Metallic limus-eluting stents abluminally coated with biodegradable polymers: angiographic and clinical comparison of a novel ultra-Thin sirolimus stent versus biolimus stent in the DESTINY Randomised Trial

AIMS:To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.METHODS:This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.RESULTS:After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.CONCLUSIONS:The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry

OBJECTIVE:To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry.BACKGROUND:Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular accessthrough complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described.METHODS:The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year.RESULTS:A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in thepercutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year.CONCLUSION:Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI.

Predictors and impact of myocardial injury after transcatheter aortic valve replacement: a multicenter registry

BACKGROUND:Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown.OBJECTIVES:This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR.METHODS:This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up.RESULTS:Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all)...