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Drug-Eluting Stents, Bare-Metal Stents, and Bypass Surgery
Data from two studies suggest that when considering PCI, the setting matters more than the stent.
Drug-eluting stents (DES) are frequently used in off-label situations. Two new observational studies illuminate the real-world use of DES.
In the first study, investigators used data from the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry to compare the safety and efficacy of DES versus bare-metal stents (BMS) for manufacturer-approved versus off-label indications. The off-label group (1312 DES recipients and 2110 BMS recipients) included patients with lesions that were restenotic; in bypass grafts; in long (>30 mm), small, and large vessels; at ostial, left main, and bifurcation locations; and totally occluded. DES recipients had longer and more complex lesions than BMS recipients and also were more likely to be receiving dual antiplatelet therapy at 1 year. In this group, mortality at 1 year was lower in DES recipients (3.7%) than in BMS recipients (6.4%, P<0.001), although no significant difference remained after adjustment for baseline characteristics. The adjusted risk for repeat revascularization was lower with DES than with BMS (hazard ratio, 0.63).
In the second study, a report from the New York State Department of Health, researchers compared outcomes in 7437 patients who underwent coronary artery bypass grafting (CABG) from October 2003 to December 2004 and in 9963 patients who received DES. The mean follow-up period was about 19 months. Adjusted mortality was lower with CABG than with DES, both in patients with 3-vessel disease (HR, 0.80) and in those with 2-vessel disease (HR, 0.71). In patients with 3-vessel disease, the adjusted survival rate was 94.0% at 18 months with CABG versus 92.7% with DES (P=0.03). In DES patients, the rate of target-vessel revascularization was 7.0%, and subsequent CABG was performed in 2.2%. Subsequent percutaneous coronary intervention was performed in 5.1% of CABG patients.
Comment: The NHLBI results suggest that although drug-eluting stents in off-label settings may pose greater risks than in approved settings, the risks are similar to those of bare-metal stents, and the need for repeat revascularization is reduced. The New York State findings of lower mortality with CABG than with DES in patients with multivessel disease, while significant, were slight (about 1%) and limited by incomplete follow-up data (deaths occurring outside of New York State were not recorded) and the need for substantial adjustment for differences in baseline characteristics. As the editorialist notes, unmeasured confounders as well as patient and physician preference may have influenced the results of both studies, and longer follow-up is necessary to confirm the relative safety profile of DES; nonetheless, these reports provide useful data for making better-informed decisions.
Published in Journal Watch Cardiology January 23, 2008
Citation(s):
Marroquin OC et al. A comparision of bare-metal and drug-eluting stents for off-label indications. N Engl J Med 2008 Jan 24; 358:342.
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- Medline abstract (Free)
Hannan EL et al. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med 2008 Jan 24; 358:331.
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- Medline abstract (Free)
Carrozza JP. Drug-eluting stents — Pushing the envelope beyond the labels? N Engl J Med 2008 Jan 24; 358:405.
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- Medline abstract (Free)