Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry

Abstract

Objectives: The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (DES) and bare-metal stents (BMS).

Background: Comparative effectiveness of DES relative to BMS remains unclear.

Methods: Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke were compared with estimated cumulative incidence rates with inverse probability weighted estimators and Cox proportional hazards ratios.

Results: The DES were implanted in 217,675 patients and BMS were implanted in 45,025. At 30 months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 of 100 patients vs. 10.0 of 100 patients), and revascularization (23.0 of 100 patients vs. 24.5 of 100 patients) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.72 to 0.79, p < 0.001) and MI (7.5 of 100 patients vs. 8.9 of 100 patients, HR: 0.77, 95% CI: 0.72 to 0.81, p < 0.001), with minimal difference in revascularization (23.5 of 100 patients vs. 23.4 of 100 patients; HR: 0.91, 95% CI: 0.87 to 0.96), stroke (3.1 of 100 patients vs. 2.7 of 100 patients, HR: 0.97, 95% CI: 0.88 to 1.07), or bleeding (3.4 of 100 patients vs. 3.6 of 100 patients, HR: 0.91, 95% CI: 0.84 to 1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30 months of follow-up.

Conclusions: In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months of follow-up and across all pre-specified subgroups.

Figure 1

Population Selection – Flow Diagram

Figure 2a

Adjusted cumulative incidence for death with 6- and 12-month landmark display

Figure 2b

Adjusted cumulative incidence for MI with 6- and 12-month landmark display

Figure 2c

Adjusted cumulative incidence for revascularization with 6- and 12-month landmark display

Figure 2d

Adjusted cumulative incidence for bleeding with 6- and 12-month landmark display

Figure 2e

Adjusted cumulative incidence for stroke with 6- and 12-month landmark display

Figure 3

Adjusted cumulative incidence for STEMI with 6- and 12-month landmark display

Figure 4a

Subgroup results – Forest plot of Hazard Ratios for death

Figure 4b

Subgroup results – Forest plot of Hazard Ratios for MI

Figure 4c

Subgroup results – Forest plot of Hazard Ratios for revascularization

Figure 4d

Subgroup results – Forest plot of Hazard Ratios for bleeding

Figure 4e

Subgroup results – Forest plot of Hazard Ratios for stroke