Clinical outcome after bleeding events following coronary stenting in patients with and without comorbid peripheral arterial disease.

Patients undergoing percutaneous coronary intervention (PCI) may experience bleeding events. Bleeding risk is increased in patients with comorbid peripheral arterial disease (PADs). To evaluate whether PCI patients with PADs have worse outcome after bleeding, we assessed pooled patient-level data of 5,989 randomized all-comer trial participants and identified those who had a bleeding (BIO-RESORT:NCT01674803, BIONYX:NCT02508714).

Cost-Effectiveness of Three Different New-Generation Drug-Eluting Stents in the Randomised BIO-RESORT Trial at 3 Years.

Background And Objective: Evidence on health economic outcomes for percutaneous coronary intervention (PCI) comparing different contemporary drug-eluting stents (DES) with each other is scarce, as most previous randomised DES trials did not assess such aspects. This prespecified health economic evaluation of the Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population (BIO-RESORT) trial aimed to compare at 3-year follow-up both health effects and costs of PCI with one of three new-generation drug-eluting stents (DES) in patients with obstructive coronary artery disease.

Methods: The randomised BIO-RESORT trial assessed in 3514 patients the ultrathin-strut biodegradable polymer Orsiro sirolimus-eluting stent (SES) and very-thin-strut Synergy everolimus-eluting (EES) stent versus the thin-strut durable polymer Resolute Integrity zotarolimus-eluting stent (ZES).

Characteristics and outcome in cardiogenic shock according to vascular access site for percutaneous coronary intervention.

Aims: The optimal vascular access site for percutaneous coronary interventions (PCIs) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains uncertain. While observational data favour transradial access (TRA) due to lower complication rates and mortality, transfemoral access (TFA) PCI offers advantages such as shorter access and procedure times, along with quicker escalation to mechanical circulatory support (MCS). In this study, we aimed to investigate factors associated with a transfemoral approach and compare mortality rates between TRA and TFA in AMI-CS patients undergoing PCI.

Impact of premature coronary artery disease on adverse event risk following percutaneous coronary intervention.

Objectives: We assessed differences in risk profile and 3-year outcome between patients undergoing percutaneous coronary intervention (PCI) for and coronary artery disease (CAD).

Background: The prevalence of CAD increases with age, yet some individuals develop obstructive CAD at younger age.

Methods: Among participants in four randomized all-comers PCI trials, without previous coronary revascularization or myocardial infarction (MI), we compared patients with premature (men <50 years; women <55 years) and non-premature CAD.

Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

Background: In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs.

Data quality and auditing within the Netherlands Heart Registration: using the PCI registry as an example.

Aim: The aim of this article is to present the method and results of the data quality control system and audit within the Netherlands Heart Registration (NHR) using data of patients treated with percutaneous coronary intervention (PCI) in the Netherlands as an example.

Methods: The NHR is a Dutch nationwide registry of all cardiac interventions, comprising data from all 71 hospitals, of which 30 are cardiac intervention or heart centres. Each year, within the NHR, data validation and verification is performed by standard quality controls and monitoring visits (audits).

Risk of bleeding after percutaneous coronary intervention and its impact on further adverse events in clinical trial participants with comorbid peripheral arterial disease.

Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs.

Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers.

Background In a previous trial, higher 5-year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus-eluting stents (SES). We assessed 5-year safety and efficacy of all-comers as well as patients with diabetes treated with SES or Synergy everolimus-eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). Methods and Results The randomized BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial enrolled 3514 all-comer patients at 4 Dutch cardiac centers.

Short-Term Outcomes of Elective High-Risk PCI with Extracorporeal Membrane Oxygenation Support: A Single-Centre Registry.

Background: If surgical revascularization is not feasible, high-risk PCI is a viable option for patients with complex coronary artery disease. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides hemodynamic support in patients with a high risk for periprocedural cardiogenic shock.

Objective: This study aims to provide data about short-term outcomes of elective high-risk PCI with ECMO support.

Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials.

Background And Aims: A considerable number of patients who undergo percutaneous coronary intervention (PCI) also have peripheral arterial disease (PAD) - a signal of more advanced atherosclerosis. After bare metal and early-generation drug-eluting coronary stent implantation, PAD patients showed inferior outcome. As stents and medical treatment were further improved, we aimed to assess the impact of PAD on outcome of PCI with contemporary new-generation stents.

Using real-world data to monitor and improve quality of care in coronary artery disease: results from the Netherlands Heart Registration.

Worldwide, quality registries for cardiovascular diseases enable the use of real-world data to monitor and improve the quality of cardiac care. In the Netherlands Heart Registration (NHR), cardiologists and cardiothoracic surgeons register baseline, procedural and outcome data across all invasive cardiac interventional, electrophysiological and surgical procedures. This paper provides insight into the governance and processes as organised by the NHR in collaboration with the hospitals.

Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials.

Background: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia.

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial.

Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES).

Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial.

Objectives: To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.

Background: In patients presenting with acute MI, higher adverse event rates have been reported.

Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial.

Background: Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.

Methods: Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred.

Treating diabetic all-comers with contemporary drug-eluting stents: Prespecified comparisons from the BIO-RESORT and the BIONYX randomized trials.

Background: Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES).

New-generation drug-eluting coronary stents in octogenarians: Patient-level pooled analysis from the TWENTE I-IV trials.

Background: Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients.

Methods: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials.

Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years.

Objectives: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.

Background: The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.

Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial.

Objective: The objective was to assess the 2-year clinical performance of three drug-eluting stents in all-comer patients with severely calcified coronary lesions.

Background: Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all-comers with severely calcified lesions who were treated with more recently introduced drug-eluting stents.

Methods: The BIO-RESORT trial (clinicaltrials.

Proximal LAD Treated With Thin-Strut New-Generation Drug-Eluting Stents: A Patient-Level Pooled Analysis of TWENTE I-III.

Objectives: This study sought to assess 2-year clinical outcome following percutaneous coronary intervention (PCI) with thin-strut new-generation drug-eluting stents (DES) in patients treated in proximal left anterior descending artery (P-LAD) versus non-P-LAD lesions.

Background: In current revascularization guidelines, P-LAD coronary artery stenosis is discussed separately, mainly because of a higher adverse event risk and benefits of bypass surgery.

Methods: The study included 6,037 patients without previous bypass surgery or left main stem involvement from the TWENTE I, II, and III randomized trials.