Safety and Efficacy of PCI at California Hospitals Without Onsite Cardiac Surgery

Design: The PCI California Audit Monitored Pilot with Offsite Surgery (PCI-CAMPOS) program
is a prospective, multi-center pilot trial allowing elective PCIs at hospitals without
on-site cardiovascular surgery in California. The pilot program was established by
California Senate Bill No. 891 (SB 891) which was enacted in January 2009 authorizing the
California Department of Public Health (CDPH) to set up a pilot program to allow California
hospitals without surgery on-site to perform elective PCIs. The PCI-CAMPOS program was
designed to compare PCI outcomes at the pilot hospitals with offsite cardiac surgery to PCI
outcomes at established California hospitals with onsite cardiac surgery.

The CDPH requested pilot hospital applications in December 2009, selected 6 hospitals out of
over 30 applicant hospitals in May 2010 and contracted with University of California, Davis
(UCD) to train, audit, and monitor the program. The CDPH appointed a 12 member Advisory
Oversight Committee (AOC) with 6 at-large members nominated by the California American
College of Cardiology (CAACC) and 6 members from the pilot hospitals (1 principal
investigator from each participating pilot hospital). The pilot program was funded by CDPH
from fee assessments of participating pilot hospitals. The study was approved by the
Institutional Review Board (IRB) at each pilot hospital and at the University of UCD
coordinating center, and each patient is asked to provide written informed consent for pilot
participation (unless unavailable in critically ill patients).

The National Cardiovascular Data Registry (NCDR®) CathPCI Registry (v. 4.3, 4.4) was
selected as the data entry format for both pilot hospitals and non-pilot hospitals. The
pilot PCI data is entered using the NCDR® CathPCI Registry v.4.3 and v.4.4 on an internet
accessible UCD Velos server (Velos eResearch v9.1.2, Velos, Inc., Fremont, CA). The
non-pilot hospitals enter their data using various NCDR® approved onsite software or the
central NCDR® CathPCI v.4.3 and v.4.4 website. The pilot hospital data is entered within 72
hours of each procedure and immediately available to the PCI-CAMPOS coordinating center. The
non-pilot data is entered individually or obtained from quarterly data harvests submitted to
NCDR®. After masking patient, operator, and hospital identity, this non-pilot California
NCDR® CathPCI registry data is downloaded annually from the NCDR® center to the UCD
PCI-CAMPOS coordinating center. The UCD coordinating center performs all pilot audits and
has full access to the pilot information. The UCD coordinating center performs all pilot and
comparative analyses. Interim data summaries and analyses are presented to the full AOC for
review at 6-12 month intervals throughout the study.

Outcomes: The pilot hospital outcomes are compared with hospital outcomes from non-pilot
California hospitals performing either elective PCIs with surgery on-site or ST segment
elevation myocardial infarction (STEMI) only PCIs. The non-pilot clinical data is obtained
from the 120 California hospitals that submit their clinical data directly to the NCDR® data
center and is used for the analysis of the data. Both the non-pilot and pilot data sets are
analyzed and compared using SAS statistical software (version 9.3 for Windows, SAS
Institute, Cary, NC).

Study Participants Hospitals: The non-pilot hospital group consists of all 120 California
hospitals which submit PCI data directly to the NCDR® central database. For all elective
PCIs, these hospitals have on-site surgery available for any post-PCI patients who require
emergency coronary artery bypass graft (CABG) surgery.

The pilot hospital group consists of all 6 hospitals selected by the CDPH, which met the
eligible hospital criteria as required by SB891 SEC.2. Section 1256.01 (c) (09/25/2008).

Operators: Operators are approved to perform procedures under the pilot program based on the
operator criteria as required by SB891 SEC.2. Section 1256.01 (c) (09/25/2008). Pilot
operators underwent training for the assessment of the operator, and the assessment of
patient inclusion and exclusion requirements by UCD staff and were also were required to
pass a competency exam. Non-pilot operators did not receive special training and their
identity was masked to comply with NCDR® requirements.

Emergency (and salvage) pilot hospital PCIs are performed by any credentialed
interventionalists at the pilot hospitals. Non-emergent (elective, urgent) PCIs are
redirected to the pre-qualified pilot operators.

Coders: Data entry coders at each pilot hospital received an initial 1 day training session,
followed by a competency exam. On-going training, telephone, and email access to the
coordinating center are available throughout the program. Non-pilot coding is also performed
by coders at each onsite hospital participating in the NCDR® CathPCI Registry.

Patients: All pilot hospital patients who consent and meet the SB891 SEC.2. Section 1256.01
(A through D) (09/25/2008) selection criteria for PCI at pilot hospitals are enrolled in the
program. All patients with STEMI who present to the pilot hospitals are included in the
STEMI PCI group. STEMI-excluded patients who are low to moderate risk for complications are
included in the STEMI-excluded group. Patients deemed high-risk (both high lesion and
patient risk) for complications are excluded from the pilot program. These high-risk
patients are either discharged or transferred to non-pilot hospitals with onsite surgery for
revascularization with PCI or CABG.

Pilot Protocol After completion of each PCI, the required information is entered online into
the NCDR® CathPCI Registry v.4.3 and v.4.4 UCD server. All cases are then reviewed by the
central coordinating site for data field completion and data consistency. All cases with
complications [death, stoke, CABG, shock, congestive heart failure (CHF), cardiac arrest,
IABP (intra-aortic balloon pump), perforation, significant dissection, tamponade, and new
requirement for dialysis] and a randomized 10% of non-complication cases are then selected
for a pilot-site audit that includes a review of all medical records and angiographic
images. Audit reviews produce multiple queries that are transmitted to the hospital coders
for discussion with operators. An iterative process eventually leads to a consensus
agreement in most cases. In rare cases, when auditor-operator agreement is not achieved, the
case is referred to the angiographic committee or to the AOC for a final determination. The
patient and procedure data is stored on the Velos Server; the angiographic images are saved
on an Xcelera R3.3L1 Server (Koninklijke Philips Electronics N.V.); and the statistical
analyses are stored and performed on SAS software, version 9.3 for Windows (SAS Institute,
Cary, NC).

Non-pilot Audits: California hospital PCI data that is submitted individually or at 3 month
harvests to the NCDR® central database is reviewed for completeness and data accuracy by
NCDR® and receives a red, yellow, or green light before acceptance. The vast majority of the
hospitals in California that perform PCI participate in the NCDR CathPCI registry. The NCDR®
in addition to employing robust data quality strategies for its participating hospitals also
performs a limited number of site audits to directly assess data accuracy. The complete
NCDR® non-pilot California data is downloaded annually to the UCD central site for
comparison analysis. The downloaded data is masked to protect patient, operator, and
hospital identity.

Statistical analysis: A PCI risk model has been developed and risk-adjusted endpoints are
compared for the 6 pilot and 120 non-pilot hospital PCI procedures. To compare the
demographic and clinical profiles and observed outcomes between CA-NCDR® (non-pilot)and
PCI-CAMPOS (pilot), all continuous and categorical variables are reported as mean ± standard
deviation (SD) or percentages, and compared with the t test or chi-square test (two tailed),
respectively. The primary safety endpoint is a composite event which includes in-hospital
death (regardless of length of stay), stroke, and/or patients who were transferred for an
emergent CABG. The non-pilot data and the pilot data are merged as a single data source for
development of the risk adjustment models for the composite outcome. With the combined data,
we perform a bi-variable analysis to identify significant demographic and clinical risk
factors for the composite outcome and serve as candidate risk factors for the multivariable
logistic risk models. We developed both parsimonious and refined risk models with the
combined data and use only non-pilot data for model validation purpose. All models are
evaluated with the Hosmer-Lemeshow goodness-of-fit statistic. The c- statistic is reported
as a measure of predictive power. The refined model is then used for computation of
provider's expected and risk-adjusted composite event rates. A general linear model for
analysis of variance (GLM/ANOVA) is used to compare observed, expected and risk-adjusted
composite event rates between CA-NCDR® and PCI-CAMPOS hospitals. We further compute 95%
confidence interval (CI) of provider's risk-adjusted composite event rate using the Poisson
exact probability method for pilot and non-pilot hospitals and pilot operators. We determine
provider's performance rating based on a comparison of the 95%CI of provider's risk-adjusted
composite event rates and to the California average composite event rate that includes both
CABG on-site and off-site hospitals. Two performance rating analyses are conducted for
hospitals (or operators in pilot hospitals): (1) based on all PCIs and (2) based on PCIs
with STEMI excluded. We also assess the correlation between provider's total and STEMI
excluded PCI volume and risk-adjusted composite event rate among hospitals and operators in
pilot hospitals. All reported p-values are 2-sided, and p-value < 0.05 are considered to be
statistically significant. All statistical analyses are conducted at the UCD with the use of
SAS software, version 9.3 for Windows (SAS Institute, Cary, NC).

Inclusion Criteria:

- clinically and angiographically significant coronary artery disease

- ability to perform PCI with equipment available at the local site

- not high-risk patient with a not high-risk lesion

- not high-risk patient with a high-risk lesion

- high-risk patient with a not high-risk lesion may be included in the pilot program
upon confirmation that a cardiac surgeon and an operating room are immediately
available if necessary

Exclusion Criteria:

- high-risk patient with a high-risk lesion

- need for coronary artery bypass surgery