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...
Courtesy of the SBHCI. This is the first randomized study comparing a durable-polymer drug-eluting stent (zotarolimus-eluting stent Onyx) and a polymer-free drug-eluting stent (biolimus-A9-coated stent BioFreedom), with only one month of dual antiplatelet therapy in patients at high risk for bleeding. Onyx ONE was a study conducted at 84 sites that randomized 1:1 2000 total patients at...
Courtesy of Dr. Carlos Fava. Peripheral vascular disease in lower limbs is on the rise. Antegrade recanalization is associated with amputation and death, and therefore contraindicated. For a while we have been using the retrograde access when classic revascularization is not possible. Even though there is evidence in favor of this access, it is just...
Angina persistence or recurrence after PCI can affect between 20 to 40% of patients in the short and mid-term. This might be true despite PCI optimization using FFR, intravascular ultrasound and the latest generation stents. This problem is associated with high healthcare cost, which can double in patients with recurrent or persistent angina compared against...
Cost and time are the two main enemies of intravascular imaging, but lack of expertise may also play a role. A new European Association of Percutaneous Cardiovascular Interventions (EAPCI) expert consensus statement released at EuroPCR 2019 argues that there is a need for more use of intracoronary imaging in settings of acute coronary syndromes and...
Courtesy of Dr. Carlos Fava. At present, the transfemoral is the preferred access site in TAVR, for it has been shown to present fewer complications. However, whenever not feasible, we can resort to other approaches. These include the subclavian, the transapical, the transcaval, the transaortic, and the transcarotid. This last one has been studied few...
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...
Both studies followed beyond 5 years patients with severe aortic stenosis who had undergone transcatheter aortic valve replacement (TAVR). Findings included low rates of significant valve degeneration and failure, in both cases. While data on the long-term degeneration of transcatheter-implanted valves are scarce, follow-up from the NOTION trial of low-risk patients and from the UK TAVI...
1- What’s New in the European Guidelines on Peripheral Arterial Disease Since the last version of the European guidelines on the diagnosis and treatment of peripheral arterial disease in 2011, there have been many trials and registries that warrant guideline adjustments in many aspects. The first novelty is the teamwork that gave way to these...
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...