Randomized comparison of the combined Sirolimus eluting and endothelial progenitor cell Combo stent vs. Biolimus eluting absorbable polymer coated BioMatrix Alpha stent in patients undergoing percutaneous coronary intervention. Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) XI trial: SORT-OUT XI Trial Design.

Rationale: The biodegradable polymer BioMatrix Alpha™ stent contains biolimus A9 drug which is sirolimus derivative increase in lipophicity. The biodegradable polymer sirolimus eluting Combo™ stent is a dual-therapy sirolimus-eluting and CD34+ antobody coated stent capturing endothelial progenitor cells (EPCs).

Hypothesis: The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 BioMatrix Alpha ™ stent is noninferior to the biodegradable polymer sirolimus eluting Combo™ stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Long-term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes.

Background: Patients with acute coronary syndromes (ACS) may have worse outcomes after percutaneous coronary intervention compared to patients without ACS.

Aims: To compare 5-year efficacy and safety outcomes in patients with and without ACS treated with biodegradable polymers, the ultrathin strut sirolimus-eluting Orsiro stent (O-SES) or the biolimus-eluting Nobori stent (N-BES).

Methods: The Scandinavian Organisation for Randomized Trials with Clinical Outcome VII is a randomized trial comparing O-SES and N-BES in an all-comer setting.

Dual-therapy CD34 antibody-covered sirolimus-eluting COMBO stents versus sirolimus-eluting Orsiro stents in patients treated with percutaneous coronary intervention: the three-year outcomes of the SORT OUT X randomised clinical trial.

Background: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing.

Aims: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention.

Impact of Percutaneous Intervention Compared to Pharmaceutical Therapy on Complex Arrhythmias in Patients With Chronic Total Coronary Occlusion. Rationale and Design of the CTO-ARRHYTHMIA Study.

Chronic total coronary occlusions (CTO) occur in up to 50 % of patients with coronary artery disease by angiography. In CTO-patients, clinically significant arrhythmia is potentially important and insufficiently investigated. Therefore, the purpose of the CTO-ARRHYTHMIA study was to investigate the incidence of loop recorder detected clinically significant arrhythmias and the effect on arrhythmias of revascularization by CTO-PCI.

Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial.

Background: Biodegradable polymer drug-eluting stents were developed to improve safety and efficacy outcomes for patients undergoing percutaneous coronary intervention. However, few long-term follow-up efficacy studies are available. The study sought to investigate 5-year results from the SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) comparing the biodegradable polymer ultrathin-strut sirolimus-eluting Orsiro stent (O-SES) versus the biodegradable polymer biolimus-eluting Nobori stent (N-BES).

Impact of acute coronary syndrome on clinical outcomes after revascularization with the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.

Objectives: To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.

Background: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.

Care of patients with ST-elevation myocardial infarction: an international analysis of quality indicators in the acute coronary syndrome STEMI Registry of the EURObservational Research Programme and ACVC and EAPCI Associations of the European Society of Cardiology in 11 462 patients.

Aims: To use quality indicators to study the management of ST-segment elevation myocardial infarction (STEMI) in different regions.

Methods And Results: Prospective cohort study of STEMI within 24 h of symptom onset (11 462 patients, 196 centres, 26 European Society of Cardiology members, and 3 affiliated countries). The median delay between arrival at a percutaneous cardiovascular intervention (PCI) centre and primary PCI was 40 min (interquartile range 20-74) with 65.

Impact of diabetes on clinical outcomes after revascularization with the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent and the sirolimus-eluting Orsiro stent.

Objectives: To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study.

Background: The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown.

Effectiveness and Safety of Ticagrelor Implementation in Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention: A Cohort Study in Western Denmark.

Background: Ticagrelor was introduced in Denmark in 2011 after randomised data showed its superiority over clopidogrel for patients with acute coronary syndrome (ACS). We assessed the effectiveness and safety of ticagrelor implementation in ACS patients undergoing percutaneous coronary intervention (PCI).

Methods: We identified PCI-treated ACS patients in Western Denmark who redeemed a P2Y12 inhibitor prescription within 14 days.

Impact of diabetes on 1-year clinical outcome in patients undergoing revascularization with the BioFreedom stents or the Orsiro stents from the SORT OUT IX trial.

This sub-study of the SORT OUT IX trial sought to compare clinical outcomes between patients with diabetes randomized to implantation of either the polymer-free biolimus A9-coated BioFreedom stent (BF-BES) or the ultra-thin strut, biodegradable polymer sirolimus-eluting Orsiro stent (O-SES). Patients with diabetes have an increased risk of target lesion failure (TLF) after percutaneous coronary intervention (PCI). The impact of different stent types in patients with diabetes is still discussed.

Polymer-free biolimus-coated stents versus ultrathin-strut biodegradable polymer sirolimus-eluting stents: two-year outcomes of the randomised SORT OUT IX trial.

Background: For patients with high bleeding risk, the BioFreedom stent is safer and more effective than a bare metal stent. However, at the one-year follow-up of the SORT OUT IX trial, the BioFreedom stent did not meet the criteria for non-inferiority for target lesion failure (TLF) when compared with the Orsiro stent and had a higher incidence of target lesion revascularisation (TLR).

Aims: The aim of the study was to compare the two-year outcomes following coronary implantation of the BioFreedom or the Orsiro stents in all-comer patients.

Cardiovascular risk in patients with and without diabetes presenting with chronic coronary syndrome in 2004-2016.

Background: It was recently shown that new-onset diabetes patients without previous cardiovascular disease have experienced a markedly reduced risk of adverse cardiovascular events from 1996 to 2011. However, it remains unknown if similar improvements are present following the diagnosis of chronic coronary syndrome. The purpose of this study was to examine the change in cardiovascular risk among diabetes patients with chronic coronary syndrome from 2004 to 2016.

Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in Europe: the ACVC-EAPCI EORP STEMI Registry of the European Society of Cardiology.

Aims: The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI).

Methods And Results: Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.

Randomized Clinical Comparison of the Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent With the Sirolimus-Eluting Orsiro Stent in Patients Treated With Percutaneous Coronary Intervention: The SORT OUT X Trial.

Background: Target lesion failure remains an issue with contemporary drug-eluting stents. Thus, the dual-therapy sirolimus-eluting and CD34+ antibody-coated Combo stent (DTS) was designed to further improve early healing. This study aimed to investigate whether the DTS is noninferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population.

Invasive aortic pulse pressure is not superior to cuff pulse pressure in cardiovascular risk prediction.

Objective: Aortic pulse pressure (PP) represents the hemodynamic cardiac and cerebral burden more directly than cuff PP. The objective of this study was to investigate whether invasively measured aortic PP confers additional prognostic value beyond cuff PP for cardiovascular events and death. With increasing age, cuff PP progressively underestimates aortic PP.

Risk of Myocardial Infarction in Patients Without Angiographic Coronary Artery Disease Compared With the General Population.

We examined the 10-year risk of myocardial infarction (MI) and death in patients without obstructive coronary artery disease (CAD) compared with the general population. We conducted a cohort study of every patient without obstructive CAD by coronary angiography (CAG) between 2003 and 2016 in Western Denmark. Patients were matched by gender and age with individuals from the general population of Western Denmark with no history of CAD.

Diabetes is not a risk factor for myocardial infarction in patients without coronary artery disease: A study from the Western Denmark Heart Registry.

Background: Diabetes is considered a risk factor for myocardial infarction. However, we have previously found that diabetes was not a short-term risk factor for myocardial infarction in the absence of obstructive coronary artery disease.

Methods: We conducted a cohort study of patients undergoing coronary angiography from 2003 to 2012 and followed them by cross-linking Danish health registries.

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial.

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent.

Comparison of Acute Versus Subacute Coronary Angiography in Patients With NON-ST-Elevation Myocardial Infarction (from the NONSTEMI Trial).

The optimal timing of coronary angiography (CAG) in high-risk patients with acute coronary syndrome without persisting ST-segment elevation (NST-ACS) remains undetermined. The NON-ST-Elevation Myocardial Infarction trial aimed to compare outcomes in NSTE-ACS patients randomized to acute CAG (STEMI-like approach) with patients randomized to medical therapy and subacute CAG. We randomized 496 patients with suspected NST-ACS based on symptoms and significant regional ST depressions and/or elevated point-of-care troponin T (POC-cTnT) (≥50 ng/l) to either acute CAG (<2 hours, n = 245) or subacute CAG (<72 hours, n = 251).

Everolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus.

Diabetes mellitus is associated with a higher risk of target lesion revascularization after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, Massachusetts) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore).

Extent of coronary artery disease is associated with myocardial infarction and mortality in patients with diabetes mellitus.

We examined risk of myocardial infarction and all-cause death associated with the extent of coronary artery disease ascertained by coronary angiography in patients with diabetes mellitus. We hypothesized that risks of myocardial infarction and death were associated with extent of coronary artery disease in diabetes patients. We conducted a cohort study of patients with type 1 and type 2 diabetes, who underwent coronary angiography from 2004 to 2012.