Ultimaster clinical results in left main and bifurcations

Transcription

1 Left main and complex bifurcation stenting clinical results in left main and bifurcations GENNARO SARDELLA MD, FACC,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences Policlinico Umberto I Sapienza University of ROME

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Biosensors,Volcano Abbott, Edwards, Boston Scientific, Alvimedica,Terumo,Astra Zeneca,Orbus Neich,Micell

3 DES Facilitates bifurcation treatment Excellent side-branch access Uniform scaffolding Uniform scaffolding for optimal coverage of bifurcation anatomy Radial strength Allows overexpansion 4.5 mm 3.5 mm 5.3 mm 4.3 mm Polymer integrity Tests performed by and data on file at Terumo Corporation (Doc nr. SideBr03-T).

4 clinical programme More than pts will be included worldwide TCD-10023PK CENTURY CENTURY II MASTER DISCOVERY 1TO3 CENTURY J SV e- MASTER-DAPT Number of patients Design Single arm, pharmacokinetics Single arm, first-in-man study Randomized 1:1 vs Xience Randomized 3:1 vs BMS in patients with STEMI Single arm, patients with multivessel disease Single arm, patients requiring 2.25 diameter stents Single arm, all-comers, realworld use; investigation of reduced DAPT regimens on clinical outcomes Randomized 1:1 abbreviated vs more prolonged DAPT in HBR patients Primary outcomes Sirolimus concentration in peripheral blood samples 28 days after implantation Late loss at 6 months Freedom from TLF at 9 months Safety at 1 month, efficacy at 6 months, safety and efficacy at 12 months OFDI strut coverage at 3 months TLF at 9 months TLF at 1 year NACE, MACCE, MCB at 12 months Stage Published Published, followup ongoing Published, followup ongoing Ongoing Ongoing Ongoing Enrolling Enrolling 4

5 -Clinical evidence Treatment of lesions at Bifurcation and Left Main CENTURY II Clinical trial bifurcation lesions substudy - 4 Years FU N=189 ( DES vs. Xience DES) E- 1 Year FU N=788 patients with lesion at bifurcation N=157 patients with lesions at left main

6 CENTURY II study and Bifurcation lesions subset design Total population N=1119 N=562 Randomization 1:1 Bifurcation lesions subgroup N=194 Xience N=557 N=95 Lesions=141 Xience N=99 Lesions=128 Clinical Follow-up 0d 0d 30d 4mo 9mo 12mo 2yr 3yr 4yr 5yr Primary End-point TLF at 9m 4 years FU rate 97%

7 E-ULTIMASTER All comers registry, 4 continents, 420 centres Study enrolment ongoing patients enrolled First interim analysis 1-year follow-up or death N=5468 Bifurcation N=788 Left Main N=177 Clinical Follow-up 0d 0d 3mo 1yr

8 Baseline procedure characteristics CENTURY II and e-ultimaster Bifurcation subsets E- CENTURY II (N=672) (N=92) Xience (N=97) P U vs. X Multivessel disease (%) Multivessel treatment (%) Nr of lesions treated (mean SD) 1.67± ± ± Nr of stents per lesion (mean SD) Total implanted stent length/pt (mm) 1.1± ± ± ± ± ± Radial access (%)

9 Bifurcation lesions treatment CENTURY II and e-ultimaster Bifurcation subsets E- CENTURY II (N lesions =788) (N lesions =135) Xience (N lesions =131) P U vs. X Two-stent technique, % T-Stenting V-Stenting TAP Crush Culottes Stent in MB, balloon in SB,% Kissing Balloon post-stent, %

10 Clinical outcomes at 1 year Very reproducible results in randomized controlled trial CENTURY II and all comers registry e-ultimaster up to 1-Year % E- (N=788) (N=92) CENTURY II Xience (N=97) P Ul.vs.X Death Cardiac death Myocardial infarction (MI) Target Vessel-MI Target Lesion Revascularization Target Vessel Revascularisation Target Lesion Failure Target Vessel Failure Stent thrombosis Orvin K et al CCI 87: (2016)

11 CENTURY II Bifurcation subset Clinical outcomes at 4 year FU P=0.14 P=0.03 P=0.96 P=0.59 P=0.84 P=0.69 P=0.59 % Xience Any death CD=Clinically Driven 0.0 Cardiac Death Any MI TV related MI TLR (CD) TVR-non TLR ST ST=Definite and probable stent thrombosis Kornowski R. et al: PCR 2017

12 CENTURY II Bifurcation subset Target Lesion Failure at 4 years Absolute risk difference 3.74% Target Vessel Failure at 4 years Absolute risk difference 4.71% Kornowski R. et al: PCR 2017

13 in Bifurcation lesions Conclusions The DES with bioresorbable polymer (in comparison to Xience DES and in absolute terms) is proven to be safe and effective in treating bifurcation lesions; The most widely used technique for bifurcation lesions in both CENTURY II trial and e-ultimaster was provisional cross over stenting using a single DES, reflecting contemporary simplified approach; Consistent results in randomized trials and all comers registry and favorable 48 months clinical outcomes, with low rates of TVF and ST following bifurcation stenting, assure the safe use of DES in daily practice.

14 e-ultimaster Left main substudy study design and aim The treatment of Left main lesions is challenging and still controversial, therefore when designing e-ultimaster study patients with left main disease were included in pre-specified substudy Patients were enrolled since October 2014, and enrollment are currently ongoing. Out of patients enrolled so far, the 5468 reached 1-year follow up or died, amongst them 157 were treated for left main disease.

15 e-ultimaster left main substudy patient characteristics Number of patients n=157 Age, years 68.7 ± 9.9 Gender, Males (%) 73.3 Body mass index, kg/m ±4.7 Diabetes mellitus (%) 21.0 Hypertension (%) 71,0 Hypercholesterolemia (%) 69.7 Current smoker (%) 20.7 Previous PCI (%) 35.1 Stable angina (%) 46.5 ACS (%) 45.9

16 e-ultimaster left main substudy procedure and lesion characteristics Number of patients n=157 Number of lesions n=310 Radial access, % 66.2 Multivessel disease, % 74.5 Ostial lesion, % 25.2 Bifurcation, % 29.4 Moderate or severe calcification, % 30.3 Num of lesions treated per patient, n 2.0±1.0 Num of implanted stents/patient, n 1.9±1.1 Total implanted stent length/patient, mm 38.7±27.0 Direct stenting, % 39.3 Post-dilatation, % 47.5

17 eultimaster left main substudy 1 year outcomes % Left main treated patients n= Cardiac death Any MI Target vessel MI CD-TLR CD-TVR TLF ST

18 12 eultimaster left main substudy 1 year outcomes Left main (n=62) vs LM +1 vessel (n=63) vs LM + 2 vessel (n=32) treated % P=0.64 P=0.22 P=0.54 P=0.92 P=0.50 P=0.70 P= LM only LM + 1 vessel LV + more than 1 vessel CARDIAC DEATH TARGET VESSEL MI CD-TLR CD-TVR TLF TVF ST 0 0

19 eultimaster left main substudy Conclusions Patients with left main disease have high risk of cardiovascular events, being older, with high incidence of multivessel disease and multivessel treatment Despite the severity of treated population the data from large, all comers, multicontinental, e- registry confirmed the good safety and performance of DES in this high risk patient population Similar results obtained for bifurcation stenting in e-ultimster and well controlled and 100% monitored CENTURY II trial reassure full reliability of data obtained in patients with left main disease

20 CENTURY II study devices Platform Drug Carrier Coating Drug DES Xience DES Thin-strut (80µm) Co-Cr Open cell design Thin-strut (81µm) Co-Cr PDLLA-PCL copolymer resorbed within 3-4m PVDF-HFP non-erodable fluorinated copolymer Abluminal gradient coating technology Circumferential coating sirolimus 70 µg/cm² everolimus 100 µg/cm²

21 CENTURY II primary endpoint TLF Kaplan-Meier curves 9 months Xience 5.27% [3.69% ; 7.50%] (95% CI [4.51% %], (95% CI [4.51%-10.15%] 4.36% [2.94% ; 6.43%] Saito S et al. Eur Heart J 2014;35: