Michela Faggioni

Comparison of Percutaneous Mitral Valve Repair Versus Conservative Treatment in Severe Functional Mitral Regurgitation.

Percutaneous mitral valve repair (PMVR) using the MitraClip System is feasible and entails clinical improvement even in patients with high surgical risk and severe functional mitral regurgitation (MR). The aim of this study was to assess survival rates and clinical outcome of patients with severe, functional MR treated with optimal medical therapy (OMT) compared with those who received MitraClip device. Sixty patients treated with OMT were compared with a propensity-matched cohort of 60 patients who underwent PMVR. Baseline demographics and echocardiographic variables were similar between the 2 groups. The mean age of patients was 75 years, and 67% were men. The median logistic EuroSCORE and EuroSCORE II were 17% and 6%, respectively, because of the presence of several co-morbidities. The mechanism of MR was functional in all cases with an ischemic etiology in 52% of patients. Median left ventricle ejection fraction was 34%. All the patients were symptomatic for dyspnea with 63% and 12% in the New York Heart Association class III and IV, respectively. In PMVR group, the procedure was associated with safety and very low incidence of procedural complications with no occurrence of procedural and inhospital mortality. After a median follow-up of 515 days (248 to 828 days), patients treated with PMVR demonstrated overall survival, survival freedom from cardiac death and survival free of readmission due to cardiac disease curves higher than patients treated conservatively (log-rank test p = 0.007, p = 0.002, and p = 0.04, respectively). In conclusion, PMVR offers a valid option for selected patients with high surgical risk and severe, functional MR and entails better survival outcomes compared with OMT.

Sex‐related differences in outcomes among men and women under 55 years of age with acute coronary syndrome undergoing percutaneous coronary intervention: Results from the PROMETHEUS Study

Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under‐treatment. We sought to compare the 1‐year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort.

TCT-658 Neurologic Outcomes with Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background: Clinical or subclinical cerebral embolization is a relatively frequent complication of transcatheter aortic valve replacement (TAVR). Randomized controlled trials (RCTs) investigating the efficacy of embolic protection devices during TAVR were relatively underpowered to detect meaningful differences in imaging and clinical endpoints. Methods: We performed a systematic review and study-level meta-analysis of RCTs that tested the efficacy and safety of EP during TAVR. RCTs using any type of EP and TAVR vascular access were included. Primary imaging efficacy endpoints were total lesion volume (TLV; in mm 3 ) and number of new ischemic lesions. Primary clinical efficacy endpoints were any deterioration in National Institute of Health Stroke Scale (NIHSS) and Montreal Cognitive Assessment (MoCA) score at hospital discharge. Primary analyses were performed with the intention-to-treat approach. Results: A total of 4 RCTs (total n=252) have been included. Use of EP was associated with lower TLV (Figure; standardized mean difference [SMD]: -0.65; 95% confidence interval [CI]: -1.06 to -0.25; p=0.002) and lower number of new ischemic lesions (Figure; SMD: -1.27; 95% CI: -2.45 to -0.09; p = 0.03). EP was associated with a trend to lower risk of deterioration in NIHSS at discharge (RR: 0.55; 95% CI: 0.27 to 1.09; p=0.09) and higher MoCA score (SMD: +0.40; 95% CI: +0.04 to +0.76; p = 0.03). Risk of overt stroke and all-cause mortality were non-significantly lower in the EP group. Conclusions: Use of EP seems to be associated with a reduction of imaging markers of cerebral infarction and early clinical neurologic effectiveness in patients undergoing TAVR. Key Words: TAVR; Embolic Protection; Stroke.

Culprit-lesion only versus complete multivessel percutaneous intervention in ST-elevation myocardial infarction: A systematic review and meta-analysis of randomized trials.

BACKGROUND ST-segment elevation myocardial infarction (STEMI) in patients with concomitant multivessel (MV) coronary artery disease (CAD) is associated with poor outcomes. Percutaneous coronary intervention (PCI) of the culprit-lesion only (CLO) as compared with a MV PCI approach to revascularization remains uncertain. Our objective is to gain a better understanding of the efficacy and safety of CLO as compared with MV PCI in patients with STEMI by conducting an updated meta-analysis. METHODS A comprehensive search of PubMed, CENTRAL, EMBASE, The Cochrane Central Register, the ClinicalTrials.gov Website, and Google Scholar databases of randomized controlled trials (RCTs) was performed. RESULTS Seven RCTs were included, enrolling a total of 2006 patients. We found that there was a significant reduction in major adverse cardiovascular events (MACE) (OR, 0.62; 95% CI, 0.43-0.90), cardiovascular mortality (OR, 0.46; 95% CI, 0.27-0.80), and repeat revascularization (RRV) (OR, 0.39; 95% CI, 0.30-0.51) favoring MV over the CLO approach for patients undergoing primary PCI. The number needed to treat in order to prevent one CV mortality, RRV, or MACE event is 47, 11, and 16 patients, respectively. No differences were observed between MV vs. CLO PCI for subsequent myocardial infarction (OR, 0.74; 95% CI, 0.40-1.39), all-cause mortality (OR, 0.78; 95% CI, 0.53-1.15), non-cardiovascular mortality (OR, 1.35; 95% CI, 0.74-2.48), all-bleeding events (OR, 0.82; 95% CI, 0.40-1.65), contrast-induced nephropathy (OR, 0.72; 95% CI, 0.33-1.54), and stroke (OR, 1.28; 95% CI, 0.47-3.46). CONCLUSIONS MV PCI significantly reduces the rate of MACE, CV mortality, and RRV without significant harm as compared to CLO PCI.

Patterns and associations between DAPT cessation and 2-year clinical outcomes in left main/proximal LAD versus other PCI: Results from the Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients (PARIS) registry

OBJECTIVES Percutaneous coronary intervention (PCI) of the left main (LM) or proximal left anterior descending artery (pLAD) is considered high-risk as these segments subtend substantial left ventricular myocardial area. We assessed the patterns and associations between dual antiplatelet therapy (DAPT) cessation and 2-year outcomes in LM/pLAD vs. other PCI from the all-comer PARIS registry. METHODS Two-year major adverse cardiovascular events (MACE) were a composite of cardiac death, myocardial infarction, definite/probable stent thrombosis or target lesion revascularization. DAPT cessation was predefined as physician-guided permanent discontinuation, temporary interruption, or non-recommended disruption due to non-compliance or bleeding. RESULTS Of the study population (n=5018), 25.0% (n=1252) underwent LM/pLAD PCI and 75.0% (n=3766) PCI to other segments. Compared to others, LM/pLAD patients presented with fewer comorbidities, less frequent acute coronary syndromes but more multivessel and bifurcation disease treated with greater stent lengths. Two-year adjusted risk of MACE (11.4% vs. 11.6%; HR 1.10, 95% CI 0.90-1.34, p=0.36) was similar between LM/pLAD vs. other patients. DAPT discontinuation was significantly higher (43.3% vs. 39.4%, p=0.01) in LM/pLAD patients with borderline significance for lower disruption (10.0% vs. 14.7%, p=0.059) compared to other patients. DAPT discontinuation was not associated with higher risk of MACE in LM/pLAD (HR 0.65, 95% CI 0.34-1.25) or other PCI groups (HR 0.67, 95% CI 0.47-0.95). CONCLUSIONS LM/pLAD PCI was not an independent predictor of 2-year MACE. Compared to other PCI, patients undergoing LM/pLAD PCI had higher rates of physician recommended DAPT discontinuation, however, discontinuation did not result in greater adverse events.

Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction: From the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration.

Importance Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear. Objective To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI. Design, Setting, and Participants Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non–ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI). Interventions Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES. Main Outcomes and Measures Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up. Results Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, −3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, −2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, −0.5% [NNT, 222]; NSTEMI, −3.1% [NNT, 33]; STEMI, −4.0% [NNT, 25] and for definite or probable ST: UA, −0.4% [NNT, 278]; NSTEMI, −2.2% [NNT, 46]; STEMI, −4.0% [NNT, 25]). Conclusions and Relevance New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

ASSOCIATIONS BETWEEN VALVE TYPE AND OUTCOMES IN WOMEN UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: RESULTS FROM THE WIN-TAVI REGISTRY

Valve type selection in women undergoing transcatheter aortic valve replacement (TAVR) may be based on clinical, anatomical or logistical factors. We sought to compare characteristics and outcomes of women receiving balloon-expandable (BEV) or self-expanding valves (SEV) in contemporary TAVR WIN-

Comparative Efficacy and Safety of Rivaroxaban-Based Dual-Pathway Antithrombotic Therapy Versus Dual Antiplatelet Therapy: A Pooled Analysis of Contemporary Randomized Controlled Trials

Dual antiplatelet therapy (DAPT) has been the mainstay of antithrombotic management for acute coronary syndrome (ACS). Approximately 5-10% of patients experience recurrent events despite standard treatment, and there is an unmet demand for secondary cardiovascular prevention in the post-ACS setting

Use of prasugrel vs clopidogrel and outcomes in patients with and without diabetes mellitus presenting with acute coronary syndrome undergoing percutaneous coronary intervention

BACKGROUND Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.

The prevalence, predictors and outcomes of guideline-directed medical therapy in patients with acute myocardial infarction undergoing PCI, an analysis from the PROMETHEUS registry

To investigate the prevalence, predictors and associations between guideline‐directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States.