Drug-coated balloon-based versus drug-eluting stent-only revascularization in patients with diabetes and multivessel coronary artery disease.

BACKGROUND: Data on drug-coated balloon (DCB) treatment in the context of diabetes mellitus (DM) and multivessel coronary artery disease (CAD) are limited. We aimed to investigate the clinical impact of DCB-based revascularization on percutaneous coronary intervention (PCI) in patients with DM and multivessel CAD. METHODS: A total of 254 patients with multivessel disease (104 patients with DM) successfully treated with DCB alone or combined with drug-eluting stent (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n = 13,160 patients) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. RESULTS: The DCB-based group was associated with a reduced risk of MACE in patients with DM (hazard ratio [HR] 0.19, 95% confidence interval [CI] 0.05-0.68, p = 0.003], but not in those without DM (HR 0.52, 95% CI 0.20-1.38, p = 0.167) at the 2-year follow-up. In patients with DM, the risk of cardiac death was lower in the DCB-based group than the DES-only group, but not in those without DM. In both patients with or without DM, the burdens of DES and small DES (less than 2.5 mm) used were lower in the DCB-based group than in the DES-only group. CONCLUSIONS: In multivessel CAD, the clinical benefit of a DCB-based revascularization strategy appears to be more evident in patients with DM than in those without DM after 2 years of follow-up. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277).

Impact of Scoring Balloon Angioplasty on Lesion Preparation for DCB Treatment of Coronary Lesions.

OBJECTIVE: The aim of this study was to evaluate the efficacy of scoring balloon angioplasty for drug-coated balloon (DCB) treatment in percutaneous coronary intervention. BACKGROUND: The scoring balloon angioplasty may play a pivotal role in enhancing the outcomes of DCB treatment. METHODS: A total of 259 patients (278 lesions) with coronary artery disease successfully treated with DCB were retrospectively enrolled. The mean age of the patients was 62.2 ± 11.1 years, and the majority of patients were men (68.7%). The study's endpoint was defined as achieving an optimal angiographic result, which consisted of Thrombolysis in Myocardial Infarction (TIMI) flow grade 3, residual diameter stenosis ≤ 30%, and dissection less than type C after the procedure. RESULTS: Angioplasty was performed for 61 lesions with a scoring balloon and 217 lesions with a non-scoring balloon. All lesions were TIMI flow grade 3 except two lesions in the non-scoring balloon group. The scoring balloon group had a higher prevalence of residual diameter stenosis ≤ 30% (68.9% vs. 39.6%, p < 0.001), while severe dissection, defined as type C or greater, was observed less frequently (9.8% vs. 31.8%, p = 0.001). Moreover, the scoring balloon group achieved a superior rate of optimal angiographic results (60.7% vs. 28.6%, p < 0.001). In multivariable analysis, scoring balloon (OR: 3.08 [95% confidence interval, 1.47-6.58], p = 0.003) and DCB balloon-to-artery ratios (OR: 5.46 [95% confidence interval, 1.43-21.93], p = 0.014) were independent factors in the increasing rate of optimal angiographic result. CONCLUSIONS: The application of a scoring balloon catheter for lesion preparation, aiming to make them suitable for DCB treatment, was associated with a decreased risk of severe dissection and a greater occurrence of optimal angiographic outcomes compared with non-scoring balloon angioplasty.

Clinical Impact of Drug-Coated Balloon-Based Percutaneous Coronary Intervention in Patients With Multivessel Coronary Artery Disease.

BACKGROUND: Data on drug-coated balloon (DCB) treatment in the context of multivessel coronary artery disease (CAD) are limited. OBJECTIVES: The purpose of this study was to investigate the impact of DCB-based treatment on percutaneous coronary intervention for multivessel CAD. METHODS: A total of 254 patients with multivessel disease successfully treated with DCBs or in combination with drug-eluting stents (DES) were retrospectively enrolled (DCB-based group) and compared with 254 propensity-matched patients treated with second-generation DES from the PTRG-DES (Platelet Function and Genotype-Related Long-Term Prognosis in Drug-Eluting Stent-Treated Patients With Coronary Artery Disease) registry (n = 13,160) (DES-only group). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent thrombosis, target vessel revascularization, and major bleeding at 2 years. RESULTS: Baseline clinical characteristics were comparable between the groups. In the DCB-based group, 34.3% of patients were treated with DCBs only and 65.7% were treated with the DES hybrid approach. The number of stents and total stent length were significantly reduced by 65.4% and 63.7%, respectively, in the DCB-based group compared with the DES-only group. Moreover, the DCB-based group had a lower rate of MACE than the DES-only group (3.9% and 11.0%; P = 0.002) at 2-year follow-up. The DES-only group had a higher risk for cardiac death and major bleeding. CONCLUSIONS: The DCB-based treatment approach showed a significantly reduced stent burden for multivessel percutaneous coronary intervention and led to a lower rate of MACE than the DES-only treatment. This study shows that DCB-based treatment approach safely reduces stent burden in multivessel CAD, and improved long-term outcomes may be expected by reducing stent-related events. (Impact of Drug-Coated Balloon Treatment in De Novo Coronary Lesion; NCT04619277).

Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial.

BACKGROUND: Dilated cardiomyopathy (DCMP) is characterized by ventricular chamber enlargement and systolic dysfunction which may cause heart failure. Patients with DCMP have overactivation of the renin-angiotensin-aldosterone systems, which can also adversely affect myocardial metabolism in heart failure. The impairment of myocardial metabolism can contribute to the progression of left ventricular remodeling and contractile dysfunction in heart failure. Although angiotensin II receptor blockers (ARBs) have been used to treat patients with DCMP, there has been no direct comparison of the efficacy of these agents. The objective of this study is to compare the effects of olmesartan and valsartan on myocardial metabolism in patients with DCMP. METHODS/DESIGN: The OVOID study (a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy) is designed as a non-blinded, open-label, parallel-group, prospective, randomized, controlled, multicenter clinical trial. A total of 40 DCMP patients aged between 20 and 85 years will be randomly allocated into the olmesartan or the valsartan group. 18F-fluoro-2-deoxyglucose (FDG) cardiac positron emission tomography (PET) will be performed at baseline and six months after receiving the study agent. The primary endpoint is myocardial glucose consumption per square meter, measured using 18F-FDG PET 6 months after receiving the study agent. DISCUSSION: The purpose of this trial is to compare the efficacy between olmesartan and valsartan in improving myocardial metabolism in DCMP patients. This will be the first randomized comparative study investigating the differential effects of ARBs on heart failure. TRIAL REGISTRATION: ClinicalTrials.gov NCT04174456 . Registered on 18 November 2019.

Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease.

PURPOSE: Although drug-coated balloon (DCB) treatment is known to be effective for de novo lesions, the influence of sex on angiographic and clinical outcomes remains unknown. This study aimed to investigate the angiographic and clinical impact of DCB treatment in patients with de novo coronary lesions according to sex. MATERIALS AND METHODS: A total of 227 patients successfully treated with DCB were retrospectively enrolled and divided into two groups according to sex. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF), which included cardiac death, target vessel myocardial infarction, target lesion revascularization, and target vessel thrombosis. RESULTS: The study enrolled 60 women (26.4%) and 167 men (73.6%). Compared to men, women had a smaller vessel size, larger DCB to reference vessel ratio, and more dissections after DCB treatment (55.0% vs. 37.1%, p=0.016). Women also had a significantly higher LLL compared to men (0.12±0.26 mm vs. 0.02±0.22 mm, p=0.012) at the 6-month follow-up angiography. During a median follow-up of 3.4 years (range 12.7-28.9 months), TVF was similar (women 6.7% vs. men 7.8%, p=0.944). In multivariable analysis, women were independently associated with a higher LLL. CONCLUSION: LLL was higher in women, but there was no difference in TVF between women and men. Based on multivariable analysis, the women sex was an independent predictor of higher LLL (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes.

PURPOSE: Dissection after plain balloon angioplasty is required to achieve adequate luminal area; however, it is associated with a high risk of vascular events. This study aimed to examine the relationship between non-flow limiting coronary dissections and subsequent lumen loss and long-term clinical outcomes following successful drug-coated balloon (DCB) treatment of de novo coronary lesions. MATERIALS AND METHODS: A total of 227 patients with good distal flow (Thrombolysis in Myocardial Infarction flow grade 3) following DCB treatment were retrospectively enrolled and stratified according to the presence or absence of a non-flow limiting dissection. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization, and target vessel thrombosis). RESULTS: The cohort consisted of 95 patients with and 132 patients without a dissection. There were no between-group differences in LLL (90.8%) returning for angiography at 6 months (0.05±0.19 mm in non-dissection and 0.05±0.30 mm in dissection group, p=0.886) or in TVF (6.8% in non-dissection and 8.4% in dissection group, p=0.799) at a median follow-up of 3.4 years. In a multivariate analysis, the presence of dissection and its severity were not associated with LLL or TVF. Almost dissections (93.9%) were completely healed, and there was no newly developed dissection at 6-month angiography. CONCLUSION: The presence of a dissection following successful DCB treatment of a de novo coronary lesion may not be associated with an increased risk of LLL or TVF (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).

Antiplatelet effect of ticagrelor compared to tirofiban in non-ST-segment elevation ACS patients undergoing PCI. The result of the TE-CLOT trial.

Addition of a potent P2Y12 inhibitor to aspirin is the standard therapy for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients undergoing percutaneous coronary intervention (PCI). Glycoprotein IIb/IIIa inhibitor, together with antiplatelet therapy, may be considered as part of initial therapy in NSTE-ACS patients with high-risk features. This study investigated the antiplatelet effect of ticagrelor loading dose (LD) versus tirofiban bolus injection with a post-bolus infusion on top of aspirin among NSTE-ACS patients planned to PCI. NSTE-ACS patients were randomised to receive either ticagrelor (n = 47) or tirofiban (n = 48). Platelet reactivity was assessed by light transmittance aggregometry at 0, 2, 8, and 24 hours (h) after treatment initiation. Primary endpoint was inhibition of platelet aggregation (IPA, 20 µM ADP, final extent) at 2 h after LD therapy, with a non-inferiority margin of 10%. The prevalence of high on-treatment platelet reactivity (HPR) was also compared at 0, 2, 8, and 24 h. The mean difference in IPA between ticagrelor and tirofiban was -9.9% (95% confidence interval: -25.7% to 5.9%) at 2 h, -1.6% (-8.0% to 4.8%) at 8 h, and -3.3% (-18.4% to 12.0%) at 24 h. The prevalence of HPR did not differ between the two groups at any time point (all p values ≥ 0.059), which was almost abolished by 8 h post-LD (< 5%). In conclusion, the antiplatelet effect during the early phase (~2 h) after ticagrelor LD appeared to be relatively strong, but it did not reach that of tirofiban in NSTE-ACS patients.

Prediction of Fractional Flow Reserve without Hyperemic Induction Based on Resting Baseline Pd/Pa.

BACKGROUND AND OBJECTIVES: The purposes of this study are 1) to investigate the relationship between resting baseline Pd/Pa, determined by the ratio of the pressures proximal (Pa) and distal (Pd) to the target lesion before, inducing hyperemia and fractional flow reserve (FFR) and 2) to identify a resting baseline Pd/Pa range that might reliably preclude the need for hyperemic induction. SUBJECTS AND METHODS: A total of 622 pressure wire data sets obtained from intermediate stenotic lesions were analyzed. RESULTS: There was a good linear relationship between resting baseline Pd/Pa and FFR (r=0.746, p<0.001). Receiver-operating characteristic curves of the resting baseline Pd/Pa with FFR ≤0.80 as the reference variable showed an area under the curve of 0.89 (95% confidence intervals 0.863-0.914, p<0.001) with a diagnostic accuracy of 82.3% when the resting baseline Pd/Pa was ≤0.92. These results showed that certain cutoff values can reliably predict FFR, whether positive or negative. The resting baseline Pd/Pa >0.95 (n=257, 41.3%) had a negative predictive value (NPV) of 98.1% and a sensitivity of 97.3%. the resting baseline Pd/Pa ≤0.88 (n=65, 10.5%) had a positive predictive value (PPV) of 96.2% and a specificity of 99.8%. These were consistent regardless of coronary vessel, lesion location, lesion length, or degree of stenosis. CONCLUSION: In intermediate lesions, the resting baseline Pd/Pa was linearly related to FFR. A certain range of the resting baseline Pd/Pa values had an excellent NPV with high sensitivity or excellent PPV with high specificity for determining the lesion significance.

Congenital giant right coronary artery aneurysm with fistula to the coronary sinus and persistent left superior vena cava in an old woman.

The combination of coronary arteriovenous fistula to the coronary sinus (CS), dilatation of the entire length of coronary artery, coronary aneurysm and persistent left superior vena cava (PLSVC) is very rare. We present the case of a 63-year-old female admitted for dyspnea on exertion, orthopnea, and facial edema. Echocardiography detected a giant coronary artery with shunt flow, dilated CS and PLSVC and a coronary angiography reaffirmed these findings. The calculated ratio of pulmonary blood flow to systemic blood flow by cardiac catheterization was 1.53. After multidisciplinary review considering old age, hypoactivity due to underlying Parkinsonism and relatively small amount of shunt flow, medical therapy was chosen. The patient remained asymptomatic for 10 months after discharge without intervention.