1. ABSORB Japan:
3-year Clinical and Angiographic Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffold vs. Metallic Drug-eluting Stent in de novo Native Coronary Artery Lesions
Ken Kozuma, Kengo Tanabe, Takeshi Kimura on behalf of the ABSORB Japan Investigators.

2. Study Design BVS N=266 CoCr-EES N=134 Post 1 M 6M 12M 13M 2Y 3Y 4Y 5Y
Patients with up to 2 de novo target lesions in separate native coronary arteries with a lesion length of ≤ 24 mm and a maximal diameter of ≥ 2.5 mm to ≤ 3.75 mm
Randomized 2:1
BVS N=266
Tx. with single study device
Diameter: 2.5, mm
Length: 8, 12, 18, 28 mm
CoCr-EES N=134
Tx. with single study device
Diameter: 2.5, mm
Length: 8, 12, 18, 28 mm
Post 1 M
6M 12M 13M 2Y 3Y
4Y 5Y
Clinical FU
Imaging
Angiogram Y*
OCT
(Subrandomized)
Clinical f/u at 3-­‐year: 96.5%
Angiographic f/u at 3-­‐year: 87.3%
PI: Takeshi Kimura, Kyoto University •
QCA Corelab: Beth Israel Deaconess Medical Center, Inc., Angiographic Core Lab, Boston
Sponsor: Abbott Vascular

3. Summary Of Key Clinical and QCA Outcomes
BVS
(266 PaDents)
CoCr-­‐EES (134 PaDents)
P-­‐value
2-­‐3 Years
TLF
1.6% (4)
1.6% (2)
1.00
-­‐ Cardiac Death
0.0% (0)
-­‐ Target Vessel MI
0.4% (1)
-­‐ ID-­‐TLR
Definite/Probable ST
0-­‐3 Years
8.9% (23)
5.5% (7)
0.23
5.4% (14)
3.1% (4)
0.31
7.0% (18)
3.9% (5)
3.6% (9)
0.35
In-device MLD
Pre
Post
13 Months
3 Years
0.96±0.33 mm
2.42 ± 0.38 mm
2.23 ± 0.47 mm
2.04 ± 0.63 mm
CoCr-EES
0.99±0.36 mm
2.64 ± 0.40 mm
2.48 ± 0.53 mm
2.40 ± 0.56 mm
P-value
0.42
<0.0001
BVS
CoCr-­‐EES
P-­‐value
BVS
(266 PaDents)
CoCr-­‐EES (134 PaDents)
P-­‐value
(266 PaDents)
(134 PaDents)

4. Relevance of the trial
The 2-year results of Absorb III and Absorb Japan showed a relatively high incidence of TLF in Absorb compared to XIENCE.
Comparable safety and effectiveness was observed in ABSORB Japan between both study arms from 2 to 3 years, with low incremental TLF rates reported for BVS (1.6%) and CoCr-EES (1.7%) due to predominant to increases in ID-TLR.
At 3-years, the question of great interest among interventional cardiologists is whether the slope of the scaffold thrombosis curve will decrease after 2 years.
Compared to the prior year, only 1 VLST occurred between 2 and 3 years, on day 810 and in a BVS-treated lesion with visibly high restenosis.
Few studies have demonstrated long-term clinical and serial angiographic outcomes of Absorb BVS in a randomized fashion both at 13-month and 3-year. The 3-year angiographic appearance would similarly be unique as this time-point is around the time of full scaffold resorption.
Late lumen loss of BVS at 3 years was within clinically acceptable range (< 0.4 mm), and consistently with that observed in ABSORB II and consistent with the low ID-TLR rates reported within 2-3 years.