BVS Expand: First Results of Wide Clinical Applications Robert-Jan van Geuns, MD, PhD Associate Professor, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands

Robert-Jan J.M. Van Geuns, MD, PhD Study Supported By: Abbott Vascular

5 years of Bioresorbable scaffolds 60 months 6 months Baseline Absorb A Absorb B Absorb Extend Absorb II Absorb III/IV BVS Expand Syntax Trial DES Vs Surgery Symptom Severity Courage Trial Stents Vs Meds BVS 5 Yr Disease Severity

BVS Expand: Single Center Registry Larger diameter up to 4.0 mm Longer length: > 32 mm Bifurcations Calcified lesions ACS patients (non-STEMI) No previous CABG or metallic stent in target vessel Target: 300 patients Start Sept 1st Absorb A Absorb B Absorb Extend Absorb II Absorb III/IV BVS Expand Syntax Trial DES Vs Surgery Symptom Severity Courage Trial Stents Vs Meds BVS 5 Yr Disease Severity

BVS Expand: Single Center Registry Larger diameter up to 4.0 mm (3.3 for A and 3.5 for B) Longer length: > 32 mm Bifurcations Calcified lesions ACS patients (non-STEMI) No previous CABG or metallic stent in target vessel Target: 300 patients Start Sept 1st Dec 15th BVS-STEMI-First Single center registry BVS in STEMI OCT at baseline for apposition

BVS Expand: Single Center Registry Objective This monocenter, prospective, observational post market registration will evaluate the long term safety and performance of the BVS coronary stent, in routine clinical practice. Its objective is to measure the incidence of Major Adverse Cardiac Events (MACE) patients with NSTEMI, stable or unstable angina, or silent ischemia

Primary Endpoint Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 12 months post-procedure

Secondary Endpoints Success Rates: Device Success: Attainment of <30% final residual stenosis of the segment of the culprit lesion covered by the BVS, by visual estimation Procedure Success: Device success and no peri-procedural complications Clinical success: Procedural success and no in-hospital MACE

BVS Expand + BVS-STEMI-First

Baseline characteristics BVS-Expand BVS-STEMI-First All N 104 23 127 Male 75 (72%) 20 (87%) 93 (73%) Hypertension 60 (58%) 11 (48%) 70 (50%) Hypercholestorolemia 46 (44%) 9 (39%) 53 (42%) Diabetes 21 (20%) 2 (9%) 22 (17%) Smoking 55 (53%) 12 (52%) 66 (52%) Family 41 (39%) 6 (26%) 45 (35%) Renal failure 7 (7%) 1 (4%) 8 (6%) Prior MI 15 (14%) 3 (13%) 17 (13%) Prior PCI 6 (6%) Prior CABG 1 (1%) 0 (0%) Prior CVA 10 (10%) 9 (7%) PAD 12 (12%) 12 (9%) COPD 8 (8%)

Indications (All patients) 47% 1% 30% 22% 18% 32% 37% 13%

Procedural characteristics Implantation instruction Use online QCA Avoid under sizing, as postdilation is limited to 0.5 mm Proper lesion preparation = sufficient large balloon (min 2.5 mm) Use more supportive wires Direct stenting possible in ACS All (N=127) MVD 33 (26%) Bif 26 (21%) CTO 8 (6%) STEMI 23 (18%) Overlap 35 (28%) Total scaffolds 218 Scaffolds per procedure 1.7 Failure to deliver 7 (5.5%) Device succes 94.5% Days since procedure 68 ± 47 Failure to deliver: LCX:4; LAD: 1; RCA: 2 No adverse events reported.

Case 4: Calcified lesion (56%!) 74 year old male, 2002 PAF, Hypertension, instable angina. Flecanaide, Furosemide, Barnidipine, Enalapril/HCT, ASA, Clopidogrel, Statin, Calcification + MLA 3,15 mm2 B MLA 8,05 mm2 MLA 1,77 mm2 B b distal b Fem: JR 4.0, Pilot 50-Whisper ES, Trek 3.0 x 20, BVS 3.5 x 28 IVUS 6441307: film 122000 30 Aug 2012:RG

Angiographic outcome Courtesy Roberto Diletti Lesion Length: Cohort B: 9.9 mm Extend: 11.7 mm N =36 Calcified (N=16) Non-Calcified (N =20) Lesion Length 21.33 ± 12.38 mm 19.26 ± 13.53 mm P=0.318 RD 3.09 ± 2.55 mm 2.50 ± 0.65 mm p=0.740 Mean Diameter 1.81 ± 0.34 mm 1.90 ± 0.56 mm p=0.446 MLD 0.87 ± 0.39 mm 1.09 ± 0.39 mm p=0.058 MD post 2.86 ± 0.33 mm 2.75 ± 0.46 mm p=0.626 MLD post 2.42 ± 0.36 mm 2.36 ± 0.47 mm Acute gain 1.59 ± 0.46 mm 1.28 ± 0.42mm p=0.077 Acute recoil 0.16 ± 0.33 mm 0.23 ± 0.21 mm p=0.682 Relative acute recoil 4 ± 12 % 8 ± 6% p=0.520 Conclusion The implantation of second generation BVS was associated with similar absolute and relative acute recoil in calcified and non-calcified coronary lesions.

Case 24: Bifurcation 71 year old male, Stable Angina. MVD BVS Absorb® scaffold 3,0 x 18 mm pre-dilatation: Abbott Trek® 2,5 x 20 mm BVS Absorb® scaffold 3,5 x 18 mm Pre-procedure 4594385 Film 122527: 1-Nov-2012: RG

Case 24: Bifurcation Angiogram Pinched side branch Hazyness Opening struts: Abbott Trek® 2,5 x 12 mm POT: Trek 3.5 x 15 NC distal Result distal scaffold Final result Courtesy Jurgen Ligthart 4594385 Film 122527: 1-Nov-2012: RG

Bifurcations N = 24 Sidebranches >2 mm 24 (19%) Sidebranches treated 7 Balloon only 6 2 scaffolds (Culotte) 1

Case 38: ACS 56 year old male, Chest pain, AMI CLS Catheter; Pilot 50: no success Miracle 3 + Trek OTW 1.5 mm - Trek: 2.0 9604757 Film 122627: RG

Case 38 56 year old male, Chest pain, AMI CLS Catheter; Pilot 50: no success Miracle 3 + Trek OTW 1.5 mm - Trek: 2.0 9604757 Film 122627: RG

Case 38 56 year old male, Chest pain, AMI MLA = 7.3 mm2 BVS: 3.0 x 18 9604757 Film 122627: RG

Summary First real world experience in >120 complex procedures very positive following a strict implantation protocol No adverse events for these cases were reported Procedural and angiographic outcome are exciting and inline with previous data. Deliveribility: Flexibilty Crossing profile/Strut thickness Longer procedural time, more supportive wires, more predilatation.