The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease (BRAVE)

The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients (Age > 75 Years Old) With Coronary Artery Disease: a Randomized Controlled Study

The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease (CAD) during the additional 12 months.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent; Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.

Detailed Description

Study Design

• Prospective, randomized, multi-center study of each 1600 subjects enrolled.
• Eligible subjects will be randomized 1:1 to a) PCI added to OMT (n=800) vs. b) OMT alone(n=800).

Subsequently, subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stent(n=400) vs. zotarolimus eluting sten(n=400). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.

• Subjects with CAD who meet all inclusion and exclusion criteria will be included
• Clinical and laboratory follow-up should be performed.

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Myeong-Ki Hong, MD.PhD; Phone Number: +82 2 2228 8458; Email: mkhong61@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Myeong-Ki, Hong
    • Contact: Myeong-Ki Hong, MD.PhD; Phone Number: +82 2 2228 8458; Email: mkhong61@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 84 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB
2. Patients with age 75 years or older
3. Patients receiving OMT (one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin)
4. Patients with stenosis of at least 70% in at least one proximal epicardial coronary artery or objective evidence of myocardial ischemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress)
5. Patients with signed informed consent

Exclusion Criteria:

1. Patients with persistence of CCS IV angina
2. Resting chest pain (≥ Braunwald classification IIB)
3. Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol)
4. Patients with age 85 years or older
5. Patients with refractory CHF or cardiogenic shock
6. Patients with an EF of less than 30%
7. Patients who have received revascularization within the previous 6 months
8. Patients with coronary anatomy not suitable for PCI
9. Life expectancy ≤ 2 year

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCI+OMT group; PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months	Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent; Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
Active Comparator: OMT alone group; OMT alone after randomization and follow up for 12 months	Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.; one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Event	The primary end-point is the occurrence of major adverse cardiac event [cardiovascular death, non-fatal MI (excluding periprocedural MI), stroke or any revascularization (PCI or coronary bypass surgery [CABG]) for 12 months following the randomization to the assigned management]	12month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac or non-cardiac major adverse event	The composite of cardiac or non-cardiac death, non-fatal MI, stent thrombosis (ST), target vessel revascularization (TVR) (either by PCI or CABG), non-TVR, hospitalization for unstable angina pectoris (UAP) or congestive heart failure (CHF), and cerebrovascular accident (CVA) for 12 months.; Major determinant for the occurrence of major events; Sub-study according to the subsets of disease; Association between parameters at index procedure and clinical outcomes	12month

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Coronary artery disease 75years of age or older
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protease Inhibitors; Everolimus; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: 1-2010-0016