A drug-eluting stent outperformed bare-metal stents for treatment of patients with lesions in the superficial femoral and proximal popliteal arteries, according to results of the EMINENT trial presented at VIVA 21.
In this multicentre ISR registry, OCT imaging demonstrated that eGFR, the time from PCI to the ISR and DES-ISR were independent predictors for neoatherosclerosis and that neoatherosclerosis in ISR lesions had a worse impact on the CD-TLR rate.
In patients with complex peripheral artery disease, a drug-coated balloon performed similarly to how it did in the general PAD population, according to new data from the IN.PACT Global registry.
According to a news release, 88% of patients exhibited freedom from target lesion revascularization (TLR), while 79% demonstrated amputation-free survival (AFS). The rate of wound healing was 79%, while 79% of patients improved their Rutherford score by at least one category as the 18-month results were sustained from the six-month and 12-month data.
The advantage of biodegradable-polymer drug-eluting stents (BP-DES) versus durable-polymer (DP) DES remains uncertain. We compared neointimal formation and endothelial barrier function of new BP sirolimus-eluting stents (BP-SES, BuMA Supreme®) to other contemporary BP-DES, DP-DES, and bare metal stents (BMS).
Boston Scientific Corporation (NYSE: BSX) announced positive data for the Eluvia™ Drug-Eluting Vascular Stent System (Eluvia stent) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Data presented included one-year results from the EMINENT trial, which demonstrated superiority of the Eluvia stent compared to self-expanding bare metal stents (BMS) for the treatment of patients with peripheral artery disease (PAD) and superficial femoral artery (SFA) or popliteal artery (PPA) lesions up to 210 mm in length. The study enrolled 775 patients, making it the largest randomized trial of a drug-eluting stent for the treatment of PAD to date.
Data from the two- year results of the RANGER II SFA randomized controlled trial confirmed the safety and efficacy of the Ranger Drug-Coated Balloon (DCB) compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Two-year data demonstrate continued high rates of primary patency, including in patients with complex lesions. Boston Scientific announced the positive results during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.
During stenting, endothelial cells are partially to completely destroyed or crushed along with medial wall injury and stretching promoting activation of platelets, and thrombus formation accompanied by inflammatory reaction. Macrophages and platelets play a central role through the release of cytokines and growth factors that induce vascular smooth muscle cell accumulation within the intima. Smooth muscle cells undergo complex phenotypic changes including migration and proliferation from the media towards the intima, and transition from a contractile to a synthetic phenotype; the molecular mechanisms responsible for this change are highlighted in this review.
Multimodal evaluation of endothelial coverage and permeability showed different endothelial healing pattern in three DESs and BMS. Overall, BP-SES potentially has rapid endothelial functional recovery as compared to DP-EES. Long-term clinical studies to examine late outcomes in patients receiving BP-SES vs DP-EES are needed.
Enhancements to the new Orsiro system include a re-engineered delivery system as well as a new deep embedding process.
The new generation of drug-eluting stents have metallic platforms with thinner struts, associated with significantly less stent thrombosis. Shortened DAPT has been investigated with these stents, with evidence from randomised clinical trials for some individual stents showing non-inferior safety and efficacy outcomes. This has to be balanced by the effect of DAPT on secondary prevention of systemic cardiovascular disease especially in high-risk populations. This review will outline the current evidence for individual stents with regards to DAPT duration for both acute coronary syndrome and chronic coronary syndrome and discuss further directions for research and personalised medicine in this contemporary percutaneous coronary intervention era.
The term "theranostic nanomaterials" refers to a multifunctional agent with both therapeutic and diagnostic abilities. Theranostic nanoparticles can provide imaging contrast for a diversity of techniques such as magnetic resonance imaging (MRI), positron emission tomography (PET) and computed tomography (CT). In addition, they can treat CVD using photothermal ablation and/or medication by the drugs in nanoparticles. This review discusses the latest advances in theranostic nanomaterials for the diagnosis and treatment of CVDs according to the order of disease development. MRI, CT, near-infrared spectroscopy (NIR), and fluorescence are the most widely used strategies on theranostics for CVDs detection. Different treatment methods for CVDs based on theranostic nanoparticles have also been discussed.
Interventional cardiologists implant stents every day. Stents are also used in numerous other medical disciplines such as plastic surgery, gastroenterology, urology, and oral and maxillofacial surgery.1–5 Uses range from rebuilding mandibles and other oral surgical procedures, constructing new ureters, keeping skin flaps, and as biliary conduits.6–11 What is the source of this word stent everyone is using in daily practice? This article describes the origin of the word, how it became so popular, its use in medicine outside the cardiovascular system, and the people who used this term first.
Covered self-expandable metal stents (CSEMS) are often used for palliative endoscopic biliary drainage; however, the unobstructed period is limited because of sludge occlusion. The present study aimed to evaluate the biosafety of a novel poly(2-methoxyethyl acrylate)-coated CSEMS (PMEA-CSEMS) for sludge resistance and examine its biosafety in vivo.
Bioresorbable stents (BRS) are safe and effective, the state-run Sri Jayadeva Institute of Cardiovascular Sciences and Research has found during a multi-centre pan-India study with 108 patients.Once the vessel blockage is treated and healed, the BRS dissolves fully and leaves the artery in its natural state with no foreign residue. This offers physicians and patients room to explore future treatment intervention in the same blood vessel if needed. In contrast, the drug-eluting stents (DES), currently in use, stay permanently in the heart’s blood vessels. They could hinder future procedures performed in the same artery. Patients are followed up for three years.
TWILIGHT-Stent is a sub-study of the TWILIGHT trial, a randomised, placebo-controlled trial, conducted in patients for whom the treating clinician intended to discharge on ticagrelor plus aspirin following successful percutaneous coronary intervention (PCI) with at least one locally approved drug-eluting stent.
Boston Scientific recently announced a clinical trial of its AGENT drug coated balloon. The device is coated with paclitaxel, an anti-restenotic drug, and aims to deliver the medication to the affected vessel wall during a percutaneous procedure. Coronary in-stent restenosis (ISR) is caused by occlusive scar tissue that develops in the stented portion of a vessel.
MedAlliance, with its Japanese partner MDK Medical, has completed enrolment in the clinical study of its novel sirolimus drug-eluting balloon (DEB), Selution SLR, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) in June 2020.
Charles Dotter came up with the idea of angioplasty, opening blockages from inside an artery using catheters and avoiding open surgery. Although he had success in peripheral arteries, his idea was rejected by vascular surgeons in the U.S. as “crazy.” But the idea traveled via Eberhard Zeitler and others to Europe, where a young angiologist, Andreas Grüntzig, made this crazy idea work in the coronaries.
For coronary in-stent restenosis (ISR), drug-coated balloons (DCB) appear to perform just as well over the long term as thin-strut drug-eluting stents after accounting for differences in patient characteristics, Polish registry data suggest.
At present, calcified coronary arteries are typically treated using high pressure balloons, which can sometimes struggle to disrupt calcified deposits and the high pressure involved can pose safety issues. Other techniques include using small drills to chip the calcium away, but these are difficult to use safely and the small pieces of calcium that are dislodged can cause blockages elsewhere.This latest technology, which has recently been FDA approved for use in the US, applies sonic waves to crack the calcium, allowing subsequent low-pressure expansion of the artery and stent placement. The company claims that the technique is safer and easier to use than many existing approaches, and has recently validated the safety and efficacy of the Shockwave Coronary IVL System in the DISRUPT CAD III study.
The study findings showed noninferiority of the abbreviated DAPT cohort compared to the standard DAPT cohort in terms of both net adverse clinical events (NACE) and major adverse cardiovascular events (MACE). However, adds Valgimigli, “we were able to prove superiority” with respect to the third co-primary endpoint—major or clinically relevant non-major bleeding.These “clear-cut” findings indicate that one month DAPT is “becoming the standard of care” for patients undergoing PCR in and where a HBR feature is present. “We have shown that there is no penalty to pay with respect to ischaemic events by reducing DAPT duration down to one month”, concludes Valgimigli.
The design of the Chocolate® balloon catheter includes a braided catheter shaft designed to provide robust push to reach and cross lesions, grooves to allow for plaque release, minimizing traumatic angioplasty effect, pillows to provide predictable vessel dilation without cutting or scoring, the tapered tip to enable lower entry profile for optimal lesion access and a nylon, semi-compliant balloon to allow for optimal balloon pillow formation. Nitinol-constraining structure shields vessel wall from shear (torsional) stress caused by balloon unfolding, enables the even distribution of radial and longitudinal forces during balloon inflation, and allows for rapid deflation and uniform rewrap.
DCB has differential relative efficacy between BMS-ISR and DES-ISR. In DES-ISR patients, DCB was associated with lower MLD, higher percent diameter stenosis, more binary stenosis, and higher rate of TVR and TLR. However, for BMS-ISR, no significant difference was found between DCB and EES. More high-quality randomized trials are needed to further evaluate the role of DCB for the treatment of ISR, especially in patients with DES-ISR. The potential mechanisms of the varying efficacy between BMS-ISR and DES-ISR for DCB need to be further investigated.
Coronary stents improve immediate and late results of balloon angioplasty by tacking up dissections and preventing wall recoil. These goals are achieved within weeks after angioplasty, but with current technology stents permanently remain in the artery, with many limitations including the need for long-term antiplatelet treatment to avoid thrombosis. We report a prospective multicentre clinical trial of coronary implantations of absorbable magnesium stents.
This is the largest DEB study ever initiated, with over 3,300 patients to be enrolled at approximately 50 sites in 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate, at both one and five years, non-inferiority and subsequently superiority for target vessel failure (TVF).This study is designed to change medical practice, as the majority of denovo coronary vessels are currently treated with a permanent metallic stent. The SELUTION SLR elutes sirolimus for over 90 days, similar to a DES, but without leaving behind a metal scaffold, which has been associated with a complication rate of 2% annually.
Results show that a cyclic damage model predicts a non-physiological, overly proliferative response, whilst the instantaneous model demonstrates that lumen loss may be regulated by re-endothelialisation.
At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.