(Circulation. 1995;91:2158-2166.)
© 1995 American Heart Association, Inc.
Articles |
One-Year Follow-up in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT I)
From the Department of Cardiology, the Cleveland Clinic Foundation, Cleveland, Ohio (J.M.E., E.J.T.); Mayo Foundation, Rochester, NY (D.R.H.); St Elizabeth's Hospital, Boston, Mass (J.M.I., M.K.); Emory University School of Medicine, Atlanta, Ga (S.B.K.); and Duke Medical Center (L.G.B., G.P.K., R.M.C.), Durham, NC, and CAVEAT sites.
Correspondence to Eric Topol, MD, Department of Cardiology, F25, the Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background Directional atherectomy is a frequently used percutaneous revascularization strategy, but its long-term outcomes have not previously been compared with those of balloon angioplasty in a prospective trial.
Methods and Results The 1012 patients enrolled in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT I) were followed for at least 1 year after randomization. Analyses of predetermined end points were performed, including a detailed analysis of the 14 patients who died. At 1 year, 11 patients had died in the atherectomy group compared with 3 in the angioplasty group (2.2% versus 0.6%, P=.035), with an excess of out-of-hospital deaths (2.2% versus 0.2%, P=.01) and late cardiac deaths (1.6% versus 0%, P=.01). Univariate predictors of death included age, abrupt closure, periprocedural enzyme elevation, and peripheral vascular complications. There was no evidence that the excess of deaths after atherectomy was linked to perforation, ectasia, or deep resection. Cumulative rates of myocardial infarction were higher in those who had been randomized to atherectomy than in those randomized to angioplasty (8.9% versus 4.4%, P=.005) with a trend toward excess Q-wave and non–Q-wave infarctions. By multivariate analysis, atherectomy was the only variable predictive of the combined end point of death or myocardial infarction. No clinical or angiographic characteristics added to this index. Rates of repeat percutaneous intervention at the target site (24.4% after atherectomy versus 25.9% after angioplasty), coronary artery bypass surgery (9.3% versus 9.1%), hospitalization (50% versus 47.1%), and stroke (1% in both groups) were not significantly different.
Conclusions Long-term follow-up of the 1012 patients randomized to atherectomy or angioplasty has revealed a statistically significant excess of deaths after directional atherectomy that was not evident at 6 months. This difference could be due to the chance occurrence of a low mortality rate in those randomized to angioplasty. The excess of myocardial infarctions after atherectomy remains statistically significant at 1 year. Further investigation is warranted to improve the safety of atherectomy.
Key Words: angioplasty • balloon • mortality • revascularization
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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 I) was a prospective multicenter trial in which patients with native coronary artery stenoses were randomly assigned to undergo directional atherectomy or balloon angioplasty.1 Both angiographic and clinical end points were analyzed. Removing coronary plaque by atherectomy led to a larger acute gain in lumen diameter and a small reduction in angiographic restenosis at 6-month follow-up, particularly for lesions in the proximal left anterior descending artery. However, this did not translate into an advantage in clinical outcomes. Atherectomy was associated with a higher rate of in-hospital myocardial infarction and increased hospitalization costs. At 6 months, the probability of the combined end point of death and myocardial infarction was higher in the atherectomy group (10.4% versus 4.6%, P<.001), but there was no difference in the composite clinical end point of death, infarction, coronary artery bypass surgery, and the need for subsequent percutaneous coronary intervention.1
The short-term results of atherectomy and angioplasty have been compared in two other randomized trials; treatment of lesions in the proximal left anterior descending coronary artery and saphenous vein grafts were assessed in the Canadian Coronary Atherectomy Trial (CCAT)2 and CAVEAT II,3 respectively. However, there are no prospective comparative studies of long-term outcomes after atherectomy or after randomization to atherectomy or angioplasty. In this study, we have extended the follow-up in the CAVEAT I project to 12 months. We have also performed a detailed analysis of the baseline characteristics and clinical courses of the 14 patients in the CAVEAT I Study who died during the first year after randomization.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Details of eligibility criteria, and methods of randomization, revascularization, and follow-up have been presented previously.1 Participating investigators were selected on the basis of experience with both balloon angioplasty and directional atherectomy. Patients with symptoms of ischemic heart disease who were deemed suitable for either procedure were asked to give informed consent. Angiographic criteria included de novo lesions causing at least 60% diameter stenosis that were less than 12 mm in length by visual estimate and that were suitable for either a
6F cutter or a
3.0-mm balloon. In the presence of multivessel disease, the target
lesion was specified. Patients with a history of myocardial infarction
within 5 days or previous percutaneous intervention of the target
vessel were excluded.
Random assignment to either atherectomy or angioplasty was made through
a telephone service to Duke University, using a blocked randomization
sequence developed on a site-by-site basis. The initial procedure was
considered successful if a residual stenosis of 
50% was obtained.
Crossover to the other treatment method was strongly discouraged.
Aspirin and a calcium antagonist were given at least once before the
procedure; the calcium-channel antagonist was continued for at least 1
month and the aspirin indefinitely. All cineangiograms were forwarded
to the Angiography Core Laboratory at the Cleveland Clinic Foundation
for independent, blinded assessment. Images that showed the treatment
device were spliced out before analysis. Tissue specimens retrieved
from the atherectomy catheter were forwarded to St Elizabeth's
Hospital in Boston for Core Pathology Laboratory assessment.
Data were prospectively recorded, and patients were followed by the research coordinators and investigators at each site. Long-term follow-up was facilitated by collecting information about next of kin and neighbors at randomization. Quality of data was ensured by audit and double data entry at the Coordinating Center. Predetermined end points were verified using clinical records and death certificates. Myocardial infarction was diagnosed clinically at the participating site and verified by an adjudication committee blinded to treatment assignment, on the basis of the development of new Q waves or an increase in creatinine kinase myocardial band isoenzymes to more than three times the upper limit of normal for the site. In all cases of death, detailed documentation was reviewed by the authors to ascertain the exact circumstances of death.
Clinical models were also developed for the three composite outcomes: death or infarction; death, infarction, or bypass surgery; and death, infarction, or repeat intervention. The clinical factors considered for each end point were age, sex, weight, height, hypertension, hyperlipidemia, diabetes, history of smoking, current smoking, previous cerebrovascular disease, previous peripheral vascular disease, angina class, angina at rest or with associated ECG changes, previous myocardial infarction, previous balloon angioplasty, prior bypass surgery, and comorbid disease. The lesion morphology factors considered were contour, eccentricity, ostial, presence of thrombus, local calcification, proximal calcification, angulation, proximal tortuosity, bifurcation, lesion length, and lesion type.4 Vessel morphology factors included the number of diseased vessels, proximal left anterior descending location, and the number of lesions (1 versus more than 1). The angiographic factors considered were preprocedural and postprocedural diameters, expressed as percent diameter stenosis and as minimum lumen diameter (millimeters).
Cox proportional hazard modeling techniques were used to determine the joint effect of these factors for each of the three outcomes. The results of both backwards and stepwise procedures for variable selection were evaluated. These evaluations led to the decisions of which important factors to retain for the joint prediction of each outcome. Univariable significance of treatment with outcome was determined using a log-rank test in each case.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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Baseline Characteristics and Clinical Outcomes
Baseline clinical and angiographic characteristics in those patients who died in the first 12 months are compared with those in the entire cohort in Table 1
. Procedural and in-hospital
outcomes are compared in Table 2. All events occurring
during the initial hospitalization were classified as
"in-hospital."
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Deaths
Eleven patients died in the first 12 months after
atherectomy
compared with 3 after angioplasty (2.2% versus 0.6%, respectively;
P=.035; Fig 1), with more out-of-hospital
deaths (2.2% versus 0.2%, P=.01) or late cardiac deaths
(1.6% versus 0%, P=.01). Baseline clinical and
angiographic characteristics and a summary of the clinical course of
each of the 14 patients who died are presented in Table 3.
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All except 1 of the patients died from cardiovascular causes, either as a consequence of the procedure or of a late cardiac event. Of the 11 deaths after atherectomy, 5 died suddenly, 3 died of cardiogenic shock, 1 of pulmonary emboli (related to a femoral hematoma), 1 of an intracerebral hemorrhage after repeat angioplasty, and 1 after vascular surgery for recurrent leg ischemia. Of the 3 patients who died after angioplasty, 2 died in-hospital of complications related to abrupt closure during or on the day of angioplasty; the late death was due to disseminated cancer.
With only 14 deaths, there was insufficient power to perform multiple comparisons. However, important differences appear from the descriptive statistics comparing the 14 patients who died with the 998 survivors. The median age of those who died was 65 years (25th to 75th percentile, 62, 70 years) compared with 59 (51, 67) years for survivors at 1 year. The treatment groups were well balanced at baseline for age with a median age of 59 years in both groups. Abrupt closure was documented in 3 (21%) of those who died compared with 60 (6%) of the survivors at 1 year. Periprocedural enzyme elevations occurred in 5 (36%) of those who died compared with 129 (13%) of survivors.
Peripheral vascular
complications occurred in 7 (50%) of the 14 who
died compared with 67 (6.6%) of the entire cohort. Five had undergone
atherectomy and 2 had undergone angioplasty. In addition to the 3
patients who had abrupt closure, a further 2 patients had important
vascular complications that contributed to their death (Table
3
). One
woman (DCA 2 in Table 3) was discharged with a large femoral
hematoma
after atherectomy and subsequently readmitted with pulmonary emboli and
died. The second (DCA 4) was found to have a pseudoaneurysm of the
femoral artery after discharge from hospital and was treated
conservatively until she developed recurrence of angina. She was then
admitted for elective repair of the femoral aneurysm before coronary
angiography. She did not receive blood products because of her
religious convictions, and her postoperative hemoglobin stabilized at 8
g/dL. On the second postoperative day, she developed atrial
fibrillation, received multiple antiarrhythmic agents, and subsequently
died after an asystolic arrest. She did not have a follow-up angiogram
or autopsy.
Other clinical, procedural, or in-hospital outcomes did not appear different, including median ejection fraction [50%, 25th, 75th quartiles of 50, 60, respectively, in those who died compared with 60% (50, 65) in survivors], the presence of multivessel disease, or comorbid conditions.
Follow-up angiography had been performed in 6 of
the 14 patients
who died including five studies within 4 weeks of death. The
completeness of angiographic follow-up was dependent on the length of
time between randomization and death. None of the 5 patients who died
in the first 2 months had angiographic follow-up, compared with 4 of
the 6 who died between 2 and 6 months and 2 of the 3 patients who died
between 6 and 12 months. Restenosis, defined as greater than 50%
diameter stenosis as assessed by the Core Lab, was demonstrated in 1
patient who was studied after myocardial infarction (DCA 8, Table
3).
Diameter stenosis ranged from 7% to 50% in the other 5 patients
(Table 3).
Myocardial Infarction
Myocardial infarction rates were low
during the year after
discharge from hospital after either procedure. Between 6 and 12
months' follow-up, there were two myocardial infarctions in each
group. However, due to the significant excess of periprocedural
infarction, the cumulative rate of myocardial infarction at 1-year
follow-up was higher after atherectomy compared with angioplasty (8.9%
versus 4.4%, P=.005, Table 4). There was an
excess of both non–Q-wave infarctions (P=.041) and
Q-wave
infarctions (P=.053, Table 4). This analysis
does not
include those patients with enzyme elevations detected only by central
adjudication. Restenosis (with stenoses of 66%, 80%, and 89%) had
been demonstrated in 3 of the 4 patients who suffered myocardial
infarctions after 6 months.
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Reintervention
Approximately one quarter of both treatment
groups underwent
repeat percutaneous intervention at the target site. A further 6% of
both groups underwent percutaneous intervention at another site in the
coronary tree, and 9 percent underwent coronary bypass surgery during
the first year (Table 4). There were no significant
differences in the rates of percutaneous or surgical intervention
in the two groups. Similarly, almost half of each group were
hospitalized during the first year (Table 4).
Multivariate Analysis of Combined Clinical End Points
The use
of atherectomy was associated with a higher risk of the
combined end point of death or infarction (P<.001, Fig
2). No clinical or angiographic characteristics added to
this finding. Atherectomy (P=.022) and unstable angina at
revascularization (P=.0062) were the only variables
associated with the combined end point of death, myocardial infarction,
and coronary bypass surgery. There were no significant differences in
the combined end points of death, myocardial infarction, coronary
bypass surgery, and target lesion percutaneous intervention (Fig
3) or in the combined end point of death, myocardial
infarction, coronary bypass surgery, and any percutaneous intervention
(Fig 4).
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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During the first 12 months of the CAVEAT I study, more deaths and myocardial infarctions occurred among those randomized to directional atherectomy than in those assigned to balloon angioplasty. The excess of infarction was predominately related to periprocedural events and was already manifest at the time of hospital discharge. There was no further divergence between the two groups over the subsequent year, with the difference in rate of clinically evident myocardial infarction increasing from 4% at hospital discharge to 4.4% at 6 months and 4.5% at 1 year. In contrast, the excess of deaths in the group randomized to atherectomy was not evident at hospital discharge or statistically significant at 6-month follow-up. At 1 year, the excess of deaths after atherectomy was statistically significant with respect to total deaths, out-of-hospital deaths, or late cardiac deaths.
Predictors of Death
Logistic regression analysis of
predictors of death alone was
not attempted in this data set because of the small numbers of deaths
at 12 months. However, univariate analysis suggests important
associations between abrupt closure, periprocedural enzyme elevations,
peripheral vascular complications, and subsequent death. Three of the
patients who had experienced abrupt closure had important cardiac and
vascular complications ultimately proving to be fatal. Even in the era
of coronary stenting, and with experienced surgical backup, abrupt
closure remains a serious complication of percutaneous
revascularization. Peripheral vascular complications directly
contributed to the death of other patients, including the patient who
died after readmission with pulmonary emboli (DCA 2, see Table
3) and
the patient who died after elective repair of a femoral pseudo-
aneurysm (DCA 4). One-year mortality was 7.5% in those who had
procedural vascular complications compared with 1.1% in those who did
not.5 Only one (7%) of the patients who died had a
diagnosis of peripheral vascular disease at baseline compared with 6%
in the entire cohort. Thus, the association between peripheral vascular
complications and subsequent death is not explained by known
preexisting vascular disease.
Comorbidity probably contributed to the late deaths of 2 patients after atherectomy. The patient on peritoneal dialysis due to end-stage renal failure (DCA 11) had two subsequent angiograms demonstrating progression of multiple coronary lesions and a myocardial infarction in a non–target artery distribution. He died after a further myocardial infarction. Comorbid disease may also have contributed to the death of DCA 9. This man had chronic atrial fibrillation and hypertension with congestive cardiac failure and diabetes. Follow-up angiography at 6 months demonstrated restenosis of the non–target lesion in the circumflex coronary artery and a severe stenosis distal to the target lesion in the right coronary artery. Both lesions were dilated successfully. However, he suffered an intracerebral hemorrhage 2 days later and died. Possible mechanisms for his intracerebral bleeding event could include cerebral embolism from mural thrombus as well as catheter-induced embolus. No autopsy was performed.
The 75-year-old woman who died of tamponade after perforation of the right ventricle is of interest. She was enrolled in the trial after her first presentation with class III angina without ST-segment changes. After her atherectomy procedure, she developed recurrent right coronary artery spasm, presenting with chest pain, hypotension, heart block, and inferior ST-elevation on her 12-lead ECG. Spasm in the right coronary artery was documented at follow-up angiography, at which time there was a 50% stenosis at the atherectomy site, and the decision was made to electively implant a permanent pacemaker. Implantation of the pacemaker was complicated by a further episode of chest pain and bradycardia then asystole. Unfortunately, her right ventricle was perforated by a temporary pacing wire during cardiopulmonary resuscitation, and she died.
Multivariate Analysis of Combined End Points
In this trial,
atherectomy was the only variable significantly
associated with the combined clinical end point of myocardial
infarction and death at 1 year; none of the baseline clinical
characteristics, procedural, or angiographic variables tested add to
this finding. The relatively small number of events gives little power
to examine additional factors. However, lesion morphology and
quantitative angiographic findings also had remarkably little
association with the combined clinical end point of death, infarction,
bypass surgery, or angioplasty at 1 year, consistent with analyses at
30 days and 6 months of follow-up.
There is thus a dichotomy between
angiographic and clinical
outcomes after atherectomy or angioplasty. As evidence of this, the
acute angiographic result obtained in the patients who subsequently
died was not inferior to that obtained in the CAVEAT group as a whole
(Tables 2 and 3), nor was there an increased
number of dissections or
vascular trauma as assessed by angiography or by postmortem histology.
Furthermore, several patients died despite a "satisfactory"
appearance of the target lesion at follow-up angiography within 4 weeks
of death (see Table 3). Restenosis was not the cause of death
of the
majority of late deaths. The cause of death was related to progression
of disease in other coronary arteries, to peripheral vascular
complications, to other cardiac events, or to a noncardiac cause, for
example, metastatic lung carcinoma. No follow-up angiograms were
obtained in the 5 patients who died within 2 months of randomization: 1
patient (DCA 1) had thrombus demonstrated at the site of atherectomy at
autopsy. Most of these patients died from procedural complications.
Comparison With Other Trials
Six-month follow-up is available
from two other randomized
prospective studies comparing atherectomy and angioplasty in the
treatment of de novo lesions in the proximal left anterior descending
coronary artery, CCAT,2 or in saphenous vein bypass
grafts, the CAVEAT II.3 In both trials, atherectomy was
associated with a higher procedural success rate and greater acute
gains in lumen diameter compared with angioplasty. However, in CCAT,
there was no excess of acute complications, including Q-wave or
non–Q-wave myocardial infarction, after atherectomy and only two
further myocardial infarctions (both in patients assigned to
angioplasty) during the first 6 months of follow-up.2 The
lower incidence in acute complications after atherectomy in CCAT
compared with CAVEAT I may be related to differences in baseline
characteristics, with trends to a higher proportion of younger men, a
lower incidence of unstable angina or multivessel disease, to the
exclusion of patients with ostial lesions or lesions that included
large side branches, to the technical differences in atherectomy of the
proximal left anterior descending artery compared with more distal
sites or with other arteries, to the less frequent use of 7F cutters,
or to the use of total CK rather than CKMB subfractions to define
myocardial infarction in CCAT. The reason(s) for the lower incidence of
events during follow-up is not certain but may be related to the
differences in baseline characteristics. The results of 1-year
follow-up have not been presented.
In CAVEAT II, 305 patients with saphenous vein bypass graft lesions were enrolled. The patients randomized in CAVEAT II were an average of 6 years older, with a lower mean ejection fraction, and were more likely to have had a previous myocardial infarction or have unstable angina or multivessel disease than the patients in CAVEAT I.3 The incidence of acute non–Q-wave infarction and abrupt closure was much higher in CAVEAT II than in CAVEAT I, presumably related to the higher risk of distal embolization during treatment of diseased vein grafts compared with native coronary vessels as well as the above differences in baseline characteristics. As in CAVEAT I and in contrast to CCAT, the risk of acute complications was greater after atherectomy than after angioplasty in CAVEAT II. However, there were no significant differences in the rates of death or myocardial infarction after 6 months of follow-up. Long-term follow-up of CCAT and CAVEAT II is in progress. Pending these results, there is no evidence that atherectomy offers any advantage over balloon angioplasty in the treatment of de novo lesions in coronary arteries.
One-year mortality was only 0.6% in the balloon angioplasty group in CAVEAT I. This rate is lower than reported rates from most recent registry and randomized trial data sets. Previous angioplasty registry reports suggest mortality rates of 1% to 2.1% in patients with single-vessel disease6 7 8 and 1.8% to 4.6% in patients with multivessel disease6 7 8 : one third of the patients in CAVEAT I had multivessel disease. An earlier analysis of the NHLBI Balloon Registry reported a 1-year mortality rate of 3% in patients undergoing angioplasty for unstable angina due to single-vessel disease9 : two thirds of the patients in CAVEAT I had unstable angina at enrollment. Data are now available from several trials in which patients have been randomized to balloon angioplasty or coronary bypass surgery. One-year mortality rates in those randomized to angioplasty have ranged from 1.2% in the GABI study10 to 2% in the RITA study, in which half the patients had single-vessel disease.11 One-year mortality in the placebo arms of recent restenosis studies was between 1.0% and 3.4%.12 13 14 In contrast, mortality after atherectomy in CAVEAT I was consistent with that in atherectomy registry data sets (2% after 1 year15 and 3% after 6 months16 ). Thus, the statistical difference in late mortality between the treatment arms in CAVEAT I may be a chance finding due to the relative paucity of deaths after angioplasty rather than an excess of deaths after atherectomy. However, it is unlikely that a randomized trial would show a difference in the most important clinical outcome by chance alone as a function of the randomized treatment assignment, when none of the other nonrandomized baseline variables appear important by chance alone.
Patients have been prospectively randomized to atherectomy or angioplasty in three trials: CAVEAT I,1 CAVEAT II,3 and CCAT.2 Directional atherectomy resulted in greater acute gain in lumen diameter than balloon angioplasty in all three trials. However, the mean residual stenosis after atherectomy still exceeded 25% in all three trials and was achieved at the expense of an increase in acute complications. The possibility that greater acute lumen gain after more aggressive atherectomy will reduce restenosis and reduce cumulative end points without further increase in acute complications is being tested in the Balloon versus Optimal Atherectomy Trial (BOAT). Multivariate regression analysis in CAVEAT I suggests that neither acute nor long-term combined clinical end points are predicted by measurements taken from the images of a successful procedure.
Conclusions
Follow-up in the CAVEAT I study was extended to 1
year to enable
longer-term prospective comparison of atherectomy and angioplasty. The
findings suggest a lack of association between angiographic outcome and
both short- and long-term clinical outcomes after either atherectomy or
angioplasty. The excess of myocardial infarction after atherectomy
remained statistically significant after 1 year, with further
divergence of the curves after discharge from hospital. At 1 year there
was also a difference in all-cause mortality (2.2% after atherectomy
versus 0.6% after angioplasty, P=.035). There is no
evidence that this excess of deaths after atherectomy is linked to
differences in baseline variables. The combined end point of death and
myocardial infarction was also increased after atherectomy but there
were no significant differences in the cumulative rates of target
lesion repeat intervention or bypass surgery. Long-term careful
surveillance of this and other prospective studies that compare
percutaneous interventional techniques is indicated; reliance on
6-month end points alone is not sufficient.
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Acknowledgments |
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This study was supported by grants from Devices for Vascular Interventions and Eli Lilly. Dr Elliott was supported by a White-Parsons Fellowship of the National Heart Foundation of New Zealand.
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Footnotes |
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1 The remaining CAVEAT investigators and study sites are listed in the "Appendix."
Participating Sites and Investigators
Study
Chairman: Eric J. Topol, MD; Cleveland Clinic Foundation,
Cleveland: Patrick Whitlow, MD (PI), Stephen G. Ellis, MD, Irving
Franco, MD, Sue DeLuca (Coordinator); Loyola Medical Center, Chicago:
Fred Leya, MD (PI), Sarah Johnson, MD, Eric Grassman, MD, Bruce Lewis,
MD, Laura Wrona (Coordinator); St Vincent's Hospital, Indianapolis:
Cass Pinkerton, MD (PI), Thomas Peters, MD, Belinda Ness (Coordinator);
Klinikurn Grosshadem Der Universitat, Munich: Berthold Hofling, MD
(PI), Tilman Kolbe (Coordinator); Carolinas Medical Center, Charlotte,
NC: Charles Simonton, MD (PI), R.M. Bersin, MD, J. Cedarholm, MD, B.
Wilson, MD, Susan Lingelbach (Coordinator); Jewish Hospital,
Louisville: Ronald Masden, MD (PI), Vicki Miracle (Coordinator);
Midwest Heart Research Foundation, Illinois: Louis S. McKeever, MD
(PI), Joseph Marek, MD, Peter Kerwin, MD, Elaine L. Enger
(Coordinator); Graduate Cardiology, Philadelphia: Ronald S. Gottlieb,
MD (PI), Helen Hunter (Coordinator); Maimonides, Brooklyn: Jacob Shani,
MD (PI), Nancy Schulhoff (Coordinator); University of Louvain Medical
School, Brussels: William Wijns, MD (PI), Jean Renkin, MD, Thierry
Baudhuin, MD (Coordinator); Methodist Hospital, Memphis: Frank Martin,
MD (PI), Kathy Garrison (Coordinator); Erasmus University, Rotterdam:
Patrick Serruys, MD, PhD (PI), P.J. de Feyter, MD, Victor Umans
(Coordinator); St Vincent's Medical Center, Bridgeport, Conn: Edward
Kosinski, MD (PI), Maria Capasso (Coordinator); John Hopkins Hospital,
Baltimore: Jeffrey Brinker, MD (PI), Mark Midei, MD, Jon R. Resar, MD,
Vicki J. Coombs, RN (Coordinator); St Francis Hospital, Beech Groove,
Ind: Mark Cohen, MD (PI), Horance Hickman, MD, Paula Cross
(Coordinator); St Joseph's Hospital, Atlanta: William Knopf, MD (PI),
Christopher Cates, MD, Jan Shaftel (Coordinator); Washington DC
Cardiology Center: Kenneth Kent, MD (Co-PI), Martin Leon, MD (Co-PI),
Augusto Pichard, MD, Lowell Satler, MD, Jeff Popma, MD, Pam Shotts
(Coordinator); Maine Medical Center, Portland: Mirle Kellett, Jr, MD
(PI), Joshua Cutler, MD, Jane Kane (Coordinator); Boston University
Medical Center, Boston: Alice Jacobs, MD (PI), David P. Faxon, MD, Mary
Mazur (Coordinator); Minneapolis Heart Institute, Minneapolis: Michael
Mooney, MD (PI), James Madison, MD, Ellen Sawicki (Coordinator); Mayo
Foundation, Rochester: David R. Holmes, Jr, MD (PI), K. Garratt, MD, J.
Bresnahen, MD, Jeanette Ramaker (Coordinator); Ochsner Foundation
Hospital, New Orleans: Christopher J. White, MD, Steven Ramee, MD,
Bryan Leasure (Coordinator); Riverside Methodist Hospitals, Columbus:
Anthony Chapekis, MD (Co-PI), N. Howard Kander, MD (Co-PI), Christine
Gilliland (Coordinator); Southwest Cardiology Presbyterian Hospital,
Albuquerque: Harvey White, MD (PI), Roann Sexson (Coordinator);
Georgetown University, Washington: Stephen N. Oesterle, MD (PI), Leni
Barry (Coordinator); Rhode Island Hospital, Providence: David O.
Williams (PI), Barry Shariff, MD, Mary Grogan (Coordinator); University
of Louisville: David J. Talley, MD (PI), ZoeAnn Yussman (Coordinator);
Sequoia Hospital, Redwood City: Tomoaki Hinohara, MD (PI), Lissa Braden
(Coordinator); Emory University Hospital, Atlanta: Spencer King, MD
(PI), Sue Mead (Coordinator); St Vincent Hospital, Portland: Phillip
Au, MD (PI), Henry Garrison, MD, Terry Glickman (Coordinator);
University of Washington, Seattle: Douglas K. Stewart, MD (PI), Joseph
Chambers, MD, Joy Dalquist (Coordinator); Beth Israel Hospital, Boston:
Richard Kuntz, MD (PI), Donald Baim, MD, Cynthia Senerchia
(Coordinator); Christ Hospital, Cincinnati: Dean Kereiakes, MD (PI),
Charles Abbottsmith, MD, David Lausten (Coordinator); Good Samaritan,
Phoenix: Marvin Padnick, MD (PI), James Schumacher, MD, Angie Stephens
(Coordinator); Medical College of Virginia, Richmond: Michael Cowley,
MD (PI), Kim Kelly (Coordinator).
Coordinating Center
Robert M. Califf, MD (Clinical Director), Lisa G. Berdan, PA-C
(Coordinator), Kerry L. Lee, PhD (Statistical Director), Gordon Keeler,
MS (Statistician), Tammy Allen, RN (Monitor), Maggie Liu, RN (Monitor),
Kathi Lucas, RN (Monitor), Karen Pieper MS (Statistician), John Snapp,
MS (Data Manager), Pamela L. Monds (Secretary/Assistant).
Angiography Core Laboratory
Stephen G. Ellis, MD
(Medical Director), Darrell Debowey, MS
(Technical Director), Timothy D. Crowe, Thomas B. Ivanc, Holly B.
Vilsack, Julie A. Merriam, Damian J. Green, Deborah L. Fisher, Sara
Brant.
Core Pathology
Jeffrey M. Isner, MD
(Chairman), Marianne Kearney, BS
(Coordinator), Kellie Wills, BS, Carrie Loushin, BS, Scott Bortman,
MD.
Data and Safety Monitoring Committee
Hugh C.
Smith, MD (Chairman), Robert M. Califf, MD, Alan Guerci,
MD, Neal S. Kleiman, MD, Kerry Lee, PhD, Daniel B. Mark, MD, Jimmy
Tcheng, MD, W. Douglas Weaver, MD.
Economics and Quality of
Life Coordinating Center
Daniel B. Mark, MD, MPH (Principal
Investigator), Linda
Davidson-Ray (EQOL Coordinator), Lai Choi Lam, MS (Statistician),
Charles Moore (Data Manager), Lura Larson (Data Technician), Courtney
Smith (Administrative Support).
Operations Committee
Eric J. Topol (Chairman), Spencer King, MD, Michael Cowley, MD,
David O. Williams, MD, Tomoaki Hinohara, MD, Patrick Serruys, MD,
Kenneth Kent, MD, Robert M. Califf, MD.
Financial Center
Val Stosik, MBA, Debra Shyne, Donna Passmore.
Received August 29, 1994; revision received November 7, 1994; accepted November 26, 1994.
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References |
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TopAbstractIntroductionMethods Results Discussion References |
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Topol EJ, Leya F, Pinkerton CA, Whitlow PL, Hofling B,
Simonton CA, Masden RR, Serruys PW, Leon MB, Williams DO, King SB, Mark
DB, Isner JM, Holmes DR, Ellis SG, Lee KL, Keeler GP, Berdan LG,
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