Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): Rationale and design of a randomized clinical trial

Background: Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance. Design: HULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (≥70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4-9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed. Conclusions: The HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance

Data on administration of cyclosporine, nicorandil, metoprolol on reperfusion related outcomes in ST-segment Elevation Myocardial Infarction treated with percutaneous coronary intervention

Mortality and morbidity in patients with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) are still high [1]. A huge amount of the myocardial damage is related to the mitochondrial events happening during reperfusion [2]. Several drugs directly and indirectly targeting mitochondria have been administered at the time of the PCI and their effect on fatal (all-cause mortality, cardiovascular (CV) death) and non fatal (hospital readmission for heart failure (HF)) outcomes have been tested showing conflicting results [3]; [4]; [5]; [6]; [7]; [8]; [9]; [10]; [11]; [12]; [13]; [14]; [15] ; [16]. Data from 15 trials have been pooled with the aim to analyze the effect of drug administration versus placebo on outcome [17]. Subgroup analysis are here analyzed: considering only randomized clinical trial (RCT) on cyclosporine or nicorandil [3]; [4]; [5]; [9]; [10] ; [11], excluding a trial on metoprolol [12] and comparing trial with follow-up length <12 months versus those with longer follow-up [3]; [4]; [5]; [6]; [7]; [8]; [9]; [10]; [11]; [12]; [13]; [14]; [15] ; [16]. This article describes data related article titled “Clinical Benefit of Drugs Targeting Mitochondrial Function as an Adjunct to Reperfusion in ST-segment Elevation Myocardial Infarction: a Meta-Analysis of Randomized Clinical Trials” [17]

Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction:A meta-analysis of randomized clinical trials

Aims: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. Methods: Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo. Odds ratios (OR) were computed from individual studies and pooled with random-effect meta-analysis. Results: Fifteen studies were identified involving 5680 patients. When compared with placebo, drugs targeting mitochondrial component/pathway were not associated with significant reduction of cardiovascular and all-cause mortality (OR 0.9, 95% CI 0.7–1.17 and OR 0.92, 95% CI 0.69–1.23, respectively). However, these agents significantly reduced hospital admission for heart failure (HF) (OR 0.64; 95% CI 0.45–0.92) and increased left ventricular ejection fraction (LVEF) (OR 1.44; 95% CI 1.15–1.82). After analysis for subgroups according to the mechanism of action, drugs with direct/selective action did not reduce any outcome. Conversely, those with indirect/unspecific action showed a significant effect on cardiovascular mortality (0.65, 95% CI 0.46–0.92), all-cause mortality (OR 0.69, 95% CI 0.52–0.92), hospital readmission for HF (OR 0.41, 95% CI 0.28–0.6) and LVEF (OR 1.49, 95% CI 1.09–2.05). Conclusions: Administration of drugs targeting mitochondrial function in STEMI patients undergoing primary PCI appear to have no effect on mortality, but may reduce hospital readmission for HF. The drugs with a broad-spectrum mechanism of action seem to be more effective in reducing adverse events

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

Background: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation. Methods: Consecutive ACS patients undergoing BRS implantation in 8 centers were com­pared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were com­pared after matching, and 117 (55.2%) BRS patients were treated with postdilatation. Results: After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p &lt; 0.001), mainly driven by TLR (6.1% vs. 1.9%, p &lt; 0.001). Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). How­ever, after sensitivity analysis, MACE rates in BRS patients with postdilatation were signifi­cantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p &lt; 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p &lt; 0.001). Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045). Conclusions: Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation

Impact of Diabetes on 10‐Year Outcomes Following ST‐Segment–Elevation Myocardial Infarction: Insights From the EXAMINATION‐EXTEND Trial

BACKGROUND: Long-term outcomes of ST-segment-elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION trial) trial was to compare 10-year outcomes of patients with ST-segment-elevation myocardial infarction with and without diabetes. METHODS AND RESULTS: Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient-oriented composite end point of all-cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient-oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05-1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19-2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow-up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13-2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. CONCLUSIONS: Patients with ST-segment-elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years

Angina and left ventricular dysfunction: can we 'reduce' it?

Despite the evolution in pharmacology and devices, recurrent and persistent angina still represent a frequent issue in clinical practice. A 69-year-old Caucasian female patient has history of surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis with subsequent transcatheter valve-in-valve implantation for bioprosthesis degeneration and single coronary artery bypass graft with left internal mammary artery on left anterior descending (LAD). After transcatheter aortic valve implantation, she started to complain angina [Canadian Cardiovascular Society (CCS) Class III], effectively treated with bisoprolol uptitration and ivabradine 5 b.i.d. addition. After 6months, she had a non-ST segment elevated myocardial infarction with evidence of left main occlusion and good functioning aortic bioprosthesis. A retrograde drug-eluting balloon percutaneous coronary intervention (PCI) on LAD (in-stent restenosis) was performed. However, the patient continued to complain angina (CCS Class II-III), even after further ivabradine increase to 7.5 mg b.i.d. After 4months, the patient underwent Reducer implantation. After 2months, angina started to improve and the patient is currently angina free. In the last decades, PCI materials and stents greatly improved. Medical therapy (such as -blockers) has been shown not only to improve symptoms but also to add a prognostic benefit in patients with reduced ejection fraction (EF). Ivabradine showed additional benefits in patients with angina and reduced EF. However, still a relevant portion of patients complain refractory angina. The COSIRA trial showed that a coronary sinus Reducer was associated with greater angina relief than the sham procedure and could be a further step in angina treatment

Uric acid and coronary artery disease: An elusive link deserving further attention

partially_open5noUric acid is the final product of purine metabolism. Classically it is recognized as the cause of gouty arthritis and kidney stones. Western civilization has increased serum levels of uric acid which is no longer considered a benign plasma solute. It has been postulated and recently demonstrated that it can penetrate cell membrane and exerts damaging intracellular actions such as oxidation and inflammation. These observations have stimulated several epidemiological researches suggesting that hyperuricemia is linked or even provokes hypertension and coronary artery disease. In this review we summarize the current evidences regarding uric acid which contribute in the pathophysiology of coronary artery disease.openBiscaglia, Simone; Ceconi, Claudio; Malagù, Michele; Pavasini, Rita; Ferrari, RobertoBiscaglia, Simone; Ceconi, Claudio; Malagu', Michele; Pavasini, Rita; Ferrari, Robert

Angina and chronic obstructive pulmonary disease: facing the perfect storm

The association of chronic obstructive pulmonary disease (COPD) and ischaemic heart disease (IHD) is challenging both in terms of prognosis and of pharmacological treatment. An 83-year-old Caucasian male patient has chronic kidney disease, COPD, previous myocardial infarction, coronary artery bypass graft with left internal mammary artery (LIMA) on left anterior descending (LAD), saphenous vein graft (SVG) on obtuse marginal (OM)1 and on right coronary artery, and percutaneous coronary intervention (PCI) on LAD (occlusion of LIMA) and on SVG for OM1 (SVG critical stenosis). Recently, the patient complained worsening angina [Canadian Cardiovascular Society (CCS) III] and had residual ischaemia in the anterior wall after an unsuccessful attempt of PCI was performed on LAD for in-stent occlusion due to restenosis. Bisoprolol uptitration failed due to worsening of pulmonary function at spirometry. For this reason, ivabradine 5mg b.i.d. was added to bisoprolol. Afterwards, the patient referred amelioration of symptoms and he is actually in CCS Class I. The control spirometry showed moderate obstruction comparable to his chronic situation. Patients with IHD and COPD often do not receive -blockers due to the fear of adverse effects. However, cardioselective -blockers do not worsen pulmonary function while they reduce mortality in COPD patients. In this setting, ivabradine could be extremely helpful in order to control symptoms since it is effective in patients with asthma and COPD, with no alteration in respiratory function or symptoms and improves exercise capacity and functional class in COPD patients

Preformed acrylic bone cement spacer loaded with antibiotics: Use of two-stage procedure in 10 patients because of infected hips after total replacement

In 10 patients having deep infection after total hip replacement, we used a two-stage revision procedure involving implantation of a preformed spacer with a cylindrical rod coated with acrylic cement containing antibiotics (Spacer-G). This device, which remained in situ for an average of 5 months, permitted healing of the infection in 8 cases and reimplantation of a new prosthesis (mean follow-up 35 months). During treatment, 1 dislocation occurred. The spacer maintained the gap between both bone segments and allowed a certain degree of joint mobility. Use of Spacer-G improved the quality of life of the patients during treatment and accelerated recovery of function after reimplantation

Remodelling after an Infarct: Crosstalk between Life and Death

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