1. Atlantic Cardiovascular Patient Outcomes Research Team
CPORT- E Trial
Randomized trial comparing outcomes of non-primary PCI at hospitals with and without on-site cardiac surgery

2. 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

3. C-PORT Elective No Consent Registry Patient for Diagnostic Cath
Not Approached
Patient for Diagnostic Cath
Refuse
Informed consent
Consent Registry
Catheterization
Exclusion
criteria
Meets
inclusion
criteria
Patients entered the CPORT E project through the community hospital where diagnostic catheterization was performed.
Prior to diagnostic catheterization, patients signed informed consent.
For those patients who were either not approached for consent or were approached but refused, a registry of baseline characteristics was developed.
For those patients who signed consent but were excluded from participation, a consent registry was developed.
Those patients meeting inclusion criteria and having no exclusion criteria were randomized.
Randomization was asymmetric (3:1) so that for every 4 study subjects, 3 remained at the hospital without surgery on-site (no SOS) and 1 was transferred to a tertiary hospital (SOS) for PCI.
3:1 Randomization
PCI no SOS
PCI with SOS

4. 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 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.
This report concerns only the first primary endpoint, mortality at 6 weeks.

5. Inclusion and Exclusion Criteria
Patient
Devices
Institution
Inclusion
Age > 18 years
Informed consent
> 50% stenosis
All target lesions approachable at no-SOS hospital
Exclusion
Unprotected LM
EF < 20%
MD-judged high risk
Inclusion
Balloon, stent
Distal protection
Covered stent
Cutting balloon - in-stent restenosis
Exclusion
Atherectomy
Cutting balloon- de novo lesion
Inclusion
> 200 PCI/year
24/7 Primary PCI
Complete formal development program
Interventionalist meets AHA/ACC competency

6. Participating Centers
Center Annual PCI Procedure Volume 150 (99,216) median (25th,75th percentile)
Median Participation Duration 2.2 years
Note that if a center did 100 cases in the first year and 200 in the second, the average center volume would be 150 cases per year.

7. 99479 Visits 23805 No Consent 75674 Consented 18867 PCI Randomized
56807
Not Randomized
There were nearly 100,000 cath lab visits among the 60 participating centers.
75% of all patients were consented for the study.
2298 PCI
Excluded
(12%)

8. Lesion Not Significant
18867 PCI
Randomized
No PCI
299 (1.6%)
PCI
(98.4%
CABG
Lesion Not Significant
Withdrawal
Medical 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%
Assigned
18496
Unassigned 72
SOS %
No-SOS %
No-SOS
13981
SOS
4515

9. No-SOS SOS p-value Age (years) (mean+/-SD) 64+/-12 0.42
Male Gender (%)
64.0
63.2
0.37
Race/Ethnicity (%)
Caucasian
79.1
80.2
0.33
Africa-American
11.8
11.3
Hispanic
5.6
Asian
2.1
1.9
Hypertension (%)
84.6
85.3
0.29
Hypercholesterolemia (%)
82.2
0.95
Smoking (Current & Former) (%)
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
Creatinine (mg/dl)
1.15+/-0.88
1.15+/-0.87
0.63
GFR ml/min/1.73 m2
76.5+/-34.1
76.3+/-27.1
BMI kg/m2
32.7+/-21.9
33.2+/-24.5
0.22

10. Presentation Clinical Characteristics Procedure Status No-SOS (%)
ACS
63.8
64.1
Stable
36.1
36.0
No-SOS (%)
SOS (%)
Elective
76.7
79.4
Urgent
22.9
20.1
Emergency
0.36
0.57
* P < 0.001

11. Baseline Diagnostic Catheterization
No-SOS (%)
SOS (%)
p-value
One vessel CAD
36.1
34.7
0.22
Two vessel CAD
35.9
37.2
Three vessel CAD
28.0
Left main disease
3.2
3.7
0.13
Graft disease
9.4
9.7
0.44
LV function (EF)
54.2 +/- 10.6
54.3 +/- 10.7
0.72
Underlying CAD severity and LV function are similar in both groups
Totals add up to >100% because Left Main and Graft disease are in addition to disease in the three major circulations

12. Procedure Characteristics
No-SOS (%)
SOS (%)
P- Value
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
The number of staged procedures – defined as multiple catheterization laboratory visits required to complete index PCI – is significantly greater in the SOS group, primarily because of the need to transfer patients to an alternative facility after diagnostic catheterization, frequently requiring a procedure on a subsequent day.
Staged Index PCI
procedure requires one or more catheterization laboratory visit
dates in addition to the diagnostic catheterization date

13. PCI Success No-SOS (%) SOS (%) Complete Success 90.8 91.9*
Partial Success
5.7
5.5
Failure
3.4
2.5*
Patient Success
P=0.0096
There are no differences in PCI success when success is classified by lesion.
When classified by patient, there are slightly but significantly more PCI’ patients classified as “failure” at no-SOS hospitals. However, the complete success rates are comparable and not significantly different.
Complete Success: all treated lesions successful
Partial Success: some treated lesions successful, others failure
Failure: no treated lesion successful
No-SOS (%)
SOS (%)
Success
93.4
94.1
Failure
6.6
5.9
Lesion Success
P=0.0474
PCI Success: <20% residual stenosis and TIMI 3 flow

14. Mortality 6- Weeks No-SOS (%) SOS (%) P-value Death 0.91 0.93 0.94
The difference in 6 week mortality is % 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.

15. 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

16. Unplanned Procedures No-SOS (%) SOS (%) P-value CABG 0.48 0.68 0.10
Emergency CABG
0.22
0.05
Unplanned Cath
4.41
3.35
0.002
Unplanned PCI
2.11
1.32
0.001

17. 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

18. 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.