Original article
Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized TrialResultados de los stents Resolute Integrity y Promus Element en el infarto de miocardio: análisis del ensayo aleatorizado DUTCH PEERS (TWENTE II)

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Abstract

Introduction and objectives

In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI.

Methods

The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non—ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization.

Results

Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non—ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56).

Conclusions

Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.

Resumen

Introducción y objetivos

En el infarto agudo de miocardio (IAM), los nuevos stents farmacoactivos (SFA) de alta liberación de fármacos pueden ser de especial utilidad, ya que su diseño flexible podría reducir los traumatismos inducidos por el dispositivo en la lesión culpable. El objetivo del estudio es evaluar la seguridad y la eficacia de las intervenciones coronarias percutáneas con 2 nuevos SFA con recubrimiento de polímero duradero en pacientes con IAM.

Métodos

El ensayo multicéntrico prospectivo y aleatorizado DUTCH PEERS (TWENTE II) compara los stents Resolute Integrity y Promus Element en 1.811 pacientes consecutivos no seleccionados (all-comers); a 817 (45,1%) de ellos se los trató por un IAM con o sin elevación del segmento ST y se dispuso de un seguimiento de 2 años del 99,9% de los casos. El objetivo clínico principal es el fallo del vaso diana (FVD), que consiste en la combinación de muerte cardiaca, infarto de miocardio relacionado con el vaso diana y revascularización del vaso diana.

Resultados

De los 817 pacientes tratados por un IAM, 421 (51,5%) recibieron un stent Resolute Integrity y 396 (48,5%), un Promus Element. A los 2 años de seguimiento, las tasas de FVD (el 7,4 frente al 6,1%; p = 0,45), revascularización de la lesión diana (el 3,1 frente al 2,8%; p = 0,79) y trombosis del stent definitiva (el 1,0 frente al 0,5%; p = 0,69) fueron bajas en los 2 grupos de stents. En consonancia con estos resultados obtenidos en el conjunto de los pacientes con IAM, los resultados observados con los 2 SFA fueron favorables y similares con ambos dispositivos en 370 pacientes con IAM con elevación del segmento ST (FVD, el 5,1 frente al 4,9%; p = 0,81) y 447 pacientes con IAM sin elevación del segmento ST (FVD, el 9,0 frente al 7,5%; p = 0,56).

Conclusiones

Los stents Resolute Integrity y Promus Element fueron seguros y eficaces en el tratamiento de pacientes con IAM. Los datos de seguimiento a 2 años subrayan la seguridad de emplear estos dispositivos en este contexto clínico específico.

Section snippets

INTRODUCTION

Early-generation drug-eluting stents (DES) were associated with an increased risk of late and very late stent thrombosis, which was particularly high after percutaneous coronary interventions (PCI) for acute myocardial infarction (MI), compared with bare metal stents.1, 2, 3, 4, 5 New-generation DES (also known as second-generation DES) have more biocompatible durable polymer-based coatings and showed more favorable safety profiles in broad patient populations6, 7, 8, 9, 10, 11, 12, 13 and in

Study Design and Patient Population

In the present substudy of the randomized, patient-blinded, multicenter DUTCH PEERS (TWENTE II) all-comer trial (ClinicalTrials.gov NCT01331707),20 we analyzed post-hoc the data of all patients who presented with acute MI at the time of enrolment. The study design and procedures of the investigator-initiated DUTCH PEERS trial have previously been described in detail20 and the 2-year clinical outcome has been reported.22 In brief, between November 25, 2010 and May 24, 2012, DUTCH PEERS enrolled

Characteristics of Patients, Lesions, and Interventional Procedures

Of all DUTCH PEERS trial participants, 817 presented with acute MI and were assessed in the present study. A total of 421 (51.5%) patients were allocated to treatment with Resolute Integrity stents and 396 (48.5%) to treatment with Promus Element stents; 370 (45.3%) patients presented with STEMI, treated by primary PCI (no rescue PCI), while 447 (54.7%) patients had NSTEMI. Of all patients with NSTEMI, 72 (16.1%) presented with nonpatent culprit vessels, and 132 (29.5%) had impaired coronary

DISCUSSION

In the present substudy of the DUTCH PEERS trial, both Resolute Integrity and Promus Element stents were safe and efficacious for treating patients with acute MI. At the 2-year follow-up, the rates of stent thrombosis were low for both devices. The observed low event rates in this acute MI population were mainly attributable to the DES used and not to the concomitant pharmacological therapy, which was quite traditional.28 In addition, we observed no significant between-stent differences in

CONCLUSIONS

Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.

Funding

The investigator-initiated, randomized DUTCH PEERS trial was funded by equal research grants from Boston Scientific and Medtronic.

Conflicts of interest

C. von Birgelen has been a consultant to Medtronic and Boston Scientific; he received lecture fees from AstraZeneca and MSD. His institution received research grants from AstraZeneca, Biotronik, Boston Scientific, and Medtronic. All other authors declare that they had no conflicts of interest.

WHAT IS KNOWN ABOUT THE TOPIC?

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    First-generation coronary DES were associated with an increased adverse event risk that was particularly high after interventions for acute MI.

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    Second-generation DES were more biocompatible and showed more

References (41)

  • T. Palmerini et al.

    Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction: evidence from a comprehensive network meta-analysis

    J Am Coll Cardiol.

    (2013)
  • P. Widimsky et al.

    Long-term outcomes of patients receiving zotarolimus-eluting stents in ST elevation myocardial infarction, non-ST elevation acute coronary syndrome, and stable angina: data from the Resolute program

    Int J Cardiol.

    (2013)
  • C. Von Birgelen et al.

    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

    Lancet.

    (2014)
  • M. Nakano et al.

    Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study

    J Am Coll Cardiol

    (2014)
  • H. Sen et al.

    Clinical events and patient-reported chest pain in all-comers treated with Resolute Integrity and Promus Element stents: two-year follow-up of the randomized DUTCH PEERS (TWENTE II) trial

    J Am Coll Cardiol Intv.

    (2015)
  • I.T. Meredith et al.

    Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial)

    Am J Cardiol.

    (2014)
  • J.M. De la Torre Hernández et al.

    Dual antiplatelet therapy for 6 months vs 12 months after new-generation drug-eluting stent implantation: Matched analysis of ESTROFA-DAPT and ESTROFA-2

    Rev Esp Cardiol.

    (2015)
  • S. Windecker et al.

    Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial

    Lancet.

    (2008)
  • K.W. Park et al.

    A Randomized Comparison of Platinum Chromium-Based Everolimus-Eluting Stents Versus Cobalt Chromium-Based Zotarolimus-Eluting Stents in All-Comers Receiving Percutaneous Coronary Intervention: HOST-ASSURE, a Randomized, Controlled, Noninferiority Trial

    J Am Coll Cardiol.

    (2014)
  • P.C. Smits et al.

    Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial

    Lancet.

    (2013)

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    © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.