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
William J. Bommer, Suresh Ram, Tanuj Patel, Laurie
Vazquez, Zhongmin Li, Geeta Mahendra, PCI-CAMPOS
Investigators, Univer sity of California, Davis, CA , USA
DISCLOSURES
This study was conducted by the California
Department of Public Health and funded by the
pilot hospitals without Onsite surgery
PCI-CAMPOS
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
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.
* C l a s s I I a – A d d i t i o n a l s t u d i es w i t h f o c us e d o b j e c t iv e s n e e d e d , i t i s r e a s o n a b l e
to p e r f o r m p r o c e d ur e / a d m in i s te r t r e a t m e n t
C l a s s I I b – A d d i t i o n a l s t u d i e s w i t h b r o a d o b j e c t i ve s n e e d e d ,
p r o c e d ur e / t r e a t me n t m ay b e c o n s i d e r e d
Class III - No benefit/harm
PCI-CAMPOS
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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
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METHOD

PCI-CAMPOS
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HOSPITAL AND OPERATOR REQUIREMENTS
Of fsite 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
Of fsite 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
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
METHOD
California patients admitted for primary and non-primary PCI (July 2010-13)
Offsite Hospitals without surgery (6)
Onsite Hospitals with surgery (122)
Offsite Exclusion Criteria
High Lesion Risk includes, but is not limited to:
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
PCI-CAMPOS
And
• 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
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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
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
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
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
BASELINE CHARACTERISTICS
Characteristics
Offsite
(N=3,773)
All PCI
Onsite
P-value
(N=150,177)
Demographics
Age (yrs.), Mean(SD) 65.6 (12.3)
Primary PCI
Nonprimary PCI
Offsite
Onsite
P-value
Offsite
Onsite
P-value
(N=1,208) (N=26,921)
(N=2,565) (N=123,213)
% /Mean (SD)
66.3 (12.1)
0.001
64.4
63.1 (13.0)
0.001
29.8
29.8
0.975
29.4
26.5
0.025
White
Black/
African American
72.4
67.0
77.5
5.8
4.7
Asian
Native Hawaiian
or Pacific Islander
American Indian/
Alaskan Native
Hispanic
or Latino Ethnicity
11.1
9.9
1.5
Female gender
66.3 (11.8) 67.05 (11.8)
30.1
30.5
81.5
83.1
80.7
7.4
4.9
4.9
4.8
13.1
9.7
10.3
10.4
0.8
1.8
0.7
1.3
0.9
0.2
0.3
0.2
0.7
0.1
0.8
9.0
16.4
10.0
17.7
8.6
16.1
0.001
0.591
Race/Ethnicity
PCI-CAMPOS
<0.0001
<0.0001
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
<0.0001
BASELINE CHARACTERISTICS
Characteristics
Offsite
(N=3,773)
All PCI
Primary PCI
Nonprimary PCI
Onsite
Offsite
Onsite
Offsite
Onsite
P-value
P-value
P-value
(N=150,177)
(N=1,208) (N=26,921)
(N=2,565) (N=123,213)
CAD Presentation
STEMI
32.0
17.9
100.0
100.0
0.0
0.0
NSTEMI
27.4
21.3
0.0
0.0
40.2
25.9
Unstable Angina
22.8
33.9
0.0
0.0
33.5
41.3
Stable Angina
13.9
17.0
0.0
0.0
20.5
20.7
Symptoms Unlikely to be
Ischemic
0.4
2.3
0.0
0.0
0.6
2.8
No Symptoms No Angina
3.6
7.7
0.0
0.0
5.2
9.3
34.6
19.9
98.3
93.0
4.6
4.0
37.4
41.3
1.7
6.1
54.3
49.0
28.0
38.7
0.0
0.9
41.1
47.0
<0.0001
<0.0001
<0.0001
0.817
<0.0001
<0.0001
PCI Status
Emergent/Salvage
Urgent
Elective
PCI-CAMPOS
<0.0001
<0.0001
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<0.0001
LESION AND PROCEDURAL
CHARACTERISTICS
All PCIs
Primary
Offsite
Onsite
p value Offsite
Onsite
Location of vessel/branch — # of lesions in individual vessels/total # of lesions (%)
0.8
1.3
0.001
0.4
0.5
Left main coronary artery
p value
Offsite
Nonprimary
Onsite
0.364
1.0
1.4
0.012
p value
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
Bypass graft lesions
Vein (% of total lesions)
Internal mammary or other
arterial graft (% of total PCIs)
Length of lesion
Total number of lesions
evaluated
Mean length — mm
>20mm length (% of lesions
evaluated)
Lesion stenosis
Stenosis Immediately Prior to
Rx (mean)
Total number of lesions
evaluated
TIMI grade 3 — # of lesions (%)
Pre-Procedure TIMI 3 Flow
1.5
1.5
0.708
0.3
0.7
0.01
2.0
1.7
0.243
5.2
5.3
0.89
2.5
2.2
0.534
6.5
5.9
0.251
0.3
0.4
0.337
0.2
0.1
0.846
0.4
0.5
0.541
5112
205117
1509
33382
3603
171735
15.7
17.7
18.8
28.6
<0.0001
<0.0001
17.1
21.9
20.3
34.4
<0.0001
<0.0001
15.1
15.7
18.4
27.3
<0.0001
<0.0001
91.4
89.2
<0.0001
97.1
96.6
0.075
88.8
87.5
<0.0001
5155
208578
1527
33971
3628
174607
45.7
50.5
12.1
13.4
61.5
58.6
PCI-CAMPOS
<0.0001
0.128
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0.003
SAFET Y ENDPOINTS
All PCI
Offsite
Onsite
End Point
#/total # (%)
Nonprimary PCI
Primary PCI
Relative
Risk
P Value*
(95% CI)*
Offsite
Onsite
#/total # (%)
Relative
P
Risk
Value*
(95% CI)*
Offsite
Onsite
Relative Risk P
(95% CI)* Value*
#/total # (%)
Primary end points (Composite of Death, Stroke, and Emergency CABG)
0.94
(0.65-1.33)
0.712
Patient
Predicted end3.58
2.31
1.55
8.19
7.00
1.17
1.41
1.29
1.09
<0.0001
0.001
point rate, % (3.36-3.80) (2.28-2.35) (1.47-1.62)
(7.48-8.90) (6.85-7.15) (1.09-1.24)
(1.24-1.57) (1.26-1.31) (0.98-1.20)
(95% CI)
0.156
Patient Riskadjusted end1.87
2.36
0.79
points rate, % (1.55-2.19) (2.29-2.43) (0.68-0.90)
(95% CI)
0.230
Observed
2.86
2.33
1.24
(1.02-1.50)
0.033
0.009
6.37
7.08
0.89
0.346
(0.71-1.13)
1.21
1.29
5.49
7.14
0.76
1.11
1.29
0.86
0.013
(4.33-6.86) (6.82-7.46) (0.63-0.92)
(0.75-1.57) (1.23-1.36) (.60-1.15)
Secondary end points (Observed)
Death (%)
Cardiac cause
(%)
Noncardiac
cause (%)
Emergency
CABG (%)
Stroke (%)
PCI-CAMPOS
2.31
1.80
78.00
72.6
1.29
(1.04-1.60)
0.020
1.35
(0.81-2.27)
0.249
5.05
5.81
82.0
77.2
18.0
22.8
0.86
0.270
(0.66-1.12)
1.34
0.385
(0.69-2.60)
1.01
0.92
69.2
66.2
30.8
33.8
1.10
(0.75-1.63)
0.627
1.15
(0.50-2.67)
0.744
21.8
27.4
0.37
0.29
1.29
(0.76-2.20)
0.351
0.83
0.8
1.03
0.923
(0.55-1.95)
0.16
0.18
0.89
(0.33-2.38)
0.810
0.24
0.26
0.93
(0.48-1.79)
0.819
0.58
0.53
1.09
0.822
(0.51-2.34)
0.08
0.2
0.39
(0.10-1.58)
0.173
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
EFFICACY ENDPOINTS
All PCIs
Characteristic
Relative
Risk
(95% CI)
Primary
Onsite
Successful
treatment of
lesion — <20%
88.40%
post PCI stenosis
and TIMI-3 post
PCI flow
91.00%
0.97
0.97
0.99
<0.0001 89.20% 92.40%
<0.0001 90.90% 91.40%
(0.96-0.98)
(0.95-0.98)
(0.99-1.00)
<20% Stenosis
Post-Procedure
91.20%
92.50%
0.98
(0.98-0.99)
Post-Procedure
TIMI 3 Flow
93.00%
94.90%
0.98
0.95
1.00
<0.0001 88.10% 93.00%
<0.0001 95.40% 95.30%
0.992
(0.97-0.99)
(0.93-0.96)
(0.99-1.00)
89.20% 92.40%
0.97
(0.95-0.98)
P Value
0.001
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
Offsite
Onsite
Relative
Risk
P Value
(95% CI)
Onsite
0.003
Offsite
Relative
Risk
(95% CI)
Offsite
PCI-CAMPOS
P Value
Nonprimary
92.10% 92.50%
0.37
1.00
0.454
(0.99-1.00)
HOSPITAL SAFETY RATINGS:
ALL PCI CASES 07/01/2010-07/31/2013
Offsite
As Expected
Better*
Worse*
As Expected
Better*
Worse*
5
1
0
106
8
6
Mean
591.8
814.0
1205.7
1751.4
1393.2
Range
317-1,150
1-4,846
130-4,323
401-4,403
2.48
1.23
3.80
Number of hospitals
Volume
Onsite
Risk adjusted event rate
(death, stroke, or
emergency CABG)
2.01
1.25
* Statistically significant with ≥ 95% confidence (Poisson exact probability method)
PCI-CAMPOS
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
SUMMARY
 California Pilot Of fsite 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
Of fsite (1 .87%) versus Onsite (2.36%) hospitals.
 The composite ef ficacy endpoint (<20%, TIMI-3) was
significantly lower in Of fsite (88.4%) versus Onsite (91%)
hospitals.
 No significant dif ferences were seen in stroke, or emergency
CABG rates.
 No significant hospital volume/outcome relationship was
seen.
PCI-CAMPOS
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
LIMITATIONS
 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
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
March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2
ACKNOWLEDGEMENTS
Of fsite Hospitals
Clovis Community Hospital
Doctors Medical Center, San Pablo
Kaiser Foundation Hospital, Walnut
Creek
Los Alamitos Medical Center
St Rose Hospital
Sutter Roseville Medical Center
Onsite Hospitals
122 Acute Care Hospitals
National Cardiovascular Data
R e g i s t r y ( N C D R ®)
Lara Slattery
Jim Beachy
California Depar tment of Public
Health
Anthony Way, MD
Chief Medical Consultant
Debby Rogers, RN
Deputy Director, Licensing and
Certification
Carol Turner, RN
Branch Chief, Licensing and
Certification
PCI-CAMPOS
Ad visor y Oversight C o mmittee
Members
(*PCI-CAMPOS I nvestigators)
S t e ph e n A r n o l d, M D *
R a l ph B r i n di s , M D
R o be r t D a v i ds o n , M D
M a h m o ud E s l a m i F a r s a n i , M D
G e o r g e F e h r e n ba c h e r , M D *
Steven Forman, MD*
William French, MD
D i pt i I t c h a po r i a , M D
A di t y a J a i n , M D *
S us h i l K a r m a r k a r , M D *
George Smith, MD
R o h i t S un dr a n i , M D *
PCI-CAMPOS Coders
R o be r t F o r e y
K e vin S pr uc e
Alfonso Brosas
Barry Howard
S t e ph e n S c o t t
Sharri Steiert
Dennis Patrick
Danielle Bennett
Mary Ann Ma
Li n da Ca m pbe l l
E di t h J o n a s
Joanne Easley
A m i e S e l da
J e n n i f e r Ca r de n a s
T h uy P h a m
University of California, Davis
Tejinder Singh
A n dr e a B l a c k w e l l , R N
Melanie Aryana, MD
R e g i n a l d Lo w , M D
Jason Rogers, MD
J e f f r e y S o ut h a r d, M D
Garrett Wong, MD
La w r e n c e La s l e t t , M D
Ca l v i n Ch a n g , M H A
P a ul P a n n u , M S
V e l o s S u p p o r t Te a m
Ci n dy S c h m i dt
V a r i n de r G o y a l
Of fice o f Statewide Health
Planning and Development
Joe Parker PhD
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