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

Phase 4

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

• Registration Number: NCT01508663
• Lead Sponsor: Yonsei University

Brief Summary

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.

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 Timeline

• Study Start: 2010-08
• Status Verified: 2012-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Study First Posted: 2012-01-12
• Last Update Posted: 2012-01-12
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI+OMT group	Everolimus Eluting Stent or Zotalolimus Eluting Stent	PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months
OMT alone group	ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.	OMT alone after randomization and follow up for 12 months

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event	12month	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\]

Secondary Outcome Measures

Name	Time	Method
cardiac or non-cardiac major adverse event	12month	1. 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.; 2. Major determinant for the occurrence of major events; 3. Sub-study according to the subsets of disease; 4. Association between parameters at index procedure and clinical outcomes

Trial Locations

Locations (1)

Myeong-Ki, Hong; 🇰🇷 Seoul, Korea, Republic of