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Belgian-Netherlands STENT Study (I) - BENESTENT I
Description:
PTCA vs. coronary stenting for mortality in stable angina.
Hypothesis:
Stents improve the long-term angiographic and clinical outcomes as compared with standard balloon angioplasty.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 516
Mean Follow Up: 12 months
Mean Patient Age: 57 ± 10 years
Female: 19
Patient Populations:
Scheduled to undergo coronary angioplasty because of stable angina for a single new lesion in a coronary artery.
Target lesion <15mm long, located in a vessel > 3mm in diameter that supplied a normally-functioning myocardium.
Suitable candidate for coronary bypass surgery.
Exclusions:
Ostial lesion
A lesion at bifurcation
A lesion in previously grafted vessel
Intracoronary thrombus suspected
Contraindications to anticoagulant or antiplatelet therapy
Primary Endpoints:
Death.
Occurrence of a cerebrovascular accident.
Myocardial infarction (MI).
Need for coronary bypass surgery.
Second percutaneous intervention involving the previously-treated lesion, either at the time of the initial procedure or during subsequent 7 months.
Angiographic end point: minimal luminal diameter at follow-up.
Secondary Endpoints:
Angiographic success rate (< 50% stenosis on visual assessment).
Procedural success rate (< 50% stenosis on quantitative assessment, without the occurrence of clinical events during hospital stay).
Functional class using Canadian Cardiovascular Society classification at 6 months or at the time of intercurrent angiography and second intervention.
Results of exercise testing at 6 months or earlier, if clinically indicated.
Rate of restenosis (> 50% at follow-up ) at 6 months.
Drug/Procedures Used:
All patients:
Palmaz-Schatz stent implant or balloon angioplasty performed by femoral approach
250 to 00mg aspirin qd started day before procedure, continued 6 months
75mg dipyridamole tid started day before procedure, continued 6 months.
Concomitant Medications:
Calcium antagonists until discharge from hospital.
Principal Findings:
20% of patients in the stent group and 30% of patients in the angioplasty group reached a primary clinical end point before the 7-month follow-up (relative risk, 0.68; 95% confidence interval, 0.50 to 0.92, p = 0.02).
The difference in clinical-event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95% confidence interval, 0.40 to 0.85, p = 0.005).
Rates of restenosis were 22% for the stent group and 32% for the angioplasty group (p =0.02).
Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1%, P < 0.001).
Mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 days vs 3.1 days, p < 0.01).
Only 12 patients (3%) who had not experienced a clinical end point at the 7-month follow-up experienced one between the 7th and 12th month. Of these, 8 had undergone a stent, 4 a standard balloon angioplasty. The small number of events does not permit a meaningful comparison.
A cost analysis based on data from the BENESTENT-I and BENESTENT-II pilot study estimated the costs per additional event-free survivor after 7 months at Dfl 88,315, Dfl 28,127 and Dfl 6747 using respectively the results from the BENSTENT-I study, the BENESTENT-II pilot study and phase IV of the BENESTENT-II pilot study.
Interpretation:
Over 12 months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site, and a longer hospital stay.
References:
1. N Engl J Med 1994;331:489-95. Design and baseline results
2. J Am Coll Cardiol 1996;27: 255-61. 1-year clinical results
3. Seminars in Interventional Cardiology 1996 1(4):263-8 Cost analysis
Keywords: Survivors, Blood Transfusion, Risk, Follow-Up Studies, Angina, Stable, Confidence Intervals, Angioplasty, Balloon, Coronary, Dipyridamole, Stents, Length of Stay
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