Hybrid Revascularization Observational Study

Coronary Artery Disease Clinical Trial

Official title: Hybrid Revascularization Observational Study

Status Completed

Clinical Trial Summary

The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries). Participation in the study will last up to 21 months after a patient's heart procedure(s). The study collects information about the medical care patients receive during their planned procedure(s) and how well they do following the procedure(s). No new testing or procedures will be done. Patients will receive only the tests or procedures their doctor already has planned for them. The information collected should help to plan the design of a pivotal comparative effectiveness study of hybrid revascularization.

Clinical Trial Description

The increasing prevalence of coronary artery disease (CAD), advances in coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and concomitant medical therapy, and the costs of revascularization have resulted in rising interest regarding the appropriate indications for coronary revascularization. For patients with 3-vessel disease, revascularization by CABG has recently been rated as appropriate while revascularization by PCI has been rated uncertain. Ideally, physicians would like to offer their multi-vessel CAD patients what they truly seek: a solution which provides a safe, minimally invasive treatment that does not compromise long term durability and survival. Integrating the positive features of both PCI and CABG has been the fundamental rationale of "hybrid" coronary revascularization.

Hybrid Coronary Revascularization (HCR) (the intended combination of CABG and PCI) as a scientifically validated approach would have a major healthcare impact. The ability to deliver a new therapy for CAD that provides durability, but without the obligatory trauma and prolonged recovery time characteristic of conventional CABG would be a major advance in the field of cardiovascular medicine. Candidates in whom HCR would be particularly advantageous would be several subgroups of CAD patients that are increasing in numbers: the elderly, patients with a high predicted risk of mortality and/or morbidity for CABG, deconditioned patients or patients with significant disabilities and patients in whom treatment durability is important, but a significantly invasive approach is not an option. Moreover, HCR is likely to bridge the divide in treatment philosophies and approaches that exist between cardiologists and cardiac surgeons. Collaboration rather than competition between these specialties will ultimately benefit patients, hospitals, payers and healthcare providers. The Hybrid Revascularization Observational Study is a multi-center observational study planning grant which will explore target populations for Hybrid Coronary Revascularization (HCR), their outcomes, and variations in specific ways these patients are managed, in order to inform the design of a pivotal comparative effectiveness trial of this emerging therapeutic strategy.

Given the observational nature of the study, the HCR and PCI groups' baseline characteristics and event rates are not directly comparable; rather, the results were intended to inform the design of a larger, randomized pivotal trial. The study was designed in two phases: Cohort 1, which captured demographic, angiographic, and practice patterns data for 6,669 consecutively screened patients; and Cohort 2 which captured demographic, angiographic, practice patterns, and outcome data for 298 patients who underwent either HCR or PCI with DES (90 of whom were also part of Cohort 1). ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01121263
• Study type: Observational
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Completion date: August 2013