TRIAS HR Pilot Study

Transcription

1 Late Breaking Clinical Trials TCT, October 22 nd 27, Washington, USA TRIAS HR Pilot Study RCT comparing Genous EPC capturing stent with Taxus Paclitaxel eluting stent Robbert J de Winter MD PhD FESC Academic Medical Center University of Amsterdam The Netherlands

2 Disclosures Dr. R.J. de Winter Grant and / or Research Support OrbusNeich Consulting OrbusNeich, Merck-Sharp Dome Speaker s Bureau Lilly

3 c r e a t e

4 Introduction

5 Introduction

6 Accelerated Healing Protects Against Thrombus Minimizes Restenosis Improved Safety Profile Over Current DES c r e a t e

7 Objective To compare the feasibility and efficacy of the Genous EPC-attracting stent with the Taxus paclitaxel-eluting eluting stent in the treatment of coronary artery stenosis in patients / lesions with high risk of restenosis.

8 Design Restricted DES use in selected patients with high risk of restenosis, BMS in patients with low risk of restenosis High risk of restenosis is defined as: Lesion 23 mm in length Lesions in vessels 2.8 mm in diameter Any lesion in diabetic patients Chronic total occlusion

9 Design Statins 1 wk High risk of restenosis Lesion 23 mm RVD 2.8mm Diabetes CTO Genous Stent Clopidogrel 1 m Angiographic Sub study Taxus stent Clopidogrel 6 Non-inferiority 12 m clinical FU 12 m clinical FU Target vessel failure Superiority 5 y clinical FU 5 y clinical FU Death / MI

10 Methods Single-center, prospective, randomized, single-blind study Inclusion period: February 26 - April 27 Patients with de novo coronary artery lesion with a high risk of restenosis Dual anti-platelet therapy for at least 1 month after Genous and 6 months after Taxus stent 3 days, 6 months and 1, 2, 3, 4, 5 year clinical FU telephone contact clinical records and discharge letters

11 Inclusion criteria Clinically stable patients undergoing a PCI for a native, de novo, coronary artery lesion(s) Target lesion considered high risk of restenosis Lesion 23 mm RVD 2.8mm Diabetes CTO All patients on statin therapy 7 days

12 Exclusion criteria < 18 years ST elevation myocardial infarction Current unstable arrhythmias Recipient of a heart transplant or any other organ transplant or is on a waiting list for any organ transplant Scheduled to receive chemotherapy or radiation therapy within 33 days prior or after the procedure Receiving immune-suppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus atc.) Hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, clopidogrel, paclitaxel,, cobalt, chromium, nickel, tungsten, acrylic and fluoro- polymers or contrast sensitivity that can not be adequately pre-medicated Planned elective surgery within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel

13 Exclusion criteria Platelet count < 1, or > 7, cells/ mm3, a WBC < 3, cells/ mm3, or liver disease (including laboratory evidence of hepatitis) Severe renal insufficiency Coronary anatomy unsuited for coronary revascularization CVA (hemorrhagic / ischemic) or TIA of any etiology within 3 days d of randomization Evidence of active abnormal bleeding within 3 days of randomization ation Severe hypertension Previous participation in this study or any other trial within the previous 3 days Circumstances that prevent follow-up Women who are pregnant or who are of childbearing potential who do not use adequate contraception. Criteria related to the EPC-attracting stent: Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Ab(HAMA).

14 Treatment strategy Randomization Randomization target lesion between Genous stent and Taxus stent Multiple lesions High risk lesions treated according to the randomized treatment assignment Low risk of restenosis lesions in non-target vessels treated with BMS Bailout procedure Use bailout-stent according to randomized treatment assignment

15 Primary endpoint Target vessel failure at 1 year: Cardiac death Myocardial infarction (unless documented to arise from the non-treated coronary artery) Repeat revascularization of the treated vessel Main long term endpoint at 5 years: Death or MI

16 Secondary endpoints Procedural success, defined as a less than 2% residual stenosis and TIMI 3 flow post PCI Within 1, 2, 3, 4, and 5 years: Target Vessel Failure Target Lesion Failure Target Vessel Revascularization Target Lesion Revascularization Hospitalization for Acute Coronary Syndrome

17 Baseline characteristics Genous N = 98 Taxus N = 95 Results P-value Age 62 ± 1 y 63 ± 1 y Male 72 (73%) 7 (74%) Risk factors Diabetes Hypertension Hypercholesterolemia Family history of CAD Current smoking (14%) (46%) (63%) (53%) (33)% (27%) (56%) (53%) (64%) (32%).25 Stable angina Unstable angina 8 18 (82%) (18%) (85%) (15%) Previous MI Previous PCI Previous CABG (38%) (26%) (3%) (41%) (26%) (3%) Aspirin Statins (95%) (1%) (96%) (98%)

18 Lesion characteristics Results Genous N = 121 Taxus N = 125 P-value Type of lesion A B1 B2 C ( %) ( 8%) (45%) (47%) (2% ) (12%) (42%) (42%) Total chronic occlusion 39 (32%) 3 (24%) Lesions 23 mm 11 (83%) 1 (8%) Vessels 2.8 mm 9 ( 7%) 7 25 (2%).4 Treated vessel RCA LM LAD CX (34%) ( 1%) 1 (4%) (26%) (39%) (1% ) (37%) (23%)

19 Procedural characteristics Results Pre-procedure TIMI 3 flow Genous N = (61%) Taxus N = (66%) P-value Pre-dilatation 18 (89%) 111 (89%) Stents per lesion 1.2 ± ±.48 Lesion length, mm 26.8 ± ± 1 Ref vessel diameter, mm 3.2 ± ±.5 Total stent length, mm 31.7 ± ± 12 Max Atm stent placement 13 ± ± 2.5 Post dilatation 88 (73%) 88 (7%) Max Atm post dilatation 18.6 ± ± 3.5 Procedural success 119 (98%) 124 (99%)

20 Procedural complications Results Genous wire perforation resulting in pericardial effusion stent loss in RCA, after dilatation TIMI 2 flow no-reflow phenomenon; after additional dilatations TIMI 3 flow; max CK-MB 145 µg/l Taxus wire perforation resulting in pericardial effusion major extravasation of contrast

21 3-Day clinical outcome Results Genous N=95 Taxus N=92 P-value Death Cardiac Non-Cardiac MI 1 (1.1%) 2 (2.2%) Stent thrombosis 1 (1.1%) 2 (2.2%) Repeat PCI TLR 1 (1.1%) 7 2 (7.6%) (2.2%).28 TVR remote Non TVR 1 (1.1%) 6 (6.5%).5 CABG

22 6-month clinical outcome Mean 192 days Genous Stent N = 95 Taxus stent N = 92 Results On Clopidogrel: 42 (44 %) 68 (73 %) Anginal complaints: No angina 74 (78 %) 79 (86 %) CCS 1 7 (7.3 %) 4 (4.3 %) CCS 2 11 (12 %) 5 (5.4 %) CCS 3 2 (2.1 %) 3 (3.3 %) CCS 4 1 (1.1 %) 1 (1.1 %)

23 6-month clinical outcome Results Death Genous N=95 Taxus N=92 P-value MI 1 (1.1%) 3 (3.2%) Repeat PCI TLR 5 (5.3%) 4 (4.3%) TVR remote Non TVR 3 (3.2%) 13 (14%).7 CABG 2 (2.1%) 1 (1.1%)

24 6-month clinical outcome Results Death Genous N=95 Taxus N=92 P-value MI 1 (1.1%) 3 (3.2%) Repeat PCI TLR 5 (5.3%) 4 (4.3%) TVR remote CABG 2 (2.1%) 1 (1.1%) Target vessel failure 8 (8.4%) 5 (5.4%)

25 6-month clinical outcome Results Stent thrombosis: 6 hours days TLR, no MI MI, TLR MI, TLR MI, TLR All angiographically documented stent thrombosis All on dual antiplatelet therapy at time of ST

26 Conclusions Randomized study comparing the Genous stent and first generation DES is feasible in patients treated with PCI for high risk restenosis lesions Similar clinical outcomes at 6-months in this (underpowered) pilot study in patients treated with PCI for high risk restenosis lesions between the Genous EPC-capturing stent and the Taxus paclitaxel eluting stent The pilot study is followed by a large multi-center study

27 AMC Genous experience Interventional operators K.T. Koch J.P. Henriques R.J. vd Schaaf J. Baan M.M.Vis J.J. piek Data collection and statistics J.G.P. Tijssen M.A. Beijk C.J. Verouden M. Klomp Cathlab nursing staff M.G. Meesterman F. Hoekstra N. van Daalen Research nursing staff M. Klees E. Schoenhagen W. Rohling Database manager I. vd Wal Project management L. Peeters de Winter RJ Drug eluting stent summit, TCT 27 AMC

28 THANK YOU