Trial Design

Rationale and design of the Coronary

Computed Tomographic Angiography for
Selective Cardiac Catheterization: Relation to
Cardiovascular Outcomes, Cost Effectiveness
and Quality of Life (CONSERVE) trial
Sang-Eun Lee, MD, a Fay Y. Lin, MD, b Yao Lu, MA, b Hyuk-Jae Chang, MD, a and James K. Min, MD b Seoul, South
Korea and New York, NY

Background Although coronary computed tomography angiography (CCTA) has shown promise as a “gatekeeper” to
invasive coronary angiography (ICA) in longitudinal cohort studies, it remains unknown whether the strategy of selective ICA
by initial performance of CCTA is either safe or effective when compared with a direct ICA strategy in patients with an
American Heart Association (AHA)/American College of Cardiology (ACC) guideline–directed indication for ICA.
Objectives The CONSERVE trial is a prospective randomized multicenter trial to determine the clinical effectiveness of
“selective catheterization” vs “direct catheterization” strategies for stable patients with suspected but without known coronary
artery disease, who meet AHA/ACC guideline indication for ICA.
Methods Patients being referred for clinically indicated nonemergent ICA with an AHA/ACC class II guideline indication
for ICA will be randomized to either direct catheterization or selective catheterization strategy. Patients in the direct
catheterization arm will proceed directly to ICA as planned, whereas patients in the select catheterization arm will undergo
initial CCTA, followed by ICA at the discretion of the site physician. All CCTAs and ICAs will be interpreted on site. Follow-up
testing and/or therapy after CCTA or ICA will be at the discretion of the site physician.
Results This trial will report a primary clinical end point of noninferiority rates of major adverse cardiac events, as defined by
the composite of death, nonfatal myocardial infarction, unstable angina, stroke, urgent or emergent coronary revascularization, or
cardiac hospitalization.
Conclusion The CONSERVE trial will determine whether selective catheterization strategy, based on initial CCTA in
patients being referred to ICA, is safe and effective. (Am Heart J 2017;186:48-55.)

Invasive coronary angiography (ICA) is a commonly
used diagnostic test, with almost 4 million tests per-
formed per year in the United States alone. 1-3 It is widely
From the aDivision of Cardiology, Severance Cardiovascular Hospital, Integrative
Cardiovascular Imaging Center, Yonsei University College of Medicine, Yonsei University
Health System, Seoul, South Korea, and bDalio Institute of Cardiovascular Imaging, New
York–Presbyterian Hospital and Weill Cornell Medical College, New York, NY.
Funding sources: This research was supported by Leading Foreign Research Institute
Recruitment Program through the National Research Foundation of Korea funded by the
Ministry of Science, ICT & Future Planning (2012027176), and MDDX—San Francisco.
RCT No. NCT01810198
Submitted April 19, 2016; accepted December 18, 2016.
Reprint requests: Hyuk-Jae Chang, MD, Division of Cardiology, Severance Cardiovascular
Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine,
Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 120-752, South Korea.
E-mails: hjchang@yuhs.ac, jkm2001@med.cornell.edu, trials.jkm@gmail.com
0002-8703
© 2016 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ahj.2016.12.007
considered as the criterion standard for diagnosis of
anatomical coronary artery disease (CAD), is the final step
in the diagnostic workup of patients with suspected CAD,
and is performed to determine the need for coronary
revascularization. 4 After ICA, patients with high-risk
obstructive CAD who undergo revascularization experi-
ence a decided improvement in quality of life and
event-free survival. 5 Although American Heart Associa-
tion (AHA)/American College of Cardiology (ACC)
clinical practice guidelines offer direction for selection
of patients for ICA, recent data suggest that this approach
misclassifies a significant proportion of patients who are
found not to have obstructive CAD at the time of ICA. 2,6
Rates of nonobstructive CAD range between 39.7% and
62.4% in the ACC National Cardiovascular Data Regis-
try. 1,2,6 For these patients, ICA is an unnecessary,
expensive, and invasive procedure that subjects
American Heart Journal
Volume 186
individuals to potential harm through periprocedural
complications and radiation exposure.
Even for many patients with obstructive CAD, ICA may not
always be beneficial. 7-9 The temporal coupling of ICA with
the ability to perform percutaneous coronary intervention
(PCI) has resulted in the widespread use of ad hoc PCI, or
PCI performed at the time of the ICA. 10,11 This “diagnos-
tic-therapeutic cascade” has resulted in increasing rates of
PCI for indications contrary to AHA/ACC guidelines, for less
severe forms of CAD, for nonmedical reasons, and at a $2
billion excess annual cost to the US health care system by
conservative estimates. 12-14
Since Because the introduction of noninvasive angiogra-
phy by 64–-detector row coronary computed tomography
angiography (CCTA), numerous studies suggest its potential
utility as a “gatekeeper” to ICA, given its ability to accurately
exclude obstructive CAD and thus identify individuals who
may not require ICA. 15,16 The prospective multicenter
ACCURACY study evaluated patients without known CAD,
who were referred for ICA, demonstrating a 99% negative
predictive value of CCTA for exclusion of obstructive CAD;
this finding has been confirmed by numerous studies. In the
multinational CONFIRM CCTA registry of nearly 25,000
patients without known CAD, those with “negative” CCTAs
experienced very favorable 3-year event-free survival (99%)
with very low associated rates of ICA (2.5%). 17-19 Although
these hypothesis-generating results offer promise for the use
of CCTA as a gatekeeper to ICA, it remains unknown
whether the strategy of selective catheterization by initial
performance of CCTA, as compared with direct catheteri-
zation, is either safe or effective. 20
This question is a contemporary and highly relevant topic.
In a recent proposed national coverage determination, the
Centers for Medicare Services emphasized the importance
of answering the question, “does coronary CTA reduce the
need for ICA?” Similarly, the Medicare Coverage Advisory
Committee released an Evidentiary Priorities List that
highlighted the question, “how cost effective is CT
angiography?” 21,22 The proposed trial will directly address
these important questions, and its findings will significantly
impact the approach to diagnosis, risk stratification, and
treatment for millions of individuals with suspected CAD. 14
Overall study design
The CONSERVE trial is a prospective randomized
controlled multicenter trial to determine the clinical
effectiveness of a “selective catheterization” strategy vs a
“direct catheterization” strategy for stable patients with
suspected but without known CAD and clinical indica-
tion for n onemergent ICA (clinicaltrials.gov
NCT01810198). Patients in the selective catheterization
arm will be followed up for a primary end point of
noninferiority for rates of major adverse cardiac events
(MACEs) as compared withpatients in the direct cathe-
terization strategy. A total of 1,600 patients will be
Lee et al 49
enrolled (1,100 from Korea and 500 from non-Korea) and
will be randomized in a 1:1 scheme to either direct
catheterization or selective catheterization. Figure depicts
the schematic summary of the trial design.
Study objectives
Primary objective
The primary objective of the CONSERVE study is to
determine the safety, costs, and effectiveness of a
CCTA-guided selective catheterization strategy for stable
patients but without known CAD and an AHA/ACC class
II indication for nonemergent ICA. Class I indications
were not included because they were thought to be
necessary, whereas class III indications were not included
because they were thought to be contraindicated.
The primary end point is the time to first occurrence of a
composite of MACE, inclusive of the following: death,
nonfatal myocardial infarction, unstable angina (including
new-onset angina or those requiring hospitalization, revas-
cularization, or that are troponin positive), stroke, urgent or
emergent coronary revascularization, or cardiovascular
hospitalization (including for angina, heart failure, or other).
Primary hypothesis
The hypothesis of the CONSERVE trial is that among
stable individuals with suspected but without known
CAD, a selective catheterization strategy, as compared
with a direct catheterization strategy, will result in a
noninferior rate of MACE.
Secondary objectives
Secondary clinical end points included the primary MACE
end point plus major bleeding, need for urgent or emergent
surgery due to hemorrhage and major transfusion.
The secondary economic objective will compare within-
trial cardiovascular costs, inclusive of index- and down-
stream CAD–related costs related to diagnostic testing,
medications, hospitalizations, emergency department visits,
outpatient visits, and coronary revascularizations. Costs will
also include non–CAD-related but test-related costs.
The secondary safety objective will be a comparison of the
rates of serious test-related complications, including
contrast-induced nephropathy, hematoma requiring transfu-
sion, arteriovenous fistula, aneurysm formation, retroperito-
neal bleed, arterial dissection, and any surgery for test-related
complications. The ICA normalcy rates will be compared.
Tertiary objectives
Tertiary objectives will include a quality of life objective, as
well as a safety objective. The quality of life tertiary end point
will be a comparison of general and angina-specific quality of
life, as measured by the EuroQol 5-Dimensions (EQ-5D) Health
Survey and Seattle Angina Questionnaire, respectively. The
safety tertiary objective will be a comparison of the cumulative
CAD test–related effective biological radiation doses.

50 Lee et al
Figure
CONSERVE study design. CACS indicates coronary artery calcium scoring.
Targeted population
The CONSERVE target population is patients with suspected
but not known CAD who are referred for nonemergent
clinically indicated ICA. Patients who meet all inclusion criteria
and no exclusion criteria detailed in Table will be enrolled.
Efficacy analyses
Primary efficacy analyses
The primary statistical measure will be time to first
occurrence of MACE, defined as time from study
enrollment to the earliest of death, nonfatal myocardial
infarction, unstable angina, stroke, urgent or emergent
coronary revascularization, or cardiovascular hospitaliza-
tion. A Cox proportional hazards model will be generated
to compare MACE-free survival between the selective
catheterization and direct catheterization arms.
Statistical hypothesis and tests of primary statistical
measures
The null and alternative hypotheses that the CONSERVE
study will test are the following:
H0. HRselective cath/HRdirect cath ≤ 1.33
H1. HRselective cath/HRdirect cath N 1.33
where HR is the hazard ratio for MACE in the selective
catheterization and direct catheterization groups, respec-
tively. The above clinical hypotheses will be tested using
a 1-sided .05 type I error rate.
Definition of successful demonstration of primary objective
The primary end point of CONSERVE will be success-
fully demonstrated if the 1-year MACE HR of the selective
American Heart Journal
April 2017
catheterization arm is no N1.33 higher than that in the
direct catheterization arm.
Secondary and tertiary analyses
Secondary outcomes will also include components of the
primary composite MACE end point, combined with major
bleeding, with major bleeding and need for urgent/
emergent surgery due to hemorrhage, and with major
bleeding, need for urgent/emergent surgery due to
hemorrhage, and need for major transfusion. Cox propor-
tional hazards models will be generated to compare
MACE-free survival, as defined above, between the
selective catheterization and direct catheterization arms.
The secondary economic end point will be within-trial
cardiovascular costs, including index- and downstream
CAD–related costs related to diagnostic testing, medica-
tions, hospitalizations, emergency department visits,
outpatient visits, and coronary revascularizations. The
tertiary economic end point will compare total health
care costs, including both CAD and non-CAD costs. These
will include, but not be limited to, additional downstream
testing (eg, follow-up CT for pulmonary nodules, etc). To
reduce variance introduced by differing health systems,
costs for each arm will be estimated using diagnosis
related group charges from the Centers for Medicare
Services Web site. Outpatient visit costs and procedure
costs will be obtained using reimbursement rates listed by
the Centers for Medicare Services. Medication costs will
be estimated by averaging generic medication costs
within each medication category. Comparisons between
the study arms will be made using the Wilcoxon rank sum
test (Mann-Whitney U test) for superiority.
The secondary safety end point will be a comparison of
the rates of serious test-related complications, including
American Heart Journal
Volume 186
Lee et al 51

Table. Inclusion and exclusion criteria

Inclusion criteria include AHA/ACC class II indications for ICA

1) Moderate or severe angina, which improves to mild with medical therapy

2) Mild or moderate angina, which is intolerant to medical therapy
3) Any angina, not evaluable by noninvasive stress testing
4) Heart failure with normal ejection fraction of unknown etiology
5) Symptomatic (chest pain) + abnormal NIST
6) Asymptomatic + 2 RF + abnormal NIST
7) Worsening NIST
8) Recurrent hospitalization for chest pain + abnormal/equivocal NIST
9) Low-risk surgery, stable angina
10) Low-risk surgery, medically stabilized moderate or severe stable angina
11) High-risk surgery with equivocal NIST
12) Asymptomatic, high-risk occupation
13) Vascular surgery with N2 RF
14) Perioperative MI
15) High risk for coronary disease when other cardiac surgical procedures are planned (eg, pericardiectomy or removal
of chronic pulmonary emboli)
16) Prospective immediate cardiac transplant donors whose risk profile increases the likelihood of coronary disease
17) Asymptomatic patients with Kawasaki disease who have coronary artery aneurysms on echocardiography
18) Before surgery for aortic aneurysm/dissection in patients without known coronary disease
19) Recent blunt chest trauma and suspicion of acute MI, without evidence of preexisting CAD

Exclusion criteria

1) Known CAD (past MI, PCI, CABG, or diagnosed by cardiac catheterization without intervention)
2) Acute coronary syndrome or MI at time of enrollment
3) Planned intervention or bypass surgery
4) Known complex congenital heart disease
5) Planned invasive angiography for reasons other than CAD
6) Noncardiac illness with life expectancy b2 y
7) Inability to provide written informed consent
8) Concomitant participation in another clinical trial in which patient is subject to investigational drug or device
9) Pregnant women
10) Allergy to iodinated contrast agent
11) Serum creatinine N1.5 mg/dL or GFR b30 mL/min
12) Baseline irregular heart rhythm
13) Heart rate ≥100 beats/min
14) Systolic blood pressure ≤90 mm Hg
15) Contraindications to β-blockers or nitroglycerin
16) Body mass index N35 kg/m 2
17) Known complex congenital heart disease
18) Age b18 y
Abbreviations: NIST, National Institute of Standards and Technology; RF, risk factor; MI, myocardial infarction; CABG, coronary artery bypass graft; GFR, glomerular filtration rate.

contrast-induced nephropathy, hematoma requiring trans-
fusion, arteriovenous fistula, aneurysm formation, retro-
peritoneal bleed, arterial dissection, and any surgery for
test-related complications. The ICA normalcy rates will be
compared. Comparisons will be made between the 2 arms
using Fisher exact test.
Tertiary quality of life end points include general and
angina-specific quality of life, as measured by the EuroQol
5-Dimensions (EQ-5D) Health Survey and Seattle Angina
Questionnaire, respectively. The quality of life question-
naires will be scored using previously published scoring
techniques and each dimension will be compared between

52 Lee et al
the 2 arms using a t test or Wilcoxon rank sum test, as
appropriate. 23,24 The tertiary safety end point will be
cumulative CAD test–related effective biological radiation
dose. Comparisons will be made between the 2 arms using
a t test or Wilcoxon rank sum test, as appropriate.
Efficacy population
All efficacy analyses will be performed on an inten-
tion-to-treat basis. For all efficacy analyses of this trial,
patients will be analyzed with their intention-to-treat arm.
The as-treated population will be based on the treatment
the patient actually receives and will only be used for
adverse event and post hoc analyses.
Sample size determination and statistical
power
The initial protocol initially specified enrollment of
1,463 patients for 48-month follow-up assuming 10%
dropout and an annualized event rate of 5.2% for 80%
power to detect a noninferiority multiplicative margin of
1.33, based on the event rates of the COURAGE trial. 7 The
protocol was amended on October 22, 2015 to enroll
1,600 patients and curtail follow-up to a median of 12
months, based on study funding considerations, as well as
the Data Safety and Monitoring Board's recommendation
of a 12-month follow-up as more reflective of the episode
of care that prompted the initial referral to ICA. No
further follow-up of patients will be performed, also
because of study funding considerations.
In a post hoc power calculation, using a null annual
composite event rate of 4.6% and a noninferiority
multiplicative margin of 1.33 (or noninferiority margin
of 0.0155), a noninferiority test of the difference between
hazard rates with an overall sample size of 1,500 patients
achieves 65% power at a .050 significance level to detect
noninferiority when the actual difference in hazard rates
is 0.000 (0.047 in the treatment minus 0.047 in the
control group). This assumes that data were approxi-
mately exponentially distributed, with uniform accrual
N2.5- and 1-year follow-up. Increasing the sample size to
1,600 will permit 5% loss to follow-up in each study arm.
The noninferiority margin is based on contemporary rates
of complications due to angiography. 25,26 A hypothesis of
noninferiority allows us to evaluate the safety of a
selective catheterization strategy compared with a direct
catheterization strategy; the standard of care that the
patients in the trial would have otherwise undergone.
Potential benefits to study participants
This prospective multicenter randomized controlled
trial will assess the clinical and economic effectiveness of
a CCTA-guided selective catheterization strategy for
stable patients suspected of having CAD and who have
American Heart Journal
April 2017
an AHA/ACC class II indication for ICA. Individuals
participating in the present study will initially undergo
the following procedures: (1) ICA (direct catheterization
strategy) or (2) initial CCTA (selective catheterization
strategy) followed by ICA if deemed clinically indicated.
Prior studies have revealed that approximately
two-thirds of patients referred for cardiac catheterizations
have no or mild angiographic CAD and thus may not need
to undergo ICA. It is thus expected that enrolled patients
within CONSERVE who undergo a CCTA as part of trial
protocol may be identified as not having obstructive
CAD. Given the high negative predictive value of CCTA to
exclude obstructive CAD, a significant majority may thus
avoid the need for an invasive and expensive cardiac
catheterization. The decision to proceed to ICA after
CCTA performance will be left solely to the discretion of
the patient and treating physician, but may result in the
clinically appropriate avoidance of invasive cardiac
catheterization in a large proportion of screened patients.
Patient follow-up
Follow-up visit intervals are as follows: 30 (±7) days, 3
months (90 ± 14 days), 6 months (180 ± 14 days), 12
months (365 ± 30 days), and annually thereafter. A final
follow-up visit will be scheduled for each patient at the
conclusion of the study. Follow-ups will be performed
either by inpatient visit or by telephone.
Organization and quality assurance of
testing
Each participating center will receive local institutional
review board approval of the study protocol before enrolling
patients. All patients will provide written informed consent
before trial participation. Completed electronic case report
forms will be entered by sites and checked locally for
possible errors or omissions. Electronic case report forms
will be transmitted to a central data repository at the Clinical
and Data Coordinating Center (CDCC).
The CDCC will qualify all investigators by determining
the following: knowledge and experience level with
standard-of-care CCTA scanning and ICA procedures,
adequate patient population to enroll within the sched-
uled timeline, and the presence of an established clinical
research department. Completion of these requirements
will be documented via a site qualification questionnaire
or equivalent, along with documentation of investigator
experience and background.
All CCTA images will be sent to a core laboratory for
image analysis. The core laboratory will perform semi-
quantitative analysis for accuracy of CCTA. Within-trial
clinical decision making will be based on site interpreta-
tion of CCTA, rather than CCTA Core Laboratory
interpretation. The CCTA Core Laboratory interpretation
will be used for post hoc analyses.
American Heart Journal
Volume 186
Clinical event ascertainment and patient
safety
To ensure patient safety, an independent Data Safety
Monitoring Board (DSMB) will be responsible for safe-
guarding the interests of trial participants, assessing the
safety and efficacy of the interventions during the trial
and monitoring overall conduct of the clinical trial. The
DSMB will provide recommendations about stopping or
continuing the trial and base termination on the
occurrence of clinical end points. To contribute to
enhancing the integrity of the trial, the DSMB may also
formulate recommendations relating to the selection or
recruitment of participants, their management, improv-
ing adherence to protocol-specified regimens, and the
procedures for data management and quality control.
The DSMB is specifically charged with making recom-
mendations, as appropriate, about the following: (1)
patient safety; (2) efficacy of the study intervention for
DSMB purposes only; (3) benefit/risk ratio of procedures
and participant burden; (4) selection, recruitment, and
retention of participants; (5) adherence to protocol
requirements; (6) completeness, quality, and analysis of
measurements; (7) amendments to the study protocol
and consent forms; (8) performance of individual centers
and core laboratories; and (9) notification of and referral
for abnormal findings.
A clinical events committee (CEC) will be established.
The CEC will be blinded to allocation and will review and
adjudicate any data requested by the CDCC or DSMB. The
CEC will also review primary and secondary end points.
Preparation of event summaries at the CDCC will be done
for review and adjudication by the CEC. After review of
the identified events by a Clinical Reviewer, support
documentation for identified events will be obtained
from the site and a summary will be written to describe
the significant details of the event. These summaries, with
appropriate support documentation, will be forwarded to
(and used by) the physician members of the CEC to
determine the relationship of the event to study
treatment. The adjudicated results will be returned to
the CDCC and added to the DSMB database.
Funding and authorship
The CONSERVE study is supported by the National
Research Foundation of Korea and MDDX—San Francisco.
The authors are solely responsible for the design and
conduct of this study, all study analyses, and the drafting
and editing of the manuscript and its final contents.
Discussion
This prospective multicenter randomized trial aims to
determine the safety and efficacy of a direct catheteriza-
tion vs a selective catheterization strategy for stable
patients without known but with suspected CAD who are
Lee et al 53
being referred to ICA based on a class II indication from
the AHA/ACC guidelines. The performance of such a trial
will inform the health care system as to the clinical
outcomes of initial performance of noninvasive angiog-
raphy by CCTA for individuals who have been historically
referred for invasive procedures.
There are many criteria within this trial design that offer
maximal information gain. First, this design enables the
determination of test efficacy rather than test accuracy.
Rather than directly comparing CCTA to ICA for test
accuracy, the CONSERVE trial has been designed as a
pragmatic comparative effectiveness trial that will test a
strategy of initial performance of CCTA for comprehensive
assessment of clinical outcomes. If proven successful and
the secondary end point of cost superiority is shown, this
trial may have important implications regarding the
downstream use of coronary revascularization. Given the
diagnostic-therapeutic cascade wherein a strong relation-
ship exists between rates of ICA and ad hoc PCI, the
introduction of a noninvasive CCTA strategy that uncou-
ples the diagnosis of CAD from the ability to perform
potentially unnecessary PCI may reduce rates of excess
PCI, test-related complications, radiation burden, and costs.
The CONSERVE study will add important complementa-
ry data to several smaller studies of different noninvasive
tests as gatekeepers to invasive angiography that were
recently published after completion of CONSERVE trial
enrollment. The CeCAT randomized controlled trial
demonstrated in 898 patients for 6 years that the stress
testing arm as a whole resulted in no overall differences in
MACE, total costs, or quality of life, despite a small
reductions in referral to ICA by 20% to 25%. 27 The planned
ICA arm of the PLATFORM trial demonstrated in 380
patients that a related technology, fractional flow reserve
(FFR) computed tomography, reduced rates of cath
normalcy but had only 3 events to evaluate safety. 28,29
However, the CONSERVE trial aims to fill the many gaps in
knowledge that remain. Most importantly, we argue that
without a noninferiority trial to prove safety, it would be
difficult for physicians to justify adoption of a selective
catheterization strategy. In addition, the benefit of a
selective catheterization strategy based on CCTA alone,
which is much more widely available and generalizable
than FFRCT, is not yet determined. The utility of a selective
catheterization strategy in all ACC/AHA class II indications
for ICA, and not only in patients with intermediate
likelihood CAD, has not been evaluated. In addition, the
relative costs of each strategy, inclusive of testing costs and
downstream care, are not known. The CONSERVE trial is
designed specifically to answer these important clinical
questions. Although funding considerations preclude
longer follow-up or larger sample size for greater statistical
power, CONSERVE will still be the largest study to date to
answer these important questions.
Furthermore, the results of this trial may allow for
contemporary revision of pretest likelihood estimates of

54 Lee et al
CAD and risk in patients being considered for ICA.
Determination of need for diagnostic testing relies on
pretest likelihood estimates of obstructive CAD that were
developed almost 40 years ago, at a time when smoking
was common and contemporary medical therapy did not
exist. Significant differences in CAD prevalence may exist
today, and revision of these estimates may significantly
reduce the referral of patients not only to ICA but also to all
diagnostic testing. The proposed trial will also allow for
development of clinical risk scores, which may enhance
targeting of therapies to patients who will benefit most.
The international setting allows for evaluation of the
generalizability of the results across different ethnicities,
health systems, and prevalences of disease for the same
group of indications for cardiac catheterization. Explor-
atory subgroup analyses may permit future evaluation of
differences in clinical characteristics, outcomes, and
costs between sites and health systems. Exploratory
analyses of cost effectiveness and downstream costs
exclusive of the index test may also be performed.
Finally, other significant public health issues will be
directly addressed by the CONSERVE trial, such as access
to care and population radiation burden. These issues not
only are patient-centered but also relate to significant
potential societal benefits. Indeed, if our hypotheses are
correct, the adoption of the selective catheterization
strategy will result in a potential annual health care
savings and without affecting the incidence of adverse
events associated with invasive procedures.
New knowledge gained
Systematic determination of the clinical effectiveness,
safety, economic efficiency, and quality of life of a selective
catheterization strategy holds the potential to shift the
paradigm of CAD assessment for patients with suspected
CAD who are referred to ICA, with aims at bringing about
similar or improved clinical outcomes while reducing rates
of unnecessary testing and invasive procedures as well as
health care costs. We believe that the proposed trial is
properly designed to answer these important questions in
the most efficient manner, and the results of this trial will
directly impact clinical practice patterns for millions of
patients in the United States annually.
Disclosures
Dr Min serves on the medical advisory boards of
Heartflow and Arineta and owns equity interest in
MDDX, Inc, and AutoPlaq.
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