The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.
The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.
- 2020
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (>=28mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions. Copyright (c) 2020 Elsevier Inc. All rights reserved.
English
0002-8703
10.1016/j.ahj.2020.08.002 [doi] S0002-8703(20)30225-8 [pii]
*Coronary Artery Disease
*Coronary Vessels/dg [Diagnostic Imaging]
*Percutaneous Coronary Intervention
*Postoperative Complications
*Risk Adjustment/mt [Methods]
*Ultrasonography, Interventional
Coronary Angiography/mt [Methods]
Coronary Artery Disease/di [Diagnosis]
Coronary Artery Disease/su [Surgery]
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention/ae [Adverse Effects]
Percutaneous Coronary Intervention/is [Instrumentation]
Percutaneous Coronary Intervention/mt [Methods]
Postoperative Complications/di [Diagnosis]
Postoperative Complications/pc [Prevention & Control]
Randomized Controlled Trials as Topic
Risk Factors
Surgery, Computer-Assisted/mt [Methods]
Ultrasonography, Interventional/ec [Economics]
Ultrasonography, Interventional/mt [Methods]
MedStar Heart & Vascular Institute
Journal Article
Research Support, Non-U.S. Gov't
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (>=28mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions. Copyright (c) 2020 Elsevier Inc. All rights reserved.
English
0002-8703
10.1016/j.ahj.2020.08.002 [doi] S0002-8703(20)30225-8 [pii]
*Coronary Artery Disease
*Coronary Vessels/dg [Diagnostic Imaging]
*Percutaneous Coronary Intervention
*Postoperative Complications
*Risk Adjustment/mt [Methods]
*Ultrasonography, Interventional
Coronary Angiography/mt [Methods]
Coronary Artery Disease/di [Diagnosis]
Coronary Artery Disease/su [Surgery]
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention/ae [Adverse Effects]
Percutaneous Coronary Intervention/is [Instrumentation]
Percutaneous Coronary Intervention/mt [Methods]
Postoperative Complications/di [Diagnosis]
Postoperative Complications/pc [Prevention & Control]
Randomized Controlled Trials as Topic
Risk Factors
Surgery, Computer-Assisted/mt [Methods]
Ultrasonography, Interventional/ec [Economics]
Ultrasonography, Interventional/mt [Methods]
MedStar Heart & Vascular Institute
Journal Article
Research Support, Non-U.S. Gov't