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CPORT- E Trial Randomized trial comparing outcomes of non-primary PCI at hospitals with and without on-site cardiac surgery.

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Presentation on theme: "CPORT- E Trial Randomized trial comparing outcomes of non-primary PCI at hospitals with and without on-site cardiac surgery."— Presentation transcript:

1 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 Patient for Diagnostic Cath Informed consent Catheterization Meets inclusion criteria PCI no SOS PCI with SOS Exclusion criteria Consent Registry Refuse No Consent Registry Not Approached 3:1 Randomization

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 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.

5 Inclusion and Exclusion Criteria Patient 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 Devices 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 60 Centers Center Annual PCI Procedure Volume 150 (99,216) median (25 th,75 th percentile) Median Participation Duration 2.2 years

7 99479 Visits 75674 Consented 23805 No Consent 18867 PCI Randomized 56807 Not Randomized 2298 PCI Excluded (12%)

8 18867 PCI Randomized No PCI 299 (1.6%) PCI 18568 (98.4% CABG Lesion Not SignificantWithdrawal Medical TxOverall SOS0.73%0.79%0.68%0.51%3.68% No-SOS0.14%0.27%0.12%0.09%0.86% Assigned 18496 Unassigned 72 SOS 0.73% No-SOS 0.28% No-SOS 13981 SOS 4515

9 No-SOSSOSp-value Age (years) (mean+/-SD) 64+/-12 0.42 Male Gender (%) Race/Ethnicity (%) Caucasian 79.180.2 0.33 Africa-American 11.811.3 Hispanic 5.6 Asian 2.11.9 Hypertension (%) 84.685.30.29 Hypercholesterolemia (%) 82.2 0.95 Smoking (Current & Former) (%) 61.662.70.20 Diabetes (%) Family History of CAD (%) 56.757.90.17 Heart Failure (%) 8.6 8.80.64 Prior MI (%) 42.543.30.35 Prior PCI (%) 31.930.40.06 Prior CABG (%) Prior Stroke or PVD (%) 17.318.40.09 Creatinine (mg/dl) 1.15+/-0.881.15+/-0.870.63 GFR ml/min/1.73 m 2 76.5+/-34.176.3+/-27.10.63 BMI kg/m 2 32.7+/-21.933.2+/-24.50.22

10 Presentation Clinical CharacteristicsProcedure Status No-SOS (%) SOS (%) Elective76.779.4 Urgent22.920.1 Emergency0.360.57 No-SOS (%) SOS (%) ACS63.864.1 Stable36.136.0 * P < 0.001

11 Baseline Diagnostic Catheterization No-SOS (%) SOS (%) p-value One vessel CAD36.134.70.22 Two vessel CAD35.937.2 Three vessel CAD28.0 Left main disease3.23.70.13 Graft disease9.49.70.44 LV function (EF)54.2 +/- 10.654.3 +/- 10.70.72 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 Staged25.767.7<0.0001 Lab Visits /Index PCI1.281.73<0.0001 Single Vessel PCI7978 Multi-Vessel PCI2122 Staged Index PCI procedure requires one or more catheterization laboratory visit dates in addition to the diagnostic catheterization date

13 PCI Success Patient Success P=0.0096 Lesion Success P=0.0474 PCI Success: <20% residual stenosis and TIMI 3 flow

14 Mortality 6- Weeks No-SOS (%) SOS (%) P-value Death0.910.930.94 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.

15 Adverse Events - 6-Weeks No-SOS (%) SOS (%) P-value Death0.910.930.94 Bleeding3.413.000.18 Vascular repair0.380.400.86 Stroke0.270.150.16 Renal Failure0.500.370.28

16 Unplanned Procedures No-SOS (%) SOS (%) P-value CABG0.480.680.10 Emergency CABG0.100.220.05 Unplanned Cath4.413.350.002 Unplanned PCI2.111.320.001

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.

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