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rino.sardella@uniroma1.it

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. rino.sardella@uniroma1.it. Consulting Fees/Honoraria.

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rino.sardella@uniroma1.it

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  1. 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 rino.sardella@uniroma1.it

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

  3. AXXESS TREatment for bifurcation coronary disease. A MulticentrerEgistry: first Italian experience (Estreme-I Registry). G.Sardella,C.Briguori et al Design Multicenter, observational, prospective registry 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. The clinical follow-up was 30 days and 12 months. 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.

  4. Exclusion criteria Clinical 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 105/mm3) • 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

  5. Results: ClinicalCharacteristics

  6. AXXESS TREatment for bifurcation coronary disease. A MulticentrerEgistry: first Italian experience (Estreme-I Registry). 9.3% 19.7% 19.7% 39.5% 7.7% 4.6%

  7. Medina Class All Patients 39.5% 7.7% 19.7% 9.3% 19.7% 4.6% 66.9% TrueBifurcation*

  8. Angiographic and Procedural Results

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

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

  11. Results: clinical follow-up TVR IMA Cumsurvival Cumsurvival Cumulative MACCE months months Cumsurvival months

  12. Conclusions

  13. Conclusions - The Axxessstentis the onlydedicated self-expandingbifurcation DES offering a uniqueapproach to fullyreconstruct the bifurcation and sparing carina -The Axxessstentis a safe and effectivedevicesuitable for complexaswellas simplebifurcation treatment strategies -In thisregistry the Axxessstentshowed a uniquesafety and efficacy in terms of procedural and clinicaloutcome

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