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

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 HS from the Agency for Healthcare Research and Quality. Drs. Krumholz and Curtis are supported by grant U01 HL (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-CDA ) 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 non- acute 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 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 Appropriate (Appropriate) Uncertain (Maybe Appropriate) Inappropriate (Rarely Appropriate) Coronary revascularization likely to improve patient’s health status and/or outcomes ++/--

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 non- acute 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 Overall2009* Overall, n2,685,683243,580538,076502,995481,889462,636456,507 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)

Absolute Change from Patient Characteristics #%#%#% N 89, , , Angina No symptoms 26, , , CCS I or II 47, , , CCS III or IV 15, , , No. of antianginal medications 0 27, , , , , , >=2 20, , Stress test results (among those with a test) Unavailable 10, , , Low or intermediate risk 33, , , High risk 12, , , Multi-vessel CAD on angiography 39, , , Changes in Baseline Characteristics Among Patients Undergoing Non-acute PCI

Year * *Includes July to December 2009 Appropriate Uncertain Inappropriate Non-acute PCIs, % Patient-level Trends in Appropriateness of Non-acute PCI

Year * *Includes July to December 2009 Appropriate Uncertain Inappropriate Non-acute PCIs, % Patient-level Trends in Appropriateness of Non-acute PCI

Year * *Includes July to December 2009 Non-acute PCIs, % 51% relative reduction, p<0.001 Patient-level Trends in Appropriateness of Non-acute PCI Appropriate Uncertain Inappropriate

Non-acute PCIs classified as inappropriate, % Year * *Includes July to December 2009 Hospital-level Trends in Inappropriate Non-acute PCIs Median (IQR) 25.8 ( )

Non-acute PCIs classified as inappropriate, % Year * *Includes July to December 2009 Hospital-level Trends in Inappropriate Non-acute PCIs Median (IQR) 25.8 ( ) 24.3 ( ) 21.4 ( ) 17.0 ( ) 14.3 ( ) 12.6 ( )

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

Year * *Includes July to December 2009 AppropriateUncertain Inappropriate Non-acute PCIs, % Year # of Inappropriate PCIs , , , , , % to 13.3%, 51% RR, p< % reduction in absolute number, p<0.001 Patient-level Trends in Appropriateness of Non-acute PCI