and intermediate-term outcomes, but since then longer term follow-up and newer trials have been published. METHODS: We performed a meta-analysis of 13 randomized trials on 7,964 patients comparing PTCA with CABG. RESULTS: We found a 1.9% absolute survival advantage favoring CABG over PTCA for all trials at five years (p < 0.02), but no significant advantage at one, three, or eight years. In subgroup analysis of multivessel disease, CABG provided significant survival advantage at both five and eight years. Patients randomized to PTCA had more repeat revascularizations at all time points (risk difference [RD] 24% to 38%, p < 0.001); with stents, this RD was reduced to 15% at one and three years. Stents also resulted in a significant decrease in nonfatal myocardial infarction at three years when compared with CABG. For diabetic patients, CABG provided a significant survival advantage over PTCA at 4 years but not at 6.5 years. CONCLUSIONS: Our results suggest that, when compared with PTCA, CABG is associated with a lower five-year mortality, less angina, and fewer revascularization procedures. For patients with multivessel disease, CABG provided a survival advantage at five to eight years, and for diabetics, a survival advantage at four years. The addition of stents reduced the need for repeat revascularization by about half.     

Tirofiban therapy for patients with acute coronary syndromes and prior coronary artery bypass grafting in the PRISM-PLUS trial

The role of glycoprotein IIb/IIIa platelet receptor antagonist therapy for patients with an acute coronary syndrome (ACS) and a history of coronary artery bypass grafting (CABG) remains incompletely defined. We examined the outcomes of patients with an ACS and prior CABG who were treated with tirofiban versus placebo among subjects with prior CABG in the Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) trial. Of 1,570 patients treated with tirofiban plus heparin (n = 773) or heparin alone (n = 797), 231 had prior CABG. Compared with patients without prior CABG, those with prior CABG were more likely to have risk factors for a complicated ACS course, including severe coronary artery disease and heart failure (all p <0.0001), typically had clinical predictors of benefit from tirofiban, such as ST-segment depression (p = 0.01) or a TIMI risk score >or=4 (p <0.001), and were more likely to die or have a myocardial infarction or refractory ischemia at all time points examined (p <0.0001). Among patients with prior CABG, decreases in the incidence of death, myocardial infarction, or refractory ischemia with tirofiban and heparin versus heparin alone were noted at 7 and 30 days (7 days: 16.9% vs 29.0%, p = 0.035; 30 days: 25.0% vs 40.2%, p = 0.015). Trends toward a decrease in death, myocardial infarction, and refractory ischemia with tirofiban and heparin versus heparin alone in the prior CABG subgroup were noted at 48 hours and 180 days (48 hours: 6.5% vs 14.0%, p = 0.09; 180 days: 37.1% vs 48.6%, p = 0.057). Bleeding rates were similar in patients with and without prior CABG. Tirofiban was well tolerated and tended to decrease the considerable risk for ischemic ACS complications in patients with prior CABG.     

The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results

OBJECTIVES: We sought to evaluate the relative efficacies of three possible therapeutic strategies for patients with multivessel coronary artery disease (CAD), stable angina, and preserved ventricular function. BACKGROUND: Despite routine use of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), there is no conclusive evidence that either one is superior to medical therapy (MT) alone for the treatment of multivessel CAD. METHODS: The primary end point was defined as cardiac mortality, Q-wave myocardial infarction (MI), or refractory angina requiring revascularization. All data were analyzed according to the intention-to-treat principle. RESULTS: A total of 611 patients were randomly assigned to either a CABG (n = 203), PCI (n = 205), or MT (n = 203) group. The one-year survival rates were 96.0% for CABG, 95.6% for PCI, and 98.5% for MT. The rates for one-year survival free of Q-wave MI were 98% for CABG, 92% for PCI, and 97% for MT. After one-year follow-up, 8.3% of MT patients and 13.3% of PCI patients underwent to additional interventions, compared with only 0.5% of CABG patients. At one-year follow-up, 88% of the patients in the CABG group, 79% in the PCI group, and 46% in the MT group were free of angina (p < 0.0001). CONCLUSIONS: Medical therapy for multivessel CAD was associated with a lower incidence of short-term events and a reduced need for additional revascularization, compared with PCI. In addition, CABG was superior to MT for eliminating anginal symptoms. All three therapeutic regimens yielded relatively low rates of cardiac-related deaths.