The number of patients eligible for randomization was not tracked during
the course of enrollment.
At 9 months, the reduction in mean percent diameter stenosis for the
paclitaxel-stent group relative to the bare metal stent (control) group was
−15.8% (95% confidence interval [CI], −18.9% to −12.7%; P<.001) for in-stent and −8.7% (95% CI, −11.5%
to −6.0%; P<.001) for analysis segment.
Negative values occur because the luminal diameter at the lesion measures
larger than the adjacent reference segment.
Customize your JAMA Network experience by selecting one or more topics from the list below.
Stone GW, Ellis SG, Cannon L, et al. Comparison of a Polymer-Based Paclitaxel-Eluting Stent With a Bare
Metal Stent in Patients With Complex Coronary Artery Disease: A Randomized Controlled Trial. JAMA. 2005;294(10):1215–1223. doi:10.1001/jama.294.10.1215
Author Affiliations: Department of Cardiology,
Columbia University Medical Center and Cardiovascular Research Foundation,
New York, NY (Dr Stone); Department of Cardiology, Cleveland Clinic Foundation,
Cleveland, Ohio (Dr Ellis); Department of Cardiology, Northern Michigan Hospitals,
Petoskey (Dr Cannon); WakeMed, Raleigh, NC (Dr Mann); Department of Cardiology,
Florida Heart Institute, Orlando (Dr Greenberg); Department of Cardiology,
Morton Plant Hospital, Clearwater, Fla (Dr Spriggs); Department of Cardiology,
Elyria Memorial Hospital, Elyria, Ohio (Dr O'Shaughnessy); Department of Cardiology,
South Austin Hospital, Austin, Tex (Dr DeMaio); Department of Cardiology,
South Carolina Heart Center, Columbia (Dr Hall); Department of Cardiology,
Brigham and Women’s Hospital, Boston, Mass (Dr Popma); and Boston Scientific
Corp, Natick, Mass (Drs Koglin and Russell).
Context Compared with bare metal stents, drug-eluting stents reduce restenosis
in noncomplex lesions. The utility of drug-eluting stents has not been evaluated
in more difficult stenoses.
Objective To investigate the safety and efficacy of the polymer-based, slow-release
paclitaxel-eluting stent in a patient population with more complex lesions
than previously studied.
Design, Setting, and Patients Prospective, placebo-controlled, double-blind, multicenter randomized
trial conducted from February 2003 to March 2004 at 66 academic and community-based
institutions with 1156 patients who underwent stent implantation in a single
coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46
mm), including 664 patients (57.4%) with complex or previously unstudied lesions
(requiring 2.25-mm, 4.0-mm, and/or multiple stents) and 9-month clinical and
Interventions Patients were randomly assigned to receive 1 or more bare metal stents
(n = 579) or identical-appearing paclitaxel-eluting stents (n = 577).
Main Outcome Measure Ischemia-driven target vessel revascularization at 9 months.
Results Baseline characteristics were well matched. Diabetes was present in
31% of patients. The mean (SD) reference vessel diameter was 2.69 (0.57) mm,
the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type
B2/C. A mean (SD) of 1.38 (0.58) stents (total mean [SD] length,
28.4 [13.1] mm) were implanted per lesion; 33% of lesions required multiple
stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and
17% of lesions, respectively. Compared with bare metal stents, paclitaxel-eluting
stents reduced the 9-month rate of target lesion revascularization from 15.7%
to 8.6% (P<.001) and target vessel revascularization
from 17.3% to 12.1% (P = .02). Similar rates were
observed for cardiac death or myocardial infarction (5.5% for bare metal stent
group vs 5.7% for paclitaxel-eluting stent group) and stent thrombosis (0.7%
in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in
the entire study cohort (P<.001), including among
patients receiving 2.25-mm stents (49.4% vs 31.2%; P =
.01), 4.0-mm stents (14.4% vs 3.5%; P = .02), and
multiple stents (57.8% vs 27.2%; P<.001).
Conclusion Compared with a bare metal stent, implantation of the paclitaxel-eluting
stent in a patient population with complex lesions effectively reduces clinical
and angiographic restenosis.
Drug-eluting stents have revolutionized the treatment of atherosclerotic
coronary artery disease. The demonstration that both sirolimus-eluting and
paclitaxel-eluting stents safely reduce clinical and angiographic restenosis
compared with bare metal stents1-4 has
resulted in an estimated 160 000 of these devices currently being implanted
per month worldwide (unpublished data, Boston Scientific Corp, Natick, Mass),
signifying drug-eluting stents as by far the most widely used permanent bioprosthesis.
Enrollment in the pivotal randomized trials,1-4 however,
was restricted to relatively simple stenoses (vessel diameter of 2.5-3.75
mm with lesion length ≤30 mm). More than 55% of lesions currently treated
with these bioactive devices may fall outside this range.5 The
efficacy of drug-eluting stents has not been established for small vessels
(in which the utility of stents as a class is still uncertain),6 large
vessels (in which outcomes with bare metal stents are favorable),7-11 or
in long lesions requiring multiple stents (a complex subset with increased
periprocedural complications and reduced efficacy).7-12 Therefore,
we performed a prospective, multicenter, randomized trial to investigate the
safety and efficacy of a paclitaxel-eluting stent in a patient population
with more complex lesions than previously studied.
Patients aged 18 years or older with stable or unstable angina or provokable
ischemia undergoing percutaneous coronary intervention of a single de novo
lesion in a native coronary artery were considered for enrollment. Clinical
exclusion criteria included previous or planned use of intravascular brachytherapy
or any antirestenotic drug-eluting stent in the target vessel; myocardial
infarction (MI) within 72 hours or creatine kinase-MB level higher than 2
times the upper limit of normal; left ventricular ejection fraction of less
than 25%; stroke within 6 months; planned coronary artery bypass graft surgery
within 9 months; hemorrhagic diatheses or contraindications or allergy to
aspirin, thienopyridines, paclitaxel, stainless steel, or anaphylaxis to iodinated
contrast; chemotherapy within 12 months, or planned use of paclitaxel, rapamycin,
or colchicine within 9 months; serum creatinine level higher than 2.0 mg/dL
(>176.8 μmol/L), leukocyte count lower than 3.5 × 109/L,
or platelet count lower than 100 000/mm3 or higher than 750 000/mm3; female with a recent positive pregnancy test, lactating, or planned
procreation within 3 months; comorbid conditions limiting life expectancy
to less than 24 months or that could affect protocol compliance; planned procedure
requiring antiplatelet therapy withdrawal within 6 months; and current participation
in other investigational trials. The study was approved by the institutional
review boards at each participating center, and consecutive, eligible patients
signed informed, written consent.
Angiographic eligibility required a single target lesion with visual
reference vessel diameter of 2.25 to 4.0 mm and lesion length of 10 to 46
mm. Exclusion criteria included left main or ostial lesion; excessive vessel
or lesion calcification, tortuosity or angulation; bifurcation disease; target
lesion occlusion or thrombus; and planned atherectomy. Enrollment was permitted
after successful treatment of 1 to 2 nonstudy lesions in a nonstudy vessel
prior to randomization.
To enrich the study population with complex lesions, the protocol specified
randomizing 200 or more patients requiring 2.25-mm stents; 200 or more patients
requiring 4.0-mm stents; and 300 or more patients with lesions longer than
26 mm in length requiring multiple overlapping stents. The protocol likewise
specified the inclusion of no more than 350 lesions with diameters equal to
or larger than 2.5 mm and less than or equal to 3.5 mm and with a lesion length
of 26 mm or less requiring only a single stent. For purposes of the present
analysis, lesions requiring 2.25-mm stents, 4.0-mm stents, or multiple stents,
or combinations thereof, were defined as complex or previously unstudied.
Telephone randomization was performed after mandatory predilatation
in random blocks of 2 to 4 patients, stratified by presence or absence of
medically treated diabetes and by lesion length (<18 or ≥18 mm). Patients
were assigned using random serial numbers to treatment with either the slow
rate-release polymer-based paclitaxel-eluting TAXUS stent or a visually indistinguishable
bare metal Express2 stent (both Boston Scientific
Corp). Stents were available in 8- to 32-mm lengths and in diameters of 2.25
to 4.0 mm. Coverage of 3 mm of the normal reference segment at both the proximal
and distal lesion margins was recommended. When multiple stents were required,
4 mm of stent overlap was specified. Antithrombin and glycoprotein IIb/IIIa
inhibitor use and performance of postdilatation were at operator discretion.
Patients were given 325 mg/d of aspirin prior to stent implantation
and were required to continue taking this dose indefinitely. A 300-mg loading
dose of clopidogrel administered more than 6 hours prior to the procedure,
followed by a dose of 75 mg/d for at least 6 months was recommended. Clinical
follow-up was scheduled at 1, 4, and 9 months and yearly thereafter for 5
years. Follow-up angiography was scheduled in all patients at 9 months.
Independent study monitors verified all data from the case report forms
onsite. Major adverse cardiac events were adjudicated by an independent committee
blinded to treatment allocation after review of original source documentation.
The clinical and angiographic endpoint definitions were identical to those
in TAXIS IV, as previously described.4 A data
and safety monitoring committee periodically reviewed safety data; the committee
recommended that the study continue without modification at each review period.
Blinded core angiographic laboratory analysis was performed using validated
quantitative methods.13 Measures were reported
separately within the stent, within 5-mm proximal and distal to each edge,
and over the entire analysis segment. The investigators had unrestricted access
to the database. The manuscript was prepared by the principal investigator
(G.W.S.) and revised after coauthor review.
The primary end point was the 9-month incidence of ischemia-driven target
vessel revascularization. Enrolling 1172 patients and allowing for 10% attrition
and using a 2-sided test for differences in independent binomial proportions
with an α level of .05 yielded 90% power to detect a reduction in the
primary end point from an anticipated 18% after implantation with bare metal
stents to 10.8% after implantation with paclitaxel-eluting stents. For the
major secondary end point of follow-up angiographic diameter stenosis, allowing
for 25% attrition for noncompliance or technical failures with an expected
mean (SD) diameter stenosis in the control group of 32.6% (16.9%), the minimum
detectable difference with 80% power afforded was 3.3%, which is a 10.1% change
relative to control.
Categorical variables were compared using the Fisher exact test. Continuous
variables are presented as mean ±1 SD and were compared using the t test. The influence of baseline variables on 9-month
categorical end points was evaluated with logistic regression using the Wald
χ2 test; all baseline clinical and angiographic features,
randomization assignment, and procedural parameters were entered. The statistical
analysis plan specified that the primary intent-to-treat population would
consist of all consenting patients in whom an attempt was made to implant
a study stent. All P values are 2-sided. All statistical
analyses were performed using SAS software version 8.2 (SAS Institute Inc,
Between February 27, 2003, and March 29, 2004, a total of 1172 patients
at 66 US centers were randomly assigned to receive either paclitaxel-eluting
stents (n = 586) or bare metal stents (n = 586) (Figure 1). Sixteen patients (1.4%) in whom no attempt was made to
implant a study stent were excluded. Therefore, the analysis population consisted
of 1156 patients: 577 assigned to paclitaxel-eluting stents and 579 to bare
metal stents (control). Baseline characteristics appear in Table 1. Diabetes mellitus was present in 31% of patients and 78%
of lesions were American College of Cardiology/American Heart Association
class type B2/C. Initial procedural results appear in Table 2. Of the 1156 lesions analyzed, 664 (57.4%)
were complex or previously unstudied as defined above. Stents of 2.25 mm and
4.0 mm in diameter were used in 18% and 17% of lesions, respectively; multiple
stents were used in 33% of lesions.
Clinical follow-up was available in 1127 patients at 9 months (97.5%)
and follow-up angiography at 9 months was completed in 990 patients (85.6%).
Compared with bare metal stents, implantation of paclitaxel-eluting stents
reduced the 9-month rate of target lesion revascularization from 15.7% to
8.6% (P<.001) and target vessel revascularization
from 17.3% to 12.1% (P = .02) (Table 3). Among patients receiving the paclitaxel-eluting stent
compared with a bare metal stent, the rate of in-stent restenosis was reduced
from 31.9% to 13.7% and analysis segment angiographic restenosis was reduced
from 33.9% to 18.9% (both P<.001; Figure 2). Restenosis was usually focal with the paclitaxel-eluting
stent but was typically diffuse or proliferative with bare metal stents. By
multivariate analysis, randomization to the paclitaxel-eluting stent was an
independent predictor of freedom from 9-month target lesion revascularization
(odds ratio [OR], 2.23; 95% confidence interval [CI], 1.49-3.34; P<.001), target vessel revascularization (OR, 1.66; 95% CI, 1.16-2.39; P = .006), and restenosis (OR, 2.89; 95% CI, 2.07-4.05; P<.001). These benefits were achieved with comparable
safety in both groups, with similar rates of cardiac death, MI, and stent
thrombosis at 1 and 9 months. Although uncommon, a statistically nonsignificant
trend toward greater late-acquired aneurysm formation was seen in patients
who received paclitaxel-eluting stents (Table
A total of 664 patients had complex or previously unstudied lesions
(requiring 2.25-mm, 4.0-mm, or multiple stents, or some combination thereof).
Clinical and angiographic follow-up were available for 648 (97.6%) and 582
(87.7%) of these patients. The use of paclitaxel-eluting stents compared with
bare metal stents in this group reduced the rate of target lesion and vessel
revascularization from 19.0% to 9.9% (P = .001) and
from 21.2% to 13.9% (P = .02), respectively (Table 4). A test for statistical heterogeneity
among the 3 subsets of complex lesions (2.25-mm stents, 4.0-mm stents, and
multiple stents) was negative, confirming that the beneficial effect of the
paclitaxel-eluting stent on target vessel revascularization was consistent
for all 3 types of complex lesions. The rate of angiographic restenosis was
also significantly reduced for all complex lesion subsets (Table 4 and Table 5).
Clinical features and results in the individual complex and previously
unstudied lesion subsets appear in Table 5.
Important baseline characteristics were equally distributed between the 2
study groups with the exception of diabetes mellitus, which was present in
a larger proportion of patients receiving the 2.25-mm paclitaxel-eluting stent.
As would be anticipated, the rates of clinical and angiographic restenosis
were high in patients receiving 2.25-mm stents and for those receiving multiple
stents and low among patients receiving 4.0-mm stents. Subgroup analysis did
not show a significant reduction in target vessel revascularization with the
paclitaxel-eluting stent among patients receiving 2.25-mm or 4.0-mm stents
(probably a consequence of the relatively small numbers of patients in these
subgroups), although target lesion revascularization and angiographic restenosis
rates were reduced.
Multiple stents were implanted in 379 patients (planned in 281 and “bail
out” for complications or suboptimal results in 98), in whom the mean
(SD) lesion and stent length were 25.3 (10.0) mm and 43.9 (10.1) mm, respectively.
In patients requiring multiple stents, paclitaxel-eluting stent use was associated
with an increased incidence of MI at 30 days (8.3% vs 3.3%; P = .047), most of which were non–Q-wave MIs (Table 5). Infarction rates were numerically increased with both
planned (6.3% vs 2.9%) and unplanned (14.0% vs 4.2%) use of multiple paclitaxel-eluting
stents. Blinded core laboratory angiographic analysis in the multiple stent
cohort demonstrated more frequent occurrence of progressive side-branch narrowing
to more than 70% diameter stenosis or to total occlusion with the paclitaxel-eluting
stent (42.6% vs 30.6%; P = .03) and a greater
likelihood of reduced side-branch thrombolysis in MI flow (41.9% vs 28.6%; P = .02). No differences were present in main vessel thrombolysis
in MI flow, acute occlusion, stent thrombosis, distal embolization, or other
angiographic complications. Reductions in clinical and angiographic restenosis
rates were present at 9 months in patients who received multiple stents and
who had been assigned to paclitaxel-eluting rather than bare metal stents,
with similar rates of cardiac death, MI, and stent thrombosis.
This clinical trial (TAXUS V) evaluated the use of paclitaxel-eluting
stents compared with bare metal stents in a patient cohort significantly more
complex than previously studied. In comparison with the prior pivotal trials
of paclitaxel-eluting and sirolimus-eluting stents, lesion length in the current
trial was substantially greater (17.2 mm vs 13.4 mm and 14.4 mm, respectively),
more lesions were type B2/C (78% vs 53% and 56%), more patients
had diabetes (31% vs 24% and 26%), and 2.25-mm and 4.0-mm stents had not been
In the entire study cohort, implantation of the polymer-based, slow-release
paclitaxel-eluting stent was associated with similar rates of death, MI, and
stent thrombosis at 1 and 9 months compared with an otherwise identical bare
metal stent. Rates of clinical and angiographic restenosis were significantly
reduced with the paclitaxel-eluting stent. Of note, however, the absolute
and relative efficacy of the paclitaxel-eluting stent in this trial were somewhat
diminished compared with earlier studies in patients with less complex lesions.3,4 However, the upper bound of the 30%
observed relative reduction in the primary end point of target vessel revascularization
with the paclitaxel-eluting stent was 47%, which is greater than the 40% improvement
anticipated, demonstrating that a significantly larger trial would have been
required for a more accurate point estimate.
In this trial, we enrolled several lesion subgroups that had not previously
been studied with drug-eluting stents but are commonly treated in clinical
practice. Whether stent implantation improves outcomes compared with balloon
angioplasty alone in small vessels is still a matter of debate.6-11 In
prior studies, clinical and angiographic outcomes with 4.0-mm bare metal stents
have been favorable,7-11 suggesting
that a large vessel drug-eluting stent may not offer significant incremental
value. Finally, long lesions requiring multiple stents represent a unique
challenge, with increased periprocedural complications and reduced efficacy.7-12
Nonetheless, the rates of both clinical and angiographic restenosis
were significantly reduced with the paclitaxel-eluting stent compared with
the bare metal stent in the 664 patients with complex or previously unstudied
lesions as defined by these criteria. A test for heterogeneity demonstrated
that the benefit of paclitaxel stents over bare metal stents was consistent
across all 3 subsets.
With a mean (SD) diameter of 2.08 (0.32) mm, vessels receiving 2.25-mm
stents represent the smallest coronary arteries studied to date in patients
in a randomized drug-eluting stent trial. Compared with patients who received
bare metal stents, restenosis rates were safely reduced with paclitaxel-eluting
2.25-mm stents, although angiographic restenosis and target lesion revascularization
still occurred in approximately 30% and approximately 10% of vessels, respectively.
Target vessel revascularization at sites remote from the target lesion was
also required in nearly 9% of 2.25-mm stent patients (compared with 1.4% in
the simpler lesion cohort in TAXUS IV4), reflecting
the diffuse and progressive nature of coronary atherosclerosis in these patients.
Whether stents that further suppress the arterial response to injury may improve
outcomes in such small vessels is unknown. In this regard, sirolimus-eluting
stents were found in a randomized trial to markedly reduce clinical and angiographic
restenosis in small coronary arteries.15 However,
the lesions treated were mostly focal (mean [SD] length, 11.8 [6.2] mm) in
this study and coverable with a single stent as large as 2.75 mm in diameter,
making direct comparison with the present study difficult.
In prior studies, clinical and angiographic outcomes with 4.0-mm bare
metal stents have been favorable,7-11 questioning
the need for a large vessel drug-eluting stent. Indeed, in the present study,
target lesion revascularization was required in only 5% of patients receiving
4.0-mm bare metal stents, and angiographic restenosis occurred in only 14.4%
of lesions. Nonetheless, paclitaxel-eluting stents further reduced angiographic
restenosis in this cohort by an additional 76% (to 3.5%), and no patient who
received a 4.0-mm stent required target lesion revascularization or developed
stent thrombosis within 9 months. As coronary vessels accommodating 4.0-mm
stents typically supply a large amount of myocardium, minimizing restenosis
in this lesion subset is desirable. However, further studies are required
to determine the cost-effectiveness of drug-eluting stents in large vessels.
Lesions requiring multiple stents for either planned or bailout use
represented the most challenging subgroup enrolled in TAXUS V with an implanted
stent length of more than 43 mm. In this cohort, paclitaxel-eluting stent
assignment was associated with increased periprocedural myonecrosis due mostly
to an excess of non–Q-wave MIs. Detailed angiographic analysis demonstrated
the likely cause to be greater side-branch compromise with paclitaxel-eluting
stents compared with bare metal stents. While the mechanism(s) underlying
this observation remain speculative, possibilities include side-branch narrowing
by thicker polymer-coated stent struts (possibly exacerbated by polymer webbing
or clumping), transient platelet or thrombus deposition, or paclitaxel-induced
spasm. Porcine studies with overlapping paclitaxel-eluting stents demonstrated
delayed reendothelialization without incremental toxicity (unpublished data,
Boston Scientific Corp). Ongoing analyses are attempting to address whether
side-branch compromise is more frequent in the overlap zone or alternatively
reflects implantation of long stents in diffusely diseased vessels. These
data highlight the desirability of preserving major side-branch patency after
drug-eluting stent implantation to prevent periprocedural MI. However, the
prognosis following side-branch occlusion complicating stent implantation
is in general favorable16,17 and
excessive rates of death or stent thrombosis were not evident in patients
treated with multiple paclitaxel-eluting stents. Moreover, among patients
treated with multiple bare metal stents, angiographic and clinical restenosis
by 9 months occurred in nearly 60% and 30%, respectively, remarkably high
failure rates that were reduced by more than half with multiple paclitaxel-eluting
stents. However, larger studies are required to determine whether the increase
in periprocedural MI is associated with an increase in late mortality.
Several limitations of the present study should be acknowledged. First,
the trial was powered to demonstrate a reduction in target vessel revascularization
for the entire study population as a whole. Inferences from underpowered subset
analyses should be considered hypothesis-generating only. However, pooled
analysis of the cohort with complex and previously unstudied lesions demonstrated
a significant reduction in the primary end point of target vessel revascularization
as well as target lesion revascularization and angiographic restenosis with
the paclitaxel-eluting stent, with no statistical heterogeneity between lesion
subgroups, suggesting that the efficacy of the TAXUS stent in enhancing freedom
from clinical and angiographic restenosis extends to these subgroups as well.
However, the trial was underpowered to definitively examine low-frequency
adverse events such as death and stent thrombosis, especially in subsets.
Second, although the clinical follow-up rate in this study was quite high
(97.5%), the results may have varied if no patients had withdrawn or been
lost to follow-up. In a sensitivity analysis performed to evaluate the potential
impact of these patients on the primary end point of target vessel revascularization,
the results were generally unchanged and the treatment effect was robust.
In addition, given the lack of complete angiographic follow-up, the restenosis
rates reported in the present study likely overestimate the true frequency
of recurrence18 (although the 85.6% rate of
follow-up angiography achieved is high for a US-based investigation). Moreover,
the performance of routine angiographic follow-up in most patients also likely
resulted in some cases of repeat angioplasty based on the “oculostenotic
reflex,”18 artificially elevating the
reported rates of target lesion and vessel revascularization (despite attempts
to adjudicate these occurrences). However, in a prior large-scale blinded
investigation of paclitaxel-eluting and bare metal stents, this phenomenon
affected both the active and control stent event rates to an equal degree,4 suggesting that any bias in the present study would
be equally distributed between the 2 groups. Third, further trials are also
required to address patients and lesions excluded from the present study,
such as acute MI, major bifurcation involvement, and diseased saphenous vein
grafts. In addition, the long-term efficacy of drug-eluting stents compared
with coronary artery bypass graft surgery is unknown, with conflicting data
regarding late freedom from adverse events recently reported in patients undergoing
multivessel drug-eluting stent implantation.19,20 Finally,
the results of the present trial apply only to the polymer-based, slow-release
paclitaxel-eluting stent. Comparative trials with the sirolimus-eluting and
emerging drug-eluting stents are required to determine the optimal platform
for specific patient and lesion subtypes.
In conclusion, the TAXUS V trial investigated the use of paclitaxel-eluting
stents in a patient population with more complex lesions than had been previously
studied. Angiographic restenosis and target vessel revascularization were
significantly reduced in the entire cohort, as well as in those patients with
complex disease. Patients receiving multiple paclitaxel-eluting stents had
a significant increase in the rate of early non–Q-wave MI, likely due
to increased rates of side branch compromise. Although the long-term significance
of this observation is unknown, treatment of long lesions with multiple paclitaxel-eluting
stents compared with bare metal stents in the present study resulted in a
marked reduction in clinical and angiographic restenosis with similar late
Corresponding Author: Gregg W. Stone, MD,
Columbia University Medical Center, Herbert Irving Pavilion, Fifth Floor,
161 Fort Washington Ave, New York, NY 10032 (firstname.lastname@example.org).
Author Contributions: Dr Stone had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Stone, Ellis, Koglin,
Acquisition of data: Ellis, Cannon, Mann, Green
berg, Spriggs, O’Shaughnessy, DeMaio, Hall, Popma, K oglin, Russell.
Analysis and interpretation of data: Stone,
Ellis, Hall, Koglin, Russell.
Drafting of the manuscript: Stone.
Critical revision of the manuscript for important
intellectual content: Stone, Ellis, Cannon, Mann, Green berg, Spriggs,
O’Shaughnessy, DeMaio, Hall, Popma, Koglin, Russell.
Statistical analysis: Koglin.
Obtained funding: Koglin, Russell.
Administrative, technical, or material support:
O’Shaughnessy, Hall, Popma, Russell.
Study supervision: Stone, Ellis, Cannon, Greenberg,
Financial Disclosures: Dr Stone is a consultant
to and has received research support from Boston Scientific Corp. Drs Ellis
and DeMaio are consultants to Boston Scientific Corp. Dr Greenberg owns 2500
shares of stock in Boston Scientific Corp. Dr Popma has received research
grants to perform angiographic analysis from Boston Scientific Corp.
Independent Statistical Analysis: Martin Fahy,
MSc, and Yingbo Na, MSc, both from the Cardiovascular Research Foundation,
an affiliate of Columbia University, received the entire trial database and
completed an independent statistical review of every data point. There was
more than 99% concordance with initial analysis. For the minor differences
that were found, the results are reported based on the independent analysis.
TAXUS V Study Organization
Executive Committee: G. Stone (principal investigator),
Columbia University Medical Center and the Cardiovascular Research Foundation,
New York, NY; S. Ellis (co-principal investigator), Cleveland Clinic Foundation,
Cleveland, Ohio; M. Russell, Boston Scientific Corp, Natick, Mass.
Data Monitoring: Bailer Research, San Ramon,
Data Management: Medidata Solutions Inc, New
York, NY, I. Shafer (system manager), K. Sachse (data manager); Boston Scientific
Corp, Natick, Mass.
Biostatistical Analysis: PAREXEL International,
Waltham, Mass, R. Sleith (manager); Boston Scientific Corp, Natick, Mass,
M. Cody (director).
Clinical Events Adjudication Committee: Harvard
Cardiovascular Research Institute, Boston, Mass: D. Cutlip (chair), J. Aroesty,
M. Chauhan, G. DiSciascio, K. Ho, J. Kannam, M. Vandormael.
Data and Safety Monitoring Committee: M. Ohman
(chair), University of North Carolina, Chapel Hill; D. Simon, Brigham and
Women’s Hospital, Boston, Mass; M. Lauer, Cleveland Clinic, Cleveland,
Ohio; J. Zidar, Duke Cardiology of Raleigh, Raleigh, NC; J. Miller, Johns
Hopkins Hospital, Baltimore, Md; V. Hasselblad, Duke Clinical Research Institute,
Angiographic Core Laboratory: Brigham and Women’s
Hospital, Boston, Mass, J. Popma (director).
Intravascular Ultrasound Imaging Core Laboratory: Washington Hospital Center, Washington, DC, N. Weissman (director).
Study Sites and Principal Investigators
Alabama: Baptist Medical Center Montclair (J.
Eagen); Baptist Medical Center (V. Goli); University of Alabama Cardiology
(V. Misra). Arizona: Arizona Heart Institute (R.
Strumpf). California: Mercy General Hospital (M.
Chang); Stanford Medical Center (A. Yeung); University of California–Davis
Medical Center (R. Low). Colorado: Aurora-Denver
Cardiology Associates (B. Molk). District of Columbia:
Washington Hospital Center (L. Satler). Florida:
Morton Plant Hospital (D. Spriggs, P. Cambier); Miami Heart Institute (K.
Coy); Florida Hospital (J. Greenberg); JFK Medical Center (J. Midwall); Mediquest
Research Group (R. Feldman). Georgia: St Joseph’s
Hospital of Atlanta (W. Knapp); Emory University Hospital (J. Douglas); Fuqua
Heart Center (W. Jacobs). Illinois: Evanston Hospital
(T. Feldman); Midwest Heart Foundation (P. Kerwin). Louisiana: Oschner Foundation Hospital (J. Reilly). Kansas: Shawnee Mission Medical Center (P. Kramer). Kentucky: Central Baptist Hospital (M. Jones). Maine:
Maine Medical Center (M. Kellett). Maryland: Washington
Adventist Hospital (M. Turco). Massachusetts: Massachusetts
General Hospital (I. Palacios); Tufts New England Medical Center (C. Kimmelstiel);
Lahey Clinical Hospital (R. Nesto); University of Massachusetts Memorial Medical
Center (M. Furman). Michigan: Cardiac and Vascular
Research Center of Northern Michigan (L. Cannon); William Beaumont Hospital
(W. O’Neill); Spectrum Health Hospital (R. McNamara). Minnesota: Abbott Northwestern Hospital (M. Mooney); Mayo Clinic (G.
Barsness). Missouri: Barnes Jewish Hospital (M. Taniuchi);
St Luke’s Hospital (B. Rutherford). North Carolina: Forsyth Memorial Hospital (J. Patterson); LeBauer Cardiovascular
Research Foundation (T. Stuckey); Mid Carolina Cardiology (D. Cox); Wake Forest
University Health Sciences (M. Kutcher); WakeMed (J. Mann). New York: Albany Medical Center (A. DeLago); Buffalo General Hospital
(A. Masud); Lenox Hill Hospital (S. Iyer); Mount Sinai Medical Center (S.
Sharma); New York Presbyterian Hospital (S. Wong); Rochester General Hospital
(J. Doling); St Francis Hospital (R. Schlofmitz, R. Timmermans). New Jersey: Hackensack University Medical Center (V. Sethi); St Michael’s
Medical Center (J. DeGregorio). Ohio: Cleveland Clinic
Foundation (R. Russell); Linder Clinical Trial Center (D. Kereiakes); Midwest
Cardiology Research Foundation (S. Yakubov); North Ohio Research (C. O’Shaughnessy). Oklahoma: Oklahoma Heart Hospital (T. McGarry). Pennsylvania: St Mary’s Medical Center (G. Heyrich). Rhode Island: Miriam Hospital (P. Gordon). South
Carolina: South Carolina Heart (M. Foster). Tennessee: St Thomas Hospital (R. Wheatley). Texas:
Cardiovascular Research Institute of Dallas (T. Das); South Austin Hospital
(S. DeMaio); University of Texas Houston Health Science Center (R. Smalling). Washington: Swedish Medical Center (M. Reisman). Wisconsin: St Luke’s Medical Center (T. Vellinga). Utah: Utah Valley Regional Medical Center (R. Badger). Virginia: Sentara Norfolk General Hospital (R. Stine);
University of Virginia Cardiology (E. Powers).
Funding/Support: This study was sponsored and
funded by Boston Scientific Corp, Natick, Mass.
Role of the Sponsor: The sponsor was involved
in the design and conduct of the study, collection, management, initial analysis
and interpretation of the data, and had the right to a nonbinding review of
the manuscript. Approval of the sponsor was not required prior to manuscript
Disclaimer: Michael Lauer, MD, was not involved
in the editorial evaluation or decision making regarding publication of this
article or in the editing of the accepted manuscript.
Create a personal account or sign in to: