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.

  • 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



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
BioMatrix NeoFlex™
Movie - Testimonials
Testimonials about the LEADERS study after 5-year results
BioMatrix NeoFlex™
Main brochure

BioMatrix NeoFlex™
Ordering information

1. Final 3-year Report of the e-BioMatrix Registry, David Hildick-Smith, 2015


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