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

The First Affiliated Hospital of Dalian Medical University

Status and phase: Completed; Phase 4

Conditions: Hibernation, Myocardial; Complete Occlusion of Coronary Artery

Treatments: Device: stenting or balloon expansion; Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc

Study type: Interventional

Funder types: Other

Identifiers

NCT02767401

LCKY2015-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

PCI using stenting or balloon expansion

Active Comparator group

Description:

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.

Treatment:

Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc

Device: stenting or balloon expansion

Optimal medical therapy

No Intervention group

Description:

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.