Department of Medicine III, Martin Luther-University Halle, Germany b. Unità Operativa di Cardiologia, Ospedale Maggiore, Bologna, Italy c

Transcription

1 Comparison of CHADS 2 -Score with CHA 2 DS 2 VASc-Score in a prospective multicenter registry on patients with atrial fibrillation undergoing coronary artery stenting -First results from the AFCAS-trial- a, Andrea Rubboli b, Heli Lahtela c, Jose Valencia d, Gregory YH Lip e, Pasi Karjalainen f, Michael Weber g, Mikko Syvänne h, Paulus Kirchhof i, Matti Niemelä j, Michael Buerke a, Juhani Airaksinen c a Department of Medicine III, Martin Luther-University Halle, Germany b Unità Operativa di Cardiologia, Ospedale Maggiore, Bologna, Italy c Department of Medicine, University of Turku, Finland d Department of Cardiology, General Hospital University of Alicante, Spain e University of Birmingham Centre for Cardiovascular Sciences, City Hospital, UK f Satakunta and Keski-Pohjanmaa Central Hospitals, Finland g Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim, Germany h Department of Medicine, Division of Cardiology, Helsinki University Central Hospital, Finland i Department of Cardiology and Angiology, University Hospital Münster, Germany j Division of Cardiology, University of Oulu, Lapland Central Hospital, Finland

2 Conflict of Interest - Disclosure Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organizations listed below. Affiliation/Financial Relationship Company 1. Honoraria for lectures Astra Zeneca, Bayer-Vital, Boehringer-Ingelheim, Cordis, MSD Sharp & Dohme, Novartis, Sanofi-Synthelabo, Servier 2. Honoraria for advisory board activities Boehringer-Ingelheim 3. Participation in clinical trials Astra Zeneca, Bristol Meyer- Squibs, Boehringer-Ingelheim, Daiichi-Sankyo, Lilly, Merck, MSD Sharp & Dohme, Roche, SanofiSynthelabo,Takeda 4. Research funding Endotis, Boehringer-Ingelheim, Sanofi-Synthelabo, Daiichi- Sankyo, Bayer-Vital, Novartis AFCAS was supported by unrestricted grants from Novartis-Pharma - Germany and Sanofi-Aventis -Germany, and by grants (K.E.J.A) from the Finnish Foundation for Cardiovascular Research, Helsinki, Finland

3 Atrial fibrillation CHADS 2 - Score One point for each criteria Congestive heart failure Hypertension Age 75 years Diabetes mellitus Two points History of Stroke Points Stroke risk/year 0 1.9% 1 2.8% 2 4.0% 3 5.9% 4 8.5% % % Fuster et al. Eur Heart J. 2006;27:

4 CHA 2 DS 2 -VASc-Score No One therapy point Congestive heart failure (Aspirin optional) Hypertension OAC Age 65 years (Aspirin optional) Diabetes mellitus Vascular Disease Female Gender OAC Two points History of Stroke Age 75 years CHA 2 DS 2 -VASc-Score Stroke risk/year 0 0 % % % % % % % % % % Camm et al. European Heart Journal. 2010; 31,

5 Indication for combined therapy with anticoagulation and platelet inhibitors -Dual antiplatelet therapy with an ADP-antagonist (clopidogrel, prasugrel, ticagrelor) and aspirin is indicated after percutaneous intervention with stent implantation (PCI- S) -Approximately 5% of all patients after PCI-S have an indication for oral indication, most of them are patients with atrial fibrillation (70%) Lip et al. Eur Heart J ;31:1311-8

6 Pro and Con for anticoagulation +/- antiplatelets in patients with atrial fibrillation after PCI-S Stroke/TIA Bleeding Peripheral Embolism Stentthrombosis Myocardial Infarction Re-PCI Triple Therapy (OAC, Clopidogrel, Aspirin) OAC + Clopidogrel Aspirin + Clopidogrel OAC + Aspirin

7 Consensus document ESC 2010 Lip et al. Eur Heart J. 2010;31:

8 AFCAS MANAGEMENT OF PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING CORONARY ARTERY STENTING: A MULTI- CENTER, PROSPECTIVE REGISTRY Inclusion criteria AFCAS -Atrial Fibrillation -Percutaneous intervention with stent implantation Exclusion criterion -unwillingness/inability to participate in the study or to give written informed consent ClinicalTrials.gov Identifier: NCT

9 AFCAS: participating centers Finland: Turku University Central Hospital Helsinki University Central Hospital Oulo University Hospital Satakunta Central Hospital Kuopio University Hospital Lappi, Kainuu and Länsi-Pohja Central Hospital Tampere University Hospital Joensuu Central Hospital K-S Central Hospital Spain: Hospital General Universitario de Alicante Sweden Södersjukhuset AB, Stockholm Great Britain City Hospital, Birmingham Italy: Ospedale Maggiore, Bologna Ospedale di Bentivoglio, Bologna S. Bortolo Hospital, Vicenza Germany Martin Luther-Universität Halle-Wittenberg Herzzentrum Leipzig Westfälische Wilhelmsuniversität Münster Kerckhoff-Klinik Bad Nauheim Städtisches Klinikum Limburg

10 Study goals and Study design Study Design observational, multicenter, prospective registry follow-up was performed by means of telephone calls or clinic visits, which were scheduled at 1, 3, 6, and 12 months after PCI-S (1 and 6 months visits were optional) Study Goals collection of data regarding the current treatment strategies of patients with atrial fibrillation undergoing PCI-S in Europe comparison of the safety and efficacy of the various antithrombotic regimens in this setting combined occurrence of cardiovascular death, non-fatal myocardial infarction, need for urgent re-revascularization, stent thrombosis, stroke, and severe bleeding was evaluated. The occurrence of the each individual component of the combined outcome measure as defined above was also evaluated.

11 Baseline and procedural characteristics (n=963) Female, n (%) 288 (29.9) Age, years, (mean±sd) 73.0±8.2 BMI, kg/m ±4.5 Hypertension, n (%) 810 (84.1) Dyslipoproteinemia, n (%) 642 (66.7) Diabetes, n (%) 350 (36.3) Current Smoker, n (%) 97 (10.1) Family History of CHD, n (%) 245 (25.4) Previous stroke or TIA, n (%) 162 (16.8) Previous PCI, n (%) 167 (17.3) Previous CABG, n (%) 141 (14.6) Previous myocardial infarction, n (%) 244 (25.3) LVEF, % (mean±sd) 49.4±14.1 Ongoing OAC at enrolment, n (%) 667 (69.3) Preinterventional INR (mean±sd) 1.93±0.72 AF-type, n (%) Paroxysmal Persistent Permanent n vessels diseased 1, n (%) Indication for PCI, n (%) Stable Angina Unstable Angina NSTEMI STEMI Other (38.9) 115 (11.9) 473 (49.1) 306 (31.8) 290 (30.1) 335 (34.8) 365 (37.9) 178 (18.5) 239 (24.8) 127 (13.2) 45 (4.7) Setting, % Elective Urgent Emergency Access site, % Radial Femoral Other Stent Type, % BMS BAS DES Other Stent diameter (mean±sd), mm 3.1±0,5 Stent length (mean±sd), mm 17.3±5.7 One stage procedure, % 93.0 n vessels treated Target vessel, % LAD RCX RCA LM SVG ,6 16,5 32,7 3,0 5,7 0,5 Arterial graft Procedural success, % 98.8 Periprocedural UFH, % 52.0 Glycoprotein IIb/IIIa-antagonists, % Abciximab Tirofiban Eptifibatide ,0 5,2 9,5

12 In-hospital outcome , ,5 3, ,5 1,9 1,2 0,6 0 (Urgent Revascularization according to acute myocardial infarction, Stent thrombosis, Re-PCI, unplanned CABG).

13 AFCAS population: CHADS 2 -Score CHADS 2 -score was in n=688 (72.1%) 2 (OAC recommended) n=222 (23.2%) =1 (aspirin or OAC recommended) n=53 (4.7%) =0 (aspirin or no treatment recommended)

14 Association CHADS 2 -Score with CHA 2 DS 2 -VASc-Score (1) CHADS2-Score (n=53) 10 1 (n=222) (n=688) CHADSVASC-Score 2 2 -VASc-Score

15 Association CHADS 2 -Score with CHA 2 DS 2 VASc-Score (2) not even one patient has a CHA 2 DS 2 VASc-Score = 0 18 patients (1.9% of the entire population) from totally 53 patients with a CHADS 2 Score = 0 had a low risk for thrombembolic events as estimated by a CHA 2 DS 2 VASc-Score of 1 point All 222 patients with a CHADS 2 Score = 1 (aspirin or OAC recommended) have a CHA 2 DS 2 VASc-Score > 2 (OAC recommended)

16 Summary/Conclusions According to CHADS 2 -score dual antiplatelet therapy (waiving of anticoagulation in long and short term) may have been treatment of choice in 275 patients (CHADS 2 -score < 2 points) with a possible low risk for stroke or other arterial embolism in the AFCAS population According to CHA 2 DS 2 VASc-Score dual antiplatelet therapy could be treatment of choice in only 18 patients (1.9%) in the AFCAS population (CHA 2 DS 2 VASc- Score < 2 points) Our data strongly encourage the usage of CHA 2 DS 2 VASc-Score for evaluating the risk for patients with atrial fibrillation and a CHADS 2 Score < 2 after PCI-S. We hypothesize that nearly all patients with AF after coronary stent implantation must receive OAC in combination with aspirin and clopidogrel (triple therapy) to reduce stroke risk after coronary stent implantation. The optimal duration of this aggressive treatment with a high risk for (severe) bleedings is still an open issue.

17 I thank You for Your attention AFCAS

18

19 In-hospital outcome (combined endpoint) in association with CHADS 2 -Score Combined endpoint, % (Cardiovascular death, myocardial infarction, urgent revascularisation, stroke/arterial embolism) p=0.549 by Chi-square test 7.7% % 4 4.4% 7, ,3 1 0 CHADS2=0 CHADS2=1 CHADS2 2

20 In-hospital outcome (combined endpoint) in association with CHA 2 DS 2 -VASC-Score 18,0 16,0 p=0.237 by chi-square test 16,1 14,0 12,0 11,1 10,0 8,0 6,0 4,0 8,3 8,7 5,3 5,3 8,3 3,8 4,0 Combined endpoint, % 2,0 0,0 CHA 2 DS 2 -VASC-Score

21 Anticoagulants and/or antiplatelets at baseline and at discharge Baseline medication, % 1 Medication at discharge, % Only Aspirin, % Only Clopidogrel, % Only Anticoagulation, % OAC LMWH Aspirin+Clopidogrel, % Anticoagulation + Aspirin, % OAC + Aspirin LMWH + Aspirin Anticoagulation + Clopidogrel, % OAC + Clopidogrel LMWH + Clopidogrel OAC + LMWH + Clopidogrel Triple therapy combinations, % OAC + Aspirin + Clopidogrel LMWH + Aspirin + Clopidogrel Quadruple therapy , OAC: Vitamin K-antagonists. 1 Approximately 10% of all patients did not receive Aspirin, Clopidogrel or OAC at baseline or received others like unfractionated heparin or dipyridamol at baseline. 2 Quadruple therapy: OAC + LMWH + Aspirin + Clopidogrel