The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.

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 (≥28 mm), 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 12 months, 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.

Drug-eluting stent task force: final report and recommendations of the working committees on cost-effectiveness/economics, access to care, and medicolegal issues.

Coronary artery disease remains a major health problem worldwide. Since introduction of percutaneous transluminal coronary angioplasty and stents, much progress has been made. Percutaneous coronary intervention, however, has been limited by restenosis (repeat obstruction of arteries that have been previously treated. Introduction of drug-eluting stents (DESs) in April 2003 was a major breakthrough in preventing restenosis. In March 2003, The Society for Cardiovascular Angiography and Interventions (SCAI) published a position statement on the clinical implications of DESs, recommending an evidence-based adoption strategy. Subsequently, in May 2003, SCAI formed a multidisciplinary Drug Eluting Stent (DES) Task Force to address the significant nonclinical ramifications posed by DESs: medicolegal, financial, and access to care. The Task Force included representatives from physician societies, industry, academia, the reimbursement community, and health policy organizations. The resultant report presents analyses, options, and recommendations regarding those nonclinical issues based on the collective experience and knowledge of the Task Force members. The Task Force trusts that this report will be of value to the diverse constituencies involved with introduction of this important new technology.