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…
EuroPCR 2019 | Stent Firehawk Continues to Show Good Results at 2 Years vs. Xience
This device, an abluminal groove-filled biodegradable-polymer sirolimus-eluting stent manufactured in China, showed very similar efficacy and safety to the “gold standard” everolimus eluting Xience at 2-year follow up, according to the TARGET outcomes, presented yesterday at the EuroPCR 2019 and simultaneously published in J Am Coll Cardiol Intv. The device, which is manufactured in China…
EuroPCR 2019 | BASKET-SMALL 2: Drug-Coated Balloons vs. DES in Small Vessels
This angiographic substudy supports the safety of drug-coated balloons in small vessels. Despite better angiographic outcomes, there were eight cases of stent thrombosis among drug-eluting stent (DES) patients, while there was none with drug-coated balloons. In patients with small vessels, using a drug-coated balloon appears safe and comparable to DES, with favorable angiographic outcomes at…
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…
EuroPCR 2019 | BIO-RESORT and SCAAR Registry: Ultrathin Struts Also in Small Vessels pequeños
Data from randomized studies are also supported by the SCAAR registry, in which ultrathin-strut stents show real-world advantages. Patients with small vessels who received ultrathin-strut stents are less likely to undergo revascularization at 3 years than those who received first-generation thin-strut devices, according to the BIO-RESORT trial, presented during the first day of the annual…
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…
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…
Drug eluting Stents vs. Drug Coated Balloons for In-Stent Restenosis
The rationale behind the decision to not add another layer of metal to the artery sounded attractive and this was what paved the way for drug coated balloons as an alternative strategy to treat in-stent restenosis. “We’ve already got a stent in place, we only have to dilate and leave the drug” is what we…
Abluminal Sirolimus and luminal CD34 antibody layer: Is COMBO the Future of Stents?
This large cohort of patients treated with the dual therapy COMBO stent has showed excellent outcomes after one year (MASCOT Post Marketing Registry). Long term follow up is still ongoing. The COMBO stent is a new device with an abluminal sirolimus biodegradable polymer and a luminal layer of antibodies that promotes endothelial healing (anti CD34+)…
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…