Tag Archives: paclitaxel

Seguridad de los balones con paclitaxel en enfermedad vascular periférica

Safety of Paclitaxel-Coated Balloons in Peripheral Vascular Disease

Safety of Paclitaxel-Coated Balloons in Peripheral Vascular Disease

Everybody keeps wondering whether drug-coated balloons can actually increase mortality. If that is the case, there is an even harder question in need of an answer: what would be the physiopathology for such increase in mortality? As a lukewarm message, the US Food and Drug Administration recommended a special informed consent form when these devices

Los balones farmacológicos pasaron la prueba del tiempo en territorio femoropoplíteo

Drug Coated Balloons vs. Drug Eluting Stents in Primary PCI

There might come the time when we are finally able to leave nothing behind, at least in the context of primary PCI. The REVELATION study, soon to be published in J Am Coll Cardiol Intv, has shown that paclitaxel coated balloons resulted non inferior to drug eluting stents (DES) in terms of FFR (fractional flow

Efecto a largo plazo de los balones liberadores con bajas dosis de paclitaxel

New FDA Updates on Paclitaxel Device Outcomes

A new FDA letter confirms late mortality signal with paclitaxel eluting stents and paclitaxel coated balloons in peripheral territory. Even though this recently published letter confirms data, there are no new recommendations on the use of these devices. After careful consideration of their own analyzis outcomes and a 2-day discussion of an advisory panel especially

Efecto a largo plazo de los balones liberadores con bajas dosis de paclitaxel

Mortality and Paclitaxel Devices, Data Are Aligning

5 years ago, several prospective randomized studies confirmed paclitaxel coated balloons were safe and effective in femoropopliteal territory. However, a recently published meta-analysis of heterogeneous studies including both paclitaxel coated balloons and drug eluting stents has linked these devices to mortality. In addition, higher doses were associated to higher mortality, both at 2 and 5

ivascular

EuroPCR 2019 | EFFPAC: New Peripheral Paclitaxel Coated Balloons, Efficacy with no Sign of Mortality

Paclitaxel coated balloons in peripheral territory have been under the spotlight for alleged increased mortality, which even though not observed in this study, experts insist, calls for new studies with enough statistical power. Compared against plain balloon angioplasty, paclitaxel coated balloons resulted in improved patency and less revascularization at 24 months in superficial or popliteal

REVELATION: Balones liberadores de droga en infartos con supradesnivel del segmento ST

EuroPCR 2019 | REVELATION: Drug Coated Balloons in ST Elevation MI

Drug coated balloons in the context of ST elevation acute myocardial infarction seem safe and feasible under certain circumstances. This single center study is the kickoff to keep studying the possibility of “leaving nothing behind” after primary PCI. This small randomized study revives drug coated balloons to be used particularly instead of stents in young

Los DES de última generación presentan mejores resultados en puentes venosos que los DES antiguos y BMS

Drug-Eluting Stents vs. Balloons While Paclitaxel Is in the Eye of the Storm

Even after the US Food and Drug Administration (FDA) issued an alert on paclitaxel devices in patients with femoropopliteal artery disease, which caused the interruption of a few ongoing studies, reality indicates that the efficacy of these devices has been proven and that they are still used. The increased mortality observed in the meta-analysis that

Los balones farmacológicos pasaron la prueba del tiempo en territorio femoropoplíteo

FDA Alert on Drug-Coated Balloons and Stents in Femoropopliteal Artery Disease

The US Food and Drug Administration (FDA) has issued an alert on the potential long-term risk of paclitaxel-coated balloons and paclitaxel-eluting stents in patients with femoropopliteal artery disease. This agency is evaluating signals of increased long-term deaths among patients with femoral or popliteal artery disease treated with paclitaxel-coated devices in a recent study.   In

Efecto a largo plazo de los balones liberadores con bajas dosis de paclitaxel

Long Term Effect of Low Dose Paclitaxel Coated Balloon

The beneficial effect of low dose drug coated balloons with paclitaxel is sustained in time according to this randomized study. In a nutshell, this study has shown a significant statistical difference in favor of paclitaxel coated balloons vs. conventional PCI at 2 years. The safety and efficacy of new generation low dose drug coated balloons

imperial-TCT 2018

TCT 2018 | IMPERIAL: First Study Comparing Drug-Eluting Stents in Patients with Femoropopliteal Disease

The IMPERIAL trial compared the safety and efficacy of a nitinol self-expanding polymer-free placlitaxel-eluting stent (Zilver PTX, Cook Medical, already approved by the US Food and Drug Administration [FDA]) and a nitinol self-expanding polymer-coating placlitaxel-eluting stent (Eluvia, Boston Scientific). This was a single-blind randomized trial in patients with symptomatic intermittent claudication (Rutherford categories 2, 3, or

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