BIOSOLVE-IV​ FULL COHORT​

24m follow-up of full cohort with 2,066 patients1

BIOSOLVE-IV 2-year results

Conclusions

  • At 24m of follow-up the Magmaris® Resorbable Magnesium Scaffold (RMS) scaffold showed excellent safety and efficacy profile
  • Target Lesion Failure (TLF)* rate at 24m is comparable to contemporary newer generation drug-eluting stents2,3,4
  • Definite/probable scaffold thrombosis rate at 24m is 0.8%
    • 0.4% scaffold thrombosis rate excluding cases with early antiplatelet or anticoagulant interruption

Study design

Prospective, multi-center, real-world setting registry

Patients

18.5% of NSTEMI patients included.#

Endpoints

Primary endpoint:

  • TLF* at 12 months;
Secondary endpoint:
  • Clinically-driven Target Lesion Revascularization (Clinically-driven TLR) and Target Vessel Revascularization (TVR)
  • Cardiac death
  • Target-Vessel Myocardial Infarction (TV-MI)
  • Definite/probable ST at 12 months powered to show the superiority of Magmaris vs. historical data of Absorb for Full cohort based on a one-sided exact binomial test 
  • Procedure and device success

24 months data
PATIENT CHARACTERISTICS n = 2,066
Age, yrso 61.9 ± 10.5  
Male 1,539 74.5%
Hypertension 1,370 66.3%
Hyperlipidemia 1,347 65.2%
Smoking 1,224 59.2%
Diabetes mellitus 446 21.6%
   Insulin dependent 94 21.1%
   Non-insulin
   dependent		 352 78.9%
History of MI 448 21.7%
Previous percutaneous intervention 594 28.8%
NSTEMI 383 18.5%

LESION LOCATION n
LAD 1,067              49.5%
LCx 442 20.5%
RCA 620 28.8%
RI 25 1.2%

LESION CHARACTERISTICS n
Lesion length (mm)o 14.8 ± 4.0  
Reference vessel diameter (mm)o 3.2 ± 0.3  
AHA/ ACC lesion class B2/C 329 15.2%
Calcification moderate/severe 162 7.5%
Bifurcation lesions 99 4.6%

Lesion characteristics are estimated by investigators

 

* TLF is defined as a composite of Cardiac Death, TV-MI, emergent Coronary Artery Bypass Grafting (CABG), and CD-TLR. Peri-procedural MI according to SCAI definition and spontaneous MI according to the Extended Historical definition.
# Please consult IFU for indications and use in special populations.
° Data shown as mean ± SD

TLF of contemporary DES2,3,4 up to 24 months

Study

 BIOFLOW-V2
n=1,334		 BIO-Resort3
n=3,514		 BIONYX4
n=2,488
Device

BP-SES

n = 884   

DP-EES   

n = 450   

EES

n = 1,172  

ZES

n = 1,173  

SES

n = 1,169  

ZES

n = 1,243  

SES

n = 1,245  
TLFΔ  7.5%   11.9%  5.8% 6.8%   5.1%  6.2% 5.8%

Δ TLF is defined as a composite of Cardiac death, TV-MI, clinically-driven TLR

BP-SES = Bioresorbable-polymer sirolimus-eluting stent
DP EES = Durable-polymer everolimus-eluting stent
EES = Everolimus-eluting stent
SES = Sirolimus-eluting stent
ZES = Zotarolimus-eluting stent

TLF* rate is comparable to contemporary newer generation drug-eluting stents.2,3,4

24-month follow-up in comparison

Study

 BIOSOLVE-IV Full cohort1
n = 2,066		 BIOSOLVE-II/-III5 
n =180
TLF* 138        6.8% 10 5.5%
  Cardiac death 10 0.5% 4 2.2%
  TV-MI 32 1.6% 1 0.5%
  Clinically-driven TLR 132 6.0% 5 2.8%
Scaffold Thrombosis (definite or probable) 17 0.8%§ 0 0.0%

§ 0.4% of cases without early antiplatelet or anticoagulant interruption at post procedure.

Presenting author

Johan Bennett, MD, PhD, UZ Leuven, Leuven, Belgium

* TLF is defined as a composite of Cardiac Death, TV-MI, emergent Coronary Artery Bypass Grafting (CABG), and CD-TLR. Peri-procedural MI according to SCAI definition and spontaneous MI according to the Extended Historical definition..

1. Bennett J. Safety and Efficacy of the Resorbable Magnesium Scaffold, Magmaris in a Real-World Setting – 24-month Follow-up of the Full Cohort (2066 subjects) of the BIOSOLVE-IV Registry. Presented at: TCT, September 2022, Boston, USA. ClinicalTrials.gov: NCT02817802; 2. Kandzari D.E. et al. JACC: Cardiovascular Interventions 2018. doi: 10.1016/j.jacc.2018.09.019; 3. Kok M. et al. Euro Intervention 2018 doi: 10.4244/EIJ-D-18-00336; 4. Buiten RA. et al. JACC: Cardiovascular Interventions 2020 doi:0.1016/j.jcin.2020.01.230; 5. Haude M et al, EuroIntervention 2017;13:432-439 published online ahead of print May 2017 .

All events have been adjudicated by an independent clinical event committee. BIOSOLVE-IV registry is based on Kaplan-Meier failure estimate analysis including censored observations. The pooled analysis of BIOSOLVE-II and -III is based on frequency analysis.

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

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