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Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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vol. 14
Short communication

Mehran in-stent restenosis classification adapted for coronary bifurcations: the impact on 4-year follow-up from randomized clinical studies POLBOS I and II

Jacek Bil, Robert J. Gil, Adam Kern, Luis A. Inigo-Garcia, Radosław Formuszewicz, Sławomir Dobrzycki

Adv Interv Cardiol 2018; 14, 3 (53): 299–303
Online publish date: 2018/09/21
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Percutaneous coronary interventions (PCI) with stent deployment are the most widely performed procedures in the therapy of symptomatic coronary artery disease (CAD). In the last three decades, PCI with stent deployment has changed the practice in cardiology. Drug-eluting stents (DES) significantly reduced in-stent restenosis (ISR) rates – one of the key limitations of bare metal stents. In consequence, DES were rapidly and widely accepted, which allowed more complex coronary interventions, including bifurcations, to be performed. Nevertheless, ISR has remained a troublesome late stent complication [1, 2].
Multiple classification systems addressed the problem of ISR severity. The Mehran classification is a morphologic system which divides ISR lesions into four patterns: from focal pattern I when ISR is ≤ 10 mm in length within the stent to pattern IV when the ISR is the cause of vessel occlusion [3].


The aim of our study was to propose a modified Mehran restenosis classification adapted to bifurcation lesions and preliminarily assess its value in the 4-year follow-up on data from two randomized studies, POLBOS I and POLBOS II, that compared dedicated bifurcation BiOSS stents with regular drug-eluting stents (rDES) [4–6].

Material and methods

POLBOS I and POLBOS II were international, multi-center, randomized, open-label, controlled studies described previously [4, 6]. Briefly, the inclusion criteria were: stable CAD or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), age ≥ 18 years, de novo coronary bifurcation lesion, main vessel (MV) diameter ≥ 2.5 mm, and side branch (SB) diameter ≥ 2.0 mm on visual estimation. The Institutional Review Board of each participating center approved the study protocol (ClinicalTrials.gov Identifier: POLBOS I – NCT02192840, POLBOS II – NCT02198300).
After providing written informed consent, patients were randomly assigned to one of two treatment strategies: BiOSS Expert (in POLBOS I)/BiOSS LIM (in POLBOS II) stent implantation or rDES implantation [7–9]. Provisional T-stenting was the default strategy. The stent nominal diameter was chosen according to the distal reference, and after stent deployment, the proximal part of the stent was optimized, if needed, with proximal optimization technique (POT) to obtain the proper apposition.
Clinical follow-up was performed by telephone 1, 6, 12, 24, 36 and 48 months after the...

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