William J. Bommer, Suresh Ram, Tanuj Patel, Laurie Vazquez, Zhongmin Li, Geeta Mahendra, PCI-CAMPOS...

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-i2PCI-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

March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2PCI-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

March 29, 2014 401:Featured Clinical Research II: TCT@ACC-i2

PCI-CAMPOS

METHOD


PCI-CAMPOS

HOSPITAL AND OPERATOR REQUIREMENTS

Offsite HospitalsApproval from California Department of Public HealthFormal PCI development programParticipation in the elective PCI pilot program and NCDR® RegistrySigned 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 OperatorsPerform at least 100 PCIs/year; 18 primary PCIs/yearLifetime experience ≥500 PCIs as primary operatorComplication rates and outcomes equivalent or superior to national benchmarksABIM Interventional Cardiology and Cardiovascular Diseases certification Active participant in hospital quality improvement program

Onsite HospitalsParticipation in NCDR® Registry

Onsite OperatorsApproval from hospital credentialing


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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 fieldsHospital Site 20%: 10% Random sample of Offsite PCI procedures and 10% selected PCI procedures with all major complicationsAngiographic: 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 powerA 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


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All PCI Primary PCI Nonprimary PCICharacteristics 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 10.4Native Hawaiian or Pacific Islander 1.5 0.8 1.8 0.7 1.3 0.9American Indian/Alaskan Native 0.2 0.3 0.2 0.7 0.1 0.8Hispanic or Latino Ethnicity 9.0 16.4 10.0 17.7 8.6 16.1

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)


Offsite (N=2,565)


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

<0.0001Urgent 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 valueLocation 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 0.012Left 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 0.243Bypass graft lesionsVein (% of total lesions) 5.2 5.3 0.89 2.5 2.2 0.534 6.5 5.9 0.251Internal 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 lesionTotal 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 stenosisStenosis 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

All PCI Primary PCI Nonprimary PCI

End Point

Offsite OnsiteRelative

Risk(95% CI)*

P Value*

Offsite OnsiteRelative

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) 0.0131.11

(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 77.21.34

(0.69-2.60) 0.38569.2 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 OnsiteRelative

Risk (95% CI)

P Value Offsite OnsiteRelative

Risk (95% CI)

P Value Offsite OnsiteRelative

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

* 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


PCI-CAMPOS

William J. Bommer, Suresh Ram, Tanuj Patel, Laurie Vazquez, Zhongmin Li, Geeta Mahendra, PCI-CAMPOS...

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