Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Two-year outcomes after percutaneous coronary intervention of calcified lesions with drug-eluting stents.

BACKGROUND: Percutaneous coronary intervention (PCI) of lesions with coronary arterial calcification (CAC) is common and has been historically associated with an increased risk of adverse events. Whether the association between target lesion calcification (CAC) and outcomes differ across drug-eluting stent generation or between patients with high vs. low residual platelet reactivity (PR) remains unknown. We assessed the association of CAC with adverse ischemic and bleeding events among patients undergoing contemporary PCI with drug-eluting stents (DES). METHODS: We included all 8582 patients who underwent successful PCI with DES in the prospective ADAPT-DES study. Patients were grouped according to whether or not they had CAC. We used a multivariable logistic regression analysis to determine independent predictors of CAC. We assessed the 2-year risk of major adverse cardiac events (MACE: Death, myocardial infarction, or stent thrombosis) and bleeding by constructing Kaplan-Meier curves and fitting unadjusted and adjusted Cox proportional hazards models. We assessed the influence of DES generation and PR on the effect of CAC on outcomes by including interaction terms in the models. RESULTS: CAC was present in 2644 (30.8%) patients. Age, smoking, hypertension, hyperlipidemia, insulin-treated diabetes, hemodialysis, and peripheral artery disease were independent predictors of CAC. Having a CAC was associated with increased unadjusted and adjusted hazards for 2-year MACE and bleeding. The association between CAC and ischemic outcomes was consistent across DES generations and PR (pinteraction>0.05). CONCLUSION: Contemporary DES PCI of calcified lesions is common and is associated with an increased risk of ischemic and bleeding complications.