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36-month pooled analysis1
 
 
 Conclusions
  • Target Lesion Failure (TLF) and Clinically-Driven Target Lesion Revascularization (CD-TLR) rates in BIOSOLVE-II and -III remain low for Magmaris® Resorbable Magnesium Scaffold and are comparable to 2nd generation drug-eluting stents out to 36 months.
  • No definite or probable Scaffold Thrombosis (ST) were reported up to 36 months.
 
 
Study design
Pooled analysis of BIOSOLVE-II and BIOSOLVE-III
Endpoints
Primary endpoint
  • BIOSOLVE-II: In-segment LLL at 6-month follow-up
  • BIOSOLVE-III: Procedure success
Secondary endpoints (selected)
  • TLF rate is defined as a composite of Cardiac Death, Target-Vessel Myocardial Infarction (TV-MI) and Clinically-DrivenTarget Lesion Revascularization (CD-TLR)
  • Definite/probable ST
 
 
 
 

 

Principal investigator
 
Prof. M. Haude, Lukaskrankenhaus, Neuss, Germany
1. Haude M. Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 36-month Follow-up-BIOSOLVE-II and -III, Presented at: TCT; September 27, 2019; San Francisco, USA; 2. TLF rate is defined as a composite of Cardiac death, Target-Vessel Myocardial Infarction (TV-MI) and Clinically-Driven Target Lesion Revascularization (CD-TLR) and CABG; 3. Cardiac Death due to ventricular arrhythmia, chronic heart failure and two unknown causes; 4. Peri-procedural MI according to SCAI definition and spontaneous MI according to the Extended Historical definition.

All events have been adjudicated by a clinical events committee.

Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies.
 

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