Dear Dr. Topol, I have another hypotheses/parallelism (DES VS HRT). I believe that one reason for the similar or the marginal benefit that we see with DES as compared to BMS in the most recent studies is related to patient selection - namely socioeconomic status (SES). In the last 2-3 years those with low SES almost always get BMS now because of fear of stopping antiplatelet therapy and therefore inherently they are different and we know the association between SES and outcomes. To me this is similar to the observational studies with HRT...the educated and higher SES women were taking HRT and they had lower events. I wonder what you think about this hypotheses. Thank you

Dear Mehdi, You've made an excellent point here.....the socioeconomic impact in interpreting the data of BMS and DES. It's likely an unmissed but important factor.

A simple tradeoff!! Properly deployed drug eluting stents clearly reduce restenosis and repeat intervention. This has never been disputed. However, interventional cardiology is heavily dependent upon the application of the technology and is heavily operator and perhaps institution dependent. Late and very late stent thrombosis may very well be traced to case selection and operator technique. Given the very low numbers of late and very late thrombosis this would be very difficult to "tease" from the data. I suggest to patients that properly utilized drug eluting stents offer the advantage of a significant reduction in restenosis, freedom from symptoms, and need for re-intervention. This is at the cost of longterm dual antiplatelet therapy. This is very similar to the decision to use valvular bioprostheses vs mechanical prostheses. I leave the choice to the patient and surprisingly have never had a patient choose BMS with this approach.

Dr. Topol, I enjoyed your blog on DES; however I am concerned with the interpretation that these devices are no longer ?guilty?. Several independent analyses have confirmed an increased risk for late DES thrombosis which is unquestionably associated with morbidity and mortality to the individual patient. All of the recent registry analyses are prone to bias no matter how much propensity analysis is performed. In the Ontario study for example, the penetration of DES was less than 40% and stable during the period of follow-up. This shows that the operators were restrictive in who received a DES, and it is likely that DES were not implanted in patients who were sub-optimal candidates. At our institution, BMS are more frequently used in patients with limited life-span, medical non-compliance, acute coronary syndrome, extensive co-morbidities, bleeding problems, or upcoming surgical procedures. While these are good devices, we should continue to be more selective, rather than going back to unrestricted use.

Tony, While there is no question that DES are associated with increased late stent thrombosis, there is no current evidence that such events result in a net excess in death or MI compared to BMS. I have not argued for DES unrestricted use; my commentary simply is aimed to point out that DES were pronounced guilty ("death stents"; "tiny time bombs" ; "in cold blood") prematurely. The Stettler paper in Lancet of all randomized trials counters your point about registries.

Dr. Topol, Thank you for your comments. I certainly agree with you that DES should not have received such sensational headlines. I also did not feel that you were calling for unrestricted DES use. Rather my concern was more that the cardiology community could tend to go back in that direction, especially in light of recent data. Regarding the Stettler analysis; this was a comprehensive network analysis that indirectly derived data from head-to-head trials, in addition to DES versus BMS trials. While this type of analysis is the largest to date, it?s methodology is unprecedented in the cardiology community and potentially could have bias. I do agree with their finding of no excess mortality, as this has been shown in other studies; however the finding of decreased MI from DES will need to be confirmed. In summary, DES are excellent devices in appropriately selected patients. For these individuals we may learn that they can reduce MI through their marked reduction in restenosis, although for less optimal patients they have the potential to magnify harm.

The Duke lacrosse players were not found innocent of rape. Because of the way evidence was gathered, it could not be proven they were the rapists. That's a very different thing, and completely crashes your very shaky metaphor.

Dear Dr. Topol, I am a pediatric cardiologist at UCSD. I spend most of my time doing research on genetic causes of congenital heart disease. The reason I'm writing is to let you know that our program was just selected as an auxiliary site for the Pediatric Heart Network's/NIH-sponsored prospective trial comparing atenolol to Losartan for patients with Marfan syndrome. As the PI for San Diego, I am trying to recruit as many patients as possible. Participating in the study would in no way take the place of their standard cardiology care that they are already receiving. The upper age limit is 25 years, so I wanted to see if you might be able to identify any potential patients from UCSD that might qualify and be interested in participating. The National Marfan Foundation is also paying travel expenses for any participants that live outside the areas where there are participating centers. So, if any of your patients have any friends or relatives outside of San Diego with Marfan syndrome that are interested, they could participate too. I look forward to hearing from you. Thanks! Sincerely Yours, Paul Grossfeld, M.D.

Dear Dr. Topol,

 

I am a scared patient who received a DES in one artery in December. I have not felt well since and seem to not be able to tolerate the Plavix medication. I have headaches daily and little quality of life dealing with this. I am told by my cardiologist I need to stay on Plavix for one year at least and here I am just four months post-stent. I have always been migrainal and wonder why they would put a DES in a patient knowing they would need to adhere to the anti-platelet medications longterm. Aspirin has never been a problem for me so after one year I could continue that medication but my research and what I am hearing is that a patient needs to stay on Plavix long term for a DES to be successful.

 I desperately need expert advice. Thank you.

 Very Sincerely,

 

Kathy Galimore