Medical Device Daily Washington Editor

Reports of higher rates of thrombosis for drug-eluting stents (DES) have been linked to the failure of patients to maintain recommended anti-platelet therapy – one reason often cited being the high cost, as much as $3,000 for a long-term regimen of plavix.

Besides the clinical implications, there is the marketing downside: a chilling of the DES market over the past year.

Reading the cardiovascular tea leaves, Boston Scientific (Natick, Massachusetts), maker of the Taxus DES, on Friday unveiled a program that pushes increased compliance with prescribed anti-platelet therapy. The effort consists of what it terms an aggressive patient education effort and adherence program that will hopefully keep patients on anti-platelet therapy for the recommended duration.

The company said it will provide up to $40 million for the program.

The initiative will not involve direct payments for any anti-platelet drugs but will include "a patient assistance program designed to facilitate access to financial support for anti-platelet therapy for patients who qualify."

Program funding will go primarily to education, outreach and patient follow-up. This will consist of phone calls, e-mails and standard mail pieces. The company said it will begin training for "the initial education component" of the initiative immediately and launch it in the U.S. "later this year."

"As the leader in interventional cardiology, Boston Scientific is committed to patient care and physician partnership," said Paul LaViolette, the company's COO in a statement.

And he noted the program isn't just for those implanted with Taxus. "We are pleased to offer this program to all DES patients, not just TAXUS patients, to encourage participation in the program for all physicians. We expect these efforts will increase compliance and optimize clinical outcomes for DES patients."

The ideal duration of anti-platelet therapy, which usually entails the use of both Plavix and aspirin, was the subject of some discussion but few firm conclusions at recent FDA hearings on DES. Following those hearings, FDA issued a statement that 12 months is probably as good an estimate as any for anti-platelet use (Medical Device Daily, March 9). On its web site, the agency indicates that "patients [should] receive aspirin indefinitely plus a minimum of 3 months (for Cypher patients) or 6 months (for TAXUS patients) of clopidogrel, with therapy extended to 12 months in patients at a low risk of bleeding."

Charles Rudnick, director of corporate communications at Boston Sci, said that the company currently has no plan to extend the program to those getting bare-metal stents, but "maybe down the road" if conditions warrant this.

As to whether Cordis might join the effort with a similar program, he said that Boston Sci "would certainly welcome participation by other companies in the industry" but is not recruiting other stent makers.

Fewer admissions for CAD seen

Though heart disease continues unabated, hospitals say they are admitting fewer patients for coronary artery disease, and the drop coincides with a number of other factors, including the increased use of cholesterol statins and drug-eluting stents.

The March 15 edition of the American Journal of Cardiology includes an article by a team of researchers at the University of Michigan Medical Center (Ann Arbor, Michigan) and the Ann Arbor Medical Center that states that recent advances in treatment "may be shifting patients with coronary artery disease away from the hospital setting despite an aging population."

Employing the Acute Care Tracker (ACT) database, which contains data on roughly 6 million annual discharges from almost 460 hospitals in the U.S., the number of admissions for acute myocardial infarction (AMI) fell from roughly 661,000 in 2002 to 591,000 in 2005, "primarily due to decreases in transmural AMI," a severe form of the condition that damages "the whole thickness of the heart, from the endocardium to the epicardium," according to Stedman's Medical Dictionary. The incidence of transmural AMI dropped from 118 to 87 per 100,000 over the specified period, a difference of 25 per 100,000, while the overall incidence of infarction 309 to 266 per 100,000, a difference of 43 per 100,000.

Janet Young, MD, one of the authors of the article, said that despite the anticipation that the oncoming "Baby Boom" will swell hospital admissions for coronary heart disease, "the reality is that changes in treatment may be causing a shift to the outpatient setting," a trend with "important implications for hospitals and health systems and their allocations of resources."

Coronary artery bypass grafts (CABG) procedures tailed off substantially between 2002 and 2005 as well, from 258,000 to 209,000 at a time when percutaneous interventions jumped from 564,000 to 592,000. The drop in CABG procedures fed an overall decrease in surgical revascularizations, which hit a rate of 358 per 100,000 in 2005, down from 382 per 100,000. This, of course, may be in response to patients generally seeking the much-publicized less interventional approaches.

The ACT database is managed by Solucient (Evanston, Illinois), a healthcare management consulting firm.

Juvenile lipid levels a future 'epidemic'?

Older cardiovascular patients may be staying out of hospitals, but a recent medical journal article indicates that hospitals might not have to wait much longer for "post"-Boomers to take up the slack.

The surge in pediatric obesity in the U.S. has come with a surge in cholesterol levels, and the American Heart Association (AHA; Chicago) used Circulation to highlight the issue.

In an article in the March 21 edition, researchers McCrindle, et al, writing for AHA, state that gathering evidence "now indicates that the atherosclerotic disease process begins in childhood" and that lipid abnormalities, which are blamed for accelerating the disease process, are rising in parallel with the "epidemic of obesity and the metabolic syndrome."

This situation, the authors say, "may soon burgeon into an epidemic of premature cardiovascular disease."

Researchers are said to have established that for those under the age of 18, statins demonstrate "effectiveness and short-term safety similar to those in adults." On the other hand, the authors are not ready to send sensible diets and steady exercise regimes to history's dustbin just yet. They indicate that they are not recommending "widespread use of medications to treat the epidemic" but are more focused on "extreme lipid abnormalities or conditions with an underlying high risk of cardiovascular disease" that might be abetted by high cholesterol levels.