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Stent or Angioplasty After Recanalization of Chronic Coronary Occlusions Trial - SARECCO
Description:
Stent or Angioplasty After Recanalization of Chronic Coronary Occlusions (SARECCO) was a randomized multicenter trial in patients with chronic total coronary artery occlusions comparing stent implantation versus no further therapy following successful balloon angioplasty.
Hypothesis:
Stent implantation in patients successfully treated with balloon angioplasty for a chronic total occlusion of a coronary artery would be associated with higher rates of acute and long-term procedural success compared to balloon angioplasty alone.
Study Design
Study Design:
Patients Enrolled: 110
Mean Follow Up: Two years; follow-up angiography performed at four months
Mean Patient Age: Mean 60.5
Female: 28%
Patient Populations:
Duration of the occlusion had to be ≥1 week, estimated from clinical events such as MI, sudden onset of symptoms, or proven by a previous angiography; vessel diameter >2.5 mm by visual assessment; and successful balloon angioplasty defined by residual stenosis of <50% on visual assessment.
Exclusions:
Contraindication to aspirin or ticlopidine, acute MI, saphenous bypass graft, severe vessel tortuosity, and bifurcational lesions
Primary Endpoints:
Acute and four-month procedural success defined as a diameter stenosis of <50% without major complications (death, myocardial infarction [MI], coronary artery bypass surgery, or repeat angioplasty)
Secondary Endpoints:
Secondary angiographic endpoints were: MLD, percent stenosis after the procedure and at follow-up assessed by quantitative angiography, reocclusion rate, and restenosis rate defined as a stenosis of >50% after four months.
Secondary clinical endpoints were: target vessel revascularization, MI, or death within two years.
Drug/Procedures Used:
After successful balloon angioplasty of a chronic (>1 week by history) totally occluded coronary artery, patients were randomized to receive stent implantation or no stent. The choice of stent was left to the discretion of the treating physician.
Concomitant Medications:
Aspirin (100 mg/day), heparin (20,000 units during the procedure), and ticlodipine (500 mg/day in the stent arm for two months following the procedure)
Principal Findings:
A total of 110 patients were enrolled after successful balloon angioplasty. The two study groups were well-balanced, and the median duration of occlusion was 16 weeks, with 91% of patients having occlusions >1 month old.
Stent implantation was successful in 54/55 patients (98%) in the stent group. Immediately after the procedure, minimal lumen diameter (MLD) was greater in the stent group compared to the no stent group (2.54 mm vs. 1.85 mm, p=0.01), percent diameter stenosis was less in the stent group (3% vs. 21%, p=0.01), and larger maximum balloon sizes were used in the stent group (3.32 mm vs. 2.86 mm, p=0.05).
Less patients in the stent group had target vessel revascularization at four months (24% vs. 55%, p=0.05) and more patients in the stent group had procedural success maintained at two years (52% vs. 26%, p<0.05). There were higher rates of restenosis, greater percent stenoses, and smaller MLDs in the no stent group at four months.
Interpretation:
Among patients undergoing successful recanalization of chronic total occlusions with percutaneous transluminal coronary angioplasty, this randomized trial of stent implantation versus no further intervention by balloon angioplasty demonstrated that stent implantation was associated with greater MLD and less residual stenosis acutely. These benefits were maintained at four-month follow-up angiography, with additional lower rates of target vessel revascularization in the stent arm of the trial.
References:
Sievert H, Rohde S, Utech A, et al. Stent or angioplasty after recanalization of chronic coronary occlusions? (The SARECCO Trial). Am J Cardiol 1999;84:386-90.
Keywords: Follow-Up Studies, Coronary Disease, Constriction, Pathologic, Coronary Vessels, Coronary Occlusion, Angioplasty, Balloon, Coronary, Stents
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