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Coronary-Artery Stenting Compared With Balloon Angioplasty for Restenosis After Initial Balloon Angioplasty - Restenosis Stent Study
Description:
The goal of this study was to assess the safety and efficacy of stenting compared with balloon angioplasty among patients with symptomatic restenosis after a successful balloon angioplasty.
Hypothesis:
Because coronary artery stenting had been shown to be superior to balloon angioplasty in the treatment of new coronary artery lesions, it was hypothesized that stenting would be superior to angioplasty alone in the treatment of patients with restenosis after successful balloon angioplasty.
Study Design
Study Design:
Patients Enrolled: 383
Mean Follow Up: Six months
Mean Patient Age: Mean age 60 years
Female: 81
Patient Populations:
Patients were eligible to participate in the trial if they had clinically significant ischemic heart disease (defined as causing angina or having an abnormality on stress echocardiography or thallium-201 imaging) after prior successful balloon angioplasty with angiographic restenosis of >50% of the luminal diameter and a lesion length of ≤10 mm.
Primary Endpoints:
The primary endpoint of this study was angiographic restenosis (i.e., stenosis >50% of the luminal diameter) at six months.
Secondary Endpoints:
The secondary endpoints of this study were the rates of death, myocardial infarction, coronary artery bypass surgery, and target vessel revascularization after randomization.
Drug/Procedures Used:
Eligible patients were randomized to receive either balloon angioplasty alone, with bailout stenting if necessary, or coronary artery stent implantation using a Palmaz-Schatz stent.
Concomitant Medications:
All patients received aspirin and 15,000 IU of heparin prior to the procedure. Patients in the stenting group additionally received intravenous heparin until their international normalized ratio was 2.0-3.5 on oral anticoagulation therapy with phenprocoumon. Oral anticoagulation therapy was continued for three months in the stenting group.
Principal Findings:
Patients in the angioplasty group had a significantly higher rate of restenosis than those who received stenting (32% vs. 18%, p=0.03). Target vessel revascularization was more common in those who received angioplasty alone (27% vs. 10%, p=0.001).
At follow-up, there was a significant difference in minimal luminal diameter between patients in the angioplasty group compared to the stenting group (1.85 ± 0.56 mm vs. 2.04 ± 0.66 mm, p=0.01). Patients who received stenting had a higher rate of bleeding compared to the angioplasty group (11.2% vs. 1.1%, p<0.001); however, those who received stents still had a higher rate of event-free survival at 250 days (84% vs. 72%, p=0.04).
Interpretation:
Among patients with restenosis after successful coronary artery angioplasty, stenting with a Palmaz-Schatz stent was associated with a reduction in the primary endpoint of angiographic restenosis at six months compared to balloon angioplasty. Additionally, while patients who received stents had a higher rate of bleeding, their overall rate of event-free survival was higher than those who received angioplasty alone. These findings suggest that coronary artery stenting is superior to balloon angioplasty in patients with restenosis after successful balloon angioplasty.
References:
Erbel R, Haude M, Hopp HW, et al. Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group. N Engl J Med 1998;339:1672-8.
Keywords: Follow-Up Studies, Disease-Free Survival, Coronary Disease, Coronary Vessels, Angioplasty, Balloon, Coronary, Stents
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