BVS+DCB for Long Diffuse LAD Disease: Current Knowledge and Strategies

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

2. Dr Rigatellihasnotconflict of interest to disclose in thispresentation

3. 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

4. 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

5. 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

6. Has the use of BVS+DCB a rationale? DCB alone: • Waksmann et al. Valentine II trialEuroIntervention. 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

7. 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

8. (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

9. 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 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. 6

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

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

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

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

14. DES+BVS+DCB strategy: some examples

15. 9 months

16. DES+BVS+DCB strategy: some examples

17. DES+BVS+DCB strategy: some examples

18. 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