Final 5-Year Outcome of DUTCH PEERS (TWENTE II) Trial

Mar 06, 2018
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Authors:
Zocca P, Kok MM, Tandjung K, et al.
Citation:
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. JACC Cardiovasc Interv 2018;11:462-469.
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What are the 5-year outcomes after treating an all-comers population with cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) versus platinum chromium-based PROMUS Element everolimus-eluting stents (EES)?

Methods:

The investigators reported the 5-year outcomes of the DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial. This was a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that investigated the Resolute Integrity ZES with EES. In total, 1,811 patients were 1:1 randomized to ZES versus EES. The authors performed a prespecified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint, target vessel failure (TVF), was a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.

Results:

Five-year clinical follow-up data were available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).

Conclusions:

The authors concluded that at 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy.

Perspective:

The present study reports the final 5-year clinical outcome of the randomized DUTCH PEERS trial, which assessed the safety and efficacy of the Resolute Integrity ZES versus PROMUS Element EES in treating all-comer patients, and reports similar outcomes with both devices. These results are consistent with the main outcome of the DUTCH PEERS trial at 1-year follow-up, which demonstrated noninferiority of ZES versus EES. The 5-year follow-up of the DUTCH PEERS trial also supports the favorable 3-year findings of the PLATINUM trial in a much broader patient population, and the findings are consistent with long-term outcomes in the COMPARE II trial. These data should help benchmark the long-term outcome of current-generation drug-eluting stents, and help compare with newer devices.

Keywords: Chromium, Cobalt, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Platinum, Polymers, Sirolimus, Stents, Thrombosis


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