The use of drug-coated balloons (DCB) offers the advantage of avoiding permanent stent implants, thus reducing the incidence of in-stent restenosis (ISR), neoatherosclerosis, and late in-stent thrombosis. Additionally, the use of DCB reduces the duration of dual antiplatelet therapy. Current evidence supports the use of DCB for ISR treatment (Class I) compared with drug-eluting stents…
EMINENT Trial | Stent Eluvia vs BMS in Femoropopliteal Territory
Endovascular therapy in femoropopliteal territory has become the standard, mainly with self-expanding stents, aimed at preventing early vascular recoil and late constrictive remodeling. Randomized studies have shown that the use of Paclitaxel drug eluting stents (DES) reduces the number of new revascularizations (even though these studies compared mostly against conventional balloons, which is why we…
The New Sirolimus Eluting Balloons Are Also Effective
The technological development of drug eluting stents has allowed us to treat increasingly complex patients, with around 10% stenosis and using more, and longer stents. This situation generates a great challenge: keep using stents or use paclitaxel coated balloons (PCB). At present, there are sirolimus drug coated balloons (SCB), but we do not have enough…
IN.PACT Global: Follow Up of Real-Life Patient in Femoropopliteal Territory
Drug coated balloons (DCB) emerged as an innovative treatment approximately 10 years ago. Since then, numerous randomized studies have shown their effectiveness and benefit in femoropopliteal territory, and even though the use of paclitaxel coated balloons has been called into question, a retrospective study including 168,553 patients was able to show paclitaxel coated balloons were…
Using Biolimus-Coated Balloons for Treating Small-Vessel Disease Yields Promising Results
Drug-eluting balloons have demonstrated safety and effectiveness in the treatment of small-vessel coronary artery disease and in-stent restenosis. However, randomized studies were performed using paclitaxel. Several studies have shown that using biolimus, a semisynthetic analog of sirolimus, optimizes drug delivery in both stents and balloons. The aim of this randomized, multicenter study was to evaluate…
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…
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…
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…
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…
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…