Optimal Medical Therapy Group Research Articles

Long-term follow-up of patients with chronic total coronary artery occlusion previously randomized to treatment with optimal drug therapy or percutaneous revascularization of chronic total occlusion (COMET-CTO).

The COMET-CTO trial was a randomized prospective study that assessed long-term follow-up in patients with chronic total occlusion (CTO) in coronary arteries treated with percutaneous coronary intervention (PCI) or with optimal medical therapy (OMT). During the 9-month follow-up, the incidence of major adverse cardiac events (MACE) did not differ between the two groups; no death or myocardial infarction (MI) was observed. There was a significant difference in quality of life (QoL), assessed by the Seattle Angina Questionnaire (SAQ), in favor of the PCI group. Here we report long-term follow-up results (56 ± 12 months). Between October 2015 and May 2017, a total of 100 patients with CTO were randomized into two groups of 50 patients: PCI CTO or OMT group. The primary endpoint of the current study was the incidence of MACE defined as cardiac death, MI, and revascularization [PCI or coronary artery bypass graft (CABG)]. As the secondary exploratory outcome, we analyzed all the cause-mortality rate. Out of 100 randomized patients, 92 were available for long-term follow-up (44 in the PCI group and 48 in the OMT group). The incidence of MACE did not differ significantly between the two groups (p = 0.363). Individual components of MACE were distributed, respectively: cardiac death (OMT vs. PCI group, 6 vs. 3, p = 0.489), MI (OMT vs. PCI group, 1 vs. 0, p = 1), and revascularization (PCI: OMT vs. PCI group, 2 vs. 2, p = 1; CABG: OMT vs. PCI group, 1 vs. 1, p = 1). There was no significant difference between the two groups regarding the individual component of MACE. Six patients died from non-cardiac causes [five deaths were reported in the OMT group and one death in the PCI group (p = 0.206)]. Kaplan-Meier survival curves for MACE did not differ significantly between the study groups (log-rank 0.804, p = 0.370). Regarding the secondary exploratory outcome, a total of 15 patients died at 56 ± 12 months (11 in the OMT and 4 in the PCI group) (p = 0.093). The Kaplan-Meier survival curves for all-cause mortality rates did not differ significantly between the two groups (log rank 3.404, p = 0.065). There were no statistically significant differences between OMT and PCI groups in all five SAQ domains. There was a significant improvement in three SAQ domains in the PCI group: PL (p < 0.001), AF (p = 0.007), and QoL (p = 0.001). After 56 ± 12 months of follow-up, the incidence of MACE, as well as QoL measured by SAQ, did not differ significantly between the PCI and OMT groups.

Impact of SGLT2 Inhibitor Therapy on Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction

Background: The impact of sodium-glucose cotransporter-2 inhibitors (SGLT2is) in addition to optimal medical therapy (OMT) on the right ventricular (RV) systolic function using advanced echocardiographic analysis among outpatients with heart failure and a reduced ejection fraction (HFrEF) has thus far been poorly investigated. Methods: This was a single-center, prospective, single-blinded study in which an echocardiographic expert was blinded to the allocation of the treatment. A total of 36 outpatients with HFrEF were randomized to either OMT or OMT+SGLT2i. Both groups underwent an echocardiographic examination of the RV systolic function at the baseline and at the 3-month follow-up (3mFU). Results: The patients in both groups did not significantly differ with respect to the relevant baseline comorbidities, therapy, and clinical characteristics. The patients receiving OMT+SGLT2i showed a significant improvement from the baseline to the 3mFU in all the measured RV echocardiographic parameters, while for the OMT group, a significant improvement after the 3mFU was observed for TAPSE and s'. The mean percent change from the baseline to the 3mFU was significant when comparing OMT+SGLT2i to the OMT group concerning RV FWS (+91% vs. +28%, p = 0.039), TR maxPG (-27% vs. +19%, p = 0.005), and TR Vmax (-17% vs. +13%, p = 0.008), respectively. Conclusions: Adding SGLT2i to OMT in patients with HFrEF resulted in a greater improvement in the RV systolic function from the baseline to the 3mFU compared to the OMT alone.

Left ventricular remodeling following aortic root and ascending aneurysm repair.

Adverse left ventricular remodeling due to a mismatch between stiffness of native aortic tissue and current polyester grafts may be under-recognized. This study was conducted to evaluate the impact of proximal aortic replacement on adverse remodeling of the left ventricle. All aortic root and ascending aortic aneurysm patients were identified (n = 2,001, 2006-2019). The study cohort consisted of a subset of patients (n = 98) with two or more electrocardiogram (ECG)-gated CT angiograms, but without concomitant aortic valve disease or bicuspid aortic valve, connective tissue disease, acute aortic syndrome or prior history of aortic repair or mitral valve surgery. LV myocardial mass was measured from CT data and indexed to body surface area (LVMI). The study cohort was divided into a surgery group (n = 47) and a control group; optimal medical therapy group (OMT, n = 51). The mean age was 60 ± 11 years (80% male). Beta-blocker use was significantly more frequent in the surgery group (89 vs. 57%, p < 0.001), whereas, all other antihypertensive drugs were more frequent in the OMT group. The average follow-up was 9.1 ± 4.0 months for the surgery group and 13.7 ± 6.3 months for the OMT group. Average LVMI at baseline was similar in both groups (p = 0.934). LVMI increased significantly in the surgery group compared to the OMT group (3.7 ± 4.1 vs. 0.6 ± 4.4 g/m2, p = 0.001). Surgery, baseline LVMI, age, and sex were found to be independent predictors of LVMI increased on multivariable analysis. Proximal aortic repair with stiff polyester grafts was associated with increased LV mass in the first-year post-operative and may promote long-term adverse cardiac remodeling. Further studies should be considered to evaluate the competing effects of aortic aneurysm related mortality against risks of long-term graft induced aortic stiffening and the potential implications on current size thresholds for intervention.

Assessing the Clinical Influence of Chronic Total Occlusions (CTOs) Revascularization and the Impact of Vascularization Completeness on Patients with Left Ventricular (LV) Systolic Dysfunction.

Objectives This paper intends to assess the clinical influence of chronic total occlusions (CTOs), revascularization, and the impact of vascularization completeness on patients with left ventricular (LV) systolic dysfunction. Background The roles of CTO vascularization in clinical benefits remain conflicting. In addition, data concerning the different results of CTO vascularization and vascularization completeness according to LV systole function were assessed. Methods From an overall 918 consecutive patients with at least one CTO, 281 patients with ejection fraction (EF) ≤40% accepted coronary angiographic analysis between Jan 1, 2012, and Dec 31, 2020, and 29 patients were excluded. Subsequently, 261 patients were grouped into the successful CTO-PCI revascularization group (SCR, n = 135) and the optimal medical therapy group (OMT, n = 126). The prognosis influence of successfully finished CTO-PCI and complete revascularization on survival was evaluated. The primary endpoint was cardiac mortality, and the secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE). Results After a median follow-up time of 38.02 months, the cardiac mortality (p=0.037) and MACCE (p=0.001) were more remarkable in the OMT group than in the SCR group. Moreover, patients with CTO-PCI had survival benefits from complete revascularization for MACCE (p=0.025) and cardiac mortality (p=0.041). Based on multivariable Cox proportional hazards regression analysis, age ≧ 75 years (HR: 3.443, 95% CI 1.719–6.897, p < 0.001) predicted a worse probability of cardiac mortality. Additionally, previous PCI (HR: 1.592, 95% CI 1.034–2.449, p=0.035) and previous MI (HR: 1.971, 95% CI 1.258–3.088, p=0.003) predicted a worse probability of MACCE, and SCR (HR: 0.499, 95% CI 0.320–0.776, p=0.002) was a protection predictor of MACCE. Conclusion In patients with LV systole dysfunction (EF ≤ 40%), successfully finished CTO-PCI is related to long-term survival benefits. The benefits were more remarkable in patients with complete coronary revascularization (CCR).

Percutaneous Coronary Intervention as Clinical Outcome Predictor for in-Hospital Adverse Events in STEMI patients

Background : Limited resources and the concurrent COVID19 pandemic hinders the appropriate time to achieve reperfusion in Infarct-related artery (IRA). The number of patients receiving late primary PCI (PPCI) and without revascularization are steadily increase within 2 years into the pandemic. The impact of PCI timing in this setting has not been fully elucidated. Objective : This study was conducted to evaluate the effect of early PPCI vs late PPCI vs non revascularization groups towards in-hospital mortality and complications. This study also aimed to determine whether PPCI is the main predictor for in-hospital adverse events in STEMI patients. Method : Data of STEMI patients registered in Saiful Anwar General Hospiital ACS registry were collected between 2018-2021 Patients were subdivided into early PPCI if receiving PCI within the recommended time of the 2017 ESC STEMI management guideline, late PPCI if receiving PCI outside the timeframe provided by the guideline, and optimal medical therapy group if not receiving any means of revascularization. Patients undergoing thrombolysis were excluded. Afterwards, the incidence of in-hospital adverse event were calculated as primary endpoints, development of immediate complications during hospitalizations were analyzed as secondary endpoints. Stratification of baseline characteristics and PCI categorizations were performed using multivariate analysis to determine the main predictor of in-hospital mortality between STEMI patients. Results : 568 STEMI patients were included in the study with 387 in early PPCI, 107 in late PPCI, and 74 in optimal medical therapy group. Incidence of in-hospital mortality were significantly higher in optimal medical therapy group and lowest in early PPCI group (32.4% and 7.5% respectively, P 0.00). Mortality odds ratio between early PPCI group and optimal medical therapy group were significantly lowest (OR 0.17, 95% CI 0.13 – 0.41). Complications between each treatment groups were significantly different with early PPCI had the lowest incidence of in-hospital complications of cardiogenic shock, cardiac arrest, and VT/VF. Stratification of baseline characteristics and PCI category reveals that timing PPCI is the main predictor for in-hospital adverse events (HR 4.506, 95% CI 2.487-6.662, P 0.00). Conclusion : Percutaneous coronary intervention is the main predictor for the incidence of in hospital mortality and complications in STEMI patients.

Impact of SGLT2i Use on Functional Capacity in Heart Failure

<h3>Purpose</h3> Recently published trials have shown benefit for patients with heart failure with reduced or preserved ejection fraction with the addition of sodium glucose co-transporter 2 inhibitors (SGLT2i) to optimal medical therapy (OMT). Outcomes are limited to readmission and mortality but fail to elucidate a benefit in functional capacity. Data regarding the impact of SGLT2i on hemodynamic optimization has not demonstrated benefit in heart failure patients. The impact of SGLT2i on peak oxygen consumption measured by cardiopulmonary stress testing (CPET) has only been evaluated in animal models. Our aim was to evaluate the physiological impact of SGLT2i in the advanced heart failure population. <h3>Methods</h3> We performed a retrospective study between August 1, 2020 and August 15, 2021 to evaluate all patients with heart failure (preserved or reduced ejection fraction) undergoing CPET. Pre and post CPET were required after initiation of SGLT2i or after OMT. The SGLT2i group was compared to matched controls on OMT. <h3>Results</h3> A total of 13,213 patients were on SGLT2i during our study period. Of those, 2,063 (16%) had a diagnosis of heart failure with a total of 96 patients with CPET. 46 of these (48%) patients were in the SGLT2i group and 50 (52%) were matched controls on OMT. Median LVEF was 33% (IQR 25-40) in the SGLT2i group and 38% (IQR 25 -50) in the OMT group, p=0.10. Median duration between baseline and follow-up CPET in SGLT2i group was 352 days and 437 days in the OMT group, p=0.06. Pre and post comparison between OMT and SGLT2i was not different for exercise time (p=0.09), VE/VCO2 (p=0.11), RER (p=0.45), METS (p=0.25) or NYHA class (p=0.28). Less ARNI use (29 vs. 39, p=0.05), higher A1C (6.5 vs 5.7, p=0.01), similar GFR (65 vs 63, p=0.25) and less hypotensive blood pressure response at peak exercise (p<0.01) was noted in the SGLT2i group. Estimated GFR was not impacted by SGLT2i use (p=0.21) There was no significant difference in VO2 max at baseline (p=0.18) or follow-up (p=0.19) between the two groups. Change in VO2 max after SGLT2i was not significant (p=0.31). <h3>Conclusion</h3> The pluripotent mechanism of SGLT2i effect in heart failure is not clearly understood. Current outcomes have limited focus on readmission and mortality. Our data suggest that SGLT2i use does not improve functional capacity in heart failure. Optimization with SGLT2i is potentially due to a predominant effect on neurohormonal modulation and diuretic effect in addition to OMT.

Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study.

IntroductionThe aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF).MethodsWe randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine (123I‑MIBG) heart-to-mediastinum ratio (HMR) at 6 months.ResultsMean age was 60 ± 9 years, 86% was male and mean LVEF was 33 ± 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (p = 0.97). At 6 months, the mean change in late HMR was −0.02 (95% CI: −0.08 to 0.12) in the RDN group, versus −0.02 (95% CI: −0.09 to 0.12) in the OMT group (p = 0.95) whereas the mean change in washout rate was 2.34 (95% CI: −6.35 to 1.67) in the RDN group versus −2.59 (95% CI: −1.61 to 6.79) in the OMT group (p-value 0.09).ConclusionRDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123I‑MIBG.Supplementary InformationThe online version of this article (10.1007/s12471-021-01633-z) contains supplementary material, which is available to authorized users.

Current trends in optimal medical therapy after PCI and its influence on clinical outcomes in China

BackgroundLimited data were available on the current trends in optimal medical therapy (OMT) after PCI and its influence on clinical outcomes in China. We aimed to evaluate the utilization and impact of OMT on the main adverse cardiovascular and cerebrovascular events (MACCEs) in post-PCI patients and analyzed the factors predictive of OMT after discharge.MethodsWe collected data from 3812 individuals from 2016.10 to 2017.09 at TEDA International Cardiovascular Hospital. They were classified into an OMT group and a non-OMT group according to their OMT status, which was defined as the combination of dual antiplatelet therapy, statins, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers after PCI. Multivariable Cox regression models were developed to assess the association between OMT and MACCEs, defined as all-cause mortality, nonfatal myocardial infarction, stroke, and target vessel revascularization. A logistic regression model was established to analyze the factors predictive of OMT.ResultsOur results revealed that the proportion of patients receiving OMT and its component drugs decreased over time. A total of 36.0% of patients were still adherent to OMT at the end of follow-up. Binary logistic regression analysis revealed that baseline OMT (P < 0.001, OR = 52.868) was the strongest predictor of OMT after PCI. The Cox hazard model suggested that smoking after PCI was associated with the 1-year risk of MACCE (P = 0.001, HR = 2.060, 95% CI 1.346–3.151), while OMT (P = 0.001, HR = 0.486, 95% CI 0.312–0.756) was an independent protective factor against postoperative MACCEs.ConclusionsThere was still a gap between OMT utilization after PCI and the recommendations in the evidence-based guidelines. Sociodemographic and clinical factors influence the application of OMT. The management of OMT and smoking cessation after PCI should be emphasized.

The application status of optimal medical therapy after percutaneous coronary intervention and its influence on prognosis

Objective: To investigate the application status of optimal medical therapy (OMT) in patients with coronary heart disease after percutaneous coronary intervention (PCI) and its influence on the 1-year prognosis of patients after surgery. Methods: Data of 3 812 patients diagnosed with coronary heart disease by coronary angiography and successfully completed PCI in the Department of Cardiology, TEDA International Cardiovascular Hospital from October 2016 to September 2017 were prospectively collected. The OMT status and the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) during the hospitalization and 1, 6, and 12 months after discharge were recorded. Patients were divided into OMT group (n=1 299) and non-OMT group (n=2 289) according to their adherence to OMT after PCI. Chi-square test was used to compare the differences of MACCE between groups, and to screen for significant differences and clinically significant variables between groups. Cox regression model was used to analyze the influencing factors of MACCE after PCI. Results: Among 3 588 patients (224 cases lost to follow-up), 58.8% (2 110/3 588) used OMT during hospitalization after PCI, and 36.0% (1 293/3 588) still adhered to OMT after 12 months of follow-up. The utilization rates of OMT showed a decreasing trend, among which till the 12th month, β-blockers and ACEI/ARB showed the greatest decreasing degree, from 75.3%(2 701/3 588) and 75.1%(2 692/3 588) to 59.1%(2 122/3 588) and 53.0%(1 903/3 588). Pearson χ2 analysis showed that elderly patients, the number of amalgamative diseases, history of PCI, history of chronic myocardial infarction, history of chronic renal insufficiency, the lesion counts, lesion type, the Gensini score, adhere to the OMT and smoking during the follow-up were related to postoperative MACCE, the difference was statistically significant (P<0.05). Cox regression model showed that OMT adherence after PCI was an independent protective factor for postoperative MACCE events (HR=0.471,95%CI: 0.300-0.734, P=0.001). Conclusion: The application of OMT after PCI was suboptimal, and the application rate decreased with the lengthening of the discharge time, among which the use of ACEI/ARB and β-blockers deserved more attention. Adherence to OMT after PCI was an independent protective factor, which could reduce the incidence of postoperative MACCE and improve the prognosis of patients.

Late Survival Benefit of Percutaneous Coronary Intervention Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion: A 10-Year Follow-Up Study.

BackgroundAs an initial treatment strategy, percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) did not show midterm survival benefits compared with optimal medical therapy (OMT). We sought to evaluate the benefit of PCI compared with OMT in patients with CTO over extended long‐term follow‐up.Methods and ResultsBetween March 2003 and February 2012, 2024 patients with CTO were enrolled in a single‐center registry and followed for ≈10 years. We excluded patients with CTO who underwent coronary artery bypass graft (n=477) and classified patients into the CTO‐PCI group (n=883) or OMT group (n=664) according to initial treatment strategy. Patients with multivessel disease received PCI for obstructive non‐CTO lesions in both groups. In the CTO‐PCI group, 699 patients (79.2%) underwent successful revascularization. The CTO‐PCI group had a lower 10‐year rate of cardiac death (10.4% versus 22.3%; hazard ratio [HR], 0.44 [95% CI, 0.32–0.59]; P<0.001) than the OMT group. After propensity score matching analyses, the CTO‐PCI group had a lower 10‐year rate of cardiac death (13.6% versus 20.8%; HR, 0.64 [95% CI, 0.45–0.91]; P=0.01) than the OMT group. The relative reduction in cardiac death at 10 years was mainly driven by a relative reduction between 3 and 10 years (8.3% versus 16.6%; HR, 0.43 [95% CI, 0.27–0.71]; P<0.001) but not at 3 years (5.7% versus 5.0%; HR, 1.12 [95% CI, 0.63–2.00]; P=0.71). The beneficial effects of CTO‐PCI were consistent among subgroups.ConclusionsAs an initial treatment strategy, CTO‐PCI might reduce late cardiac death compared with OMT in patients with CTO. Extended follow‐up of randomized trials may confirm the findings of the present study.

A meta-analysis of randomized controlled trials comparing percutaneous coronary intervention with optimal medical therapy in stable obstructive coronary artery disease.

The optimal treatment for patients suffering from stable obstructive coronary artery disease (SOCAD) is controversial. Many studies have examined the value of performing percutaneous coronary intervention (PCI) in these patients but so far no study has been able to demonstrate an improvement in outcomes by performing PCI in addition to optimal medical therapy (OMT). This study aimed to examine the added value of performing PCI plus OMT vs. OMT alone regarding cardiovascular outcomes. We performed a systematic search and a meta-analysis for randomized controlled trials comparing PCI plus OMT vs. OMT in SOCAD patients. We included six trials (N = 11 144) with follow-up ranges 2.2-11.4 years. The pooled analysis showed no significant difference between PCI + OMT vs. OMT group regarding all-cause mortality, odds ratio (OR) = 0.98 [confidence interval (CI) 0.86-1.12, P = 0.79, I2 = 0%]. In addition, we have found no difference between the two groups regarding cardiovascular mortality, OR = 0.91 (CI 0.76-1.08, P = 0.27, I2 = 24%). Moreover, there was no difference in the incidence of myocardial infarction, OR = 0.92 (CI 0.81-1.04, P = 0.18, I2 = 49%). Our results suggest that there is no improvement in cardiovascular outcomes of patients with SOCAD by performing PCI plus OMT vs. OMT alone. This study provides an insight that should be taken under consideration in the management of SOCAD patients.

Two-year left ventricular systolic function of percutaneous coronary intervention vs optimal medical therapy for patients with single coronary chronic total occlusion.

In this study, two-dimensional speckle tracking echocardiography (2D-STE) and real-time three-dimensional echocardiography (RT-3DE) were applied to compare the changes of left ventricular systolic function associated with percutaneous coronary intervention (PCI) versus optimal medical therapy (OMT) in patients with single chronic total occlusion (CTO). 63 single CTO patients (age 61.88±8.86years) were examined by echocardiography and were divided into the PCI group (n=27) and OMT group (n=36) according to the initial treatment strategy. Two-dimensional left ventricular ejection fraction (2D-LVEF), two-dimensional indexed left ventricular end-systolic volume (2D-LVESVI), and two-dimensional indexed left ventricular end-diastolic volume (2D-LVEDVI) were measured using two-dimensional echocardiography (2DE). Three-dimensional left ventricular ejection fraction (3D-LVEF), three-dimensional indexed left ventricular end-systolic volume (3D-LVESVI), and three-dimensional indexed left ventricular end-diastolic volume (3D-LVEDVI) were measured using RT-3DE. Global circumferential strain (GCS) and global longitudinal strain (GLS) were measured using 2D-STE. After 2years of follow-up, there were no significant differences in the 2D-LVEF, 2D-LVESVI, 3D-LVEF, 3D-LVESVI, 3D-LVEDVI, and GCS, except for GLS (P=.001) between the CTO-PCI and CTO-OMT groups. GLS decreased significantly in OMT group (P=.016) in contrast with PCI group in which GLS increased significantly (P=.007). Left ventricular systolic function assessment using 2D-STE showed a significant difference in GLS between CTO-PCI and CTO-OMT. And the patients who chose PCI revascularization at the 2-year follow-up had better left ventricular systolic function improvement than those who were conservatively treated with OMT.

Evaluation of optimal medical therapy in acute myocardial infarction patients with prior stroke.

Background:Treatment of acute myocardial infarction (AMI) patients with prior stroke is a common clinical dilemma. Currently, the application of optimal medical therapy (OMT) and its impact on clinical outcomes are not clear in this patient population.Methods:We retrieved 765 AMI patients with prior stroke who underwent percutaneous coronary intervention (PCI) during the index hospitalization from the international multicenter BleeMACS registry. All of the subjects were divided into two groups based on the prescription they were given prior to discharge. Baseline characteristics and procedural variables were compared between the OMT and non-OMT groups. Mortality, re-AMI, major adverse cardiovascular events (MACE), and bleeding were followed-up for 1 year.Results:Approximately 5% of all patients presenting with AMI were admitted to the hospital for ischemic stroke. Although the prescription rate of each OMT medication was reasonably high (73.3%–97.3%), 47.7% lacked at least one OMT medication. Patients receiving OMT showed a significantly decreased occurrence of mortality (4.5% vs 15.1%, p < 0.001), re-AMI (4.2% vs 9.3%, p = 0.004), and the composite endpoint of death/re-AMI (8.6% vs 20.5%, p < 0.001) compared to those without OMT. No significant difference was observed between the groups regarding bleeding. After adjusting for confounding factors, OMT was the independent protective factor of 1-year mortality, while age was the independent risk factors.Conclusions:OMT at discharge was associated with a significantly lower 1-year mortality of patients with AMI and prior stroke in clinical practice. However, OMT was provided to just half of the eligible patients, leaving room for substantial improvement.Clinical Trial Registration:NCT02466854

Quality of life in patients receiving percutaneous coronary intervention and optimal medical therapy in Ho Chi Minh City, Vietnam

This study assessed Health-Related Quality of Life (HRQOL) of patients with Acute Coronary Syndrome (ACS) 6 to 12 months after receiving Percutaneous Coronary Intervention (PCI) and/or Optimal Medical Therapy (OMT) at a hospital in Ho Chi Minh City, Vietnam. A cross-sectional study was conducted on 113 patients. Data on demographic, lifestyle behaviours, and HRQOL were collected using a structured questionnaire through face-to-face interviews. HRQOL was measured using EQ-5D-5L and EQ-VAS. Data on co-morbidity and other clinical characteristics were extracted from hospital records. Bivariate and multivariable linear regression models were run to test the differences in EQ-5D-5L utility index and EQ-VAS scores between PCI/OMT and OMT alone groups. EQ-5D-5L utility index and EQ-VAS scores were lower in PCI/OMT compared to OMT groups, although the differences were not clinically meaningful. Weight status, smoking, and physical activity were associated with EQ-5D-5L utility index score, whereas only physical activity was associated with EQ-VAS score. The findings suggested that improving sufficient physical activity levels and stopping smoking after PCI or/and OMT may help increase HRQOL among ACS patients.

Medical therapy vs early revascularization in diabetics with chronic total occlusions: A meta-analysis and systematic review.

BACKGROUNDManagement of chronic total occlusions (CTO) in diabetics is challenging, with a recent trend towards early revascularization [ER: Percutaneous coronary intervention (PCI) and bypass grafting] instead of optimal medical therapy (OMT). We hypothesize that ER improves morbidity and mortality outcomes in diabetic patients with CTOs as compared to OMT. AIMTo determine the long term clinical outcomes and to compare morbidity and mortality between OMT and ER in diabetic patients with CTOs.METHODSPotentially relevant published clinical trials were identified in Medline, Embase, chemical abstracts and Biosis (from start of the databases till date) and pooled hazard ratios (HR) computed using a random effects model, with significant P value < 0.05. Primary outcome of interest was all-cause death. Secondary outcomes included cardiac death, prompt revascularization (ER) or repeat myocardial infarction (MI). Due to scarcity of data, both Randomized control trials and observational studies were included. 4 eligible articles, containing 2248 patients were identified (1252 in OMT and 1196 in ER). Mean follow-up was 45-60 mo.RESULTSOMT was associated with a higher all-cause mortality [HR: 1.70, 95% confidence interval (CI): 0.80-3.26, P = 0.11] and cardiac mortality (HR: 1.68, 95%CI: 0.96-2.96, P = 0.07). Results were close to significance. The risk of repeat MI was almost the same in both groups (HR: 0.97, 95%CI: 0.61-1.54, P = 0.90). Similarly, patients assigned to OMT had a higher risk of repeat revascularization (HR: 1.62, 95%CI: 1.36-1.94, P < 0.00001). Sub-group analysis of OMT vs PCI demonstrated higher all-cause (HR: 1.98, 95%CI: 1.36-2.87, P = 0.0003) and cardiac mortality (HR: 1.87, 95%CI: 0.96-3.62, P = 0.06) in the OMT group. The risk of repeat MI was low in the OMT group vs PCI (HR: 0.53, 95%CI: 0.31-0.91, P = 0.02). Data on repeat revascularization revealed no difference between the two (HR: 1.00, 95%CI: 0.52-1.93, P = 1.00).CONCLUSIONIn diabetic patients with CTO, there was a trend for improved outcomes with ER regarding all-cause and cardiac death as compared to OMT. These findings were reinforced with statistical significance on subgroup analysis of OMT vs PCI.

Late survival benefit of percutaneous coronary intervention compared with medical therapy in patients with coronary chronic total occlusion: a 10-year follow-up study

Abstract Background As an initial treatment strategy, percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) did not show mid-term survival benefits compared with optimal medical therapy (OMT). Purpose To compare 10-year clinical outcomes between OMT and PCI in CTO patients. Methods Between March 2003 and February 2012, 2,024 patients with CTO were enrolled in a single center registry and followed for about 10 years. We excluded CTO patients who underwent coronary artery bypass grafting, and classified patients into the OMT group (n=664) or PCI group (n=883) according to initial treatment strategy. Propensity-score matching was performed to minimize potential selection bias. The primary outcome was cardiac death. Results In the PCI group, 699 patients (79.2%) underwent successful revascularization. Clinical and angiographic characteristics revealed more comorbidities and more complex lesions in the OMT group than in the PCI group. At 10 years, the PCI group had lower risks of cardiac death (10.4% versus 22.3%; HR 0.43; 95% CI 0.32 to 0.57; p&amp;lt;0.001) than the OMT group. After the propensity-score matching analyses, the PCI group had lower risks of cardiac death (13.6% versus 20.8%; HR 0.62; 95% CI 0.44 to 0.88; p=0.007), acute myocardial infarction (6.3% versus 11.2%; HR 0.55; 95% CI 0.34 to 0.91; p=0.02), any revascularization (23.9% versus 32.2%; HR 0.67; 95% CI 0.51 to 0.88; p=0.004) than the OMT group. The beneficial effects of CTO PCI were consistent across various subgroups (all p-values for interaction: non-significant). Conclusions As an initial treatment strategy, PCI reduced late cardiac death compared with OMT in CTO patients. Cardiac death in matched population Funding Acknowledgement Type of funding source: None

Impact of caval vein implantation on severity of tricuspid regurgitation, renal and hepatic function in patients with severe secondary tricuspid regurgitation

Abstract Background Severe tricuspid regurgitation (TR) is an important determinant for functional capacity and survival. It frequently occurs in patients with advanced heart failure resulting in progressive venous congestion with cardiorenal and cardiohepatic syndrome. The prospective, randomized TRICAVAL study reported the effect of inferior caval vein implantation of an Edwards Sapien XT valve (CAVI) in comparison to optimal medical therapy (OMT) in patients with severe TR. The study did not detect a superior functional outcome after CAVI, but a significant improvement in quality of life. Due to safety concerns, the study was stopped prematurely after 4 periprocedural complications. Purpose We hypothesised that CAVI reduces reflux into the inferior vena cava and leads to an increase in systolic right atrial pressure, which may result in an improvement of TR severity. The present subanalysis of the TRICAVAL study evaluates the impact of inferior caval vein implantation on TR severity, right heart parameters and renal and hepatic function. Methods Twenty-eight patients with severe TR were randomized in either CAVI group (n=14) with caval vein implantation of an Edwards Sapien XT valve or OMT group (n=14). Medical history, clinical examination, laboratory testing and echocardiographic measurements were analysed in patients with completed FUP (OMT [n = 10], CAVI [n = 8]). Follow-up examinations were performed at baseline and three months after enrolment. Results After three months, the CAVI group exhibited a significant reduction of systolic hepatic vein reflux volume (5.0 [1.3–11.0] ml vs. 14.0 [10.3–18.0] ml, p&amp;lt;0.05) and hepatic vein diameter (10.8 [10.0–12.0] mm vs. 14.0 [11.5–15.0] mm, p&amp;lt;0.05) in comparison to OMT. Compared to baseline, CAVI improved body weight (80.7 [69.0–87.7] kg versus 75.5 [63.8–84.6] kg, p&amp;lt;0.05) and abdominal circumference (101.5±13.8 cm versus 96.3±15.4 cm, p≤0.01) paralleled by a trend to lower doses of diuretics. However, over the FUP period, there were no significant changes regarding TR severity, right heart function and morphology as well as renal and hepatic function within both groups, nor in the comparison between CAVI and OMT. Conclusion As a proof of our concept, CAVI resulted in a decrease in systolic hepatic vein reflux, hepatic vein diameter and clinical signs of venous congestion. However, TR severity, right heart function and morphology as well as renal and hepatic function remained stable. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Edwards Lifesciences, Incorporated (Irvine, CA)

ISCHEMIA Trial and the Significance of MI.

During the past decade, the treatment of choice for chronic coronary syndromes (CCS) has been a contentious issue. Whether revascularisation, either percutaneous or surgical, or optimal medical therapy, offers better prognosis in terms of mortality, MI, and symptom relief, has yet to be confirmed. The long-awaited and recently published International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial randomised more than 5,000 patients into a revascularisation plus optimal medical therapy group and an optimal medical therapy alone group. The authors analyse the trial, with particular emphasis on the incidence of MI. They propose a patient-centred approach to incorporate the results of the ISCHEMIA trial into daily practice and determine the best treatment strategy for patients with CCS.

Comparison effectiveness of acute coronary syndrome treatments on geriatric function

ObjectivesThe study objectives were to compare short time complications, mortality, and effectiveness of primary Percutaneous Coronary Intervention (PCI) with optimal medical therapy in older adults with acute coronary syndromes (ACS). MethodsA prospective cohort study, which patients 60 years old and over with ACS were collecting by face to face interview and assessment of the electronic document, in two educational hospitals of Tehran medical university from May 2018 to Jan. 2019. Patients were evaluated in two groups (primary PCI and medical) in terms of complications, mortality and effectiveness, 24hours and 30 days after treatment. Initially, 312 patients were enrolled in the study that 192 were excluded for different reasons. In the final, 120 patients have met all inclusion criteria. ResultsOne hundred and twenty patients were collected with mean age 71.2±8.2 years old. In both groups every 1 point increase in Instrumental Activity Daily Living (IADL), the Major Adverse Cardiac Effect (MACE) was significantly reduced up to 88% (P=0.007). Short-term mortality was significantly higher in the optimal medical therapy group (P=0.006). In comparison complications 24hours between two groups, atrial fibrillation was significantly higher in the medical group which risk increased 11 times (OR=10.93, CI95%=1.38–87.04, P=0.02). ConclusionsNotwithstanding, primary PCI reduced poor outcomes, and improve quality of life, but a lesser option for older adult patients. Primary PCI in older adult patients could maintain independence in functional daily living that results in reduced mortality and MACE considerably.

The impact of optimal medical therapy on patients with recurrent acute myocardial infarction: Subanalysis from the BleeMACS study

BackgroundAcute myocardial infarction (AMI) recurrence is still high despite great progress in secondary prevention. Patients with recurrent AMI suffer worse prognosis compared to those with first AMI. The objective was to evaluate the effect of optimal medical therapy (OMT) on these patients with recurrent AMI. Methods and resultsSub-analysis was performed including 13,343 patients with AMI from the international multicenter Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome (BleeMACS) registry. OMT was defined as the combination of aspirin, any P2Y12 inhibitor, statin, angiotensin converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. Among 1285 patients with prior AMI, 56.8% received OMT prescription. Patients receiving OMT suffered from less congestive heart failure, peripheral artery disease, malignancy, and bleeding history. Kaplan-Meier survival estimates revealed that OMT was strongly related to decreased in all-cause death (4.2% vs. 10.1%, p < .001) and the composite endpoint of death/re-AMI (11.1% vs. 16.9%, p = .005) at 1-year follow-up. OMT was the independent protect factor of primary endpoint even after adjusting for multiple possible confounders (HR, 0.46; 95% CI, 0.27–0.78; p = .004). However, no significant difference was observed regarding re-AMI between OMT and non-OMT groups. OMT also reduced all-cause death in patients with recurrent AMI after propensity score matching. ConclusionsThe prescription of OMT was seriously insufficient in patients with recurrent AMI, especially high-risk patients, even though OMT was associated with improved prognosis. Further improvements in pharmacological therapy are needed to reduce subsequent recurrent events.