DEScover Registry - DEScover Registry - Presented at TCT 2006

Description:

The goal of the registry was to evaluate patients undergoing percutaneous coronary intervention (PCI) with stenting in the United States.

Study Design

Study Design:

Patients Enrolled: 6,906
Mean Follow Up: 1 year
Mean Patient Age: Mean age 64 years
Female: 32

Patient Populations:

PCI with stenting at one of the 140 participating sites

Exclusions:

Patient refusal to be included in the registry

Drug/Procedures Used:

Patients at 140 US medical centers undergoing PCI with stenting were followed for up to 1 year for clinical outcomes. Stent distribution type included bare-metal (BMS; n = 397), sirolimus-eluting (SES; n = 3,873), and paclitaxel-eluting (PES; n = 2,636). Any patients receiving more than one type of stent (11% of the registry) were excluded from the analysis.

Principal Findings:

Only 5.7% of patients in the registry were treated with BMS; the remaining 94.3% were treated with drug-eluting stents (DES). Patients treated with BMS were older, had more co-morbidities, and had more severe coronary disease presentation, including higher rates of triple-vessel disease and ST elevation myocardial infarction (MI) as the indication for PCI. Ejection fraction was significantly lower in patients treated with BMS (mean 49.5% vs. 52.7% with SES and 52.8% with PES). Total occlusion was more frequent at baseline in patients treated with BMS (19.1% vs. 11.2% with SES and 9.9% with PES). Despite more frequently having triple-vessel disease, multilesion intervention was less frequent in the BMS group (25.5% vs. 34.7% for SES and 32.3% for PES). Bypass grafts were more often treated with BMS (15.9% vs. 6.5% with both SES and PES).

At 1 year, mortality was 5.9% in the BMS group and 3.1% in the DES groups (p = 0.005). There was no difference in MI (3.5% for BMS vs. 2.4% for DES, p = 0.19) or repeat PCI (9.3% vs. 8.4%, p = 0.62). Bypass surgery was performed more frequently in the BMS group (3.5% vs. 1.4%, p = 0.0007). Stent thrombosis by 1 year occurred in 0.8% of the BMS group and 0.6% of the DES group (p = 0.67). In an adjusted analysis, there was no difference in death or MI by 1 year (hazard ratio 0.74, 95% confidence interval 0.52-1.07).

Clinical outcomes at 1 year were similar between SES and PES, with the exception of stent thrombosis, which occurred in 0.5% of the SES group and 0.8% of the PES group (p = 0.06).

Interpretation:

Among patients undergoing PCI in this US registry, the large majority were treated with DES, and those treated with BMS represent a very different cohort, with more severe coronary disease.

Efficacy conclusions regarding clinical outcomes between BMS and DES are not possible given the nonrandomized nature of the data, the fact that so few patients were treated with BMS (only ~5%), and the extreme differences between BMS and DES patients. What can be drawn from these data are the differences in patient selection for the different stent types. BMS patients were significantly older with much more severe disease and more ST elevation MI at presentation. As such, one would expect a higher mortality rate in patients with more triple-vessel disease and more ST elevation MI compared with more single-vessel disease and more stable angina.

Despite statistical adjustment with multivariable modeling, the substantial differences at baseline and the small number treated with BMS in this nonrandomized study do not allow for valid efficacy comparisons. The number of deaths in the BMS arm may not be sufficient to adjust for all potential confounders. Additionally, the propensity to use one type of stent versus another was not included in the multivariable modeling.

References:

Williams DO, Abbott JD, Kip KE. Outcomes of 6906 Patients Undergoing Percutaneous Coronary Intervention in the Era of Drug-Eluting Stents. Report of the DEScover Registry. Circulation 2006;114:epub before print.

Presented by Dr. David O. Williams at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Angina, Stable, Patient Selection, Metals, Thrombosis, Drug-Eluting Stents, Confidence Intervals, Sirolimus, Stents, Percutaneous Coronary Intervention


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