Session: EBC s position on dedicated devices Pro Robert J. Gil 1,2, MD, PhD, FESC 1- Mossakowski Medical Research Centre, Polish Academy of Sciences 2- Invasive Cardiology Dept., Central Hospital of the Internal Affairs Ministry, Warsaw, Poland
Disclosure Statement of Financial Interest Within the past 12 months, I Robert J. Gil or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consul3ng Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company NA BALTON, AbboL Vascular, Medtronic, Boston Scien3fic, Eli Lilly, Astra Zeneca NA NA NA NA NA
EuroIntervention 2014;10:545-560
Conventional DES for coronary bifurcation treatment
Importance of proximal stent`s apposition 3,0мм DES After POT (NC 3,5 мм BA) After KBI (3,5x2,75 мм NC BA) But: ü risk of carina shift ü risk of SB compromise ü risk of eluting drug failure or even stent`s desintegration
Importance of inflation pressure and strut position 1 st random factor strut / carina tip relative position Prox strut Dist strut 10 atm 10 atm 15 atm 20 atm Luc Chopin, Balton, Poland
Regular DES is not designed for coronary bifurcation treatment Therefore we need dedicated coronary bifurcation stent(s), which allow us to avoid all the weak regular DES features (!)
NORDIC I + BBC I composed metaanalysis Behan et al. Circ Cardiovasc Interv. 2011;4:57-64
Tryton AXXESS stent BiPax BiOSS stent
Three-year clinical results of the Axxess Biolimus A9 eluting bifurcation stent system: the DIVERGE study. Aims: To report the three-year clinical outcome of the Axxess stent, a nitinol self-expanding Biolimus A9 eluting stent for treatment of de novo coronary bifurcation lesions. The MACE rate was 9.3% at one year, 14.0% at two years and 16.1% at three years. Individual Methods and results: The DIVERGE study was a multicentre, prospective, single-arm trial. The primary components at three years were 10.1% for ischaemia-driven TLR, 3.0% for death (2.0% cardiac endpoint was the cumulative rate of major adverse cardiac events (MACE), a composite of all-cause death, death), myocardial and infarction 7.4% for (MI), MI. and ischaemia-driven target lesion revascularisation (TLR) at one, two and three years. Secondary safety endpoints were cumulative stent thrombosis (ST). A total of 302 patients were included across 14 sites: 77.4% had a true bifurcation lesion, with the left anterior descending/diagonal as target vessel in 80.8%. The Axxess stent was placed in 299 patients (99.0%) and scored as optimal in 93.0%. Two hundred and ninety-eight patients (98.7%) returned for the three-year In follow-up. the secondary The MACE safety rate endpoint was 9.3% at three at one years, year, 14.0% a total at of two seven years patients and 16.1% (2.3%) at three had years. ST with Individual six (2.0%) components definite at three and years two (0.7%) were 10.1% probable for ischaemia-driven ST events. TLR, 3.0% for death (2.0% cardiac death), and 7.4% for MI. In the secondary safety endpoint at three years, a total of seven patients (2.3%) had ST with six (2.0%) definite and two (0.7%) probable ST events. Conclusions: The present large study of the Axxess stent reports a good cumulative MACE rate during three years of long-term follow-up. The Axxess stent offers a promising treatment strategy for bifurcation lesions. EuroIntervention. 2013 Sep;9(5):573-81. doi: 10.4244/EIJV9I5A93. Buysschaert I 1, Dubois CL, Dens J, Ormiston J., Worthley S, McClean D, Ottervanger JP, Meredith I, Uren N, Wijns W, Whitbourn R, Mehran R, Lansky AJ,Bichalska M, Meis S, Verheye S.
Procedural and early clinical outcomes of patients with de novo coronary bifurcation lesions treated with the novel Nile PAX dedicated bifurcation polymer-free paclitaxel coated stents: results from the prospective, multicentre, non-randomised BIPAX clinical trial. AIMS: To demonstrate the acute and early outcomes of the novel Nile PAX dedicated polymer-free paclitaxel-coated stents (Minvasys SAS, Gennevilliers, France) in the treatment of de novo coronary bifurcation lesions. METHODS AND RESULTS: The Nile PAX device incorporates a cobalt-chromium alloy with a side aperture in the mid-stent designed to optimise scaffold at the bifurcation carina and side branch (SB) ostium, while maintaining SB access during procedure. From December 2008 to February 2010, 101 patients were prospectively enrolled in a nonrandomised, There was multicentre only one non-q study. Lesion myocardial criteria infarction were: vessel during size 2.5-3.5 hospitalisation, mm in the parent and vessel no additional (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mm in the PV, and <5 mm in the SB. Mean age was 63 years, events up to 30 days. 29% had diabetes, LAD/Dg was involved in 80.4%, and 61.7% had significant involvement of both branches. The study stent was successfully attempted and implanted in 98%. SB received additional stent in 26% final kissing-balloon inflation was performed in 93% and lesion (angiographic) success was achieved in 98%. There was only one non-q myocardial infarction during hospitalisation, and no additional events up to 30 days. CONCLUSIONS: Preliminary results of the prospective, non-randomised, multicentre BIPAX clinical trial demonstrated encouraging results with the novel Nile PAX bifurcation DES in the treatment of coronary bifurcation lesions, including high device and procedural success. Overall, there was only one major adverse cardiac event during hospitalisation, with no additional events up to 30 days follow-up. Long-term follow-up is warranted EuroIntervention. 2012 Mar;7(11):1301-9. doi: 10.4244/EIJV7I11A205. Costa RA,et al BIPAX Investigators.
OPEN II Study - Results
Tryton IDE Study
Bifurcation Optimization Stent System - BiOSS
BiOSS vs regular DES in IVUS analysis Gil RJ et al.: BiOSS vs DES mechanisms of lumen enlargement. Int J Cardiovasc Imaging 2013, DOI 10.1007/s10554-013-0264-0 DES BiOSS p pre post pre post pre post MLA target [mm 2 ] 2.87±0.78 6.08±2.01 2.99±0.82 6.49±2.2 0.68 0.68 LA PL [mm 2 ] 4.78±1.49 7.86±2.08 3.89±0.98 7.84±1.99 0.06 0.97 LA DL [mm 2 ] 5.21±3.18 7.46±2.2 4.78±2.18 6.44±1.85 0.66 0.17 LA window [mm 2 ] 4.86±2.44 7.63±2.03 3.99±1.19 6.52±1.64 0.21 0.1 Window length (mm) 2.31±0.38 1.76±0.52 2.09±0.50 2.21±0.37 0.79 0.01
BiOSS vs regular DES implantations Gil et al.: Can J Cardiol. 2015 May;31(5):671-8. Gil RJ et al.: EuroIntervention 2015, accepted
POLBOS I+II Studies Clinical characteristics
POLBOS I+II Studies Gil et al.: Can J Cardiol. 2015 May;31(5):671-8. Gil RJ et al.: EuroIntervention 2015, accepted BiOSS Lim BiOSS Expert
POLBOS I+II Studies Procedural characteristics
POLBOS I+II Studies Clinical outcomes at 12 month * * Gil et al.: Can J Cardiol. 2015 May;31(5):671-8. Gil RJ et al.: EuroIntervention 2015, accepted
BiOSS Lim in LMS Gil R. et al.:eurointervention 2015, accepted for publication
POLBOS I+II Studies Gil et al.: Can J Cardiol. 2015 May;31(5):671-8. Gil RJ et al.: EuroIntervention 2015, accepted
Among commercially available BDS, sirolimus eluting BiOSS stent seems to be a valuable alternative to workhorse DES. However, randomised data on BDS are sparse and more randomised trials are needed to provide evidence as to whether these devices will need improve procedural and clinical outcomes in pts with bifurcations treated.