Gender-related differences in changes of estimated bleeding risk in patients on dual antiplatelet therapy: the RE-SCORE multicenter prospective registry.

The risk of bleeding as predicted by the PRECISE-DAPT score can vary over time after percutaneous coronary intervention (PCI). We sought to compare the predictive ability of the PRECISE-DAPT score calculated at baseline and reassessed during follow-up in male and female patients undergoing PCI. The RE-SCORE was a multicenter, prospective registry including patients undergoing PCI treated with dual antiplatelet therapy (DAPT) for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. The PRECISE-DAPT score was determined for each patient at the time of PCI and at 1, 4 and 8-month follow-up visits or before the occurrence of an endpoint event. A total of 480 patients undergoing PCI were included. At baseline, median PRECISE-DAPT score was similar in males (23.2 [IQR 20.1-24.2]) and females (23.4 [IQR 20.2-25.3]; p = .22). During follow-up, an increase in the PRECISE-DAPT occurred significantly more often in females (44%) than in males (23%; p < .001). The discrimination of the PRECISE-DAPT score calculated at baseline was marginal in both males (c-index = 0.59, 95% CI: 0.51-0.65) and females (c-index = 0.55, 95% CI: 0.49-0.60). The discriminative ability of the score reassessed at follow-up was excellent in females (c-index = 0.84; 95% CI: 0.77-0.91) but remained modest in males (c-index = 0.61; 95% CI: 0.55-0.70). The bleeding predictive ability of the PRECISE-DAPT score can vary over time, more commonly in females than males. The discrimination of the score calculated during follow-up appeared improved in females but remained modest in males.Clinical Trial Registration - ClinicalTrials.gov Identifier: NCT03526614.

The co-predictive value of a cardiovascular score for CV outcomes in diabetic patients with no atrial fibrillation.

BACKGROUND: Risk factors included in the cardiovascular (CHA2 DS2 -VASc) score, currently used for atrial fibrillation (AF), may predispose to cardiovascular events whether or not AF is present. The aim was to explore the predictive role of CHA2 DS2 -VASc score on cardiovascular outcomes in diabetic patients without AF. METHODS: We accessed individual data from 610 diabetic patients without AF at baseline included in the prospective cohort of the Malmö Diet and Cancer study. Main outcome measure was the occurrence of cardiovascular events (stroke, coronary events) and death. Mean follow-up was 14.5 ± 5 years (8845 person/years). RESULTS: The CHA2 DS2 -VASc score significantly predicted the risk of all outcome measures. There was a significant increase in stroke, coronary events, and death risk by each point of CHA2 DS2 -VASc score elevation [stroke: adjusted hazard ratio (aHR) 1.43, 95% CI 1.14-1.79, P = 0.001; coronary events: aHR 1.55, 95% CI 1.34-1.80, P < 0.0001; death: aHR 1.94, 95% CI 1.71-2.21, P < 0.0001]. A CHA2 DS2 -VASc score ≥4 was associated with higher incidence of ischemic stroke (aHR 1.47, 95% CI 1.18-1.82; P = 0.001), coronary events (aHR 1.32; 95% CI 1.11-1.58; P = 0.002), and death (aHR 1.36; 95% CI 1.20-1.54; P < 0.001). CONCLUSIONS: In this population-based study on diabetic patients without AF, the CHA2 DS2 -VASc score was an independent predictor of ischemic stroke, coronary events, and overall mortality. Regardless of the AF status, the CHA2 DS2 -VASc score might represent a rapid and user-friendly tool for clinical assessment of diabetic patients at higher cardiovascular risk.

Statin pretreatment and risk of in-hospital atrial fibrillation among patients undergoing cardiac surgery: a collaborative meta-analysis of 11 randomized controlled trials.

AIMS: Statin pretreatment in patients undergoing cardiac surgery is understood to prevent postoperative atrial fibrillation (AF). However, this is based on observational and limited randomized trial evidence, resulting in uncertainty about any genuine anti-arrhythmic benefits of these agents in this setting. We therefore aimed to quantify precisely the association between statin pretreatment and postoperative AF among patients undergoing cardiac surgery. METHODS AND RESULTS: A detailed search of MEDLINE and PubMed databases (1st January 1996 to 31st July 2012) was conducted, followed by a review of the reference lists of published studies and correspondence with trial investigators to obtain individual-participant data for meta-analysis. Evidence was combined across prospective, randomized clinical trials that compared the risk of postoperative AF among individuals randomized to statin pretreatment or placebo/control medication before elective cardiac surgery. Postoperative AF was defined as episodes of AF lasting ≥5 min. Overall, 1105 participants from 11 trials were included; of them, 552 received statin therapy preoperatively. Postoperative AF occurred in 19% of these participants when compared with 36% of those not treated with statins (odds ratio 0.41, 95% confidence interval 0.31-0.54, P < 0.00001, using a random-effects model). Atrial fibrillation prevention by statin pretreatment was consistent across different subgroups. CONCLUSION: Short-term statin pretreatment may reduce the risk of postoperative AF among patients undergoing cardiac surgery.

A prognostic index for risk stratification for acute heart failure and death in subjects with ischemic cardiomyopathy and cardiac defibrillator.

To propose a clinical prognostic index for death and heart failure in patients with ischemic cardiomyopathy implanted with an ICD. This prospective study included 192 consecutive patients (age 68 ± 10) recruited from 2004 to 2009 and implanted with an ICD for MADIT II criteria. All patients performed 24-h ambulatory blood pressure monitoring after discharge and common haematological samples. The prognostic index (PI) was built according to the formula: 120 - age + mean 24 h systolic blood pressure--(creatinine 9 10). Other variables were assessed: EF, haemoglobin concentration, mean 24 h heart rate and diastolic blood pressure, sodium level, pacing mode and diabetes. Non-arrhythmic cardiac death and new hospitalizations for heart failure during 1-year follow-up were the combined end point. A total of 48 events (25%) occurred during the follow-up: 7 cardiac deaths and 41 hospitalizations for acute heart failure. Cox proportional hazards model showed that PI was the only predictor of events (HR = 0.96; CI 95% 0.944­0.976, p < 0.0001). ROC curve showed that PI best cut-off was 144, with AUC 0.79, p < 0.0001; sensitivity 77%, specificity 74%, positive predictive value 50%, negative predictive value 90%. PI was predictive of events in a clinical setting where EF had no predictive value. PI works according to the rule ''the lower the worse''. The high negative predictive value (90%) of PI allows to identify subjects at lower risk for death and heart failure. PI can be a practical tool to stratify risk in ischemic cardiomyopathy.

Clinical effects of routine postdilatation of drug-eluting stents.

OBJECTIVES: To assess the clinical effects of postdilatation of drug-eluting stents (DES). BACKGROUND: Subotpimal stent expansion occurs after DES deployment. Postidlatation may improve DES expansion, but it is unclear whether postdilatation may also improve clinical outcomes. METHODS: Since July 2009, we adopted a strategy of routine postdilatation with noncompliant balloons of all DES, while previously postdilatation was performed only for suboptimal results. The first 279 consecutive patients (age 62 ± 9 years, 231 men) who underwent routine postilatation were compared with 262 patients (age 61 ± 9 years, 220 men) who received DES in the previous 6 months (standard treatment). RESULTS: The two groups were similar for age, sex, clinical presentation, and main risk factors, including incidence of diabetes. Routine postdilatation resulted in an improved minimal lumen diameter at the end of the procedure (2.60 ± 0.34 vs. 2.51 ± 0.37 mm, P = 0.003). At 12-month follow-up incidence of MACE (including periprocedural myocardial infarction) was 19.5% in the standard treatment group and 12.5% in routine postdilatation group (P = 0.04), with a significant difference in target vessel revascularization (10.7% vs. 5.4%, P = 0.03), while incidence of myocardial infarction was not significantly different between the two groups (10.7% vs. 9.3%, P = 0.70). Stent thrombosis (definite or probable) occurred in 3 patients in standard treatment group, while no case of stent thrombosis occurred among patients treated with routine postdilatation (1.1% vs. 0%, P = 0.11). CONCLUSIONS: Our results suggest that a strategy of routine postdilatation with non compliant balloons may improve clinical outcomes of DES.

Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.

Endothelial progenitor cells predict long-term prognosis in patients with stable angina treated with percutaneous coronary intervention: five-year follow-up of the PROCREATION study.

BACKGROUND: The association between endothelial progenitor cells (EPCs) at the time of percutaneous coronary intervention (PCI) and the subsequent long-term clinical outcome remains undefined. To address this issue, a pre-specified analysis of the PROgenitor Cells role in Restenosis and progression of coronary ATherosclerosis after percutaneous coronary intervention (PROCREATION) study was done. METHODS AND RESULTS: A total of 155 patients with stable angina treated with PCI had flow cytometry before PCI. Patients had a 5-year follow-up. Primary outcome was the composite of major adverse cardiac or cerebrovascular events (MACCE), that is, death, stroke, myocardial infarction, and revascularization. During follow-up, MACCE occurred in 65 of 155 patients (42%). There were no significant differences in clinical and angiographic variables between patients with or without MACCE, apart from a different extent of coronary atherosclerosis. The incidence of MACCE increased significantly over tertiles of CD34+/KDR+/CD45- cells and CD133+/KDR+/CD45- cells, with rates of 25%, 39%, and 69% (P=0.0001), and 26%, 44%, and 59% (P=0.003), respectively. On multivariate analysis it was estimated that the increase in CD34+/KDR+/CD45- cells was associated with a 35% higher risk for MACCE (hazard ratio [HR], 1.75; 95% confidence interval [CI]: 1.07-1.99; P=0.001), and the increase in CD133+/KDR+/CD45- cells was associated with a 25% higher risk for MACCE (HR, 1.35; 95% CI: 1.01-1.74; P=0.03). CONCLUSIONS: Assessment of subpopulations of circulating EPCs in patients with stable angina treated with PCI can improve characterization of long-term prognosis (ClinicalTrials.gov: NCT01575431).

Symptoms-to-emergency-call timing delay in acute coronary syndrome before and during COVID-19: independent predictors and their impact on mortality.

BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.

Clinical benefit of statin pretreatment in patients undergoing percutaneous coronary intervention: a collaborative patient-level meta-analysis of 13 randomized studies.

BACKGROUND: Previous studies suggested that statin pretreatment reduces cardiac events in patients undergoing percutaneous coronary intervention. However, most data were observational, and single randomized trials included limited numbers of patients. METHODS AND RESULTS: We performed a collaborative meta-analysis using individual patient data from 13 randomized studies in which 3341 patients received either high-dose statin (n=1692) or no statin/low-dose statin (n=1649) before percutaneous coronary intervention, with all patients receiving statin therapy after intervention. Occurrence of periprocedural myocardial infarction, defined as postintervention creatine kinase-MB increase ≥3 times the upper limit of normal, and 30-day major adverse cardiac events (death, myocardial infarction, target-vessel revascularization) was evaluated. Incidence of periprocedural myocardial infarction was 7.0% in the high-dose statin versus 11.9% in the control group, which corresponds to a 44% risk reduction in the active-treatment arm (odds ratio by fixed-effects model 0.56, 95% confidence interval, 0.44 to 0.71, P<0.00001). The rate of major adverse cardiac events at 30 days was significantly lower in the high-dose statin group (7.4% versus 12.6%, a 44% risk reduction; P<0.00001), and 1-month major adverse cardiac events, excluding periprocedural events, were also reduced (0.6% versus 1.4%; P=0.05). The benefit of high-dose statins was realized irrespective of clinical presentation (P for interaction=0.43) and was maintained across various subgroups but appeared greater in the subgroup with elevated baseline C-reactive protein levels (n=734; 68% risk reduction for periprocedural myocardial infarction versus 31% in those 1861 patients with normal CRP; P for quantitative interaction=0.025). CONCLUSIONS: High-dose statin pretreatment leads to a significant reduction in periprocedural myocardial infarction and 30-day adverse events in patients undergoing percutaneous coronary intervention. This strategy should be considered in all patients with planned percutaneous coronary intervention.

A pilot randomized study of ranolazine for reduction of myocardial damage during elective percutaneous coronary intervention.

BACKGROUND: Ranolazine is a new antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia, thus potentially limiting myocardial ischemia. It remains unknown, however, if the drug can play a role in the pathophysiology of periprocedural myocardial infarction. The aim of this study was to verify in a randomized study if pretreatment with ranolazine before percutaneous coronary intervention (PCI) has any protective effect on periprocedural myocardial damage. METHODS: Seventy patients with stable angina (age 62 ± 18 years, 42 men) scheduled for elective coronary intervention entered a randomized, double-blind, placebo-controlled pilot trial. For 7 days before the procedure, 35 patients were assigned to receive ranolazine (1,000 mg twice daily) and 35 patients had placebo. Creatine kinase-MB and troponin I levels were measured at baseline and at 8 and 24 hours postprocedure. RESULTS: Comparison between the 2 groups did not show any difference in clinical features, extent of coronary artery disease, and technical aspects of PCI. Periprocedural myocardial infarction (ie, postprocedural increase of creatine kinase-MB ≥ 3 times above the upper limit of normal) was less commonly seen after PCI in the ranolazine than in the placebo group (6% vs 22%, P = .041). Detection of markers of myocardial injury above the upper limit of normal was less common [corrected] in the ranolazine vs placebo group: 23% vs 40% for creatine kinase-MB (P = .010) and 31% vs 48% for troponin I (P = .011). [corrected] Postprocedural peak markers levels were also significantly lower in the ranolazine vs placebo group (creatine kinase-MB: 3.1 ± 15.0 and 7.7 ± 19.1 ng/mL, P < .05; troponin I: 0.15 ± 0.35 and 0.47 ± 0.49 ng/mL, P < .05). No significant adverse effect was reported by the 2 groups of patients. CONCLUSIONS: Pretreatment with ranolazine 1,000 mg twice daily for 7 days significantly reduced procedural myocardial injury in elective PCI.

Early beneficial effects of drug-eluting stents in vein grafts wane during long term follow-up: a case-control study.

OBJECTIVES: The aim of the study was to compare outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein graft (SVG) interventions in a case-control study with a long-term follow-up. BACKGROUND: Safety and efficacy of DES in SVG interventions are still controversial. METHODS: We performed a multicenter registry assessing clinical outcomes with DES vs. BMS. We included 311 patients (239 men, age 68 ± 8 years) who underwent percutaneous coronary interventions (PCI) of SVG lesions with DES (n = 138) or BMS (n = 173) with a 2-year follow-up. RESULTS: The two groups were similar for age, sex, main risk factors, incidence of diabetes, use of IIb/IIIa antagonists, use of aspiration devices or filters, number of stents, and total stent length. Overall, at 9 months follow-up incidence of major adverse cardiac events (MACE) and target vessel revascularization (TVR) were significantly lower in the DES group compared with the BMS group (10.9% vs. 22.0%, P = 0.014 and 8.7% vs. 19.1% in DES and BMS respectively, P = 0.015), while there was no significant difference in incidence of myocardial infarction (5.1% vs. 5.2%, P = 0.96) or death (2.2% vs. 4%, respectively, P = 0.54). However, at 24-month follow-up incidence of MACE was 29.7% in the DES group and 37.0% in BMS group (P = 0.29); incidence of TVR (23.2% vs. 28.9% P = 0.39), myocardial infarction (9.4% vs. 9.2%), death (7.2% vs. 6.9%) were also similar in the two groups. CONCLUSIONS: Although DES appear safe, our findings suggest that the early benefit of DES in SVG may rapidly wane during long-term follow-up.

Optimization of the atrioventricular delay in sequential and biventricular pacing: physiological bases, critical review, and new purposes.

Atrioventricular (AV) delay optimization in sequential and biventricular (BiV) pacing, although widely recommended, is often poorly performed in clinical practice as an improper setting can reduce the success of the stimulation. Despite the several methods proposed, the AV delay is frequently programmed in an empirical way or left to a predefined value (usually the manufacturer's setting), without considering the different variables involved in this context, concerning the intra- and interindividual variability of the electromechanical events, the peculiarities of the several cardiopathies, the spontaneous interatrial and AV conduction, the pharmacological therapy, and the pacing mode. The manuscript illustrates the physiological bases of the optimization, describes why and how to programme the best AV delay at rest and during daily activities and discusses critically all methods proposed, divided into three groups: predefined formulas, iterative attempts, and automatic settings. The manuscript is not only a review because it tries to clarify this complex topic, stating the fundamental concept in BiV pacing; the optimal AV delay should be short enough to have always a pre-exitated stimulation and contemporary an optimal left ventricular filling. The paper suggests new purposes and new solutions for this goal, it shows the limits of the actual guidelines and the disappointing results obtained in several studies by automatic methods, goading to find new algorithms.

Endothelial Progenitor Cells in Coronary Atherosclerosis and Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

INTRODUCTION: The role of endothelial progenitor cells (EPCs) in atherosclerosis progression and neointimal growth after percutaneous coronary intervention (PCI) remains controversial. The purpose of this study was to perform a systematic review and meta-analysis of studies on EPCs in patients who had PCI. METHODS: We searched Pubmed, Embase and Cochrane databases and reviewed cited references up to August 31, 2021. Overall, we selected 9 studies, including 4612 patients. RESULTS: Lower baseline EPC count was associated with a significantly greater occurrence of in-stent restenosis (HR 1.33; 95% CI 0.97-1.82, P = 0.045). As for EPC coating, there was no significant difference in the 1-year occurrence of cardiac death between EPCs-capturing drug-eluting stents (DES) and standard DES (Relative Risk [RR] 1.146; 95% CI 0.666-1.974, P = 0.98), but target lesion revascularization (RR 1.727; 95% CI: 1.199-2.487, P = 0.025), and target vessel failure (RR 1.591; 95% CI 1.213-2.088, P = 0.04) were significantly more common with EPCs-capturing DES than with standard DES. CONCLUSION: Circulating EPC count might improve risk stratification after PCI, as it is correlated with the occurrence of in-stent restenosis. Currently available EPCs-capturing DES use was associated with an increased risk of 1-year adverse events, mainly driven by an increase in target lesion revascularization and target vessel failure, not cardiac death.

Risk Scores of Bleeding Complications in Patients on Dual Antiplatelet Therapy: How to Optimize Identification of Patients at Risk of Bleeding after Percutaneous Coronary Intervention.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor in patients undergoing percutaneous coronary intervention (PCI) reduces the risk of ischemic events but reduces the risk of ischemic events but increases the risk of bleeding, which in turn is associated with increased morbidity and mortality. With the aim to offer personalized treatment regimens to patients undergoing PCI, much effort has been devoted in the last decade to improve the identification of patients at increased risk of bleeding complications. Several clinical scores have been developed and validated in large populations of patients with coronary artery disease (CAD) and are currently recommended by guidelines to evaluate bleeding risk and individualize the type and duration of antithrombotic therapy after PCI. In clinical practice, these risk scores are conventionally computed at the time of PCI using baseline features and risk factors. Yet, bleeding risk is dynamic and can change over time after PCI, since patients can worsen or improve their clinical status and accumulate comorbidities. Indeed, evidence now exists that the estimated risk of bleeding after PCI can change over time. This concept is relevant, as the inappropriate estimation of bleeding risk, either at the time of revascularization or subsequent follow-up visits, might lead to erroneous therapeutic management. Serial evaluation and recalculation of bleeding risk scores during follow-up can be important in clinical practice to improve the identification of patients at higher risk of bleeding while on DAPT after PCI.

Meta-Analysis Comparing Fractional Flow Reserve and Angiography-Guided Complete Revascularization of Nonculprit Artery for ST-Elevation Myocardial Infarction.

This study aimed to compare complete revascularization (CR) guided by angiography with a fractional flow reserve (FFR)-guided strategy in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). CR is preferred to culprit-only revascularization for patients with STEMI and MVD. However, whether FFR-guided CR is superior to angiography-guided CR is unclear in patients presenting with STEMI who have MVD. Randomized controlled trials comparing CR with an FFR- or angiography-guided strategy to culprit-only revascularization in patients with STEMI and MVD were systematically identified. A random-effects network meta-analysis was performed comparing clinical outcomes in the 3 arms. A total of 13 studies with a total of 8,927 patients were included in our analysis. Compared with culprit-only revascularization, angiography-guided CR was associated with a significantly decreased risk of myocardial infarction (MI) (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.37 to 0.82), all-cause death (HR 0.69, 95% CI 0.49 to 0.97), and cardiovascular death (HR 0.54, 95% CI 0.34 to 0.85) but FFR-guided CR was not (MI: HR 0.77, 95% CI 0.53 to 1.12; cardiovascular death: HR 0.89, 95% CI 0.64 to 1.24; all-cause death: HR 0.93, 95% CI 0.72 to 1.18). The network meta-analysis comparison of angiography- versus FFR-guided CR showed an HR of 0.75 (95% CI 0.50 to 1.11) for all-cause death and an HR of 0.71 (95% CI 0.54 to 1.17) for MI. In conclusion, for patients with MVD presenting with STEMI, angiography-guided CR may provide additional benefits compared with FFR-guided CR.

The Incidence and Impact of In-Hospital Bleeding in Patients with Acute Coronary Syndrome during the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.

Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial.

AIMS: To evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Five hundred and three patients on >10 days clopidogrel therapy (41% with non-ST-segment elevation acute coronary syndrome, ACS) randomly received 600 mg clopidogrel loading 4-8 h before PCI (n = 252) or placebo (n = 251). Primary endpoint was 30-day incidence of major adverse cardiac events (MACE). In the overall population primary endpoint occurred in 6.7% of patients in the reload vs. 8.8% in the placebo arm [odds ratios (OR) 0.75, 95% confidence intervals (CI) 0.37-1.52; P = 0.50]. In stable angina patients, 1-month MACE were not significantly different (7.0 vs. 3.9%; OR 1.84, 0.60-5.88; P = 0.36), whereas ACS patients had significant clinical benefit with reloading (6.4 vs. 16.3%; OR 0.34, 95% CI 0.32-0.90, P = 0.033 at multivariable analysis; interaction test: P = 0.01). There was no excess bleeding in the reload arm (6% in both groups). CONCLUSION: ARMYDA-4 RELOAD reveals no overall benefit from reloading patients on chronic clopidogrel therapy prior to PCI; the benefit observed in ACS patients is a hypothesis-generating finding that needs to be confirmed by larger studies.

[Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: the emerging role of the Cardiomyopathy Team]. / L'alcolizzazione del setto interventricolare nella cardiomiopatia ipertrofica ostruttiva: il ruolo emergente del Cardiomyopathy Team.

Alcohol septal ablation is a minimally invasive, safe, and effective procedure for the treatment of left ventricular outflow tract (LVOT) obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM) who remain symptomatic despite maximal medical therapy. Originally performed by Ulrich Sigwart in 1994, the procedure causes a iatrogenic infarction - through the injection of absolute alcohol - of the basal portion of the interventricular septum and aims at reducing LVOT obstruction in order to improve patient's hemodynamics and symptoms. Numerous studies have demonstrated the effectiveness and safety of the procedure, making it a valid alternative to surgical myectomy. The success of alcohol septal ablation depends upon the selection of the patient and the experience of both the operators and the center where the procedure is performed. In this review, we summarize current evidence on alcohol septal ablation, describe its procedural aspects and propose a multidisciplinary approach that involves a team of clinical cardiologists, interventionists, and cardiac surgeons, the Cardiomyopathy Team, with high experience in the clinical management of these patients.

PSYChosomatic Medicine in ONcologIc and Cardiac Disease (PSYCHONIC) Study-A Retrospective and Prospective Observational Research Protocol.

Psychosocial factors play an important role in non-communicable diseases (NCDs). This observational study is primarily aimed at assessing the relationship of psychological characteristics of patients with the outcomes of different NCDs, and to assess short-term psychotherapy (STP) efficacy in the real world. Methods: One hundred and forty patients with recent acute myocardial infarction, Takotsubo syndrome, or non-metastatic breast cancer and a control group of 140 age and sex-matched healthy subjects, will be enrolled. All subjects will be administered psychometric tests, quality of life tests, a specific body perception questionnaire, a dream questionnaire, and a projective test, the Six Drawing test at baseline and follow-up. All subjects with medical conditions will be asked to freely choose between an ontopsychological STP along with standard medical therapy and, whenever indicated, rehabilitation therapy or medical therapy plus rehabilitation alone. The study endpoints will be to evaluate: the relationship of the psychological characteristics of enrolled subjects with the outcomes of different NCDs, predictors of the choice of psychotherapy, and the efficacy of ontopsychological intervention on psychological and medical outcomes. Conclusion: This study will generate data on distinctive psychological characteristics of patients suffering from different CDs and their relationship with medical outcomes, as well as explore the efficacy of ontopsychological STP in these patients in the real world. (Number of registration: NCT03437642).