Continuing Medical Implementation...bridging the care gap Διαδερμική επαναγγείωση με χρήση ενδοστεφανιαίας πρόθεσης. Μπορούμε να εγκαταλείψουμε την ασπιρίνη; Ε. Βαβουρανάκης
ASA: Efficacy Relative- risk reduction ASA 25% ASA reduces the risk of stroke, MI, or vascular death by 25% relative to placebo Antiplatelet Trialists Collaboration. BMJ 1994; 308: : 81 106. 106.
Antithrombotic therapy in SCAD and PCI
CURE Design (3) Patients with ACS (unstable angina or NQMI without ST elevation) R Day 0 Clopidogrel 300 mg loading dose Placebo loading dose Day 1 Day 1 12 months 12 months Clopidogrel 75 mg od + standard therapy (n=6259) Placebo 1 tab od + standard therapy (n=6303) R=Randomization, occurred within 24 hours of symptom onset Standard therapy always included ASA, and could also include heparin, LMWH, GP IIb/IIIa IIIa inhibitors post-randomization, beta-blockers, blockers, ACE-inhibitors, lipid-lowering lowering agents, and/or other therapies or interventions (e.g. PTCA, CABG) at physician s discretion. LMWH, low-molecular molecular-weight heparin; GP, glycoprotein; PTCA, percutaneous transluminal coronary angioplasty; CABG, coronary artery bypass graft CURE Study Investigators. Eur Heart J 2000;21:2033 2041 2041 Continuing Medical Implementation...bridging the care gap The CURE Investigators. N Eng J Med N Eng J Med 2001;345:494-502 502
JACC, 2013
Ασθενείς με κολπική μαρμαρυγή που υποβάλλονται σε τοποθέτηση stent
Συγχορήγηση αντιαιμοπεταλιακών αντιπηκτικών αυξάνει τον αιμορραγικό κίνδυνο Ελαχιστοποίηση περιόδου συγχορήγησης
Nationwide cohort study, 82854 ασθενείς - Μέση παρακολούθηση: 3.3 έτη Θανατηφόρες και μη θανατηφόρες αι Hansen ML Arch Intern Med 2010;170:1433-1441
όσο και στην ομάδα της βαρφαρίνης Ο συνδυασμός αντιπηκτικής και αντιαιμοπεταλιακής αγωγής αυξάνει τον αιμορραγικό κίνδυνο δεδομένα από τη μελέτη RELY Παρόμοια υψηλός αιμορραγικός κίνδυνος τόσο στις ομάδες της νταμπιγκατράνης
614 patients were randomised to receive aspirin (75mg-200 mg) and a vitamin-k antagonist (target INR 2.0 or 2.5 in patients with mechanical valves) plus 6 weeks (n=307) or 6 months of clopidogrel (n=307; 75 mg) following PCI with DES TCT 2014
Dabigatran 110mg or 150mg plus clopidogrel or ticagrelor Warfarin + aspirin plus clopidogrel or ticagrelor
Αγγειοπλαστική εγγύς Υποτροπιάζον έμφραγ Ασθενείς με ΚΜ και σταθερή αγγειακή νόσο - recommendations Class IIa: μονοθεραπεία με VKA ή NOAC Class IIb: προσθήκη αντιαιμοπεταλιακού σε πολύ επιλεγμένες περιπτώσεις υψηλού κινδύνου Αγγειοπλαστική στελέχους Αγγειοπλαστική σε εγγύς διχασμό
Αγγειοπλαστική σε ασθενείς με κολπική μαρμαρυγή Consensus recommendations (1) 1. 2. 3.
Αγγειοπλαστική σε ασθενείς με κολπική μαρμαρυγή Consensus recommendations (2) 4. 5.
WOEST ESC, Hotline III, Munchen, August 28th, 2012 The WOEST Trial: First randomised trial comparing two regimens with and without aspirin in patients on oral anticoagulant therapy undergoing coronary stenting Willem Dewilde, Tom Oirbans, Freek Verheugt, Johannes Kelder, Bart De Smet, Jean-Paul Herrman, Tom Adriaenssens, Mathias Vrolix, Antonius Heestermans, Marije Vis, Saman Rasoul, Kaioum Sheikjoesoef, Tom Vandendriessche, Carlos Van Mieghem, Kristoff Cornelis, Jeroen Vos, Guus Brueren, Nicolien Breet and Jurriën ten Berg The WOEST Trial= What is the Optimal antiplatelet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (clinicaltrials.gov NCT00769938)
573 adults receiving oral anticoagulants and undergoing PCI + stenting
WOEST Primary Endpoint: Total number of TIMI bleeding events 50 % Triple therapy group Double therapy group 44.9% Cumulative incidence of bleeding 40 % 30 % 20 % 19.5% 10 % 0 % p<0.001 HR=0.36 95%CI[0.26 0.50] 0 30 60 90 120 180 270 365 Days n at risk: 284 210 194 186 181 173 159 140 279 253 244 241 241 236 226 208
WOEST Secondary Endpoint (Death, MI,TVR, Stroke, ST) 20 % Triple therapy group Double therapy group 17.7% 15 % Cumulative incidence 10 % 11.3% 5 % 0 % p=0.025 HR=0.60 95%CI[0.38 0.94] 0 30 60 90 120 180 270 365 Days n at risk: 284 272 270 266 261 252 242 223 279 276 273 270 266 263 258 234
WOEST All-Cause Mortality 7.5 % Triple therapy group Double therapy group 6.4% Cumulative incidence of death 5 % 2.5 % HR=0.39 95%CI[0.16 0.93] p=0.027 2.6% 0 % 0 30 60 90 120 180 270 365 Days n at risk: 284 281 280 280 279 277 270 252 279 278 276 276 276 275 274 256
WOEST Conclusions 1. First randomized trial to address the optimal antiplatelet therapy in patients on OAC undergoing coronary stenting 2. In this study which was specifically designed to detect bleeding events, the bleeding rate was higher than expected 3. Primary endpoint was met: OAC plus clopidogrel causes less bleeding than triple antithrombotic therapy, but now shown in a randomized way 4. Secondary endpoint was met: with double therapy there is no excess of thrombotic/thromboembolic events: stroke, stent thrombosis, target vessel revascularisation, myocardial infarction or death 5. Less all-cause mortality with double therapy
WOEST study Only 69% of patients received OAC due to AF Most of the patients underwent elective PCI (70 75%) Femoral approach was used in 74%, increasing access site bleeding. The differences between dual and triple therapy for the primary endpoint of all bleeding were driven by minor bleeding events. Proton pump inhibitors (PPIs) were not used routinely Triple therapy was continued for 12 months! - increased risk of bleeding