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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