Background: Randomized evidence suggested improved outcomes in fractional flow reserve (FFR) guidance of coronary revascularization compared to medical therapy in well-defined patient cohorts. However, the impact of FFR-guided revascularization on long-term outcomes of unselected patients with chronic or acute coronary syndromes (ACS) is unknown.
Aims: The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided vs.
Randomized trials suggest benefits for fractional flow reserve (FFR)-guided vs. angiography-guided treatment strategies in well-defined and selected patient cohorts with acute coronary syndromes (ACS). The long-term prognostic value of FFR measurement in unselected all-comer ACS patients, however, remains unknown.
View Article and Find Full Text PDFEur Heart J Suppl
November 2022
Healthcare has entered a brave new world in the early part of the 21st century: the landscape has changed and continues to change rapidly, evolving at a rate as never seen before. Fuelled by technological advancement, big data analytics, and the explosion of apps and sensors, as well as by telemedicine and remote monitoring needs driven by the COVID-19 pandemic, the healthcare ecosystem is metamorphosing literally before our eyes. So, what is the role for the Medtech industry as healthcare systems reshape themselves to address emerging patients' needs and desires, and how can the use of data and novel technologies be leveraged to bring about the kind of change needed to deliver truly holistic patient care?
View Article and Find Full Text PDFThe global COVID-19 pandemic has led to unprecedented change throughout society. As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world.
View Article and Find Full Text PDFAims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios.
Methods And Results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration.
Background: A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.
Methods And Results: One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial.
Background: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies.
Methods: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) versus the TAXUS Paclitaxel Eluting Coronary Stent System (TAXUS(R) PECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different epicardial vessels. Three hundred patients with evidence of myocardial ischaemia were allocated to stent implantation with an everolimus-eluting stent (n=223) or a paclitaxel-eluting stent (n=77).
Background: The ACHIEVE Paclitaxel Eluting Coronary Stent System (CSS) is a non-polymeric paclitaxel coated stent loaded with a dose density of 3.0 microg/mm2 stent surface area. DELIVER II set out to evaluate the use of this stent in the treatment of patients with coronary lesions with a higher risk of revascularization including chronic total or sub-total occlusion, small vessel, bifurcated, and long lesions, multivessel disease, and restenotic lesions.
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