Raising the standard in treating bifurcation lesions GENNARO SARDELLA MD, FACC,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences Policlinico Umberto I “Sapienza “ University of ROME

Disclosure Statement of Financial Interest Consulting Fees/HonorariaBisensor CID TERUMO LILLY ASTRA ZENECA Within the past 12 months, I GENNARO SARDELLA have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany

AXXESS TREatment for bifurcation coronary disease. A Multicentre rEgistry: first Italian experience (Estreme-I Registry). The clinical follow-up was 30 days and 12 months. All consecutive patients referred to cath-lab with de novo bifurcation lesions, in which we implanted bifurcation dedicated self-expandable biodegradable polymer stent, were included in our registry. The choice of this stent has been left to the operator's discretion considering the coronary anatomy and bifurcation characteristics. Design Multicenter, observational, prospective registry Primary end-point: is to evaluate the feasibility in terms of procedural technique and success, the efficacy in terms of MACCE (cardiac death, Q-wave-MI, non Q-wave-MI, TVR,TLR and stroke) and the safety in terms of stent thrombosis occurrence at 30 days and 12 months follow-up of a new bifurcation dedicated self-expandable biodegradable polymer BES. G.Sardella,C.Briguori et al

Exclusion criteria - Pregnant female -myocardial infarction (MI) within the previous 72 h - cardiogenic shock - creatine kinase level above the upper limit of normality at the time of the procedure - documented left ventricular ejection fraction 30% - cerebrovascular accident or gastrointestinal/genitourinary bleeding within the past 6 months - renal insufficiency (creatinine 2.0 mg/dl) - thrombocytopenia (platelet count 10 5 /mm 3 ) - anemia (hemoglobin 10 g/dl) - current or planned use of oral anticoagulant agents; - contraindications to aspirin, clopidogrel, heparin, or contrast agents - known sensitivity to sirolimus, stainless steel, titanium, nickel - life expectancy 2 years - or current participation in another investigational drug or device study. Angiographic exclusion criteria - Previous PCI in the target vessel 9 months from the index procedure - Left main stenosis - severe calcification - excessive tortuosity - presence of intraluminal thrombus by visual estimation Clinical exclusion criteria

Results: Clinical Characteristics n = 83 pts Male, %81.2 Age mean, yrs ± SD65.1 ± 11.7 Hypertension, %79.2 Dyslipidemia, %68.7 Diabetes Mellitus, % Type 1 Type Smoker, %65.0 Family for CAD, %31.2 Pre-PCI, %22.5 Pre-CABG, %3.7 Clinical Presentation, % Stable Angina UA/NSTEMI STEMI Admission FE, %49.1 ± 9.2 Radial access, %56.2 Femoral access, %43.8

19.7% 39.5% 9.3% 4.6% 7.7% Patients n°83 Axxess impl. n°87 AXXESS TREatment for bifurcation coronary disease. A Multicentre rEgistry: first Italian experience (Estreme-I Registry).

Medina Class All Patients 66.9% True Bifurcation * 39.5%7.7%19.7%9.3%19.7%4.6%

Angiographic Characteristics B2/C (MB) 68.9% Stenosis (%) MB 83.9±11.8 Stenosis (%) SB 77.5±18.3 RVD MB mm 3.1±0.26 RVD SB mm 2.5±0.27 Lesion Lenght MB mm 17.5±10.1 Lesion Lenght SB mm 10.9±8.4 MLD MB mm 0.57±0.50 MLD SB mm 0.97±0.93 Bifurcation Angle 57.3°±15.9 Procedural Characteristics Procedural angio success82.7% Pre-dilation98.8% Kissing Balloon (pre STENT)43.6% Post-dilation with kissing balloon65.5% Rotablator distal in MB only11.8% Additional stent Additional STENT MB only Additional STENT distal / prox in MB only Additional STENT prox in MB only Additional STENT distal in MB only 74.6% 41.3% 3.4% 8.0% 29.8% Additional STENT SB only12.6% Additional STENT both branches20.6% Final in Axxess MLD, ±SD3.11±0.26 Angiographic and Procedural Results

Stent Distribution Patterns 25.3% 41.3% 12.6%20.6% 33.2%

Acute ST (30 minutes) of the stent implanted on SB distally to Axxess G.Sardella,C.Briguori et al Results: clinical follow-up

Results: clinical follow-up months Cum survival IMA months TVR Cum survival months Cumulative MACCE

Conclusions

Conclusions - The Axxess stent is the only dedicated self-expanding bifurcation DES offering a unique approach to fully reconstruct the bifurcation and sparing carina -The Axxess stent is a safe and effective device suitable for complex as well as simple bifurcation treatment strategies -In this registry the Axxess stent showed a unique safety and efficacy in terms of procedural and clinical outcome