Aims: The AXXESS stent is a nitinol self-expanding Biolimus A9™ eluting stent that deploys at the carina, providing easy access to the distal branches. The aim of this study was to evaluate the acute performance of the device and the type of strategy intended.
Methods and results: A total of 24 consecutive patients (67±9 years, 70% men, 45% diabetic and 25% with previous revascularisation procedures) were included in our centre. The clinical presentation was ACS all cases (37.5% NSTEMI, 16.8% STEMI). The access was 95.8% by radial approach (7 Fr). The bifurcation treated was: 75% LAD-diagonal; 4.2% CX-marginal; 4.2% RCA-PDA; 16.7% LM-LAD-CX. There were 83.4% of true bifurcations lesions. The most frequent type was Medina 1,1,1 (79.2%), followed by 1,0,0 (12.5%), 0,1,1 (4.2%), 0,1,0 (4.2%). The bifurcation angle was less than 70º in 79.2% of patients. In 37.5% only an AXXESS was implanted, 29.2% AXXESS +MB stent, 20.8% AXXESS +SB stent and in only 12.5% were necessary implant AXXESS +MB+SB stents. Sixteen (16) patients had multivessel disease (66.6%) and complete revascularisation was performed in 95.8% of patients. Antiplatelet therapy was 79.2% clopidogrel, 16.7% ticagrelor and 4.2% prasugrel. Most of the lesions were (70.8%) highly calcified and 45.8% (n=11) long lesions. Only a 4.2% (n=1) of CTOs were treated with AXXESS s. We passed a wire to protect the SB in 91.7% of cases. Differently from what is recommended in the IFU’s, we implanted the device over the MB, irrespective of the angulation. Predilatation was done in all cases (25% MB only; 4.2% SB only; 70.8% MB+SB), and the most frequently diameter used was 2.5 and 3 mm (mean 2.6 mm) by 10 mm of length. Balloon PTCA on SB was done in 91% and SB stenting was needed in 25% of cases using a mean stent diameter of 2.79 with a mean length of 16.5 mm. MB distal stent was performed in 50% of cases with a mean diameter of 2.8 mm and with a length of 21.1 mm. All stents used were biolimus eluting stents. Post-dilatation was done in 95.8% (50% MB+SB; 45.8% MB only), and the mean diameter was 3.2 mm, using pressures higher than 16 atm in most lesions (86%). Final kissing was performed in 41.7% of patients. Intracoronary imaging techniques were performed pre-PCI in 4.2% and post PCI in 45.8% (25% OCT vs. 20.8% IVUS). The most frequent diameter used for AXXESS was 3.5 mm (62.5%) and the most frequent length was 14 mm (70.8%). Implant success was achieved in 93.1% of patients. At the end of procedure in 8.3% the SB remain with dissection, but with TIMI 3 flow. In two cases of LMCA bifurcation, the stent was not implanted because the excessive angle prevented it from stabilising, and finally we needed to retrieve them. During a mean follow-up of 203±113 days there was a MACE rate of 8.4% (1 non-CV death and 1 restenosis of SB).
Conclusions: In our series, the AXXESS stent performed well, offering a unique approach to bifurcation treatment. Those with angles wider than 70º should be avoided, as stabilising the stent is far more difficult. |
