C-PORTAtlantic

Atlantic Cardiovascular Patient Outcomes Research Team

CPORT- E TrialRandomized trial comparing medical, economic and

quality of life outcomes of non-primary PCI at hospitals

with and without on-site cardiac surgery

C-PORTAtlantic

Motivation for TrialSustain primary PCI program at no-SOS

hospitalsImprove access to PCI servicesReduce pressure to create additional cardiac

surgery programsNeed for research to inform healthcare policy

decisions by state and national organizations

C-PORTAtlantic

C-PORT ElectivePatient for Diagnostic Cath

Informed consent

Catheterization

Meetsinclusioncriteria

PCI no SOS PCI with SOS

Exclusioncriteria

Consent Registry

Refuse

NoConsent RegistryNot Approached

3:1 Randomization

Analysis by intention-to-treat

C-PORTAtlantic

Study EndpointsNon-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.

C-PORTAtlantic

Inclusion and Exclusion CriteriaPatient InstitutionInclusion• Age > 18 years• Informed

consent• > 50% stenosis• All target

lesions approachable at no-SOS hospital

Exclusion• Unprotected LM• EF < 20%• MD-judged high

risk

DevicesInclusion• 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

C-PORTAtlantic

Participating Centers60 Centers

Center Annual PCI Procedure Volume

150 (99,216) median (25th,75th percentile)

Median Participation Duration 2.2 years

C-PORTAtlantic

99479 Visits

75674 Consented

23805 No Consent

18867 PCI Randomized

56807 Not Randomized

2298 PCIExcluded

(12%)

C-PORTAtlantic

18867 PCI Randomized

No PCI299

(1.6%)

PCI18568 (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%

Assigned18496

Unassigned72

SOS 0.73%No-SOS 0.28%

No-SOS13981

SOS4515

C-PORTAtlantic

No-SOS SOS p-valueAge (years) (mean+/-SD) 64+/-12 64+/-12 0.42Male Gender (%) 64.0 63.2 0.37Race/Ethnicity (%)

Caucasian 79.1 80.2

0.33Africa-American 11.8 11.3

Hispanic 5.6 5.6Asian 2.1 1.9

Hypertension (%) 84.6 85.3 0.29Hypercholesterolemia (%) 82.2 82.2 0.95Smoking (Current & Former) (%) 61.6 62.7 0.20Diabetes (%) 39.0 39.7 0.41Family History of CAD (%) 56.7 57.9 0.17

Heart Failure (%) 8.6 8.8 0.64Prior MI (%) 42.5 43.3 0.35Prior PCI (%) 31.9 30.4 0.06Prior CABG (%) 13.1 13.5 0.47Prior Stroke or PVD (%) 17.3 18.4 0.09

Creatinine (mg/dl) 1.15+/-0.88 1.15+/-0.87 0.63GFR ml/min/1.73 m2 76.5+/-34.1 76.3+/-27.1 0.63BMI kg/m2 32.7+/-21.9 33.2+/-24.5 0.22

C-PORTAtlantic

PresentationClinical Characteristics Procedure Status

No-SOS(%)

SOS(%)

Elective 76.7 79.4Urgent 22.9 20.1Emergency 0.36 0.57

No-SOS(%)

SOS(%)

ACS 63.8 64.1

Stable 36.1 36.0

* P < 0.001

C-PORTAtlantic

Baseline Diagnostic CatheterizationNo-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 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

Totals add up to >100% because Left Main and Graft disease are in addition to disease in the three major circulations

C-PORTAtlantic

Procedure CharacteristicsNo-SOS(%)

SOS(%)

P-Value

Staged 25.7 67.7 <0.0001

Lab Visits /Index PCI 1.28 1.73 <0.000

1Single Vessel PCI 79 78

Multi-Vessel PCI 21 22Staged Index PCI

procedure requires one or more catheterization laboratory visit dates in addition to the diagnostic catheterization date

C-PORTAtlantic

PCI Success

No-SOS(%)

SOS(%)

Success 93.4 94.1Failure 6.6 5.9

No-SOS(%)

SOS(%)

Complete Success 90.8 91.9*

Partial Success 5.7 5.5Failure 3.4 2.5*

Patient SuccessP=0.0096

Lesion SuccessP=0.0474

PCI Success: <20% residual stenosis and TIMI 3 flow

C-PORTAtlantic

Mortality 6- Weeks

No-SOS(%)

SOS(%) P-value

Death 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.

C-PORTAtlantic

Adverse Events - 6-WeeksNo-SOS

(%)SOS(%) P-value

Death 0.91 0.93 0.94

Bleeding 3.41 3.00 0.18Vascular repair 0.38 0.40 0.86

Stroke 0.27 0.15 0.16

Renal Failure 0.50 0.37 0.28

C-PORTAtlantic

Unplanned ProceduresNo-SOS

(%)SOS(%) P-value

CABG 0.48 0.68 0.10Emergency

CABG 0.10 0.22 0.05

Unplanned Cath 4.41 3.35 0.002

Unplanned PCI 2.11 1.32 0.001

C-PORTAtlantic

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

C-PORTAtlantic

ConclusionIn 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.

C-PORTAtlantic

C-PORTAtlantic

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

C-PORTAtlantic

SummaryNo SOS

(%)

SOS

(%)

Relative Differenc

eAbsolute

Difference

PCI Success 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 % 184Unplanned emergency CABG 0.10 0.2

2 50 % 22

Mortality .91 .93 3.2 % 4Bleeding 3.4 3 13 % 76

C-PORTAtlantic

Summary - 1Historical, 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.

C-PORTAtlantic

Six weeks after index PCIMortality is similar at hospitals with and without

SOSIncidence of bleeding, renal failure and stroke are

similar at hospitals with and without SOSUnplanned CABG, particularly emergency CABG,

are more frequent at hospitals with SOSUnplanned catheterization and PCI procedures are

more frequent in patient assigned to no-SOS hospitals

Summary - 2

C-PORTAtlantic

Catheterization Laboratory VisitsNo-SOS SOS

Diagnositic Cath Visits 14023 4545

Visits to Complete Index PCI

Visits/PCI

179641.28

78551.73

Unplanned Visits 618 152Total

Visits/PCI183021.31

80071.76

C-PORTAtlantic

Reason No PCI – consented, not randomized

Left Main; 9% Poor LV Function; 7%

Need Excluded Device; 16%

Unavailable Device; 8%

Bifurcation; 9%

Calcification; 20%Thrombus; 3%Tortuous; 12%

High Risk Anatomy; 23%

Comorbidity; 9%

High Risk (other); 18%

C-PORTAtlantic

Consented But Not RandomizedPCI at alternate site

Exclusion CriteriaNeed Excluded Device 368 16%

Left Main 218 9%Poor LV Function 161 7%

High RiskHigh Risk Anatomy 537 23%

Calcification 452 20%High Risk (other) 410 18%

Tortuous 270 12%Co-morbidity 200 9%

Bifurcation 197 9%Thrombus 70 3%

Total > 100 % because of multiple reasons for some patients

C-PORTAtlantic

PCI Success

No-SOS(%)

SOS(%)

Off-Site*(%)

On-Site*(%)

Success 94.3 95.2 95 94Partial Success or Failure

5.7 4.8

PCI Success: <50% residual stenosis and TIMI 3 flow

* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24

C-PORTAtlantic

No-SOS SOS Off-Site* On-Site*Age (years) (mean+/-SD) 64+/-12 64+/-12 64.2 64 + 12 Male Gender (%) 64.0 63.2 65 66Race/Ethnicity (%)

Caucasian 79.1 80.2Africa-American 11.8 11.3

Hispanic 5.6 5.6Asian 2.1 1.9

Hypertension (%) 84.6 85.3 76 77Hypercholesterolemia (%) 82.2 82.2 71 76Smoking (Current & Former) (%) 61.6 62.7Diabetes (%) 39.0 39.7 32 33Family History of CAD (%) 56.7 57.9Heart Failure (%) 8.6 8.8 11 11

Prior MI (%) 42.5 43.3 29 31Prior PCI (%) 31.9 30.4 36 37Prior CABG (%) 13.1 13.5 14 21Prior Stroke or PVD (%) 17.3 18.4

Creatinine (mg/dl) 1.15+/-0.88 1.15+/-0.87GFR ml/min/1.73 m2 76.5+/-34.1 76.3+/-27.1BMI kg/m2 32.7+/-21.9 33.2+/-24.5

* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24

C-PORTAtlantic

Adverse Events - 6-WeeksNo-SOS(%)

SOS(%)

Off-Site*(%)

On-Site*(%)

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* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24

C-PORTAtlantic

Unplanned ProceduresNo-SOS

(%)SOS(%)

Off-Site*(%)

On-Site*(%)

CABG 0.48 0.68

Emergency CABG 0.10 0.22 0.3 0.4

Unplanned Cath 4.41 3.35

Unplanned PCI 2.11 1.32

* Kutcher MA et al. J Am Coll Cardiol, 2009, 54:16-24

C-PORTAtlantic

DisclosureParticipating sites supported study

infrastructure and personnel atJohns Hopkins – Clinical Coordinating CenterDuke – Economics and Quality of LifeClinical Trials and Survey Corporation – Data

Analysis