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)

Hanim Sen, Ming Kai Lam, Marije M. Löwik, Peter W. Danse, Gillian A.J. Jessurun, K. Gert Van Houwelingen, Rutger L. Anthonio, R. Melvyn Tjon Joe Gin, Raymond W.M. Hautvast, J. W. Louwerenburg, Frits H.A.F. De Man, Martin G. Stoel, Liefke C. Van Der Heijden, Gerard C.M. Linssen, Maarten J. Ijzerman, Kenneth Tandjung, Carine J.M. Doggen, Clemens Von Birgelen*

*Corresponding author for this work

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Abstract

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. 

Methods:

The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations. 

Results:

The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03). 

Conclusions:

During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.

Original languageEnglish
Article number2003
Pages (from-to)889-899
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume8
Issue number7
DOIs
Publication statusPublished - Jun 2015
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2015 American College of Cardiology Foundation.

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