BIOSOLVE-IV

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  12-month follow-up of first 400 patients1

 
 Conclusions
  • Target Lesion Failure (TLF) rates at 6 and 12 months are comparable to 2nd generation drug-eluting stents
  • Magmaris shows an excellent safety profile up to 12 months in BIOSOLVE-IV
  • These promising outcomes included 15.8% of NSTEMI patients, a challenging patient group
 
 
Study design
Prospective, multi-center, real-world setting registry.
 
Patients
15.8% of NSTEMI patients included.
Endpoints
Primary endpoint
  • TLF at 12 months defined as a composite of Target-Vessel Myocardial Infarction (TV MI), Clinically-Driven Target Lesion Ravascularization (CD-TLR), cardiac death and CABG
Secondary endpoints
  • CD-TLR and TVR
  • Cardiac death
  • Target-vessel MI
  • Scaffold Thrombosis (ST)
  • Procedure and device success
 
 








 
 
1. Kang-Yin Lee M. Twelve-Month Outcomes With a Resorbable Magnesium Scaffold in a Real-world Setting. Presented at: TCT; Sept 23, 2018; San Diego, USA. ClinicalTrials.gov: NCT02817802 (n=2054; first 400 patients presented); 2. Composite of cardiac death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (CD-TLR) and CABG. Peri-procedural MI according to SCAI definition and spontaneous MI according to the Extended Historical definition; 3. One patient with an MI experienced a TLR as well. For TLF rate calculation time to first event is taken into consideration; 4. Patient underwent MIDCAB with subsequent DAPT interruption 5 days after the procedure. Same patient had a scaffold thrombosis and target vessel MI; 5. Haude M, Ince H, Kische S, et al. 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 12-month follow-up- BIOSOLVE-II and BIOSOLVE-III. Journal of the American College of Cardiology. 2017; 70(18). DOI: 10.1016/j.jacc.2017.09.071 n = 184; 6. Haude M, Ince H, Abizaid A. Long-term clinical data and multimodality imaging analysis of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries – BIOSOLVE-II. Presented at: EuroPCR; May 23, 2018; Paris. France; 7. Data pooled analysis of SPIRIT II, SPIRIT III, SPIRIT IV and SPIRIT-II-IV: Stone, G. Everolimus-Eluting Stents: SPIRIT and PLATINUM Update. Presented at: TCT; Oct 22-26, 2012; Miami, USA. ClinicalTrials.gov: NCT00180310, NCT00180479, NCT00307047 (n = 3,350); 8. Data from EVOLVE FIM and EVOLVE FHU 24m: Meredith I, Verheye S, Weissmann N, et al. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013; 9: 308-315 (n = 291).

* Kaplan Meier failure estimate analysis.
All events have been adjudicated by a clinical event committee.
Xience is a registered trademark of Abbott Cardiovascular Systems/Synergy is a registered trademark of Boston Scientific.

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