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Doppler Endpoints Balloon Angioplasty Trial Europe - DEBATE
Description:
DEBATE was designed to identify Doppler flow velocity indices predictive of the short- and long-term clinical outcomes after angioplasty.
Hypothesis:
A normalization of flow velocity patterns and rheology within the dilated segment would have a favorable impact on the restenosis process.
Study Design
Study Design:
Patients Screened: 297
Patients Enrolled: 225
Mean Follow Up: 6 months
Female: 23
Patient Populations:
Balloon angioplasty of a single lesion in a major native coronary artery because of chest pain and/or other documented signs of ischemia (electrocardiographic, scintigraphic, or echocardiographic) at rest or with exertion.
Exclusions:
Multivessel disease, previous transmural myocardial infarction in the territory of distribution of the vessel to be dilated, acute myocardial infarction <1 week before PTCA, total coronary occlusion, LBBB or second- to third-degree atrioventricular block, open bypass graft distal to the lesion to be treated, extreme tortuosity of the vessel to be dilated, use of alternative or additional interventional treatments (directional or rotational atherectomy, stent implantation, etc).
Primary Endpoints:
Postprocedural distal coronary flow reserve and percent diameter stenosis were correlated with: 1) symptoms and/or ischemia at 1 and 6 months 2) the need for target lesion revascularization 3) angiographic restenosis.
Secondary Endpoints:
Determine the prognostic cutoff value of CFR and DS separately and in combination.
Drug/Procedures Used:
A Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty.
Principal Findings:
Postprocedural CFR had a modest prognostic value in predicting the incidence of symptoms and/or ischemia at 4 weeks (ROC area, 64%) but a weak prognostic value for the need for target lesion reintervention (ROC areas, 58%). The "optimal" prognostic cutoff for CFR was 2.5. Diameter stenosis (DS) had a reasonable prognostic value in predicting angiographic restenosis (ROC area, 68%) and a weaker value in predicting recurrence of symptons at 6 months (ROC area, 60%). The "optimal" cutoff value for DS was 35%. A distal CFR post-angioplasty >2.5 and a residual diameter stenosis <=35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% vs 19%, p=0.149) and at 6 months (23% vs 47%, p=0.005), a low need for reintervention (16% vs 34%, p=0.024), and a low restenosis rate (16% vs 41%, p=0.002) compared with patients who did not meet these criteria.
Interpretation:
The combined use of post-PTCA distal CFR and diameter stenosis has a moderate predictive value for short- and long-term outcomes after PTCA. Based on these results, a patient with a DS <=35% will have a 26% incidence of events at 6 months; a patient with a CFR >2.5 will have a 24% incidence of events, while a patient with a DS <35% and a CFR >2.5 will have the best long-term result with an event rate of 16%, a rate comparable to optimal stent results. As a result of this study, the DEBATE II trial was designed to assess the cost-effectiveness of a therapeutic policy based on these guidelines.
References:
Circulation. 1997;96:3369-3377.
Keywords: Rheology, Coronary Disease, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents
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