A Post-market Study to Assess the STENTYS Self-exPanding COronary Stent In AcuTe myocardial InfarctiON in Real Life APPOSITION III

Transcription

1 A Post-market Study to Assess the STENTYS Self-exPanding COronary Stent In AcuTe myocardial InfarctiON in Real Life APPOSITION III Gilles Montalescot, MD, PhD Pitié-Salpêtrière Hospital, Paris, France On behalf of the APPOSITION III investigators

2 The Sizing Dilemma in STEMI Malapposition / Underexpansion Overdilation Stent thrombosis Restenosis Dissection/ Perforation No reflow

3 Malapposition in a STEMI patient Balloon-expandable stent STENTYS Self-Apposing Stent Malapposition at 3 days Good apposition at 3 days 3 day OCT pictures from patients enrolled in the STENTYS Apposition II Trial

4 STENTYS Self-Apposing Stent Self-expanding Nitinol stent deployed by retracting a sheath (no balloon) Bare or Paclitaxel-eluting with Polysulfone biostable polymer 6 French, single-wire, rapid exchange Disconnecting struts for side-branch access Disconnectors along the stent Disconnectable interconnector Disconnection

5 STEMI Clinical Study Program Reference vessel showed a 19% lumen area increase distal to the occlusion at three days in STEMI patients. (APPOSITION I) OCT follow-up at three days showed all STENTYS stents perfectly apposed, while 28% of balloon-expandable stents were malapposed. (APPOSITION II) The STENTYS nitinol platform therefore accommodates early changes in AMI vessel anatomy that are caused by thrombus dissolution and resolution of vessel spasm. The APPOSITION III study evaluates the long-term clinical benefit of the STENTYS BMS and DES (P) stents in STEMI patients in a real-life setting. APPOSITION I: G. Amoroso et al. EuroIntervention 2011;7: APPOSITION II: J Am Coll Cardiol Intv. 2012;5(12):

6 APPOSITION III Study DESIGN Prospective, non-randomized, single-arm, multi-centre study of the STENTYS coronary stent OBJECTIVE Evaluate safety and performance of the STENTYS stent in routine clinical practice in 1000 STEMI patients STUDY DEVICE PES and BMS STENTYS stents were available (use at operator s discretion) PRIMARY ENDPOINT MACE at 12 months: cardiac death, target-vessel re-mi, or clinicallydriven TLR SECONDARY ENDPOINTS Definite / probable stent thrombosis All-cause mortality, any MI, any TVR

7 Study organization Steering Committee G. Amoroso G. De Luca U. Limbruno M. Wiemer Project Management E. Versteven Independent Monitoring Genae Associates Clinical Event Committee P.F. Agostoni G.J. Laarman Data Analysis (AMC Amsterdam) M.J. Grundeken J.G.P. Tijssen

8 Inclusions: 51 Centers 14 Countries

9 Eligibility Criteria Inclusion criteria Patients with STEMI caused by a de novo lesion in a native coronary artery Reference vessel diameter between 2.5 and 4.5mm by visual estimate Exclusion criteria Unprotected left main coronary artery Cardiogenic shock Any vasculature lesions or characteristics preventing PCI, introduction of the STENTYS delivery system or placement of the STENTYS stent

10 Study population 1002 patients enrolled Not fulfilling inclusion criteria (n=24) No STEMI/not a de novo lesion (n=15) Left main (n=2) RVD < 2.5 or > 4.5 mm (n=2) No informed consent obtained (n=1) Cardiogenic shock (n=2) STENTYS was used as second (bail-out) stent (n=2) Stent placement unsuccessful (n=10) Stent did not pass the lesion (n=7) Stent could not be deployed (n=3) No follow-up available (n=3) Study population (n=965)

11 Patient Characteristics n=965 Age (mean) 60±12 Male gender 77% Diabetes mellitus 15% Hypertension 47% Hypercholesterolemia 42% Smoking (current) 56% Previous MI 5% Previous PCI 6% Median STB time (hrs:min) 3:30

12 Angiographic Characteristics n=965 Target vessel LAD/LCX/RCA (%) 37 / 14 / 49 Lesion B2/C (%) 68 Visible thrombus (%) 89 Tortuosity (moderate/severe) (%) 12 Calcification (%) 43 TIMI at baseline 0-1/2/3 (%) 70 / 17 / 13 Median lesion length (mm) 18 Median vessel diameter (mm) 3.5

13 Procedural Characteristics n=965 Preload P2Y 12 inhibitors (%) 81 GP IIb/IIIa inhibitors (%) 39 Thromboaspiration (%) 74 Pre-dilation performed (%) 54 Overlapping stents (%) 22 Post-dilation performed (%) 71 Median final balloon diameter (mm) 3.5 Median maximal pressure (atm) 14 Final TIMI post-procedure 0-1/2/3 (%) 1 / 4 / 95 BMS/DES (%) 74 / 26

14 Clinical outcomes at 1 year Event Patients Event rate* MACE % Cardiac death % Target vessel MI % Clinically driven TLR % Cardiac Death/target vessel MI % Death from any cause % Any MI % Any TVR % Definite/probable ST % Definite ST % Acute / Sub-Acute / Late 13 / 11 / / 1.2 / 0.3% Probable ST 6 0.6% Acute / Sub-Acute / Late 0 / 6 / 0 0 / 0.6 / 0% * Kaplan-Meier estimate at one year

15 Clinical outcomes over time MACE: 9.3% Cardiac death or TV-MI: 3.2% Cardiac death: 2.0%

16 STENTYS BMS / DES (P) subgroups Population Differences n=717 n=248 BMS DES P-value Age (mean) 59±12 62± Diabetes mellitus (%) < Hypertension (%) Hypercholesterolemia (%) Previous MI (%) Previous PCI (%) Bifurcation (sidebranch >2.25mm) DES patients had more complex baseline characteristics

17 STENTYS BMS / DES (P) subgroups Results at 1 year BMS DES P-value n=717 n=248 MACE 8.8% 10.7% NS Cardiac death 2.2% 1.7% NS Target-Vessel re-mi 1.3% 1.3% NS Clinically-indicated TLR 6.9% 9.1% NS Cardiac death/tv-mi 3.3% 2.9% NS Definite/probable ST 3.2% 4.1% NS Definite ST 2.5% 3.7% NS Kaplan-Meier estimates

18 MACE according to post-dilation

19 Landmark analysis of MACE according to post-dilation

20 Cardiac death/tv-mi and ST by post-dilation Cardiac death or TV-MI Definite ST Advantage of post-dilation is sustained at 1 year

21 No difference in 1-year MACE in the following sub-groups

22 Comparative Studies 7% 6% Death at 1 year 5% 4% 3.9% 3% 2% 2.0% 1% 0% Pooled analysis conducted by the ACTION Study Group (La Pitié-Salpêtrière Hospital, Paris) on the most recent studies representing 19,767 patients since 2006 Some studies report all death, others cardiac death. APPOSITION III reports cardiac death.

23 Conclusions The Self-Apposing STENTYS stents show good long-term clinical outcomes in a real-life STEMI population These results support the hypothesis that correct stent sizing and the elimination of malapposition after primary PCI lead to good long-term results Post-dilation significantly improves 30-day outcome with good sustained results in the long-term APPOSITION V the FDA-approved, randomized study (currently enrolling) will provide further evidence