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Randomized controlled trial

Question 1: Validity

The assignment of patients to treatments was randomized. As discussed in this research study, it was a randomized trial of revascularization with solitaire FR devices and Best Medical Therapy. The assignment of the patients was randomized as all the treatments were allowed treatments randomization of patients. The two treatments trails that are “SWIFT PRIME (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment of Acute Ischemic Stroke) and EXTEND IA (Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arteria)” trials randomized to treatment specifically to the patients who have received IV thrombolysis. The rest three trials that are “MR CLEAN, ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times) and REVASCAT allowed treatment randomization of patients who were excluded from receiving IV thrombolysis. MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke)” was allowed in randomization of 500 patients who were enrolled. The randomized clinical trial of endovascular stroke therapy was carried out in this study in which treatment was given to patients. 

The randomization is also concealed in this randomized controlled trial study. The data from the randomized controlled trials is also not complete and the full information is lacking and this is the reason that there are many gaps in this research study. This study only reveals the names of treatments that are being given under endovascular therapy like “MR CLEAN (Multicentre Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times), SWIFT PRIME (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment of Acute Ischemic Stroke), EXTEND IA (Extending the Time for Thrombolysis in Emergency Neurological), REVASCAT (Randomized Trial of Revascularization with Solitaire FR Device vs Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset)”. This study lacks the information about the way randomization has been carried out and this data is missing. 

The groups that were selected to be examined under the treatment of endovascular therapy were similar at the start of trial. The experimental therapy was also conducted on specific target group that was selected to be examined under this study. At the start of these treatment rials, there were two groups that is control group and the sub group. The group of people under medical therapy is known as the control group in “MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke)” treatment for ischemic stroke. The subgroup patients were the ones which received the treatment of “ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times)” who were treated within the window of hours that is within 6 to 12 hours treatment. Apart from the experimental therapy, the groups that were selected at the start of trails were similar. The sub groups which received the treatment trial were same throughout the study.

This study does not describe the information about follow ups like till how long the follow- ups were taken, how frequently they were taken and so on. The follow – up of the patients should be taken for long and enough time after they have undergone an experimental study or a treatment trial. This study does not mention the information about whether follow- ups were taken or not and if they were taken for enough time. In this study, the patients with ischemic stroke underwent different treatment trials and thus follow – up is very important. This study lacks the information on follow – up and directly answers the results that are derived from this randomization controlled study. the follow – ups were not taken in this research study and thus there is no information regarding follow- ups. The follow- ups confirms the results whether they are positive or negative as per the condition of the patients after they have received the treatment trials. 

All the patients were analysed in the groups in this research study where the patients were given treatment trials and they were analysed in the groups to which they were randomised to. The subgroups in which the patients were divided for the relevant treatments were properly analysed and these were analysed within specific three trials that showed positive results of endovascular therapy. The subgroups were analysed only for the groups that showed benefits of endovascular therapy. The advantages of endovascular therapy was only seen in patients who were under the clinical trial of three trials that showed positive results and in patients who did not receive IV rtPA, and the AHA/ ASA guidelines. The analysis of subgroups was done in this study to which they were randomised to. The patients were also analysed in SWIFT and STAR trials so they were analysed in the groups in which they were randomized. 

In this randomized controlled clinical trial study, no one was kept blind to treatment. The treatment trial was given to the patients with ischemic stroke and it the treatment guidelines was clearly mentioned. This research study is about five different types of treatment trials given to the patients under endovascular therapy to determine its effectiveness. The patients were well aware of the treatment and the fact that they are under treatment trials. The treatment trial thing was not at all kept hidden. This article discuss the changes that are done in stroke systems of care because this is a review of five trials which gave positive results. Based on this article, principal changes are made in the guidelines and thus this is one of very important studies. The five recent treatment trials were done with the patients and they were informed of this thus it can be concluded that treatment was not kept hidden from anyone in this study. 

The groups who were allotted as sub groups and control groups were initially treated equally that is they were given equal resources and were kept under similar condition. The difference in the groups was done when experimental treatment was given. This is because the control group was given medical therapy whereas the sub group was given endovascular treatment. This is the study to analyse the positive effects of endovascular therapy in patients with ischemic stroke. The sub group under study was given a different line of treatment that is different from the control group. Other than this, the control group and the sub group were handled in equal manner. Both the groups that is sub group and control group were kept at the same place and were given similar conditions. They both were given the same resources and there was no prominent difference between both control and sub group apart from when experimental study of endovascular therapy was given to the sub group under study. 

Question 2: Importance

This study is the review of recent five treatment trials of endovascular therapy that are “MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke), ESCAPE (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times), SWIFT PRIME (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment of Acute Ischemic Stroke), EXTEND IA (Extending the Time for Thrombolysis in Emergency Neurological) and REVASCAT (Randomized Trial of Revascularization with Solitaire FR Device vs Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset)”. The magnitude of the treatment effect is that these five treatments under endovascular therapy have given the positive results thus it can be concluded that they are effective to be used as a treatment for ischemic heart stroke. This study identified the successful use of thrombectomy procedures and these are proved in the first five trials.

Question 3: Application

The positive results identified in these five treatment trials ca be applied and will contribute in changing the guidelines. In this study, the key results are examined and the principal changes are made and updated in the guidelines. The results of this study will be used to update 2013 guidelines for early management of acute ischemic stroke that are set by “The American Heart Association/ American Stroke Association”. They have released a focused and updated 2013 guidelines on early management of acute ischemic strokes. The committee of guideline also incorporated three preceding non- positive randomized trial of endovascular therapy and five positive randomized trials of endovascular therapy that is identified in this study. Thus, the results of this randomized controlled clinical trial study is well established in 2013 guidelines by “The American Heart Association/ American Stroke Association” on early management of acute ischemic strokes. The current guidelines and practice has been altered after the results of this study and have a great application in the study related to management of acute ischemic stroke in patients. 

The results of this study states that thrombectomy procedures can be used on patients with acute ischemic stroke and also that the treatment with endovascular therapy is also effective in early handling of acute ischemic stroke in patients. The patients are different because they are under examination and are given different type of conditions which may not be similar for all and especially for people who have different co morbidities existing. The conditions of these patients and the actual patients who are suffering from acute ischemic stroke are different. The treatment that is given to patient with acute ischemic stroke is very specific according to their health conditions and other conditions. The results of this study cannot be directly applied for the care of their patients because when they showed positive results, they were under examination so they had different conditions. Patients under study of clinical trials are thus very different from those in real and actual health care setting that the results of this study cannot be applied for their care.

The treatment of endovascular therapy is a complex procedure that involves proper management and execution of successful thrombectomy procedures that leads to reperfusion of ischemic brain and also recognition of certain timings so that prevention can be made. It also involves the use of very expensive and complicated instruments and devices thus this treatment is not feasible in our setting. It is such a complex procedure and the use of thrombectomy devices and the devices of “REVASCAT (Randomized Trial of Revascularization with Solitaire FR Device vs Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset)” which are beyond to go for in our setting. There are many potential changes that are required to be changed for such devices to be incorporated in our setting thus it can be concluded that this treatment for acute ischemic stroke is not feasible in our setting. There is a mandated use of certain devices for this endovascular therapy that cannot be avoided. 

The treatment therapy that is discussed in this article is endovascular therapy. There are majorly five treatment trials under endovascular therapy. This therapy has its potential benefits and harms for the patients and for its use within health care settings. The potential benefits of endovascular therapy is that the stents are retrievable. The retrievable stents do not cause harm and are very safe for the use in patient’s body. It ensures patient safety and is effective in its application with overall low procedural complications. The intravenous r- tPA is the standard care that is given to the patients with acute ischemic stroke. It aims at obtaining early reperfusion and maintains the most critical element over here that is time between neuroimaging and reperfusion. The potential disadvantages of endovascular therapy is that it is difficult to make this therapy accessible in developing countries. The second limitation of using endovascular therapy is that this is a slow treatment time procedure so it makes difficult for the patients to undergo this treatment.

References

Mokin, M., Snyder, K. V., Siddiqui, A. H., Levy, E. I., & Hopkins, L. N. (2016). Recent endovascular stroke trials and their impact on stroke systems of care. Journal of the American College of Cardiology, 67(22), 2645-2655.



 

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