Appropriate Use Criteria for Coronary
Revascularization and Trends in Utilization,
Patient Selection and Appropriateness of
Percutaneous Coronary Intervention
Nihar R. Desai, MD, MPH; Steven M. Bradley, MD, MPH; Craig S. Parzynski, MS;
Brahmajee K. Nallamothu, MD, MPH; Paul S. Chan, MD, MSc; John A. Spertus, MD,
MPH; Manesh R. Patel, MD; Jeremy Ader, AB; Aaron Soufer, MD;
Harlan M. Krumholz, MD, SM; Jeptha P. Curtis, MD
Funding Support and Disclaimer
This research was supported by the American College of Cardiology
Foundation’s National Cardiovascular Data Registry (NCDR). The views
expressed in this presentation represent those of the author(s), and do not
necessarily represent the official views of the NCDR or its associated
professional societies identified at www.ncdr.com.
Disclosures
Drs. Desai and Krumholz are recipients of a research agreement from Johnson & Johnson, through Yale
University, to develop methods of clinical trial data sharing. Drs. Desai, Krumholz and Curtis receive
funding from the Centers for Medicare & Medicaid Services to develop and maintain performance
measures that are used for public reporting. Dr. Krumholz receives research support from Medtronic,
through Yale University, to develop methods of clinical trial data sharing and of a grant from the Food and
Drug Administration to develop methods for post-market surveillance of medical devices. Dr. Krumholz
chairs a cardiac scientific advisory board for UnitedHealth. Dr. Spertus discloses funding from the American
College of Cardiology to analyze the NCDR registries, membership on the United Healthcare cardiac
scientific advisory board and an equity interest in Health Outcomes Sciences. Dr. Patel has research grants
through Duke University with Johnson and Johnson, AstraZeneca, Maquet, National Heart Lung and Blood
Institute, AHRQ, and is on the Advisory Board for Bayer Healthcare, Jansen, and Genzyme. Dr. Curtis
discloses equity interest in Medtronic. No other disclosures were reported.
Dr. Desai is supported by grant K12 HS023000-01 from the Agency for Healthcare Research and Quality.
Drs. Krumholz and Curtis are supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes
Research at Yale University) from the National Heart, Lung, and Blood Institute. Dr. Bradley is supported by
a Career Development Award (HSR&D-CDA2 10-199) from Veterans Affairs Health Services Research and
Development. This research was supported by the NCDR. The analytic work for this investigator-initiated
study was performed by the Yale Center for Outcomes Research and Evaluation Data Analytic Center with
financial support from the American College of Cardiology.
Background
• The Appropriate Use Criteria (AUC) for Coronary Revascularization were
developed to critically examine and improve patient selection for PCI as
well as address concerns about potential overuse.
• Previous studies have demonstrated that 1 in 6 PCIs performed for nonacute indications were classified as inappropriate with substantial
variation in performance across hospitals.
• Reducing the number of inappropriate PCIs became and remains a
priority for national performance improvement initiatives.
• Despite the attention this topic has received, the quality improvement
initiatives that have been launched in response, and the implications
for health care quality and spending, there has been no national
examination of trends in patient selection and appropriateness of PCI
following the introduction of the AUC.
Study Aims
1. Examine national trends in the characteristics of patients
undergoing PCI between July 2009 and December 2014.
2. Evaluate trends in the appropriateness of PCI over the
study interval.
3. Identify the presence and extent of hospital-level variation
in inappropriate PCI.
AUC Methods Overview
• The AUC synthesize clinical trial evidence, practice guidelines, and
expert opinion to determine procedural appropriateness based upon:
1. Clinical indication (i.e. acute or non-acute);
2. Angiographic findings;
3. Magnitude of ischemia on non-invasive testing;
4. Severity of anginal symptoms; and
5. Intensity of background medical therapy,
AUC Rating
Coronary revascularization likely to
improve patient’s health status and/or
outcomes
Appropriate
(Appropriate)
Uncertain
(Maybe Appropriate)
Inappropriate
(Rarely Appropriate)
+
+/-
-
Methods
• Study population: All patients undergoing PCI between July 1, 2009
and December 31, 2014 at hospitals continuously participating in
NCDR CathPCI Registry and performing at least 10 non-acute PCIs each
year.
• Primary Outcome: Proportion of non-acute PCIs classified as
inappropriate at the patient- and hospital-level using the 2012 AUC.
• Statistical analysis plan:
– PCI volume and the relative proportions of acute, non-acute, and
non-mappable PCIs were examined over time.
– Baseline demographic and clinical characteristics were compared
among those undergoing non-acute PCI over time.
– The proportions of appropriate, inappropriate, and uncertain nonacute PCIs at the patient-level were calculated for each 6-month
interval and compared over time. The proportion of non-acute PCIs
considered inappropriate at the hospital level was calculated by
aggregating all non-acute PCIs in the calendar year.
Study Population
Percutaneous coronary interventions
between July 1, 2009 and December 31,
2014 submitted to NCDR CathPCI Registry
(n=3,604,365; 1561 hospitals)
Final Study Cohort
(n=2,685,683; 766 hospitals)
Exclusions
• Hospital did not participate in NCDR
CathPCI registry over the entire study
period (n=550,836; 583 hospitals)
• Hospital with an average of fewer than
10 non-acute PCIs per year (n=273,167;
212 hospitals)
• Second PCI if multiple PCIs in a single
visit (n=94,679)
Trends in Indication for PCI
PCI
indication/Year
Overall
2009*
2010
2011
2012
2013
2014
Overall, n
2,685,683
243,580
538,076
502,995
481,889
462,636
456,507
Acute, n (%)
2,047,853
(76.3)
168,366
(69.1)
377,540
(70.2)
373,423
(74.2)
380,331
(78.9)
373,650
(80.8)
374,543
(82.0)
Non-acute, n
(%)
397,737
(14.8)
41,024
(16.8)
89,704
(16.7)
78,328
(15.6)
66,849
(13.9)
62,457
(13.5)
59,375
(13.0)
Non-mappable,
n (%)
240,093
(8.9)
34,190
(14.0)
70,832
(13.2)
51,244
(10.2)
34,709
(7.2)
26,529
(5.7)
22,589
(4.9)
*Includes 6-months of data (July 1 to December 31, 2009)
Changes in Baseline Characteristics Among
Patients Undergoing Non-acute PCI
#
89,704
%
22.6
#
59,375
%
14.9
Absolute Change from
2014-2010
#
%
-30,329
-7.7
26,313
47,710
15,681
29.3
53.2
17.4
12,890
23,689
22,796
21.7
39.9
38.4
-13,423
-24,021
+7,115
-7.6
-13.3
+21.0
27,076
42,610
20,011
30.2
47.5
22.3
11,521
27,031
20,816
19.4
45.5
35.1
-15,555
-15,579
+805
-10.8
-2.0
+12.8
10,328
33,468
12,460
39,231
18.4
59.5
22.2
43.7
4,708
23,475
14,018
28,192
11.2
55.6
33.2
47.5
-5,620
-9,993
+1,558
-11,039
-7.2
-3.9
+11.0
+3.8
2010
Patient Characteristics
N
Angina
No symptoms
CCS I or II
CCS III or IV
No. of antianginal medications
0
1
>=2
Stress test results (among those with a test)
Unavailable
Low or intermediate risk
High risk
Multi-vessel CAD on angiography
2014
Patient-level Trends in
Appropriateness of Non-acute PCI
100
90
Non-acute PCIs, %
80
70
60
50
Uncertain
40
Appropriate
30
Inappropriate
20
10
0
2009*
2010
*Includes July to December 2009
2011
2012
Year
2013
2014
Patient-level Trends in
Appropriateness of Non-acute PCI
100
90
Non-acute PCIs, %
80
70
60
Appropriate
50
40
Uncertain
30
20
Inappropriate
10
0
2009*
2010
*Includes July to December 2009
2011
2012
Year
2013
2014
Patient-level Trends in
Appropriateness of Non-acute PCI
100
90
Non-acute PCIs, %
80
70
60
Appropriate
50
40
Uncertain
30
20
Inappropriate
10
51% relative
reduction, p<0.001
0
2009*
2010
*Includes July to December 2009
2011
2012
Year
2013
2014
Non-acute PCIs classified as inappropriate, %
Hospital-level Trends in
Inappropriate Non-acute PCIs
100
90
80
70
60
50
40
30
20
10
0
2009*
Median
(IQR)
2010
2011
2012
25.8
(16.7-37.1)
Year
*Includes July to December 2009
2013
2014
Non-acute PCIs classified as inappropriate, %
100
Hospital-level Trends in
Inappropriate Non-acute PCIs
90
80
70
60
50
40
30
20
10
0
2009*
Median
(IQR)
25.8
(16.7-37.1)
2010
24.3
(15.2-33.3)
*Includes July to December 2009
2011
21.4
(13.3-30.7)
2012
17.0
(9.1-26.8)
Year
2013
2014
14.3
(6.3-24.4)
12.6
(5.9-22.9)
Limitations
• Not all hospitals that perform PCI in the United States participate in the
registry and we further excluded hospitals that did not participate in the
registry throughout the entire study period.
• Our analysis focused mostly on trends in potential overuse of PCI.
Understanding whether the AUC have introduced new barriers to the
performance of medically necessary procedures remains an important
topic that could not be fully addressed in our study.
• We cannot determine whether the observed changes fully reflect
improvements in the quality of care and patient selection.
• Specifically, we cannot exclude the possibility that the findings may
derive, at least in part, from changes in documentation or even
intentional up-coding, particularly of subjective data elements such as
symptom severity.
Conclusions
This study of a large, national cohort of patients undergoing PCI
from July 2009 to December 2014 demonstrates:
1. There has been a significant, 34% decline in non-acute PCI
volume while the volume of acute PCIs remained stable.
2. Among patients undergoing non-acute PCI, there have been
marked increases in reported angina severity, use of
background anti-anginal medications, and high-risk findings on
non-invasive testing.
3. Among non-acute PCIs, there has been a highly significant 51%
reduction in the proportion classified as inappropriate and a
64% reduction in the absolute number of inappropriate PCIs.
4. Hospital-level variation in the proportion of inappropriate PCI
persisted over the study interval.
Implications
• This is the first study to assess the national impact of a societal
effort to quantify the appropriateness of a procedure on clinical
practice.
• Taken together, these findings suggest that there has been a
marked change in patient selection for PCI and the practice of
interventional cardiology since the introduction of the AUC.
• There is a need for ongoing performance improvement initiatives
and continued investigation of procedural appropriateness
particularly as the AUC are further refined and revised.
Backup Slides
Patient-level Trends in
Appropriateness of Non-acute PCI
100
Appropriate
90
Inappropriate
Uncertain
Year
2010
2011
2012
2013
2014
Non-acute PCIs, %
80
70
60
# of
Inappropriate
PCIs
21,781
16,429
11,779
9,299
7,921
64% reduction in
absolute number,
p<0.001
50
40
30
20
26.2% to 13.3%,
51% RR, p<0.001
10
0
2009*
2010
*Includes July to December 2009
2011
2012
Year
2013
2014