(Circulation. 1995;91:1966-1974.)
© 1995 American Heart Association, Inc.
Articles |
A Multicenter, Randomized Trial of Coronary Angioplasty Versus Directional Atherectomy for Patients With Saphenous Vein Bypass Graft Lesions
From the Mayo Foundation, Rochester, Minn (D.R.H., P.B.B.); the Cleveland (Ohio) Clinic Foundation (E.J.T., P.L.W., S.G.E.); Duke University Medical Center, Durham, NC (R.M.C., L.G.B., K.L.L., G.P.K.); Loyola Medical Center, Chicago, Ill (F.L.); William Beaumont–Royal Oak Hospital, Royal Oak, Mich (R.S.); the University of Louisville, Ky (J.D.T.); Maine Medical Center, Portland (M.A.K.); Maimonides Medical Center, Brooklyn, NY (J.S.); Graduate Hospital, Philadelphia, Pa (R.S.G.); Toronto (Ontario) General Hospital (A.G.A.); and St Vincent's Hospital, Indianapolis, Ind (C.A.P.).
Correspondence to David R. Holmes, Jr, MD, Director, Cardiac Care Unit, Mayo Clinic, 200 First St SW, Rochester, MN 55905.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background Directional coronary atherectomy and percutaneous transluminal coronary angioplasty have both been used in symptomatic patients with coronary saphenous vein bypass graft stenoses. The relative merits of plaque excision and removal versus balloon dilatation remain uncertain. We compared outcomes after directional coronary atherectomy or angioplasty in patients with de novo bypass graft stenoses.
Methods and Results Fifty-four North American and European sites randomized 305 patients with de novo vein graft lesions to atherectomy (n=149) or angioplasty (n=156). Quantitative coronary angiography at a core laboratory assessed initial and 6-month results. Initial angiographic success was greater with atherectomy (89.2% versus 79.0%), as was initial luminal gain (1.45 versus 1.12 mm, P<.001). Distal embolization was increased with atherectomy (P=.012), and a trend was shown toward more non–Q-wave myocardial infarction (P=.09). Although the 6-month net minimum luminal diameter gain was 0.68 mm for atherectomy and 0.50 mm for angioplasty, the restenosis rates were similar, 45.6% for atherectomy and 50.5% for angioplasty (P=.491). At 6 months, there was a trend toward decreased repeated target-vessel interventions for atherectomy (P=.092); in addition, 13.2% of patients treated with atherectomy versus 22.4% of the angioplasty patients (P=.041) required repeated percutaneous intervention of the initial target lesion.
Conclusions Atherectomy of de novo vein graft lesions was associated with improved initial angiographic success and luminal diameter but also with increased distal embolization. There was no difference in 6-month restenosis rates, although primary atherectomy patients tended to require fewer target-vessel revascularization procedures.
Key Words: angioplasty • revascularization
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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Treatment of patients with coronary artery bypass graft stenoses constitutes an increasingly large part of the practice of interventional cardiology.1 2 3 4 5 6 7 8 Percutaneous transluminal coronary angioplasty (PTCA) has been relatively widely used, but the clinical outcomes have varied, depending on the age of the graft, the location of the stenosis within the graft, and the specific anatomic features.1 2 3 4 5 6 9 10 Restenosis rates in grafted vessels are markedly higher than those in native vessels, particularly in older grafts (>3 years old) and in stenoses involving the aortic ostium or graft body. In addition to restenosis, embolization of atheromatous or thrombotic material during the procedure has been reported in up to 5% of patients.
Directional coronary atherectomy (DCA) has also been used to treat these patients.7 8 11 12 13 14 15 16 In the initial Devices for Vascular Intervention (DVI) Registry (Redwood City, Calif), 17% of procedures involved saphenous vein bypass grafts. Observational studies of DCA have reported restenosis rates of approximately 40% for de novo vein graft lesions.7 13 15 A decrease in restenosis rates could theoretically be achieved by debulking the lesion rather than through dilatation alone. The hypothesis of this randomized, multicenter trial was that atherectomy would result in lower restenosis rates than conventional angioplasty in patients with de novo vein graft stenoses.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Study Sites and Operators
Fifty-four experienced centers enrolled patients (52 in North America and 2 in Europe; see the Appendix). These centers and investigators were selected because they had experience with both coronary atherectomy and angioplasty and had a background of clinical investigation in interventional cardiology.17 To qualify as investigators, individual operators had to have performed more than 400 angioplasty procedures with a success rate exceeding 85% and more than 50 DCA procedures with a success rate exceeding 80%. At each site, the Institutional Review Board approved the protocol.
Patient Selection
Patients with prior coronary bypass surgery
and de novo vein
graft lesions who required revascularization and were suitable for
either DCA or PTCA were considered for enrollment. The angiographic
inclusion criteria were (1) de novo vein graft lesion; (2) vein graft
suitable for 
6F atherectomy catheter (3.0 mm); (3) a subtotal
diameter stenosis 60% and <100% by visual assessment; and (4)
lesion length 
12 mm. If more than one lesion was present in the
vein graft, all had to be amenable to either technique to conform with
a single treatment assignment. Patients who had had a myocardial
infarction within the previous 5 days were excluded. A log of each
atherectomy performed on a vein graft outside of CAVEAT-II was
maintained at each site (Table 1
). The reasons for not
including patients in CAVEAT-II varied, although the most common reason
was investigator preference, which occurred in only 36% of the
patients. Participation in another investigational study and repeated
treatment of lesions were the reasons for exclusion in 10% and 19% of
the patients, respectively.
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Randomization
The coordinating center was Duke University in
Durham, NC. After
informed consent was obtained, the randomization center was contacted
by telephone for treatment assignment.
Revascularization Procedures
Procedural technical details
were published previously for
atherectomy and PTCA.17 18 19 Although
technical success was
defined conventionally as achieving 50% stenosis, the goal of
revascularization was to achieve an angiographic result of the minimum
possible residual stenosis (<20% residual stenosis). Crossover to the
other treatment modality was strongly discouraged, but predilatation
with a 2.0-mm balloon was permitted before atherectomy. The operators
prospectively identified patients in whom predilatation would be
needed; this was not considered crossover.
Aspirin (160 mg) and at
least one dose of a calcium channel blocker
were administered within 24 hours before the procedure. Activated
clotting times were maintained at >350 seconds during the procedure by
administering a 10 000-U bolus of heparin; supplemental boluses were
given, depending on the size of the patient and the length of the
procedure. Femoral access sheaths were removed 4 to 24 hours after the
procedure was completed. After the procedure, aspirin (325 mg q.d.) and
a calcium channel blocker were given for approximately 1 month.
Warfarin was not routinely administered. ECGs were obtained before and
within 24 hours after the procedure. Creatine kinase levels with
myocardial isoenzymes (MB) were obtained 12 and 24 hours after the
procedure.
Angiography
At the beginning of each procedure, after a dose
of 100 to 200
mcg of intracoronary nitroglycerin, coronary angiography was obtained
of the target graft in two orthogonal views with a 7F or an 8F
diagnostic coronary arterial catheter. These views were repeated at the
end of the procedure, again with a 7F or an 8F catheter. This procedure
was repeated for the 6-month follow-up angiogram.
The Cleveland Clinic Foundation Angiographic Core Laboratory performed independent, blinded assessment by use of quantitative coronary angiography (QCA) (Image Com). Paired acute and follow-up angiograms were measured by technicians blinded to treatment assignment; the device-containing images were spliced out. The most severe hemiaxial end-diastolic view without foreshortening was used for analysis, although both orthogonal views were analyzed. Preprocedure films were analyzed for extent of coronary artery disease, number of lesions, and lesion complexity and morphology. Each lesion was assessed in all films for vessel caliber, absolute minimum diameter, percent diameter stenosis, and percent stenosis by cross-sectional area.
Quantitative analysis was performed with the use of a validated edge-detection algorithm.20 Vessel edges were determined with the computerized algorithm, and luminal diameters were measured with the empty and contrast-filled catheters as references.
The long-term interobserver variability of the Angiographic Core Laboratory was determined by analyzing 15 cineangiograms on two occasions 8 months apart. Each reviewer independently selected projection angle and frame selection. Standard errors (and correlation coefficient, r) of the measurements for reference diameter and minimum luminal diameter values were 0.25 (.89) and 0.18 (.81) preintervention and 0.23 (.91) and 0.16 (.97) postintervention.
Core Pathology Laboratory
St Elizabeth's Hospital
(Boston, Mass) served as the core
pathology laboratory. Tissue specimens from atherectomy were
immediately placed in 4% paraformaldehyde/PB5 for 2 hours, stored at
4°C in 30% sucrose/phosphate-buffered saline, and sent to the core
laboratory for light microscopy and immunohistochemistry.
End Points
Acute end points included procedural success
(50% diameter
stenosis by QCA), major complications, a composite index of
complications (death, myocardial infarction, emergency bypass, or
abrupt-closure syndrome), abrupt closure, hospital charges, quality of
life, and length of hospital stay. The diagnosis of myocardial
infarction by each site was defined as creatine kinase MB greater than
twice the upper limit of normal. Q-wave changes were recorded. Abrupt
closure was defined by the site as angiographically documented
Thrombolysis in Myocardial Infarction (TIMI) grade 0 or 1 flow
with 100% stenosis and clinical or ECG evidence of ischemia lasting
>5 minutes. Distal embolization was defined according to the clinical
judgment of the individual investigators and included decreased flow in
a previously patent vessel distal to the target lesion in the absence
of an occlusion at the treatment site.
End points assessed during follow-up included restenosis (by absolute luminal diameter), major late clinical events (death, myocardial infarction, and coronary bypass surgery), functional capacity, and exercise time. Other follow-up events included angina pectoris; need for repeated intervention; and a composite index of death, myocardial infarction, coronary bypass graft surgery, and repeated intervention.
Determination of Sample Size
The sample size calculation was
based on the assumption that the
restenosis rate after angioplasty would be approximately 60% compared
with approximately 40% after
atherectomy.1 2 3 10 13
It was
assumed that 15% of patients would have an unsuccessful procedure or
crossover, and 15% would not return for angiographic follow-up. Given
these assumptions and using an 
of .05 and 80% power, we estimated
that 300 patients would be required.
Data Management and Statistical Analysis
The research
coordinator and investigators prospectively
entered the data on a case report form at each site.17
These case report forms were forwarded to the coordinating center and
verified by range and consistency checks. Cardiology nurse monitors
audited all case report forms. Continuous data are presented as
median (25th, 75th percentiles); to test for a difference between
treatment groups, we used the Wilcoxon rank-sum test.21
Categorical data are presented as frequency (percentage); we used
the 
2 test or Fisher's Exact Test when comparing
treatment groups. Kaplan-Meier survival methods were used to determine
the 6-month event rates for clinical outcomes. The event rates were
compared between treatment groups using the log-rank test, which
incorporated data from a follow-up window that extended through 240
days after enrollment.
Patients with missing data for a given variable were excluded from the calculation of the percentage of patients having that characteristic. This prevented the addition of bias that would result from assuming that patients with missing data were negative for that characteristic.
Relation With Sponsors
The Steering Committee set standards
for protocol design and
execution that were independent of the sponsors (DVI and Eli Lilly
Inc). No member of the Steering Committee or coordinating center was
permitted to have any financial equity position with either sponsor.
All data were managed at the Duke University Coordinating Center, and
no data were accessible to the investigators or sponsors until all
6-month follow-up angiographic data had been analyzed.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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From March 12, 1992, to April 16, 1993, 305 patients were randomized: 149 to DCA and 156 to PTCA (Table 2
). The
majority of patients had unstable angina. Comorbid conditions were
frequent; they were seen in 36.9% of the DCA patients and 27.6% of
PTCA patients. Rates of infarction within 14 days, congestive heart
failure, and cerebrovascular disease were similar in both groups,
although peripheral vascular disease occurred more frequently in the
DCA group (26.2% versus 15.4%). The grafts being treated were old:
9.5 years old for DCA and 9.9 years old for PTCA (Table 3).
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The distributions of vein graft locations and locations of the stenoses within the grafts were similar between the two groups; grafts with single distal insertion sites were most commonly treated. In the DCA patients, a vein graft to the circumflex was most common, while in the PTCA group, an equal number of left anterior descending and circumflex coronary grafts were treated. Typically, the lesion was within the body of the graft (81.9% for DCA; 89.1% for PTCA); only a minority of patients had aorto-ostial lesions treated (14.8% and 9.0% for DCA and PTCA, respectively). As per the protocol, the initial TIMI grade flow of 2 or 3 was predominant in each group (89.5% for DCA; 92.7% for PTCA). A small percentage of patients had decreased flow at baseline.
There was no difference in lesion length between the DCA (10.9
mm) and PTCA (11.0 mm) groups. Adverse specific lesion morphology was
common and similar in the two groups (Table 4). Lesion
eccentricity was the most common morphology (54.1% for DCA; 58.4% for
PTCA). An irregular contour or thrombus often was present.
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Procedure Performance
The initial success rates varied,
depending on whether
success was determined by the clinical center or the core angiographic
laboratory (Table 5). Success was not different in the
two groups when site assessment was considered (98.0% for DCA; 97.4%
for PTCA). With blinded core laboratory assessment, the success rate
was significantly higher for DCA at 89.2% versus 79.0% for PTCA. With
QCA, the initial minimum luminal diameter was 0.92 mm for DCA and 1.03
mm for PTCA, and the corresponding diameter stenoses were 73.7% and
71.7% (Table 7). The initial gain achieved by treatment was
significantly greater after DCA (1.45 versus 1.12 mm for PTCA,
P<.001), so the postprocedure diameter stenosis was also
less (31.5% versus 37.6% for PTCA, P<.001).
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Predilatation
was common in the DCA patients (Table 5
). Other
adjunctive devices were also used more frequently in these patients:
28.2% versus 14.1% of PTCA patients (P=.003). Patients
undergoing DCA also required more radiographic contrast (225 versus 175
mL for DCA and PTCA, respectively) and had longer procedure times.
Complications
The in-hospital rates for most major
complications were similar in
the two treatment groups (Table 6). Mortality was low
(2.0% for DCA; 1.9% for PTCA), as was the need for coronary bypass
graft surgery. The most important differences were in the rate of acute
myocardial infarction and distal embolization. The incidence of Q-wave
myocardial infarction was low in each group (1.3% for atherectomy;
1.9% for PTCA). There was a trend toward more non–Q-wave myocardial
infarction after DCA (16.1%) than after PTCA (9.6%,
P=.09). This usually happened in association with distal
embolization, which occurred significantly more often with DCA
(P=.012). However, abrupt closure of the treated segments
was low in both treatment arms. With the composite adverse end point,
there was a trend for a higher rate in the DCA group, mainly because of
the excess non–Q-wave myocardial infarctions (P=.059)
(Table 6).
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Follow-up
The rate of angiographic follow-up for the entire
cohort was 80%
after a median of 5.9 months (Table 7). The primary end
point of angiographic restenosis, >50% stenosis after an initially
successful procedure, occurred less often with DCA (43.2% versus
52.1% using site readings and 45.6% versus 50.5% using QCA
readings); however, the difference was not significant.
With continuous QCA data, the initial gain with atherectomy was greater: 1.45 versus 1.12 mm with PTCA. At follow-up, the late loss was also somewhat greater (0.62 versus 0.53 mm). At 6 months, the net gain with DCA was still greater (0.68 versus 0.50 mm), but this was not significant (P=.066) and the variability was high.
Figs
1 and 2 show the distribution of
lesions. The initial minimum luminal diameter achieved with DCA was
significantly larger. By the time of the follow-up angiogram, the
minimum lumen diameter with DCA remained larger, but it was no longer
significant. The distribution of follow-up stenoses showed that the
most common follow-up diameter stenosis for directional coronary
atherectomy was 30% to 40%, while with PTCA it was 40% to 50% (Fig
2). Again, this was not significantly different
(P=.10).
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Clinical follow-up data were available for 300
patients (98%) during a
median follow-up of 6.2 months (Table 8). Six-month
survival was 95.3% for DCA and 92.3% for PTCA (P=.411).
Q-wave infarction was rare in both groups (2.7% for DCA; 4.0% for
PTCA), as was the development of stroke. Survival without repeated
coronary bypass graft surgery was also excellent: 94.5% and 95.3% for
DCA and PTCA, respectively. The survival rate without repeated
percutaneous target-vessel intervention was 86.8% for DCA patients
versus 77.6% for PTCA patients (P=.041).
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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This randomized trial of DCA versus PTCA documented that DCA resulted in a higher angiographic success rate and larger initial improvement in graft dimensions for de novo vein graft lesions. Given the large number of patients who have undergone coronary bypass graft surgery with venous conduits and the well-documented continuous rate of attrition in these grafts, treating these patients will continue to be a significant clinical problem.22 23 The underlying pathophysiology in these patients is complex, with degenerated atheromatous lesions and often superimposed thrombus.24 25 26 27 28 29 The results of dilatation depend in part on the age of the graft, the discrete (versus diffuse) nature of the lesion, and the location of the stenosis in the graft. Treatment of older grafts, >3 to 5 years old, and stenosis of the aortic origin or in the body of the graft have been associated with markedly increased restenosis rates.1 2 5 9 10
DCA has been used relatively frequently in venous conduits because of their lack of side branches, their usually straight and nontortuous course, and their large size. In the initial DVI Registry, 17% of cases involved treatment of vein grafts.8 Restenosis rates in these and other series have varied, while embolization has been relatively low.7 8 12 13 14 15 16 30
Although both continuous and discrete dichotomous criteria were used to define restenosis, the latter was chosen as the primary end point using a definition of >50% diameter stenosis at follow-up. Restenosis defined in this manner occurred in a similar proportion of patients who received DCA (45.6%) or PTCA (50.5%, P=.491). This rate of restenosis after DCA is similar to that previously reported by Garratt et al,13 who found a restenosis rate of 42% in patients treated for de novo vein graft lesions in whom there was no deep vessel wall resection. It is lower than other series have documented.31 An equally important finding was that the restenosis rate in these 9.7-year-old vein grafts after PTCA was considerably lower (50%) than that previously recorded.2 10 This contrasts with published series of dilatation in old bypass graft stenoses, which document a restenosis rate of >60% to 70%. Platko et al2 reported a restenosis rate of 83% in patients with vein grafts >3 years old, while Douglas et al10 found a restenosis rate of 64% in patients with vein grafts >5 years of age. These previous studies did not have complete angiographic follow-up, however, so selection bias may explain the differences—more patients with symptomatic restenosis returned for follow-up angiography. Regardless of these considerations, PTCA still resulted in very reasonable intermediate-term outcomes in these patients.
Restenosis was also assessed with continuous QCA criteria. Although the initial gain with DCA was significantly greater, the loss was also somewhat greater. The overall net gain at the end of 6 months did remain larger with DCA (0.68 versus 0.50 mm), but not significantly so (P=.066). The relation between acute gain and late loss has been the subject of intense study.17 18 32 33 34 A critical determinant of subsequent restenosis is the minimum luminal diameter achieved17 32 33 ; new devices may decrease angiographic restenosis by yielding significantly better initial results. The inevitable neointimal hyperplasia is then better tolerated and may not result in clinical restenosis. It is possible that the lack of decreased restenosis with DCA in this trial is related to the fact that a residual diameter stenosis of 31.5% remained.
Although the primary end point of this study was angiographic restenosis, important secondary end points were also assessed. As was true in CAVEAT-I17 and CCAT,18 DCA resulted in improved initial success rates and a larger median initial lumen. In DCA-treated patients in this series, the initial success rate was 89.2% versus 79.0% for PTCA patients, findings very similar to the success rates in CAVEAT-I. The median initial luminal gain was substantially larger: 1.45 mm for DCA versus 1.12 mm for PTCA. There were no differences in in-hospital mortality, need for coronary bypass graft surgery, and Q-wave myocardial infarction, but there was a trend toward increased non–Q-wave myocardial infarction in DCA patients and a significant increase in distal embolization (P=.012).
Follow-up Events
In CAVEAT-I, there was a moderate decrease
in restenosis rates
with DCA, but there was no difference in follow-up clinical events or
need for repeated intervention.17 In the CCAT trial, there
were no differences with respect to repeated
intervention.18 In CAVEAT-II, although the 6-month
cumulative mortality and Q-wave myocardial infarction rates were
similar, there was a trend toward a decreased need for repeated
target-vessel intervention or coronary artery bypass graft: 18.6% of
DCA patients required repeated target-vessel revascularization versus
26.2% of PTCA patients. The need for any later intervention was also
decreased in DCA patients, although the difference was smaller (24.8%
versus 31.5% for DCA and PTCA, respectively). There are limited other
well-controlled data on follow-up of patients treated for vein graft
disease. It is known, however, that vein graft disease is progressive.
Longer-term follow-up of these randomized patients in CAVEAT-II will be
required to ascertain how long the modestly improved outcome with DCA
lasts. It is also possible that this difference in favor of DCA could
have resulted partly from the higher rate of distal embolization and
non–Q-wave myocardial infarction in this group, leaving patients with
a lower likelihood of undergoing symptom-driven repeated
interventions.
Other interventional approaches are also being tested in patients with focal vein graft disease, particularly stents.20 35 36 37 There is substantial enthusiasm because of the large initial minimum luminal diameter that can be achieved. The long-term results have not been subjected to a well-controlled trial, although one is now being planned. In a retrospective comparative assessment of a small group of patients, Pomerantz et al30 found no difference in restenosis rates between DCA and one specific stent configuration.
Limitations
Some limitations should be kept in mind in the
interpretation of
this study. The first and perhaps most important is that the number of
patients was relatively small. The estimated sample size was based on
published rates of restenosis of de novo vein graft lesions treated
with DCA and PTCA. While the restenosis rate for atherectomy was
similar to what had been published, the PTCA restenosis rate was
substantially better than expected for these 9.9-year-old grafts.
Whether this better-than-expected outcome with PTCA related to patient
selection, dilatation performance, or bias in the previous literature
cannot be determined. If larger numbers of patients had been
randomized, the differences between the two treatment arms might have
been more striking. The second limitation relates to the fact that even
in the group with the better postprocedure result (DCA), the diameter
stenosis was 31.5%. More aggressive DCA or post-DCA dilatation might
have resulted in better immediate postprocedure results and improved
outcome, although this is controversial.
Conclusions
In this randomized trial, DCA resulted in a
higher initial
angiographic success rate and a larger initial improvement in graft
dimensions than conventional PTCA with the use of QCA techniques.
Achievement of this improved success rate was at least partially offset
by the moderate initial increase in distal embolization and non–Q-wave
myocardial infarction, which are probably the results of passage of the
large atherectomy device and active debulking and manipulation of the
lesion. There was a trend toward decreased performance of repeated
target-vessel intervention at 6 months in patients treated with DCA,
but there was no difference in angiographic restenosis rates. Overall,
our findings suggest that both forms of revascularization are viable
strategies for this complex patient group.
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Acknowledgments |
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This study was supported by grants from DVI and Eli Lilly, Inc.
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Footnotes |
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A complete list of investigators and centers is provided in the Appendix.
CAVEAT-II Sites and Investigators
Cleveland
(Ohio) Clinic Foundation (P. Whitlow, S. Ellis,
I. Franco, E. Topol [study chair], D. Debowey [Angiographic
Core
Laboratory], M. Lincoff); Christ Hospital, Cincinnati, Ohio (D.
Kereiakes, C. Abbottsmith); Washington (DC) Cardiology Center (K. Kent,
M. Leon, A. Pichard, L. Satler, J. Popma); Sequoia Hospital, Redwood
City, Calif (T. Hinohara); St Vincent's Medical Center, Bridgeport,
Conn (E. Kosinski); Carolinas Medical Center & Carolinas Heart
Institute, Charlotte (C. Simonton, R.M. Bersin, J. Cedarholm, B.
Wilson); Mayo Clinic Foundation, Rochester, Minn (D.R. Holmes, Jr);
Midwest Heart Research Foundation, Lombard, Ill (L.S. McKeever);
Methodist Hospital, Memphis, Tenn (F. Martin); Riverside Methodist
Hospital, Columbus, Ohio (A. Chapekis, B.S. George); Medical College of
Virginia, Richmond (M. Cowley); St Vincent's Hospital, Indianapolis,
Ind (C. Pinkerton, T. Peters); St Francis Hospital, Beech Grove, Ind
(M. Cohen); Boston (Mass) University Medical Center (A. Jacobs, D.P.
Faxon, G. Levine); Maimonides Medical Center, Brooklyn, NY (J. Shani);
Maine Medical Center, Portland (M. Kellett, Jr); Emory Hospital,
Atlanta, Ga (S. King); Jewish Hospital, Louisville, Ky (R. Masden);
Graduate Cardiology Consultants, Philadelphia, Pa (R.S. Gottlieb);
Minneapolis (Minn) Heart Institute (M. Mooney); Ochsner Foundation
Hospital, New Orleans, La (C.J. White); Klinikum Grosshadern Der
Universitat, Munich, Germany (B. Hofling); Rhode Island Hospital,
Providence (D. Williams); University of Louisville, Ky (D. Talley);
Southwest Cardiology Associates, Albuquerque, NM (H. White); Johns
Hopkins Hospital, Baltimore, Md (J. Brinker); Loyola Medical Center,
Maywood, Ill (F. Leya); University of Washington, Seattle (D.K.
Stewart, J. Chambers); St. Vincent–Portland, Ore (P. Au);
Massachusetts General Hospital, Boston (I. Palacios); Beth Israel
Hospital, Boston, Mass (R. Kuntz); William Beaumont–Royal Oak (Mich)
Hospital (R. Safian); Florida Hospital, Orlando (R. Ivanhoe);
Cardiologie/CHU Ranguiel, Toulouse, Cedex, France (J. Puel); Fairfax
Hospital, Annandale, Va (B. Raybuck); Montreal Heart Institute, Quebec,
Canada (R. Bonan); Walter Reed Army Medical Center, Washington, DC (C.
Pearson, J.R. Laird); University of Virginia, Charlottesville (L.
Burwell); Mother Frances, Tyler, Tex (R.J. Carney); Sutter Hospitals,
Sacramento, Calif (R. Bellinger); Hahnemann University Hospital,
Philadelphia, Pa (M. Cohen); Vancouver General Hospital, British
Columbia, Canada (D. Ricci); New York Hospital–Cornell Medical Center,
New York (A. Spokojny); Henrico Hospital, Fredericksburg, Va (T.E.
Martyak); Toronto General Hospital, North York, Ontario, Canada (E.
Cohen); Mount Sinai Hospital, Toronto, Ontario, Canada (A. Adelman);
Charleston (WV) Medical Center (S. Lewis); St Paul's Hospital,
Vancouver, British Columbia, Canada (J. Webb); Foothills Hospital,
Calgary, Alberta, Canada (D. Traboulsi); Presbyterian Hospital,
Charlotte, NC (B. Reen, G. Niess); St Lukes–Roosevelt Hospital, New
York, NY (J. Slater); Ottawa Heart, Ontario, Canada (J-F. Marquis);
Cleveland Clinic Florida, Ft Lauderdale, Fla (H.S. Bush); Lenox Hill
Hospital, New York, NY (J.W. Moses); Healthwest Regional Medical
Center, Phoenix, Ariz (R. Heuser); Ft Sanders Regional Medical Center,
Knoxville, Tenn (M. Ayres); Columbia Presbyterian Medical Center, New
York, NY (M.A. Apfelbaum); East Jefferson Hospital, Metairie, La (S.
Bleich); University of Alabama, Birmingham (G. Roubin); Sentara Norfolk
General Hospital, Norfolk, Va (R. Stein, C.W. Hartman); St Mary's
Hospital, Saginaw, Mich (R. DeNardo); Shadyside Hospital, Pittsburgh,
Pa (D. Lindsey); Presbyterian Medical Center, Philadelphia, Pa (W.
Corin, B. Unterecker); Medical Center of Delaware, Newark (M.
Stillabower); Methodist Hospital of Indiana, Indianapolis (M. Mick); Mt
Sinai Medical Center, New York, NY (S. Sharma); St John's Hospital,
Santa Monica, Calif (H. Cohen); Laval Hospital, St-Foy, Quebec, Canada
(G. Barbeau); Virginia Beach (Va) General Hospital (J. Griffin);
Olympia Fields (Ill) Hospital (A. Arnold); McLaren Regional Medical
Center, Flint, Mich (R. DeNardo); and Duke University Medical Center
(study coordinating center), Durham, NC (R. Califf).
Received August 9, 1994; revision received November 2, 1994; accepted November 13, 1994.
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References |
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TopAbstractIntroductionMethods Results Discussion References |
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