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Background: Tools for precise prediction of bleeding risk in patients undergoing percutaneous coronary intervention (PCI) with cangrelor are lacking., Methods: Consecutive patients undergoing PCI and treated with cangrelor in 7 centers were retrospectively enrolled. The primary endpoint was Bleeding Academic Research Consortium (BARC) BARC 2, 3, or 5 bleeding 48 h after PCI. Predictors of BARC 2-5 bleeding were identified in a derivation cohort and combined into a numerical risk score. Discrimination and calibration were assessed in the derivation and validation cohorts. A threshold to define high bleeding risk (HBR) was identified and its diagnostic accuracy was compared with that of currently recommended bleeding risk scores., Results: 1071 patients undergoing PCI with cangrelor were included. Fifty-four patients (5 %) experienced a BARC 2-5 bleeding, of whom 24 (44 %) from the access site. Age ≥ 75 years (odds ratio [OR] 2.58, 95 % confidence interval [CI] 1.21-5.48, p = 0.01), acute coronary syndrome at presentation (OR 8.14, 95 % CI 2.28-52, p = 0.01), and femoral access (OR 6.21, 95 % CI 2.71-14, p < 0.001) independently predicted BARC 2-5 bleeding at 48 h after PCI. The three items were combined to form a new risk score, the ICARUS score, showing good discrimination in both the derivation (area under the curve [AUC] 0.78) and internal validation (AUC 0.77) cohorts, and excellent calibration. An ICARUS score > 9 points accurately identified patients at HBR, showing better discrimination than other risk scores., Conclusions: A risk score based on age, clinical presentation and access site, predicts the risk of periprocedural bleeding in patients receiving cangrelor (ClinicalTrials.gov ID: NCT05505591)., (Copyright © 2024. Published by Elsevier B.V.)

Aim: To evaluate the association between raphe in bicuspid aortic valve (BAV) patients and valve dysfunction, aortopathy and aortic valve surgery in the REBECCA registry [REgistro della valvola aortica Bicuspide della Società Italiana di ECocardiografia e CArdiovascular Imaging (SIECVI)]., Methods: Prevalence of aortic valve dysfunction and aortopathy was investigated in BAV patients with and without raphe. Aortic valve dysfunction (regurgitation or stenosis) was categorized as mild, moderate and severe. Aortopathy was defined as annulus ≥14 mm/m 2 ; root ≥20 mm/m 2 ; sinotubular junction ≥16 mm/m 2 ; ascending aorta ≥17 mm/m 2 , and classified in Type A, isolated ascending aorta dilatation; Type B, aortic root and ascending aorta dilatation; and Type C, isolated aortic root dilatation., Results: Overall, 695 patients with BAV were enrolled; 520 (74.8%) with raphe and 175 (25.2%) without raphe. BAV patients with raphe presented more frequently with moderate or severe aortic stenosis than BAV patients without raphe (183 [35.2%] vs 34 [19.4%], p < 0.001). A higher prevalence of aortopathy, particularly Type B, was observed in patients with vs without raphe. At multivariable analysis, raphe was a predictor of aortic valve surgery at three-year follow-up (odds ratio 2.19, 95% confidence interval 1.08-4.44, p < 0.001)., Conclusions: Patients with BAV and raphe have a higher prevalence of significant aortic stenosis, aortopathy, especially Type B, and a higher risk of undergoing aortic valve surgery at three-year follow-up., Competing Interests: Declaration of competing interest None to disclose., (Copyright © 2024. Published by Elsevier B.V.)

Background: To assess the performance of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in stratifying the risk of bleeding and ischaemic events after percutaneous coronary intervention (PCI)., Methods: MEDLINE, COCHRANE, Web of Sciences, and SCOPUS were searched for studies aimed at validating the ARC-HBR criteria in patients treated with PCI. The primary outcome measure of this meta-analysis was major bleeding., Results: The analysis included 10 studies encompassing 67,862 patients undergoing PCI; the HBR definition was fulfilled in 44.7% of the cases. The risk of major bleeding was significantly higher in HBR vs. Non-HBR group (RR, 2.56, 95% CI 2.28-2.89). The average C-statistic was 0.64 (95% CI 0.60-0.68), indicating modest discrimination. The risk of intracranial hemorrhage, gastrointestinal bleeding, fatal bleeding, ischaemic stroke, cardiac death and all-cause death was higher in HBR vs. Non-HBR group. Despite a higher incidence of myocardial infarction and stent thrombosis in patients deemed at HBR, the rate of target lesion revascularization was comparable between groups (RR, 1.01, 95% CI 0.88-1.16). The mean effect size for the cumulative incidence of major bleeding exceeded the HBR cut-off value of 4% for all major criteria except one, and for two out of six minor criteria, namely age ≥ 75 years and moderate CKD., Conclusion: The ARC-HBR definition identifies patients at higher risk of major bleeding and other adverse cardiovascular events after PCI. Almost all major criteria, but also two of the minor criteria, were individually associated with rates of major bleeding above 4% thus fulfilling the definition of major HBR criteria., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: The prognostic predictors of outcome in patients with functional mitral regurgitation (FMR) undergoing MitraClip implantation (MCi) are still poorly known. The aim of our study is to identify the baseline predictors of outcome in FMR patients candidate to MCi., Methods: All patients with symptomatic moderate-to-severe or severe FMR undergoing MCi at our institution were consecutively and prospectively enrolled. Baseline clinical and instrumental data were collected. Primary endpoint was the occurrence of cardiac death; secondary endpoints were all-cause death and the composite of cardiac death or rehospitalization for heart failure., Results: 74 patients (mean 71.6 ± 8.3 years) were enrolled. During follow-up (median 416.0 days), the primary endpoint occurred in 15 (20.3%), all-cause death in 26 (35.1%) and the composite endpoint in 25 (33.8%). At multivariate analysis, the left atrial volume index (LAVi; HR:1.02; P = 0.048) and the low peak oxygen uptake (peak VO 2 ; HR:0.73; P = 0.018) increased the risk of cardiac death at follow-up; atrial fibrillation (AF; HR:2.69; P = 0.027) was independently associated to all-cause death and the low level of peak VO 2 was an independent predictor of overall mortality (HR:0.70; P < 0.001) as well as of the composite endpoint (HR:0.73; P < 0.001). The ROC analysis identified a peak VO 2 cut-off of 10.0 mL/kg/min as the best predictor for the three study endpoints; the best LAVi cut-off for cardiac death was 67 mL/m 2 . Kaplan-Meier analysis for the individual and combined outcome predictors confirmed their significant stratification ability during follow-up., Conclusions: Peak VO 2 , along with LAVi and AF, identify FMR patients with the worst prognosis after MCi., (Copyright © 2018. Published by Elsevier B.V.)

Background: Elderly treated with dual antiplatelet therapy after percutaneous coronary intervention (PCI) represent a challenging population because of increased risk of both ischemic and bleeding events. We aimed to investigate the association between high on-treatment platelet reactivity (HPR) and long-term outcome in elderly with non-ST-elevated acute coronary syndromes (NSTE-ACS) undergoing PCI., Methods: Platelet reactivity was measured by vasodilator-stimulated phosphoprotein (VASP) assay at three time-points (baseline, discharge, 1 month after PCI) in 1053 NSTE-ACS patients (311 elderly) treated with clopidogrel. Major adverse cardiac events (MACE) were assessed up to 1 year-follow-up., Results: Elderly with HPR at discharge showed a significantly higher incidence of overall MACE (13 vs 4%, p = .006), cardiac death (6 vs 0.7%, p = .020), myocardial infarction (MI, 12 vs 4%, p = .031) and a trend for higher stent-thrombosis (5 vs 0.7%, p = .068). Similarly, elderly with 1-month-HPR showed between 1 month and 1 year significantly higher incidence of MACE (10 vs 4%, p = .012), cardiac death (6 vs 0.7%, p = .019) and composite cardiac death/MI (11 vs 4%, p = .014). Up to 1 year, elderly with HPR showed a 4-fold increased risk of MACE compared to both elderly without HPR (for discharge-HPR: p = .005; for 1-month-HPR: p = .01) and non-elderly with HPR (for discharge-HPR: p < .001; for 1-month-HPR: p < .0001). At multivariable analysis, HPR could independently predict 1-year-MACE in elderly (for discharge-HPR: HR = 3.191, CI: 1.373-7.417, p = .007; for 1-month-HPR: HR = 3.542, CI: 1.373-9.137, p = .009)., Conclusions: In elderly with NSTE-ACS undergoing PCI and treated with clopidogrel, HPR was independently associated with an increased risk of MACE up to 1 year., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Cardiac resynchronization therapy (CRT) is an effective treatment for left ventricular reverse remodeling (LVRR) in patients with congestive heart failure (HF) and ventricular dyssynchrony. Melatonin is a secretory product of the pineal gland with highly beneficial effects from any tissues including the heart. Herein, we investigated whether the response to CRT is associated with levels of melatonin before CRT implantation in patients with HF and ventricular dyssynchrony., Methods: Diurnal melatonin levels were performed in serum from 93 patients with HF and ventricular dyssynchrony before CRT implantation. Moreover, we calculated the MADIT-CRT score. Evaluation of patients at 1-year follow-up included an echocardiographic study since the patients were categorized as responders if they presented both a reduction in left ventricular end-systolic volume index >10% and an increase in left ventricular ejection fraction >10%., Results: At 1-year, 34 patients (36.5%) were considered responders to CRT according to the predefined criteria. The diurnal melatonin levels were significantly lower in the non-responder group (9.9±2.84 vs 14.7±2.32pg/mL). After adjustment by multivariate analysis, diurnal serum melatonin levels (P<0.001) and diabetes mellitus (P=0.03) were predictors of LVRR. On Cox regression analysis, diurnal serum melatonin levels (P<0.001) and left atrial volume<40mL/m(2) (P=0.04) remained independent predictors of the adverse clinical events. The area under of curve for the prediction LVRR of melatonin (0.91, 95%CI 0.85-0.97; P<0.001) was significantly higher compared to MADIT-CRT score (0.69, 95%CI 0.58-0.80; P=0.002)., Conclusion: Diurnal levels of melatonin before CRT implantation are associated with LVRR at 12month follow-up., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aim: To determine the prevalence, clinical characteristics, in-hospital course and determinants of major adverse events in a cohort of Caucasian patients with Takotsubo syndrome (TTS) and right ventricular involvement (RVi), regardless of left ventricular variant forms., Methods and Results: The study population consisted of 424 patients (mean age 69.1±11.5years; female 92.2%) with a diagnosis of TTS divided into two groups according to the presence or absence of RVi. RVi patients (n=57; 13.4%) showed a higher prevalence of comorbidities, especially respiratory diseases (p=0.011), and a higher Charlson comorbidity index (CCI; p=0.006) than non-RVi patients. In-hospital major adverse events (acute heart failure, cardiogenic shock and death) occurred more frequently in RVi patients (p<0.001). Heart rate and CCI, along with the echocardiographic parameters of wall motion score index, E/e' ratio, tricuspid annular plane systolic excursion (TAPSE) and systolic pulmonary artery pressure (sPAP) were associated with adverse in-hospital outcome. At multivariate analysis, CCI (HR: 1.871; 95% CI: 1.202-2.912; p=0.006), sPAP (HR: 1.059; 95% CI: 1.016-1.104; p=0.007) and TAPSE (HR: 0.728; 95% CI: 0.619-0.855; p<0.001) were independent correlates of the composite outcome in patients with RVi., Conclusion: Patients with RVi are characterized by distinct clinical profile and should undergo closely clinical and echocardiographic monitoring. The presence of echocardiographic signs of right ventricular failure along with substantial comorbidities burden identify a cohort at higher risk of in-hospital major adverse cardiovascular events., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: To investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤ 15-day or >15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn--ARGENTO study)., Methods: Consecutive patients without ≤ 12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated., Results: Between March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8 ± 13.6 months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤ 15-day and >15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer-Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history, <45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57-6.80, p=0.27) was not independent risk factor for MACEs., Conclusions: In consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤ 15 days or >15 days)., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: It is well established that both PES and SES reduce the need for reintervention as compared with bare-metal stents. Whether everolimus-eluting stent (EES) a "second-generation" drug-eluting stent, further improves clinical outcomes compared to PES and SES still remains uncertain. The aim of this study was to perform a meta-analysis of randomized trials evaluating safety and efficacy of EES compared with paclitaxel- (PES) and sirolimus-eluting stent (SES), in patients undergoing percutaneous coronary intervention (PCI)., Methods: We undertook a literature search using Medline, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, until August 2010. Included studies comprised randomized trials evaluating EES vs PES/SES, in patients undergoing PCI, at 1-year follow-up., Results: Five studies, enrolling 8058 patients, were included. At 12-month follow-up, patients treated with EES, as compared with PES/SES, experienced lower target-lesion revascularization (OR [95% CI] = 0.56 [0.45-0.70], p<0.00001) and myocardial infarction rates (OR [95% CI] = 0.57 [0.43-0.77], p = 0.0002), without difference in mortality (OR [95% CI] = 0.88 [0.62-1.24], p = 0.46). A trend towards lower stent thrombosis rates in favour of EES vs PES/SES was found (OR [95% CI] = 0.45 [0.20-1.01], p = 0.05). However, after the exclusion of SES, EES significantly reduced stent thrombosis as compared with PES (OR [95% CI] = 0.35 [0.14-0.86], p = 0.02)., Conclusions: At 12-month follow-up, treatment with EES is associated with decreased target-lesion revascularization and myocardial infarction rates, without differences in mortality, as compared with PES/SES. EES vs PES/SES use is associated with a trend towards lower stent thrombosis rates. Moreover, EES significantly reduce stent thrombosis with respect to PES., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: Optimal strategy for patients who need coronary revascularization before undeferrable non-cardiac surgery is still unknown. We performed a pilot study of dual antiplatelet therapy discontinuation followed by major non-cardiac surgery and endovascular aortic repair early after successful endothelial-progenitor cell-capture coronary stent deployment., Methods and Results: Thirty consecutive patients underwent coronary angioplasty plus stenting, before upcoming endovascular or surgical procedures requiring early interruption of antiplatelet therapy. An optimal acute procedural result was observed in all patients. Antiplatelet therapy was stopped before surgery in all patients, achieving an average antiplatelet therapy time of 12.2 ± 3.9 days. Surgery was performed after antiplatelet therapy interruption at an average time interval from revascularization of 17.2 ± 3.9 days. No patient suffered cardiac events during the perioperative period. At thirty day follow-up after surgery there were no cardiac events in all patients., Conclusions: Our preliminary data might suggest a role for EPC-capture stent in patients requiring surgical procedures early after coronary stent placement. Further studies on larger population are needed to confirm the clinical impact of our findings., (Copyright © 2009 Elsevier Ltd. All rights reserved.)

Older age is an independent predictor of mortality after percutaneous coronary intervention (PCI) in patients with Non-ST elevation Acute Coronary Syndrome (ACS). GPIIb/IIIa inhibitors are proved to improve outcome in high risk patients, but conflicting data are available about the effects of these inhibitors in elderly. Accordingly, we studied a consecutive population of elderly patients undergoing PCI for Non-ST elevation ACS. A total of 500 patients were divided in: GPI group (247 pts; mean age 77+/-1.9 years) treated by stenting plus abciximab and, no GPI group (253 pts; mean age 77+/-2.4 years) treated by stenting alone. Propensity analysis was used to account for the nonrandomized use of GPIIb/IIIa inhibitors. During hospitalization, incidence of death was similar among groups (3.2% vs 4.6%) without difference regarding incidence of major (1.6% vs 1.1%) and minor bleedings (4% vs 3%). At long-term follow-up the rate of death was significantly lower in GPI group (4.5% vs 12.3%; p=0.002) as well as the rate of acute myocardial infarction (2.8% vs 11.1%; p=0.0001), and pre-PCI (5.7% vs 13.4%; p=0.003). Cox regression analysis identified abciximab use as an independent predictor of lower long-term major adverse cardiac event (MACE) after adjustment for propensity score (Exp (B) 0.620, 95%CI 0.394-0.976, p=0.039). Our results suggest that addition of abciximab to stenting improves outcome in elderly patients with Non-ST elevation ACS, leading to an absolute benefit for reduction of death and MACE, with an acceptable rate of major and minor bleedings.