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e-BioMatrix Registry: A Post Market Registry For The BioMatrix™ Stent P. Urban, J. Berland, D. Hildick-Smith, D.G. Iosseliani, X. Kleber, K. Oldroyd, M. Roffi, M. Valdés, P. Juni, P. Eerdmans for the e-BioMatrix Registry investigators

Abstract Drug-eluting stents (DES) effectively reduce the rate of TLR compared with bare metal stents (BMS). However, there is concern of an increased incidence of very late stent thrombosis (ST) associated with 1st generation DES potentially related to the durable polymer. The Biolimus-A9™ eluting stent platform (BioMatrix™; BES) releases Biolimus-A9, a sirolimus analogue, from a biodegradable polymer, polylactic acid (PLA), which is degraded into carbon dioxide and water during a period of 6-9 months. The Biolimus-A9 stent with biodegradable polymer has already been shown to be a safe and effective alternative to a sirolimus-eluting stent with a durable polymer (LEADERS). The purpose of the present registry is to capture longterm clinical data of the BioMatrix stent system in relation to safety and effectiveness in a large population. Methods: This registry is a prospective, multi-center registry conducted at 55 European interventional cardiology centers. The studied population is a “real-world, all comers” patients population with no limitations on the number of treated lesions and vessels, and lesion length as well as clinical indication (chronic stable angina vs. acute coronary syndromes). The primary endpoint of the registry is a composite of cardiac death, myocardial infarction (Qwave and non Q-wave), or clinically driven Target Vessel Revascularization at 12 months. Full monitoring of all major cardiac adverse events (MACE) up to 5 years will be obtained, and all MACEs will be adjudicated by an independent Critical Events Committee. Results: Currently 2618 patients have been recruited in the e-BioMatrix registry (status Sept 4, 2009). The 6 months follow-up were performed for the first approximate 400 patients and are still ongoing for the remaining population. Conclusion: The 6-month follow-up adjudicated data of the first 400 patients of the e-BioMatrix registry will be presented at the time of meeting.

Objectives   To evaluate the safety and efficacy of BioMatrixTM in routine clinical use.

Interim Results

Unique Study Design Data as of September 4th 2009

Patient Enrollment Status 2618

Same Protocol

2186

1,000 patients

4,000 patients

100 % monitoring

100 % MACE monitoring

1049 227

Independent CEC Angiography corelab evaluates reported stent thrombosis

Planned total enrollment = 5,000 patients

e-BioMatrix Registry Prospective, Multi-Center, Observational Study to assess outcomes of Real World, All Comers Patients

Stable+SI N=269

5000 patients in 70 European centers Follow-Up

1° Endpoint: Key 2° Endpoints:

6 mo

12 mo

2 yrs

3 yrs

4 yrs

*MACE as defined by ARC Definitions (Composite of Cardiac Death, MI and TVR)

DAPT Duration: Min 6 months, Recommended up to 12 months ASA indefinitely

STEMI N=115

Ongoing CEC adjudication

All** N=593

65.7 ± 10.6

64.7 ± 11.6

61.5 ± 11.3

64.6 ± 11.1

55 (20.5%)

39 (21.2%)

12 (10.4%)

113 (19.1%)

Diabetes

55 (20.5%)

43 (23.4%)

14 (12.2%)

122 (20.6%)

Renal Insufficiency*

7 (2.6%)

10 (5.4%)

1 (0.9%)

20 (3.4%)

Prior PCI or CABG

104 (38.7%)

40 (21.7%)

11 (9.6%)

161 (27.2%)

LVEF (<40%)

10 (3.7%)

12 (6.5%)

9 (7.8%)

33 (7.4%)

5 yrs

Registry device oriented MACE* in overall population at 12 months Registry device oriented MACE* at 30 days, 6 months and 2, 3, 4 and 5 years Total Revascularization Rate at 30 days, 6 months and 2, 3, 4 and 5 years

% ACS N=184

BMI ≥30

Age 30 d

6 Month Follow-Up

Indication for PCI n = 593 patients

* Renal insufficiency : Creatinine > 2.95 mg/dL or 260 µmol/L ** Including Asymptomatic Patients

  Evaluate the reproducibility of the Randomized Clinical Trial (RCT) LEADERS, with all-comers design.

*Clinically driven

  To evaluate the effect of monitoring on the quality (outcome) of a post marketing registry.

PCI Procedure

Participating Centers

  This poster shows the results of the first 593 patients that received 6-month follow-up.

BioMatrixTM Platform

High Risk Subsets %

# of Patients

Centers Profile 22.0% 29.0%

< 1000 PTCA 1000 to 2000 PTCA > 2000 PTCA

49.0%

Locations of participating centers

Novos

ibirsk

6 Month Follow-Up: Subsets

Multi-vessel procedure (Index + Staged)

22.9% (150/660)

Multi-vessel procedure (Index)

15.4% (91/592)

Multi-lesion procedure (Index + Staged)

37% (243/660)

Multi-lesion procedure (Index)

36.4% (215/592)

Pressure deployment (atm)

15.2 ± 3.1

Average stent diameter per lesion

3.0 ± 0.4

Average stent diameter per patient

3.0 ± 0.3

Total stent length per patient (mm)

35.2 + 22.9

Total stent length per lesion (mm)

21.4 + 10.1

Multiple BES per lesion

16.2%

≥ 3 BES per lesion Multiple BES per patient ≥ 3 BES per patient

**Definite and Probable (ARC definition)

%

Ongoing CEC adjudication

2.8% 54.1% 25.3%

*Clinically driven

**Definite and Probable (ARC definition)

Conclusions •  The e-BioMatrix registry preliminary data suggest that the good results from the Biolimus-A9™ eluting stent used in the LEADERS RCT can be reproduced in routine clinical practice. •  In e-BioMatrix, the incidence of stent thrombosis at 6-month appears to be acceptably low. Although the results are preliminary, they suggest the safety profile remains good. •  In this real-world registry the compliance with antiplatelet therapy duration was excellent (95.9% of patients were on DAPT at 6-month).


e-BioMatrix-Registry  

Diabetes 55 (20.5%) Average stent diameter per lesion 3.0 ± 0.4 Average stent diameter per patient 3.0 ± 0.3 Total stent length per patient...

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