EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
The three year follow-up of the randomised "all-comers" trial of a biodegradable polymer biolimus-eluting stent versus permanent polymer sirolimus-eluting stent (LEADERS).
The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES). ⋯ The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.
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Unprotected left main (ULM) coronary artery disease is encountered in 3%-10% of coronary angiograms and is associated with high mortality. The survival of patients with ULM disease presenting with acute coronary syndromes (ACS) depends on different variables and is lowest in those with cardiogenic shock (CS). The aim of the present study was to estimate the impact of baseline characteristics on the subsequent clinical outcome in patients treated by percutaneous coronary intervention (PCI) of ULM for ACS. ⋯ Acute coronary syndrome due to critical ULM stenosis is associated with high mortality even after successful PCI. Patients presenting with CS or STEMI are at particular risk.
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The intra-aortic balloon pump (IABP) is recommended by current guidelines as adjunct in patients with cardiogenic shock, despite the lack of larger clinical trials. We sought to investigate the use and impact on mortality of IABP in current practice of percutaneous coronary interventions in Europe. ⋯ In current clinical practice in Europe, IABP is used only in one quarter of patients with cardiogenic shock treated with primary PCI. However, there was no hint of a beneficial effect of IABP on outcome. Therefore, a large randomised clinical trial is urgently needed to define the role of IABP in patients with PCI for shock.
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Randomized Controlled Trial Multicenter Study Comparative Study
Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus.
Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients. ⋯ The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.
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Randomized Controlled Trial Multicenter Study
Optical coherence tomography (OCT) in PCI for in-stent restenosis (ISR): rationale and design of the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) study.
The optimal treatment of bare metal stent restenosis is still not defined. The most employed contemporary option is the implantation of a drug-eluting stent (DES). However, this procedure implies the addition of a second metal layer in the vessel wall, which is linked to delayed healing. Furthermore, there may be a increased risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stent. These phenomena may give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) have been proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising. ⋯ Currently no prospectively collected data on vessel wall healing after treatment of in-stent restenosis, whether with DES or with DEB, are available. Therefore, the SEDUCE trial will yield pivotal insights on this important topic and guide further optimisation of the interventional treatment for this condition.