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STEMI Due to Stent Thrombosis: An Enlarging Subgroup of High Risk Patients

STEMI Due to Stent Thrombosis: An Enlarging Subgroup of High Risk Patients. Bruce Brodie, Adam Bensimhon, Nathan Fleishman, Charles Hansen, Mike Cooper, Henry Smith, John Edmunds, Jay Varanasi and Tom Stuckey LeBauer Cardiovascular Research Foundation Greensboro, NC TCT 2009

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STEMI Due to Stent Thrombosis: An Enlarging Subgroup of High Risk Patients

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  1. STEMI Due to Stent Thrombosis:An Enlarging Subgroup of High Risk Patients Bruce Brodie, Adam Bensimhon, Nathan Fleishman, Charles Hansen, Mike Cooper, Henry Smith, John Edmunds, Jay Varanasi and Tom Stuckey LeBauer Cardiovascular Research Foundation Greensboro, NC TCT 2009 San Francisco

  2. No Conflicts

  3. Background and Purpose Early and late stent thrombosis (ST) is a major complication following PCI with stenting and is associated with a high incidence of myocardial infarction and death. ST elevation myocardial infarction (STEMI) is often a consequence of stent thrombosis and is usually treated with repeat PCI. The frequency of STEMI due to ST and outcomes of STEMI due to ST treated with primary PCI have not been well documented. The purpose of this study is to evaluate the changing frequency of STEMI due to ST and to compare outcomes of STEMI due to ST with STEMI due to de novo coronary artery occlusion treated with primary PCI.

  4. Study Population • Our study population consists of consecutive patients with • STEMI treated with primary PCI at our institution by our • study group from 1997-2008 (N = 1,688). • a) Primary PCI has been used almost exclusively at • our institution since 1984. • b) STEMI was defined as AMI with STE > 1mm • in > 2 contiguous leads or LBBB. Patients with prior • fibrinolytic therapy were excluded. • Patients with STEMI due to stent thrombosis (N = 137) • were compared with patients with STEMI due to de novo • coronary artery occlusion (N = 1,551).

  5. Definitions • STEMI due to stent thrombosis: • STEMI with angiographically documented • thrombotic occlusion within the stent in the IRA • Re-infarction: • Recurrent ischemic symptoms with re-elevation • of the cardiac enzymes or documented IRA • re-occlusion • Urgent Target Vessel Revascularization: • Revascularization of the target vessel (PCI or • CABG) for recurrent ischemia

  6. Treatment Protocol • All patients received ASA 325 mg • Ticlopidine or clopidogrel were standard in all stented pts • and in recent years clopidogrel has been given prior to • PCI as standard treatment. • UFH and GP IIb/IIIa platelet inhibitors were standard • treatment in the early years of the study, but recently • bivalirudin with bail-out GP IIb/IIIa inhibitors has become • standard treatment. • In patients with stent thrombosis -- GP IIb/IIIa inhibitors, • adjunctive thrombectomy, and additional stents were • used at the discretion of the operator.

  7. Data Collection • Patients were identified prospectively and enrolled • in our ongoing database of consecutive primary PCI pts. • Angiographic and procedural data were entered at the • time of the procedure by the investigators. In-hospital • data were entered by clinical coordinators from chart • reviews. Post-hospital follow-up data were obtained from • EMR reviews and phone contact. Deaths were also sought • through the social security index. • Identification of all cases of STEMI due to stent thrombosis • and all major adverse events were adjudicated by • principal investigators.

  8. Statistical Methods • Comparisons of categorical variables were performed with • chi-square or Fisher’s exact test. • Multivariable analyses of predictor variables of in-hospital • outcomes were performed with logistical regression • Kaplan-Meier event curves were constructed and • comparisons between patients with stent thrombosis and • de novo occlusion were made with log rank tests.

  9. STEMI due to Stent Thrombosis: Frequency by Year 36 DES Introduced 34 12 12.4% Number Patients % 11 26 23 19 24 23 13 5 7 Year

  10. Baseline Clinical Variables Stent De Novo Thrombosis Occlusion (n = 137) (n = 1551) p value Age > 70 years 18.2% 24.8% 0.08 Male 82.5% 67.6% 0.0003 Diabetes (any) 18.2% 16.0% 0.49 Hypertension 69.3% 45.9% <0.0001 Smoker (current) 54.7% 49.3% 0.22 Prior MI 56.2% 11.9% <0.0001 Prior CABG 11.7% 4.8% 0.0006 Anterior MI 41.6% 35.8% 0.17 Cardiogenic Shock 16.1% 6.8% <0.0001

  11. Angiographic and Procedural Variables Stent De Novo Thrombosis Occlusion (n = 137) (n = 1551) p value 3 Vessel CAD 21.9% 25.1% 0.40 LVEF < 40% 31.4% 20.1% 0.002 TIMI Flow 2-3 Pre-PCI 10.3% 25.8% <0.0001 GP IIb/IIIa Used 80.3% 73.5% 0.082 Stent Used 46.7% 80.5% <0.0001 TIMI 3 Flow Post-PCI 93.4% 98.1% 0.047 PCI Success 93.4% 97.6% 0.004

  12. In-Hospital OutcomesStent Thrombosis vs De Novo Occlusion

  13. In-Hospital Death or Re-infarctionStent Thrombosis versus De Novo Occlusion 25 log rank p value = 0.0007 20 14.8% 15 Stent Thrombosis Death or Re-infarction % 10 8.1% De Novo Occlusion 5 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Days

  14. Multivariable Predictors ofIn-hospital Reinfarction 6.6 CHF 4.9 Stent Thrombosis 0.1 1 10 Log Odds Ratio (95% CI)

  15. Multivariable Predictors ofIn-Hospital Death or Reinfarction 5.1 Cardiogenic Shock 3.9 CHF 2.3 CPR 2.1 Age > 70 years 2.1 Stent Thrombosis 0.1 1 10 Log Odds Ratio (95% CI)

  16. Late Cardiac MortalityStent Thrombosis versus De Novo Occlusion 25 20.3% 20 Stent Thrombosis 15 Cardiac Mortality % 11.3% De Novo Occlusion 10 5 log rank p value = 0.0016 0 1 2 3 Years

  17. Comparisons of BMS and DES

  18. Off-Label Indications at Original Stent Implant BMS DES p value (n=81) (n=54) STEMI 54.3% 37.0% 0.08 Multi-lesion PCI 29.6% 29.6% 0.85 Overlapping stents 19.8% 18.5% 0.96 Long lesions (>28) 16.0% 22.2% 0.50 Multi-vessel PCI 4.9% 16.7% 0.02 Ostial lesions 3.7% 11.1% 0.07 SVG 8.6% 0.0% 0.07 In-stent restenosis 2.5% 7.4% 0.14 Bifurcation lesions 3.7% 3.7% 0.35 Any Off Label 86.4% 87.0% 0.88

  19. Time to Stent Thrombosis 48% Very Late 26% Very Late • Off Clopidogrel at Time of ST • < 1 Year: BMS 53% • DES 54% • 1 Year: BMS 76% • DES 89%

  20. Adjunctive Treatment of Stent Thrombosisand Procedural Results BMS DES p value (n=81) (n=54) GP IIb/IIIa Inhibitor 77.8% 81.5% 0.76 Thrombectomy Aspiration 22.8% 63.0% 0.0001 Rheolytic 12.3% 9.3% 0.19 Any 32.1% 68.5% 0.0001 IVUS 29.6% 53.7% 0.009 New Stent 44.4% 46.3% 0.97 TIMI 3 Flow post-PCI 96.3% 94.5% 0.62 Procedural Success 95.1% 91.1% 0.35

  21. In-Hospital Outcomes in Patients with STBMS vs DES BMS DES p value (n=81) (n=54) Death 8.6% 8.9% 0.95 Re-infarction 3.7% 8.9% 0.20 Urgent TVR 3.7% 7.1% 0.37 Death/Re-MI 12.3% 16.1% 0.54

  22. Conclusions • Stent thrombosis accounts for in increasing proportion • of STEMI patients treated with primary PCI. • (now about 12%) • The great majority (87%) of original stent implants (both • BMS and DES) were performed for “off-label” use and • almost half (47%) were implanted initially for STEMI. • Patients with STEMI due to stent thrombosis have higher • baseline risk compared with de novo occlusion --- a • higher frequency of prior MI, prior CABG and shock and • lower EF and lower frequency of TIMI 2-3 flow pre-PCI.

  23. Conclusions (cont) • Patients with STEMI due to stent thrombosis have • worse procedural outcomes --- less TIMI 3 flow post-PCI • and lower procedural success. • Patients with STEMI due to ST have a higher frequency • of in-hospital death or re-infarction and a higher • frequency of late cardiac mortality • STEMI due to ST remains an independent predictor • of in-hospital re-infarction and death or re-infarction after • adjustments for baseline clinical risk.

  24. Limitations • This is an observational registry. The population of stented • pts at risk for STEMI due to ST is not known. Consequently, • we cannot assess the risk of STEMI due to ST in stented • patients, and we cannot assess the relative risks of STEMI • due to ST in patients treated with DES versus BMS. • We have late survival data, but we don’t have data for post- • hospital re-infarction and stent thrombosis which are • important endpoints in patients with STEMI due to ST.

  25. Clinical Implications • It is clear from our data that STEMI due to stent thrombosis • represents an enlarging population of STEMI patients with • poor outcomes. • Efforts to prevent this problem are most important. These • may include the development of new stents with lower • risk of stent thrombosis, improved techniques for stent • deployment and improved anti-platelet therapies. Since • so many of these patients had the original stent implanted • for “off-label” use and especially for STEMI, new PCI • strategies may be needed in these subgroups.

  26. Clinical Implications (cont) • Since procedural results in patients with STEMI due to • stent thrombosis are suboptimal, new methods are needed • to improve procedural results. • Since death and re-infarction and recurrent stent thrombosis • are frequent after STEMI due to ST, new treatment • strategies are needed post-PCI. These might include new • and intensive anti-platelet therapies and prophylactic • revascularization with CABG.

  27. Cardiac DeathStent Thrombosis versus De Novo Occlusion 30 27.5% 25 Stent Thrombosis 20 15.5% Cardiac Death % 15 De Novo Occlusion 10 log rank p value = 0.0016 5 0 1 2 3 4 5 6 Years

  28. Conclusions • Stent thrombosis accounts for in increasing proportion • of STEMI patients treated with primary PCI. • Patients with STEMI due to stent thrombosis have higher • baseline risk compared with de novo occlusion --- a • higher frequency of prior MI, prior CABG and shock and • lower EF and lower frequency of TIMI 2-3 flow pre-PCI. • Patients with STEMI due to stent thrombosis have • worse procedural outcomes --- less TIMI 3 flow post-PCI • and lower procedural success.

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