Category Archives: Clinical Trials

Endologix Study on AAA treatment for women shows promise

In the past, I have written about how studies on devices and drugs seem to lack focus on women, for several reasons. Reasons range from a poor understanding of the differences in male and female anatomy and physiology, poor access to healthcare, lack of awareness and efforts to enroll women, and lesser demands for evidence from journals, insurers and other healthcare stakeholders. I previously posted about Boston Scientific’s efforts to enroll more women, and now, here is another positive study from Endologix.

Enrolling women, or studying the effects of devices, procedures and therapies exclusively in women go further than improving medical knowledge, when successful, they can also make for sound business sense, regardless of the risks and expenditure.

AAA – Abdominal Aortic Aneurysms 

The aorta is the main artery that supplies blood to most of the body, and in the abdominal region, it splits into two arteries that supply blood to the pelvis and legs. Due to smoking, high blood pressure and/or other risk factors, the aorta can come under pressure and enlarge, and eventually burst, which can cause hemorrhage and death, if not operated on immediately. Aneurysm also presents with a lot of pain, and the risk of rupture when the aneurysm reaches a certain size, requires surgical correction and grafting/stenting.

 Open Vs. Minimally Invasive Repair

There are two ways an abdominal aortic aneurysm is surgically treated – open surgery and minimally invasive repair through a groin incision. Both surgeries have approximately the same effectiveness, but open surgeries can take a long time to recovery, while minimal surgeries requires numerous post-surgical visits to ensure no leaks or other morbidity is present. However, eligibility for surgery varies.

Learn more about Endovascular Aneurysm Repair (EVAR)from this brief video (note that Cook Medical provided a grant towards the video):

The Endologix Lucy Trial

Endologix, which has developed a stent for AAA treatment, enrolled 225 patients, 149 male and 76 female. They claim that, with their stent, termed the Ovation® Abdominal Stent Graft System, increased eligibility for women by 28%.

Besides claims that the device reduces mortality and is better suited for women, the study is also the first to study the effects of the device and surgery on women. Women are at a lower risk for AAA, but the outcomes are worse for women treated through EVAR or through open surgery. I found a study that confounded this outcome difference, however, the study was not specifically well designed to study gender differences. However, it is clear that anatomical differences remain, and thus drive the variability in outcomes, and this is potentially why the Endologix device claim makes sense.

The results Endologix has presented, are of course, initial results based on the 30-day follow up period common for EVAR, and observations over long term will yield more confidence in the device’s ability to treat women better.

However, as I mentioned earlier, it makes for good clinical sense and business sense to enroll more women in clinical trials, and the Lucy trial is one more step in the right direction!

References:

  1. The MASS Device Article: http://www.massdevice.com/endologix-touts-30-day-data-study-ovation-stent-graft-women/
  2. A Business Wire write-up by Endologix: http://www.businesswire.com/news/home/20170531006467/en/Endologix-Reports-Positive-Clinical-Data-Ovation-LUCY
  3. A large, open-access study on gender based outcomes: http://www.jvascsurg.org/article/S0741-5214(12)02188-X/fulltext
  4. A Mayo Clinic Overview of AAA: http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/home/ovc-20197858
  5. Society for Vascular Surgery on AAA Repair: https://vascular.org/patient-resources/vascular-treatments/endovascular-repair-abdominal-aortic-aneurysms#whyitsdone
  6. Image courtesy, Pexels: https://www.pexels.com/photo/woman-water-girl-lake-134670/

 

Early Menopause and lack of child birth increase risks for Heart Failure

Heart Health in Women has many risk factors associated with it. A new study, another retrospective one, examined 28,516 women, who were enrolled as part of the Women’s Health Initiative (link below), a great effort that is now providing invaluable statistics that can be used to identify root causes and create awareness.

Eliminating all other known factors, such as BMI, smoking etc., two new factors popped up:

  1. Early Menopause
  2. Lack of pregnancy

They also identified that for every year’s worth of delay in menopause initiation, a woman’s heart failure rate drops by 1%. The other risk is caused by nulliparity, or lack of pregnancy. I am quoting directly here:

The latest study also found that women who had never given birth were 2.75 times more likely to have diastolic heart failure than women who had children.

The study authors did not establish a direct causal link, but they were able to identify a statistical link. The lead author did mention that polycystic ovary syndrome (a blog post for another day) has been known to increase cardiovascular risk. Diastolic Heart Failure happens when the heart is not able to pump enough blood to the body.

Study Limitations

Retrospective studies, especially ones based on efforts such as the Women’s Health Initiative, where large amount of data can be a treasure trove of information, just as this study has been. However, there are limitations. The current study only shows an association, not a causation, and no clues on the actual causation.

Such limitations however can be overcome by future studies, that focus on trying to identify causes.

Mitigating Circumstances

The more causes that are identified for the risk of heart failure, the better. Instead of considering these things in a negative light, women and doctors can better prepare ahead, taking precautionary measures ensuring a long and fruitful lifespan. It is also true that women in this century, prefer to make their life choices and therefore, knowing that avoiding pregnancy means a need to plan and prepare ahead for optimal health is always very good!

References:

  1. The study (sits behind a paywall): http://www.sciencedirect.com/science/article/pii/S0735109717367694
  2. The Guardian Article summarizing the study: https://www.theguardian.com/science/2017/may/15/earlier-menopause-puts-women-at-greater-risk-of-heart-failure-study-shows
  3. The Women’s Health Initiative: https://www.nhlbi.nih.gov/whi/
  4. Nulliparity: http://medical-dictionary.thefreedictionary.com/nulliparity
  5. A simple review of early menopausehttp://www.webmd.com/menopause/guide/premature-menopause-symptoms#1
  6. Diastolic Heart Failure: http://www.webmd.com/heart-disease/heart-failure/tc/diastolic-heart-failure-topic-overview#1
  7. Image Courtesy, Pexelshttps://www.pexels.com/photo/sunset-hands-love-woman-5390/

Quick Post: Boston Scientific’s efforts to enroll more women in medical device trials

I love Qmed. They provide great news updates all the time. This morning, I came across an important bit of news through one of their newsletters.

Boston Scientific apparently has an initiative called WIN-Her. Marketing must have gone into a frenzy to come up with this, which, expands to:  Women Opt-In for Heart Research.

Boston Scientific points to research (link, obtained through BSC press release, below) that indicates that only one-third of patients enrolled in a cardiovascular clinical trial between 2000 and 2007. I am sure there is not much reason to believe the situation has improved much.

They are now using this program of theirs to enroll more women in two of their own clinical trials (please see links below). It is very important to know if women and men experience the effects of devices and treatments differently, and for this, it is key that enough women be enrolled in clinical trials for non-sex specific health conditions. However, major barriers exist. This is a theme that I will expand on this blog extensively, over time.

There is of course the added benefit that it makes the sales of devices, proven by clinical trials, that much easier and the prospects of profits higher!

It is true that women not only have lesser access to healthcare, they are also not given information about the possibilities of clinical trials, treatment options and so on. As pointed out, in the Qmed article, logistical challenges in clinical trial participation are already high, and for women who might have income barriers, transportation and continual access issues, this probably makes things worse.

Only a concerted effort by industry, academia, hospitals, non profits (including, organizations like Planned Parenthood) and the various levels of Government can help ensure enough women enroll and participate in clinical trials. This is true of not just cardiovascular health conditions, but all health conditions.

On a slightly different note, I found this interesting read about a Stanford University Undergraduate Student who survived AML, and apparently, enrolling in a clinical trial helped the young lady who wrote the blog post, furthering the argument that it is very important that women of all walks of life be encouraged to join clinical trials where feasible.

References:

  1. Image courtesy, pexels: https://www.pexels.com/photo/view-of-operating-room-247786/
  2. The Qmed article: http://www.qmed.com/mpmn/medtechpulse/can-boston-scientific-woo-more-women-clinical-trials?cid=nl.x.qmed02.edt.aud.qmed.20170502
  3. The Boston Scientific Press Release: http://news.bostonscientific.com/2017-04-18-Boston-Scientific-Initiates-Global-Study-To-Assess-Sudden-Cardiac-Arrest-Prevention-Therapy-In-Patients-With-Diabetes-Who-Have-Previously-Experienced-A-Heart-Attack
  4. The gender bias paper mentioned by Boston Scientific: http://circoutcomes.ahajournals.org/content/4/2/165.long
  5. The blog post by the AML survivor: https://medium.com/stanford-magazine/i-didnt-beat-cancer-my-doctors-did-ec6c3a92d426