ReCre8 Trial: All-Comers Evaluation of PP-ZES vs. PF-AES Stents

Sep 25, 2018
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Authors:
Rozemeijer R, Stein M, Voskuil M, et al.
Citation:
Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent: (ReCre8): A Multicenter, Non-Inferiority Trial. Circulation 2018;Sep 22:[Epub ahead of print].
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What is the clinical efficacy and safety of the polymer-free amphilimus-eluting stents (PF-AES) as compared to latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES)?

Methods:

ReCre8 was a physician-initiated, prospective, multicenter, randomized, noninferiority trial, performed at three European Centers. All patients requiring percutaneous coronary intervention were randomized to PP-ZES or PF-AES stent after stratification for troponin status, and diabetes. Duration of dual antiplatelet therapy (DAPT) was 12 months for troponin-positive patients and 1 month for troponin-negative patients. The primary endpoint of the study was target-lesion failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12 months.

Results:

Among the study population of 1,491 patients, there was no difference in the primary endpoint (5.6% with PP-ZES vs. 6.2% with PF-AES; risk difference, 0.5%; upper limit one-sided 95% confidence interval, 2.6%; p for noninferiority = 0.0086). There was no difference in cardiac death (1.3% in each arm, p = 1.0), target-vessel myocardial infarction (2.4% vs. 2.3%, p = 0.87), and target-lesion revascularization (2.9% vs. 2.6%, p-value for difference, 0.75).

Conclusions:

The PF-AES stent was noninferior to PP-ZES with respect to target-lesion failure at 12 months in this large all-comers patient population.

Perspective:

The increase in late stent thrombosis observed with first-generation drug-eluting stents prompted multiple modifications to stent and drug delivery approaches. One such approach involves a stent that is polymer-free and releases the antiproliferative drugs by means of an amphiphilic carrier stored in abluminal wells. This study demonstrates noninferiority of this stent compared with the Resolute Integrity stent, suggesting an excellent outcome with either approach.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Diabetes Mellitus, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Sirolimus, Stents, Thrombosis, Troponin, Vascular Diseases


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