DES in primary PCI for STEMI: contra

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DES in primary PCI for STEMI: contra Philippe Gabriel Steg Department of Cardiology Hôpital Bichat Claude Bernard, AP-HP Université Paris VII Denis Diderot INSERM U-698 Paris, France

Ph. Gabriel Steg - Disclosures Research grant: Servier Speaking or consulting: Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi-Sankyo- Lilly, GSK, Medtronic, Merck, Otsuka, Pfizer, Roche, sanofi-aventis, Servier, The Medicines Company Stockholding: Aterovax 2

DES in primary PCI for STEMI DES reduce restenosis and TVR compared to BMS

Reintervention after DES vs BMS after PCI for STEMI Kastrati, A. et al. Eur Heart J 2007

DES in primary PCI for STEMI DES reduce restenosis and TVR compared to BMS However, DES have a greater risk of very late stent thrombosis than BMS, and therefore require longer duration of DAPT

Cumulative Incidence of Definite ST in 8,146 Patients During a 4-Year Follow-Up Period Wenaweser et al. J Am Coll Cardiol 2008;52:1134-1140

PREMIER Registry: Outcomes of Premature Discontinuation of Thienopyridine After DES 50 Cardiac Rehospitalization (%) 15 Mortality (%) Continued Discontinued 40 30 P = 0.079 10 P <0.001 20 5 10 0 0 2 4 6 8 10 12 Months N at Risk Continued 422 421 408 393 360 348 323 Discontinued 59 58 57 53 47 41 40 0 0 2 4 6 8 10 12 Months 431 431 431 431 430 429 420 68 68 67 66 65 65 62 Spertus JA et al. Circulation 2006;111:341-348

Independent Predictors of Stent Thrombosis 1.3% incidence (0.6% early 0.7% late) 45 % Case-fatality rate Iakovou, I. et al. JAMA 2005;293:2126-2130.

DES in primary PCI for STEMI DES reduce restenosis and TVR compared to BMS However, DES have a greater risk of very late stent thrombosis than BMS, and therefore require longer duration of DAPT Therefore, before implanting a DES, patient tolerance and compliance to DAPT needs to be assessed

Primary PCI is a race against time, not a setting for inquiring about long term risk of bleeding «Tears, idle tears, i know not what they mean»

DES should not be routine in primary PCI for STEMI Reason 1: It is difficult to assess whether patients will tolerate and comply with long term dual antiplatelet therapy in the context of emergency primary PCI for STEMI

Mortality for DES vs BMS after PCI for STEMI Kastrati, A. et al. Eur Heart J 2007

HORIZONS AMI: Paciltaxel vs BMS in STEMI: 1-year outcomes TLR MACE Death or MI Stent thrombosis Stone GW et al. N Engl J Med 2009;360:1946-1959

DES vs BMS for STEMI Outcomes in Randomized Trials Brar, et al. J Am Coll Cardiol 2009;53:1677-1689

But most of these data are for 1 year follow up only

A first signal for concern: increased long term post discharge mortality with DES vs BMS in GRACE Landmark post-discharge survival analysis of STEMI pts treated with DES or BMS Log-rank : p=0.29 Death, 180 730 d, adjusted for GRACE risk score, number of dilated vessels, diabetes, type of PCI: HR 6.69 p=0.002 N = 1729 All patients that died in hospital were excluded, as well as the patients without follow-up N = 569 Steg et al. Eur Heart J 2009

A second signal for concern: increased mortality at 3 year follow up of the DEDICATION randomized trial Kaltoft, A. et al. J Am Coll Cardiol 2010;56:641-645

The Dedication trial MACE During 3 Years of Follow-Up Kaltoft, A. et al. J Am Coll Cardiol 2010;56:641-645

DES should not be routine in primary PCI for STEMI Reason 1: It is difficult to assess whether patients will tolerate and comply with long term dual antiplatelet therapy in the context of primary PCI for STEMI Reason 2: there is uncertainty regarding long term safety of DES after STEMI: some data (not all) suggest increased risk of mortality with DES vs BMS

Why is there a specific risk of late death with DES and not BMS?

ACS pts are at higher risk of early and late stent thrombosis than stable angina pts with either BMS or DES, although very late stent thrombosis seems uniquely associated with DES The Thoraxcenter experience of stent thrombosis Classification of Stent Thrombosis Timing for BMS, and DES 5816 pts stented Kukreja, et al. J Am Coll Cardiol Intv 2009;2:534-541

OCT: Uncovered struts and Incomplete Stent Apposition Gonzalo, N. et al. J Am Coll Cardiol Intv 2009;2:445-452 Copyright 2009 American College of Cardiology Foundation. Restrictions may apply.

Incomplete stent apposition and delayed tissue coverage after DES placement is more frequent after primary PCI than in stable/unstable angina Difference in ISA Frequency Between STEMI and Stable/Unstable Angina Patients Gonzalo, N. et al. J Am Coll Cardiol Intv 2009;2:445-452

DES should not be routine in primary PCI for STEMI Reason 1: It is difficult to assess whether patients will tolerate and comply with long term dual antiplatelet therapy in the emergency setting of primary PCI for STEMI. Routine use of DES may result in catastrophic stent thrombosis and death if the patient discontinues prematurely antiplatelet therapy Reason 2: there is uncertainty regarding long term safety of DES after STEMI: some data (not all) suggest increased risk of mortality with DES vs BMS. This late risk may be related to a specific greater risk of late stent thrombosis with DES after STEMI due to more frequent incomplete stent apposition Therefore, when in doubt, abstain