Vest trial

The primary outcome of the study was sudden death SD and death due to ventricular arrhythmias. A pre-defined secondary endpoint was total mortality. Since the results were presented, prior to publication of the manuscript, the findings have led to mixed reactions in the cardiology community. Most of the criticism is regarding the trial missing the pre-specified primary endpoint of reduction in the rate of SD during the first 90 days after MI.

However, simply coming to the conclusion that the trial was negative and thus discounting the potential benefit of the WCD is problematic and might be missing the point. Over a mean follow-up of 84 days, the rate of SD was 1. However, the total mortality was 3. There are many potential contributing factors for this seemingly contradictory result. Though it is possible that patients receiving the WCD received better care or closer follow-up, potentially influencing total mortality and not the SD rate, there was not a significant difference in GDMT therapy between the two groups.

There was a statistical difference in the rate of death related to stroke, with no stroke deaths seen in the study group versus 4 deaths 0. However, the study was not powered to study a difference in stroke rate and there are statistical traps in comparing event rates between two groups where one group has a zero incidence of an event. Interestingly, the reduction of SD represented the majority of total mortality reduction in the trial. Fourteen of the 20 patients receiving an appropriate shock survived to the 90 days.

This difference between the SD rates and total mortality rates could be explained by several other factors. Compliance in the VEST trial appears to be lower than what we see in clinical practice, and lower than what has been observed in previously reported WCD registry data. Thus, despite accurately projecting event rates for study population, this non-compliance would result in a decreased power for detecting a difference in SD.

In fact, of the 25 patients who were adjudicated as having had SD in the treatment group, only 8 were wearing the WCD at the time of their death. Of the 8 patients, 5 had recurrent ventricular arrhythmia suggestive of ongoing ischemia and 3 suffered asystole or pulseless electrical activity, and thus could not be treated. In addition, correctly adjudicating SD is difficult without detailed medical records or witnessed accounts without the use of device data.

The investigators went to great lengths to eliminate any potential bias and thus the independent reviewers were blinded to any device data. Five percent of all deaths in the trial were classified as indeterminate. Seventy patients aborted therapy by using the response buttons, which potentially dilutes the primary outcome of treatment of ventricular arrhythmia. This finding is an important consideration, given that we compare the WCD data and event rates in this population to classical primary prevention ICD trials, trials which included treated events that may not have resulted in SCD.

Randomized clinical trials are the cornerstone of our practice of evidence-based medicine. The VEST trial did not meet its primary endpoint; however, the Kaplan—Meier curve for SD mortality separates early and continues to separate to 90 days, showing a positive trend. The discussion regarding whether or not the WCD should be utilized is very similar to the debate surrounding primary prevention ICD therapy. We knew from MADIT 5 that patients with ischemic cardiomyopathy and additional risk factors such as nonsustained ventricular tachycardia NSVT and programmed stimulation arrhythmia inducibility benefit from ICD implantation.

It did, however, show a significant decrease in arrhythmic death. These trials were designed to prove risk and efficacy of therapy which we already understood to be true through real-world clinical practice. The same point can be made about the efficacy of WCD therapy for patients at risk of SCD while awaiting long-term therapy. One can certainly appreciate that if the pre-defined primary endpoint of the VEST trial was total mortality like primary prevention ICD trials , we might be looking at this trial differently.

The VEST trial demonstrates a significant mortality benefit in this group of high-risk patients. It stands to reason that the benefit on arrhythmic mortality is only seen if the patients use the device. Finally, it is the obligation of physicians and other caregivers to employ a shared decision-making approach regarding the use of potentially life-saving therapies such as the WCD.

Disclosures: Dr. Navigation menu Personal tools Create account Log in. Namespaces Page Discussion. Views Read View source View history. Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Last Update Posted : October 6, Study Description. Detailed Description:. However, the negative results did not seem to dissuade WCD use and instead encouraged researchers to challenge its findings. When examining the pattern of WCD prescription, the authors made the interesting observation that the ongoing use of WCD "is likely driven by the finality of SCD and partly by fear of litigation, despite the absence of data to support it.

More recently, two additional studies have offered additional insight to justify WCD use. In the first of these studies, Olgin, the lead author of VEST, reexamined the same 2, patients from the VEST trial using a per-protocol analysis instead of intention-to-treat that more accurately censored patient data during non-WCD wear time.

A key driver of WCD efficacy was patient adherence. The second of these studies examined the mortality and costs associated with WCD use in 16, patients from Medicare claims data.

Although the journey for WCD acceptance has been circuitous, it has earned its place among the short list of modern day, lifesaving medical devices.