Author + information
- Enrico Cerrato1,
- Salvatore Geraci2,
- Dario Buccheri3,
- Cristina Rolfo4,
- Giorgio Quadri4,
- Fabio Mariani1,
- Francesco Tomassini4,
- Fabio Ferrari1 and
- Ferdinando Varbella4
- 1Interventional Cardiology Unit , San Luigi Gonzaga University Hospital, Orbassano and Infermi Hospital, Rivoli, Turin, Turin, Italy
- 2San Giovanni di Dio Hospital, Agrigento, Agrigento, Italy
- 3Interventional Cardiology Unit, San Giovanni di Dio Hospital, Agrigento, Italy, AGRIGENTO, Agrigento, Italy
- 4Interventional Cardiology Unit , Infermi Hospital, Rivoli and San Luigi Gonzaga University Hospital, Orbassano, Turin, Turin, Italy
Although recent discouraging data on poly-L-lactic bioresorbable scaffolds (BrS), there is still a strong rationale in scaffold employment for coronary stenosis treatment. New magnesium- made BrS MAGMARIS showed promising results in clinical trials in terms of efficacy and safety nevertheless few data regarding its implantation in real world and complex lesions are available.
All consecutive patients undergoing PCI with implantation of at least one Bioresorbable (BrS) MAGMARIS Scaffolds (BIOTRONIK, Buelach, Switzerland) using a standardized PSP-technique (pre-dilation, proper sizing, and post-dilation) were eligible. Patient were enrolled in two Italian Institution with high volume PCI. Device acute success was defined as 1) successful BRS delivery and implantation 2) post-procedural residual diameter stenosis <30% within the treated segment; 3) restoration of Thrombolysis in Myocardial Infarction (TIMI) grade 3 antegrade flow. In-hospital and thirty-days Major adverse cardiac events (MACE) were evaluated.
Between September 2016 and June 2017, 39 patients were included. They were mainly males (n=31; 79.5%) with a mean age of 59.6±9.4 years and presented lower rate of diabetes (n=9; 23%) and chronic kidney disease (n=4; 10.2%) with preserved Ejection Fraction (56.5±6.9%). Stable CAD (n=18; 46.1%) or ACS/NSTE (n=17; 43.6%) were the most common admission diagnoses. Mean lesion length was 35.3± 21.8 mm treated with a mean of 1.6±1.0 MAGMARIS scaffolds (mean scaffold diameter 3.2±0.2). ACC/AHA type B2/C was 31 (79.5%). BrS predilatation and postidilatation were performed in 100% of cases, using non-compliant balloon in 64% and 100% of cases respectively. Use of intravascular imaging was high (n=29; 74.3%; 26 OCT and 3 IVUS). Provisional bifurcations treatment occurred in 7 (17.9%) cases with side branch balloon dilatation in 2 cases. Marker-to-marker overlapping technique was used 39 times in 19 patients (48.7%). Device acute success was achieved in all cases without any in-hospital MACE. At thirty-days follow-up (available in 79.4%, n=31) two MACE occurred: 1 in-stent restenosis and 1 early subacute stent thrombosis, both successfully treated with DES implantation.
MAGMARIS BrS implantation adopting the PSP-technique is feasible with an high intraprocedural success also in complex lesions. Longer follow-up data and larger samples are required.
CORONARY: Bioresorbable Vascular Scaffolds