PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions

Conditions
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Coronary Artery Disease, Angina Pectoris

Intervention / Treatment
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* Procedure: OCT-guided PCI
* Procedure: Angiography-guided PCI
* Device: Drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCT-guided PCI arm<br>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. | Procedure: OCT-guided PCI<br>* For patients randomly allocated to this arm, PCI for complex lesions will be performed using OCT. OCT Reference site: Most normal looking segment, No Lipidic plaque. Operator can decide 1 of 2 methods for stent sizing. By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane [EEL] can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm (Ex> mean external elastic membrane reference diameter 3.35mm, 3.25mm stent diameter will be chosen). By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25mm (Ex> mean distal reference lumen diameter 2.55mm, 2.75mm stent diameter will be chosen).<br>Device: Drug-eluting stent<br>* All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.<br>|
| Active Comparator: Angiography-guided PCI arm<br>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. | Procedure: Angiography-guided PCI<br>* For patients randomly allocated to this arm, PCI for complex lesions will be performed using angiography only. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 30% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.<br>Device: Drug-eluting stent<br>* All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suboptimal post-PCI physiological results | Proportion of patients with a final post-interventional fractional flow reserve <0.85 | Immediate after the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of target vessel failure (TVF) | a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR) | 2-Year after the index procedure | 
| Rate of all-cause death | death from any-cause | 2-Year after the index procedure | 
| Rate of cardiac death | death from cardiac-cause | 2-Year after the index procedure | 
| Rate of target vessel MI without periprocedural MI | Myocardial infarction without periprocedural myocardial infarction | 2-Year after the index procedure | 
| Rate of target vessel MI with periprocedural MI | Myocardial infarction with periprocedural myocardial infarction | 2-Year after the index procedure | 
| Rate of target lesion revascularization (TLR) | ischemia-driven or all | 2-Year after the index procedure | 
| Rate of target vessel revascularization (TVR) | ischemia-driven or all | 2-Year after the index procedure | 
| Rate of any MI | any myocardial infarction | 2-Year after the index procedure | 
| Rate of any revascularization | ischemia-driven or all | 2-Year after the index procedure | 
| Rate of stent thrombosis | definite, probable, or possible | 2-Year after the index procedure | 
| FFR gain between pre- and post-interventional stages | [Post-interventional fractional flow reserve value] - [Pre-interventional fractional flow reserve value] | Immediate after the index procedure | 
| Trans-stent FFR gradient | FFR gradient across the stent (ΔFFRstent) | Immediate after the index procedure | 
| Post-interventional non-hyperemic pressure ratios | Values of post-PCI non-hyperemic pressure ratios | Immediate after the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Intravascular Imaging, Optical Coherence Tomography, Fractional Flow Reserve, Complex Lesion