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      Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography

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          Abstract

          Introduction

          Stent underexpansion is a predictor of in-stent-restenosis and stent thrombosis. Semi-compliant balloons (SCBs) are generally used for lesion preparation. It remains unknown whether routine predilatation using non-compliant balloons (NCBs) improves stent expansion in ordinary coronary lesions.

          Methods

          The PREdilatation by high-pressure NC balloon catheter for better vessel preparation and Optimal lesion preparation with non-compliant balloons for the implantation of bioresorbable vascular scaffolds studies randomised patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs. Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications were compared.

          Results

          We enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively. Predilatation pressure was higher in the NCB group (24±7 atmospheres (atm) vs 14±3 atm, p<0.0001). Postdilatation using NCBs was performed in 41 (76%) lesions vs 46 (82%) lesions pretreated with NCBs versus SCBs (p=0.57). Similar pressures were used for postdilatation with NCB in both groups (23±8 atm vs 23±9 atm, p=0.65). SEI after stent implantation was 0.88±0.13 in the NCB vs 0.85±0.14 in the SCB group (p=0.18). After postdilatation, SEI increased to 0.94±0.13 in the NCB group vs 0.88±0.13 in the SCB group (p=0.02). No relevant complications occurred.

          Conclusions

          In simple coronary lesions, predilatation/postdilatation with NCBs at high pressures appears to result in better scaffold and stent expansion. Using SCBs only for predilatation might lead to inadequate stent expansion and postdilatation with NCBs might only partially correct this. Predilatation and postdilatation using NCBs at high pressure is safe.

          Trial registration number

          ClinicalTrials.gov no. NCT03518645.

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          Most cited references19

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          In-stent restenosis in the drug-eluting stent era.

          The introduction of the drug-eluting stent (DES) proved to be an important step forward in reducing rates of restenosis and target lesion revascularization after percutaneous coronary intervention. However, the rapid implementation of DES in standard practice and expansion of the indications for percutaneous coronary intervention to high-risk patients and complex lesions also introduced a new problem: DES in-stent restenosis (ISR), which occurs in 3% to 20% of patients, depending on patient and lesion characteristics and DES type. The clinical presentation of DES ISR is usually recurrent angina, but some patients present with acute coronary syndrome. Mechanisms of DES ISR can be biological, mechanical, and technical, and its pattern is predominantly focal. Intravascular imaging can assist in defining the mechanism and selecting treatment modalities. Based upon the current available evidence, an algorithm for the treatment approaches to DES restenosis is proposed. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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            Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry.

            Angiography has limited value for identifying the causes of stent thrombosis (ST). We studied a large cohort of patients by optical coherence tomography (OCT) to explore ST characteristics and mechanisms.
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              Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis

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                Author and article information

                Journal
                Open Heart
                Open Heart
                openhrt
                openheart
                Open Heart
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2053-3624
                2020
                23 January 2020
                : 7
                : 1
                Affiliations
                [1 ] departmentCardiology Division, Heart Center , Luzerner Kantonsspital , Luzern, Switzerland
                [2 ] Krakow Cardiovascular Research Institute (KCRI) , Krakow, Poland
                [3 ] departmentDepartment of Cardiology , UMC Utrecht , Utrecht, The Netherlands
                [4 ] departmentInstitute of Public Health, Faculty of Health Sciences , Jagiellonian University Medical College , Kraków, Poland
                Author notes
                [Correspondence to ] Dr Matthias Bossard; matthias.bossard@ 123456gmx.ch ; Dr Florim Cuculi; florim.cuculi@ 123456luks.ch

                FC and MB are joint first authors.

                Article
                openhrt-2019-001204
                10.1136/openhrt-2019-001204
                6999685
                5f210bfd-bbef-48de-a950-c68c4db763b0
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                Product
                Funding
                Funded by: SIS (Swiss Interventional Systems);
                Categories
                Interventional Cardiology
                1506
                Original research
                Custom metadata
                unlocked

                angioplasty,percutaneous coronary intervention,stent,scaffold,lesion preparation,optical coherence tomography

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