Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital Registry - RESEARCH

Oct 14, 2003
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Date Presented:
01/01/2003
Date Published:
01/01/2003
Date Updated:
10/14/2003
Original Posted Date:
10/14/2003
References

Description:

The goal of the RESEARCH study was to evaluate outcomes of patients with acute coronary syndromes (ACSs) treated with sirolimus-eluting stents (SESs) compared with bare stents.

Study Design

Study Design:

Patients Enrolled: 499
Mean Follow Up: 30 days and one year
Mean Patient Age: Mean age 61 years
Female: 28

Patient Populations:

Presentation with ACS (acute MI or unstable angina) at the Rotterdam Cardiology Hospital and treated with PCI

Primary Endpoints:

MACE, defined as death, nonfatal MI, repeat TLR, or TVR

Drug/Procedures Used:

The RESEARCH registry consisted of a consecutive group of patients with ACS treated exclusively with SESs (n=198) from the Rotterdam Cardiology Hospital during the four months following implementation of the RESEARCH registry protocol, which required utilization of the SES as the device of choice for every percutaneous coronary intervention (PCI) performed at the institution. All consecutive procedures were included, without any specific anatomical or clinical restriction.

Sixty-four percent of those treated in the four-month period received a SES. The control group was made up of consecutive patients treated with bare stents (n=301) during the four-month period immediately before the registry.

Concomitant Medications:

Glycoprotein IIb/IIIa inhibitors were given at the discretion of the operator; aspirin lifelong; and clopidogrel 75 mg/day for one month (patients treated with bare stent only) or three months (patients treated with SES).

Principal Findings:

Patients receiving both bare stents and SESs in the same procedure (32 patients; 10%) and those treated without SES implantation (81 patients; 26%) were not included in the present analysis. Reason for PCI was acute myocardial infarction (MI) in 32% of patients and unstable angina in 68% in both groups. Glycoprotein IIb/IIIa inhibitors were used more in the bare stent group than the SES group (42% vs. 27%, p<0.01).

Angiographic success was similar in both groups (97% vs. 96%). There was no difference in the 30-day MACE rate between patients treated with bare stents and those treated with SESs (6.1% vs. 6.6%, p=0.85 by log-rank test). There was no difference in any component of the composite: death (3.0% each, p=1.0); nonfatal MI (3.0% vs. 1.0%, p=0.17); and target lesion revascularization (TLR) (1.0% vs. 2.7%, p=0.33). Most complications occurred in the first week after the procedure. Stent thrombosis occurred in one patient (0.5%) in the SES group and in five patients (1.7%) in the control group (p=0.41).

In a larger analysis reported at the European Society of Cardiology Congress with 508 patients in the SES group and 663 patients in the control group, the one-year MACE rate was lower in the SES group than the control group (9.1% vs. 14.9%, p=0.002), driven primarily by a reduction in target vessel revascularization (TVR) (4.1% vs. 10.9%, p=0.0001). There was no difference in the composite of one-year death or MI.

Interpretation:

Among patients with ACSs, treatment with a SES was associated with a reduction in one-year, but not 30-day MACE compared with bare stents in this nonrandomized registry trial. The reduction in the one-year MACE was driven primarily by a reduction in TVR.

The registry included off-label use of the SES, which has not been approved in the United States for use in restenosis and has not been studied in randomized trials in patients with acute MI, saphenous vein graft, or bifurcated lesions, all of which were included in the registry. The data should be interpreted with caution, given the off-label use and single-center, nonrandomized registry design of the study.

References:

Lemos PA, Lee CH, Degertekin M, et al. Early outcome after sirolimus-eluting stent implantation in patients with acute coronary syndromes: insights from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol 2003;41:2093-9.

Presented at the European Society of Cardiology Congress, Vienna, Austria, September 2003.

Keywords: Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Drug-Eluting Stents, Off-Label Use, Sirolimus, Percutaneous Coronary Intervention, Stents, Registries, omega-Chloroacetophenone, Thrombosis, Saphenous Vein


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