Coronary artery disease
Comparison of Drug-Eluting Versus Bare Metal Stents on Later Frequency of Acute Myocardial Infarction and Death

https://doi.org/10.1016/j.amjcard.2006.08.032Get rights and content

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.

Section snippets

Methods

Patients at our institution who underwent percutaneous coronary intervention from April 2002 to April 2005 were included in the study. All 1,164 patients who underwent percutaneous coronary intervention between April 2002 and April 2003 received BMSs and served as the control group. The study group consisted of 1,285 consecutive patients who received DESs after these stents were fully available (February 2004) and had replaced BMSs as routine stents of choice (≥90% utilization). Patients were

Results

Baseline clinical characteristics of the 2 groups were similar (Table 1). Acute coronary syndromes were present overall in 72% of patients (p = 0.24, BMS vs DES); 41% of the BMS group and 37% of the DES group (p = 0.08) had an AMI within 7 days before their index percutaneous coronary intervention. Lesion and procedural details are listed in Table 2. Procedural success was >99% for the 2 groups (p >0.99). Single lesions were treated in 67.4% of the BMS group and 65.5% of the DES group (p =

Discussion

In this large, contemporary percutaneous coronary intervention experience of unselected, consecutive patients, we observed a significantly lower risk adjusted incidence of AMI and death at 9 months after DES versus BMS implantation. The benefit of DESs appeared to extend across a wide range of patient and lesion characteristics, including patients who would not have been included in previous RCTs, i.e., those with AMI within 7 days before their index procedure and those with multiple lesions.

Acknowledgment

We gratefully acknowledge Tammy Davis for manuscript preparation and Aruna Joel, BS, RN, Sabrina Smith, BS, RN, and Robin Taylor, BS, RN, for data collection and database entry.

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    This study was supported by a grant from Cordis Corporation, Miami Lakes, Florida, and a fellowship from Boston Scientific Corporation, Natick, Massachusetts.

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