Release date: 2007-08-09
How does the drug-eluting stent come out of confusion and move forward? This year, various sounds about the stent problem are filled with major cardiovascular conferences. Various related reports cover the layout of professional media and even mass media, right and wrong, stagnation and development... ... The American Journal of Circulation has published a heavyweight article in the journal - Drug-Eluting Stents "Deliver Heartburn" How Do We Spell Relief Going Forword?
Drug Stents Inducing Heartache "Breakthrough" technology may have a very prominent or unexpected effect after going public, especially if its market penetration rate in large-scale patient populations exceeds the progress of clinical knowledge. Although high-end conferences or news media reports will draw attention to such new technologies, in the final analysis, they are rigorous scientific issues related to safety and effectiveness. These technologies require transparent public channels to help doctors and patients decide how and when to use these technologies. In view of this, the US FDA held a two-day consultation and discussion meeting on drug-eluting stent (DES) thrombosis in December 2006.
From 2003 to 2004, concerns about DES safety were of concern, and it has been reported that DES may cause thrombosis after stent implantation despite rare but very severe stenting. Since then, the security of DES has attracted widespread attention from the industry and the public. In the spring of 2006, at the European Society of Cardiology in Barcelona, ​​reports of increased rates of stent thrombosis in DES triggered media coverage, the most striking of which was the headline of The Wall Street Journal – “Drug-eluting stents cause heartache†". Although the article does not specifically point out that this conclusion comes from patients who have heartache after stent placement, cardiologists, DES producers, FDA or Wall Street Journal itself, in fact, the issue of DES touches all of the above.
The FDA team's meeting at the end of 2006 summarized the safety and effectiveness of DES over bare metal stents (BMS) by reviewing the information currently available, and these advantages can be written into product labels. At the same time, the FDA team also noted that patients who have been treated for more than one year have a lower risk of bleeding according to the dual anticoagulant regimen (DAP treatment regimen) recommended by the American College of Cardiology/American Heart Association/Energy Imaging and Interventional Association. The FDA also said it will pay close attention to the security issues of DES. In addition, the FDA pointed out that there are some specific questions that are not yet answered explicitly, such as whether the use of the product description will increase the incidence of thrombosis, the optimal course of antiplatelet therapy, and so on.
The evaluation process Towards clarification After the results of the FDA panel's deliberations came out, the FDA, clinicians, and companies exchanged ideas on how best to interpret and implement the group's recommendations. Businesses, research institutions, and researchers should collaborate to continue to collect and deliver scientifically sound, new, long-term patient data and data. Several important journals in the field have also accelerated the publication of relevant research results. For example, as of August 2007, the New England Journal of Medicine published seven papers on the results of DES research, including five peer-reviewed scientific analysis reports, all of which included a large number of patients, and patients were followed longer than Previous research. These results all have certain limitations because they all come from retrospective analysis. These reports are the result of past research, based on the good side of the observations, in many cases from the perspective of companies, research institutes or consultants. Obviously, the information contained in these studies is not suitable for the needs of the present and future. For example, in any of the reports, there is little data on the actual compliance of DAP treatment or treatment interruption in the complex group of real patients in a randomized group. Therefore, although the New England Journal of Medicine has made a lot of efforts in reviewing the safety of DES, it also points out the potential risks of retrospective data collection. Four of the five reports mentioned the same clinical trial, but reported differently. When the results of the new analysis lead to more confusion than clarification, we need to consider the extent to which the past has been recognized to the limit. From this point of view, we should pay more attention to how to make research in this field continue to progress.
Subsequent research results Key research continues to be a top priority for clinicians, researchers, authoritative consultants, and businesses in 2007. Future goals can be considered in three ways: 1 For patients who have been permanently implanted with an approved DES stent platform, the best care should be given. 2 For patients requiring stent treatment, the existing approved DES platform should be best utilized. 3 For the new, under-developed DES platform, the best approach should be used to evaluate its safety and effectiveness.
No medical device is completely safe, and the application of medical devices should achieve a certain clinical balance between effectiveness and safety risks. Regarding DES should be balanced in the following aspects: the balance between the occurrence of restenosis or recanalization and stent thrombosis; or whether the use of stents for angioplasty can achieve the desired results compared with medical treatment and bypass surgery . These are a basic judgment for doctors, academic groups and even patients. However, how to accurately determine the incidence of clinical adverse events, especially rare but very serious events, such as stent thrombosis, remains a challenge and should be of concern to all sectors, including authoritative counseling agencies.
For patients who are using or will be using an approved DES stent platform, FDA will re-evaluate the DES label to ensure that the information provided to physicians and patients is up-to-date, accurate, and as much as possible. Monitoring the labeling of medical products is a powerful tool for the FDA to ensure that the information provided to users is well documented and comprehensive. Labels are also the basis for agents to evaluate and advertise. Labels should be updated in a timely manner to reflect the most up-to-date information.
Evaluation methods face breakthroughs Over time, DES products have evolved to a higher stage of the product cycle, and the evaluation of risks and benefits may eventually shift large amounts of data or vertical analysis to low-load RCTs, or answer without RCT Specific DES security and feasibility issues.
An important aspect of the continued development of DES research is the recognition that the safe use of these devices is directly related to DAP treatment with aspirin and thienopyridines such as ticlopidine or clopidogrel, although this relationship is Stent implantation was established early, but the optimal time to use DAP therapy is still unclear and varies across different DES platforms. Now we have realized that further development of DES, patient education, detailed documentation of patient compliance, interruption of treatment, and patient care strategies during interruption of treatment are important.
On the other hand, combining drugs and devices can produce more innovative products. This means that the FDA must strengthen its own internal cooperation to ensure that such products can be evaluated smoothly without human or material reuse.
The FDA will continue to conduct pathophysiology of coronary artery disease, biological response to DES, other treatment options, design and production of other complexes, and research related to DES applications. The FDA will work together to develop effective policies through key channel operations and medical device surveillance networks, and joint ventures and research institutions to advance this area.
How to establish a new DES evaluation system When establishing an evaluation system for the new DES platform, it is difficult to understand the characteristics of rare adverse events related to DES thrombosis from clinical and other aspects. These adverse effects are usually first seen after marketing, and after more and more different patients use, rather than in the initial clinical study. Due to the different quality of the instruments produced and the different techniques of the clinical surgeon, the quality of the collected patient data and the utilization of the patient data are different, which leads to the complexity of the application. Stent thrombosis may also be affected by differences in the biological characteristics of the individual patient, the DES structure used (including the material of the stent, the drug, and the metal stent platform). Over time, it is difficult to determine that the adverse reaction is caused by the stent thrombosis itself. It is also caused by the progression of potential coronary artery disease or related complications.
Strengthening research before and after DES marketing These complex factors make it difficult to evaluate whether new DES is superior to existing treatments in terms of safety and efficacy. The DES platform is very complex and repetitive. DES classified as Class III medical devices need to meet the following requirements: 1 complete the required research report before listing; 2 submit annual report, adverse reaction report, and listed research data; 3 if the medical device or its use label If there are major changes, the pre-marketing supplementary application should be approved. The FDA's approach to the “total product cycle†of medical devices reflects the FDA's expectation that new data and new knowledge of one or a class of medical devices can be applied to future research and development and can be used to update relevant regulations. The laboratory equipment, animal experiments, and clinical studies required for DES approval are provided by BMS, using pharmacological elution system software to analyze the pharmacological data obtained, plus our inference from actual experience. The development in this field requires us to have a better understanding of such chemical compounds today.
In addition, the FDA will re-evaluate the information necessary to determine the safety and effectiveness of DES, including when DES is marketed and when it is widely used. This does not mean that the current research will be abandoned or that the future “threshold†will change. This merely indicates that the relevant new issues need to be considered under reasonable scientific principles. The FDA believes that we should carefully consider how to better define the risk of stent thrombosis and how to reduce restenosis in patients over the life of the patient. These issues can be addressed through pre-marketing and post-marketing research. The ultimate goal of these studies is to design a comprehensive clinical plan to achieve a balance between product availability and patient safety.
Uniform definition, unified evaluation criteria Pre-marketing licensing evaluations generally require the use of randomized clinical trials (RCTs). The RCT of DES should be based on current scientifically careful and scientific statistical analysis. The analysis of data currently available from the DES RCT trial should provide us with information on the selection, definition and efficacy evaluation of safety and efficacy. The Academic Union endorses the final definition of the DES outcome proposed by the FDA team and most publications. A consistent definition of this series of related conditions - the possibility of stent thrombosis, the possibility of stent thrombosis, and the formation of a clear thrombus stent, are very important, although these definitions are in practical applications, due to how There are limitations in sensitivity or specificity for use, but the FDA team has identified the use of these final definitions in clinical trials and case reports. Due to the rare or undesired events that occur after listing, the use of a uniform definition is important for observing the safety signals and the mechanistic evaluation of their source – at this point it is like “smoke†and “fire†The description is the same.
It is also critical to select an appropriate effect endpoint for effective evaluation of DES. According to the latest literature bulletin on the characteristics of the stent, the characteristics of the procedure, and the complex interactions between individual patient differences, the efficiency of evaluation using angiography is low. Recent analyses of death and myocardial infarction combined with landmark analysis have helped to understand whether there are time-limited problems with susceptible cases in some specially treated groups, and also provide useful information for retrospective analysis, and can be considered later. Used in the experimental design. Angiography and intravascular ultrasound serve as biomarkers for the response of blood vessels to DES implants, which are more effective than alternative criteria for evaluating DES efficiency.
—— Information from: Shanghai Medical Device Industry Association website
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