Doppler Endpoints Balloon Angioplasty Trial Europe - DEBATE II
DEBATE II sought to determine if limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) is as effective and less expensive as primary stenting.
Optimal balloon angioplasty would yield a clinical outcome similar to stenting primary stenting at a lower cost. An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%.
Patients Enrolled: 620
Mean Follow Up: 1 year
Scheduled to undergo angioplasty for stable or unstable angina pectoris (excluding Braunwald classification III); documented myocardial ischemia due to a single de novo coronary stenosis potentially amenable to stent implantation; the target lesion supplied viable myocardium and was <25 mm long.
Total coronary occlusion; lesions that were ostial or at a bifurcation; lesions in vessels that were previously bypassed, tortuous, or contained thrombus; previous Q-wave infarction (in the target vessel territory or from an evolving myocardial infarction of the previous week).
Death from any cause, nonfatal MI infarction, and percutaneous or surgical target lesion revascularization.
Patients were randomized to receive primary stenting or balloon angioplasty guided by Doppler flow velocity and angiography. Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure.
Bailout stenting was required in 25% of patients randomized to balloon angioplasty, and an optimal result was obtained in 35% of patients. Event-free survival at 1 year did not differ between primary stenting (86.6%) and provisional angioplasty (85.6%, p=NS). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 vs EUR 5885, p=0.014). The higher costs were due to longer hospitalizations and surgical revascularization. After the second randomization, stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% vs 84.1%. p=0.066) and suboptimal balloon angioplasty (89.3% vs 73.3%. p=0.005).
Provisional angioplasty lacked clinical benefit and was more expensive after 1 year of follow-up. The point estimate of the incremental cost-effectiveness ratio suggests that provisional angioplasty is less effective and more expensive than primary stenting. An unexpected observation was a further reduction in major adverse cardiac events in patients stented after optimal balloon angioplasty.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Follow-Up Studies, Coronary Stenosis, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents
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