Three-months optical coherence tomography analysis of a biodegradable polymer, sirolimus-eluting stent.

OBJECTIVE: We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus-eluting stent with biodegradable polymer. BACKGROUND: New generations of drug-eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers. METHODS: In this prospective, open-label study, 34 patients received an Orsiro® sirolimus-eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT-examination at three months. The primary endpoint was 3-month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months. RESULTS: At 3 months, NIH score was 13.7 (5.4-22), covered struts per lesion were 90% (84-97%), malapposed struts were 2.7% (0.8-5.4%) and rate of mature tissue coverage was 47% (42-53%). No target lesion failure occurred up to 12 months. Patients with OCT-guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8-26.4]; OCT-guided: 9.8% [4.0-15.5]; mean difference -8, [95%CI: -18.7-2.9], P = 0.123). This group had significantly more covered struts per lesion (angio-guided: 86% [82-90]; 95% [92-99]; mean difference 9% [95%CI: 3-15], P = 0.001). CONCLUSION: The Orsiro® sirolimus-eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3-month follow-up. OCT guided stent implantation had a positive impact on early vascular healing.

A randomized trial of bifurcation stenting technique in chronic total occlusions percutaneous coronary intervention.

BACKGROUND: The optimal strategy to treat bifurcation lesions (BFLs) in a percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) remains unknown. AIMS: We sought to assess whether T-provisional or mini-crush is appropriate for BFLs within CTO vessels. PATIENTS AND METHODS: From January 2011 to December 2013, patients who underwent successful CTO guidewire crossing and with a BFL within the CTO target vessel were enrolled prospectively and assigned randomly to either T-provisional stenting or the mini-crush technique for BFL treatment. One-year clinical follow-up was performed. Major adverse cardiac and cerebrovascular events (MACCE) were defined as the composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke. RESULTS: The prevalence of BFLs was 54.3%. A total of 146 patients with BFLs within CTO vessel were enrolled prospectively and assigned randomly to either T-provisional stenting (N=73) or the mini-crush technique (N=73). Angiographic and clinical success rates were similar in the two groups: 91.8 versus 97.2% (P=0.27) and 91.8 versus 94.5% (P=0.67), respectively.Although T-provisional stenting was associated with a nonsignificantly lower incidence of MACCE in case of BFLs located far from the CTO (9.3 vs. 22.2%; P=0.426), the mini-crush technique resulted in higher MACCE-free survival at 1 year in the presence of BFLs within the CTO body or close to the proximal or the distal cap (89.1 vs. 64.9%; P=0.007). CONCLUSION: The mini-crush technique appeared to be associated with improved 1-year clinical and angiographic outcomes, particularly when used to treat BFLs located within the CTO body or close to the proximal or the distal cap.

Mid-term outcome of biolimus-eluting stents with biodegradable polymer: results from a multinational prospective 'all-comers' registry.

BACKGROUND: The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES. AIM: We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention. PATIENTS AND METHODS: A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year. RESULTS: At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS). CONCLUSION: Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.