Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Rate of successful uncomplicated PCI as per coronary physiology ratios
研究概览
简要总结
Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).
详细描述
Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.
Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.
Hypothesis
Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic result.
The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.
排除标准
- •Unable to understand study design or objectives of study.
- •Unable to sign informed consent.
- •Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)
- •Inability to comply with the study follow-up
结局指标
主要结局
Rate of successful uncomplicated PCI as per coronary physiology ratios
时间窗: Transprocedural, initial and final values
Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .
次要结局
- Incidence and types of further interventions or imaging techniques(Historical and immediately after the procedure, up to 36 months)
- Incidence of successful distal positioning of pressurewire(Transprocedural)
- Residual symptoms and quality of life after repeat angiography(up to 30 days)
- Rates of repeat interventions(Historical and immediately after the procedure)
研究者
Olivier F. Bertrand
Director of the International Chair of Interventional Cardiology and Transradial Approach
Laval University