Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy.

Introduction: For patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced/metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after osimertinib and platinum-based chemotherapy (PBC), no uniformly accepted standard of care exists. Moreover, limited efficacy of standard treatments indicates an unmet medical need, which is being addressed by ongoing clinical investigations, including the HERTHENA-Lung01 (NCT04619004) study of patritumab deruxtecan (HER3‑DXd). However, because limited information is available on real-world clinical outcomes in such patients, early-phase trials of investigational therapies lack sufficient context for comparison.

Tafamidis medication adherence and persistence in patients with transthyretin amyloid cardiomyopathy in Japan.

Aims: This study aimed to describe baseline characteristics and adherence among patients with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with tafamidis (VYNDAQEL®) in Japan using the Japanese Medical Data Vision (MDV) database.

Methods And Results: This study was a non-interventional, retrospective cohort study of adult (≥18 years old) patients in the Japanese MDV claims database diagnosed with ATTR-CM and with at least two tafamidis prescriptions of dose strength 4 × 20 mg/day between 1 March 2019 and 31 August 2021. The date of the first prescription was defined as the index date, with follow-up time defined as the time between the first and last prescription plus the days' supply from the last refill.

Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.

Background: Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR.

Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial.

Background: The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD).

Aims: We sought to determine whether these outcomes remained consistent regardless of geography of enrolment.

Methods: We performed a prespecified subgroup analysis based on regional enrolment.

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

Background: Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events.

Aims: We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation.

Impact of renin-angiotensin system inhibitors after revascularization of patients with left main coronary artery disease.

Background: There is a paucity of data regarding the effect of inhibition of the renin-angiotensin system on outcomes after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). We sought to examine long-term outcomes of patients with left main coronary disease (LMCAD) randomized to PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents or CABG according to treatment at discharge with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) in the large-scale, multicenter, randomized EXCEL trial.

Methods: EXCEL randomized 1905 patients with LMCAD of low and intermediate anatomical complexity (visually-assessed SYNTAX score ≤32) to PCI (n = 948) versus CABG (n = 957).

Relationship between primary percutaneous coronary intervention time of day, infarct size, microvascular obstruction and prognosis in ST-segment elevation myocardial infarction.

Background: Whether the time of day of primary percutaneous coronary intervention (pPCI) in patients with ST-segment elevation myocardial infarction (STEMI) is associated with infarct size, microvascular obstruction (MVO), and prognosis is uncertain. We compared infarct size assessed by cardiac MRI (CMR) and clinical outcomes in STEMI patients according to the pPCI time of day from a large, individual patient-data pooled database.

Methods: We pooled patient-level data from five randomized pPCI trials in which infarct size was measured within 1 month by CMR.

Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study.

Background: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs).

Methods: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden.

Outcomes of transcatheter mitral valve repair for secondary mitral regurgitation by severity of left ventricular dysfunction.

Background: In the COAPT trial, transcatheter mitral valve repair with the MitraClip plus maximally tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction.

Aims: In this COAPT substudy, we sought to evaluate two-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF ≤40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF ≤30%) versus moderate (LVEF >30%) LV dysfunction.

Methods: The principal effectiveness outcome was the two-year rate of death from any cause or HF hospitalisations (HFH).

Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials.

Introduction: The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis.

Evidence Acquisition: In line with the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines, we performed a comprehensive search for RCTs which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.

Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque.

Background: Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.

Objectives: This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.

Methods: Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI).

The win ratio approach for composite endpoints: practical guidance based on previous experience.

The win ratio was introduced in 2012 as a new method for examining composite endpoints and has since been widely adopted in cardiovascular (CV) trials. Improving upon conventional methods for analysing composite endpoints, the win ratio accounts for relative priorities of the components and allows the components to be different types of outcomes. For example, the win ratio can combine the time to death with the number of occurrences of a non-fatal outcome such as CV-related hospitalizations (CVHs) in a single hierarchical composite endpoint.

Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial.

Background: Transcatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF).

Objectives: This study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial.

Methods: Patients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone.

Association of Natriuretic Peptide Levels After Transcatheter Aortic Valve Replacement With Subsequent Clinical Outcomes.

Importance: Among those with aortic stenosis, natriuretic peptide levels can provide risk stratification, predict symptom onset, and aid decisions regarding the timing of valve replacement. Less is known about the prognostic significance and potential clinical utility of natriuretic peptide levels measured after valve replacement.

Objective: To determine the associations of elevated B-type natriuretic peptide (BNP) levels after transcatheter aortic valve replacement (TAVR) and change in BNP levels between follow-up time points with risk of subsequent clinical outcomes.

Prognostic Impact of Race in Patients Undergoing PCI: Analysis From 10 Randomized Coronary Stent Trials.

Objectives: The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials.

Background: Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies.

Methods: Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials.

Prognostic implications of baseline 6-min walk test performance in intermediate risk patients undergoing transcatheter aortic valve replacement.

Background: While slow gait speed is known to be associated with poor outcomes in patients at high surgical risk who undergo transcatheter aortic valve replacement (TAVR), the prognostic significance of slow gait speed in intermediate risk TAVR patients is poorly understood.

Objectives: We assessed the association between baseline 6-min walk test (6MWT) performance and both 2-year mortality and health status in intermediate risk patients undergoing TAVR as a part of the PARTNER II/S3i studies.

Methods: The association of baseline 6MWT with mortality over 2-years after TAVR was examined using Cox regression; both unadjusted and adjusted for age, left ventricular ejection fraction, coronary artery disease, pulmonary disease, renal insufficiency, and STS score.

Impact of recent heart failure hospitalization on clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: an analysis from the PARTNER 2 trial and registries.

Aims: Heart failure (HF) hospitalization prior to transcatheter aortic valve replacement (TAVR) is associated with increased post-procedural mortality. We sought to assess the association between recent (≤6 months) HF hospitalization and long-term adverse outcomes in patients with symptomatic, severe aortic stenosis, undergoing TAVR in the PARTNER 2 trial and registries.

Methods And Results: Intermediate to high or even prohibitive risk patients who underwent TAVR in the PARTNER 2 trial and registries were included in the analysis.

Outcomes After Left Main Coronary Artery Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting According to Smoking Status.

Cigarette smoking is a well-known risk factor for coronary artery disease (CAD). However, the impact of smoking on outcomes after coronary revascularization, especially in patients with left main CAD (LMCAD) is less well understood. The EXCEL trial randomized 1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to PCI with everolimus-eluting stents or CABG.

BMI, Infarct Size, and Clinical Outcomes Following Primary PCI: Patient-Level Analysis From 6 Randomized Trials.

Objectives: The aim of this study was to examine the association between body mass index (BMI), infarct size (IS) and clinical outcomes.

Background: The association between obesity, IS, and prognosis in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction is incompletely understood.

Methods: An individual patient-data pooled analysis was performed from 6 randomized trials of patients undergoing pPCI for ST-segment elevation myocardial infarction in which IS (percentage left ventricular mass) was assessed within 1 month (median 4 days) after randomization using either cardiac magnetic resonance (5 studies) or Tc sestamibi single-photon emission computed tomography (1 study).