Tag Archives: paclitaxel

ELUVIA: DES en territorio femoropoplíteo con lesiones complejas

ELUVIA: DES in Complex Femoropopliteal Lesions

ELUVIA: DES in Complex Femoropopliteal Lesions

Paclitaxel-eluting stent Eluvia showed promising results after two years with a revascularization freedom rate of 80% despite the fact that these were complex femoropopliteal lesions. As the safety of paclitaxel-eluting devices becomes more consistent, more studies on its efficacy are being published. Back in 2018, the safety of paclitaxel-eluting balloons and stents was under scrutiny

SAFE-PAD: Dispositivos liberadores de paclitaxel en enfermedad periférica

ACC 2021 | SAFE-PAD: Paclitaxel-Eluting Devices in Peripheral Disease

This work was conducted alongside the US Food and Drug Administration (FDA) to investigate the association between all-cause mortality and paclitaxel-eluting devices in peripheral vascular disease. According to data from SAFE-PAD, presented at the American College of Cardiology (ACC) 2021 Congress and simultaneously published in JAMA, there is no increase in mortality compared with conventional

balon farmacologico

Drug-Coated Balloons in Critical Ischemia: The Paradigm of Randomized Evidence vs. Logbooks

This research, which included thousands of patients treated for chronic inferior limb ischemia with drug-coated balloons, did not show an association between said devices and the increased mortality observed in some randomized trials.  The long-term evidence from plenty of real-world patients contradicts what has been shown in randomized trials, leaving an information gap. Endovascular revascularization

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IN.PACT AV ACCESS | Drug-Coated Balloons for Dialysis Fistulas

The IN.PACT AV Access study, recently published in the New England Journal of Medicine (NEJM), showed that drug-coated balloons are superior for the treatment of stenotic lesions in arteriovenous fistulas for dialysis compared with conventional balloons. Dialysis fistulas are an unknown territory for paclitaxel-eluting balloons, since the formal recommendation in the guidelines is conventional angioplasty

Los balones farmacológicos pasaron la prueba del tiempo en territorio femoropoplíteo

Drug-Coated Balloons in Infrapopliteal Disease: Much Ado About Nothing

The revascularization of tibial arteries in patients with critical lower limb ischemia using drug-coated balloons vs. conventional angioplasty resulted in comparable long-term outcomes in terms of both safety and efficacy. Paclitaxel exposure was not related to a higher risk of amputation or all-cause mortality at 5 years (which is the good news for much questioned drug-coated

balon liberador de paclitaxel eficacia a largo plazo

Felling Reassured with Paclitaxel Coated Devices in Peripheral Artery Disease

This big analysis shows rapid absorption of paclitaxel coated devices for PCI in femoropopliteal territory, which reassures us about its alleged association to increased mortality. In fact, survival, amputation-free survival and cardiovascular events rate resulted better with paclitaxel coated devices in the treatment of chronic limb ischemia.  This study emphasizes the difference that might exist

Seguridad de los balones con paclitaxel en enfermedad vascular periférica

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

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