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Drug-eluting stents do not increase risk of death, MI relative to bare-metal stents in patients with diabetes during long-term follow-up, analysis reveals

Thursday, November 13 2008 | Comments
Evidence Grade 7 What's This?
By Selma Kaszczuk

Patients with diabetes who are treated with drug-eluting stents (DES) experience no increased risk of death or myocardial infarction (MI) during long-term follow-up as compared with patients who receive bare-metal stents (BMS), new findings suggest.

Approximately one-third of individuals presenting for coronary stenting have diabetes, Dr. Laura Mauri of Brigham and Women's Hospital and Harvard Medical School noted, adding that diabetes is associated with increased rates of restenosis, procedural MI and mortality, and long-term MI and mortality. As a result, there is a need to compare the long-term safety of DES with that of BMS in people with diabetes, particularly given the conflicting results from earlier, smaller studies.

All percutaneous coronary intervention (PCI) procedures in Massachusetts are reported to the Massachusetts Data Analysis Center (Mass-DAC).  Dr. Mauri and colleagues analyzed PCI procedures from April 2003 through September 2004 that involved either DES or BMS in patients with diabetes. The sample included 5,051 subjects with diabetes who had been treated with either DES (n=3,341; 75% sirolimus-eluting and 23% paclitaxel-eluting; 2% received both) or BMS (n=1,710). Approximately two-thirds of the patients in both stent groups had non-insulin-dependent diabetes.

The subjects were propensity-score matched for 67 variables, and the final analysis included 1,476 patients in each stent group. The primary outcomes were risk differences at 3 years between DES and BMS for mortality, MI, and target vessel revascularization (TVR).

The matched risk differences at 3 years for mortality, MI, and TVR all significantly favored the DES group. Specifically, patients who received a DES had a 3.2% reduction in mortality (95% CI, -6.0% to -0.4%; P=.02), a 3.0% reduction in MI (95% CI, -5.6% to -0.5%; P=.02), and a 5.4% reduction in TVR (95% CI, -8.3% to -2.4%; P<.001) relative to those who received a BMS.

"Our primary concern really was to look at DES safety," Dr. Mauri said, noting that the study was designed to see whether there was an increase in the hazard associated with DES versus. BMS. "So it was to our surprise that we actually found significant differences in the opposite direction." (Abstract Oral Session 1311.)

Results of this study were published online Nov. 10 ahead of print by Garg P, et al. in Circulation.

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