The aim of this study was to evaluate the safety and efficacy of coronary orbital atherectomy system Diamondback to prepare de novo lesions severely calcified to stent implantation. This orbital atherectomy system is the first approved by the FDA to treat this type of injury, so the study had no control group. The rate of…
APPOSITION IV: self-expanding DES in acute coronary syndrome
This study was designed to compare the apposition and neointimal coverage of struts by optical coherence tomography (OCT) of the new self-expanding sirolimus eluting stent (STENTYS SES) at 4 and 9 months in patients with STE-ACS. 152 patients randomized to STENTYS SES (n = 90) versus zotarolimus-eluting balloon-expandable stent (n = 62) were included. The…
ROBUST: Routinely use of OCT in primary angioplasty with DES showed no benefit
This work aimed to evaluate the use of optical coherence tomography (OCT) to guide the drug-eluting stent implantation during primary angioplasty. 201 patients experiencing STEMI to use or not OCT during primary angioplasty were randomized. The clinical and angiographic characteristics were well balanced, and no differences in MACE, cardiac death, TLR, or stent thrombosis at…
TRYTON: dedicated stent for bifurcations not inferior than the provisional technic
This study compared the clinical and angiographic results of the use of the provisional stent technique versus the 2 stents technique (TRYTON device at the side branch) in true bifurcations. The study with non-inferiority design, randomized 704 patients in total to drug-eluting stent in the main branch plus the TRYTON device in the side branch…
COBRA: culotte technique versus self-expanding dedicated stent to treating bifurcations
This work compared the safety and efficacy of the culotte technique versus the use of self-expanding Biolimus A9 (AXXESS) eluting stent evaluating the healing of the vessel by OCT besides quantitative angiography and clinical events. In one, group (n = 20) bifurcated stent system AXXESS plus everolimus-eluting stents in the main distal branch and side…
MITRAL: First cases of Transcatheter Mitral Valve Implantation (TMVI)
Severe mitral regurgitation is three times more prevalent than aortic stenosis in the elderly population at high risk and poor prognosis if not treated. Fortis mitral valve was designed using several preclinical models and are now tested for the first time in 4 patients resulting in various technical difficulties and finally the death of 3…
BABILON: Pharmacological balloon to treat the lateral branch in coronary bifurcations
The paclitaxel-eluting balloon could be an option to minimize the side branch restenosis in coronary bifurcations. In this study, the angiographic and clinical outcomes of paclitaxel-eluting balloon plus conventional stent versus DES in bifurcation “de novo” lesion were compared. This multicenter study included 108 patients randomized to sequential dilation of the main branch and the…