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Background

Relationship of Time to Treatment and Door-to-Balloon Time to Mortality in Patients with Acute Myocardial Infarction Treated with Primary Angioplasty.

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Background

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  1. Relationship of Time to Treatment and Door-to-Balloon Time to Mortality in Patients with Acute Myocardial Infarction Treated with Primary Angioplasty Christopher P. Cannon, M.D., C. Michael Gibson, M.D., Costas T. Lambrew, M.D., David A. Shoultz, Ph.D., William J. French, M.D., Joel M. Gore, M.D., W. Douglas Weaver, M.D., William J. Rogers, M.D., Alan J. Tiefenbrunn, M.D., for the NRMI-2 Investigators

  2. Background • Increasing time to treatment with thrombolysis has been associated with increased mortality • Rapid reperfusion -> improved survival • Angiographic trials (e.g., GUSTO -I) have shown link between 90 minute, but not 180 minute, patency and improved survival • Small differences in time to reperfusion make clinically important differences in survival

  3. Background • In randomized trials of primary angioplasty, mortality was low and superior to thrombolytic therapy • "Door-to-Balloon" times 60-90 mins • Experienced operators • In registries, when time delays were greater, mortality higher and not different than thrombolysis • Suggesting that the "door-to-balloon" time may be an important factor in mortality. • Prior studies had limited power to evaluate effects of time delays on mortality

  4. Methods • NRMI-2 is registry conducted from 6/94 to 3/98 at 1,474 hospitals across the U.S.; 661 perform primary PTCA. • Participants in the registry agree to enroll all consecutive MI patients regardless of type, treatment, or outcome. • Edit checks on the Case Report Forms are carried out by Data Coordinating Center, and queries sent to the Coordinators for clarification. However, no independent, on-site monitoring of the data is performed.

  5. Statistical Analysis Plan • In this pre-specified analysis: • Patients included with primary PTCA as initial reperfusion strategy + ST elevation or new LBBB. • Patients were divided into 6 groups by their time -to-treatment and by door-to-balloon time • Baseline characteristics compared • Univariate and Multivariate analysis was performed • Subgroups evaluated (e.g., thrombolytic eligible, cardiogenic shock)

  6. Baseline Characteristics - Time to Treatment 0-2 h >2-3 >3-4 >4-6 >6-12 >12 P value No. Pts 2,176 6,353 5,718 5,852 4,680 2,301 Age 58.3 60.2 61.7 63.0 62.9 61.3 <0.00001 Male (%) 80.1 75.1 70.3 66.5 65.5 64.5 <0.00001 DM (%) 11.6 14.1 17.3 19.9 22.7 23.7 <0.00001 Prior MI (%) 17.1 17.5 18.1 17.8 17.4 15.1 0.05 Anterior (%) 41.9 39.4 38.0 38.3 40.7 40.5 0.003 Shock % 4.2 4.3 3.8 3.7 3.0 2.2 <0.00001 Lytic contra 10.9 14.5 18.2 21.2 18.7 12.2 <0.00001 Transferred 2.1 5.1 11.1 16.5 22.7 24.3 <0.00001

  7. Baseline Characteristics - Door to Balloon Time 0-60 61-9091-120 121-150151-180>180 Pvalue No Pts 2,230 5,732 6,614 4,459 2,625 5,406 Age 60.1 60.3 61.4 62.3 63.0 62.3 <0.00001 Male (%) 76.3 74.2 71.1 68.1 65.7 65.5 <0.00001 Diabetes (%) 13.2 14.1 16.9 19.9 20.8 23.2 <0.00001 Prior MI (%) 15.4 15.5 16.9 18.0 17.1 20.8 <0.00001 Anterior (%) 37.3 37.9 38.2 40.3 43.1 40.6 <0.00001 Card. Shock 4.1 3.1 3.5 4.1 4.6 3.4 0.006 Tlytic contra 10.0 11.7 14.7 18.4 23.3 24.0 <0.00001 Transferred 1.7 2.2 6.2 10.8 17.7 38.4 <0.00001

  8. Multivariate Model of in-hospital Mortality Characteristic Odds Ratio P value Systolic BP (per 10mmHg) 0.81 <0.0001 Age (per 10 years) 1.70 <0.0001 Killip class IV 6.27 <0.0001 Heart rate (10 beats/min) 1.18 <0.0001 Anterior MI 1.86 <0.0001 Killip class III 3.08 <0.0001 Killip class II 1.95 <0.0001 Hypercholesterolemia 0.58 <0.0001 Diabetes 1.56 <0.0001 Tlytic contraindication 1.54 <0.0001 Door-to-balloon >180 mins 1.61 0.0003 Door-to-balloon 150-180 mins 1.62 0.0007 Hypertension 1.18 0.005 Prior CHF 1.32 0.008 Door-to-balloon 120-150mins 1.41 0.01

  9. NRMI-2: Primary PCI Time to Treatment vs. Mortality N=27,080 P = 0.0001 Door-to-Balloon Time (minutes)

  10. NRMI-2: Primary PCI Time-to-Treatment vs. Mortality P=NS 1.19 1.17 1.13 0.99 1.07 N=2,176 6,353 5,718 5,852 4,680 2,301

  11. NRMI-2: Primary PCI Distribution of Door-to-Balloon times N=27,080 Door-to-Balloon Time (minutes)

  12. NRMI-2: Primary PCI Door-to-Balloon time vs. Mortality N=27,080 P < 0.00001 Door-to-Balloon Time (minutes)

  13. NRMI-2: Primary PCI Door-to-Balloon time vs. Mortality P=NS P=NS P=0.01 P=0.0007 P=0.0003 1.62 1.61 1.41 1.15 1.14 N=2,230 5,734 6,616 4,461 2,627 5,412

  14. Primary PCI Door-to-Balloon time vs. Mortality Thrombolytic Eligible Patients only N=22,483 1.77 1.54 1.44 1.22 1.19 P=NS P=NS P=0.02 P=0.0005 P=0.004

  15. Primary PCI Door-to-Balloon time vs. Mortality Excluding Patients Transferred-in N=23,484 1.77 1.54 1.44 1.22 1.19 P=NS P=NS P=0.02 P=0.001 P=0.005

  16. Limitations • Observational database and Patients not randomized • Caputo showed  D-B time and  mortality • No on-site monitoring • But NRMI-2 database validated >95% vs. CCP • Most hospitals low-volume centers • Not necessarily indicative of “center of excellence” • Accounting for volume: D-B time assoc. with  mortality • NRMI-2 includes 661 of 1190 (56%) hosp with 1oPCI

  17. Summary and Conclusions • In a cohort over 27,000 Patients at 661 US hospitals, Door to balloon times > 2 hours was • Present in 46 % Patients • Associated with 40-60% increase in adjusted mortality • Association present in pre-specified subgroups • MD’s and Healthcare systems should monitor and work to  door-to-balloon time. • Door-to-balloon time should be considered when choosing between thrombolysis and Primary PCI

  18. NRMI-2: Hospital Volume of Primary PCI vs. Mortality 0.86 0.67 P=0.033 P=0.0001 N=4,740 14,078 8,262

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