ArticlesThird-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
Introduction
Drug-eluting stents that counteract the development of restenosis by delivering antiproliferative drugs from polymer-based coatings have revolutionised the percutaneous treatment of obstructive coronary artery disease.1, 2 First-generation durable-polymer drug-eluting stents were made from bare-metal stent platforms with little flexibility and fairly plain permanent-polymer coatings, which were associated with an increased risk of late and very late stent thrombosis.3, 4 Second-generation drug-eluting stents with durable coatings that were more biocompatible than those of first-generation stents were then developed. These newer stents showed superior safety profiles in various clinical settings.5, 6, 7, 8, 9
Most recently, third-generation, durable-polymer-based drug-eluting stents were developed to answer the demand for more flexible and highly deliverable devices that can tackle very challenging coronary lesion and vessel anatomies, as are increasingly encountered in ageing western patient populations. Although the coatings of these stents contain the same established drug and durable polymer combinations as their second-generation counterparts, the design and material of their bare-metal stent platforms have been changed substantially.10, 11, 12, 13, 14 However, such changes might have the trade-off of reducing longitudinal stent stability,15, 16 which would account for the occurrence of longitudinal stent deformation that has been reported after contact between deployed stents and guiding catheters, balloon catheters, or other catheter-based devices.16, 17, 18, 19 Data so far reported about the incidence and clinical significance of longitudinal stent deformation have been conflicting.16, 17, 18, 19
A cobalt-chromium-based zotarolimus-eluting stent, made from a single sinusoidal-formed wire (Resolute Integrity, Medtronic, Santa Rosa, CA, USA), and a laser-cut platinum-chromium-based everolimus-eluting stent (Promus Element, Boston Scientific, Natick, MA, USA), are two such third-generation drug-eluting stents.11, 12, 13, 14 Although clinical outcome data for the use of the Promus Element stent in patients with mild-to-moderate clinical risk have been reported,11, 19 no such data are available for the Resolute Integrity stent. We aimed to compare clinical outcomes from the use of these two third-generation drug-eluting stents in a broad population of all-comer patients.
Section snippets
Study design and patients
We undertook a randomised trial entitled DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): randomized multicenter trial in all comers population Treated Within Eastern NeThErlands II (TWENTE II) at four Dutch centres (Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede; Rijnstate Hospital, Arnhem; Scheper Hospital, Emmen; and Medisch Centrum Alkmaar, Alkmaar). In this investigator-initiated, single-blind, multicentre, randomised, two-arm,
Results
Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, aged 21–91 years, with 2371 target lesions, were enrolled and randomly assigned to treatment with third-generation zotarolimus-eluting Resolute Integrity stents (906 patients, 1205 lesions) or everolimus-eluting Promus Element stents (905 patients, 1166 lesions; figure 1). One patient from the zotarolimus-eluting stent group withdrew consent after 1 day; therefore, baseline data and interventional results are reported for
Discussion
DUTCH PEERS is the first randomised comparison of the third-generation zotarolimus-eluting Resolute Integrity and everolimus-eluting Promus Element stents. It is also the first trial ever to investigate the Resolute Integrity stent. In this all-comer patient population, no significant difference was seen between stent groups in the primary endpoint of target-vessel failure at 12-month follow-up. As a result, the zotarolimus-eluting Resolute Integrity stent met the criterion of non-inferiority
References (32)
- et al.
Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis
Lancet
(2012) - et al.
Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial
Lancet
(2010) - et al.
A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial
J Am Coll Cardiol
(2012) - et al.
Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial
J Am Coll Cardiol
(2011) - et al.
DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population
Am Heart J
(2012) - et al.
A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a prospective, randomized, multicenter trial to assess an everolimus-eluting coronary stent system [PROMUS Element] for the treatment of up to two de novo coronary artery lesions) trial
J Am Coll Cardiol
(2011) - et al.
Stent longitudinal integrity bench insights into a clinical problem
JACC Cardiovasc Interv
(2011) - et al.
Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial
J Am Coll Cardiol
(2013) - et al.
Survival plots of time-to-event outcomes in clinical trials: good practice and pitfalls
Lancet
(2002) - 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)
Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial
Lancet
Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial
Lancet
Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents
N Engl J Med
Drug-eluting coronary-artery stents
N Engl J Med
Coating irregularities of durable polymer-based drug-eluting stents as assessed by scanning electron microscopy
EuroIntervention
Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease
N Engl J Med
Cited by (164)
Small Coronary Vessel Size: A Great Need for a Standardized Definition
2022, Journal of the Society for Cardiovascular Angiography and InterventionsCurrent status and future direction of metallic and polymeric materials for advanced vascular stents
2022, Progress in Materials ScienceInvasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting
2024, Cardiovascular Intervention and Therapeutics