LEADERS 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 PCI
- 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-BIOMATRIX
Excellent and impressive long term data for BioMatrix Family in more than 5’000 real-world patients.
- 5,000 all comer patient registry
Results at 3 years1:
- MACE 9%
- Cardiac Death 2.1%
- Ci-TVR 5.6%
- MI 3.2%
COMFORTABLE AMI 2 year follow-up
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
Thus, BioMatrix Flex has become the Gold Standard in biodegradable technology.
11134-000-EN - Rev.02 + 11136-000-EN - Rev.02 + 11140-000-EN - Rev.01 + 11881-000-EN - Rev.04
