DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

Conditions

Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Coronary Artery Disease, Coronary Restenosis, Coronary Stenosis, Myocardial Infarction

Keywords

drug-eluting stent, Zotarolimus, Everolimus, all comers population, target vessel failure, coronary artery disease

Brief summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Tineke H. Pinxterhuis, Eline H. Ploumen, Carine J.M. Doggen, Daphne van Vliet, Marlies M. Kok et al. (12 authors)

European Heart Journal Open2024-12-24

10.1093/ehjopen/oeaf006

Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease.

Pinxterhuis TH, Ploumen EH, van Vliet D, Gert van Houwelingen K, Stoel MG, de Man FH, Hartmann M, Zocca P, Linssen GC, Geelkerken RH, Doggen CJ, von Birgelen C.

2024-03-263 citations

10.1016/j.atherosclerosis.2024.117488

Premature coronary artery disease in all-comers undergoing first PCI

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carl E. Schotborgh, Rutger L. Anthonio et al. (10 authors)

European Heart Journal2023-11-01

10.1093/eurheartj/ehad655.1342

First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents

Tineke H. Pinxterhuis, Eline H. Ploumen, Carine J.M. Doggen, Marc Hartmann, Carl E. Schotborgh et al. (12 authors)

European Heart Journal Acute Cardiovascular Care2023-08-224 citations

10.1093/ehjacc/zuad098

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

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carine J.M. Doggen, Carl E. Schotborgh et al. (13 authors)

Frontiers in Cardiovascular Medicine2023-06-195 citations

10.3389/fcvm.2023.1160201

Clinical outcome up to 2 years after percutaneous coronary intervention in all-comers with concomitant symptomatic peripheral arterial disease: a pooled analysis in 9,204 randomized trial participants

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carine J.M. Doggen, Carl E. Schotborgh et al. (14 authors)

European Heart Journal2022-10-01

10.1093/eurheartj/ehac544.2044

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS.

Hommels TM, Hermanides RS, Berta B, Fabris E, De Luca G, Ploumen EH, von Birgelen C, Kedhi E.

2020-10-021 citations

10.1186/s12933-020-01116-2

2925Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: insights from the DUTCH PEERS trial

Marije M. Löwik, Liefke C. van der Heijden, Marlies M. Kok, Paolo Zocca, Peter W. Danse et al. (12 authors)

European Heart Journal2017-08-011 citations

10.1093/eurheartj/ehx504.2925

Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial.

van der Heijden LC, Kok MM, Löwik MM, Danse PW, Jessurun GAJ, Hartmann M, Stoel MG, van Houwelingen KG, Hautvast RWM, Linssen GC, Doggen CJM, von Birgelen C.

2017-04-273 citations

10.1159/000464320

Small-vessel treatment with contemporary newer-generation drug-eluting coronary stents in all-comers: Insights from 2-year DUTCH PEERS (TWENTE II) randomized trial.

van der Heijden LC, Kok MM, Danse PW, Schramm AR, Hartmann M, Löwik MM, Linssen GC, Stoel MG, Doggen CJ, von Birgelen C.

2016-03-1752 citations

10.1016/j.ahj.2016.02.020

Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial.

von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Löwik MM, Linssen GC, Saïd SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K.

2013-10-31137 citations

10.1016/s0140-6736(13)62037-1

Interventions

DEVICEResolute Integrity (Zotarolimus-eluting stent)

Third generation drug-eluting stent

DEVICEPromus Element (Everolimus-eluting stent)

Third generation drug-eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Minimum age of 18 years; * Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement; * Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.

Exclusion criteria

* Participation in another randomized drug or device study before reaching primary endpoint; * Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period; * Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined; * Known pregnancy; * Life expectancy of less than 1 year.

Design outcomes

Primary

Measure	Time frame
Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization	1 year

Countries

Netherlands

Outcome results

None listed