Effect of Arm-Ergometry Versus Treadmill Supervised Exercise on Cardiorespiratory Fitness and Walking Distances in Patients With Peripheral Artery Disease: The ARMEX Randomized Clinical Trial.

PURPOSE: To compare arm-ergometry and treadmill supervised exercise training on cardiorespiratory fitness and walking distances in patients with peripheral artery disease (PAD). METHODS: ARMEX was a single-center, single-blinded, parallel group, non-inferiority trial enrolling symptomatic patients with PAD. Patients were randomized (1:1 ratio) to a 12-wk arm-ergometry (AEx) or standard treadmill (TEx) supervised exercise training protocol. The powered primary end point was the change in peak oxygen uptake (VO2) at 12 wk, measured on a treadmill cardiopulmonary exercise test (CPX). Secondary outcomes included changes in VO2 at the first ventilatory threshold (VT-1), ventilatory efficiency (ratio of minute ventilation [VE] to carbon dioxide production [VCO2], VE/VCO2), walking distances by CPX and 6-min walking test (6MWT), and self-reported walking limitations. RESULTS: Fifty-six patients (66 ± 8 yr; 88% male) were randomized (AEx, n = 28; TEx, n = 28). At 12 wk, VO2peak change was not significantly different between groups (0.75 mL/kg/min; 95% CI, -0.94 to 2.44; P= .378), despite a significant increase only in AEx. VO2 at VT-1 improved in both groups without between-group differences, and VE/VCO2 slope improved more in AEx. The TEx attained greater improvements in walking distance by CPX (121.08 m; 95% CI, 24.49-217.66; P= .015) and 6MWT (25.08 m; 95% CI, 5.87-44.29; P= .012) and self-perceived walking distance. CONCLUSIONS: Arm-ergometry was noninferior to standard treadmill training for VO2peak, and treadmill training was associated with greater improvements in walking distance. Our data support the use of treadmill as a first-line choice in patients with PAD to enhance walking capacity, but arm-ergometry could be an option in selected patients.

Impact of disease duration on proteomic bioprofile and prognosis in rheumatoid arthritis patients.

OBJECTIVES: Cardiovascular disease worsens the prognosis of rheumatoid arthritis (RA) and vice-versa. Inflammation may be a common pathway for both conditions. It is expected that a longer RA duration leads to a greater inflammatory cumulative exposure burden; however, studies on the association between RA disease duration and outcomes are scarce. Our aim is to compare the characteristics, biomarker expression and outcomes according to the duration of RA. METHODS: Prospective cohort study including 399 RA patients, with detailed clinical, echocardiographic, and proteomic phenotyping that were compared across tertiles of RA disease duration. Cox proportional models were used to study the association of disease duration with cardiovascular outcomes. RESULTS: RA duration tertiles were: tertile 1 with median of 3.2; tertile 2 with median of 8.8; and tertile 3 with median of 21.8 years. Compared to tertile 1, patients in tertile 3 were older, had more erosive disease, more frequent echocardiographic alterations, lower haemoglobin and walked a shorter distance on the 6MWT. Natriuretic peptides, cathepsin L1, galectin 9, matrix metalloproteinase-12, adrenomedullin and tumour necrosis factor receptor 11A were higher in patients with longer disease duration. Compared to patients in tertile 1, those in tertile 3 had higher risk of a subsequent cardiovascular hospitalisation or cardiovascular death (HR 2.71, 95%CI 1.06-6.92, p=0.04). CONCLUSIONS: RA patients with longer disease duration had more organ damage and worse outcomes than those with shorter disease duration. Biomarker expression suggested that patients with longer RA duration had activation of pathways related to inflammation, extracellular matrix organisation, fibrosis and congestion.

Fifteen years of coronary intravascular ultrasound in percutaneous coronary intervention in Portugal. / Quinze anos de ecografia intravascular coronária em intervenção coronária percutânea em Portugal.

INTRODUCTION: Coronary intravascular ultrasound (IVUS) is increasingly important in catheterization laboratories due to its positive prognostic impact. This study aims to characterize the use of IVUS in percutaneous coronary intervention (PCI) in Portugal. METHODS: A retrospective observational study was performed based on the Portuguese Registry on Interventional Cardiology of the Portuguese Society of Cardiology. The clinical and angiographic profiles of patients who underwent PCI between 2002 and 2016, the percentage of IVUS use, and the coronary arteries assessed were characterized. RESULTS: A total of 118 706 PCIs were included, in which IVUS was used in 2266 (1.9%). Over time, use of IVUS changed from none in 2002 to generally increasing use from 2003 (0.1%) to 2016 (2.4%). The age of patients in whom coronary IVUS was used was similar to that of patients in whom IVUS was not used, but in the former group there were fewer male patients, and a higher prevalence of cardiovascular risk factors (hypertension, hypercholesterolemia and diabetes), previous myocardial infarction, previous PCI, multivessel coronary disease, C-type or bifurcated coronary lesions, and in-stent restenosis. IVUS was used in 54.8% of elective PCIs and in 19.15% of PCIs of the left main coronary artery. CONCLUSION: Coronary IVUS has been increasingly used in Portugal since 2003. It is used preferentially in elective PCIs, and in patients with higher cardiovascular risk, with more complex coronary lesions and lesions of the left main coronary artery.

Comparison between diabetic and non-diabetic patients after successful percutaneous coronary intervention for chronic total occlusions in the drug-eluting stent era.

OBJECTIVE: Diabetes mellitus and chronic total occlusions are associated with unfavorable outcome after percutaneous coronary intervention. We sought to assess the clinical and angiographic outcomes of diabetic and non-diabetic patients who underwent successful percutaneous revascularization of chronic total occlusions with drug-eluting stents. METHODS: Baseline clinical and angiographic characteristics, procedural details, nine-month angiographic follow-up and clinical events at 12 months were compared between 75 diabetic and 132 non-diabetic patients included in a clinical trial that randomized successful recanalization of chronic total occlusions to receive sirolimus- or everolimus-eluting stents. RESULTS: In both diabetic and non-diabetic groups there was a favorable non-significantly different angiographic result at nine months, with low in-stent late loss (0.14±0.60 mm vs. 0.25±0.68 mm, p=0.305) and rates of binary restenosis (4.0% vs. 10.6%, p=0.180) and reocclusion (0.0% vs. 2.3%, p=0.334). During follow-up similar survival from death (97.3±1.9% vs. 99.2±0.8%, log-rank p=0.273), acute myocardial infarction (100.0±0.0% vs. 97.7±1.3%, log-rank p=0.192), target vessel revascularization (88.7±3.8% vs. 88.2±2.9%, log-rank p=0.899) and stent thrombosis (100.0±0.0% vs. 97.7±1.3%, log-rank p=0.192) was observed. Furthermore, the presence of more diffuse peripheral and coronary artery disease and higher frequency of calcified lesions in diabetic patients did not lead to significant differences in the approach (20.0% vs. 25.0% radial approach, p=0.413), strategy (6.7% vs. 3.8% retrograde strategy, p=0.353), total stent length (48.1±24.6 mm vs. 49.2±23.9 mm, p=0758) or contrast volume (261.3±116.4 ml vs. 297.4±135.9 ml, p=0.109) required for revascularization. CONCLUSIONS: In the drug-eluting stent era, diabetic and non-diabetic patients have comparable favorable clinical and angiographic outcomes after successful percutaneous revascularization of chronic total occlusions.

Thrombus aspiration for reperfusion in myocardial infarction: Predictors and clinical impact of ineffectiveness.

INTRODUCTION AND OBJECTIVES: The benefit of manual thrombus aspiration (TA) in the reperfusion of patients with ST-elevation myocardial infarction (STEMI) has been hotly debated. In most series, failure of TA has been largely unreported. Our objectives were to assess the rate, predictors, and impact on cumulative mortality of failed TA during primary percutaneous coronary intervention (PPCI). METHODS: This was a single-center, retrospective study of consecutive STEMI patients undergoing PPCI with TA. TA was considered ineffective if, before angioplasty, coronary flow was TIMI <2. Independent predictors of TA failure were assessed by logistic regression, and predictors of cumulative mortality were assessed by Cox regression analysis. RESULTS: Of 574 patients, TA was used in 417 (72.6%), and was effective in 365 (87.5%) and ineffective in 52 (12.5%). On multivariate analysis, SYNTAX score (OR=1.049, 95% CI: 1.015-1.084, p=0.005) and total ischemic time (OR=1.001, 95% CI: 1.000-1.003, p=0.02) were independent predictors of TA failure. Moderate or severe left ventricular dysfunction (HR=6.256, 95% CI: 1.896-20.644, p=0.003), APPROACH score (HR=1.094, 95% CI: 1.016-1.177, p=0.017), Killip class III/IV (HR=2.953, 95% CI: 1.122-7.770, p=0.028) and creatinine clearance on admission (HR=0.973, 95% CI: 0.953-0.994, p=0.011) were independently related to cumulative mortality at 24 ± 0.82 months. CONCLUSIONS: Total ischemic time and SYNTAX score were independent predictors of TA failure. However, in medium-term follow-up, ineffective manual TA was not independently related to cumulative mortality.

[Patency of Coronary Artery Bypass Graft]. / Permeabilidade dos Bypass Aorto-Coronários.

INTRODUCTION: Coronary heart disease is the leading cause of death and disability in the U.S. and Europe. When significant, the coronary disease can be treated medically or surgically. The medical treatment is performed in the catheterization laboratory and consists in the re-permeabilization of the coronary arteries by percutaneous approach, whereas the surgical myocardial revascularization consists in performing aorto-coronary bypass using arterial or venous conduits. OBJECTIVE: This study is sought to assess the patency and longevity of bypass in patients requiring new catheterization after surgery for recurrence of ischemic heart disease and to evaluate its relationship with factors such as the type of bypass, cardiovascular risk factors and left ventricular ejection fraction. METHODS: This study retrospectively analysed a sample of 260 surgically revascularized patients who required a new catheterization at the Hospital of Vila Nova de Gaia - Espinho between 2007 and 2012, for recurrence of ischemic heart disease. The degree of patency of the bypass was evaluated and sought a relationship with other variables such as gender, age, cardiovascular risk factors, left ventricular ejection fraction, the time interval between bypass surgery and the new catheterization. RESULTS: The patency of the arterial bypass using the left internal mammary artery proved to be superior to the venous conduit bypass. There was no statistically significant relationship between the patency of the bypass, the cardiovascular risk factors and the left ventricle ejection fraction. CONCLUSION: In this study we found a greater patency of the arterial bypass compared to the venous bypass.

Techniques and material used in the percutaneous treatment of chronic coronary occlusions. Data from the CIBELES study.

INTRODUCTION: In recent years, various specific techniques and materials have been developed for the treatment of coronary chronic total occlusions (CTO). OBJECTIVE: To evaluate the current situation in the treatment of CTO (techniques and material) in our setting. METHODS: We evaluated data on techniques and material used in the CIBELES (ChronIc coronary occlusion treated By EveroLimus Eluting Stent) trial, a randomized comparison of sirolimus- and everolimus-eluting stents in 207 patients with CTO in 13 centers in Spain and Portugal. RESULTS: A radial approach was used in 23% of patients, and retrograde techniques were used in only 5%. A high number of balloons were used (2.2±0.9 per patient). Microcatheters were used in 33% of patients, and post-dilatation balloons in only 25%. The mean number of stents implanted per patient was 2.1±1.0, with a mean total stent length of 49±24 mm. Other devices and techniques used were: Tornus penetration catheter in 4% of patients, rotational atherectomy in 2%, and cutting balloon in 1%. Intracoronary ultrasound was used in only 6% of patients. In 34% of cases, operators used guidewires that were not specifically for CTO. Considerable variability between centers was detected in the use of different techniques, the highest and lowest variability being observed in the use of intracoronary ultrasound and the use of CTO guidewires, respectively. CONCLUSIONS: In the CIBELES trial, techniques and devices specifically designed for the treatment of CTO were used in a relatively low proportion of patients. Considerable variability between centers was detected.

Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial.

BACKGROUND: Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions. METHODS AND RESULTS: A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was -0.16 mm (95% confidence interval, 0.04 to -0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075). CONCLUSIONS: In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

Small coronary arteries treated with sirolimus-eluting stents: one-year results of the PORTO multicentre registry.

AIMS: To assess the effectiveness and safety of sirolimus-eluting stents (SES) in de novo native coronary lesions in small vessels (/= 23 mm).The mean (SD) reference vessel diameter of the treated segment was 2.08 (0.33) mm and lesion length 11.04 (6.0) mm. After six months, LL was 0.07 (0.37) mm. BR was 5.1% in-stent and 9.1% in-segment. At one year, TLR was 5.6% and TVR was 9.0%. MACE rate was 2.6% at six months and 8.6% at one year with 2.3% cardiac death and 1.5% non-fatal myocardial infarction. Stent thrombosis rate at one year was 0.8% per protocol. There were more MACE in diabetic patients (12.8%) than in non-diabetic (5.4%, p=0.046), but no other significant differences in clinical and angiographic parameters were noted between the subgroups analysed. CONCLUSIONS: The use of SES for lesions in very small coronary arteries proved to be safe and efficacious, irrespective of the size and length of the stents, with low restenosis and repeat revascularisation rates at one year.