­ Up date on the Absorb Extend Trial

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Presentation transcript:

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

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

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

814 Subjects Enrolled Up to 100 International Sites ABSORB EXTEND Design 30 d 6 mo 12 mo 24 mo 36 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

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.

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%

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

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.

Propensity Score Matched: MACE through 36 Months 37 194 393 758 1123 ABSORB EXTEND at Risk 174 169 166 161 157 XIENCE V (SPI,II,III) at Risk 290 285 279 271 255 252

Propensity Score Matched: TVF through 36 Months 37 194 393 758 1123 ABSORB EXTEND at Risk 174 169 166 160 156 XIENCE V (SPI,II,III) at Risk 290 285 276 264 246 241

Propensity Score Matched: MI through 36 Months 37 194 393 758 1123 ABSORB EXTEND at Risk 174 169 168 164 163 XIENCE V (SPI,II,III) at Risk 290 286 285 279 269 266

Propensity Score Matched: ID-TLR through 36 Months 37 194 393 758 1123 ABSORB EXTEND at Risk 174 172 169 166 161 XIENCE V (SPI,II,III) at Risk 290 289 284 278 264 260

Propensity Score Matched: ST (def/prob) through 36 Months 37 194 393 758 1123 ABSORB EXTEND at Risk 174 172 171 170 168 XIENCE V (SPI,II,III) at Risk 290 286 277 275

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

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