The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

NCT ID: NCT02767401

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2018-12-15

Brief Summary

The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.

Detailed Description

Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.

Conditions

Hibernation, Myocardial; Complete Occlusion of Coronary Artery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI using stenting or balloon expansion

Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy. Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed. Optimal medical therapy includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-angina therapy should be used if the patients have symptoms.

Group Type: ACTIVE_COMPARATOR

stenting or balloon expansion

Intervention Type: DEVICE

all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)

aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc

Intervention Type: DRUG

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

Optimal medical therapy

Optimal medical therapy. It includes dual antiplatelet therapy and statins. And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

stenting or balloon expansion

all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)

Intervention Type: DEVICE

aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

Intervention Type: DRUG

Other Intervention Names

percutaneous coronary intervention

Eligibility Criteria

Inclusion Criteria

• History of stable or unstable angina
• LVEF > 35% on transthoracic echocardiography measurement
• Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
• Availability for follow-up for up to 12 months
• No major barriers to provide written consent

Exclusion Criteria

• Acute Q-wave myocardial infarction during the latest 3 months
• Revascularization in the non-culprit artery during the latest one month
• Unsuitable for PCI
• Unable to tolerate dual antiplatelet treatment (DAPT)
• Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
• Active bleeding or bleeding tendency
• Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
• Life expectancy < 12 months
• Pregnancy or planning pregnancy
• Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
• Participation or planning to participate in another clinical trial during the same period
• Refusal to comply with the study protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongchong Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

References

Namazi M, Safi M, Vakili H, Saadat H, Alipour S, Mahjoob P, Taherkhani M, Pedari S, Taherion M, Rajabi Moghaddam H, Alhazifi A, Vatanparast M, Khaligh S. Evaluation of effective factors in success rate of intervention on CTO. Acta Med Iran. 2015;53(3):173-6.

Reference Type: BACKGROUND

PMID: 25796024 (View on PubMed)

Stuijfzand WJ, Raijmakers PG, Driessen RS, van Royen N, Nap A, van Rossum AC, Knaapen P. Value of Hybrid Imaging with PET/CT to Guide Percutaneous Revascularization of Chronic Total Coronary Occlusion. Curr Cardiovasc Imaging Rep. 2015;8(7):26. doi: 10.1007/s12410-015-9340-2.

Reference Type: BACKGROUND

PMID: 26029338 (View on PubMed)

Lee SH, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-Term Clinical Outcomes of Medical Therapy for Coronary Chronic Total Occlusions in Elderly Patients (>/=75 Years). Circ J. 2015;79(8):1780-6. doi: 10.1253/circj.CJ-15-0041. Epub 2015 May 28.

Reference Type: BACKGROUND

PMID: 26017064 (View on PubMed)

Other Identifiers

LCKY2015-22

Identifier Type: -

Identifier Source: org_study_id