(DES)+BVS +DCB for long diffuse LAD disease Busan 9-10 December 2016 Gianluca Rigatelli, MD, PhD, EBIR, FACP, FACC, FESC, FSCAI Cardiovascular Interventions Unit Rovigo General Hospital Italy (DES)+BVS +DCB for long diffuse LAD disease

Dr Rigatelli has not conflict of interest to disclose in this presentation

Current knowledge about BVS Accepted indications to BVS: Young patients No massive tortuosity, no massive calcification Current contraindications to BVS: Major bifurcations Complex bifurcations Massive calcifications or tortuosity Possible indications to BVS: In-stent Restenosis AMI Long diffuse disease

Current knowledge about DCB Field of use of DCB: Native vessel with vessel reference diameter <2.25 mm Cortese et al. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003 9: 156 patients: binary restenosis 6.2%, No difference in MACCE bentween residual dissection and no dissection In-stent restenosis Hulhemann et al. Circ J. 2016 Jan 25;80(2):379-86: 484 patients: TLR rate was 4.9% at 12 months and 8.7% at 2.3 years.  Contraindications to DCB: Massive calcifications

Has the use of BVS+DCB a rationale? DES+ DCB: Worthley et al. BIOLUX-I study. Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):413-7: 35 patients DES on main branc, DCB on side branch >> no binary restenosis no thrombosis at 12 months. Costopoulos C et al. JACC Cardiovasc Interv. 2013 Nov;6(11):1153-9. 69 patients: outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84 DES+ BVS: Rigatelli G et al. J Intervent Cardiol 2016 23 patients: at 12 months follow-up no thrombosis , no restenosis, no malapposition on IVUS

Has the use of BVS+DCB a rationale? DCB alone: Waksmann et al. Valentine II trial EuroIntervention. 2013 Sep;9(5):613-9. Procedural success was 99%. Coronary dissections occurred in 14.7%, and bail-out BMS implantation was required in 13 patients (11.9%). Mean follow-up was 7.5 months; follow-up rate was 99%. Cumulative MACE at follow-up was 8.7%, with 1% all-cause death, 1% MI, 6.9% overall TVR, of which 2.9% were target lesion revascularisations, and no vessel thrombosis. Angiographic follow-up on a subset of patients (n=35) demonstrated late luminal loss of 0.38±0.39 mm for both the in-balloon and in-segment analyses

Suggested strategy -Long diffuse disease –preferably LAD- including a -Proximal bifurcation- which is usually calcified- -DCB on distal shaft -Multiple BVS on vessels mid shaft -DES at Main Branch the simple bifurcation -DES at MB and BVS or DCB at SB depending of vessel size > or < 2.5 mm

1 2 3 (DES) +BVS+DCB strategy: Steps Intravascular ultrasound evaluation of the vessel diameter and lesion length: pre-dilation using non- compliant balloons on the basis of IVUS findings with 1:1 ratio at nominal atmospheres (atm) until the residual stenosis by QCA was less than 10%. 1 BVS size and length was chosen on the basis of IVUS findings following the company charts (2.25 to 2.5 mm, 2.5 mm device; 2.5 to 3.0 mm, 3.0 mm device; 3.0 to 3.5 mm, 3.5 mm device). 2 DES at the bifurcation site was implanted following a standard protocol, as suggested by the European Bifurcation Club recommendations . 3

4 5 6 Hybrid strategy: Steps In complex bifurcation the choice is: A-DES also at SB (DK-crush, Nano-crush, Culotte) B-BVS (TAP, MiniCrush) or DCB at SB 4 Post dilation of BVS with non-compliant balloons not exceeding 0.5 mm of the scaffold diameter at 20 atm. Post-dilation of DES at 20 atm with non-compliant balloons of diameter up to 1.5 mm exceeding the stent diameter. 5 6 Control IVUS: eventual additional post-dilation at increasing pressure till the RBP was reached or until a residual stenosis of <10% was obtained or strut malapposition on IVUS was noticed.

Hybrid strategy: minimizing BVS/BVS and BVS/DES overlapping

Hybrid strategy: minimizing BVS/BVS and BVS/DES overlapping BVS/BVS 2.5-3.0 overlapping

Hybrid strategy: minimizing BVS/BVS and BVS/DES overlapping BVS/BVS 3.5 overlapping

Hybrid strategy: minimizing BVS/BVS and BVS/DES overlapping

DES+BVS+DCB strategy: some examples

9 months

DES+BVS+DCB strategy: some examples

DES+BVS+DCB strategy: some examples

CONCLUSIONS…. At the moment, complex bifurcations and very calcified lesions are still not reccomended for the bioadsorbable scaffold use: DES have excellent results Although large studies are lacking , to mix DCB with BVS and DES for long diffuse diseased vessel not amenable of open surgery appears of good sense Efficient evaluation of vessel size in order to optimize devices use is likely to be the key step