The PERFORMANCE II Trial: A Prospective Multicenter Investigation of a Novel Carotid Stent System.

Background: Several randomized clinical trials have shown that the composite endpoint of death, stroke, and myocardial infarction (MI) is equivalent between carotid artery stenting and carotid endarterectomy. However, the risk of minor stroke has been consistently higher with carotid artery stenting.

Objectives: The authors sought to evaluate the safety and effectiveness of a novel carotid stent system comprised of a stent, an adjustable integrated embolic filter and a postdilation balloon, in patients at elevated risk for adverse events from carotid endarterectomy.

Routine Spironolactone in Acute Myocardial Infarction.

Background: Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain.

Methods: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo.

Sex differences in transradial access failure in ST segment elevation myocardial infarction.

Background: Transradial access (TRA) is now the default access site for PPCI, but technically is a more challenging approach mostly due to anatomic challenges connected to the RA.

Aims: To assess the differences according to sex in radial artery (RA) access site characteristics during primary percutaneous coronary intervention (PPCI) for ST segment elevation myocardial infarction (STEMI).

Material And Methods: All 5092 consecutive STEMI patients from our center in the period from March 2011 until December 2017 were examined.

Early coronary revascularization among 'stable' patients with non-ST-segment elevation acute coronary syndromes: the role of diabetes and age.

Aims: To investigate the impact of an early coronary revascularization (<24 h) compared with initial conservative strategy on clinical outcomes in diabetic patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who are in stable condition at hospital admission.

Methods And Results: The International Survey of Acute Coronary Syndromes database was queried for a sample of diabetic and nondiabetic patients with diagnosis of NSTE-ACS. Patients with cardiac arrest, haemodynamic instability, and serious ventricular arrhythmias were excluded.

Navigating complexity with low-crossing profile dual-layer micromesh carotid stent: implications for contemporary carotid artery stenting outcomes (ROADSAVER study insights).

Background: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS.

Methods: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021.

Comparative analysis of carotid artery stenting practice and outcomes across operator specialties: insights from a prespecified subanalysis of a large real-world patient cohort (ROADSAVER Study).

Background: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature.

Coronary revascularization and sex differences in cardiovascular mortality after myocardial infarction in 12 high and middle-income European countries.

Background: Existing data on female sex and excess cardiovascular mortality after myocardial infarction (MI) mostly come from high-income countries (HICs). This study aimed to investigate how sex disparities in treatments and outcomes vary across countries with different income levels.

Methods: Data from the ISACS-Archives registry included 22 087 MI patients from 6 HICs and 6 middle-income countries (MICs).

Traditional risk factors and premature acute coronary syndromes in South Eastern Europe: a multinational cohort study.

Background: The age-standardized death rates under 65 years from ischemic heart disease in South Eastern Europe are approximately twice as high than the Western Europe average, but the reasons are not completely recognized. The aim of the present study was to address this issue by collecting and analyzing data from a large, multinational cohort.

Methods: We enrolled 70,953 Caucasian patients with first acute coronary syndrome, from 36 urban hospital in 7 South Eastern European countries and assessed their life expectancy free of acute coronary syndrome and mortality within 30 days after hospital admission from acute coronary syndrome as estimated in relation to dichotomous categories of traditional risk factors (current smoking, hypertension, diabetes and hypercholesterolemia) stratified according to sex.

SYNERGY-Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry.

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent (Boston Scientific Corporation, Marlborough, Massachusetts) in patients with ST-elevation myocardial infarction (STEMI). The only drug-eluting stent approved for treatment of STEMI by the Food and Drug Administration is the Taxus stent (Boston Scientific) which is no longer commercially available, so further data are needed. The CLEAR (Colchicine and spironolactone in patients with myocardial infarction) SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (n = 7,000), comparing colchicine versus placebo and spironolactone versus placebo.

Transradial carotid artery stenting using double layer micromesh stent and novel post-dilation balloon with integrated embolic protection.

Objectives: The highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-ɥm pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation.

Methods: 25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent.

Clinical determinants of ischemic heart disease in Eastern Europe.

Cardiovascular inequalities remain pervasive in the European countries. Disparities in disease burden is apparent among population groups based on sex, ethnicity, economic status or geography. To address this challenge, The Lancet Regional Health - Europe convened experts from a broad range of countries to assess the current state of knowledge of cardiovascular disease inequalities across Europe.

Carotid artery interventions - endarterectomy versus stenting.

Current management of patients with carotid artery stenosis is based on well-established guidelines, including surgical procedures - carotid endarterectomy (CEA) and endovascular carotid artery stenting (CAS) - and optimal medical treatment alone. Outcomes in the postprocedural period after CAS and CEA are similar, suggesting strong clinical durability for both treatments. Recent advances, which include the emergence of novel endovascular treatment tools and techniques, combined with more recent randomised trial data shed new light on optimal patient selection and treatment in contemporary practice.

A Randomized Controlled Trial Comparing BioMime Sirolimus-Eluting Stent With Everolimus-Eluting Stent: Two-Year Outcomes of the meriT-V Trial.

Background: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of lesions.

Methods: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil.

Relationship Between Azithromycin and Cardiovascular Outcomes in Unvaccinated Patients With COVID-19 and Preexisting Cardiovascular Disease.

Background Empiric antimicrobial therapy with azithromycin is highly used in patients admitted to the hospital with COVID-19, despite prior research suggesting that azithromycin may be associated with increased risk of cardiovascular events. Methods and Results This study was conducted using data from the ISACS-COVID-19 (International Survey of Acute Coronavirus Syndromes-COVID-19) registry. Patients with a confirmed diagnosis of SARS-CoV-2 infection were eligible for inclusion.

Sex Differences in Heart Failure Following Acute Coronary Syndromes.

Background: There have been conflicting reports regarding outcomes in women presenting with an acute coronary syndrome (ACS).

Objectives: The objective of the study was to examine sex-specific differences in 30-day mortality in patients with ACS and acute heart failure (HF) at the time of presentation.

Methods: This was a retrospective study of patients included in the International Survey of Acute Coronary Syndromes-ARCHIVES (ISACS-ARCHIVES; NCT04008173).

Sex differences and disparities in cardiovascular outcomes of COVID-19.

Aims: Previous analyses on sex differences in case fatality rates at population-level data had limited adjustment for key patient clinical characteristics thought to be associated with coronavirus disease 2019 (COVID-19) outcomes. We aimed to estimate the risk of specific organ dysfunctions and mortality in women and men.

Methods And Results: This retrospective cross-sectional study included 17 hospitals within 5 European countries participating in the International Survey of Acute Coronavirus Syndromes COVID-19 (NCT05188612).

Radial and ulnar approach for carotid artery stenting with Roadsaver™ double layer micromesh stent: Early and long-term follow-up.

Aims: We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease.

Materials And Methods: Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG.

Impact of Sex on Clinical Outcomes in Patients undergoing Complex Percutaneous Coronary Angioplasty (from the e-ULTIMASTER Study).

Female gender has been shown to be associated with worse clinical outcomes after percutaneous coronary intervention (PCI). However, the impact of gender on the clinical outcomes of complex PCI is still poorly understood. This study examined the differences in patient and coronary lesion characteristics and longer-term clinical outcomes in male and female patients who underwent complex PCI.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

Objectives: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis.

Background: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting.

Methods: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe.