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Aspirin: The Good, the Bad and the Ugly

Last week, I was talking to one of my patients about her ischemic stroke, which led her to be admitted to the hospital. I discussed that I would be prescribing a daily aspirin along with other medications to reduce her risk of recurrent stroke. She replied, “But doc! I just read on the news that aspirin is no longer recommended to prevent heart attack and stroke.” It took me a moment to realize that she was referring to the recently released guidelines for “primary prevention of cardiovascular disease.” I explained to her the rationale, benefits, risks and evidence supporting the use of aspirin for secondary stroke prophylaxis. She felt better after our detailed conversation and agreed to initiate the medication as recommended. Later that day, I read several potentially misleading headlines on major news media websites about this new guideline. The headline on CNN1 read, “Daily aspirin to prevent heart attacks no longer recommended for older adults,” while USA Today2 reported, “Don’t take an aspirin a day to prevent heart attacks and strokes.”

The guidelines issued by the ACC now recommend against routine use of aspirin for primary cardiovascular prophylaxis in adults older than 70 years. This new recommendation is based on the ASPREE trial, published in 20183. During this trial, healthy adults older than 70 years with no prior history of cardiovascular disease were randomized to receive 100 mg aspirin or placebo. The low dose aspirin lead to a significantly higher risk of major hemorrhage without a significant benefit in terms of cardiovascular event prevention. The guidelines recommend using low dose aspirin for primary prophylaxis of cardiovascular events only in adults aged 40-70 years who are at a higher risk of atherosclerotic cardiovascular disease. The guidelines no longer recommend using the 10 year estimated ASCVD risk threshold of 10%, but in fact propose a more tailored approach to primary cardiovascular prophylaxis.  Patients at a high risk of cardiovascular disease and whose risk factors are not optimized despite maximal medical therapy may be candidates for prophylactic aspirin at low doses. Physicians should have a careful discussion of the individual risks and benefit of aspirin before prescribing a daily aspirin regimen to their patients. Aspirin should not be prescribed for primary prophylaxis to patients with an increased risk of hemorrhage, such as a history of gastrointestinal bleeding or thrombocytopenia.

These guidelines are obviously for patients without a prior history of a cardiovascular events such as an MI or ischemic stroke. There is unambiguous data that supports the use of aspirin for secondary cardiovascular prophylaxis. My patient from last week belonged to this category and I started our aspirin discussion with her by explaining this clear distinction. She understood the rationale for aspirin in her case and how the new guidelines did not apply to her. The news headlines are sometimes sensationalized which can render them misleading for the reader. The two news articles did in fact report that the guidelines refer to use of aspirin in healthy older adults with no history of heart disease or stroke. In today’s world of fast paced digital information, there is a tendency to just read the headlines and move on to the next thing. This can be very problematic if patients on aspirin for secondary prophylaxis stop taking their medication after reading these news headlines.

As healthcare professionals, it is our responsibility to tackle this kind of misinformation which can lead to potentially bad outcomes for our patients. One of the ways to do that is to enhance our presence on social media platforms which are increasingly becoming the major source of news and information for the public. The AHA Early Career Blogging Program is one such avenue which can help young healthcare professionals strengthen their digital and social media footprint. This also helps facilitate collaborative projects and ideas among healthcare professionals and can lead to improved patient outcomes, which is the ultimate goal in all our endeavors.

 

References:

  1. https://www.cnn.com/2019/03/17/health/aspirin-heart-disease-guidelines/index.html
  2. https://www.usatoday.com/story/news/health/2019/03/18/aspirin-prevent-heart-attacks-strokes-doctors/3199831002/
  3. N Engl J Med 2018; 379:1509-1518 DOI: 10.1056/NEJMoa1805819

 

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Success Does Not Always Leave A ‘Footprint’

Stroke is one of the leading causes of mortality and morbidity in the United States (US). Approximately one‐third of all ischemic strokes are considered cryptogenic, i.e not attributed to large‐vessel atherosclerosis, small‐artery disease, or embolism despite extensive vascular, serological, and cardiac evaluation. Until recently, the relationship between patent foramen ovale (PFO) and cryptogenic stroke was highly debated. Prior to 2006, use of transcatheter based PFO closure procedures were only permitted under Food and Drug Administration (FDA) Humanitarian Device Exemption for recurrent cryptogenic stroke from a PFO after failed conventional medical therapy1. However, the number of eligible patients exceeded the regulatory mandated annual limit of 4,000 patients in 2006. Thus, the Humanitarian Device Exemption process was voluntarily withdrawn1.

In the past two decades, several randomized clinical trials using the Amplatzer PFO Occluder, the Starflex Septal Occluder (NMT Medical Inc, Boston, MA), and the Gore Cardioform Septal Occluder were conducted. Based on long term follow up results of the RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment] and REDUCE [GORE® Septal Occluder Device for PFO Closure in Stroke Patients] trials, US FDA approved the Amplatzer PFO Occluder in 2016 and the Gore Cardioform Septal Occluder in 20181,2.  FDA approval for these devices for PFO closure in the United States is to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke2.”

Despite proven efficacy, the use of device based PFO closure techniques have potential risks of several early and late complications, including infection, thrombosis, device dislodgement, atrial wall erosion, perforation, fracture, migration-embolization, allergic reaction to nickel used in PFO occluder device, and induction of arrhythmias3,4. Further, there is need of post procedure antiplatelet therapy after implantation of these devices. These concerns lead to need for a ‘deviceless’ transcatheter system to close PFO. Ruiz et al have performed first-in-man transcatheter suture closure of a PFO in an 18-year-old female with chronic migraine with aura in 2008 without leaving ‘footprint’5.  Results of this novel approach were exciting; however, safety and efficacy of ‘deviceless’ transcatheter techniques on large scale was not established until early results of the NobleStitch EL Italian Registry were reported few months ago6. In this prospective registry, investigators successfully used suture based PFO closure system in 186 (out of 192) patients across 12 sites in Italy with no device related complication on 206±130 days follow-up6. FDA approves the NobleStitch™ EL for Vascular and Cardiovascular suturing in the US (interestingly the technique is not specifically labeled for treating PFOs).

Due to projected increase in numbers of left sided transcatheter interventions (e.g. left atrial appendage closure, arrhythmia ablation and mitral valve interventions), the deviceless technique could be a very attractive option in selected patient population as presence of interatrial septal prosthesis make trans-septal puncture more challenging. Though this technology has huge potential, we should still wait for long term data on safety and efficacy of this no foot print PFO closure system before advocating and supporting its widespread use.

 

References:

  1. Writing Group Members , American Heart Association Statistics Committee; Stroke Statistics Subcommittee . Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016; 133:e38–e360
  2. .https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm527096.htm
  3. Luermans JG, Post MC, Yilmaz A. Late device thrombosis after atrial septal defect closure. Eur Heart J. 2010;31:142
  4. Merkler AE, Gialdini G, Yaghi S, Okin PM, Iadecola C, Navi BB, Kamel H. Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale. Stroke. 2017;48:3073-7
  5. Ruiz CE, Kipshidze N, Chiam PT, et al. Feasibility of patent foramen ovale closure with no-device left behind: first-in-man percutaneous suture closure. Catheter Cardiovasc Interv. 2008 Jun 1;71(7):921-6.
  6. Gaspardone A, De Marco F, Sgueglia GA, et al. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279.

 

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What’s Happening Here At The International Stroke Conference in Hawaii?

Getting to Hawaii was quite the event! I underestimated the flight and how I would feel with such time zone changes. However, the International Stroke Conference 2019 (#ISC19) was worth all the efforts. The meeting objectives were sufficiently described in the program book and my previous blog. As promised, there were sessions to equip scientists and clinicians with tools in diagnosis, treatment, prevention, management, and rehabilitation of cerebrovascular disease as well as nursing. The sessions that I was able to partake in were the following:

  1. Clinical Rehabilitation and Recovery Oral – I spent the first part of the morning here learning about the biomarkers to improve stroke rehabilitation covered in the clinical trial data and predictors of post stroke depression using qualitative data in patient after ischemic stroke. Although these presentations were informative, I had my eye set on other topics as well, so I had to leave the session a tad early.
  2. Medical therapy for Symptomatic Carotid Stenosis: Time for Modern Data – Seemant Chaturvedi, MD shared his research on ‘Genetic Guidance for Antiplatelet Therapy’ followed by Brian Hoh, MD discussing the answers he found to the question ‘Do HTN Targets Matter?’ Studies presented here show there is a link between hypertension and changes in white matter in the brain that affect cognitive functions. Dr. Bath expounded on his recent article in Stroke (2018) sharing mechanisms of how this damage could potentially occur.
  3. Looking into the Brain Through the Eye: Re-examining the Retina as a Surrogate Marker for Cognitive Disorders – There is growing evidence that the dental and optical examinations can be a window into health. I previously blogged about the bacteria found in the mouth is also identified in atherosclerotic plaques. In this session, clinicians/scientist looked at the retina as a window to the brain and subsequently health. These sessions suggested the retina can assist in the post-mortem prediction of Alzheimer’s disease and stroke based on the linear relationship between number of plaques in the retina and the brain. Current research tools are extremely invasive thus predictions are not feasible in living patients. The tools described here included Optical Coherence Tomography (OCT, not to be confused with over-the-counter) as a diagnostic tool, adding to repertoire of skills to increase the ability to interpret cognitive impairment.

I am looking forward to the information presented on tomorrow. I will give more insights into what I think is the highlights of the meet in my next blog. Keep following me on Twitter @AnberithaT and be sure to ask any question that may be answered during the ISC19 or after.