1. (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

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

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 Nov;6(11):
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 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

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. 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

9. 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.

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

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

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