Meet the Guidelines 2017. Le principali novità che modificheranno la nostra pratica clinica: STEMI Guido Parodi Cardiologia Interventistica AOU Sassari Scuola di Specializzazione in Malattie dell Apparato Cardiovascolare Università di Sassari
DISCLOSURE INFORMATION il Prof Guido Parodi negli ultimi due anni ho avuto i seguenti rapporti anche di finanziamento con soggetti portatori di interessi commerciali in campo sanitario: AstraZeneca, Bayer, Chiesi, Daichii, Merck
What is new in 2017 Guidelines on STEMI? REPERFUSION ADJUNCTIVE THERAPY
What is new in 2017 Guidelines on STEMI? REPERFUSION ADJUNCTIVE THERAPY
What is new in 2017 Guidelines on STEMI? 2017 REVISED CONCEPTS: 1) Clear definition of first medical contact 2) Definition ot time 0 = STEMI diagnosis 3) Door-to-balloon term eliminated
Target times according to reperfusion strategy
Left and right bundle branch block considered equal for recommending urgent angiography if ischemic symptoms
What is new in 2017 Guidelines on STEMI? 2012 2017
MATRIX trial Radial access N=4197, % Femoral access N=4207, % p MACE 8.8 10.3 0.031 All-cause mortality 1.6 2.2 0.045 MI 7.2 7.9 0.20 Stroke 0.4 0.4 1.00 BARC 3 bleeding 1.3 2.1 0.0098 BARC 5 bleeding 0.2 0.3 0.82 BARC 3 or 5 bleeding 1.6 2.3 0.013 NACE 9.8 11.7 0.009 Valgimigli M et al. Lancet 2015; 385: 2465-2476.
What is new in 2017 Guidelines on STEMI? 2012 2017
The COMFORTABLE AMI trial A. Composite primary endpoint B. Cardiac death 1161 pazienti con STEMI 578 nel braccio BES vs 583 nel braccio BMS C. Reinfarction due to TVR C. Ischemia-driven TLR Endpoint primario composito (morte cardiaca, infarto miocardico nel vaso target, TLR) 103 pazienti sottoposti a controllo angiografico a 13 mesi Raber L et al. Circ Cardiovasc Interv 2014;7:355-364.
The EXAMINATION trial Primary endpoint Log-rank p=0.03 1498 patients, with STEMI Randomization 1:1 to BMS or EES Primary EP (all-cause death, any MI, any revascularization) @ 5 years Sabate M et al. Lancet 2016;387:357-66.
The EXAMINATION trial EES BMS Sabate M et al. Lancet 2016;387:357-66.
The NORSTENT trial 9103 patients, with stable or unstable CAD (26% STEMI) Randomization to BMS or DES (96% with EES or ZES) Primary EP (death, non fatal MI) @ 5 years Secondary EP (repeat revascularization, stent thrombosis and quality of life) @ 5 years Bonaa KH et al. NEJM 2016;375:1242-52.
What is new in 2017 Guidelines on STEMI? 2012 2017
MV Primary PCI Staged MV PCI
The COMPARE ACUTE trial 885 patients, with STEMI Randomization 1:2 to FFR-guided complete revascularization or infarct artery only revascularization FFR procedure was measured in both groups Primary EP (all-cause death, non fatal MI, revascularization, cerebrovascular events) @ 12 months Smits PC et al. NEJM 2017;376:1234-44.
What is new in 2017 Guidelines on STEMI? 2012 2017
TASTE trial 7244 pts with STEMI Randomization 1:1 to routine manual thrombectomy + PCI vs PCI only Primary EP (all-cause mortality) @ 30 days Hazard ratio 0.94 (95%CI 0.72-1.22) P=0.63 Frobert O et al. NEJM 2013; 369:1587-97
We do not know whether a more effective thrombectomy device..might have provided better outcomes than manual thrombus aspiration Parodi G et al. NEJM 2014; 369:1587-97
TOTAL trial 10732 pts with STEMI Randomization to thrombectomy vs PCI alone Primary EP (death from CV causes, recurrent MI, cardiogenic shock, NYHA IV heart failure @ 6 months The key safety outcome was stroke at 30 days Jolly SS et al. NEJM 2015;372:389-1398
TOTAL trial Jolly SS et al. NEJM 2015;372:389-1398
What is new in 2017 Guidelines on STEMI? 2012 2017
Bivalirudin in ACS: MATRIX Rate ratio 0.94 (95%CI 0.81-1.09) P=0.44 Rate ratio 0.89 (95%CI 0.78-1.03) P=0.12 Valgimigli M. NEJM 2015;373:997-1009
Ischemic endpoint, % Bleeding, % Bivalirudin vs UFH: HEAT-PPCI Relative risk 1.52 (95%CI 1.09-2.13) P<0.01 Relative risk 1.15 (95%CI 0.70-1.89) P=0.59 8.7% ARD=0.4% 3.5% ARD=3.0% 3.1% 5.7% a composite of all-cause death, reinfarction, cerebrovascular accident and unplanned TLR Shahzad A et al. Lancet 2014;384:1849-1858
What is new in 2017 Guidelines on STEMI? REPERFUSION ADJUNCTIVE THERAPY
2012
High Residual Platelet Reactivity % 100 90 80 70 60 50 40 30 20 10 0 No Morphine p= 0.030 Morphine p= 0.0001 p= 0.0001 p= 0.029 p= 0.726 1 hr 2 hrs 2 hrs 4 hrs 8 hrs (PRU cut-off 208) The difference between the 2 groups persisted after excluding patients with vomit. No difference between prasugrel and ticagrelor patients (39% vs 37%; p= 0.719). Parodi G et al. Circulation Cardiovasc Interv 2015
2012
Troponin AVOID trial CK Ratio of means (O 2 /noo 2 ): 1.20 95% CI 0.92-1.55, p=0.18 Ratio of means (O 2 /noo 2 ): 1.26 95% CI 1.05-1.52, p=0.01 Multicenter, prospective, randomized controlled trial 441 patients with STEMI with SO2>94 Randomization 1:1 to oxygen 8L/min, vs no oxygen Primary endpoint: myocardial infarct size assessed by cardiac enzymes Stub D et al. Circulation 2015;131:2143-2150
AVOID trial Oxygen group No Oxygen group p Recurrent MI, % 5.5 0.9 0.006 Arrhythmia,% 40.4 31.4 0.05 Infarct size at MRI, g 20.3 (IQR 9.6-29.6) 13.1 (IQR 5.2-23.6) 0.04 Potential adverse effects of supplemental oxygen: Reduction in coronary blood flow Increased coronary vascular resistance Production of reactive oxygen species Stub D et al. Circulation 2015;131:2143-2150
DETO2X trial RCT 6629 patients with suspected myocardial infarction and an oxygen saturation 90%. Randomization 1:1 to oxygen 6L/min for 6-12 hours (delivered through open-face mask), vs no oxygen Hoffman R et al. NEJM 2017;377:1240-9
FOURIER Trial
PEGASUS TIMI-54 Trial
What is new in 2017 Guidelines on STEMI? Piccoli dettagli che risultano impercettibili decidono tutto Winfried Georg Sebald Premio Nobel per la letteratura deceduto prematuramente nel 2001 per infarto