The effectiveness and safety of the RESTORE® drug-eluting balloon versus a drug-eluting stent for small coronary vessel disease: study protocol for a multi-center, randomized, controlled trial.

OBJECTIVE: Small coronary vessel disease (disease affecting coronary vessels with main branch diameters of ≤ 2.75 mm) is a common and intractable problem in percutaneous coronary intervention (PCI). This study was designed to test the theory that the effectiveness and safety of drug-eluting balloons for the treatment of de novo lesions in small coronary vessels are non-inferior to those of drug-eluting stents. METHODS: We designed a prospective, multicenter, randomized, controlled clinical trial aiming to assess the effectiveness and safety of the RESTORE® (Cardionovum, Bonn, Germany) drug-eluting balloon (DEB) versus the RESOLUTE® (Medtronic, USA) drug-eluting stent (DES) in the treatment of small coronary vessel disease. This trial started in August 2016. A total of 230 patients with a reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 2.75 mm were randomly assigned to treatment with a DEB or a DES at a 1:1 ratio. The study was also designed to enroll 30 patients with an RVD ≥ 2.00 mm and ≤ 2.25 mm in the tiny vessel cohort. RESULTS: The key baseline data include demographic characteristics, relative medical history, baseline angiographic values and baseline procedural characteristics. The primary endpoint is in-segment diameter stenosis at nine months after the index procedure. Secondary endpoints include acute success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis. CONCLUSIONS: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEBs compared to DESs in the treatment of de novo coronary artery lesions in small vessels.

[Value of measuring ankle brachial index for diagnosing peripheral arterial disease in Chinese patients with high cardiovascular risk].

OBJECTIVE: To evaluate the value of measuring ankle brachial index (ABI) for diagnosing peripheral arterial disease(PAD) compared with conventional digital subtraction angiography (DSA) as the reference standard. METHODS: A total of 383 consecutive inpatients (245 male, mean age 64.1 +/- 11.7 years) underwent both conventional DSA and ABI measurements. RESULTS: The rate of statin intervention was 90.9%, ACEI 69.2%, antiplatelet 96.6% and beta-blockers 67.9%. The intravascular stenosis was classified into six degrees: normal, < 30%, 30% - 49%, 50% - 69%, 70% - 89% and > or = 90%. Compared to the traditional gold standard (DSA) in diagnosis PDA, the ABI value decreased in proportion to the severity of PAD (the ABI value was 1.08 +/- 0.11, 1.05 +/- 0.16, 0.99 +/- 0.17, 0.66 +/- 0.24, 0.55 +/- 0.28 and 0.54 +/- 0.00 respectively in the six ranks). There was a significant correlation between DSA and ABI in diagnosis PAD. CONCLUSION: ABI measurement is an accurate and reliable non-invasive alternative to conventional DSA in the assessment of lower extremity arteries in patients with peripheral arterial disease.

[Single nucleotide polymorphism and haplotype in TBX1 gene of patients with conotruncal defects: analysis of 130 cases].

OBJECTIVE: To investigate the distribution of the single nucleotide polymorphism (SNP) sites in TBX1 gene and the distribution of related haplotypes in the patients with conotruncal defects (CTD) and normal people. METHODS: The genotypes of the 3 selected SNPs: G2857C (rs737868), G2963A (rs28649236), and A6571T (rs28939675) in TBX1 gene were analyzed by PCR-RFLP among 130 patients with CTD and 200 normal people. Contingency table was applied to analyze the frequencies of these SNP genotypes and related alleles. PHASE software was used to construct the haplotypes and analyze the haplotype frequencies in these 2 groups. RESULTS: There were no significant differences in the allele frequency and genotype rates of the SNPs G2587C and A6571T between the CTD patients and normal controls (all P > 0.05). However, the allele frequency and genotype rates of the SNP G2963A were significant different between he CTD patients and normal controls: the G allele frequency in the CTD patients was 53.8%, significantly higher than that in the normal controls (42.5%, chi(2) = 8.14, P < 0.005); and the AA genotype rate of the CTD patients was 21.6%, significantly lower than that of the controls (38.0%), and the GA genotype rate in the CTD patients was 49.2%, significantly higher than that in the controls (39.0%) (both chi(2) = 9.9, P < 0.05). The haplotype frequencies of G2587/G2963/A6571 and G2587/A2963/T6571 of the CTD patients were 49.2% and 14.6% respectively, both significantly higher than those of the normal controls (36.3% and 9.5% respectively), and the haplotype frequencies of G2587/G2963/T6571 and G2587/A2963/A6571 in the CTD patients were 34.6% and 3% respectively, both significantly lower than those in the normal controls (48.3% and 18% respectively) (chi(2) = 22.39, P < 0.005). CONCLUSION: The SNP site G2963A located in the coding-region of TBX1 gene is associated with CTD. The persons with G2963 have higher risk of CTD than those with A2963. The haplotypes constructed with these 3 SNP sites may be linked with the susceptibility gene of CTD.

[Determining the relationship between coronary artery and coronary sinus and its tributaries using multislice computed tomography].

OBJECTIVE: To obtain the coronary artery and coronary sinus (CS) and its tributaries imaging with multislice computed tomography (MSCT), measure the distance between coronary artery and CS and its tributaries and analyze their spatial relationships. METHODS: The MSCT scans of 117 patients (67 men, 50 women, age 56 +/- 10 years) were obtained, 3D image reconstructed and the vessels courses evaluated. The concomitant distances and spatial relationships of the vessels were determined. RESULTS: Right coronary artery domination was found in 107 cases (91.4%), left coronary artery domination in 7 cases (6.0%), and co-domination in 3 cases (2.6%). Left circumflex artery (LCX) was concomitant with CS or the great cardiac vein (GCV) in 81 cases (69.2%), intersected with left posterior vein in 62 cases (53.0%) and with middle cardiac vein (MCV) in 5 cases (4.3%), respectively. The dominant coronary artery branched out into the posterior descending artery (PDA) and the left posterior artery (LPA) in 112 cases (95.7%). PDA was concomitant with MCV in 93 cases (79.5%) and intersected with MCV in 44 cases (37.6%). LPA was intersected with MCV in 106 cases (90.6%), and concomitant with CS in 50 cases (42.7%). CONCLUSIONS: MSCT is a reliable tool to visualize the relationship between coronary artery and CS and its tributaries. Owing to the multiple possibilities inherent to this technique, MSCT has broad potential for more clinical use.