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Angeli F.,Teaching Hospital Sm Della Misericordia | Verdecchia P.,Hospital of Assisi | Savonitto S.,IRCCS Arcispedale S. Maria Nuova | Morici N.,Hospital Niguarda Ca Granda | And 2 more authors.
Catheterization and Cardiovascular Interventions | Year: 2014

Background It is unclear whether the benefits of an early invasive strategy (EIS) in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) equally apply to younger and older individuals. Elderly patients are generally less likely to undergo EIS when compared with younger patients. Objectives We conducted a meta-analysis to compare the benefit of an EIS versus a selectively invasive strategy (SIS) in patients with NSTEACS. We tested the hypothesis that the magnitude of benefit of an EIS over a SIS mainly applies to older individuals. Methods We extracted data from randomized controlled trials (RCTs) identified through search methodology filters the primary outcome of the analysis was the composite of all-cause death and myocardial infarction (MI). Secondary outcomes were death and MI taken alone and re-hospitalization. Results Nine trials (n = 9,400 patients) were eligible the incidence of the composite end-point of MI and all-cause death was 16.0% with the EIS and 18.3% with the SIS (OR: 0.85, 95% CI: 0.76-0.95) the incidence of MI was 8.4% with the EIS and 10.9% with the SIS (OR: 0.75, 95% CI: 0.66-0.87). Similar results were obtained for rehospitalization (OR: 0.71, 95% CI: 0.55-0.90) the incidence of all-cause death did not differ between the two groups the EIS reduced the composite end-point and re-hospitalization to a greater extent in elderly than in younger patients (P for interaction = 0.044 and <0.0001, respectively) these findings were confirmed in meta-regression analyses. Conclusions In patients with NSTEACS, a routine EIS reduces the risk of rehospitalization and the composite end point of recurrent MI and death to a greater extent in elderly than in younger individuals. © 2013 Wiley Periodicals, Inc. Copyright © 2013 Wiley Periodicals, Inc.


Verdecchia P.,Hospital of Assisi | Angeli F.,Hospital Sm Della Misericordia | Gentile G.,Royal Cornwall Hospitals | Reboldi G.,University of Perugia
Hypertension | Year: 2016

Several randomized trials compared a more versus less intensive blood pressure-lowering strategy on the risk of major cardiovascular events and death. Cumulative meta-analyses and trial sequential analyses can establish whether and when firm evidence favoring a specific intervention has been reached from accrued literature. Therefore, we conducted a cumulative trial sequential analysis of 18 trials that randomly allocated 53 405 patients to a more or less intensive blood pressure-lowering strategy. We sought to ascertain the extent to which trial evidence added to previously accrued data. Outcome measures were stroke, myocardial infarction, heart failure, cardiovascular death, and all-cause death. Achieved blood pressure was 7.6/4.5 mm Hg lower with the more intensive than the less intensive blood pressure-lowering strategy. For stroke and myocardial infarction, the cumulative Z curve crossed the efficacy monitoring boundary solely after the SPRINT (Systolic Blood Pressure Intervention Trial) study, thereby providing firm evidence of superiority of a more intensive over a less intensive blood pressure-lowering strategy. For cardiovascular death and heart failure, the cumulative Z curve crossed the conventional significance boundary, but not the sequential monitoring boundary, after SPRINT. For all-cause death, the SPRINT trial pushed the cumulative Z curve away from the futility area, without reaching the conventional significance boundary. We conclude that evidence accrued to date strongly supports the superiority of a more intensive versus a less intensive blood pressure-lowering strategy for prevention of stroke and myocardial infarction. Cardiovascular death and heart failure are likely to be reduced by a more intensive blood pressure-lowering strategy, but evidence is not yet conclusive. © 2016 American Heart Association, Inc.


Reboldi G.,University of Perugia | Angeli F.,University of Perugia | De Simone G.,University of Naples Federico II | Staessen J.A.,Catholic University of Leuven | And 2 more authors.
Hypertension | Year: 2014

An excessive blood pressure (BP) reduction might be dangerous in high-risk patients with cardiovascular disease. In the Studio Italiano Sugli Effetti CARDIOvascolari del Controllo della Pressione Arteriosa SIStolica (Cardio-Sis), 1111 nondiabetic patients with systolic BP ≥150 mm Hg were randomly assigned to a systolic BP target <140 mm Hg (standard control) or <130 mm Hg (tight control). We stratified patients by absence (n=895) or presence (n=216) of established cardiovascular disease at entry. Antihypertensive treatment was open-label and tailored to each patient's needs. After 2-year follow-up, the primary end point of the study, electrocardiographic left ventricular hypertrophy, occurred less frequently in the tight than in the standard control group in the patients without (10.8% versus 15.2%) and with (14.1% versus 23.5%) established cardiovascular disease (P for interaction=0.82). The main secondary end point, a composite of cardiovascular events and all-cause death, occurred less frequently in the tight than in the standard control group both in patients without (1.47 versus 3.68 patient-years; P=0.016) and with (7.87 versus 11.22 patient-years; P=0.049) previous cardiovascular disease. In a multivariable Cox model, allocation to tight BP control reduced the risk of cardiovascular events to a similar extent in patients with or without overt cardiovascular disease at randomization (P for interaction=0.43). In conclusion, an intensive treatment aimed to lower systolic BP<130 mm Hg reduced left ventricular hypertrophy and improved clinical outcomes to a similar extent in patients with hypertension and without established cardiovascular disease. © 2013 American Heart Association, Inc.


Verdecchia P.,Hospital of Assisi | Angeli F.,University of Perugia | Lip G.Y.H.,University of Birmingham | Reboldi G.,University of Perugia
PLoS ONE | Year: 2014

Background: Edoxaban recently proved non-inferior to warfarin for prevention of thromboembolism in patients with non-valvular atrial fibrillation (AF). We conducted an imputed-placebo analysis with estimates of the proportion of warfarin effect preserved by each non vitamin K antagonist oral anticoagulant (NOAC) and indirect comparisons between edoxaban and different NOACs. Methods and Findings: We performed a literature search (up to January 2014), clinical trials registers, conference proceedings, and websites of regulatory agencies. We selected non-inferiority randomised controlled phase III trials of dabigatran, rivaroxaban, apixaban and edoxaban compared with adjusted-dose warfarin in non-valvular AF. Compared to imputed placebo, all NOACs reduced the risk of stroke (ORs between 0.24 and 0.42, all p<0.001) and all-cause mortality (ORs between 0.55 and 0.59, all p<0.05). Edoxaban 30 mg and 60 mg preserved 87% and 112%, respectively, of the protective effect of warfarin on stroke, and 133% and 121%, respectively, of the protective effect of warfarin on all-cause mortality. The risk of primary outcome (stroke/systemic embolism), all strokes and ischemic strokes was significantly higher with edoxaban 30 mg than dabigatran 150 mg and apixaban. There were no significant differences between edoxaban 60 mg and other NOACs for all efficacy outcomes except stroke, which was higher with edoxaban 60 mg than dabigatran 150 mg. The risk of major bleedings was lower with edoxaban 30 mg than any other NOAC, odds ratios (ORs) ranging between 0.45 and 0.67 (all p<0.001). Conclusions: This study suggests that all NOACs preserve a substantial or even larger proportion of the protective warfarin effect on stroke and all-cause mortality. Edoxaban 30 mg is associated with a definitely lower risk of major bleedings than other NOACs. This is counterbalanced by a lower efficacy in the prevention of thromboembolism, although with a final benefit on all-cause mortality. © 2014 Verdecchia et al.


Persu A.,Catholic University of Louvain | O'Brien E.,University College Dublin | Verdecchia P.,Hospital of Assisi
Hypertension research : official journal of the Japanese Society of Hypertension | Year: 2014

Resistant hypertension as defined by the European Society of Hypertension and American Heart Association is a blood pressure that remains uncontrolled despite concomitant intake of at least three antihypertensive drugs (one of them preferably being a diuretic) at full doses. This definition is still based on office rather than out-of-office blood pressure measurement. In this review we propose a new, stricter definition of resistant hypertension based on ambulatory blood pressure measurement. The main arguments in favor of this are: (1) in patients with resistant hypertension, ambulatory blood pressure is an independent predictor of cardiovascular morbidity whereas, after adjustment for conventional risk factors, conventional blood pressure has little added value; (2) white-coat resistant hypertension (uncontrolled office with normal ambulatory blood pressure) is frequent (30-40% of patients with apparently resistant hypertension) carrying a prognosis similar to that of controlled hypertension, and intensification of blood pressure lowering treatment, or the use of nondrug treatment strategies such as renal denervation or carotid baroreceptor stimulation, is not justified; (3) masked resistant hypertension (controlled office with elevated ambulatory blood pressure) is frequent (approximately one-third of patients with controlled office blood pressure on triple antihypertensive therapy) and associated with an increased risk of cardiovascular events; in such patients, treatment intensification should be considered; (4) the current definition of resistant hypertension (office blood pressure ⩾ 140/90 mm Hg on triple antihypertensive therapy) allows a substantial proportion of patients with spurious or white-coat resistant hypertension to undergo renal denervation in the absence of proven long-term benefits.


Verdecchia P.,Hospital of Assisi | Angeli F.,Struttura Dipartimentale di Cardiologia | Mazzotta G.,University of Perugia | Garofoli M.,University of Perugia | And 4 more authors.
Hypertension | Year: 2012

We investigated the relationship between the day-night blood pressure (BP) dip and the early morning BP surge in an cohort of 3012 initially untreated subjects with essential hypertension. The day-night reduction in systolic BP showed a direct association with the sleep trough (r=0.564; P<0.0001) and the preawakening (r=0.554; P<0.0001) systolic BP surge. Over a mean follow-up period of 8.44 years, 268 subjects developed a major cardiovascular event (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and heart failure requiring hospitalization) and 220 subjects died. In a Cox model, after adjustment for predictive covariates, including age, sex, diabetes mellitus, cigarette smoking, total cholesterol, left ventricular hypertrophy on ECG, estimated glomerular filtration rate, and average 24-hour systolic BP, a blunted sleep trough (≤19.5 mm Hg; quartile 1) and preawakening (≤9.5 mm Hg; quartile 1) BP surge was associated with an excess risk of events (hazard ratio, 1.66 [95% CI, 1.14-2.42]; P=0.009; hazard ratio, 1.71 [95% CI, 1.12-2.71]; P=0.013). After adjustment for the same covariates, neither the dipping pattern nor the measures of early morning BP surge were independent predictors of mortality. In conclusion, in initially untreated subjects with hypertension, a blunted day-night BP dip was associated with a blunted morning BP surge and vice versa. In these subjects, a blunted morning BP surge was an independent predictor of cardiovascular events, whereas an excessive BP surge did not portend an increased risk of events. © 2012 American Heart Association, Inc.


Mancia G.,University of Milan Bicocca | Verdecchia P.,Hospital of Assisi
Circulation Research | Year: 2015

This article reviews the clinical value of ambulatory blood pressure (BP) vis-à-vis the traditional BP measurements taken in the physician's office or in the hospital. Mention is initially made that longitudinal studies conducted in the general population or in hypertensive cohorts have shown that ambulatory BP provides a more accurate prediction of outcome than office BP. Namely, that (1) the risk of cardiovascular events increases in a less steep fashion with office than with 24-hour mean BP, (2) the 24-hour BP-dependent prediction is maintained after adjustment for office BP values, and (3) among individuals with normal office BP, those with increased ambulatory BP (masked hypertension) have an increased prevalence of organ damage, a more frequent unfavorable metabolic profile and a higher risk of new onset sustained hypertension, diabetes mellitus, and cardiovascular events than those with normal ambulatory BP. It is further mentioned, however, that more recently similar observations have been made for individuals with high office but normal ambulatory BP (white coat hypertension) suggesting a complementary role of out-of-office and office BP values in the determination of patients' prognosis. The evidence in favor of an independent prognostic value also of some within 24-hour BP phenomena (night BP reduction or absolute values, short-term BP variations, and morning BP surge) is then critically appraised for its elements of strength and weakness. Finally, whether the clinical advantages of ambulatory BP make this approach necessary for all patients with hypertension is discussed. The conclusion is that this is at present still premature because crucial evidence pro or against routine use of this approach in untreated and treated hypertensives is not yet available. It will be crucial for future studies to determine whether, compared with a treatment guided by office BP, a treatment tailored on ambulatory BP allows to improve prevention or regression of organ damage as well as protection from major cardiovascular complications to a degree that justifies the complexity and cost of the procedure. © 2015 American Heart Association, Inc.


Angeli F.,Hospital S Maria Della Misericordia | Reboldi G.,University of Perugia | Verdecchia P.,Hospital of Assisi
American Journal of Hypertension | Year: 2010

Blood pressure (BP) may be high during usual daily life in one out of 7-8 individuals with normal BP in the clinic or doctor's office. This condition is usually defined as masked hypertension (MH). Prevalence of MH varied across different studies depending on patient characteristics, populations studied, and different definitions of MH. Self-measured BP and ambulatory BP (ABP) have been widely used to identify subjects with MH. Various factors have been identified as possible determinants of MH. Cigarette smoking, alcohol, physical activity, job, and psychological stress may increase BP out of the clinical environment in otherwise normotensive individuals, leading to MH. In most studies, target organ damage was comparable in subjects with MH and those with sustained hypertension, and greater than in those with true normotension. Subjects with MH showed a 1.5-to 3-fold higher risk of major cardiovascular (CV) disease than those with normotension, and their risk was not different from that of patients with sustained hypertension. In an overview of literature, we found that the risk of major CV disease was higher in subjects with MH than in the normotensive subjects regardless of the definition of MH based on self-measured BP (hazard ratio (HR) 2.13; 95% confidence interval (CI): 1.35-3.35; P = 0.001) or 24-h ABP (HR 2.00; 95% CI: 1.54-2.60; P < 0.001). MH is an insidious and prognostically adverse condition that can be reliably diagnosed by self-measured BP and ABP. MH should be searched for in subjects who appear to be more likely to have this condition. Antihypertensive treatment is envisaged in these subjects, although the associated outcome benefits are still undetermined. © 2010 American Journal of Hypertension, Ltd.


Verdecchia P.,Hospital of Assisi | Gentile G.,University of Perugia | Angeli F.,Hospital Media Valle Del Tevere | Reboldi G.,University of Perugia
Therapeutic Advances in Cardiovascular Disease | Year: 2012

For patients with hypertension, effective control of blood pressure (BP) reduces cardiovascular (CV), and renal risk. Antihypertensive agents that offer benefits that extend beyond those associated with BP reduction alone, to include tissue protective effects and effects on the vasculature, may be of benefit for many patients with increased CV risk due to comorbidities or prior history of CV events. Renin-angiotensin system (RAS) blockers [angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs)] are guideline-recognized, highly effective antihypertensive agents that exert their BP-lowering action through different mechanisms at different levels of the RAS. Large-scale clinical studies suggest that small, between-treatment differences in BP lowering do not account for observed outcome differences between RAS blockers and other antihypertensive agents. Analysis of data from seminal clinical studies and meta-analyses identify that, controlling for effects on BP control, RAS blockers may be more effective than calcium channel blockers (CCBs) in reducing risk of myocardial infarction and congestive heart failure; ARBs may be more effective than either ACEIs or β blockers in stroke prevention; CCBs may be more effective than RAS blockers in stroke prevention; and ARBs may be more effective than β blockers in reducing left ventricular hypertrophy. This review considers the rationale and evidence for benefits of RAS blockade beyond BP lowering, and highlights the differences between ARBs and ACEIs, and between agents within these drug classes. © The Author(s), 2012.


Reboldi G.,University of Perugia | Angeli F.,Hospital Media Valle Del Tevere | Verdecchia P.,Hospital of Assisi
Cerebrovascular Diseases | Year: 2013

The term 'multivariate analysis' is often used when one is referring to a multivariable analysis. 'Multivariate', however, implies a statistical analysis with multiple outcomes. In contrast, multivariable analysis is a statistical tool for determining the relative contributions of various factors to a single event or outcome. The purpose of this article is to focus on analyses where multiple predictors are considered. Such an analysis is in contrast to a univariable (or 'simple') analysis, where single predictor variables are considered. We review the basics of multivariable analyses, what assumptions underline them and how they should be interpreted and evaluated. Copyright © 2013 S. Karger AG, Basel.

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