CPORT- E Trial
Randomized trial comparing medical, economic and quality of
life outcomes of non-primary PCI at hospitals
with and without on-site cardiac surgery
Atlantic
C-PORT
Motivation for Trial
 Sustain primary PCI program at no-SOS hospitals
 Improve access to PCI services
 Reduce pressure to create additional cardiac surgery
programs
 Need for research to inform healthcare policy
decisions by state and national organizations
Atlantic
C-PORT
C-PORT Elective
Patient for Diagnostic Cath
Not Approached
No
Consent
Registry
Informed consent
Consent
Registry
Catheterization
Meets
inclusion
criteria
Exclusion
criteria
3:1 Randomization
PCI no SOS
PCI with SOS
Atlantic
Analysis by intention-to-treat
C-PORT
Study Endpoints
 Non-inferiority trial
 Primary Endpoints
 All-cause mortality at 6 weeks
 MACE at 9 months



All-cause mortality
Q-wave myocardial infarction
Target vessel revascularization
 Assuming 6 week mortality to be 0.8%, a sample size of
18360 was selected to define a non-inferiority margin of
0.4% with a one-sided test for non-inferiority using
α=0.05 and β=0.80 for both primary endpoints.
Atlantic
C-PORT
Inclusion and Exclusion Criteria
Patient
Devices
Institution
Inclusion
• Age > 18 years
• Informed
consent
• > 50% stenosis
• All target lesions
approachable at
no-SOS hospital
Inclusion
• Balloon, stent
• Distal protection
• Covered stent
• Cutting balloon in-stent
restenosis
Exclusion
• Unprotected LM
• EF < 20%
• MD-judged high
risk
Exclusion
• Atherectomy
• Cutting balloonde novo lesion
Inclusion
• > 200 PCI/year
• 24/7 Primary PCI
• Complete formal
development
program
• Interventionalist
meets AHA/ACC
competency
Atlantic
C-PORT
Participating Centers
60 Centers
Center Annual PCI Procedure Volume
150 (99,216)
median (25th,75th percentile)
Median Participation Duration
2.2 years
Atlantic
C-PORT
99479
Visits
23805
No Consent
75674 Consented
18867 PCI
Randomized
56807
Not Randomized
2298 PCI
Excluded
(12%)
Atlantic
C-PORT
18867 PCI
Randomized
PCI
18568
(98.4%
No PCI
299
(1.6%)
Lesion Not
Medical
CABG Significant Withdrawal
Tx
Overall
SOS 0.73%
0.79%
0.68%
0.51% 3.68%
No-SOS 0.14%
0.27%
0.12%
0.09% 0.86%
No-SOS
13981
Assigned
18496
Unassigned
72
SOS
0.73%
No-SOS
0.28%
SOS
4515
Atlantic
C-PORT
No-SOS
SOS
p-value
64+/-12
64+/-12
0.42
Male Gender (%)
64.0
63.2
0.37
Race/Ethnicity (%)
Caucasian
79.1
80.2
11.8
5.6
2.1
11.3
5.6
1.9
Hypertension (%)
84.6
85.3
0.29
Hypercholesterolemia (%)
82.2
82.2
0.95
Smoking (Current
61.6
62.7
0.20
Diabetes (%)
39.0
39.7
0.41
Family History of CAD (%)
56.7
57.9
0.17
Heart Failure (%)
8.6
8.8
0.64
Prior MI (%)
42.5
43.3
0.35
Prior PCI (%)
31.9
30.4
0.06
Prior CABG (%)
13.1
13.5
0.47
Prior Stroke or PVD (%)
17.3
18.4
0.09
1.15+/-0.88
1.15+/-0.87
0.63
76.5+/-34.1
76.3+/-27.1
0.63
32.7+/-21.9
33.2+/-24.5
0.22
Age (years) (mean+/-SD)
Africa-American
Hispanic
Asian
& Former)
Creatinine (mg/dl)
GFR ml/min/1.73
BMI
kg/m2
m2
(%)
0.33
Atlantic
C-PORT
Presentation
Clinical Characteristics
ACS
Stable
No-SOS
(%)
SOS
(%)
63.8
64.1
36.1
36.0
Procedure Status
No-SOS
(%)
SOS
(%)
Elective
76.7
79.4
Urgent
22.9
20.1
Emergency
0.36
0.57
* P < 0.001
Atlantic
C-PORT
Baseline Diagnostic Catheterization
One vessel CAD
No-SOS
(%)
36.1
SOS
(%)
34.7
Two vessel CAD
35.9
37.2
Three vessel CAD
28.0
28.0
Left main disease
3.2
3.7
0.13
Graft disease
9.4
9.7
0.44
54.2 +/- 10.6
54.3 +/- 10.7
0.72
LV function (EF)
p-value
0.22
Atlantic
C-PORT
Totals add up to >100% because Left Main and Graft disease are in addition to disease in the three major circulations
Procedure Characteristics
No-SOS SOS
(%)
(%)
PValue
Staged
25.7
67.7 <0.0001
Lab Visits /Index PCI
1.28
1.73
Single Vessel PCI
79
78
Multi-Vessel PCI
21
22
<0.0001
Staged Index PCI
procedure requires one or more catheterization laboratory visit
dates in addition to the diagnostic catheterization date
Atlantic
C-PORT
PCI Success
No-SOS
(%)
SOS
(%)
90.8
91.9*
5.7
3.4
5.5
2.5*
Complete Success
Partial Success
Failure
Success
No-SOS
(%)
93.4
SOS
(%)
94.1
Failure
6.6
5.9
Patient Success
P=0.0096
Lesion Success
P=0.0474
Atlantic
PCI Success: <20% residual stenosis and TIMI 3 flow
C-PORT
Mortality 6- Weeks
Death
No-SOS
(%)
SOS
(%)
P-value
0.91
0.93
0.94
The difference in 6 week mortality is -0.014% with a 90% confidence interval of
-0.26% to 0.28%. The upper bound is <0.4%, so that the hypothesis of inferior 6
week mortality for the no-SOS hospitals is rejected at the one-sided P<0.05 level.
Atlantic
C-PORT
Adverse Events - 6-Weeks
No-SOS
(%)
SOS
(%)
P-value
Death
0.91
0.93
0.94
Bleeding
3.41
3.00
0.18
Vascular repair
0.38
0.40
0.86
Stroke
0.27
0.15
0.16
Renal Failure
0.50
0.37
0.28
Atlantic
C-PORT
Unplanned Procedures
No-SOS
(%)
SOS
(%)
P-value
0.48
0.68
0.10
0.10
0.22
0.05
Unplanned Cath
4.41
3.35
0.002
Unplanned PCI
2.11
1.32
0.001
CABG
Emergency CABG
Atlantic
C-PORT
Summary

PCI success is greater than 90% in both groups but lower in patients
randomized to hospitals without surgery on-site
(success rate difference of 1.1% on per patient basis; 0.7% on per lesion basis)

Number of cath lab visits required to complete the index PCI is
greater in patients randomized to hospitals with surgery on-site
(1.3 versus 1.7 visits/patient)

Unplanned catheterization and PCI procedures are uncommon but
occur more frequently in patients randomized to hospitals without
surgery on-site
(4.4% no-SOS vs 3.4% SOS)

Emergency CABG procedures are rare, but occur more frequently in
patients randomized to hospitals with surgery on-site
(0.1% no-SOS vs 0.2% SOS)

Mortality is similar in both groups
(0.91% no-SOS vs 0.93% SOS)

The incidence of bleeding, vascular repair, stroke and renal
failure is similar in both groups
Atlantic
C-PORT
Conclusion
 In hospitals without on-site cardiac surgery that
complete a formal PCI development program, adhere
to C-PORT participation requirements, and whose
outcomes are monitored, non-primary PCI is safe and
associated with similar rates of adverse events
including mortality.
 Long-term, quality outcome data are currently being
collected on these study subjects and will be reported
early in 2012.
Atlantic
C-PORT
Atlantic
C-PORT
Summary

Angiographic Outcomes
 PCI Success > 90% in both groups but lower in hospitals without surgery on-site
(success rate difference of 1.1% on per patient basis; 0.7% on per lesion basis)

Number of catheterization laboratory visits required to complete the index PCI is greater in
patients randomized to hospitals with surgery on-site
(1.3 versus 1.7 visits/patient)

Unplanned procedure outcomes
 Unplanned catheterization and PCI procedures were uncommon but occurred more frequently in
patients randomized to hospitals without surgery on-site
(4.4% no-SOS vs 3.4% SOS)

Emergency coronary CABG was rarely required, but was utilized more among patients at hospitals
with surgery on-site
(0.1% no-SOS vs 0.2% SOS)

Patient Outcomes
 Mortality is similar in both groups
(0.91% no-SOS vs 0.93% SOS)

The incidence of bleeding, vascular repair, stroke and renal failure is similar in both groups
Atlantic
C-PORT
Summary
No
SOS
(%)
Relative
SOS
Difference
(%)
90.8
91.9
1.2 %
204
Number procedures / index PCI
1.3
1.7
30 %
5570
Unplanned cath or PCI
4.4
3.4
29 %
184
Unplanned emergency CABG
0.10
0.22
50 %
22
Mortality
.91
.93
3.2 %
4
Bleeding
3.4
3
13 %
76
PCI Success
Absolute
Difference
Atlantic
C-PORT
Summary - 1
 Historical, angiographic and clinical characteristics of study




subjects are similar at hospitals with and without on-site surgery
Acute coronary syndrome is the most frequent clinical
presentation in both groups
Fewer procedures are classified as “elective” at hospitals without
surgery on-site
PCI success rate differs by less than 1% in the two groups, but is
statistically lower at hospitals without on-site surgery
In patients assigned to hospitals with on-site surgery there are
more staged procedures and more catheterization laboratory
visits are required to complete the index PCI.
Atlantic
C-PORT
Summary - 2
 Six weeks after index PCI
 Mortality is similar at hospitals with and without SOS
 Incidence of bleeding, renal failure and stroke are similar at
hospitals with and without SOS
 Unplanned CABG, particularly emergency CABG, are more
frequent at hospitals with SOS
 Unplanned catheterization and PCI procedures are more
frequent in patient assigned to
no-SOS hospitals
Atlantic
C-PORT
Catheterization Laboratory Visits
No-SOS
SOS
Diagnositic Cath Visits
14023
4545
Visits to Complete Index PCI
Visits/PCI
17964
1.28
7855
1.73
Unplanned Visits
618
152
Total
Visits/PCI
18302
1.31
8007
1.76
Atlantic
C-PORT
Reason No PCI – consented, not randomized
High Risk (other), 18%
Left Main, 9%
Poor LV Function, 7%
Comorbidity, 9%
Need Excluded Device,
16%
Unavailable Device, 8%
High Risk Anatomy,
23%
Bifurcation, 9%
Tortuous, 12%
Thrombus, 3%
Calcification, 20%
Atlantic
C-PORT
Consented But Not Randomized
PCI at alternate site
Exclusion Criteria
Need Excluded Device
Left Main
Poor LV Function
368
218
161
16%
9%
7%
High Risk
High Risk Anatomy
Calcification
High Risk (other)
Tortuous
Co-morbidity
Bifurcation
Thrombus
537
452
410
270
200
197
70
23%
20%
18%
12%
9%
9%
3%
Atlantic
Total > 100 % because of multiple reasons for some patients
C-PORT
PCI Success
Success
Partial Success or
Failure
No-SOS
(%)
94.3
SOS
(%)
95.2
5.7
4.8
Off-Site* On-Site*
(%)
(%)
95
94
PCI Success: <50% residual stenosis and TIMI 3 flow
* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24
Atlantic
C-PORT
No-SOS
SOS
Off-Site*
On-Site*
64+/-12
64+/-12
64.2
64 + 12
64.0
63.2
65
66
Caucasian
79.1
80.2
Africa-American
11.8
11.3
Hispanic
5.6
5.6
Asian
2.1
1.9
Hypertension (%)
84.6
85.3
76
77
Hypercholesterolemia (%)
82.2
82.2
71
76
Smoking (Current
61.6
62.7
Diabetes (%)
39.0
39.7
32
33
Family History of CAD (%)
56.7
57.9
Heart Failure (%)
8.6
8.8
11
11
Prior MI (%)
42.5
43.3
29
31
Prior PCI (%)
31.9
30.4
36
37
Prior CABG (%)
13.1
13.5
14
21
Prior Stroke or PVD (%)
17.3
18.4
Creatinine (mg/dl)
1.15+/-0.88
1.15+/-0.87
GFR ml/min/1.73 m2
76.5+/-34.1
76.3+/-27.1
Atlantic
32.7+/-21.9
33.2+/-24.5
C-PORT
Age (years) (mean+/-SD)
Male Gender (%)
Race/Ethnicity (%)
BMI
kg/m2
& Former)
(%)
* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24
Adverse Events - 6-Weeks
No-SOS
(%)
SOS
(%)
Death
0.91
0.93
0.8
0.8
Bleeding
3.41
3.00
2.3
2
Vascular repair
0.38
0.40
0.8
1.1
Stroke
0.27
0.15
Renal Failure
0.50
0.37
Off-Site* On-Site*
(%)
(%)
Atlantic
C-PORT
* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24
Unplanned Procedures
No-SOS
(%)
SOS
(%)
0.48
0.68
0.10
0.22
Unplanned Cath
4.41
3.35
Unplanned PCI
2.11
1.32
CABG
Emergency CABG
Off-Site* On-Site*
(%)
(%)
0.3
0.4
Atlantic
C-PORT
* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24
Disclosure
 Participating sites supported study infrastructure
and personnel at
 Johns Hopkins – Clinical Coordinating Center
 Duke – Economics and Quality of Life
 Clinical Trials and Survey Corporation – Data Analysis
Atlantic
C-PORT