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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.; Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01508663

1-2010-0016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 75 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,600 participants in 2 patient groups

PCI+OMT group

Experimental group

Description:

PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months

Treatment:

Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent

OMT alone group

Active Comparator group

Description:

OMT alone after randomization and follow up for 12 months

Treatment:

Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.