Author + information
- Stefano Galli1,
- Piero Montorsi1,
- Sarah Troiano1,
- Altin Palloshi2,
- Claudio Rapetto3,
- Franco Fabbiocchi4,
- Giovanni Teruzzi1,
- Massimo Leoncini3,
- Michele Bianchi5,
- Paolo Mario Ravagnani1 and
- Antonio Bartorelli6
- 1Department of Clinical Sciences and Community Health, Centro Cardiologico Monzino, IRCCS, Milan, Italy, Milan, Milan, Italy
- 2ICCS, Milano, Milan, Italy
- 3Cardiologia Invasiva Endovascolare, Sanremo, Imperia, Italy
- 4Centro Cardiologico Monzino, IRCCS, Milan, Milan, Italy
- 5Istituto Clinico Città Studi, Milan, Milan, Italy
- 6University of Milan, Milan, Milan, Italy
Evaluation of new magnesium bioabsorbable scaffold (Magmaris) in de-novo coronary, in initial experience centers.
89 patients with 93 coronary de-novo lesions were enrolled from 3 Italian centers. All lesions were treated with Magmaris bioabsorbable scaffold (manufactured by Biotronik, Bülach, Switzerland). To implant Magmaris was mandatory to follow PSP rule: NC balloon 1:1 predilatation, correct sizing (IVUS or OCT suggested) and NC balloon post-dilatation. DAPT per protocol was for at least 6 months, but 12 months was suggested. Procedural, clinical-angiographic results and MACCE (Cardiac/Non- death, MI, stroke, TLR and stent thrombosis (ST) are collected at 1, 6 and 12 months.
Clinical characteristics were: mean age 61.1+/9.7 years; male 85% and 21% were diabetics. PCI was elective in 84% due to stable angina or silent ischemia and NSTE-ACS in 16%. 93 de-novo lesions, in reference diameter of 2.7 to 4.2 mm, were located 44% in LAD, 27% in LCx and 26% in RCA, respectively. In 4 pts were treated 2 vessel and in other 3 pts 2 Magmaris in overlapping were implanted. Lesion length was 15.1±6.3 mm, % diameter stenosis was 81.9±10.4%. Predilatation was performed in all cases with 1:1 NC balloon at 15.8±3.25 atm; scaffold mean diameter was 3.28±0.25 and mean scaffold length was 20.4±3.9: Post dilatation was performed in all cases with NC balloon, mean diameter 3.56±0.41 inflated at 18.6±3.2 atm. Diameter of post-dilatation balloon was > 0,5 mm to avoid scaffold oversized limits. All Magmaris were successfully deployed and imaging guidance (OCT/IVUS) was used in 56% of the cases. Procedural success rate was 100% (93/93 les.) and clinical results 97% (87/89 pts) due MI Tn-I elevation. At 30 day no MACCE was observed. At mid-term F/U (completed in 50%) were observed 1 NSTEMI due to scaffold thrombosis at 3 months and 1 case of ISR, both treated successfully with DES in scaffold. Overall Event-free survival at 6 months was 4,6% (2/43 pts).
Initial experience with Magmaris in de-novo lesions, with PSP rule and high imaging guidance, confirmed efficacy and safety observed in the controlled-studies. Preliminary results will be confirmed in large series and complex lesions.
CORONARY: Bioresorbable Vascular Scaffolds