1. Clinical outcomes after implantation of Absorb BVS in small vessels
Clinical outcomes after implantation of Absorb BVS in small vessels. Results from the Italian RAI multicenter registry
Giulia Masiero, MD1
Giuseppe Tarantini MD; Attilio Varricchio MD; Alfonso Ielasi MD; Bernardo Cortese MD; Paola Tellaroli PhD and Giuseppe Steffenino MD
on behalf of the RAI Investigators
1Department of Cardiac, Thoracic and Vascular Sciences,
University of Padua Medical School

2. Disclosure Statement of Financial Interest
I, Giulia Masiero DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. MPS EVIDENCE
RISK OF MACE AFTER PCI
Study/Sub
category
Treatment
n/N
Control OR
95% CI
PES vs BMS
TAXUS V
20/106
25/93
0.63(0.32,1.23)
SES vs BMS
SES-SMART
11/129
39/128
0.21(0.10,0.44)
EES vs PES
SPIRIT 2-3
19/366
17/159
0.46(0.23,0.91)
SES vs PES
SIRTAX
28/241
55/264
0.50(0.30,0.82)
Total Events
78/842
136/644
0.43(0.32,0.59)
A small vessel diameter is a well recognised indipendent predictor of a higher rate of in-stent restenosis and poorer clinical outcomes with MPS.
RISK OF ANGIOGRAPHIC RESTENOSIS AFTER PCI
LARGE
(>3.25 mm)
SMALL
(<2.75 mm)
POBA
20-35%
15-20%
35-55%
BMS
15-20%
10-30%
25-50%
DES
5-12.5% %
0-5%
20-30%
10-20%
5-10%
30-35%
20-25%
10-15%
Small vessel coronary artery disease is a recognized challenging subset within the field of coronary artery intervention, even though the use of DES in this setting has led to more acceptable long-term results compared with balloon angioplasty and BMS.
But a a high degree of vessel stretch and injury, (2) a smaller postprocedural lumen area, and (3) a higher metal density have all been proposed as a contributing factors to explain the poorer outcomes associated with SVs.
Current consensus is however that the bigger is better paradigm is likely to be the most plausible mechanism to explain poorer aoutcomes associated with SV disease (smaller vessel size would be less able to accomodate the same absolute volume of neointimal hyperplasia as a larger vessel with the resultant increase in the rate of binary restenosis)
relatively high late loss
(eg EndeavorTM)
medium late loss
(eg TaxusTM)
low late loss
(eg CypherTM or XienceTM)
“BIGGER IS BETTER” PARADIGM
Biondi-Zoccai G. et al. Cardiovasc Revasc Med 2010;11:189–98

4. BVS PERSPECTIVE Post-Procedure 6-Months 2-years 5-years
Despite the current thick strut BVS, the progressive loss in scaffold structural integrity leads to proven return of the vasomotion properties, positive remodelling and late lumen enlargement that may play a role in the prevention of EVENTS in the small lesion subset
5-years
Cohort B OCT images – courtesy of RJ Van Geuns; Erasmus Medical Center
Karanasos A et al. JACC 2014 Dec;64 (22):

5. BVS EVIDENCE Cohort B2, 1-year follow-up Cohort B1, 2-year follow-up
Small Vessels
(<2.5 mm) (N=21)(L=21)
Large Vessels
(≥2.5 mm) (N=35)(L=36)
P Value
(≥2.5 mm) (N=35) (L=36)
The NET GAIN index
0.41±0.18 (20)
0.34±0.12 (34)
0.0564
0.43±0.14 (18)
0.35±0.16 (19)
0.1040
The LOSS index
0.23±0.32 (19)
0.20±0.22 (34)
0.8311
0.21±0.15 (18)
0.23±0.22 (20)
0.7041
Neointimal Hyperplasia area (mm2)
0.16±0.24 (21)
0.05±0.09 (35)
0.0556
0.25±0.26 (19)
0.23±0.28 (19)
0.4813
((((Absorb cohort B vessel size 2.5 vs 3.0 with BVS 3.0: larger relative gain correlates with an higher degree of vessel injury during the index procedure (disruption internal elastic membrane) small vess are less amenable to accomodate the same absolute amount of neointimal tissue compared with large vessel))))
Encouraging long term clinical and angiographic results in small vessel as been shown in this post-hoc analys of the Absorb cohhort B trial, maybe explained by a favourable balanced between vessel injury and luminal expansion and late lumen enlargement. More results are needed in bigger and more complex population.
Diletti R et al. Heart 2013 Jan;99(2):98-105

6. “Registro ABSORB Italiano”
DESIGN: ongoing, spontaneous, multicenter, prospective data collection on consecutive patients undergoing Absorb BVS implantation in Italy
OBJECTIVE: To evaluate the long-term safety and efficacy of Absorb BVS within an unrestricted cohort of patients undergoing PCI
PRINCIPAL INVESTIGATOR: Giuseppe Steffenino, MD (Cuneo, Italy)
Cortese B et al. Cardiovasc Revasc Med Sep; 16(6):340-3

7. “Registro ABSORB Italiano”
Flow algorithm
Succesful BVS implantation
Patient signs
informed consent
Enrolment in the RAI Registry
6-month follow up through 5 years.
Records of health status, clinical
events and biochemistry
The RAI Registry
Number of patients
1089 pts (on June 10th, 2015)
Enrollement period
March ongoing
Study centers
22 Italian sites
Inclusion criteria
successful implantation of 1 or more coronary BVS
age <75 years
patient’s informed consent
After first patient is enrolled, centres are asked to enroll all BVS-treated patients
consecutively for the duration of the study, with a minimun of 50.
Random source verification of all data within the CRF is performed by the PI, requiring submission of the original documents covering 5% of patients in each centre.
Cortese B et al. Cardiovasc Revasc Med Sep; 16(6):340-3

8. Small vessel analysis - RAI-BVS
All enrolled pts treated by BVS implantation in at least one small vessel, defined as pre-procedure reference vessel diameter (RVD) ≤2.5 mm at quantitative coronary analysis (QCA).
1089 consecutive patients undergoing PCI with second-generation Absorb BVS between March 2012 and June 2015
123 patients who received Absorb BVS implantation in at least one small vessel in 6 clinical sites in Italy
111 patients with treated de novo lesions
12 patients with treated restenotic lesions
2 Deaths
121 patients at median F-U of 21 months
PROCEDURE: following the manufacturer and the expert consensus paper indications
FOLLOW-UP:
CLINICAL (visit/telephone call)
ANGIOGRAPHIC (clinically driven)
END-POINTS:
Death, miocardial infarction, TLR, TVR
TLF (cardiac death, TV-MI, TLR)
Scaffold thrombosis (acute, subacute, late and very late)

10. PATIENTS n=123 Age (years) 61.8 ± 10.3 Male sex 95 (72.4%)
Hypertension
90 (73.2%)
Diabetes
30 (24.4%)
Smokers
Former
Current
21 (17.1%)
32 (26.0%)
Glomerular filtration rate
89.7 ± 31.7
Prior MI
40 (32.5%)
Prior PCI
49 (39.8%)
Prior CABG
7 (5.7%)

11. LESIONS n=123 SYNTAX score 16.8 ± 14.5 Multivessel CAD 77 (62.6%)
Overall lesions/pts
1.6 ± 0.9
SVs lesions/pts
1.2 ± 0.5
Treated Vessel
LMCA
LAD
LCX
RCA
1 (0.5%)
112 (53.1%)
43 (20.4%)
56 (26.5%)
(6.8%)
(6.3%)
(4.2%)
(5.7%)

12. PROCEDURE Baseline TIMI flow Total scaffold lenght (9.4%) (8.3%)
(7.3%)
(5.7%)
(3.6%)
(58.9%)
(76.0%)
(13.0%)
(39.1%)
(27.6%)
(37.5%)
(31.8%)
(10.4%)
(7.8%)
Baseline TIMI flow
Total scaffold lenght

13. PROCEDURE DIiameter (mm) Lenght (mm) PATIENTS n=123 N° BVS per patient
2.0 ± 1.2
Multivessel treatment
21 (17.1%)
MPS implantation
28 (22.8%)
Overlap
Scaffold-to-scaffold
Marker-to-marker
Marker-over-marker 58 12 24
Post-dilatation
115 (93.5%)
Angiographic success
121 (98.4%)
Procedural success
119 (96.7%)
DIiameter (mm)
Lenght (mm)

14. MEDIAN FOLLOW UP OF 21 MONTHS (IQR, 11 – 32 MONTHS)
FOLLOW-UP EVENTS
MEDIAN FOLLOW UP OF 21 MONTHS (IQR, 11 – 32 MONTHS) %

15. MEDIAN FOLLOW UP OF 21 MONTHS (INTERQUARTILE RANGE, 11 – 32 MONTHS)
FOLLOW-UP EVENTS
MEDIAN FOLLOW UP OF 21 MONTHS (INTERQUARTILE RANGE, 11 – 32 MONTHS)
6 months
1,6%
12 months
3,3%
21 months
5,7%
CUMULATIVE INCIDENCE OF TLF
TIME (DAYS)
DEFINITE ST
Clinical presentation
Event
ST type
DAPT
PRE-RVD
BVS
Pts 1
STEMI
TLR + TV-MI
ACUTE
Yes
2.24 mm
2.5 X 18 mm
Pts 2
NSTEMI
LATE
2.5 mm
2.5 x 18 mm
Pts 3
Stable angina
TLR
VERY-LATE No
2.35 mm
2.5 x 28 mm
Cumulative incidence of Target Lesion Faiulure
Cumulative incidence of Target Lesion Faiulure
Cumulative incidence of Target Lesion Faiulure
Cumulative incidence of Target Lesion Faiulure

16. CONCLUSIONS
Patients treated by BVS for small vessel disease showed early and mid term TLF result similar to those previously reported for unselected lesions type (GHOST-EU, Absorb FIRST, Absorb EXPAND ).
More analysis are needed to assess the potential role of BVS in this subset compared to large vessels or MPS.
We are waiting for the end of the enrollemnt to have more substantial results.