For patients with symptomatic coronary artery disease, the best course of action often involves implanting a drug-eluting stent into the artery where a plaque buildup is blocking blood flow to the heart. The metallic stent props the artery open while releasing a drug that helps to suppress restenosis — the re-closure of the artery due to excess tissue growth around the stent. However, the body’s response to tissue inflammation and arterial injury around the stent’s edges can still sometimes cause restenosis.
The PIONEER-IV study will involve careful physiological identification of heart blood vessels that need to be treated or deferred. A narrowing located in a coronary vessel is deemed flow limiting if QFR <0.80 . After stenting, the QFR measurement is repeated in the stented vessel(s) to verify the success of the intervention. In case distal QFR is <0.91 or delta QFR (across the stent is >0.05), post-dilatation of stented segment or additional stenting is recommended.
PIONEER IV CHINA 研究由哈尔滨医科大学第二医院于波教授担任研究主席及首席研究者。该研究是一项前瞻性、多中心、单组目标值上市后临床研究，计划纳入1555例受试者数据，其中在中国入组285例患者（含OCT亚组80例），研究计划在受试者入组后进行三年随访，主要终点是观察PCI术后12个月随访时患者的相关复合终点（PoCE：Patient-oriented Composite Events，PoCE定义为：全因死亡，全因卒中，全因心梗，全部临床或生理学驱动的血运重建），所有受试者植入HT Supreme DES，术后均采用1个月DAPT（阿司匹林+替格瑞洛）+11个月替格瑞洛作为常规抗血小板用药方案。
As newer-generation drug-eluting stent (DES) technologies continue to raise the bar for the treatment of coronary artery disease (CAD), offering improved rates of target lesion failure (TLF), low levels of stent thrombosis, and benefits in revascularisation compared to earlier-generation devices, the search for the next frontier in DES innovation becomes ever more challenging for device manufacturers.
Compared with 12-month DAPT, clopidogrel monotherapy after 3-month DAPT showed comparable cardiovascular outcomes in patients undergoing PCI.
The results suggest that CathPCI Registry data could be used to support future clinical trials, decreasing the burden of data collection on sites participating in both trials and the registry. However, variables that could be considered more subjective, such as clinical presentation, would likely need to be defined more precisely. Future trials leveraging the CathPCI Registry would also need to ensure that the key data elements are suitable to answer key trial questions.
Researchers at the Korea Institute of Science and Technology have developed a technique to coat implantable materials, such as stents, with extracellular matrix components and cells. The new approach could lead to implantable devices that suffer fewer adverse events, such as fibrosis, inflammation, and clotting, because of the foreign body response.
The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126)
Abbott has today announced that its Xience family of stents has received US Food and Drug Administration (FDA) approval for one-month (as short as 28 days) dual antiplatelet therapy (DAPT) labelling for high bleeding risk (HBR) patients in the USA. This follows the receipt of CE mark in Europe for shorter duration DAPT in April 2021.
Andrew Holden (Auckland, New Zealand) presents the latest results from the IN.PACT™ AV Access trial (Medtronic), which indicate “outstanding” target-lesion primary patency rates of 52.2% through 24 months in dialysis patients with dysfunctional arteriovenous fistulas (AVFs), offering a “highly-significant advantage” over standard balloon angioplasty procedures. These findings were announced in a podium 1st presentation at the Charing Cross (CX) 2021 Digital Edition (19–22 April, online).
“There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons [PCBs] in the peripheral arteries,” findings from a systematic review and meta-analysis of randomised controlled trials (RCTs) published in the European Journal of Vascular and Endovascular Surgery (EJVES) this week suggest. However, the authors clarify that the level of evidence is graded moderate, not high, due to scarce events in some studies.
We compared the three DES groups such as BES, EES, or ZES and matched the difference of baseline characteristics using IPTW analysis. After IPTW, BES showed superior efficacy to EES in reducing total death, cardiac death, TLF, and MACE in AMI patients and similar efficacy to EES or ZES in revascularization and ST.
The management of DAPT in patients with high CV risk is a challenging task, with new data on the subject constantly being reported. Balancing ischaemic benefit with potential bleeding complications adds to the complexity of managing DAPT in these patients. With all the available data and current clinical guidelines, patients deemed at high CV risk should be considered for DAPT, taking into account individual risk:benefit ratio. In most individuals with high CV risk, the net clinical benefit favours the use of DAPT.
Single-cell RNA sequencing analysis identified unique transcriptional changes within regenerated endothelium after plain old balloon angioplasty and stent implantation. These data suggest unique endothelial transcriptional differences, which characterize the different response of the endothelium to vascular injury and may help explain why long-term responses in DES remain suboptimal.
Among patients on DAPT, smoking status and a 2-stent strategy significantly increased the risk of ST, while intracoronary imaging and FKB reduced the isk. In conclusion, age, smoking status, chronic kidney disease and a 2-stent strategy were significant predictors of ST, whereas intracoronary imaging use and FKB had a protective effect. Only smoking status and a 2-stent strategy significantly predicted ST in DAPT subgroup, while intracoronary imaging and FKB had a protective role.
During the catheter-based procedure, the balloon inflates within the artery, while the drug is delivered to the arterial tissue where it is absorbed. The Prevail DCB utilizes a rapid absorption drug – paclitaxel – to enable treatment of de novo lesions, small vessel disease, and in-stent restenosis (ISR). DCB angioplasty does not require a permanent implant and is often used in cases where the implantation of a drug-eluting stent (DES) is not desirable or is technically challenging.
ORIGIN SC is a semi-compliant (SC) PTCA balloon with a very low crossing profile, making it an excellent choice for challenging lesions. ORIGIN SC offers one of the broadest portfolio of sizes available for an SC balloon, including 1.00 mm, 1.25 mm, 1.50 mm and 1.75 mm balloon diameters to treat very small vessels and complex cases.
Fucoidan is a polysaccharide largely made up of l-fucose and sulfate groups. Fucoidan is favorable worldwide, especially amongst the food and pharmaceutical industry as a consequence of its promising therapeutic effects. Its applaudable biological functions are ascribed to its unique biological structure. Classical bioactivities associated with fucoidan include anti-oxidant, anti-tumor, anti-coagulant, anti-thrombotic, immunoregulatory, anti-viral and anti-inflammatory effects. More recently, a variety of in vitro and in vivo studies have been carried out to further highlight its therapeutic potentials.
Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced its development program for PerQseal® Blue, the company’s new investigational product. PerQseal Blue is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). The PerQseal Blue technology is based on PerQseal, the company’s vascular closure device approved in Europe for use in femoral arteries.
In patients undergoing percutaneous coronary intervention, ultrathin DES improve long term clinical outcomes.
There has been a great evolution in the development of coronary stents in order to avoid both restenosis and thrombosis. Improvements have led to improvements in the design and conformation of metallic or resorbable structures, with an adequate balance between trackability and radial force, the development of antiproliferative drugs and the polymers to control release and allow adequate endothelialisation and an optimal duration of the antiplatelet regimen. Some suggestions are provided about the ideal characteristics of future coronary stents.
Drug-eluting stents (DES) have been widely used for the treatment of cardiovascular diseases. Nevertheless, chronic inflammation and delayed re-endothelialization still represent challenges for their clinical use. In the present work, we developed novel bilayer coatings for stent applications that could overcome these limitations, exclusively using biodegradable plant-based drugs and polymers. In particular, stainless steel surfaces were coated with rutin-loaded zein (the active layer) and cross-linked alginate (the sacrificial layer) via facile dip and spray coating methods.
PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction.
The second CE Mark has been awarded to MedAlliance for the new Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR 014 PCTA. This is used to treat coronary arterial disease.
In participants with critical limb ischemia, the drug-coated balloon angioplasty group and the conventional percutaneous transluminal angioplasty group had similar primary patency rates at 6 months after treatment of below-the-knee arteries. Amputation-free survival rates through 12 months were higher in the percutaneous transluminal angioplasty group.
More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underrepresented in pivotal DES trials.
リーダー的存在の国際医療機器会社のSINOMEDは本日、アイルランド国立大学ゴールウェイ校（NUI Galway)と協力し、ステンティングの新しい評価法の臨床試験を実施すると発表しました。この試験では、新規特許取得のHT Supreme(R) Healing-Targeted Drug-Eluting Stent (DES)を使います。これは、心臓病患者の治療において新機軸を打ち出す可能性があります。
NUI Galway and leading international medical device company SINOMED have teamed up to conduct a clinical trial of a special stent which has the potential to break new ground in the treatment of patients with heart disease. The PIONEER-IV trial will take place over several years in 30 hospital centres across Europe and involve 2,540 patients. The trial will use the newly patented Healing-Targeted Supreme Stent (HT Supreme™) from SINOMED. The novel drug-eluting stent is designed to encourage rapid healing of the treated blood vessel, thereby potentially reducing reliance on some long-term medications such as blood thinners.
The potential of CD31 as a therapeutic target in atherosclerosis has been considered ever since its cloning in the 1990s, but the exact role played by this molecule in the biologic events underlying atherosclerosis has remained controversial, resulting in the stalling of any therapeutic perspective. Due to the supposed cell adhesive properties of CD31, specific monoclonal antibodies and recombinant proteins were regarded as blocking agents because their use prevented the arrival of leukocytes at sites of acute inflammation.