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Open Access Study protocol

A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

Koen Teeuwen1*, Tom Adriaenssens2, Ben JL Van den Branden3, José PS Henriques4, Rene J Van der Schaaf5, Jacques J Koolen6, Paul HMJ Vermeersch7, Mike AR Bosschaert1, Jan GP Tijssen3 and Maarten J Suttorp1

Author Affiliations

1 Department of Cardiology, St. Antonius Hospital, Koekoekslaan1, 3435 CM, Nieuwegein, the Netherlands

2 Department of Cardiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

3 Department of Cardiology, Amphia Hospital, Molengracht 21, 4818 CK, Breda, the Netherlands

4 Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands

5 Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Oosterpark 9, 1091 AC, Amsterdam, the Netherlands

6 Department of Cardiology, Catharina Hospital, Michalangelolaan 2, 6523 EJ, Eindhoven, the Netherlands

7 Department of Cardiology, Middelheim Hospital, Lindendreef 1, 2020, Antwerpen, Belgium

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Trials 2012, 13:240  doi:10.1186/1745-6215-13-240

Published: 15 December 2012

Abstract

Background

Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO.

Methods/Design

The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events.

Trial registration

Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.

Keywords:
Chronic total occlusion; Drug-eluting stent; Angioplasty