The BASE-ACS Trial. A Randomized Comparison of a TITAN-2 BAS with XIENCE-V- EES Stent in Acute Coronary Syndrome. 18 months Follow-up results
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1 The BASE-ACS Trial A Randomized Comparison of a TITAN-2 BAS with XIENCE-V- EES Stent in Acute Coronary Syndrome 18 months Follow-up results Pasi Karjalainen, MD, PhD, adjunct Professor on behalf of the Investigators Heart Center, Satakunta Central Hospital, PORI, Finland AsiaPCR Jan-2012
2 Potential conflicts of interest Speaker s name: Pasi P Karjalainen I have the following potential conflicts of interest to report: Research contracts Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest
3 BASE-ACS Patients presenting with Acute Coronary Syndrome (ACS) TITAN-2 stent Titanium-Nitride-Oxide Coated Bio-Active Stent (BAS) 417 Patients N = International Sites Randomisation 1:1 XIENCE-V /PROMUS stent Everolimus-Eluting Stent (EES) 410 Patients Clinical Follow-up 30d 6mo 12mo 18mo 2yr 3yr 4yr Clinical endpoints 5yr Primary Endpoint: Secondary Endpoints: MACE (MI, TLR and Cardiac Death) at 12 months All Cause Death; Cardiac Death/Non-Fatal MI, Stent Thrombosis Investigators: P Karjalainen (Finland), Principal Investigator (PI) A Ylitalo (Finland), co-pi O Hess (Switzerland), co-pi KEJ Airaksinen (Finland), co-pi M Niemelä (Finland), co-pi 3
4 Clinical Sites BASE-ACS Investigators Hospital Patients P Karjalainen, A Ylitalo, J Mikkelsson Satakunta Central Hospital, Pori, Finland 270 M Niemelä, K Kervinen, H Romppanen Oulu University Hospital, Oulu, Finland 151 F Rivero, J Salamanca Hospital Universitario de la Princesa, Madrid, Spain 69 J Airaksinen, M Pietilä Turku University Hospital,Turku, Finland 60 J Sia Kokkola Central Hospital, Kokkola, Finland 49 J Lalmand, A Aminian, D Dolatabadi, P Lefebvre C.H.U. de Charleroi, Charleroi, Belgium 46 O Hess, B Meier Bern University Hospital, Bern, Switzerland 36 B De Bruyne, W Wijns Cardiovascular Center Aalst, Aalst, Belgium 32 M Carlier, S Fasseaux, C Mortier, Y Dascotte Grand Hôpital de Charleroi, Charleroi, Belgium 26 A debelder Royal Sussex County Hospital, Brighton, UK 25 J R López-Minguez, J M Nogales Asensio Infanta Cristina University Hospital, Badajoz, Spain 20 M Laine Helsinki University Hospital, Helsinki, Finland 19 P Tedjokusumo, A F Yahya,C Ahmad,J W Marta Dr. Hasan Sadikin Hospital, Bandung, Indonesia 19 K Nyman Jyväskylä Central Hospital, Jyväskylä, Finland 5
5 BASE-ACS: Devices Stent Platform Titanium-Nitride-Oxide coated Bio-Active-Stent (Titan-2 BAS) Stainless Steel BMS Helicoidal Design Strut Thickness 91 µm Everolimus-Eluting Stent (Xience-V /Promus EES) Cobalt Alloy BMS Slotted Tube Strut Thickness 81 µm Drug --- Everolimus Drug Density µg/mm 2 Coating Titanium-Nitride-Oxide (TiNoX) --- Polymer --- Fluoropolymer Polyvinylidene fluoride Manufacturer Hexacath, France Abbott vascular
6 Titanium-Nitride-Oxide coated BAS What is known from the literature? Hexacath, France Inhibits Platelet Aggregation Minimizes Fibrin Growth Minimizes Thrombus Formation Reduce Inflammation Promotes Endothelial Healing
7 BASE-ACS: Background MACE at 12 months (late breaking clinical trial; EuroPCR2011) %* 15 Titan-2 BAS (n=417) Xience-V EES (n=410) P = 0.89 P = 0.81 HR (95% CI) = 0.94 ( ) P = % 2.6% More MI and ST with EES BAS restenosis 7.2% 6.8% Days after Index PCI EES restenosis 9.6% 9.0% Log-Rank P = % * Cumulative incidence of events (%)
8 Primary Endpoint MACE at 12 Months Titan-2 BAS (n=427) Xience-V EES (n=410) Difference : 0.6% (Upper 1-sided 95% CI) P Value (Noni-nferiority) 9.6% 9.0% 0.6% + 95% CI = 3.5% Primary Non-Inferiority Endpoint Met Zone of Non-inferiority Pre-specified margin = 5.0% %
9 BASE-ACS 18 months FU Background Premature discontinuation of thienopyridine therapy is recently recognized as the most important predisposing factor for late and very late ST following DES implantation. BASE-ACS trial Clopidogrel treatment beyond 12 months was discouraged Duration of DAPT was 8.7 (BAS) and 10.2 (EES) months We sought to examine whether clopidogrel diacontinuation will predispose late thrombotic events?
10 BASE-ACS Patient Eligibility Inclusion Criteria: Exclusion Criteria: Written informed consent Age > 18 years Patient with acute coronary syndrome (ACS) requiring PCI ACS: - Unstable angina - Non-ST-elevation myocardial infarction - ST-elevation myocardial infarction Prior PCI on target vessel (ISR) Unprotected LM disease Aorto-ostial lesion Contraindication to: - aspirin, heparins, clopidogrel Life expectancy < 12 months Stent length needed > 28 mm
11 BASE-ACS trial Stent Thrombosis Academic Research Consortium (ARC) definition: (Circulation 2007;115: ) Definite: - Acute coronary syndrome and angiographic (or autopsy) confirmation of stent thrombosis Probable: - Any unexplained death within the first 30 days - Target vessel related acute MI Possible: - Any unexplained death from 30 days after PCI
12 Baseline Demographics Titan-2 BAS (n=417) Xience-V EES (n=410) P value Age (years) 63 ± ± Male 76.0% 76.1% 0.94 Diabetes 15.6% 18.3% Insulin treated 4.6% 4.1% 0.87 Hyperlipidemia 45.8% 48.0% 0.53 Hypertension 48.2% 51.7% 0.33 Current smoker 34.5% 32.7% 0.61 Prior myocardial infarction 13.4% 9.8% 0.10 Prior PCI 9.6% 10.5% 0.73 Prior CABG 4.8% 4.1% 0.74 NSTEMI 49.4% 45.6% 0.30 STEMI 38.8% 38.8% 1.0 BASE-ACS
13 Procedural Characteristics Titan-2 BAS (n=417pts) (n=480 lesions) Xience-V EES (n=410pts) (n=484 lesions) Stents per culprit lesion 1.15 ± ± Stent diameter (mm) 3.15 ± ± Stent length (mm) 18.0 ± ± Total stent length per lesion (mm) 20.8 ± ± Thrombus aspiration 19.7% 17.6% 0.48 Post-Dilatation 42.2% Stent failure 0% 1.0% 0.03 Procedural success 99.8% 99.8% 0.99 P value BASE-ACS
14 Antiplatelet Agent Utilization Aspirin Titan-2 BAS (n=417) Xience-V EES (n=410) P value - At 6 months 99.8% 99.5% NS - At 12 months 99.5% 99.3% NS - At 18 months 99.3% 99.1% NS Clopidogrel - At 6 months 89.7% 99.3% < At 12 months 51.3% 68.3% < At 18 months 2.2% 2.7% NS Mean duration of Clopidogrel (months) 8.7 ± ± 3.0 < BASE-ACS
15 BASE-ACS MACE %* 3.9% Titan-2 BAS (n=417) Xience-V EES (n=410) P = % 6.8% P = 0.81 HR 0.94 ( ) 9.6% 9.0% 0 2.6% Log-Rank P = Months after Index PCI * Cumulative incidence of events (%) BASE-ACS
16 BASE-ACS MACE %* 3.9% Titan-2 BAS (n=417) Xience-V EES (n=410) P = % 6.8% 9.6% 9.0% P = 0.74 HR 0.96 ( ) 11.7% 10.8% 0 2.6% Log-Rank P = Months after Index PCI * Cumulative incidence of events (%) BASE-ACS
17 MACE Components 18 months Follow-up % Titan-2 BAS (n=417) Xience-V EES (n=410) 15 P = 0.01 P = 0.64 P = 0.89 P = % 11.7% % 7.0% 6.6% 3 2.6% 2.2% 1.7% 0 Myocardial Infarction Cardiac Death Ischemia-driven TLR MACE TLR = Target Lesion Revascularization BASE-ACS
18 Secondary Endpoints 18 months Follow-up % Titan-2 BAS (n=417) Xience-V EES (n=410) 12 P = P = 0.45 P = 0.37 P = % 4.6% 4.3% 3.2% 2.4% 2.4% 1.5% 0.7% Definite ST Non-Cardiac Death All Cause Death MI or Cardiac Death ST = Stent Thrombosis MI = Myocardial Infarction BASE-ACS
19 ARC Stent Thrombosis Titan-2 BAS (n=417) n (%) Xience-V EES (n=410) n (%) P Value Definite ST Acute/Subacute (<30 days) 3 (0.7) 7 (1.7) 0.19 Late ( days) 0 (0) 2 (0.5) 0.15 Very Late (>360 days) 0 (0) 1 (0.2) 0.31 All ST 3 (0.7) 10 (2.4) Definite or Probable ST Subacute (< 30 days) 5 (1.2) 8 (2.0) 0.39 Late ( days) 0 (0) 3 (0.7) 0.08 Very Late (>360 days) 0 (0) 4 (1.0) 0.04 All ST 5 (1.2) 15 (3.7) 0.021
20 Events Between months FU % Titan-2 BAS (n=417) P = 0.09 Xience-V EES (n=410) P = % 2 1.7% % 0.5% Myocardial Infarction 0.2% 0.7% Cardiac Death 0.5% Ischemiadriven TLR 0% 0.2% ST 1.2% MACE TLR = Target Lesion Revascularization ST = Definite Stent Thrombosis BASE-ACS
21 MACE Components After Clopidogrel Discontinuation % Titan-2 BAS (n=417) Xience-V EES (n=410) 5 4 P = 0.08 P = 0.06 P = 0.08 P = % 3 2.7% 2 2.2% 1 1.2% 1.2% 0.7% 1.0% 0.7% 0 Myocardial Infarction 0% Cardiac Death Ischemiadriven TLR 0% ST MACE FU = 6-12 months BASE-ACS
22 BASE-ACS 18 months FU Conclusions TITAN-2 BAS and XIENCE-V EES were associated with a comparable frequency of efficacy adverse events (TLR) in patients presenting with acute coronary syndrome (ACS) However, the rate of MI and ST tended to be higher in the EES group The present study suggest that a stent coated with Titanium- Nitride-Oxide (TITAN-2 BAS) represents a safe and effective alternative to Xience-V EES in ACS patients
23 Thank You Kiitos BASE-ACS Investigators P Karjalainen, A Ylitalo, J Mikkelsson, Minna Ampio M Niemelä, K Kervinen, H Romppanen, Eija Niemelä F Rivero, J Salamanca J Airaksinen, M Pietilä, Tuija Vasankari J Sia J Lalmand, A Aminian, D Dolatabadi, P Lefebvre, V Piamonte O Hess, B Meier, C SchoenenbergerWeber B De Bruyne, W Wijns, An Roets M Carlier, S Fasseaux, C Mortier, Y Dascotte, A. Jourdan A debelder, Nina Cooter J R López-Minguez, J M Nogales Asensio M Laine P Tedjokusumo, A F Yahya,C Ahmad,J W Marta K Nyman Hospital Satakunta Central Hospital, Pori, Finland Oulu University Hospital, Oulu, Finland Hospital Universitario de la Princesa, Madrid, Spain Turku University Hospital,Turku, Finland Kokkola Central Hospital, Kokkola, Finland C.H.U. de Charleroi, Charleroi, Belgium Bern University Hospital, Bern, Switzerland Cardiovascular Center Aalst, Aalst, Belgium Grand Hôpital de Charleroi, Charleroi, Belgium Royal Sussex County Hospital, Brighton, UK Infanta Cristina University Hospital, Badajoz, Spain Helsinki University Hospital, Helsinki, Finland Dr. Hasan Sadikin Hospital, Bandung, Indonesia Jyväskylä Central Hospital, Jyväskylä, Finland
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