..."the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.This could spell more bad news for Johnson and Johnson and Boston Scientific if further cuts in reimbursement for drug-eluting stents are implemented.
Almost on cue, data from a single-center observational study were published earlier this week in the American Journal of Cardiology that suggested that drug-eluting stents might be superior to bare metal stents in such "off-label" patients:
Abstract: In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.This study was sponsored by Johnson and Johnson. What the effect on long-term clopidogrel therapy, recently recommended to prevent the late in-stent thrombosis of drug-eluting stents has on these "off-label" patients, especially after nine months (when in-stent thrombosis is seen), remains untested. Look for significant positioning by these companies to continue the status quo.
References: Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Talal T. Baki, Sanjay K. Gandhi, Renato M. Santos and William C. Little, Comparison of Drug-Eluting Versus Bare Metal Stents on Later Frequency of Acute Myocardial Infarction and Death, The American Journal of Cardiology, Volume 99, Issue 3, 1 February 2007, Pages 333-338.
Keith Winstein, "Agency Reviews Stent Coverage," Wall Street Journal (Subscription), 6 February 2007, Page D4.