PCI Outcomes in 153,950 California Procedures

William J. Bommer, Suresh Ram, Tanuj Patel, Laurie
Vazquez, Zhongmin Li, Geeta Mahendra, PCI-CAMPOS
Investigators, University of California, Davis, CA, USA
THE PERCUTANEOUS CORONARY
INTERVENTION CALIFORNIA AUDIT
MONITORED PILOT WITH OFFSITE
SURGERY (PCI-CAMPOS) OUTCOMES
IN 153,950 PATIENT PROCEDURES IN
HOSPITALS WITH AND WITHOUT
ONSITE CARDIAC SURGERY

DISCLOSURES
This study was conducted by the California
Department of Public Health and funded by the
pilot hospitals without Onsite surgery
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
PCI-CAMPOS

BACKGROUND
The ACCF/AHA/SCAI Guideline recommendations
for primary and elective percutaneous coronary
intervention (PCI) at hospitals without cardiac
surgery (Offsite) were changed from Class IIb*
(primary) and III (elective) in 2005 to Classes IIa
(primary) and IIb (elective) in 2011.
* Class IIa – Additional studies with focused objectives needed, it is reasonable
to perform procedure/administer treatment
Class IIb – Additional studies with broad objectives needed,
procedure/treatment may be considered
Class III - No benefit/harm
PCI-CAMPOS

AIM
To determine and compare the initial safety
and efficacy outcomes of PCIs performed at
hospitals with (Onsite) and without cardiac
surgery (Offsite) in California
PCI-CAMPOS

METHOD

PCI-CAMPOS

HOSPITAL AND OPERATOR REQUIREMENTS
Offsite Hospitals
Approval from California Department of Public Health
Formal PCI development program
Participation in the elective PCI pilot program and NCDR® Registry
Signed emergency transfer agreement with Onsite surgery hospital (24/7 backup,
transfer within 60 minutes)
Capacity to perform minimum of 200 PCIs/year; 36 primary PCIs/year
Offsite Operators
Perform at least 100 PCIs/year; 18 primary PCIs/year
Lifetime experience ≥500 PCIs as primary operator
Complication rates and outcomes equivalent or superior to national benchmarks
ABIM Interventional Cardiology and Cardiovascular Diseases certification
Active participant in hospital quality improvement program
Onsite Hospitals
Participation in NCDR® Registry
Onsite Operators
Approval from hospital credentialing
PCI-CAMPOS

METHOD
California patients admitted for primary and non-primary PCI (July 2010-13)
Offsite Hospitals without surgery (6) Onsite Hospitals with surgery (122)
High Patient Risk includes, but is not limited to:
• Clinical risk
• Decomp. CHF (Killip3) without evidence for
active ischemia
• 3-VD unprotected by prior CABG with >70%
stenosis in the prox. segment of all major
coronary arteries
• recent cerebrovascular attack
• LVEF ≤ 25%
• advanced malignancy
• known clotting disorders
• Myocardial risk
• left main stenosis ≥50%
• single target lesion that jeopardizes over 50%
of remaining viable myocardium
High Lesion Risk includes, but is not limited to:
• diffuse disease (>2cm in length) and excessive
tortuosity of proximal segments
• more than moderate calcification of a stenosis or
proximal segments
• location in an extremely angulated segment (>90
degrees)
• inability to protect major side branches
• degenerated older vein grafts with friable lesions
• substantial thrombus in the vessel or at the lesion site
• any feature that may, in the operator’s judgment,
impede stent deployment
Offsite Exclusion Criteria
And
PCI-CAMPOS

METHOD: AUDITS
Offsite:
Central 100%: PCI-CAMPOS review of all Cath/PCI fields
Hospital Site 20%: 10% Random sample of Offsite PCI procedures
and 10% selected PCI procedures with all major complications
Angiographic: 20% assessed for NCDR® Cath/PCI Mechanical
Ventricular Support, Coronary Anatomy, Lesions and Devices, and
Intraprocedure Events fields and Quantitative Coronary Angiography
(QCA) accuracy.
Onsite:
Central: 100% NCDR® review of certain fields (Data are filtered
through the registry-specific algorithms)
Hospital Site: Selected NCDR® hospital review (25 randomly
identified national sites)
PCI-CAMPOS

STATISTICAL METHODS
 A multivariate PCI risk model was developed and risk‐adjusted
primary outcomes were compared for the 6 pilot and 122 non‐pilot
hospital PCI procedures
 Bivariate analysis was used to create complete, parsimonious, and
refined multivariable logistic risk models
 All models were evaluated with the Hosmer‐Lemeshow
goodness‐of‐fit statistics
 C‐statistics were reported as a measures of predictive power
 A general linear model for analysis of variance (GLM/ANOVA) was
used to compare observed, expected, and risk‐adjusted composite
event rates
 The Poisson exact probability method was used to calculate and
compare provider risk-adjusted composite rates
PCI-CAMPOS

BASELINE CHARACTERISTICS
PCI-CAMPOS
All PCI Primary PCI Nonprimary PCI
Characteristics Offsite
(N=3,773)
Onsite
(N=150,177)
P-value Offsite
(N=1,208)
Onsite
(N=26,921)
P-value Offsite
(N=2,565)
Onsite
(N=123,213)
P-value
Demographics % /Mean (SD)
Age (yrs.), Mean(SD) 65.6 (12.3) 66.3 (12.1) 0.001 64.4 63.1 (13.0) 0.001 66.3 (11.8) 67.05 (11.8) 0.001
Female gender 29.8 29.8 0.975 29.4 26.5 0.025 30.1 30.5 0.591
Race/Ethnicity
White 72.4 67.0
<0.0001
77.5 81.5
<0.0001
83.1 80.7
<0.0001
Black/
African American 5.8 4.7 7.4 4.9 4.9 4.8
Asian 11.1 9.9 13.1 9.7 10.3 10.4
Native Hawaiian
or Pacific Islander 1.5 0.8 1.8 0.7 1.3 0.9
American Indian/
Alaskan Native 0.2 0.3 0.2 0.7 0.1 0.8
Hispanic
or Latino Ethnicity 9.0 16.4 10.0 17.7 8.6 16.1

BASELINE CHARACTERISTICS
PCI-CAMPOS
Characteristics
Offsite
(N=3,773)
Onsite
(N=150,177)
P-value
Offsite
(N=1,208)
Onsite
(N=26,921)
P-value
Offsite
(N=2,565)
Onsite
(N=123,213)
P-value
CAD Presentation
STEMI 32.0 17.9
<0.0001
100.0 100.0 0.0 0.0
NSTEMI 27.4 21.3 0.0 0.0 40.2 25.9
<0.0001
Unstable Angina 22.8 33.9 0.0 0.0 33.5 41.3 <0.0001
Stable Angina 13.9 17.0 0.0 0.0 20.5 20.7
0.817
Symptoms Unlikely to be
Ischemic
0.4 2.3 0.0 0.0 0.6 2.8
<0.0001
No Symptoms No Angina 3.6 7.7 0.0 0.0 5.2 9.3
<0.0001
PCI Status
Emergent/Salvage
34.6 19.9
<0.0001
98.3 93.0
<0.0001
4.6 4.0
<0.0001
Urgent
37.4 41.3 1.7 6.1 54.3 49.0
Elective 28.0 38.7 0.0 0.9 41.1 47.0

LESION AND PROCEDURAL
CHARACTERISTICS
PCI-CAMPOS
All PCIs Primary Nonprimary
Offsite Onsite p value Offsite Onsite p value Offsite Onsite p value
Location of vessel/branch — # of lesions in individual vessels/total # of lesions (%)
Left main coronary artery 0.8 1.3 0.001 0.4 0.5 0.364 1.0 1.4 0.012
Left anterior descending artery 40.2 42.5 0.006 42.0 41.1 0.571 42.8 40.0 0.006
Circumflex artery 23.9 23.5 0.631 16.9 14.0 0.012 27.2 25.6 0.08
Right coronary artery 36.4 33.2 0.001 46.5 43.4 0.05 31.6 31.0 0.492
Ramus 1.5 1.5 0.708 0.3 0.7 0.01 2.0 1.7 0.243
Bypass graft lesions
Vein (% of total lesions) 5.2 5.3 0.89 2.5 2.2 0.534 6.5 5.9 0.251
Internal mammary or other
arterial graft (% of total PCIs)
0.3 0.4 0.337 0.2 0.1 0.846 0.4 0.5 0.541
Length of lesion
Total number of lesions
evaluated
5112 205117 1509 33382 3603 171735
Mean length — mm 15.7 18.8 <0.0001 17.1 20.3 <0.0001 15.1 18.4 <0.0001
>20mm length (% of lesions
evaluated)
17.7 28.6 <0.0001 21.9 34.4 <0.0001 15.7 27.3 <0.0001
Lesion stenosis
Stenosis Immediately Prior to
Rx (mean)
91.4 89.2 <0.0001 97.1 96.6 0.075 88.8 87.5 <0.0001
Total number of lesions
evaluated
5155 208578 1527 33971 3628 174607
TIMI grade 3 — # of lesions (%)
Pre-Procedure TIMI 3 Flow 45.7 50.5 <0.0001 12.1 13.4 0.128 61.5 58.6 0.003

SAFETY ENDPOINTS
PCI-CAMPOS
End Point
Offsite Onsite Relative
Risk
(95% CI)*
P Value*
Offsite Onsite Relative
Risk
(95% CI)*
P
Value*
Offsite Onsite
Relative Risk
(95% CI)*
P
Value*
#/total # (%) #/total # (%) #/total # (%)
Primary end points (Composite of Death, Stroke, and Emergency CABG)
Observed 2.86 2.33
1.24
(1.02-1.50)
0.033 6.37 7.08
0.89
(0.71-1.13)
0.346 1.21 1.29
0.94
(0.65-1.33)
0.712
Patient
Predicted end-
point rate, %
(95% CI)
3.58
(3.36-3.80)
2.31
(2.28-2.35)
1.55
(1.47-1.62)
<0.0001
8.19
(7.48-8.90)
7.00
(6.85-7.15)
1.17
(1.09-1.24)
0.001
1.41
(1.24-1.57)
1.29
(1.26-1.31)
1.09
(0.98-1.20)
0.156
Patient Risk-
adjusted end-
points rate, %
(95% CI)
1.87
(1.55-2.19)
2.36
(2.29-2.43)
0.79
(0.68-0.90)
0.009
5.49
(4.33-6.86)
7.14
(6.82-7.46)
0.76
(0.63-0.92)
0.013
1.11
(0.75-1.57)
1.29
(1.23-1.36)
0.86
(.60-1.15)
0.230
Secondary end points (Observed)
Death (%) 2.31 1.80
1.29
(1.04-1.60)
0.020 5.05 5.81
0.86
(0.66-1.12)
0.270 1.01 0.92
1.10
(0.75-1.63)
0.627
Cardiac cause
(%)
78.00 72.6
1.35
(0.81-2.27)
0.249
82.0 77.2
1.34
(0.69-2.60)
0.385
69.2 66.2
1.15
(0.50-2.67)
0.744
Noncardiac
cause (%)
21.8 27.4 18.0 22.8 30.8 33.8
Emergency
CABG (%)
0.37 0.29
1.29
(0.76-2.20)
0.351 0.83 0.8
1.03
(0.55-1.95)
0.923 0.16 0.18
0.89
(0.33-2.38)
0.810
Stroke (%) 0.24 0.26
0.93
(0.48-1.79)
0.819 0.58 0.53
1.09
(0.51-2.34)
0.822 0.08 0.2
0.39
(0.10-1.58)
0.173

EFFICACY ENDPOINTS
PCI-CAMPOS
All PCIs Primary Nonprimary
Characteristic Offsite Onsite
Relative
Risk
(95% CI)
P Value Offsite Onsite
Relative
Risk
(95% CI)
P Value Offsite Onsite
Relative
Risk
(95% CI)
P Value
Successful
treatment of
lesion — <20%
post PCI stenosis
and TIMI-3 post
PCI flow
88.40% 91.00%
0.97
(0.96-0.98)
<0.0001 89.20% 92.40%
0.97
(0.95-0.98)
<0.0001 90.90% 91.40%
0.99
(0.99-1.00)
0.37
<20% Stenosis
Post-Procedure
91.20% 92.50%
0.98
(0.98-0.99)
0.003 89.20% 92.40%
0.97
(0.95-0.98)
0.001 92.10% 92.50%
1.00
(0.99-1.00)
0.454
Post-Procedure
TIMI 3 Flow
93.00% 94.90%
0.98
(0.97-0.99)
<0.0001 88.10% 93.00%
0.95
(0.93-0.96)
<0.0001 95.40% 95.30%
1.00
(0.99-1.00)
0.992

HOSPITAL SAFETY RATINGS:
ALL PCI CASES 07/01/2010-07/31/2013
PCI-CAMPOS
Offsite Onsite
As Expected Better* Worse* As Expected Better* Worse*
Number of hospitals 5 1 0 106 8 6
Volume
Mean 591.8 814.0 1205.7 1751.4 1393.2
Range 317-1,150 1-4,846 130-4,323 401-4,403
Risk adjusted event rate
(death, stroke, or
emergency CABG)
2.01 1.25 2.48 1.23 3.80
* Statistically significant with ≥ 95% confidence (Poisson exact probability method)

SUMMARY
 California Pilot Offsite hospitals perform proportionately more
primary PCIs (32.0%) than Onsite hospitals (17.9%).
 The risk-adjusted composite safety endpoint (in-hospital
death, stroke, emergency CABG) was significantly lower in
Offsite (1.87%) versus Onsite (2.36%) hospitals.
 The composite efficacy endpoint (<20%, TIMI-3) was
significantly lower in Offsite (88.4%) versus Onsite (91%)
hospitals.
 No significant differences were seen in stroke, or emergency
CABG rates.
 No significant hospital volume/outcome relationship was
seen.
PCI-CAMPOS

 Similar cohorts but non-randomized (allocation bias).
 Higher level of audit in Offsite PCI procedures.
 Exclusion criteria were seen in 0.40-0.64% of Offsite
and 1.68-2.97% of Onsite patients. These patients did
not experience worse outcomes.
 Confirmed Operator feedback was available to Offsite
operators but not confirmed for Onsite operators.
 High risk Compassionate Use Criteria were not
included in risk adjustment.
PCI-CAMPOS
LIMITATIONS

CONCLUSIONS
1. Pilot Offsite hospitals showed slightly better PCI
composite safety and worse PCI composite efficacy
endpoints than Onsite hospitals.
2. Emergency CABG rates are low in both Offsite and
Onsite hospitals reducing the need for Onsite
Cardiac Surgery.
3. Offsite hospitals perform more primary and fewer
elective PCIs than Onsite hospitals.
4. A significant composite safety variation with
outliers remains for Onsite hospitals.
PCI-CAMPOS

ACKNOWLEDGEMENTS
Of fsite Hospitals
C l o v i s C o m m u n i t y H o s p i t a l
D o c t o r s M e d i c a l C e n t e r , S a n P a b l o
K a i s e r F o u n d a t i o n H o s p i t a l , W a l n u t
C r e e k
L o s A l a m i t o s M e d i c a l C e n t e r
S t R o s e H o s p i t a l
S u t t e r R o s e v i l l e M e d i c a l C e n t e r
Onsite Hospitals
1 2 2 A c u t e C a r e H o s p i t a l s
National Cardiovascular Data
Registry (NCDR®)
L a r a S l a t t e r y
J i m B e a c h y
California Department of Public
Health
A n t h o n y W a y , M D
C h i e f M e d i c a l C o n s u l t a n t
D e b b y R o g e r s , R N
D e p u t y D i r e c t o r , L i c e n s i n g a n d
C e r t i f i c a t i o n
C a r o l T u r n e r , R N
B r a n c h C h i e f , L i c e n s i n g a n d
C e r t i f i c a t i o n
Advisory Oversight Committee
Members
( * P C I - C A M P O S I n v e s t i g a t o r s )
Stephen Arnold, MD*
Ralph Brindis, MD
Robert Davidson, MD
Mahmoud Eslami Farsani, MD
George Fehrenbacher, MD*
Steven Forman, MD*
William French, MD
Dipti Itchaporia, MD
Aditya Jain, MD*
Sushil Karmarkar, MD*
George Smith, MD
Rohit Sundrani, MD*
University of California, Davis
Tejinder Singh
Andrea Blackwell, RN
Melanie Aryana, MD
Reginald Low, MD
Jason Rogers, MD
Jeffrey Southard, MD
Garrett Wong, MD
Lawrence Laslett, MD
Calvin Chang, MHA
Paul Pannu, MS
PCI-CAMPOS Coders
Robert Forey
Kevin Spruce
Alfonso Brosas
Barry Howard
Stephen Scott
Sharri Steiert
Dennis Patrick
Danielle Bennett
Mary Ann Ma
Linda Campbell
Edith Jonas
Joanne Easley
Amie Selda
Jennifer Cardenas
Thuy Pham
Velos Support Team
Cindy Schmidt
Varinder Goyal
Of fice of Statewide Health
Planning and Development
Joe Parker PhD
PCI-CAMPOS

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