Heartfelt with Dr Melissa Walton-ShirleyView all posts »
FAME or COURAGE: Can we have both?May 19, 2012 07:50 EDT
She came into the office as a 67-year-old postmenopausal female with dyslipidemia on atorvastatin (Lipitor), asking me to "check out" her heart. She takes warfarin for a deep venous thrombosis (DVT) and suspected pulmonary embolism (PE) over 10 years ago, which was unprovoked. She has about 40 pounds to lose around her middle and no definite family history of heart disease. She cannot really tell me about her exercise tolerance because she is sedentary. When she initially developed shortness of breath, for which she had an exhaustive workup including a Mayo Clinic visit, she subconsciously began to avoid doing anything that made her winded. She just assumed her "laziness" was caused by her prior "blood clot." Doing my due-diligence as a cardiovascular healthcare provider, I put her through the usual rigors of cardiovascular risk assessment:
- Resting echo: Normal LVEF and size, diastolic noncompliance, no significant valvular pathology, right ventricular systolic pressure (RVSP) 48 mm Hg.
- Calcium score: Total: 350-260 counts involving the left main coronary artery, no counts in the left anterior descending (LAD) artery, the remaining counts in the proximal circumflex and right coronary artery (RCA).
- Stress nuclear: Moderate distal lateral apical reversibility in a small segment, but only five and a half minutes of bike protocol testing was completed.
- * Lipids: Fairly well-controlled for the average American on Lipitor but with an LDL of 90.
- Postprandial blood sugar at two hours with 75-g Glucola: 170.
We had a couple of discussions by phone and a couple of office visits. We discussed the periprocedural awkwardness of stopping and starting warfarin and the option of a radial-artery approach in order to avoid it. Since her exercise tolerance was poor on little-acknowledged dyspnea, I really couldn't tell whether her symptoms were cardiac (ischemia or diastolic dysfunction), deconditioning, or "leftover" pulmonary vascular bed injury. I was nervous about the left main calcium counts. My tendency to cath in face of ischemia and minimal symptoms in a sedentary patient is fueled by my having been burned twice by that exact scenario. Those two patients failed "optimal medical therapy" in a big way despite having been deemed "stable." In addition, my prior invasive-cardiology mentor, J Davis Talley, always taught me to "worship at the tomb of the open artery," a "weakness" I struggle with on a daily basis. Although I haven't talked with him in many years, as closely as he watches the literature, I'm certain he has morphed his stance on that topic significantly. I wonder what he would have done with this patient.
My patient chose to undergo coronary angiography. To the interventionalist's credit, he resisted the oculostenotic reflex despite a 90% stenosis of the LAD, two diagonal branches that were also 90%, and an RCA of 60%. She walked back into my office with her boyfriend for another discussion as to "what to do now." Her family doctor cited the COURAGE trial, offered a change to rosuvastatin (Crestor), and recommended watchful waiting. The morning I opened the exam room door for her discussion was the morning that Shelley Wood, our managing editor of heartwire, posted the FAME II preliminary data from EuroPCR. It confirmed the suspicions we've all lived with throughout the interventional era but until now, the proof of it had slipped through our fingers. Indeed, we still aren't sure of how firmly we have that proof in our grasp until the data on hard outcomes are completely calculated.
FAME II begs for fractional flow reserve (FFR), but the patient is now back on warfarin and requires we go back through a DVT risk, bridging with enoxaparin (Lovenox), then the risk of "triple therapy" with warfarin, aspirin, and a thienopyridine. At the same time, she is not on the "optimal medical therapy" described by Dr De Bruyne in FAME II, when he stated that "over 86% of patients received beta blockers, 90% received ACE inhibitors, and 93% received statins." I have concerns regarding the lack of OMT because my patient had neither the heart rate nor the blood pressure for addition of a beta blocker or an ACE inhibitor. The day before the preliminary FAME II data were published; I would have folded my hands, admittedly with some reservation, and rested on the laurels of the COURAGE trial. Now, I think the best advice is to proceed on with a flow wire study, notwithstanding the hassles of bridging and juggling INRs. She asked me point blank what I'd do, and I told her that I would undergo a flow wire study if it were my coronary anatomy.
For now, the patient and her significant other are mulling over their options. They seem to be learning toward watchful waiting and a three-month follow-up. I explained that as long as she has 40 pounds of weight to lose, she will not be optimally managed. A failure to perform daily exercise will also contribute to her risk of plaque rupture, further fueled by her mild glucose intolerance. She joked that she had just stopped at Dairy Queen last week and wasn't sure she could give up her ice-cream habit. I worried as she left the office that despite such superbly designed studies, those outcomes could still misadvise us, as they cannot possible take into consideration the very impactful issues of compliance, glucose intolerance, sedentary lifestyle, and the professional and personal interpretations of whether or not the patient is truly symptomatic.
"Heavy is the head who wears the crown" as the decision maker with regard to recommending for or against coronary intervention in the patient without STEMI. In my 21 years of private practice, there have never been so many pieces of the puzzle to consider in this decision-making tree. It seemed so much easier, back in the day when we practiced the "caveman" mentality of "see blocked artery, do blocked artery." The complication rates were low, but the costs of medical therapy were high, and we can no longer afford it. All we can do is weigh the information we have against individual patient characteristics; do what has worked well for the majority of our patients throughout our practice experiences; arm our patients with information on diet, exercise, and the importance of medical compliance; load them up with medications proven to reduce risk; and cath those who worry us. It seems that FAME II may have just taken a whole lot of guesswork out of this formula, and I hope cath labs across the country will adopt this approach if the final calculations in the primary end points are impressive.
I want what all cardiologists want for our patients. We want them to be safe, and we want them to have a good quality of life. We must acknowledge that we cannot just hang our hats on mortality reduction alone as our guide. We need to analyze as much data as possible to continue our quest to advise our patients we well as possible. At the end of the day, I do not want to be labeled as COURAGEOUS or FAMOUS.
For the sake of my patients, I just want to be right.