Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts

Laura Mauri, Treacy S Silbaugh, Robert E Wolf, Katya Zelevinsky, Ann Lovett, Zheng Zhou, Frederic S Resnic, Sharon-Lise T Normand, Laura Mauri, Treacy S Silbaugh, Robert E Wolf, Katya Zelevinsky, Ann Lovett, Zheng Zhou, Frederic S Resnic, Sharon-Lise T Normand

Abstract

Background: Drug-eluting stents (DES) reduce the need for repeat revascularization, but their long-term safety relative to that of bare-metal stents (BMS) in general use remains uncertain. We sought to compare the clinical outcome of patients treated with DES with that of BMS.

Methods and results: All adults undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at non-US government hospitals in Massachusetts were identified from a mandatory state database. Patients were classified from the index admission according to stent types used. Clinical and procedural risk factors were collected prospectively. Risk-adjusted mortality, myocardial infarction, and revascularization rate differences (DES-BMS) were estimated through propensity score matching without replacement. A total of 11 556 patients were treated with DES, and 6237 were treated with BMS, with unadjusted 2-year mortality rates of 7.0% and 12.6%, respectively (P<0.0001). In 5549 DES patients matched to 5549 BMS patients, 2-year risk-adjusted mortality rates were 9.8% and 12.0%, respectively (P=0.0002), whereas the respective rates for myocardial infarction and target-vessel revascularization were 8.3% versus 10.3% (P=0.0005) and 11.0% versus 16.8% (P<0.0001).

Conclusions: DES treatment was associated with lower rates of mortality, myocardial infarction, and target-vessel revascularization than BMS treatment in similar patients in a matched population-based study. Comprehensive follow-up in this inclusive population is warranted to identify whether similar safety and efficacy remain beyond 2 years.

Figures

Figure 1. Massachusetts Stent Study: Study Flow…
Figure 1. Massachusetts Stent Study: Study Flow Diagram
Figure 2. Massachusetts DES vs BMS Procedure…
Figure 2. Massachusetts DES vs BMS Procedure Number According to Time on Market
Histogram demonstrating index procedures performed with BMS (n=6210) in gray and DES (n=11516) in black, according to time from study initiation April 2003, chosen to coincide with the time of introduction of DES in the United States. Overall, the rate of DES use was 65% and BMS 35%, but ranged from 83% BMS use at study initiation to 92% DES use by the end of the study enrollment.
Figure 3. Percent Standardized Differences in Clinical…
Figure 3. Percent Standardized Differences in Clinical and Procedural Characteristics: DES vs BMS
The percent standardized differences were calculated for each of 63 baseline variables (clinical, procedural, hospital, and insurance characteristics) before and after propensity matching. The open circles represent the standardized differences in baseline clinical and procedural characteristics between patients treated with DES and BMS. The closed circles represent standardized differences in the same characteristics after propensity matching.
Figure 3. Percent Standardized Differences in Clinical…
Figure 3. Percent Standardized Differences in Clinical and Procedural Characteristics: DES vs BMS
The percent standardized differences were calculated for each of 63 baseline variables (clinical, procedural, hospital, and insurance characteristics) before and after propensity matching. The open circles represent the standardized differences in baseline clinical and procedural characteristics between patients treated with DES and BMS. The closed circles represent standardized differences in the same characteristics after propensity matching.
Figure 4. Cumulative Incidence of (A) Mortality…
Figure 4. Cumulative Incidence of (A) Mortality (B) Myocardial Infarction and (C) Repeat Revascularization in the Matched Sample at 2 years
Solid lines indicate drug-eluting stents (DES) and dashed lines indicate bare-metal stents (BMS). Error bars are 95% confidence intervals.
Figure 4. Cumulative Incidence of (A) Mortality…
Figure 4. Cumulative Incidence of (A) Mortality (B) Myocardial Infarction and (C) Repeat Revascularization in the Matched Sample at 2 years
Solid lines indicate drug-eluting stents (DES) and dashed lines indicate bare-metal stents (BMS). Error bars are 95% confidence intervals.
Figure 4. Cumulative Incidence of (A) Mortality…
Figure 4. Cumulative Incidence of (A) Mortality (B) Myocardial Infarction and (C) Repeat Revascularization in the Matched Sample at 2 years
Solid lines indicate drug-eluting stents (DES) and dashed lines indicate bare-metal stents (BMS). Error bars are 95% confidence intervals.

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