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.

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.

Three-year clinical outcome in all-comers with "silent" diabetes, prediabetes, or normoglycemia, treated with contemporary coronary drug-eluting stents: From the BIO-RESORT Silent Diabetes study.

Background: Patients with coronary disease may have unknown diabetes or prediabetes. We evaluated 3-year outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) in patients with silent diabetes, prediabetes, and normoglycemia.

Methods: All BIO-RESORT trial (NCT01674803) participants without known diabetes, enrolled at our center, were invited for oral glucose tolerance testing (OGTT) and measurements of fasting plasma glucose and glycated hemoglobin (HbA1c).

Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.

Importance: Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.

Objective: To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.

High bleeding risk patients with acute coronary syndromes treated with contemporary drug-eluting stents and Clopidogrel or Ticagrelor: Insights from CHANGE DAPT.

Background: The prospective observational CHANGE DAPT study compared clopidogrel versus ticagrelor-based dual antiplatelet (DAPT) regimens in consecutive patients with acute coronary syndrome (ACS), treated with percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES). During the ticagrelor period (TP, May 2014-August 2015) there were more major bleedings than during the clopidogrel period (CP, December 2012-April 2014).

Methods And Results: To evaluate whether the excess of major bleedings during TP may be limited to high bleeding risk (HBR) patients, we performed an explorative analysis of all 2062 CHANGE DAPT participants, of whom 547(26.

5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial.

Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).

Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.

"Silent" Diabetes and Clinical Outcome After Treatment With Contemporary Drug-Eluting Stents: The BIO-RESORT Silent Diabetes Study.

Objectives: This study sought to assess the prevalence and clinical impact of silent diabetes and pre-diabetes in "nondiabetic" percutaneous coronary intervention (PCI) all-comers.

Background: Patients with undetected and thus untreated (silent) diabetes may have higher event risks after PCI with contemporary drug-eluting stents (DES).

Methods: The BIO-RESORT Silent Diabetes study, performed at Thoraxcentrum Twente, is a substudy of the randomized multicenter BIO-RESORT (BIOdegradable Polymer and DuRable Polymer Drug-eluting Stents in an All COmeRs PopulaTion) trial (NCT01674803).

Long-Term Outcome of Consecutive Patients With Previous Coronary Bypass Surgery, Treated With Newer-Generation Drug-Eluting Stents.

Background: Percutaneous coronary intervention (PCI) in patients with previous coronary artery bypass grafting (CABG) is associated with adverse clinical events. Although newer generation drug-eluting stents showed favorable short-term safety profiles, there is a lack of long-term outcome data. We evaluated the impact of previous CABG on 5-year clinical outcomes of patients treated with PCI using newer-generation drug-eluting stents.

Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT.

Aims: Acute coronary syndrome (ACS) guidelines have been changed, favouring more potent antiplatelet drugs. We aimed to evaluate the safety and efficacy of a ticagrelor- instead of a clopidogrel-based primary dual antiplatelet (DAPT) regimen in ACS patients treated with newer-generation drug-eluting stents (DES).

Methods And Results: CHANGE DAPT (clinicaltrials.

Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported.

Objective: To assess 5-year safety and efficacy of 2 newer-generation DESs in randomized participants with non-ST-elevation acute coronary syndromes or stable angina and to evaluate long-term outcomes of nonenrolled eligible patients treated with the same DESs.

Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial.

Background: In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers.

Two-year outcome after treatment of severely calcified lesions with newer-generation drug-eluting stents in acute coronary syndromes: A patient-level pooled analysis from TWENTE and DUTCH PEERS.

Background: Data on medium-term outcome of patients with acute coronary syndrome (ACS), treated with newer-generation durable polymer drug-eluting stents (DES) in severely calcified coronary lesions, are scarce. We aimed to assess the impact of severe coronary lesion calcification on clinical outcome of patients with ACS, treated with newer-generation DES.

Methods: The TWENTE and DUTCH PEERS randomized trials comprise 1779 ACS patients, who were categorized into patients with versus without severe target lesion calcification.

Sex Difference in Chest Pain After Implantation of Newer Generation Coronary Drug-Eluting Stents: A Patient-Level Pooled Analysis From the TWENTE and DUTCH PEERS Trials.

Objectives: This study sought to assess sex differences in chest pain after percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES).

Background: Sex-based data on chest pain after PCI with DES are scarce.

Methods: The authors performed a patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials, in which patients were treated with newer generation permanent polymer-coated DES.

Patient preference regarding assessment of clinical follow-up after percutaneous coronary intervention: the PAPAYA study.

Aims: To keep patients in long-term clinical follow-up programmes after percutaneous coronary intervention (PCI), knowledge of the patient-preferred mode for follow-up assessment is crucial. We systematically assessed patient preference, and explored potential relationships with age and gender.

Methods And Results: In the prospective, observational PAPAYA study (ClinicalTrials.

Value of the SYNTAX score for periprocedural myocardial infarction according to WHO and the third universal definition of myocardial infarction: insights from the TWENTE trial.

Aims: The SYNTAX score is a tool to quantify the complexity of coronary artery disease. We investigated the relation between the SYNTAX score and the occurrence of a periprocedural myocardial infarction (PMI) according to the historical definition of the World Health Organization (WHO) and the recently updated universal definition of MI.

Methods And Results: The SYNTAX score was calculated in 1,243 patients enrolled in TWENTE, a randomised trial which assessed second-generation drug-eluting stents.

Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II).

Objectives: This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).

Background: For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.

Three-year clinical outcome of patients with bifurcation treatment with second-generation Resolute and Xience V stents in the randomized TWENTE trial.

Background: Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions.

Methods: We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifurcation lesions with 2 widely applied second-generation drug-eluting stents, the zotarolimus-eluting Resolute stent (Medtronic Inc, Santa Rosa, CA) and the everolimus-eluting Xience V stent (Abbott Vascular, Santa Clara, CA). Three-year follow-up was available in 99.

Assessment of the relation between initial culprit vessel patency in acute ST-elevation myocardial infarction and endothelial function.

Aims: To assess whether better endothelial function increases the likelihood of patients with acute ST-elevation myocardial infarction (STEMI) having initially patent culprit vessels. Clinical data on the relation between endothelial function and culprit vessel patency in STEMI patients are scarce.

Methods And Results: In this prospective cohort study in 71 patients with STEMI, endothelial function was non-invasively assessed by use of the reactive hyperaemia peripheral artery tonometry (RH-PAT) method at four to six weeks after the primary percutaneous coronary intervention (PPCI).

Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial.

Objective: To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only.

Background: Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. However, long-term outcome data from prospective studies with second-generation drug-eluting stent (DES) use in CTO lesions is scarce.

Clinical outcome following second-generation drug-eluting stent use for off-label versus on-label indications: insights from the two-year outcome of the TWENTE trial.

Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only.

Impact of previous coronary artery bypass surgery on clinical outcome after percutaneous interventions with second generation drug-eluting stents in TWENTE trial and non-enrolled TWENTE registry.

Background: Patients with previous coronary artery bypass grafting (CABG) who underwent percutaneous coronary intervention (PCI) have an increased repeat revascularization rate, but data on contemporary second-generation drug-eluting stents (DES) are scarce.

Methods: We evaluated 1-year clinical outcome following secondary revascularization by PCI in patients of the TWENTE trial and non-enrolled TWENTE registry, and compared patients with previous CABG versus patients without previous CABG.

Results: Of all 1709 consecutive patients, 202 (11.

Safety of second-generation drug-eluting stents three years after randomised use in the TWENTE trial.

Aims: To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.

Methods And Results: The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.

Coronary artery dominance and the risk of adverse clinical events following percutaneous coronary intervention: insights from the prospective, randomised TWENTE trial.

Aims: To investigate the prognostic value of coronary dominance for various adverse clinical events following the implantation of drug-eluting stents.

Methods And Results: We assessed two-year follow-up data of 1,387 patients from the randomised TWENTE trial. Based on the origin of the posterior descending coronary artery, coronary circulation was categorised into left and non-left dominance (i.

Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome.

Objective: To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents (ZES) versus Xience V everolimus-eluting stents (EES).

Background: Nowadays, many complex patients with coronary disease are treated with percutaneous coronary interventions, using drug-eluting stents (DES).

Methods: We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial, treated with second-generation Resolute ZES or Xience V EES.