Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Cuculi, Florim, Bossard, Matthias, Zasada, Wojciech, Moccetti, Federico, Voskuil, Michiel, Wolfrum, Mathias, Malinowski, Krzysztof Piotr, Toggweiler, Stefan, Kobza, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999685/
https://www.ncbi.nlm.nih.gov/pubmed/32076567
http://dx.doi.org/10.1136/openhrt-2019-001204
_version_ 1783493953118535680
author Cuculi, Florim
Bossard, Matthias
Zasada, Wojciech
Moccetti, Federico
Voskuil, Michiel
Wolfrum, Mathias
Malinowski, Krzysztof Piotr
Toggweiler, Stefan
Kobza, Richard
author_facet Cuculi, Florim
Bossard, Matthias
Zasada, Wojciech
Moccetti, Federico
Voskuil, Michiel
Wolfrum, Mathias
Malinowski, Krzysztof Piotr
Toggweiler, Stefan
Kobza, Richard
author_sort Cuculi, Florim
collection PubMed
description 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.
format Online
Article
Text
id pubmed-6999685
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-69996852020-02-19 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 Cuculi, Florim Bossard, Matthias Zasada, Wojciech Moccetti, Federico Voskuil, Michiel Wolfrum, Mathias Malinowski, Krzysztof Piotr Toggweiler, Stefan Kobza, Richard Open Heart Interventional Cardiology 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. BMJ Publishing Group 2020-01-23 /pmc/articles/PMC6999685/ /pubmed/32076567 http://dx.doi.org/10.1136/openhrt-2019-001204 Text en © 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. http://creativecommons.org/licenses/by-nc/4.0/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/.
spellingShingle Interventional Cardiology
Cuculi, Florim
Bossard, Matthias
Zasada, Wojciech
Moccetti, Federico
Voskuil, Michiel
Wolfrum, Mathias
Malinowski, Krzysztof Piotr
Toggweiler, Stefan
Kobza, Richard
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Interventional Cardiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999685/
https://www.ncbi.nlm.nih.gov/pubmed/32076567
http://dx.doi.org/10.1136/openhrt-2019-001204
work_keys_str_mv AT cuculiflorim performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT bossardmatthias performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT zasadawojciech performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT moccettifederico performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT voskuilmichiel performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT wolfrummathias performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT malinowskikrzysztofpiotr performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT toggweilerstefan performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography
AT kobzarichard performingpercutaneouscoronaryinterventionswithpredilatationusingnoncompliantballoonsathighpressureversusconventionalsemicompliantballoonsinsightsfromtworandomisedstudiesusingopticalcoherencetomography