OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs (OPTI-XIENCE)

Hypothesis: the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with a widespread use of intra-coronary tools that allow a PCI optimization (i.e. functional assessment by pressure guidewire and intra-coronary imaging techniques).

Objective: to evaluate whether the use of pressure guidewire and intra-coronary imaging techniques (mainly optimal coherence tomography) in patients at high risk of events undergoing coronary angiography for myocardial revascularization is associated with an improved clinical outcome in comparison with patient with angiographic alone guided cobalt-chromium everolimus-eluting coronary stenting.

Methods: Prospective observational multicentric international study with a follow-up of 12 months, including 1.000 patients in 40 sites located in 3 European countries (Spain, France, and Portugal). The control group will be comprised by a similar number of matched patients included in the "extended-risk" cohort of the XIENCE V USA study. PCI will be performed following local standard protocols and accordingly to the physician criteria. The use of pressure guidewire will be recommended according to the current guidelines, in patients with angiographically intermediate lesions and in those with multivessel disease. The use of OCT will be strongly recommended, as patients included will be considered to be at high risk of events, accordingly to the current recommendations. The primary endpoint will be target lesion failure (TLF) at 1 year.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Pressure guidewire, optimal coherence tomography

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Raul Moreno, MD, PhD; Phone Number: 917277355; Email: raulmorenog@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prospective observational multicentric international study with a follow-up of 12 months, including 1.000 patients treated with coblat-chromium everolimus-eluting coronary stents and high risk of events in 40 sites located in 3 European countries (Spain, France, and Portugal). The control group will be comprised by a similar number of matched patients included in the "extended-risk" cohort of the XIENCE V USA study.

Description

Inclusion Criteria:

• At least one of the following high-risk characteristics: lesion length > 28 mm; reference vessel diameter < 2.5 mm or > 4.25 mm; chronic total occlusion; bifurcation with side branch ≥ 2 mm; ostial lesion; left main; in-stent restenosis; more than 2 lesions stented in the save vessel; more than 2 vessels treated; acute myocardial infarction; renal insufficiency; ejection fraction < 30%; or staged procedure. There will be no protocol exclusions on the basis of clinical features or angiographic criteria. The indication of using CCEES will be determined by the implanting physician.
• Informed consent signed

Exclusion Criteria:

• Patients whose survival is expected to be lower than 1 year at hospital discharge.
• Patients not willing to participate
• Patient not simultaneously participating in any interventional study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	composite of ischemia-driven target lesion revascularization, myocardial infarction (MI) related to the target vessel, or cardiac death related to the target vessel.	1 year

Collaborators and Investigators

• Sponsor: Spanish Society of Cardiology

Study record dates

Study Major Dates

• Study Start (Anticipated): May 3, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): June 16, 2023

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: SpanishSC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No