CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY
Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts
Ellen C. Keeley, MDa,1,
Carlos A. Velez, MDa,
William W. O’Neill, MD, FACCa and
Robert D. Safian, MD, FACCa
a Department of Internal Medicine (Cardiovascular Division), William Beaumont Hospital, Royal Oak, Michigan, USA
Manuscript received January 14, 2000;
revised manuscript received March 15, 2001,
accepted May 17, 2001.
Reprint requests and correspondence: Dr. Robert D. Safian, Interventional Cardiology, William Beaumont Hospital, 3601 West Thirteen Mile Road, Royal Oak, Michigan 48073
rsafian{at}beaumont.edu
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Abstract
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OBJECTIVES
The purpose of this study was to examine the long-term clinical outcome after percutaneous intervention of saphenous vein grafts (SVG) and to identify the predictors of major adverse cardiac events (MACE).
BACKGROUND
Percutaneous interventions of SVGs have been associated with more procedural complications and higher restenosis rates compared with interventions on native vessels.
METHODS
From 1993 to 1997, 1,062 patients underwent percutaneous intervention on 1,142 SVG lesions. Procedural, in-hospital and long-term clinical outcomes were recorded in a database and analyzed.
RESULTS
In-hospital MACE occurred in 137 patients (13%) including death (8%), Q-wave myocardial infarction (MI) (2%) and coronary artery bypass surgery (3%). Late MACE occurred in 565 patients (54%) including death (9%), Q-wave MI (9%) and target vessel revascularization (36%). Any MACE occurred in 457 (43%) patients. Follow-up was available in 1,056 (99%) patients at 3 ± 1 year. Univariate predictors were restenotic lesion (odds ratio [OR]: 2.47, confidence interval [CI]: 1.13 to 3.85, p = 0.0003), unstable angina (OR: 1.99, CI: 1.27 to 2.91, p = 0.04) and congestive heart failure (CHF) (OR: 1.97, CI: 1.14 to 3.24, p = 0.02) for in-hospital MACE, and peripheral vascular disease (PVD) (OR: 2.18, CI: 1.34 to 3.44, p = 0.002), intra-aortic balloon pump placement (OR: 2.08, CI: 1.13 to 3.85, p = 0.02) and previous MI (OR: 1.97, CI: 1.14 to 3.25, p = 0.007) for late MACE. Independent multivariate predictors for late MACE were restenotic lesion (relative risk [RR] 1.33, p = 0.02), PVD (RR: 1.31, p = 0.01), CHF (RR: 1.42, p = 0.01) and multiple stents (RR: 1.47, p = 0.004). Angiographic follow-up was available for 422 patients. Angiographic restenosis occurred in 122 (29%) of stented SVGs and 181 (43%) of nonstented SVGs (p = 0.04). Stent implantation did not confer a survival benefit.
CONCLUSIONS
Despite the use of new interventional devices, SVG interventions are associated with significant morbidity and mortality; SVG stenting is not associated with better three-year event-free survival. This may be due to progressive disease at nonstented sites.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft surgery | | CHF | = congestive heart failure | | IABP | = intra-aortic balloon pump | | MACE | = major adverse cardiac event | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty | | PVD | = peripheral vascular disease | | SVG | = saphenous vein graft | | TIMI | = Thrombolysis In Myocardial Infarction |
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Coronary artery bypass graft surgery (CABG) provides symptomatic benefit for patients with ischemic heart disease and may prolong life in selected patients (1,2). Recurrent angina occurs in 5% to 10% of patients per year, primarily due to saphenous vein graft (SVG) failure. The probability of graft degeneration increases with time and, by 10 years after CABG, approximately 50% of SVGs are occluded and up to 40% of patent SVGs have significant stenoses (3,4). Repeat CABG is feasible but is associated with more morbidity and mortality and less symptomatic improvement compared with the initial operation (5–7).
Compared with percutaneous transluminal coronary angioplasty (PTCA) of native coronary vessels, PTCA of SVG lesions is associated with less favorable immediate results, more adverse in-hospital events and lower event-free survival (8). Restenosis is more frequent in SVGs than it is in native vessels, particularly in older grafts and in stenoses involving the aortic ostium or graft body (8). Although stents have been shown to decrease restenosis and improve the safety and outcome of PTCA in native vessels, they have not been consistently shown to do so after SVG interventions. We reported the immediate and long-term clinical outcome in a series of 1,062 patients who underwent 1,142 SVG interventions in our institution.
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Methods
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Patients.
Between September 1993 and June 1997, percutaneous intervention was performed on 1,142 SVG lesions in 1,062 patients, representing 9% of the 12,265 coronary interventions performed in our institution. All patients were selected for treatment on the basis of spontaneous angina or provocable ischemia documented by noninvasive testing.
Procedures.
Selection of devices was left to operator discretion and evolved during the course of the study. Interventional devices included PTCA alone on 483 lesions (42%), extraction atherectomy on 91 lesions (8%), directional atherectomy on 46 lesions (4%), rotational atherectomy on 34 lesions (3%) and excimer laser on 10 lesions (0.9%) according to techniques that have been previously described (9–12). Stenting was performed after pretreatment with PTCA (396 lesions [35%]) or another device (82 lesions [7%]) and was followed by high pressure adjunctive PTCA (after 1994). Prophylactic intra-aortic balloon pump (IABP) was used at the discretion of the operator. During the procedure, all patients received intravenous heparin to maintain an activated clotting time >300 s. No patients received abciximab. No-reflow was treated with intragraft administration of verapamil (500 µg) and nitroglycerin (250 µg). Creatine kinase levels were routinely obtained 12 h to 18 h after the intervention. All patients who received a stent were treated with aspirin, heparin, dextran and coumadin (1991 to 1994) or aspirin and ticlopidine for four weeks (after 1994).
Data collection and follow-up.
Angiographic results and in-hospital outcome were prospectively entered into a dedicated interventional cardiology database. Clinical follow-up was obtained by telephone interviews with the patient or family and by review of medical records. Mean follow-up after three years (range one to four years) was available for 1,056 patients (99%).
End points and definitions.
The primary end points of this study were in-hospital and late major adverse cardiac events (MACE), defined as death, Q-wave myocardial infarction (MI) and the need for repeat revascularization by redo-CABG or repeat percutaneous intervention. Secondary end points included in-hospital angiographic complications, including no-reflow (defined as Thrombolysis In Myocardial Infarction [TIMI] flow grade  1 not due to dissection or high-grade residual stenosis adjacent to the target lesion); acute occlusion (defined as new angiographic occlusion within 24 h); subacute occlusion (defined as new in-hospital angiographic occlusion more than 24 h after the procedure). Clinical complications included blood transfusion, vascular repair (by ultrasound compression or surgery), renal failure (defined as a rise in baseline creatinine >25%), serious arrhythmia (ventricular tachycardia, ventricular fibrillation or heart block requiring treatment), Q-wave MI (defined as new Q-waves on the electrocardiogram and elevated creatine kinase) and non–Q-wave MI (defined as elevation of creatine kinase >3 times the upper limit of normal in the absence of pathological Q-waves). Angiographic restenosis was defined as target lesion diameter stenosis >50% at follow-up angiography.
Statistical analysis.
Categorical variables were expressed as frequencies and continuous variables as mean ± SD. Predictors of late outcome were determined by univariate logistic regression analysis. The 20 covariates with a univariate p value <0.07 were entered into the Cox proportional hazard model. The covariates were: recurrent angina, prior MI, age of SVG, stent, congestive heart failure (CHF), gender, hypertension, hypercholesterolemia, slow flow, smoking, multiple stents, IABP, diabetes, peripheral vascular disease (PVD), unstable angina, restenosis, number of diseased vessels, arrhythmias, left ventricular ejection fraction and age of patient. A step-down analysis was performed until only those variables with p < 0.05 were in the final model. The stent variable was kept in until the last step even if it was not significant. Late total and event-free survival analysis for all patients was performed using the Kaplan-Meier method, including: 1) freedom from death (total survival), 2) freedom from death and nonfatal MI (infarct-free survival), 3) freedom from death, nonfatal MI and CABG (infarct and CABG-free survival), and 4) freedom from death, nonfatal MI, CABG and target vessel revascularization (event-free survival). Event-free survival was also determined for subgroups of patients with and without stents. A p value <0.05 was considered statistically significant.
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Results
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Patient characteristics.
The study population included 1,062 patients with a mean age of 67 ± 8 years. Baseline demographic and clinical characteristics are described in Table 1. The mean age of the SVGs was 9.1 ± 5 years. Indications for revascularization included stable angina in 170 patients (16%), unstable or postinfarction angina in 828 patients (78%) and acute MI in 64 patients (6%). Of the patients, 16% had undergone previous PTCA at the site of the stenosis.
Procedure.
Percutaneous intervention was performed in 1,142 lesions, including stents in 478 lesions (42%), PTCA alone in 483 lesions (42%) and laser or atherectomy in 181 lesions (16%) (Table 2). An IABP was placed in 91 (9%) patients (Table 3).
Immediate results.
Cardiopulmonary resuscitation was performed during intervention in 10 (0.9%) patients; no-reflow phenomenon and life-threatening arrhythmias occurred in 90 (8%) and 67 (6%) patients, respectively (Table 3). Non–Q-wave MI occurred in 95 patients (9%). Other complications included stroke in 6 patients (0.6%), subacute occlusion in 8 patients (0.8%) and blood transfusion in 95 patients (9%) (Table 3). In-hospital MACE occurred in 13% of patients (Table 4). Univariate predictors of in-hospital MACE included restenotic lesion, unstable angina and CHF (Fig. 1). Late MACE occurred in 54% of the patients (Table 4). Univariate predictors included PVD, IABP placement and previous MI; multivariate predictors of late MACE included restenotic lesion, PVD, CHF and placement of multiple stents (Fig. 1, Table 5).
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Figure 1 Univariate predictors for (A) in-hospital and (B) late major adverse cardiac events (MACE). CHF = congestive heart failure; IABP = intra-aortic balloon pump; MI = myocardial infarction; PVD = peripheral vascular disease; USA = unstable angina.
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Long-term follow-up.
Clinical follow-up was available in 1,056 (99%) patients at 3 ± 1 year after intervention. Late MACE occurred in 565 patients (54%) (Table 4). Univariate and multivariate predictors of late MACE are shown in Figure 1 and Table 5. Event-free survival (freedom from death, nonfatal MI and revascularization) is shown in Figure 2. Within the first 200 days after the procedure, 65% of the late MACE occurred. The majority of these late events (36%) were repeat revascularization procedures including redo-CABG and percutaneous interventions. After the first 200 days, MI and death constituted the majority of late MACE.
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Figure 2 Total and event-free survival for patients after percutaneous revascularization of saphenous vein grafts. Solid diamond = death; solid square = death, MI; solid triangle = death, MI, repeat CABG; solid circle = death, MI, any target vessel revascularization. CABG = coronary artery bypass graft surgery; MI = myocardial infarction.
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A total of 422 patients (40%) underwent repeat angiography for recurrent angina at 3.6 ± 1.8 (range 1 to 9) months after initial intervention. Of these patients who underwent repeat angiography for clinical symptoms, 303 (72%) had angiographic evidence of either restenosis or presence of a new lesion in the target vessel. Restenosis or the presence of a new lesion occurred in 122 (29%) of SVGs treated with stents and 181 (43%) of those without a stent (p = 0.04). Of the remaining 119 (28%) of the patients, 25 (21%) had no new lesions, 56 (47%) had new lesions in other SVGs and 38 (32%) had new lesions in their native coronary arteries. There was no difference in event-free survival for patients treated with a stent compared with those without a stent (Figs. 3 and 4).
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Figure 3 Freedom from repeat target vessel revascularization (percutaneous and surgical revascularization) after saphenous vein graft intervention. Solid diamond = stent (n = 415); solid square = no stent (n = 614). p = 0.4.
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Figure 4 Freedom from death, myocardial infarction, percutaneous revascularization or redo-bypass surgery after saphenous vein graft intervention. Solid diamond = stent (n = 415); solid square = no stent (n = 614). p = 0.2.
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Discussion
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In this study, three-year event-free survival after percutaneous intervention in SVGs was 47%; there was no benefit in event-free survival for stent patients. The independent multivariate predictors of late MACE included PVD, restenotic lesion, CHF and placement of multiple stents, suggesting that late outcome is most dependent on the extent and progression of atherosclerosis and not the target lesion per se.
Percutaneous transluminal coronary angioplasty of SVGs is associated with angiographic restenosis rates as high as 68%, with a correspondingly high incidence of late cardiac events (8,13). Although newer interventional devices such as atherectomy and laser have been proposed as alternative techniques to PTCA, their use is frequently associated with angiographic complications, including distal embolization (10,12), no-reflow (11,14), perforation, abrupt closure (15,16) and a high incidence of MACE (17,18).
Progressive nature of vein graft disease.
The attrition rate in SVGs is dissimilar from native coronary arteries, continuing beyond six months. Most late events are attributed to the progression of coronary artery disease elsewhere, both in native arteries and SVGs, a process not prevented by stenting. Continued "attrition" despite stenting is supported by the findings in our study and is also supported by previously published data. For example, in the randomized Saphenous Vein De Novo trial (SAVED) (PTCA versus Palmaz-Schatz stent) (9) and WINS (Wallstent versus Palmaz-Schatz stent) (19) trials, 30% to 50% of late cardiac events (after one year) were due to death, MI or revascularization of sites other than the initial target lesion, which contrasts sharply with native vessel stenting in which 90% of late cardiac events are due to target lesion revascularization. Although newer stent designs are now available, they only modestly impact SVG interventions, mainly with respect to stent delivery. It is unlikely that stent type will alter long-term clinical outcome.
More than half (65%) of the MACE in our study occurred within the first 200 days, and the remaining events occurred incrementally over the subsequent 1,000 days. The majority of these early events were target vessel revascularization procedures and redo-CABG. The importance of the progression of SVG disease at untreated sites and the low event-free survival rate in patients without restenosis has been reported by others (20). Half of the clinical events after SVG interventions occur within the first 6 to 12 months, the majority being related to revascularization to treat progressive disease at different sites rather than late deterioration at the stent site itself (21). A recent study evaluating the predictors of clinical outcome in 106 patients after SVG interventions reported a 44% event-free survival rate and a 15% death rate at 18 months (22). They found that the presence of a high-grade lesion ( 50%) in the SVG detected by visual inspection in a patent nonstented graft was the strongest predictor of MACE. Even in the patients without restenosis, the event-free survival was only 29%.
Redo-CABG versus percutaneous intervention.
Patients undergoing redo-CABG have been reported to have increased in-hospital mortality, decreased long-term survival and significantly greater recurrent angina compared with those undergoing initial CABG (4,23). Percutaneous revascularization, on the other hand, has been associated with lower procedural morbidity and mortality but less complete revascularization and a greater need for repeat procedures compared with both initial and redo-CABG (5,23,24). After controlling for the major correlates of survival, one study showed that redo-CABG resulted in equivalent overall survival, event-free survival and relief of angina compared with percutaneous intervention (7). These studies indicate that, in patients who have undergone CABG, the principal determinant of survival is the extent and rate of progression of underlying coronary artery disease and that all modalities of revascularization are primarily palliative in nature (25). Our data is consistent with these findings in that stents, despite reducing restenosis and procedural morbidity in SVGs, do not improve event-free survival.
Recent advances in SVG interventions.
Although not yet published, results of the Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial (26) indicate an improvement in TIMI 3 flow, a decrease in no-reflow and a 50% to 60% reduction in 30-day MACE in patients undergoing vein graft stenting with the Guardwire (PercuSurge, Inc., Sunnyvale, California) (27). This device was not available during the course of our study and is presently not a standard of care during SVG interventions. It is uncertain as to whether its use will alter long-term outcome. Although several studies have demonstrated little or no impact on clinical end points with the use of the IIb/IIIa inhibitor abciximab, some report modest benefit in thrombus score (28–30). It is unclear as to whether the use of IIb/IIIa inhibitors are beneficial in decreasing in-hospital MACE (31); whether they will impact the long-term results of SVG interventions remains to be seen.
Study limitations.
This study has several important limitations: 1) it is a retrospective and nonrandomized observational study, 2) its results may be skewed by the procedural preferences and patient population seen at our institution, and 3) routine angiographic follow-up was not obtained; therefore, we cannot distinguish between target lesion revascularization and target vessel revascularization.
Conclusions.
This study shows that, despite the use of new interventional devices including stents, patients who undergo percutaneous revascularization procedures for SVG disease have significant morbidity and mortality within the first year. Although stent implantation was associated with less restenosis, it was not associated with better event-free survival. Progressive disease at nontreated sites in the SVG or in the native coronary arteries may be an important factor leading to cardiac events after stent implantation.
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Acknowledgments
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The authors thank Judith A. Boura, MS, for her statistical expertise.
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Footnotes
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1 Dr. Keeley is currently affiliated with the Division of Cardiology, UT Southwestern Medical Center, Dallas, Texas. 
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References
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J. H. Traverse, M. R. Mooney, W. R. Pedersen, J. D. Madison, T. F. Flavin, V. R. Kshettry, T. D. Henry, F. Eales, L. D. Joyce, and R. W. Emery
Clinical, Angiographic, and Interventional Follow-Up of Patients With Aortic-Saphenous Vein Graft Connectors
Circulation,
July 29, 2003;
108(4):
452 - 456.
[Abstract]
[Full Text]
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P.J. de Feyter
Percutaneous Treatment of Saphenous Vein Bypass Graft Obstructions: A Continuing Obstinate Problem
Circulation,
May 13, 2003;
107(18):
2284 - 2286.
[Full Text]
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How Common Are Adverse Events After SVG Interventions?
Journal Watch Cardiology,
November 30, 2001;
2001(1130):
9 - 9.
[Full Text]
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