1. ­ Up date on the Absorb Extend Trial
Alexandre Abizaid, MD, PhD, FACC
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil

2. Alexandre Abizaid, MD, PhD, FACC
Research Grants and Advisory Board:
Abbot Vascular

3. Absorb: A Revolutionary Therapy Building Evidence
First in Man
Cohort A
Cohort B
Expanding Experience
Novel
Endpoints
ABSORB EXTEND
ABSORB FIRST
ABSORB UK
ABSORB II
ABSORB lll
ABSORB IV
ABSORB Japan
Pivotal Trials
ABSORB III US RCT
ABSORB Japan RCT
ABSORB China RCT

4. 814 Subjects Enrolled Up to 100 International Sites
ABSORB EXTEND Design
30 d mo mo mo mo
Clinical follow-up (n=814)
MSCT follow-up (n=100)
ENROLLMENT COMPLETE
814 Subjects Enrolled Up to 100 International Sites
Study Objective:
Continued Access Trial
First Patient Enrolled: January 11, 2010
Enrollment Complete: October 2, 2013
Endpoints:
No hypothesis-testing, typical PCI clinical endpoints
Treatment:
Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and ≤ 28 mm
Device Sizes:
Scaffold diameters: 2.5, 3.0, 3.5 mm; Scaffold lengths: 12, 18, 28 mm
Sponsor and Funding: Abbott Vascular

5. ABSORB EXTEND Trial Management
Principal Investigator: Alexandre Abizaid, MD, PhD; San Paulo, Brazil
Regional Co-Principal Investigators: Antonio Bartorelli, MD; Milano, Italy;
Robert Whitbourn, MD; Fitzroy Victoria, Australia
Chairman: Patrick W. Serruys, Prof, MD, PhD;
Rotterdam, The Netherlands
Imaging Core Lab: Cardialysis B.V.; Rotterdam, The Netherlands
Clinical Events Committee: Claude Hanet, MD, Ralph Tölg, MD, Angela Hoye, MD, Benno Rensing, MD, Karel Koch, MD, Eugene McFadden, MD, Vadim A. Kuznetsov, MD, Giampaolo Niccoli, MD, Ralph Birkemeyer, MD, Rostock, Germany
DSMB: Jan G.P. Tijssen, PhD, Philip Urban, MD,
Marcus Wiemer, MD
Source Document Verification: Routinely performed in 100% of all site reported events and 100% of patients through 30-day follow-up.
Subsequent SDV is performed in a random 20% of patients for all remaining follow-up visits.

6. Demographics and Lesion Characteristics (ITT)
250 Pts
Male
74%
Mean age
62 yrs
Prior Cardiac Intervention on Target Vessel 6%
Previous MI
29%
Unstable Angina
35%
Diabetes mellitus
25%
Dyslipidemia req. med.
60%
Hypertension req. med.
64%
Current smoker
20%
QCA Pre-procedure
265 Lesions
RVD
MLD
% DS
Proximal Dmax
Distal Dmax
2.58 ± 0.35mm
1.02 ± 0.29mm
60%
2.8mm
2.7mm
Lesion Length
Mean
Range (min, max)
11.67 ± 4.81mm
(3.13, 33.16)
Lesion Location
265 Lesions
LAD
LCX
RCA
LMCA/Ramus
40%
31%
28% 1%
ACC/AHA Lesion Classification A B1 B2 C 3%
57%
34% 6%

7. Clinical Outcomes – ARC Scaffold Thrombosis
Non-Hierarchical
250 Patients
Definite Scaffold Thrombosis %
Acute (0-1 day)
0.0
Sub-acute (2-30 days)
Late (31 days- 1 year)
0.4
Very Late (>1 year)
Probable Scaffold Thrombosis %
Total at 3 years: (ARC Def/Prob) %
1.2
* Reflects an interim snapshot of patients with 36 month follow-up
as of the cut-off date of July 7th 2014
** Per protocol definition

8. Propensity Score Matched Analysis
BEFORE Propensity Matching
250 Absorb
EXTEND
862 XIENCE
SPIRIT I
SPRIIT II
SPIRIT III
AFTER Propensity Matching
174 Absorb
290 XIENCE
Using a 1:2 case-control ratio, and excluding Absorb patients without a matched XIENCE
Unadjusted data showed statistical differences in patient characteristics of prior MI, unstable angina, dyslipidemia, hypertension, and familial history of CAD, multiple vessel disease and all lesion characteristics except for percentage of LCX/Ramus treated.
Adjusted data showed that the above baseline characteristics were no longer significantly different, indicating an effective PSA.

9. Propensity Score Matched: MACE through 36 Months37
194
393
758
1123
ABSORB EXTEND at Risk
174
169
166
161
157
XIENCE V (SPI,II,III) at Risk
290
285
279
271
255
252

10. Propensity Score Matched: TVF through 36 Months37
194
393
758
1123
ABSORB EXTEND at Risk
174
169
166
160
156
XIENCE V (SPI,II,III) at Risk
290
285
276
264
246
241

11. Propensity Score Matched: MI through 36 Months37
194
393
758
1123
ABSORB EXTEND at Risk
174
169
168
164
163
XIENCE V (SPI,II,III) at Risk
290
286
285
279
269
266

12. Propensity Score Matched: ID-TLR through 36 Months37
194
393
758
1123
ABSORB EXTEND at Risk
174
172
169
166
161
XIENCE V (SPI,II,III) at Risk
290
289
284
278
264
260

13. Propensity Score Matched: ST (def/prob) through 36 Months37
194
393
758
1123
ABSORB EXTEND at Risk
174
172
171
170
168
XIENCE V (SPI,II,III) at Risk
290
286
277
275

14. Angina KM Curve Through 3 Years PS-Matched ABSORB EXTEND and SPIRIT IV Populations*37
194
393
758
1123
Absorb Extend* *
483
459
437
370
258
111
1.7%
5.0%
9.5%
13.0%
17.4%
17.9%
SPIV**
430
382
340
299
276
4.6%
11.0%
19.5%
26.8%
34.4%
38.4%
Difference
2.9%
6.0%
10.0%
13.8%
17.0%
20.5%
Speaker notes:
Entry into the PS analysis:
All Absorb patients from EXTEND (812);
XIENCE V patients from SPIRIT IV non-complex subgroup (2051)
Exit from PS analysis: 483 patients in each arm
Results:
KM shows only those patients evaluable at 1, 2, and 3 years. That is, at 2 years, data reflects that subset of PS-matched patients who reached 2 years. At 3 years, data reflects that subset with 3 year follow-up only, sample size is smaller than 2 year group because fewer patients reached 3 years and not because of censoring through events.
Key points
VISUALLY, the curves shown to separate over time.
This slide a preview of the ACC 2014 presentation where angina and clinical outcomes for all patients up to 1 year will be presented.
* EXTEND and SPIRIT IV non-complex subgroup ** Includes in-hospital angina events; angina reported via AE forms Evaluable patients only at 1, 2, and 3 years

15. Conclusion
Clinical data from the first 250 patients enrolled in ABSORB EXTEND demonstrate that the low rates of MACE, repeat revascularization and scaffold thrombosis seen at 12 and 24 months are sustained through 36 months
At 3 years, after propensity score matching, the clinical safety and effectiveness of Absorb remained comparable to XIENCE V :
No statistical difference between Absorb and XIENCE V with regards to MACE, MI, ID-TLR and ST
The statistical difference seen in TVF requires further investigation