Download Finding the Optimum in the Use of Elective Percutaneous Coronary

Clinical Review
Finding the Optimum in the Use of Elective
Percutaneous Coronary Intervention
Preston M. Schneider, MD, and Steven M. Bradley MD, MPH
Abstract
• Objective: To review the use of elective percutaneous
coronary intervention (PCI), evaluate what is currently
known about elective PCI in the context of appropriate
use criteria, and offer insight into next steps to optimize
the use of elective PCI to achieve high-quality care.
• Methods: Review of the scientific literature, appropriate use criteria, and professional society guidelines
relevant to elective PCI.
• Results: Recent studies have demonstrated as many
as 1 in 6 elective PCIs are inappropriate as determined by appropriate use criteria. These inappropriate PCIs are not anticipated to benefit patients and result in unnecessary patient risk and cost. While these
studies are consistent with regard to overuse of elective PCI, less is known about potential underuse of
PCI for elective indications. We lack health status data
on populations of ischemic heart disease patients to
inform PCI underuse that may contribute to patient
symptom burden, functional status, and quality of life.
Optimal use of PCI will be attained with longitudinal
capture of patient-reported health status, study of factors contributing to overuse and underuse, refinement
of the appropriate use criteria with particular focus
on patient-centered measures, and incorporation of
patient preference and shared decision making into
appropriateness evaluation tools.
• Conclusion: The use of elective PCI is less than optimal in current clinical practice. Continued effort is
needed to ensure elective PCI is targeted to patients
with anticipated benefit and use of the procedure is
aligned with patient preferences.
P
roviding the right care to the right patient at the
right time is essential to the practice of highquality care. Reducing overuse of health care
services is part of this equation, and initiatives to reduce
inappropriate use and to encourage physicians and patients to “choose wisely” have been introduced [1]. One
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procedure that is being examined with a focus on appropriateness is percutaneous coronary intervention (PCI).
This procedure is common (nearly 1 million inpatient
PCI procedures performed in 2010), presents risks to the
patient, and is expensive (attributable cost approximately
$10 billion in 2010) [2,3]. While the clinical benefit of
PCI in acute settings such as ST-segment elevation myocardial infarction is well established [4], the benefit of
PCI in nonacute (elective) settings is less robust [5–7].
Prior studies have demonstrated PCI for stable ischemic
heart disease does not result in mortality benefit [6].
Furthermore, PCI as an initial strategy for symptom
relief of stable angina may offer little benefit relative
to medications alone [5]. Given that PCI is common,
costly, and associated with both short- and long-term
risks [8,9], ensuring this therapy is provided to the right
patient at the right time is important.
In 2009, appropriate use criteria (AUC) were developed by 6 professional organizations to support the
rational and judicious use of PCI [10]; a focused update
was published in 2012 [11]. In this review, we discuss the
recommendations for appropriate use and their application and offer thoughts on next steps to optimize the use
of elective PCI as part of high-quality care.
Variation in the Use of PCI
Since 1996, the Dartmouth Atlas of Health Care has
documented substantial geographic variation in health
care utilization and spending in the United States [12].
This variation includes a 10-fold difference in the use of
PCI across geographic regions [13] (Figure 1). Several
studies have suggested that much of this variation reflects
overuse. For example, in a cohort study of patients with
From the VA Eastern Colorado Health Care System, University of Colorado School of Medicine, and the Colorado Cardiovascular Outcomes Research Group, Denver and
Aurora, CO.
Vol. 21, No. 6 June 2014 JCOM 281
Appropriateness of Elective PCI
Ratio of Rates of Percutaneous
Coronary Interventions to the
U.S. Average, 2003
1.30 to 3.73 (42)
1.10 to < 1.30 (54)
0.90 to < 1.10 (94)
0.75 to < 0.90 (63)
0.32 to < 0.75 (53)
Not populated
Figure 1. Rate ratios by hospital referral region for percutaneous coronary intervention in 2003. Number of hospital referral
regions shown in parentheses. (Courtesy of the Dartmouth Atlas of Health Care [13].)
acute myocardial infarction, patients who lived in regions
with lower health care expenditures were more likely to
receive guideline-recommended medications at discharge,
had similar access to follow-up care, reported similar functional health status and satisfaction with care, and had
lower mortality than patients in high-expenditure regions
[14,15]. These findings suggest overuse, as higher healthcare expenditures were not associated with better quality
of care or patient outcomes.
Additionally, significant public attention has been focused on the issue of overuse after lay press investigations
into community practice patterns. In particular, a case
study presented in the New York Times highlighted the
community of Elyria, Ohio, which was found to have a
PCI rate that was 4 times the national average [16]. This
investigation sparked public debate and further focused
attention on the issue of overuse of elective PCI. Conversely, others have pointed to data that suggest underuse
of coronary procedural care, particularly among women
and racial and ethnic minorities [17–22].
Appropriate Use Criteria
Development Methodology
AUC for PCI, which were developed through the collaborative efforts of 6 major cardiovascular professional
282 JCOM June 2014 Vol. 21, No. 6
organizations, are intended to support the effective,
efficient, and equitable use of PCI [10,11]. They were
developed in response to a growing need to support
rational use of cardiovascular procedures as part of highquality care. The methods of development for the AUC
have been described in detail in the criteria publications
[10,11]. We briefly review these methods here.
In developing the criteria, a writing group created
clinical scenarios for which coronary revascularization
might be considered in everyday clinical practice [23]
(Figure 2). These clinical scenarios were then presented
to a 17-member technical panel, members of which were
nominated by national cardiology societies. Technical
panel members then rated the appropriateness of PCI for
each scenario based on randomized trial data, clinical
practice guidelines, and their expert opinion. For purposes of AUC development, appropriateness was defined
as “when the expected benefits, in terms of survival or
health outcomes (symptoms, functional status, and/or
quality of life) exceed the expected negative consequences of the procedure [10].”
Panel members first individually assigned ratings to
each clinical scenario that ranged from 1 (least appropriate) to 9 (most appropriate). This was followed by an
in-person meeting in which technical panel members
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Clinical Review
Literature review and synthesis of the evidence
List of indications and definitions
Appropriateness Determination
Expert panel assigns appropriateness ratings (range, 1–9) in 2 rounds
1st Round – No interaction
2nd Round – Panel interaction
Appropriateness Scores
(7–9) Appropriate
(4–6) Uncertain
(1–3) Inappropriate
Figure 2. Appropriate use criteria development. (Adapted from reference 23.)
discussed scenarios for which there was wide variation in
appropriateness assessment. After this meeting, technical
panel members again assigned ratings for each scenario
from 1 to 9. After this second round, the median values for
the pooled ratings were used as the appropriateness classification for each scenario. Scenarios with median values
of 1–3 were classified as “inappropriate,” 4–6 as “uncertain,” and 7–9 as “appropriate.” A rating of “appropriate”
represented clinical scenarios in which the indication is
considered generally acceptable and likely to improve
health outcomes or survival. A rating of “uncertain”
represented clinical scenarios where the indication may
be reasonable but more research is necessary to further
understand the relative benefits and risks of PCI in this
setting. Finally, a rating of “inappropriate” represented
clinical scenarios in which the indication is not generally
acceptable as it is unlikely to improve health outcomes or
survival.
The approach used for AUC development appears to
be valid, as Class III indications for PCI in the ACC/
AHA clinical guideline [24] (Class III = PCI should
NOT be performed since it is not helpful and may be
harmful) and AUC scenarios rated as inappropriate are
in 100% agreement (personal communication, Ralph
Brindis, past president of the American College of Cardiology).
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Application
It is important to remember that the AUC are intended
to aid in patient selection and are not absolute. Unique
clinical factors and patient preference cannot feasibly be
captured by the AUC scenarios. It should also be noted
that the intent of the AUC is not to be punitive but rather
to identify and assess variation in practice patterns. To
reflect this intent, the terminology applied to appropriateness ratings has recently changed. Clinical scenarios
previously classified as “inappropriate” are now termed
“rarely appropriate” and clinical scenarios classified as
“uncertain” are now termed “may be appropriate.”
Although the AUC were developed to help evaluate
practice patterns of care delivery and serve as guides
for clinical decision making, they were not intended to
serve as mandates for or against treatment in individual
patients or to be tied to reimbursement for individual
patients. Despite this, health care organizations and
payors have used other AUC documents for incentive pay
and prior authorization programs, specifically for cardiovascular imaging [25]. Use of the AUC in this manner
may still be reasonable if application and measurement
is at the level of the practice, rather than the individual
patient, but much remains to be understood about
the implications of applying AUC in reimbursement
decisions.
Vol. 21, No. 6 June 2014 JCOM 283
Appropriateness of Elective PCI
Table. Studies Applying the 2009 Appropriate Use Criteria for Coronary Revascularization to Registry Data
Study
Setting (Dates)
PCI Indication
Chan et al [26]
(JAMA 2011)
NCDR Cath-PCI Registry (7/2009–9/2010)
Acute
Appropriate
Inappropriate
98.6%
1.1%
11.6%
Nonacute
50.4%
Bradley et al [28] All WA State PCIs (2010)
(Circ CQO 2012)
Acute
98%
1%
Nonacute
44%
17%
Hannan et al [27]
(JACC 2012)
Nonacute
36.1%
14.3%
All NY State Nonacute PCIs (2009–2010)
Refinement
The AUC for PCI are designed to be dynamic and
continually updated. As additional evidence becomes
available regarding the efficacy of PCI in specific clinical scenarios, there will be ongoing efforts to update the
AUC to reflect this new evidence. This is highlighted by
the first update to the AUC occurring less than 3 years
after the original publication date [11].
In addition to perpetual review of the data used to inform scenario ratings, there are opportunities to improve
measurement of the clinical variables that are considered
in rating PCI appropriateness (eg, clinical presentation,
symptom severity, ischemia severity, extent of medical
therapy, extent of anatomic disease). For example, in the
current AUC, symptom severity is dependent on clinician
assessment using the Canadian Cardiovascular Society
Classification [25]. Moving toward a patient-centered
assessment of symptom severity would ensure that the
AUC more closely reflect the patient-perceived symptom
burden. Further, the use of a patient-centered instrument
would reduce the possibility of physician manipulation of
symptom severity to influence the apparent appropriateness of PCI. There are similar opportunities to improve
reporting of noninvasive stress test data, such as through
standardized reporting of ischemic risk. Finally, the use of
physiologic assessments of stenosis severity (eg, fractional
flow reserve) and quantitative coronary angiography to
standardize interpretations of diagnostic angiography may
further optimize the assessment of PCI appropriateness.
Application of the Appropriate Use Criteria
in Clinical Practice—Study Results
Application of the AUC to clinical practice has highlighted potential overuse of PCI (Table). The first report
came from applying the AUC to the National Cardiovascular Data Registry (NCDR) CathPCI Registry [26]. In
284 JCOM June 2014 Vol. 21, No. 6
this study of more than 500,000 PCIs from over 1000
facilities across the country, the authors found that PCIs
performed in the acute setting (STEMI, NSTEMI, and
high-risk unstable angina) were almost uniformly classified as appropriate. However, for nonacute (elective)
PCI, application of the AUC resulted in the classification of 50% as appropriate, 38% as uncertain, and 12%
as inappropriate. The majority of patients who received
inappropriate PCI had a low-risk stress test (72%) or
were asymptomatic (54%). Additionally, 96% of patients
who received PCI classified as inappropriate had not
been given a trial of adequate anti-anginal therapy. This
analysis was supported by subsequent analyses of 2 other
state-specific registries (New York and Washington),
which found similar rates of PCI for nonacute indications
rated as inappropriate [27,28]. Additionally, all 3 studies
showed wide facility-level variation in the percentage of
appropriate and inappropriate PCI for elective indications.
These studies also highlight a gap in preprocedural
care. The anticipated benefit of elective PCI is related
to patient symptom burden, adequacy of anti-anginal
therapy, and ischemic risk as determined by noninvasive
stress testing. However, 30% to 50% of patients undergo
elective PCI without evidence of preprocedural stress
testing. Attempts are being made to address this gap with
the recent release of PCI performance measures [29].
These performance measures, intended for cardiac catheterization labs, include comprehensive documentation
of the indication for PCI, which is central to determination of appropriateness. This integration of procedural
indication into a performance measure marks the first
such occurrence in cardiology.
As documentation of procedural indication and appropriateness have become part and parcel of assessing
quality of care, concerns about “gaming” have become
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Clinical Review
more pertinent. Providers who perform PCI could potentially enhance the appearance of appropriateness by
overstating the clinical symptom burden or stress test
findings. The incorporation of validated, patient-centered
health status questionnaires along with data audit programs have been proposed as measures to prevent this
type of abuse. Addressing quality gaps in preprocedural
assessment and documentation is critical to optimizing
use of elective PCI [28].
The apparent overuse of PCI for elective indications
may be a reflection of our fragmented, fee-for-service
health care delivery system. However, recent studies challenge these assumptions. In a Canadian study, Ko et al
found that 18% of elective PCIs were classified as inappropriate, a proportion similar to what had been found
previously in the United States [30]. In a US study of
Medicare beneficiaries, Matlock and colleagues observed
a fourfold regional variation in use of elective coronary
angiography and PCI in both Medicare fee-for-service
and capitated Medicare Advantage beneficiaries [31].
Collectively, these studies suggest barriers to optimal
patient selection for invasive coronary procedures in both
capitated and fee-for-service health care systems. Without addressing factors that contribute to variation in the
absence of fee-for-service incentives, efforts to improve
integration and reduce fee-for-service reimbursement
may be inadequate to optimize PCI use.
Evaluating Underuse
While potential underuse of PCI has been described
for acute indications [17–22], study of underuse of PCI
for elective indications is more challenging. Population
data on the effect of underuse of elective PCI on patient
symptom burden, functional status, and quality of life is
lacking.
A population-based study from Australia highlights
the potential importance of underuse in the care of patients with stable coronary disease. This study assessed
symptom burden among patients with chronic stable
angina using the Seattle Angina Questionnaire and included patients cared for by 207 primary care practitioners [32]. The authors noted that there was considerable
variation in patient symptom burden between practices,
with 14% of practices having no patients with more than
1 episode of angina per week and 18% of clinics having
more than half of enrolled patients with at least 1 episode of angina per week. The authors postulate that this
variability may be due to differences among providers in
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the identification and management of angina, including
using PCI to minimize symptom burden.
In the Ko study mentioned earlier, the AUC was used
to examine potential underuse of coronary revascularization procedures. In this study, they analyzed the association between AUC ratings and outcomes in patients
undergoing diagnostic coronary angiography [30]. Of
patients considered “appropriate” for revascularization
following completion of diagnostic angiography, only
69% underwent revascularization. However, the clinical aspects that influence the decision to proceed with
revascularization may not be fully captured in this study.
Thus, the true degree of underuse of PCI remains elusive.
In summary, the relative lack of data that would allow
for the assessment of underuse of elective PCI is an
important quality concern. Health systems should work
to systematically capture patient-reported health status,
including symptom burden data, to identify inadequate
symptom control and potential underuse of procedural
care for CAD.
Facilitating Optimal Use
In current practice, the AUC hold promise to minimize
the overuse of elective PCI. This likely involves addressing
processes occurring upstream of the cardiac catheterization lab, including employing systems to ensure that procedures are avoided in patients who are unlikely to benefit
(eg, asymptomatic, low ischemic burden) (Figure 3) [33].
Studying hospitals that already have low rates of inappropriate PCI may inform the design and dissemination
of strategies that will help improve patient selection at
hospitals with higher rates. Although professional organizations have developed tools intended to facilitate
appropriateness evaluation at the point-of-care [34], the
use of these tools are likely to be sporadic without greater
integration into the health care delivery system. Further,
these applications are currently limited to determination
of appropriateness of PCI after completion of the diagnostic coronary angiogram. Identifying processes prior
to catheterization that contribute to PCI appropriateness
may also streamline appropriate ad hoc PCI, as the need
to reassess appropriateness after the diagnostic angiogram may be mitigated.
Significant barriers exist to the application of the AUC
for determination of procedural underuse. As described
above, we lack adequate data to ascertain gaps in symptom management that could be mitigated by proper use
of PCI. Further study of symptom burden in populations
Vol. 21, No. 6 June 2014 JCOM 285
Appropriateness of Elective PCI
Systems to Promote High-Quality PCI
Patients Considered for PCI
Measurement of PCI Quality
Decision-making tools and interventions
to ensure proper patient selection:
• Avoid treatment in asymptomatic patients at
low risk for mortality
• Assessment of ischemic risk
• Adequate anti-anginal therapy
Patients Undergoing PCI
Patient Selection
• PCI Appropriateness
Minimization of procedural complications
and optimization of post-procedural care:
• Bleeding avoidance strategies
• Renal protective measures
• Care pathways to encourage guidelinedirected medical therapy
PCI Outcomes
Procedural Care
• Procedural complications (eg, bleeding, mortality)
• Discharge medications
Figure 3. Conceptual framework for systems and measurement of high-quality PCI.
of patients with coronary artery disease is needed. This
may help in the identification of patient populations
whose symptom burden may warrant consideration of
invasive coronary procedures, including coronary angiography and PCI.
Finally, it is important to note that the AUC are based
on technical considerations, ie, practice guidelines and
trial evidence. They do not take into consideration patient
preferences. For example, PCI can be technically appropriate for the scenario but inappropriate for the individual
if the procedure is not desired by the patient. Similarly, a
procedure may be of uncertain benefit but appropriate if
the patient desires more aggressive procedural care and has
a full understanding of the risks and benefits. Currently,
we fail to convey this information to patients, as evidenced
286 JCOM June 2014 Vol. 21, No. 6
by patients’ overestimation of the benefits of PCI [34]. As
we continue to work toward optimal use of PCI, we must
not only address the technical appropriateness of care, but
move toward incorporating patient preferences through a
robust process of shared decision-making.
Corresponding author: Preston M. Schneider, MD, VA
Eastern Colorado Health Care System, Cardiology Section
(111B), 1055 Clermont St., Denver, CO 80220, Preston.
[email protected].
Funding/support: Dr. Schneider is supported by a T32 training grant from the National Institutes of Health (5T32HL00
7822-15). Dr. Bradley is supported by a Career Development Award (HSR&D-CDA2 10-199) from VA Health
Services Research & Development.
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Clinical Review
Financial disclosures: None.
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