1. Predictors of Acute, Subacute and Late Stent Thrombosis After Acute MI Primary Angioplasty in the Horizons AMI Trial George D. Dangas, Alexandra J. Lansky, Bruce R. Brodie, Bernhard Witzenbichler, Giulio Guagliumi, Jan Z. Peruga, Dariusz Dudek, Martin Moeckel, Helen Parise, Roxana Mehran, and Gregg W. Stone
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4. H armonizing O utcomes with R evascular iz ati on and S tents in AMI Clinical FU at 30 days, 6 months, 1 year, and then yearly through 5 years; angio FU at 13 months 3602 pts with STEMI with symptom onset ≤12 hours Emergent angiography, followed by triage to… Primary PCI CABG – Medical Rx – UFH + GP IIb/IIIa inhibitor (abciximab or eptifibatide) Bivalirudin monotherapy (± provisional GP IIb/IIIa) Aspirin, thienopyridine R 1:1 3006 pts eligible for stent randomization R 3:1 Bare metal EXPRESS stent Paclitaxel-eluting TAXUS stent
5. Primary Endpoints at 30 Days Diff = 0.0% [-1.6, 1.5] RR = 0.99 [0.76, 1.30] P sup = 0.95 Diff = -3.3% [-5.0, -1.6] RR = 0.60 [0.46, 0.77] P NI ≤ 0.0001 P sup ≤ 0.0001 Diff = -2.9% [-4.9, -0.8] RR = 0.76 [0.63, 0.92] P NI ≤ 0.0001 P sup = 0.005 1 endpoint 1 endpoint Major 2 endpoint Stone GW et al. NEJM 2008;358:2218-30
10. 1-Year Stent Thrombosis: Impact of Implanted Stent Type 3.3% 3.4% HR [95%CI] = 0.98 [0.64-1.51] P = 0.93 2261 2171 2147 2123 2097 1900 872 832 818 805 791 720 Number at risk Any DES BMS only Def/Prob Stent Thrombosis (%) 0 1 2 3 4 Time in days 0 30 60 90 120 150 180 210 240 270 300 330 365 Any DES BMS Only
11. 1-Year Stent Thrombosis: Impact of Antithrombin (Primary Randomization) 3.2% 3.6% HR [95%CI] = 1.13 [0.77-1.65] P = 0.53 1611 1540 1525 1506 1485 1355 1591 1518 1495 1476 1457 1315 Number at risk Bivalirudin UFH+GPIIb/IIIa Def/Prob Stent Thrombosis (%) 0 1 2 3 4 Time in days 0 30 60 90 120 150 180 210 240 270 300 330 365 Bivalirudin monotherapy Heparin + GPIIb/IIIa inhibitor
12. Acute Stent Thrombosis: Impact of Antithrombin (Primary Randomization) 0.3% 1.5% HR (95%CI) = 5.93 [2.06,17.04] P = 0.0002 1611 1583 1580 1578 1577 1591 1587 1584 1583 1583 Number at risk Bivalirudin UFH+GPIIb/IIIa Def/Prob Stent Thrombosis (%) 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Time in Hours 0 6 12 18 24 Bivalirudin monotherapy Heparin + GPIIb/IIIa inhibitor
13. Stent Thrombosis 1-Day Landmark Analysis: Impact of Antithrombin 2.2% 3.0% 1.5% 0.3% HR [95%CI] = 1.73 [0.47-1.13] P = 0.06 HR [95%CI] = 5.93 [2.06-17.04] P = 0.0002 1611 1591 1600 1562 1525 1506 1485 1355 1587 1521 1495 1476 1457 1315 Number at risk Bivalirudin UFH+GPIIb/IIIa Def/Prob Stent Thrombosis (%) 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Time in Days 0 1 30 90 180 270 365 Bivalirudin monotherapy Heparin + GPIIb/IIIa inhibitor
14. 1-Year Stent Thrombosis: Impact of GPI in the UFH Group 2.8% 3.6% HR [95%CI] = 0.78 [0.44-1.37] P = 0.38 727 693 685 678 668 592 829 793 778 768 759 698 Number at risk Eptifibatide Abciximab Def/Prob Stent Thrombosis (%) 0 1 2 3 4 Time in days 0 30 60 90 120 150 180 210 240 270 300 330 365 Eptifibatide Abciximab
24. Independent Predictors of Subacute ST (Cox Model) Variable HR [95% CI] P-value Insulin-treated diabetes 4.43 [2.03, 9.65] 0.0002 History of CHF 4.16 [1.61, 10.76] 0.003 Pre-PCI TIMI flow 0/1 2.21 [1.05, 4.63] 0.04 Final TIMI flow 0/1 3.72 [1.10, 12.55] 0.03 Stent to lesion length ratio 1.44 [1.20, 1.71] <0.0001 Clopidogrel loading dose 600 mg (vs. 300 mg) 0.49 [0.27, 0.89] 0.01
25. Independent Predictors of Late ST (Cox Model) Variable HR [95% CI] P-value Current smoking 4.05 [1.73, 9.48] 0.001 Insulin-treated diabetes 3.17 [0.95, 10.61] 0.06 History of prior MI 3.15 [1.39, 7.13] 0.006 Post stent dilation balloon used 2.75 [1.31, 5.80] 0.008