Physicians, Academics Clash Over Stents

Angioplasty and the insertion of stents are among the more widely accepted and seemingly understood medical procedures, even among laypeople. For instance, my octogenarian mother told me the other day about an acquaintance with a heart condition. "He's only in his 40s, but he's had a stent, and he's doing great. You know, an angioplasty." She's no M.D., but she is conversant in the subject.

But after decades of acceptance, this commonplace surgical procedure is at the center of many heated discussions in medical circles these days. Academics and doctors are clashing over the proper surgical procedures for stents and angioplasties and, even more surprisingly, challenging the fundamental necessity for stents, the "tiny mesh sleeves" designed to keep coronary arteries open.

It's not an open or closed case.

Stents are under the microscope now more than ever, especially with the recent focus on the for-profit hospital chain investigating HCA in the wake of a New York Times report of allegations that some HCA hospitals were performing unnecessary and sometimes dangerous heart procedures with the aim of driving up revenue.

One of the key focuses of the investigation is whether there was unnecessary stenting for patients who did not have significant coronary artery blockage. About 1,200 cardiac interventions that were deemed to be unnecessary were completed at the Lawnwood Regional Medical Center in Fort Pierce, Fla., according to the Times.

The 4,000-member Society for Cardiovascular Angiography and Interventions (SCAI), a Washington, D.C.-based organization representing invasive and interventional cardiologists, is one of the main special interest physician groups whose constituents perform such procedures. SCAI is watching the unfolding scenario involving HCA closely.

The group also monitors clinical trials and studies that often report contradictory findings about stent use, raising concerns among physicians. The question of unnecessary stenting goes to the heart of what SCAI is trying to do to improve outcomes for hospitals as well as physicians, and especially patients, says Jeffrey Marshall, MD, president of the SCAI, who practices at the Northeast Georgia Medical Center in Gainesville, GA.

With all the controversy involving stents, SCAI is stepping up its accreditation process for cardio labs and stepping up calls for hospitals to use registries to document stent use.

The organization has partnered with the American College of Cardiology to form a separate not-for-profit named Accreditation for Cardiovascular Excellence "to evaluate and accredit cath labs in our country," Marshall says. The organization was established two years ago. "These things started before (the HCA questions arose,) and now there is beginning to be a groundswell of support in the medical community for it," Marshall says.

"There's a vigorous evaluation of cath labs. Processes are being examined for quality. So the SCAI has been way ahead of the curve on these things."

Indeed, there has been a curve, in the unsteady and contradictory studies and reports on the use of stents or angioplasty. One of the most significant and highly publicized was the 2007 COURAGE study (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), which essentially found that patients undergoing medical therapy had outcomes that were just as good as angioplasty or stent placement to relieve their angina.

The study revealed that percutaneous coronary intervention (PCI)—the medical term for angioplasty—offered "no benefit over aggressive medical management when performed in patients with stable artery disease and suggests that PCI may be deferred in patients with stable disease as long as medical therapy is optimized and maintained."

On the flip side, another recent clinical trial gained attention this year because it seemed to favor stenting in particular cases, although it was never completed, prompting even more debate. That study, from St. Jude Medical, a medical technology company, called FAME II, examined the outcomes of 888 patients with significant blockage of at least one coronary artery.

Researchers used a new technique—known as fractional flow reserve—to decide if a patient should have a stent or not. The study authors suggested that FFR could help doctors figure out whether a patient's coronary blockage was going to put them at risk for a heart-related emergency, such as a heart attack or chest pain. The trial was stopped early because those who had not received stents experienced more heart attack symptoms and emergency hospitalizations than their stent counterparts.

St. Jude Medical acted after the Data Safety and Monitoring Board found "increased patient risk for major adverse cardiac events among patients randomized to optimal medical therapy alone compared with patients randomized to optimal medical therapy plus (fractional flow reserve) guided PCI. At the time the study was stopped, 12.7% of patients without stents had experienced one of these cardiac events while only 4.3% of people who received stents had.

In an understatement, the American College of Cardiology Foundation and SCAI issued a report  this year on cath lab standards that notes stents have become a "particular hot button issue since the publication of certain politically provocative articles."

The report noted that stents have been overwhelmingly successful, citing, among other things, a Mayo Clinic report in 2009 that published 25-year trend data regarding the hospital's experience with angioplasty or PCI procedures. It found that despite an older and sicker population with more comorbid conditions, the success rate from PCI had improved from 78% to 94%, while hospital mortality had fallen from 3.0% to 1.8%.

But as my colleague Cheryl Clark writes, a study reported this year in the Journal of the American Medical Association noted that inappropriate angioplasty "still goes on—a lot." Of 14,737 non-acute patients who underwent a PCI, 11.6% did not meet the necessary criteria for a 15-month period ending in September 2010.

One of the ways that physicians can evaluate stents is by becoming involved in registries, SCAI's Marshall says.  Indeed, the American College of Cardiology report notes that it strongly encourages all laboratories to participate in national registries. That way, "all laboratories can benchmark their performance and make appropriate corrections."

The controversy over the use of stents will not go away, no matter how familiar the little artery openers are to the patient population. From Marshall's perspective, patients' quality of life generally improves with angioplasty or stents. "I think it's very clear, in certain situations—specifically if you are having a heart attack, for instance—the best treatment, and to save lives, is to have a stent," Marshall says.

But, he adds emphatically, "SCAI is very concerned, I would say deeply concerned about any inappropriate use for stenting," referring to the HCA allegations. "There's a real sense of dismay, and that bothers us." Marshall says. "Ultimately, quality of life is what we are most concerned about."