Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Suboptimal post-PCI physiological results
研究概览
简要总结
The aim of the study is to compare post-interventional fractional flow reserve (FFR) value between optical coherence tomography(OCT)-guided and angiography-guided strategy for treatment of complex coronary lesion.
详细描述
There has been ample evidence of the role of intracoronary imaging for optimizing the stent, especially among the patients with complex coronary lesions. Intracoronary imaging can be used during the entire process of percutaneous coronary intervention (PCI), from pre-PCI to post-PCI stages. Notably, approximately 15-20% of patients who underwent angiographically successful PCI showed significant stent underexpansion, malapposition, intra-stent thrombus formation, and edge dissection on intracoronary imaging studies, including optical coherence tomography (OCT).
Meanwhile, the role of pre-interventional fractional flow reserve (FFR) measurement has been well established and recommended by recent guideline. However, although previous studies evaluated the efficacy and safety of FFR-guided decision-making followed by angiographic stent implantation, they did not evaluate functionally optimized revascularization. Actually, the vessels with low post-PCI FFR had substantial proportions of suboptimized stented (underexpansion and acute malapposition) and residual disease in non-stented segments. Furthermore, several large observational studies have suggested that suboptimal physiologic results after PCI is associated with an increased risk of clinical events. Previously, the DOCTORS trial found out that OCT-guided PCI was associated with higher post-PCI FFR than angiography-guided PCI (0.94±0.04 vs. 0.92±0.05, P=0.005).
Therefore, OCT can be a useful tool for acquiring functional optimal results after stent implantation. This synergic effect between OCT and post-PCI FFR can be maximized when the investigators perform PCI for complex lesions. This study sought to evaluate compare post-interventional FFR value between OCT-guided and angiography-guided strategy for treatment of complex coronary lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients >18 years old
- •Patients with stable or unstable angina and complex coronary lesions*
- •Patients who were indicated revascularization
- •Diameter stenosis >90% by angiography
- •Diameter stenosis with 50~90% with pre-interventional FFR ≤0.80
- •Patients who underwent implantation of 2nd generation drug-eluting stent
- •Definitions of complex coronary lesions
- •True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
- •Chronic total occlusion (≥3 months) as target lesion
- •PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
- •Long coronary lesions (implanted stent ≥38 mm in length)
- •Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
- •Multiple stents needed (≥3 more stent per patient)
- •In-stent restenosis lesion as target lesion
- •Severely calcified lesion (encircling calcium in angiography)
- •Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
排除标准
- •Target lesions not amenable for PCI by operators' decision
- •Cardiogenic shock (Killip class IV) at presentation
- •Less than TIMI 3 flow of target vessel after index procedure
- •Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
- •Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- •Renal insufficiency such that an additional contrast medium would be harmful for patient
- •Recent ST-segment elevation myocardial infarction (STEMI)
- •Inability to receive adenosine or nicorandil injection
- •Pregnancy or breast feeding
- •Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Unwillingness or inability to comply with the procedures described in this protocol
研究组 & 干预措施
OCT-guided PCI arm
Use of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
干预措施: OCT-guided PCI (Procedure)
OCT-guided PCI arm
Use of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
干预措施: Drug-eluting stent (Device)
Angiography-guided PCI arm
The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
干预措施: Angiography-guided PCI (Procedure)
Angiography-guided PCI arm
The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
干预措施: Drug-eluting stent (Device)
结局指标
主要结局
Suboptimal post-PCI physiological results
时间窗: Immediate after the index procedure
Proportion of patients with a final post-interventional fractional flow reserve \<0.85
次要结局
- Rate of target vessel failure (TVF)(2 years after last patient enrollment)
- Rate of all-cause death(2 years after last patient enrollment)
- Rate of cardiac death(2 years after last patient enrollment)
- Rate of target vessel MI without periprocedural MI(2 years after last patient enrollment)
- Rate of target vessel MI with periprocedural MI(2 years after last patient enrollment)
- Rate of target lesion revascularization (TLR)(2 years after last patient enrollment)
- Rate of target vessel revascularization (TVR)(2 years after last patient enrollment)
- Rate of any MI(2 years after last patient enrollment)
- Rate of any revascularization(2 years after last patient enrollment)
- Rate of stent thrombosis(2 years after last patient enrollment)
- FFR gain between pre- and post-interventional stages(Immediate after the index procedure)
- Trans-stent FFR gradient(Immediate after the index procedure)
- Post-interventional non-hyperemic pressure ratios(Immediate after the index procedure)
研究者
Seung Hun Lee
Clinical Assistant Professor
Chonnam National University Hospital