We have known since the publication of the COURAGE trial in 2007 that percutaneous coronary intervention (PCI) does not reduce the risk of cardiovascular events among patients with stable angina. Interventional cardiologists, however, continue to recommend widespread use of these procedures on the basis that PCI may relieve symptoms of angina. In what will likely prove to be another landmark study on the topic, in the ORBITA trial – published recently in the Lancet — researchers randomized 230 patients with stable angina and at least 70% single vessel coronary stenosis who had been optimized on medical therapy to receive either a stent or a sham procedure. At 6 weeks of follow-up, patients in both groups had similar changes in their exercise capacity. While ORBITA was a small study, and may have been underpowered to detect small benefits to exercise capacity, these findings reinforce our current practice. We advocate lifestyle changes and medication therapy for most patients with stable coronary disease, reserving consideration of revascularization (either PCI or CABG) only for patients with severe persistent symptoms or certain specific findings (i.e., a markedly abnormal exercise stress test involving hypotension during stage 1 of the Bruce protocol, patients with left main stem coronary disease, or those with ejection fractions <30% since all of these were exclusion criteria in COURAGE and/or ORBITA). We hope this study's results will help bring others in the medical community in line with the Slow Medicine approach to stable angina.
Earlier this month, Milton Packer, MD, – co-principal investigator of the PARADIGM-HF trial (sacubitril/valsartan) and chair of the executive committee for the EMPEROR trial program (empagliflozin) — wrote a compelling MedPage Today perspective piece that has garnered widespread attention. In the piece, Packer describes speaking about recent advances in heart failure to a group of physicians who evaluate prior authorization requests for insurance companies. At the end of the talk, he asks his audience whether they were encouraged by the data he presented, and if they plan to begin authorizing the new medications like sacubitril/valsartan. He received an astonishing answer. One of the physicians explained: “Yes, you were very convincing. But the drugs are too expensive. So we typically reject requests, at least the first time. We figure that, if doctors are really serious, then they should be willing to make the request again and again … Plus, if I approve too many expensive drugs, I won’t get my bonus at the end of the month. So giving out too many approvals wouldn’t be a smart thing for me to do. Would it?” This story is of course disturbing, and we are disheartened – though not surprised – to learn the extent to which the drug approval process is influenced by the bottom line. But also disturbing (though perhaps not quite as appalling) are all the times in which unnecessary, ineffective, and potentially harmful therapies are approved by insurance companies. As we’ve previously written, too often new medications such as sacubitril/valsartan or empagliflozin are widely adopted in clinical practice before it is clear that their benefits outweigh the harms. While we find it disgraceful that physicians reviewing authorizing requests receive bonuses for denying medication requests, we believe there is a need for a general re-thinking of the utilization review process such that it better aligns with the evidence.
How should we incorporate nutrition counseling into our busy clinical practices? JoAnn Manson and a colleague discuss practical approaches for doing so in a recent JAMA Viewpoint. We particularly like their emphasis on small, sustainable steps and a team-based approach. While we might not have time to explore an individual’s dietary approach during each visit, we do try to use almost every visit as an opportunity to emphasize the relative importance of lifestyle changes compared to the medical interventions we have to offer.
According to important new research in JAMA, among women “without a history of infertility who had been trying to conceive for 3 months or less, biomarkers indicating diminished ovarian reserve compared with normal ovarian reserve were not associated with reduced fertility.” Writes the editorialist: “women who have never attempted to conceive should not be evaluated in a manner similar to those with infertility. Doing so can not only provide potentially misleading and anxiety-producing results but may also lead to costly fertility preservation treatments that have no value.”
Which patients with an ischemic stroke will benefit from closure of a patent foramen ovale (PFO) — a defect found in 25% of healthy people — remains an area of controversy. The authors of a recent NEJM perspective describe a thoughtful approach to making the decision: closure should only be pursued after consultation with both a cardiologist and a neurologist along with an extensive work-up for alternative etiologies.
A pair of studies in last month’s JAMA has shed light on the overly exuberant adoption of robotic surgery. The first study found that between 2003 and 2015, the use of robotic surgery for radical nephrectomy increased from 1.5% to 27%. This change was not associated with changes in surgical complications, however, it was associated with prolonged operating time with laparoscopic surgery. In the second study, the authors conducted an randomized controlled trial comparing robotic-assisted versus conventional laparoscopic surgery among patients undergoing resection for rectal cancer, and concluded that the robotic-assisted procedure “does not confer an advantage in rectal cancer resection.” An accompanying editorial concludes: “for procedures in which a minimally invasive laparoscopic procedure is already in use, there is often no meaningful incremental benefit in the use of robotic assistance in terms of complication rates or recovery. Importantly, in these scenarios, robotic-assisted operations are often associated with longer operating times.”
Canakinumab, a human monoclonal antibody against interleukin-1 beta, was recently found to have beneficial effects in patients with stable coronary artery disease in a major study in the NEJM. There are trade-offs, however, including life-threatening infections that merit serious pause, and we agree with the editorialist that more research is needed to determine when canakinumab is indicated for stable coronary heart disease.
As we have explained in our “Disruptions or Distractions” series, even intuitive care delivery interventions may not work as intended. This appears to have been the case for a care management program targeting nursing home residents that was evaluated in JAMA Internal Medicine. The program involved several strategies, including helping nursing home staff be more systematic about identifying acute changes in their patients and promoting advanced care planning. The analysis found no impact on emergency room and hospitalization rates among the nursing home residents. Similarly, a recent systematic review in the Journal of General Internal Medicine concluded that primary care interventions focused on high-need, high-cost patients do not consistently prevent subsequent hospital utilization nor do they uniformly improve outcomes. As Stanford professor Steve Asch put it in a piece we wrote last year on the topic, “because so few controlled trials have been undertaken” on programs targeting high risk patients, “the jury is still out” regarding what works.
A new study in JAMA has found, disappointingly, that sertraline is ineffective for major depressive disorder among patients with non-dialysis-dependent chronic kidney disease. This finding comes in the wake of mounting evidence that many therapies found to work in the general population may be ineffective among patients with chronic kidney disease. For example, research has failed to demonstrate a benefit of statins in patients undergoing dialysis. Research has also raised questions about the value of SSRIs among patients with other chronic conditions, such as heart failure. These findings are noteworthy because use of antidepressants and statins are common among patients with CKD and heart failure, yet it now appears these therapies may not be broadly effective in these populations. More generally, it highlights the importance of rigorously assessing therapies in different populations. Just because an approach works in one population does not guarantee it will work in another.
Finally, a JAMA case report highlights the potential value of using a “patient safety framework” for addressing the problem of overuse in healthcare. According to the editorialist, the National Academy of Medicine includes underuse, misuse, and overuse as part of their framework for assessing quality and safety. To date, however, the lion’s share of quality improvement work has emphasized underuse and misuse. Perhaps it’s time to begin tackling the problem of overuse with this same resolve.
“Updates in Slow Medicine” applies the latest medical research to support a thoughtful approach to clinical care. It is produced by Pieter Cohen, MD, of Harvard Medical School, and Michael Hochman, MD, MPH, of the Keck School of Medicine at the University of Southern California. To learn more, visit their website.