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Effect of Early revascularization versus delayed revascularization versus medical therapy on inpatient mortality in patients with non ST elevation MI in a community hospital Setting Owais Jeelani ,MBBS Mentor:Dr.A.Herle,MD,FACC Background • Coronary heart disease is the leading cause of death in the United States, with myocardial infarction a common manifestation of this disease. • Of all patients having a myocardial infarction, 25 to 35% die before receiving medical attention, most often from ventricular fibrillation. For those who reach a medical facility, the prognosis is considerably better and has improved over the years: in-hospital mortality rates fell from 11.2% in 1990 to 9.4% in 1999 Background • In 2006, approximately 1.2 million Americans sustained a myocardial infarction. Of these, two third had a myocardial infarction without STsegment elevation Background • Randomized trials have shown that a routine invasive strategy is beneficial in high-risk patients with acute coronary syndromes. Non-ST Elevation ACS Generally caused by partially occlusive, platelet-rich thrombus Results from cross-linking of fibrinogen by platelet GP IIbIIIa receptors at sites of plaque rupture Unobstructed lumen GP IIb-IIIa platelet thrombus fibrinogen Ruptured plaque Artery wall Background • In patients with myocardial infarction with ST-segment elevation, in which the infarct-related artery is usually occluded and there is ongoing transmural ischemia, it is well established that the earlier primary percutaneous coronary intervention can be performed, the lower the mortality. • By contrast, in patients with acute coronary syndromes without ST-segment elevation (including unstable angina and myocardial infarction), the culprit artery is often patent, there is usually no ongoing transmural ischemia, and the patient may have a good response to initial medical treatment. Background • Although meta-analyses of previous randomized trials that compared an invasive strategy with a conservative strategy in patients with acute coronary syndromes have shown a benefit for an invasive strategy, the timing of angiography in the invasive-strategy group of these previous studies ranged from as early as 19 hours after randomization in one large trial to as late as 96 hours in another large trial. Invasive vs. Conservative Strategy for UA/NSTEMI – All Studies ISAR-COOL RITA-3 VINO VANQWISH TRUCS MATE ICTUS TIMI IIIB TACTICSTIMI 18 FRISC II Invasive Conservative # Pts: 1140 1674 7018 Background • Given this wide variation in the timing, there remains substantial uncertainty regarding the optimal timing for intervention in such patients. • Small, randomized trials comparing early intervention with delayed intervention have generated conflicting results. Background • Although some observational analyses have suggested that earlier intervention, as compared with delayed intervention, may reduce events, others have suggested that outcomes appear to be similar between the two approaches. • Also, there has been a suggestion of a hazard associated with routine early intervention. Study Objective • Primary endpoint: -Is early revascularization better than delayed revascularization or Medical therapy alone in reducing in hospital mortality in Patients with non ST elevation MI in a community care setting? Secondary endpoint • What is the relative mortality of NSTEMI patients undergoing early revascularization vs delayed revascularization vs medical therapy alone? • What is the relative length of hospital stay in the three groups studied? • What percentage of coronary angiography patients actually underwent intervention (PCI or CABG)? Methods • Retrospective Data Analysis of patients at Mercy Hospital who have documented non ST elevation MI from June 2008 to June 2009 • Institutional Review Board approval through the Catholic Health System • 383 out of 591 patients reviewed were enrolled in the study after meeting the inclusion criteria Inclusion criteria • Based on ICD Coding 410.71 • Patients with non ST elevation MI with chest pain at rest, lasting > 30 minutes and nonresponding to sublingual nitroglycerin tablets in addition to elevated troponins greater than or equal to 0.1. Exclusion criteria • Patients with ST elevation MI not fulfilling the above criteria. • Patients with MI not fulfilling the above inclusion criteria Analysis of Data • Mortality odds ratios used for the comparison of proportion of deaths in each arm (primary end point). • Length of Stay comparison evaluated by mean number of days along with 95% confidence interval standard deviations. • paired t-test with a p-value of <0.05 deemed statistically significant BASELINE CHARACTERISTICS Variable Early Delayed P value Revascularization Revascularization Medical P value Management 2 63.75 63.64 0.9388 76.87 0.0001 41.93 79.34 0.0001 38.67 0.0001 Previous MI 13.978 19.56 0.3174 21.69 0.3237 Diabetes 30.10 23.36 0.2452 31.13 0.3049 28.8 0.0153 34.90 0.9043 Demographic Characteristics Age Male Sex(%) Medical history(%) Ischemic changes on 44.08 EKG Previous Coronary Procedure PCI 9.67 20.10 0.0274 23.58 0.1411 CABG 2.15 3.26 0.7219 2.83 0.7344 BASELINE CHARACTERISTICS Variable In Hospital Medication Early Delayed Revascularization Revascularization % P value Medical Management % P Value* % Aspirin 96.774 94.021 0.3968 90.566 0.1547 Clopidogrel 72.043 75.543 0.5613 41.509 0.0001 GPIIb/IIIa Inhibitor 38.709 28.260 0.1007 17.924 0.0074 Heparin/LMW 77.419 77.717 1.0000 74.528 0.5887 B-Blockers 92.473 91.847 0.8156 92.452 1.0000 Anti Coagulation Statins 83.870 76.086 0.1625 81.13 0.6729 ACE- Inhibitors 78.494 73.913 0.4611 69.811 0.2983 CABG 22.580 20.108 0.6416 - - Primary Outcome Characteristic Revascul arized % Medical % Odd’s ratio for event(95%CI) P-Value for Interaction 20 2.166 13.207 0.1455 (0.0543 to 0.3897) 0.0001 <65 4 1.515 8.34 0.1692(0.0226 to 1.2646) 0.2143 >65 16 2.758 14.634 0.1655(0.0515 to 0.5318) 0.0020 Female 9 3.488 9.23 0.3315(0.0798 to 1.3776) 0.2163 Male 11 1.621 19.51 0.068(0.0171 to 0.2697) 0.0001 No 5 1.092 4.347 0.2431 (0.0397 to 1.487) 0.2519 Yes 15 4.255 29.729 0.1051(0.0309 to 0.3577) 0.0001 No 6 1.960 6.349 0.295(0.0524 to 1.6601) Yes 14 1.142 23.25 0.0772(0.0228 to 0.261) Overall No of Patients Age Sex ST segment deviation More than 3 Risk Factors 0.3007 0.0001 Results • Primary End-Point – There is statistically significant difference in inhospital mortality between patients treated with revascularization versus patients treated conservatively. – This difference is reflected in patients >65 yrs of age. – There is no statistically significant difference in inhospital mortality in patients younger than 65 yrs. – There is statistically significant difference in inhospital mortality in males, patients with ischemic changes on EKG and patients having more than 3 risk factors. Primary Outcome Characteristic No of Patients Early % Delayed % Odd’s ratio for event(95%CI) 6 2.1505 2.1739 0.99 (0.1778 to 5.5012 ) 0.9899 <65 2 2.084 1.19 1.766(0.1079 to 28.8922) 0.6862 >65 4 2.23 1 0.734(0.0743 to 7.2639) 0.7914 Female 3 1.85 5.35 0.33(0.0336 to 3.3079) 0.6183 Male 3 2.56 1.369 3.342(0.204 to 54.710) 0.4136 Overall P-Value for Interaction Age Sex ST segment deviation No 2 - 0.90 - - Yes 4 4.878 5.6603 0.855(0.1361 to 5.3686) 0.8669 No 4 2.87 3.75 0.754(0.0758 to 7.5213) 0.8100 Yes 2 1.724 0.96 1.807(0.1109 to 29.439) 0.6735 Revascularized Results • Primary End-Point -No statistically significant difference in in-hospital mortality in patients treated with early revascularization versus patients treated with delayed vascularization Secondary Outcome Variable Early Delayed P value Revascularization Revascularization Medical P value* Management Length of Stay Mean 4.14 Age>65 5.25 6.04 0.0006 7.90 0.0001 5.62 0.6090 7.34 0.0009 5.376 9.293 0.3487 8.490 0.8364 0 1.086 0.5523 0.943 1.0000 6.451 8.895 0.6407 11.320 0.2333 Bleeding Complications % Acute Stroke % Acute Renal Failure % Results • Secondary Outcome – Statistically significant difference in hospital length of stay in patients treated with re vascularization versus patients treated conservatively – Statistically significant difference in hospital length of stay in patients treated with early revascularization versus patients treated with delayed revascularization. – Statistically significant difference in hospital length of stay in patients >65 years treated with revascularization versus patients treated conservatively. Conclusion Revascularization offers benefit in reducing short term mortality over medical therapy alone Benefit is more pronounced in elderly high risk male patients. Immediate catheterization and intervention does not offer a benefit over initial medical stabilization followed by delayed catheterization and intervention How are we doing? • Comparison with Action registry data Comparative Data with GWTG Action Registry for 2010 Characteristic 2008-2009 % 2010 % Odd’s ratio for event(95%CI) P-Value for Interaction Nation Top10% 0.1455 (0.0543 to 0.3897) 0.3571 3.6 Unadjusted Death 5.22 7.0 Risk Adjusted Death 3.63 4.6 0.8483 (0.413 to 1.7425) 0.7151 3.8 8 8 1 (0.36 to 2.778) 1 8 Bleeding Events Medications Aspirin 94.2 99 0.1903(0.0649 to 0.5579) 0.0010 99 Clopidogrel 68.76 41 3.1572(2.3307 to 4.2769) 0.0001 59 - 4 Prasugrel 7 Revascularization overall Within 24 hrs 55.59 56 0.9603(0.5497 to 1.6775) 1.0000 36 21 12 1.477( 0.9595 to 2.2757) 0.0811 35 24 30 0.7452(0.5374 to 1.0334) 0.0808 54 Catheterization Within 24 hrs Thinking outside the box… References • • • • • • • • • • • • • 1. Keeley EC, Boura JA, Grines CL. 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