GATHER ALL YE FACTORS
I’m trying very hard to make a rational decision on an important medical consideration with a brain that is being kept from thinking by the drug supposedly required to keep my new stents from causing me problems themselves.*
Why? Because the side effects are not only bad, but getting worse daily.
THE PROBLEM
What’s at stake?
Possibly life vs. being a thinking being.
What is a clear statement of the problem?
The drug clopidogrel (generic Plavix) has side effects which are making this writer’s life impossible to live: I can’t think, ergo I can’t write. And since writing is the only thing left in my life that I can do, this is a very big deal. Pain levels are hugely larger: I have acquired a chronic headache, and my pain control meds for CFS don’t work properly. Taking extra over-the-counter drugs is a problem for bleeding and long-term liver damage, and they are not really helping.
Timing considerations?
They want me to take the clopidogrel for 10 more months at a minimum.
I haven’t had enough energy + brainpower to write fiction since April 8; I started the drug in question (clopidogrel) on March 23 when the previous anti-platelet drug sent me to the ER with a huge BP spike (the BP had been increasing, hockey stick exponentially, for several days at that point).
Complicating factors
Chronic health conditions already in place: ME/CFS, twenty-seven years duration; severely limited mobility, due to botched back surgery ten years ago.
Clopidogrel has the side effect, among others, of bleeding; being on it increases my risk of stroke; since I’m also taking Celebrex and OTC NSAIDS, the risks are additive.
Due to the CFS, my body is highly intolerant of most meds; they started two BP meds and a cholesterol lowering statin at the same time as the Effient (anti-platelet); the side effects were ferocious. I dumped them all, except for the Effient, within three weeks of getting the stents.
When switched to clopidogrel, it took about two weeks for the side effects to build (typical for this drug), and three weeks for me to figure that out (typical for this brain on these drugs).
Alternatives?
Effient – which raised my blood pressure to high enough levels for me to end up at the ER five weeks after starting it; and Brillinta – which has its own whole host of potential side effects; the doctor said her patients on it complain fiercely of the side effect of shortness of breath.
NOTE: I have not yet tried Brillinta; would probably face a similar decision in whatever time it takes for its side effects to become intolerable.
Fish oil has some anti-platelet effect; I have taken it with no problem in the past.
Resources for making the decision:
Doctor’s recommendations – never stop clopidogrel for any reason. No concern about or help with side effects.
Online scientific papers exploring the drug and the possible complications both of taking it AND of not taking it.
Severely limited human brain – having zombie side effects from said clopidogrel while trying to make a decision.
Vague information in papers of the effectiveness – and dose – of fish oil.
Previous experience making difficult decisions:
While I was doing my PhD in Nuclear Engineering (plasma physics) at the U. Wisconsin-Madison, the only woman in my cohort, I would tell myself that I was under such stress it was impossible to make good decisions; that making a good decision on whether to quit the program and do something else with my life was too important to be made unless I did it well; and that I would have to be finished with the PhD before it would be possible for me to make a decision NOT to finish it. (With the complication that I planned to apply to the astronaut program, and KNEW NASA would never consider me if I dropped out of a PhD program.)
I am happy I finished. I got my chance at NASA, though one of my eyes missed their cutoff, and they had candidates without that limitation to choose from so did not make exceptions. But I made it to Houston, almost made the cutoff, and will always treasure that.
Difficult MEDICAL decision: I was 24. I started running. I developed bursitis in my right hip. Doctors at University of Wisconsin hospitals wanted to operate on my hip. That sounded crazy to me, so I got myself out of there, found an orthopedist who specialized in sports medicine (yeah, me, the total non-athlete), explained I had just started ‘running.’ He told me no guarantees, but built me orthotics – and that was all I needed for running for many years.
Difficult MEDICAL decision: After back surgery in 2007, I couldn’t walk properly, and had a fair amount of pain. The same surgeons who made this possible wanted to operate again, would not guarantee any improvement, only ‘keeping things from deteriorating further,’ and I walked out of there, learned to deal with the pain with yoga and stretching and strengthening exercises (THEN lost weight). In 2014, another round of the same – two more orthopedic surgeons – with the exact same words: ‘less than 50% chance of walking properly, but prevent further deterioration.’ Have not taken them up on their ludicrous offer; if I’m going to put myself through the hell of another 6-12 months recovering from back surgery, it’s going to be for someone who knows what he/she is doing enough to give me MUCH better odds of walking again. I don’t want even more scar tissue back there when I find the right surgeon. I’m not necessarily saying these are GOOD decisions, but they were certainly the right decision for THOSE doctors. I try again periodically, but there is little energy to work with.
THE GOAL
Simple: I wanted to go off the anti-platelet drugs, and I wanted to know how much risk I would assume by doing so, if such were known.
This is what is meant by ‘Informed consent.’
[NOTE: this is not my job, calculating risks, but it freaked the cardiologist out even to be asked. You would have thought I was intending to jump out of a plane with no parachute, and I was warned of immediate massive heart attacks and told anecdotes about same in people who were so foolish as to stop their anti-platelet ‘therapy’ and ended up immediately back in the hospital.]
THE DECISION PROCESS
*NOTE: I started this post when I had not made the decisions I’m talking about. WITH ZOMBIE BRAIN.
On inspection, I find it awkward and rough, and have decided NOT to change what I wrote precisely because that is the way most of us have to face these decisions: not in the comfort of hindsight, but right in the middle of the fray, with everything going on, with side effects rampant, and the doctor’s ‘advice’ ringing in our ears – and OFTEN without any actual DATA. The ‘recommendations’ created by a panel of medical experts are only as useful as the specificity they include; if they don’t take into account your gender, age, previous medical condition, and the particular side effects, they are USELESS for you in making an INFORMED DECISION.
So what did I do to acquire all the information to make the best decision?
I read. Probably a hundred scientific papers on:
- Short- and long-term dual anti-platelet therapy (DAPT)
- Anti-platelet drugs
- Drug-eluting stents (DES), especially the second generation ones such as the ones I’ve had implanted
- Discontinuation reasons and side effects
I also read about:
- Cardiac rehab
- Heart attacks in women and differences (heartily recommend Heart Sisters blog)
I consulted my online groups:
- CFS Support group
- CFS Exercise with a heart rate monitor group
- and comments on my blog posts
I read the journals I have been maintaining since stent installation – I have over 60,000 of my own words recorded, side effects and observations and BP readings and drug history. (Okay – 10% of that is the automatic time stamp from Scrivener – everything has one.)
It was done with ZOMBIE BRAIN; my notes are erratic, and all over the place, when I want to find something I thought I had made a copy of.
Most researchers did NOT study the cohort of people who dropped out of their studies on the effectiveness of these drugs and stents. I find that medical malpractice: they had data, didn’t analyze it and/or didn’t publish it.
Once patterns started emerging, I was more focused, and could look for specific papers.
A specific link led the way: Medtronic, in 2013, announced that its new second-generation stent had ‘No Stent Thrombosis Seen When Plavix and Aspirin Stopped Early.‘ They actually STUDIED the people who stopped taking the drug for various reasons; out of a 5000 people study, ONE THOUSAND did so. The conclusion – not much difference in results, as long as the DAPT was maintained for the first month (during which it was hypothesized that the stents hadn’t finished their new inner layer of epithelial cells in the cases that had problems – or were not placed correctly – or some such).
THE DECISION
My decision – not to take clopidogrel any more, NOR ANY OTHER ANTI-PLATELET DRUG, after I’d already taken Effient for 5 weeks and clopidogrel for a month after that:
April 25, 2017 at 11:21 PM
Nervous – who wouldn’t be.
TAKING FISH OIL 1200 MG. CAPSULE WITH NIGHT PILLS, INCLUDING BABY ASPIRIN, BUT NOT CLOPIDOGREL.
[Note: fish oil has mild anti-platelet and BP lowering effects – I’ve taken it before with no problems; don’t remember why I stopped. Sympathetic magic?]
From what I had found and read, I expected a small – if any – additional risk factor. In the papers which were against taking this or any risks, the few numbers available often indicated a tiny ABSOLUTE risk increment (1.2% to 1.8%) blown up to look horrible by being quoted, based on the risks of taking the stuff, as a FIFTY PERCENT larger risk [RELATIVE risk: 1.2% plus 50%(1.2%) = 1.8% risk IS a 50% larger risk – the statistics are correct and insignificant and inflammatory – cf. How to Lie with Statistics, a wonderful little book for non-scientists and non-mathematicians.]
I assumed that risk knowingly, and in consultation with my life partner.
THE ANTICLIMAX (of course)
AFTER I had made my agonized (and much discussed with spouse) decision, I found the paper I SHOULD have been pointed to in the manufacturer’s information on the stents in the family of second generation DES called XIENCE, and by the doctors:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3706013/
ISRN Cardiol. 2013; 2013: 748736.
Published online 2013 Jun 23. doi: 10.1155/2013/748736
PMCID: PMC3706013
Risk Factors for Coronary Drug-Eluting Stent Thrombosis: Influence of Procedural, Patient, Lesion, and Stent Related Factors and Dual Antiplatelet Therapy
Krishnankutty Sudhir, 1 , 2 ,* James B. Hermiller, 3 Joanne M. Ferguson, 1 and Charles A. Simonton 1
NOTE THAT THE VERY TITLE MAKES IT UNLIKELY TO COME UP IN CASUAL SEARCHES. Title doesn’t even mention the brand of stents, nor does the title imply there will be far-reaching recommendations at the end about DAPT.
The relevant parts of the conclusions (ST is stent thrombosis, literally, the stent clogging up, a very rare but potentially fatal complication – see Sec. 8 of paper for details):
9. Conclusions
ST represents a major complication of DES implants, usually leading to either cardiac death or MI. Preclinical studies have shown that inflammation, parastrut fibrin, and endothelial coverage vary between stents, and more biocompatible polymers in newer DES may have improved endothelial coverage and thus less ST. The risk of ST in an individual patient is related to numerous factors that include patient and lesion complexity, suboptimal stent deployment, adherence to and duration of dual antiplatelet therapy, and stent type and design (see Table 1). There is emerging evidence that second-generation stents, particularly XIENCE V, have significantly lower ST rates compared to first generation stents. Various components of the newer DES… may all contribute synergistically to the preclinical and clinical evidence of enhanced safety. …Treatment with DAPT for a year is currently the standard of care for DES, but more potent antiplatelet agents such as prasugrel and ticagrelor may be beneficial in high-risk patients. DAPT interruption appears safe beyond 30 days in standard risk patients and beyond 6 months in an all-comers population that received the XIENCE V DES. The optimal duration of DAPT for DES is unknown; recent data indicate that short-term therapy may well be sufficient for real-world patients treated with XIENCE, a finding that should be systematically confirmed in large-scale randomized controlled trials.
Weasel wording in various places reminds us that these things – stents AND DAPT – are very big business (in 2011, Plavix was the second largest drug in the WORLD, bringing in 9 BILLION dollars for its creator; even now that generics are available, these are still very remunerative drugs), and researchers have to mind their ps and qs until recommendations change for the medical boards – if they ever do.
Bleeding risk due to DAPT not mentioned in this paper, but it is, of course, larger with clopidogrel than without. And one of the main problems of long-term DAPT.
THE AFTERMATH
I have NOT changed my decision, but finding this paper – on the very XIENCE stents I have in my arteries – really took a lot of the residual stress (stress is bad for cardiac patients; stress kills) out of my life.
I’m not saying I will not have an ‘adverse effect.’ No one can guarantee that. I’m saying that my INCREASED risk is negligible to zero, and now doesn’t include the component of BLEEDING that is the bane of long-term DAPT, and since I’m also terrified of strokes, and believe I may be at an increase risk of those because of my pain meds, that has ALSO reduced my stress.
For normal people, clopidogrel is out of their systems in 5.5 days. I’m not normal (my liver seems to process things very slowly, possibly why I have so many side effects), but it’s been that long now, and the first thing to go was the back pain, and the exaggeratedly painful flares after exercise (my EIGHT pitiful minutes of cardiac rehab three times a week set off days of unmanageable pain). I still haven’t heard back from the doctor’s office about my request for pain med prescriptions and advice on OTC amount limits. My next appointment is scheduled in three months. I guess I could call back, but maybe I’ll just wait until July. My husband knows what I did.
The brain may be coming back (this latter part of this post is far more coherent, I think) – I had a short period yesterday in which I was able to read my notes about where I am in Chapters 22 and 23 of Pride’s Children: NETHERWORLD, and sketch out a few dialogue exchanges. Rough when I reread them, possibly usable. I hope I was not on clopidogrel long enough to do actual damage.
This is part of me working through my Post-Traumatic Stress – writing and talking about things, and resuming control of my life where possible.
I am STILL grateful to be alive. I am STILL not happy with any of the process.
I would have willingly assumed a reasonable additional risk, as the side effects were escalating, and I had no desire to go through every anti-platelet drug in their arsenal to try the more esoteric ones. But I have the very strong feeling I have assumed NONE.
My thanks to Stencil for providing the ability – and a nice clean interface – to make the graphics I use for many of these posts. I’m using a free account, but would use them in a flash if I needed more than the 10 free images a month.
Keep me stress-free – recommend my fiction.
I couldn’t put a tenth of what I found into this post; please ask any questions you have.
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Dear Frank
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