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The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

ABSTRACT: Success of opening single (SOS)-comedy is a prospective multicenter study to compare the improvement in the decrease of myocardial viability by percutaneous coronary intervention (PCI) with that by optimal medical therapy (OMT) alone in patients with chronic total occlusion (CTO) of a single coronary artery.The risks and the benefits of both options (PCI and OMT) were listed in a CTO decision aid (DA). Eligible participants detected by invasive coronary angiography (ICA) or coronary computed tomography angiography (CCTA) were divided into PCI or OMT groups according to patients' choice after shared-decision making process with DA. Participants will undergo positron emission tomography/computed tomography (PET/CT), cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE), and proceed to ICA and revascularization if possible. Blinded core laboratory interpretation will be performed for ICA, CCTA, PET/CT, CMR, and TTE. All participants will be followed up for 12 months. The primary endpoint is the improvement to the decrease of myocardial viability from baseline assessed with the use of PET/CT after 12-month follow-up.All of the patients are appropriately consented before enrolling in this study, which has been approved by the Ethics Committee. Results of SOS-COMEDY will be helpful to develop a strategy for single CTO patients.

SUBMITTER: Huang R

PROVIDER: S-EPMC5916680 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

Huang Rongchong R Song Xiantao X Zhang Haishan H Tian Wen W Huang Zheng Z Zhang Xingwei X Yang Junqing J Zhang Dongfeng D Wu Jian J Zhong Lei L Ting Henry H HH

Medicine 20180401 16

<h4>Aims</h4>Success of opening single (SOS)-comedy is a prospective multicenter study to compare the improvement in the decrease of myocardial viability by percutaneous coronary intervention (PCI) with that by optimal medical therapy (OMT) alone in patients with chronic total occlusion (CTO) of a single coronary artery.<h4>Methods and results</h4>The risks and the benefits of both options (PCI and OMT) were listed in a CTO decision aid (DA). Eligible participants detected by invasive coronary a ...[more]

PMID: 29668609

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Project description:BackgroundThis study aimed to reveal the association of diabetes mellitus and dialysis-dependent renal failure with the lesion severity and chronic total occlusion (CTO) in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.MethodsThis multicenter retrospective study analyzed the data of 2056 consecutive patients with moderate to severe intermittent claudication, who underwent endovascular therapy for de novo lesions in the superficial femoral artery to the proximal popliteal artery between 2010 and 2018 at five cardiovascular centers in Japan. The association of the clinical characteristics with severity of the lesions, as assessed by the Trans-Atlantic Inter-Society Consensus (TASC) II classification, was investigated using the ordinal logistic regression model. Their association with CTO, lesion length, and severity of calcifications was additionally analyzed using the binomial logistic regression model.ResultsThe prevalence of diabetes mellitus and dialysis-dependent renal failure was 54.7% and 21.4%, respectively; 12.5% of the patients had lesions corresponding to TASC II class D, and 39.3% of the patients had CTO. Current smoking and severe claudication were associated with more severe lesions assessed according to the TASC II classification; diabetes mellitus and dialysis dependence were inversely associated with disease severity. The adjusted odds ratios of diabetes mellitus and dialysis dependence were 0.82 (95% confidence interval 0.70-0.97; p = 0.018) and 0.76 (0.62-0.94; p = 0.009), respectively. Diabetes mellitus and dialysis dependence were also inversely associated with CTO (both p < 0.05). Furthermore, diabetes mellitus was inversely associated with a long lesion (p < 0.05). Diabetes mellitus and dialysis dependence were positively associated with severe calcification (both p < 0.05).ConclusionsDiabetes mellitus and dialysis-dependent renal failure were inversely associated with the lesion severity, as assessed by the TASC II classification, and CTO in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.

Dataset Information

The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

Publications

The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

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