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(Circulation. 1995;92:734-740.)
© 1995 American Heart Association, Inc.
Articles |
Predictors and Sequelae of Distal Embolization During Saphenous Vein Graft Intervention From the CAVEAT-II Trial
From the Department of Cardiology, the Cleveland Clinic Foundation, Cleveland, Ohio (J.L., E.J.T.); the Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn (D.R.H.); the Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (R.M.C., K.P., G.K.); and the Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich (R.D.S.).
Correspondence to Eric J. Topol, MD, Department of Cardiology, One Clinic Center, Cleveland Clinic Foundation, Cleveland, OH 44195.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background The purpose of this study was to identify the predictors and sequelae of distal embolization from a multicenter, randomized trial of saphenous vein graft intervention. The CAVEAT-II trial demonstrated that saphenous vein graft directional coronary atherectomy (DCA) was associated with greater angiographic success and less need for repeat intervention compared with percutaneous transluminal coronary angioplasty (PTCA) but at the cost of more acute complications—notably distal embolization.
Methods and Results In CAVEAT-II, 305 patients were randomly
assigned to DCA (149 patients) or PTCA (156 patients) for lesions with
>60% diameter stenosis in vein grafts 
3 mm in diameter.
Distal embolization occurred in 20 patients (13.4%) assigned to DCA
and 8 patients (5.1%) assigned to PTCA (P=.011).
Independent predictors of distal embolization were use of DCA (71% in
distal embolization patients versus 47% in patients without distal
embolization, P=.011) and presence of thrombus (39% in
distal embolization patients versus 14% in patients without distal
embolization, P<.00). In-hospital adverse events were more
frequent after distal embolization: 71% versus 20%, odds ratio plus
(95% confidence intervals) 9.87 (4.65, 20.94). At 12-month follow-up,
adverse event rates were also higher in patients with distal
embolization (odds ratio, 3.05 [1.95, 4.76]).
Conclusions In this first prospective multicenter trial of saphenous vein graft intervention, distal embolization was more common after DCA than PTCA and in lesions containing thrombus. It also was associated with worse in-hospital and 12-month outcomes. The risk and sequelae of distal embolization should be considered when choosing a treatment strategy for vein graft disease.
Key Words: embolism • angioplasty
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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The Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT)-II1 prospectively compared directional coronary atherectomy with percutaneous transluminal coronary angioplasty (PTCA) for discrete saphenous vein graft lesions. The study demonstrated that directional atherectomy resulted in greater initial angiographic improvement, better initial procedural success, and a trend toward a reduction in need for repeat intervention. Yet, as was also demonstrated in the CAVEAT-I trial evaluating the same two interventional modalities in native coronary artery disease,2 directional atherectomy was associated with a higher incidence of acute complications, principally distal embolization and periprocedural myocardial infarction.
Saphenous vein graft atherosclerosis is typically characterized by large friable and ulcerated plaques distributed throughout the length of the graft, with a propensity for thrombus formation. Together, these features make manipulation of the graft, either surgically or by percutaneous techniques, prone to distal embolization.3 4 However, the issue of the true incidence and sequelae of distal embolization is confused by differences in criteria used for its diagnosis.5 6 7 Furthermore, while several investigators have reported their experience with newer technologies including various atherectomy devices6 7 8 9 10 11 12 13 14 15 16 and stents11 17 18 19 20 21 for treatment of vein graft disease, these studies represent nonrandomized, retrospective, and observational series. To date, there are no data on direct, head-to-head comparisons of distal embolization risk for these different modalities, and there is a paucity of information regarding its long-term sequelae.
The aim of this study therefore was to identify from the CAVEAT-II trial the clinical and angiographic factors that were associated with the development of distal embolization and to determine the clinical consequences of this complication.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Study Design
The CAVEAT-II trial was conducted in 54 centers experienced in percutaneous intervention (52 in North America and 2 in Europe). Patients with a de novo target lesion in a vein graft were eligible for enrollment if they also had symptoms of ischemia or were asymptomatic with a positive functional study. The angiographic criteria included (1) vein graft caliber
3.0 mm, (2)
diameter stenosis >60% by visual assessment, and (3) lesion
length 
12 mm. If more than one lesion was present in the target
vein graft, all had to be amenable to either technique to conform with
single-treatment assignment. After informed consent was obtained,
patients were randomized to either conventional balloon angioplasty or
directional atherectomy. All patients received aspirin 160 mg and at
least one dose of a calcium channel antagonist before the
procedure. Coronary angioplasty or directional atherectomy was
performed according to techniques previously
described.22 23 Femoral access sheaths were removed 4
to
24 hours after completion of the procedure; ECG were obtained before
and within 24 hours of the procedure. Serial creatine kinase levels
with myocardial isoenzymes were measured every 8 hours after the
procedure for a total of three samples.
Assessment of Distal Embolization
The diagnosis of distal
embolization was based on the clinical
judgment of the individual investigators performing the procedures.
Each of these operators was required to be experienced in
interventional cardiology, having performed at least
400 coronary angioplasty procedures with 85% success rate
and more than 50 directional coronary atherectomy procedures
with 80% success in order to participate in the trial. Criteria for
diagnosis of distal embolization were provided in the investigators'
instruction manual sent to all participating sites. They included
angiographic cutoff of a distal branch or vessel at any point during
the procedure and/or decreased flow in a distal vessel that was
previously patent in the absence of an occlusion at the site of the
target lesion. Although all coronary angiograms were also
independently assessed by the Cleveland Clinic Foundation angiographic
core laboratory, distal embolization was not a prespecified
variable and was therefore not systematically looked for.
Accordingly, the site-determined definition of distal embolization was
used.
Outcomes
For in-hospital outcomes, a composite clinical
outcome was used
that included death, myocardial infarction, repeat intervention, or
emergency coronary artery bypass graft (CABG) surgery. The
diagnosis of myocardial infarction was based on the development of new
Q waves or creatine kinase myocardial isoenzyme elevation greater than
two times the upper limit of normal. Determination of myocardial
infarction was performed by an independent adjudication committee
blinded to treatment assignment.
The 12-month outcomes were assessed by a composite clinical end point defined as death, myocardial infarction, repeat target vessel intervention, or elective CABG surgery.
Statistical Analysis
Continuous variables are presented as
median (25th,
75th percentiles) and categorical variables as frequencies
(percentages). A 
2 test was used to establish the
univariable relation between treatment and distal embolization.
Because of the infrequency of distal embolization, a limited number of
variables were selected as potentially important descriptors.
Logistic regression modeling techniques were used to determine the
joint effect of these variables with distal embolization. The
importance of each of the final predictor variables is illustrated
using the adjusted odds ratios (95% confidence intervals). The
coefficients from the final logistic models were used to determine
these adjusted odds ratios.
Logistic regression was used to establish the univariable effect of distal embolization on each of the acute outcomes. The interaction of distal embolization with treatment was evaluated for each outcome. Estimates of the 12-month binary outcomes for patients with and without distal embolization were established using Kaplan-Meier survival estimates. The difference in these two rates was tested using a log-rank test. Cox proportional hazard modeling techniques were used to establish the estimates of the distal embolization versus no distal embolization rates for the PTCA and directional atherectomy groups by modeling treatment, distal embolization, and the interaction of the two.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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Baseline and Angiographic Characteristics
Three hundred five patients were enrolled into the study; 149 were randomized to directional atherectomy and 156 to PTCA. Distal embolization occurred in 28 patients (9.2%): 20 (13.4%) patients assigned to directional atherectomy and 8 patients (5.1%) in the PTCA group (P=.011). Baseline characteristics of the patients with and without distal embolization were similar between the two groups (Table 1
). For patients who experienced distal
embolization, there were no differences in baseline characteristics
between those who underwent directional atherectomy or PTCA. Baseline
characteristics were also similar between directional atherectomy and
PTCA patients who did not experience distal embolization.
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The
angiographic characteristics of the patients with and without
distal embolization are shown in Table 2. While median
graft age and target lesion location were similar in the two groups,
the median vessel diameter was larger in patients with distal
embolization (3.7 versus 3.4 mm, P=.04). Higher rates of
distal embolization were seen in patients with angiographic thrombus
present before treatment (11 [39%] of 28 patients with distal
embolization versus 39 [14%] of 277 patients without distal
embolization, P=.002). Patients with distal embolization
also had more complex lesions, defined as the presence of ulceration or
irregular borders (12 patients [43%] with distal embolization versus
74 patients [27%] without distal embolization,
P=.081).
Treatment crossover from directional atherectomy to PTCA or PTCA to
directional atherectomy occurred in 8 patients (29%) with distal
embolization and 41 patients (15%) without distal embolization
(P=.07).
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Predictors of Distal Embolization
Clinical and angiographic
variables used to predict distal
embolization included treatment assignment, patient age, sex, presence
of unstable angina, graft age, vessel size, lesion length, lesion
complexity, and lesion thrombus. Multivariable logistic
modeling demonstrated that the use of directional atherectomy (odds
ratio [OR] plus [95% confidence intervals], 2.87
[1.26, 6.54])
and the presence of thrombus (OR, 3.95 [1.80, 8.66]) were
independently associated with distal embolization. The other
variables tested were not independently predictive of
embolization.
In-Hospital Outcomes
Twenty (71%) of 28 patients with distal
embolization had an
adverse clinical outcome during their hospital stay compared with 56
(20%) of 277 patients without distal embolization (P<.001)
(Table 3). The incidences of death and myocardial
infarction were higher after distal embolization (2 patients [7%]
with distal embolization versus 4 patients [1%] without distal
embolization, P=.096, and 19 patients [68%] with
distal
embolization versus 46 patients [17%] without distal embolization,
P<.001, respectively). The need for repeat intervention or
emergency CABG was similar in the two groups. For patients with
myocardial infarction after distal embolization, 2 of the 5 myocardial
infarctions in the PTCA group were Q wave, while 13 of the 14
myocardial infarctions in the directional atherectomy group were non–Q
wave. Odds ratios for adverse clinical outcomes after distal
embolization are shown in Fig 1. Using the composite
clinical end point of death, myocardial infarction, repeat
intervention, or emergency CABG, distal embolization was associated
with an almost 10-fold increase in risk of an adverse acute outcome.
The median length of hospitalization was also increased from 2 days to
5 days in patients with distal embolization (P<.001).
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12-Month Outcomes
One-year follow-up was obtained in 284 of
305 patients (93%). At
12 months, the death rates and need for repeat intervention or CABG
were similar between the two groups. However, distal embolization was
associated with a higher 1-year incidence of myocardial infarction (OR,
4.39 [2.61, 7.38]). The odds ratio for an adverse clinical outcome
based on the composite end point of death, myocardial infarction,
repeat percutaneous intervention, or elective CABG
after distal embolization was 3.05 (1.95, 4.76) (Fig 2).
Fig 3 shows the Kaplan-Meier plot of freedom from the
composite end point.
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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This analysis of the CAVEAT-II trial confirms that intervention in old vein grafts (mean age, 10 years) is associated with an approximate 10% risk of distal embolization. It also demonstrated that there was a greater than twofold increase in distal embolization with directional atherectomy compared with PTCA. Distal embolization was associated with worse acute and 12-month clinical outcomes, with more than two thirds of the patients experiencing an adverse event during their hospital stay. Length of hospitalization was also prolonged by approximately 3 days. At 12 months, only 17% of patients with distal embolization had not experienced an adverse clinical event (death, myocardial infarction, or repeat revascularization) compared with almost 50% of patients without distal embolization. The use of directional atherectomy and the presence of thrombus within the graft were identified as independent predictors of distal embolization risk overall.
The higher rate of distal embolization with directional atherectomy appears to be a principal factor limiting the potential efficacy of this technique for vein graft intervention. The distinct pathological changes within saphenous vein grafts probably account for these higher embolization rates, with plaque distribution tending to be more diffuse and superficial, often very friable, and with an element of overlying thrombus.24 25 26 27 28 29 30 31 The passage of the large, bulky atherectomy device appears to further aggravate this predilection for embolization.
It is noteworthy that while overall myocardial infarction rates after distal embolization were similar in the two groups, two of the five myocardial infarctions after PTCA were Q wave, while 13 of the 14 myocardial infarctions in the directional atherectomy group were non–Q wave. This propensity for significant serum creatine kinase elevations after directional atherectomy was found in the CAVEAT-I trial2 and has subsequently been confirmed in preliminary results from more recent trials of directional atherectomy.32 33 Although some authors have suggested that isolated creatine kinase elevations, especially if less than five times the upper limit of normal, have no long-term sequelae,34 35 36 our data showed a 4.7% in-hospital death rate and 50% incidence of an adverse clinical outcome at 1 year in the 54 patients with non–Q-wave myocardial infarction. Higher non–Q-wave myocardial infarction rates (15.2% directional atherectomy versus 5.5% PTCA) were also found in 199 directional atherectomy patients in the Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC) trial.37 However, treatment with bolus plus infusion of chimeric 7E3 Fab, a platelet glycoprotein IIb/IIIa receptor antagonist, decreased the non–Q-wave myocardial infarction rate to 4.5% in the directional atherectomy patients. This suggests that the etiology of directional atherectomy–related non–Q-wave myocardial infarction may in fact be platelet-mediated and that potent platelet antagonism can substantially ameliorate the myocardial infarction risk associated with directional atherectomy and saphenous vein graft intervention in general.38
Predictive Factors
Although directional atherectomy was
associated with higher acute
complication rates in CAVEAT-II overall, there was a trend toward less
myocardial infarction and lower CABG surgery rates in those directional
atherectomy patients without distal embolization compared with the PTCA
group as a whole. This, together with the principal findings of the
CAVEAT-II trial, suggests that directional atherectomy may be a useful
therapeutic strategy if patients at high risk of distal embolization
could be identified and excluded. We demonstrated that the presence of
angiographically definable thrombus in the target vessel was strongly
associated with distal embolization. The lack of a fibrous cap to vein
graft atheromatous plaque, absence of side branches,
and relatively low flow velocities have all been put forward as factors
contributing to the formation of thrombus within vein
grafts.30 Other studies have also found graft
age,30 39 40 41 42
indices of plaque burden,5 and
diffuseness of disease5 39 to be predictors of distal
embolization.
Comparison With Previous Experience
Several other
investigators have reported their experience with
directional atherectomy in saphenous vein grafts (Table 4). In
the series by Cowley and colleagues6
of 318 directional atherectomy procedures, the distal embolization rate
was 7.2%, while initial success rates and incidence of death and
bypass surgery were quite similar to CAVEAT-II. Other reports have
found that vein graft atherectomy was associated with a low incidence
of major complications (0% to 4%), myocardial infarction and
embolization rates similar to PTCA for vein grafts, and inconclusive
trends for prediction of significant
complications6 10 11
(Table 4). However, the data from these earlier series may have
been
influenced by case-selection bias, and they contrast starkly with the
findings from CAVEAT-II, which was the first trial to use a
prospective, randomized design to evaluate percutaneous
saphenous vein graft intervention. Furthermore, although a number of
studies have reported lower incidences of myocardial infarction after
directional atherectomy than
CAVEAT-II,6 10 11 this may in
fact represent underreporting of non–Q-wave myocardial
infarction by individual investigating sites. As found in CAVEAT-I,
only half of the infarctions detected by the core laboratory were
identified by individual sites2 ; this highlights the
importance of independent adjudication of key study end points in
multicenter trials.
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Alternative Strategies
There is now a mounting experience
with alternative
percutaneous techniques for vein graft disease (Table 4
).
Stenting of graft lesions not only provides the potential
advantages of reliable large lumen attainment, reduction in turbulent
flow, and resistance to elastic recoil but also offers a specific
mechanism to reduce distal embolization by entrapment of friable
atheroma. Leon and colleagues20 reported a
97% procedural success rate for the Palmaz-Schatz stent in saphenous
vein graft lesions in a multicenter observational study of 589
patients. The incidence of major complications was 3%, and distal
embolization occurred in only 1.5%. Incidences of distal embolization
ranging from 0% to 3% have been reported in a number of other
series.17 43 44 Despite these encouraging
results, vein
graft stenting still carries an appreciable risk of stent thrombosis
and anticoagulation-related
bleeding17 18 19 20 21
as well as the
problem of restenosis. Piana and colleagues21
further demonstrated that even with low restenosis rates
(17%), the long-term results of stenting old grafts (mean age, 8.7
years) were sobering, with 49% of patients requiring
revascularization within 2 years, mainly as a
result of progression of disease at other sites.
Transluminal
extraction coronary atherectomy (TEC) has been
used in stenosed vein
grafts,7 12 14 45 46
particularly
because of its ability to cut and aspirate clot and
atheromatous material, thus theoretically minimizing
the risk of distal embolization. However, Safian and
colleagues7 found in their series of 146 patients that TEC
resulted in frequent acute complications and high
restenosis rates. Distal embolization occurred in 11.9%,
although the authors point out that one quarter of these were due to
air embolism, which may have resulted from improper technique. Hong and
colleagues46 found a 12.8% rate of distal embolization in
86 consecutive cases, which was associated with a greater number of
major in-hospital complications. The overall application of this
technique appears to be limited to selected cases that are still likely
to require adjunctive angioplasty.7 46 Laser vein
graft
angioplasty also has been
reported,15 16 47 and although
distal embolization rates appear to be lower than for directional
atherectomy or TEC (Table
46 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 39 42 46 49 50 51 52 53 54 55 ),
a recent
report on the acute complications associated with excimer laser
angioplasty found a sixfold increase in distal embolization during vein
graft laser angioplasty and recommended a cautious approach,
particularly with friable lesions.48
Limitations
This study has a number of limitations that
should be kept in
mind. The definition of distal embolization used in this study included
patients with reduced distal flow in the graft after the procedure.
This is a relatively nonspecific marker and could have led to the
inclusion of cases that could have otherwise been labeled "no
reflow" or classified as microvascular spasm. However, while the
pathogenesis of these events remains uncertain, they may have been due
to distal microembolization. Furthermore, investigators have used
varying definitions of distal
embolization,5 6 7 leaving the
issue of the most appropriate definition confusing and uncertain. The
choice of angiographic cutoff of a distal vessel or reduced flow in an
otherwise patent graft in this study is representative
of other investigators' definitions and can be justified on
pathological grounds.
Second, the inclusion criteria for this study stipulated that lesions were to be discrete and in vein grafts not diffusely diseased. Despite this, the average age of the grafts was 9.6 years for directional atherectomy patients and 9.9 years in the PTCA group. Thus, this study may in fact represent a distinct population of grafts that are old but not diffusely diseased, making extrapolation of its results to younger grafts or those with diffuse disease uncertain.
While the diagnosis of myocardial infarction was performed by an independent adjudication committee blinded to treatment assignment, the occurrence of distal embolization was determined by the individual site investigators, introducing a potential source of bias. Although all coronary angiograms in CAVEAT-II were reviewed by a core angiographic laboratory, distal embolization was not one of the prespecified angiographic variables and was therefore not systematically looked for. It was also considered that individual sites were in a better position to identify more subtle instances of distal embolization such as transient distal vessel cutoff or reduced flow that coincided with device manipulation within the graft, which may have otherwise gone undetected by the core angiographic laboratory.
Conclusions
With increasing numbers of CABG operations being
performed, the
need for effective treatment for vein graft disease will continue to
expand. Reoperation is technically difficult and associated with
increased morbidity and mortality. Yet old vein grafts are especially
challenging for conventional balloon angioplasty, being limited by high
restenosis and reocclusion rates. The overall results of
the CAVEAT-II trial demonstrated that directional atherectomy has a
modest advantage over PTCA. However, this was at the price of increased
acute complications—notably distal embolization, which in turn was
associated with worse in-hospital outcomes, prolonged hospital stays,
and more clinical ischemic events in the ensuing 12 months.
Although identification of factors predictive of distal embolization
such as the presence of thrombus may help exclude patients at high
risk, future improvements such as ultrasound-guided directional
atherectomy, coated stents, and potent adjunctive antithrombotic and
antiplatelet therapy may offer further refinements to
percutaneous interventional techniques. While
approaches may differ, the search for the optimal therapy continues, as
effective treatment of vein graft atherosclerosis is
and will continue to be a paramount challenge for
cardiovascular medicine.
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Acknowledgments |
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The authors wish to thank Nicole Gershov for her helpful comments and expert assistance with the preparation of the manuscript.
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Footnotes |
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1 A list of CAVEAT-II participating investigators and centers is published in Circulation (1995;91:1966-1974).
Received December 19, 1994; revision received February 19, 1995; accepted February 28, 1995.
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