Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI.

BACKGROUND: Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DESIGN: The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SUMMARY: The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.

Safety and feasibility of balloon aortic valvuloplasty in non-TAVI centers: The "BAV for life" experience.

OBJECTIVES: To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI). BACKGROUND: BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery. METHODS: Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B). RESULTS: Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality. CONCLUSIONS: BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI.

Pericardial thrombus and cardiac tamponade after pericardiocentesis with intact heart walls.

A young patient affected by a lung neoplasm, presented at emergency department with cardiac tamponade, underwent pericardiocentesis with a prompt restoration of hemodynamic stability. An hour later, the patient presented again signs of tamponade, without evidence of fluids in the drainage that was left in pericardial space. The echocardiography revealed an intrapericardial thrombus compressing the right chambers. An emergency pericardiotomy was performed and a large thrombus was removed from the pericardial space; cardiac walls were intact. Echocardiography played a pivotal role for the identification of a pericardial thrombus as a complication of pericardiocentesis.

Lights and shadows of long-term dual antiplatelet therapy in "real life" clinical scenarios.

Dual antiplatelet therapy (DAPT) is a cornerstone of treatment for patients with acute coronary syndromes (ACS). Mounting evidences have opened the debate about the optimal DAPT duration. Considering the ACS-pathophysiology, the most recent guidelines recommend DAPT in all ACS patients for at least 12 months unless there are contraindications such as excessive risk of bleeding. Thus, it can be considered acceptable earlier discontinuation if the risk of morbidity from bleeding outweighs the anticipated benefit. On the other hand, several studies have clearly indicated that a significant burden of platelet related-events, such as stroke and new ACS might occur after this period, suggesting that potential benefits might derive by prolonging DAPT beyond 12 months (Long DAPT). Indeed, although current guidelines give some indications about patients eligible for Long DAPT, they do not embrace several real-life clinical scenarios. Thus, in such scenarios, how to decide whether a patient is eligible for Long DAPT or not might be still challenging for clinicians. This position paper presents and discusses various "real-life" clinical scenarios in ACS patients, in order to propose several possible recommendations to overcome guidelines potential limitations.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

A Rare Case of Cerebral Venous Thrombosis and Disseminated Intravascular Coagulation Temporally Associated to the COVID-19 Vaccine Administration.

Globally, at the time of writing (20 March 2021), 121.759.109 confirmed COVID-19 cases have been reported to the WHO, including 2.690.731 deaths. Globally, on 18 March 2021, a total of 364.184.603 vaccine doses have been administered. In Italy, 3.306.711 confirmed COVID-19 cases with 103.855 deaths have been reported to WHO. In Italy, on 9 March 2021, a total of 6.634.450 vaccine doses have been administered. On 15 March 2021, Italian Medicines Agency (AIFA) decided to temporarily suspend the use of the AstraZeneca COVID-19 vaccine throughout the country as a precaution, pending the rulings of the European Medicines Agency (EMA). This decision was taken in line with similar measures adopted by other European countries due to the death of vaccinated people. On 18 March 2021, EMA's safety committee concluded its preliminary review about thromboembolic events in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting, confirming the benefits of the vaccine continue to outweigh the risk of side effects, however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets with or without bleeding, including rare cases of cerebral venous thrombosis (CVT). We report the case of a 54-year-old woman who developed disseminated intravascular coagulation (DIC) with multi-district thrombosis 12 days after the AstraZeneca COVID-19 vaccine administration. A brain computed tomography (CT) scan showed multiple subacute intra-axial hemorrhages in atypical locations, including the right frontal and the temporal lobes. A plain old balloon angioplasty (POBA) of the right coronary artery was performed, without stent implantation, with restoration of distal flow, but with persistence of extensive thrombosis of the vessel. A successive thorax angio-CT added the findings of multiple contrast filling defects with multi-vessel involvement: at the level of the left upper lobe segmental branches, of left interlobar artery, of the right middle lobe segmental branches and of the right interlobar artery. A brain magnetic resonance imaging (MRI) in the same day showed the presence of an acute basilar thrombosis associated with the superior sagittal sinus thrombosis. An abdomen angio-CT showed filling defects at the level of left portal branch and at the level of right suprahepatic vein. Bilaterally, it was adrenal hemorrhage and blood in the pelvis. An evaluation of coagulation factors did not show genetic alterations so as the nasopharyngeal swab ruled out a COVID-19 infection. The patient died after 5 days of hospitalization in intensive care.

Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion.

OBJECTIVE: To report, for the first time, angiographic and ECG results as well as in-hospital and 1-month clinical follow-up, after MGuard net protective stent (Inspire-MD, Tel-Aviv, Israel-MGS) implantation in consecutive, not randomized, STEMI patients undergoing primary or rescue PCI. BACKGROUND: Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI), in ST-elevation myocardial infarction (STEMI) setting. METHODS: One-hundred consecutive patients underwent PCI, with MGS deployment for STEMI, in five different high-volume PCI centres. Sixteen patients presented cardiogenic shock at admission. RESULTS: All patients underwent successful procedures: mean TIMI flow grade and mean corrected TIMI frame count-cTFC(n)-improved from baseline values to 2.85 +/- 0.40 and to 17.20 +/- 10.51, respectively, with a mean difference in cTFC(n) between baseline and postprocedure of 46.88 +/- 31.86. High-myocardial blush grade (90% MBG 3; 10% MBG 2) was also achieved in all patients. Sixty minutes post-PCI, a high rate (90%) of complete (>or=70%) ST-segment resolution was achieved. At in-hospital follow-up, seven deaths occurred: noteworthy, 5 of 16 patients with cardiogenic shock at admission died. After hospital discharge, no Major Adverse Cardiac Events have been reported up to 30-day follow-up. CONCLUSIONS: MGS might represent a safe and feasible option for PCI in STEMI patients, providing high perfusional and ECG improvement. Further randomized trials comparing this strategy with the conventional one are needed in the near future to assess the impact on clinical practice of this strategy.

Effect of right ventricular apical pacing in survivors of myocardial infarction.

BACKGROUND: Much information is available regarding the possible negative effects of long-term right ventricular (RV) apical pacing, which may cause worsening of heart failure. However, very limited data are available regarding the effects of RV pacing in patients with a previous myocardial infarction (MI). METHODS AND RESULTS: We screened 115 consecutive post-MI patients and matched a group of 29 pacemaker (PM) recipients with a group of 49 unpaced patients, for age, left ventricular (LV) ejection fraction, and site of MI. During a median follow-up of 54 months, echocardiograms showed a decrease in LV ejection fraction in the paced group, from 51 +/- 10 to 39 +/- 11 (P < 0.01), and a minimal change in the unpaced group, from 57 +/- 8 to 56 +/- 7 (P = 0.98). Similar change was observed in systolic and diastolic diameters and volumes. CONCLUSIONS: The study showed that, in post-MI patients, RV apical pacing was associated with a worsening of LV function, suggesting that, among MI survivors, the need for a PM is a marker of worse outcome.

Efficacy of LOw-dose DObutamine stress-echocardiography to predict cardiac resynchronization therapy response (LODO-CRT) multicenter prospective study: design and rationale.

BACKGROUND: Although cardiac resynchronization therapy (CRT) has a well-demonstrated therapeutic effect in selected patients with advanced heart failure on optimized drug therapy, nonresponder rate remains high. The LODO-CRT is designed to improve patient selection for CRT. Design and rationale of this study are presented herein. METHODS: LODO-CRT is a multicenter prospective study, started in late 2006, that enrolls patients with conventional indications for CRT (symptomatic stable New York Heart Association class III-IV on optimized drug therapy, QRS > or =120 milliseconds, left ventricular [LV] dilatation, LV ejection fraction < or =35%). This study is designed to assess the predictive value of LV contractile reserve (LVCR), determined through dobutamine stress echocardiography (defined as an LV ejection fraction increase >5 units), in predicting CRT response during follow-up. Assessment of CRT effects will follow 2 sequential phases: in phase 1, CRT response end point is defined as LV end-systolic volume reduction > or =10% at 6 months; in phase 2, both LV end-systolic volume reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 (with 95% confidence, 80% power, alpha < or = .05). Enrollment should be complete by the end of 2008. CONCLUSIONS: The LODO-CRT trial is testing the hypothesis that LVCR assessment, using low-dose dobutamine stress echocardiography test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.

A radial global dyssynchrony index as predictor of left ventricular reverse remodeling after cardiac resynchronization therapy.

BACKGROUND: Cardiac mechanical efficiency requires that opposing left ventricular regions are coupled both in shortening and lengthening during the same phase of cardiac cycle. Aim of this study was to evaluate whether global measures of mechanical dyssynchrony are able to predict reverse remodeling of the left ventricle in patients receiving cardiac resynchronization therapy (CRT). METHODS: Sixty-two patients underwent a clinical examination, including New York Heart Association class evaluation and 6-minute walking distance and both echocardiographic study before and 6 months after CRT. Intraventricular dyssynchrony was evaluated by two-dimensional strain echocardiography, measuring the amount of uncoordinated contraction and relaxation between septum and free wall for both longitudinal and radial function and was presented as the longitudinal global dyssynchrony index (LGDI) and the radial global dyssynchrony index (RGDI). Reverse remodeling was defined by a left ventricular end systolic volume reduction >or= 15%. RESULTS: After CRT 39 patients showed reverse remodeling. In this group, RGDI (0.74 +/- 0.26 vs 0.32 +/- 0.30; P = 0.0001) and LGDI (0.52 +/- 0.28 vs 0.30 +/- 0.24; P = 0.002) were significantly higher than in nonresponders. A receiver-operating characteristic curve analysis showed that RGDI >0.47 and LGDI >0.34 had a sensitivity and a specificity to predict reverse remodeling of 87% and 74%, 82%, and 74%, respectively. Stepwise forward multiple logistic regression analysis showed that RGDI (O.R.:13.4; 95%C.I.:4.2-120.5; P < 0.0001) was an independent determinant of a positive response to CRT. CONCLUSION: A radial global dyssynchrony index predicts left ventricular reverse remodeling after CRT.

Presence of left ventricular contractile reserve, evaluated by means of dobutamine stress-echo test, is able to predict response to cardiac resynchronization therapy.

INTRODUCTION: We evaluated whether the dobutamine stress-echo test can select responders to cardiac resynchronization therapy (CRT). Up to 50% of patients do not respond to CRT. Lack of response may be due to a significant amount of scar or fibrotic tissue at myocardial level. METHODS AND RESULTS: We studied 42 CRT patients. After clinical and echocardiographic evaluation, all patients underwent a dobutamine stress-echo test to assess contractile reserve. Cut-off for the test was an increase of 25% of the left ventricular ejection fraction. Patients were implanted with a CRT-defibrillator and followed up at 6 months. Cut-off for CRT response was a reduction of 15% of left ventricular end-systolic volume. Twenty-five patients responded to CRT; all of them showed presence of contractile reserve. The test showed a sensitivity of 100% and a specificity of 88%. CONCLUSION: Contractile reserve was a strong predictive factor of response to CRT in the studied population.

Effect of pacing the right ventricular mid-septum tract in patients with permanent atrial fibrillation and low ejection fraction.

INTRODUCTION: Permanent right ventricular (RV) pacing leads have been traditionally implanted in the right ventricular apex (RVA). Nowadays, some deleterious effects of RVA pacing have been recognized. The aim of this study was to evaluate the effect of different sites of RV pacing in patients with permanent atrial fibrillation (AF) and low ejection fraction (LEF) needing a pacemaker (PM) implantation. METHODS: Two hundred seventy-three patients with permanent AF and EF <30% underwent a one-chamber rate responsive (VVIR) PM implant procedure. Patients were divided into two groups: Group A, including 113 patients with the pacing lead tip placed in the RV mid-septum, and Group B of 120 patients with the pacing lead tip placed at the apex of RV. All patients had clinical and Echo control after 1, 3, 6, 12, and 18 months after PM implantation to assess New York Heart Association (NYHA) class and EF. RESULTS: After 18 months, NYHA class changed in Group A from 2.9 +/- 0.4 at implant to 1.7 +/- 0.3 at 18 months (P = 0.01), and in Group B from 3.0 +/- 0.5 at implant to 3.3 +/- 0.6 at 18 months (P = n.s.). EF increased in Group A: 28 +/- 2% at implant, 33 +/- 1% at 18 months (P = 0.0125), while no significant changes were observed in Group B: at implant 27 +/- 2%, 26 +/- 2% at 18 months (P = n.s.). CONCLUSION: The present study suggests that more physiological pacing from the RV sept can improve EF and quality of life (QoL) in patients with permanent AF and low EF needing a PM.

Is it possible to perform a linear lesion with no local electrograms using a three-dimensional mapping system for the ablation of typical atrial flutter?

AIMS: A randomized prospective study to evaluate the efficacy, safety and long-term outcomes of the complete disappearance of local electrograms along the linear lesion using the EnSite NavX three-dimensional mapping system compared to the conventional fluoroscopy-based mapping for the ablation of typical atrial flutter (AFL). METHODS: 83 patients with spontaneous AFL episodes were randomized to the conventional procedure (group I, 41 patients) or to the EnSite NavX three-dimensional mapping system (group II, 42 patients). When bidirectional block was achieved, a renavigation of the ablation line was performed to verify the absence of local potentials along the line. RESULTS: In all patients, bidirectional isthmus block was achieved. Total mean fluoroscopy time was 19.8 +/- 4.1 min and 9.1 +/- 3.5 min (p < 0.001) and radiofrequency (RF) mean fluoroscopy time was 6.9 +/- 1.4 min and 0.6 +/- 0.3 min (p < 0.001), respectively, in group I and II. During long-term follow-up of 16 +/- 9 months, there were 4 (10%) AFL recurrences in group I and 0 in group II (p < 0.005). CONCLUSION: NavX accurately renavigates the lesion line and verifies local potentials. The electro-anatomic activation map accurately identifies gaps in the RF lesion line and no recurrences were found compared with 10% recurrences after standard procedures for typical AFL.

Antiplatelet Therapy for Non-ST-Segment Elevation Myocardial Infarction in Complex "Real" Clinical Scenarios: A Consensus Document of the "Campania NSTEMI Study Group".

The incidence of ST-segment elevation myocardial infarction (STEMI) has significantly decreased. Conversely, the rate of non-STEMI (NSTEMI) has increased. Patients with NSTEMI have lower short-term mortality compared to patients with STEMI, whereas at long-term follow-up, the mortality becomes comparable. This might be due to the differences in baseline characteristics, including older age and a greater prevalence of comorbidities in the NSTEMI population. Although antithrombotic strategies used in patients with NSTEMI have been well studied in clinical trials and updated guidelines are available, patterns of use and outcomes in clinical practice are less well described. Thus, a panel of Italian cardiology experts assembled under the auspices of the "Campania NSTEMI Study Group" for comprehensive discussion and consensus development to provide practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of antithrombotic therapy in patients with NSTEMI. This position article presents and discusses various clinical scenarios in patients with NSTEMI or unstable angina, including special subsets (eg, patients aged ≥85 years, patients with chronic renal disease or previous cerebrovascular events, and patients requiring triple therapy or long-term antithrombotic therapy), with the panel recommendations being provided for each scenario.

Incremental diagnostic value of ultrasonographic assessment of coronary flow reserve with high-dose dipyridamole in patients with acute coronary syndrome.

BACKGROUND: Coronary flow reserve (CFR) assessment by transthoracic Doppler echocardiography has been found to be useful in subjects with suspected coronary artery disease. An important clinical question is whether such technique can be successfully applied in patients admitted to the coronary care unit with an acute coronary syndrome to detect a significant left anterior descending (LAD) disease. METHODS: One hundred fifty-nine patients with acute coronary syndrome (93 patients with unstable angina, 66 with acute inferior or lateral myocardial infarction) were included in the present analysis. Patients underwent a high-dose dipyridamole stress (0.84 mg/kg) with combined assessment of CFR in the LAD and regional wall motion. Blood flow velocities were recorded in the mid-distal portion of the LAD using a digital ultrasonographic system and CFR was calculated as the ratio of hyperemia-induced peak diastolic velocity to resting peak diastolic flow velocity. All patients underwent coronary angiography and a significant LAD stenosis was classified for lumen narrowing > or = 70%. RESULTS: Adequate Doppler recordings in the LAD were obtained in 92% of patients. A contrast agent was used in the 39% of examinations. No major adverse reaction occurred in any patient. A receiving operating characteristic curve showed that a CFR value < 1.9 had a sensitivity of 85%, a specificity of 87%, a positive predictive value of 71%, a negative predictive value of 94% and a diagnostic accuracy of 86% for identifying a significant LAD stenosis. The area under the receiving operating characteristic curve computed for CFR was significantly higher than for wall motion score index (p < 0.001). In a stepwise forward, multiple logistic regression analysis, both CFR (OR = 4.8, 95% C.I. 3.7-5.3; p < 0.00001) and the wall motion score index for the LAD territory (OR = 4.2, 95% C.I. 2.6-6.8; p < 0.0001) were independent determinants of LAD stenosis > or = 70%. CONCLUSION: Early assessment of CFR by transthoracic Doppler echocardiography is feasible and safe and provides additional information to identify subjects with acute coronary syndrome and significant LAD stenosis.

Three-dimensional echocardiographic and magnetic resonance assessment of the effect of telmisartan compared with carvedilol on left ventricular mass a multicenter, randomized, longitudinal study.

BACKGROUND: The hypothesis that left ventricular hypertrophy regression in hypertension relates to blood pressure (BP) control and to non-antihypertensive activity of some drugs was tested by comparing the effects of telmisartan and carvedilol on 24-h mean ambulatory BP and left ventricular mass (LVM) regression, measured using three-dimensional echocardiography (3-DECHO) and magnetic resonance imaging (MRI). METHODS: A total of 82 patients with mild-to-moderate hypertension and an optimal echocardiographic acoustic window were randomized to receive once-daily telmisartan 80 mg or carvedilol 25 mg for 44 weeks. RESULTS: Ten patients withdrew from the study because office diastolic BP remained >90 mm Hg. The 24-h mean ambulatory systolic/diastolic BP reductions were similar in both treatment groups (telmisartan, from 159.6 +/- 10.2/97.8 +/- 5.4 to 128.6 +/- 6.5/78.2 +/- 5.8 mm Hg; carvedilol, from 157.8 +/- 11.1/95.7 +/- 11.9 to 128.2 +/- 5.6/78.7 +/- 5.2 mm Hg). However, night-time and last 6-h mean BP reductions were nonsignificantly greater with telmisartan. Using 3-DE, telmisartan (P< .001) and carvedilol (P< .001) progressively reduced LVM index by 21.97 +/- 5.84 (15.7%) and 12.31 +/- 3.14 (9.1%) g/m2, respectively, at week 44. Similar magnitudes of reductions were observed using MRI (15.5% and 9.6%, respectively). Reductions in LVM index achieved with telmisartan were statistically superior to carvedilol (P< or = .001). CONCLUSIONS: The superior LVM regression with telmisartan versus carvedilol suggests telmisartan has a mechanism that may be beyond that of lowering BP in hypertensive patients.

Contemporary antithrombotic strategies in patients with acute coronary syndromes managed without revascularization: insights from the EYESHOT study.

AIMS: Patients with acute coronary syndromes (ACSs) who are managed without coronary revascularization represent a mixed and understudied population that seems to receive suboptimal pharmacological treatment. METHODS AND RESULTS: We assessed patterns of antithrombotic therapies employed during the hospitalization and in-hospital clinical events of medically managed patients with ACS enrolled in the prospective, multicentre, nationwide EYESHOT (EmploYEd antithrombotic therapies in patients with acute coronary Syndromes HOspitalized in iTalian cardiac care units) registry. Among the 2585 consecutive ACS patients enrolled in EYESHOT, 783 (30.3%) did not receive any revascularization during hospital admission. Of these, 478 (61.0%) underwent coronary angiography (CA), whereas 305 (39.0%) did not. The median GRACE and CRUSADE risk scores were significantly higher among patients who did not undergo CA compared with those who did (180 vs. 145, P < 0.0001 and 50 vs. 33, P < 0.0001, respectively). Antithrombotic therapies employed during hospitalization significantly differ between patients who received CA and those who did not with unfractioned heparin and novel P2Y12 inhibitors more frequently used in the first group, and low-molecular-weight heparins and clopidogrel in the latter group. During the index hospitalization, patients who did not receive CA presented a higher incidence of ischaemic cerebrovascular events and of mortality compared with those who underwent CA (1.6 vs. 0.2%, P = 0.04 and 7.9 vs. 2.7%, P = 0.0009, respectively). CONCLUSION: Almost one-third of ACS patients are managed without revascularization during the index hospitalization. In this population, a lower use of recommended antiplatelet therapy and worse clinical outcome were observed in those who did not undergo CA when compared with those who did. CLINICAL TRIAL REGISTRATION: Unique identifier: NCT02015624, http://www.clinicaltrials.gov.

Usefulness of the mitral/aortic flow velocity integral ratio as a screening method to identify patients with hemodynamically significant mitral regurgitation.

OBJECTIVE: We sought to test the value of a simple Doppler index, the mitral/aortic flow velocity integral ratio (MAVIR), as a screening method to identify patients with hemodynamically significant mitral regurgitation (MR). METHODS: Included in the study were 91 patients (mean age 61 +/- 14 years; 54% men) with echocardiographically diagnosed MR. The cause was organic in 23 patients and ischemic/functional in 68. MR degree was assessed by 2 quantitative echocardiographic measures: the regurgitant fraction and the regurgitant orifice area. RESULTS: A good correlation was found between MAVIR and both regurgitant fraction (r = 0.75) and orifice (r = 0.60). When we divided patients into 3 groups on the basis of the regurgitant fraction, used as reference standard, MAVIR significantly increased in proportion to MR severity (0.7 +/- 0.1 for mild MR vs 1.1 +/- 0.2 for moderate and 1.4 +/- 0.3 for severe regurgitation; P <.0001). A ratio > 1 identified 28 of 30 patients with severe MR (regurgitant fraction > 60%), whereas all patients with mild MR (regurgitant fraction < 40%) had a ratio < 1. Using a regurgitant orifice >or= 40 mm(2) as threshold for severe MR, a significant difference in MAVIR was also present among patients who had severe MR compared with those having mild and moderate regurgitation (P <.0001). CONCLUSIONS: These findings suggest that MAVIR is a sensitive index, potentially widely applicable in clinical practice as a screening parameter for identifying patients with hemodynamically significant MR.

Effect of acute hyperhomocysteinemia on coronary flow reserve in healthy adults.

BACKGROUND: B-mode ultrasound studies indicate that hyperhomocysteinemia is associated with preclinical structural and functional arterial abnormalities. This study was designed to evaluate the effect of elevated plasma homocysteine levels on coronary flow reserve (CFR). METHODS: A total of 20 healthy subjects aged 41 +/- 7 years were studied on 2 separate days, a week apart, before and after methionine load (100 mg/kg of body weight) or placebo in a double-blind crossover study. At each visit, homocysteine levels were measured by high performance liquid chromatography and CFR was determined by transthoracic Doppler echocardiography. RESULTS: After methionine load, plasma homocysteine increased from 10.7 +/- 2.8 mumol/L to 30.4 +/- 5.1 mumol/L ( P < .0001) and CFR decreased from 3.0 +/- 0.4 to 2.3 +/- 0.3 ( P < .001). CFR was inversely related to postload homocysteine levels ( r = -0.21, P = .02). After placebo, there was no change in CFR. CONCLUSION: In asymptomatic adults, acute hyperhomocysteinemia is associated with a significant reduction in CFR.