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THE BIOMATRIX ALPHA REGISTRY1
First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent

Single arm, prospective, multi-center registry, 400 patients from 12 sites in 4 countries.
All patients received BioMatrix Alpha™ stents as per clinical practice and were  followed for 2 years for data collection.

Primary Endpoint Major adverse cardiac events (MACE) composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave),or clinically driven target vessel revascularization (TVR) at 9 months.
 

Results at 9 months

> MACE 3.78% - Cardiac Death: 0.75% - MI: 1% - Def/Prob ST: 0.25%
 

Results at 24 months

> MACE 6.65% - Cardiac Death: 1.29% - MI: 2.82% - Def/Prob ST: 1.12%
 
 

LEADERS2 the first all comers trial of PCI
(Limus Eluted from A Durable versus ERodable Stent coating)

1:1 randomized control trial to prove non-inferiority to the current gold standard stent BioMatrix Flex™ vs Cypher® Select™
1700 patients from 10 European centers. Patients suitable for PCI enrolled, with limited exclusion criteria
Primary endpoint was non-inferiority of MACE (Cardiac death, MI, cd-TVR) at nine months
Planned follow-up of 5 years – subgroups.
 

Results:

> MACE non-inferior at 9 months
> 0.66% ST from 1-5 years
> Significant reduction in Patient Oriented Composite Endpoint (All-cause Death, Any MI, All Revascularization) at 3,4 & 5 year follow-up
 

Clinical benefit shown in patients undergoing complex PCI2

> 5 year MACE significantly reduced BES vs SES in high Syntax score ≥12 patients
> BioMatrix™ achieved a significant reduction in Stent Thrombosis in high Syntax score ≥12 patients
> Significant reduction in MACE driven by a reduction in Cardiac Death in STEMI subgroup at 1 year
> In CTO patients 30 days post implant BioMatrix demonstrated a significant reduction in MACE, ci-TVR and Stent Thrombosis
> Significant reduction in Cardiac death in AMI STEMI patients at 5 years
 
 

e-BIOMATRIX3

Excellent and impressive long term data for BioMatrix™ Family in more than 5’000 real-world patients.
> 5,000 all comer patient registry
 

Results 3 years4:

> MACE 9%
> Cardiac Death 2.1%
> ci-TVR 5.6%
> MI 3.2%
 

COMFORTABLE AMI 2 year follow-up5

A randomized trial 1:1 BioMatrix Flex vs Gazelle BMS
To evaluate the BioMatrix Flex in an AMI population vs the current BMS gold standard.
Primary endpoint MACE (Cardiac Death, TV-MI, cd-TLR): 52% reduction in MACE vs the BMS
> 64% reduction in ci_TLR
> 3% reduction in TV-MI
> 1.4% ST at 2 years
> A safety and efficacy benefit maintained out to 5 years
 

Thus, BioMatrix has become the Gold Standard in biodegradable technology.

 

12244-000-EN, 11140-000-EN - Rev.01 + 11134-000-EN, 11136-000-EN - Rev.02 + 11881-000-EN - Rev.04
BioMatrix™ Alpha
BMX Alpha Registry 2-year FU Results

1. Clinical Outcomes with Cobalt Chromium Biolimus DES compared with Stainless Steel Biolimus DES in All-Comers Patients after 2 years. Presentation I. Menown TCT CONNECT 2020.
2. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. Serruys P. et al JACC Cardiovasc Interv. 2013 Aug;6(8):777-89
3. Outcomes Following Implantation of the Biolimus A9-Eluting BioMatrix Coronary Stent: Primary Analysis of the e-BioMatrix Registry. Urban P. et al. Cathet. Cardiovasc. Intervent 86:1151–1160 20154. Final 3-year Report of the e-BioMatrix Registry, David Hildick-Smith, 2015
5. Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction. Raber et al.  Eur Heart J. 2019 Jun 21;40(24):1909-1919.
 

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