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

Florim Cuculi, Matthias Bossard, Wojciech Zasada, Federico Moccetti, Michiel Voskuil, Mathias Wolfrum, Krzysztof Piotr Malinowski, Stefan Toggweiler, Richard Kobza, Florim Cuculi, Matthias Bossard, Wojciech Zasada, Federico Moccetti, Michiel Voskuil, Mathias Wolfrum, Krzysztof Piotr Malinowski, Stefan Toggweiler, Richard Kobza

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.

Keywords: Angioplasty; Lesion preparation; Optical coherence tomography; Percutaneous coronary intervention; Scaffold; Stent.

Conflict of interest statement

Competing interests: FC has received speaker fees and research grants from Abbott Vascular and SIS Medical. RK has received institutional grant support from Abbott, Biotronik, Biosense Webster, Boston Scientific, Medtronic and SIS Medical. None of the other authors had any relevant conflicts of interest.

© 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.

Figures

Figure 1
Figure 1
Study flow chart of the Pre-NC and OPRENBIS trials. NC, non-compliant; SCB, semi-compliant balloon.
Figure 2
Figure 2
Stent expansion index (SEI) assessed by optical coherence tomography (A) after device implantation and postdilatation in the semi-compliant balloon (SCB) group vs non-compliant balloon (NCB) group, (B) SEI after predilatation and postdilatation in the NCB group and (C) SEI after predilatation and postdilatation in the SCB group.

References

    1. Kastrati A, Schömig A, Elezi S, et al. . Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 1997;30:1428–36. 10.1016/S0735-1097(97)00334-3
    1. Fujii K, Carlier SG, Mintz GS, et al. . Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 2005;45:995–8. 10.1016/j.jacc.2004.12.066
    1. Attizzani GF, Capodanno D, Ohno Y, et al. . Mechanisms, pathophysiology, and clinical aspects of incomplete stent apposition. J Am Coll Cardiol 2014;63:1355–67. 10.1016/j.jacc.2014.01.019
    1. de Ribamar Costa J, Mintz GS, Carlier SG, et al. . Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol 2007;100:812–7. 10.1016/j.amjcard.2007.03.100
    1. Jujo K, Saito K, Ishida I, et al. . Intimal disruption affects drug-eluting cobalt-chromium stent expansion: a randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol 2016;221:23–31. 10.1016/j.ijcard.2016.07.002
    1. Fabris E, Caiazzo G, Kilic ID, et al. . Is high pressure postdilation safe in bioresorbable vascular scaffolds? optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres. Catheter Cardiovasc Interv 2016;87:839–46. 10.1002/ccd.26222
    1. Secco GG, Ghione M, Mattesini A, et al. . Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon. EuroIntervention 2016;12:359–65. 10.4244/EIJY15M06_04
    1. Felekos I, Karamasis GV, Pavlidis AN. When everything else fails: high-pressure balloon for undilatable lesions. Cardiovasc Revasc Med 2018;19:306–13. 10.1016/j.carrev.2017.11.004
    1. Adriaenssens T, Joner M, Godschalk TC, et al. . Byrne RA and prevention of late stent thrombosis by an interdisciplinary global European effort I. optical coherence tomography findings in patients with coronary stent thrombosis: a report of the prestige Consortium (prevention of late stent thrombosis by an interdisciplinary global European effort). Circulation 2017;136:1007–21.
    1. Cutlip DE, Windecker S, Mehran R, et al. . Serruys PW and academic research C. clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51.
    1. Thygesen K, Alpert JS, Jaffe AS, et al. . Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551–67. 10.1093/eurheartj/ehs184
    1. Park S-J, Ahn J-M, Kim Y-H, et al. . Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med 2015;372:1204–12. 10.1056/NEJMoa1415447
    1. Kodumuri V, Balasubramanian S, Vij A, et al. . A meta-analysis comparing percutaneous coronary intervention with drug-eluting stents versus coronary artery bypass grafting in unprotected left main disease. Am J Cardiol 2018;121:924–33. 10.1016/j.amjcard.2017.12.039
    1. Head SJ, Milojevic M, Daemen J, et al. . Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet 2018;391:939–48. 10.1016/S0140-6736(18)30423-9
    1. Doi H, Maehara A, Mintz GS, et al. . Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the Taxus IV, V, and VI and Taxus atlas workhorse, long lesion, and direct stent trials. JACC Cardiovasc Interv 2009;2:1269–75. 10.1016/j.jcin.2009.10.005
    1. Dangas GD, Claessen BE, Caixeta A, et al. . In-Stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010;56:1897–907. 10.1016/j.jacc.2010.07.028
    1. Ong DS, Jang I-K. Causes, assessment, and treatment of stent thrombosis--intravascular imaging insights. Nat Rev Cardiol 2015;12:325–36. 10.1038/nrcardio.2015.32
    1. Cuculi F, Puricel S, Jamshidi P, et al. . Optical coherence tomography findings in Bioresorbable vascular scaffolds thrombosis. Circ Cardiovasc Interv 2015;8:e002518 10.1161/CIRCINTERVENTIONS.114.002518
    1. Souteyrand G, Amabile N, Mangin L, et al. . Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the National PESTO French registry. Eur Heart J 2016;37:1208–16. 10.1093/eurheartj/ehv711
    1. Karjalainen PP, Niemelä M, Laine M, et al. . Usefulness of post-coronary dilation to prevent recurrent myocardial infarction in patients treated with percutaneous coronary intervention for acute coronary syndrome (from the base ACS trial). Am J Cardiol 2017;119:345–50. 10.1016/j.amjcard.2016.09.057
    1. Mintz GS. Intravascular ultrasound and outcomes after drug-eluting stent implantation. Coron Artery Dis 2017;28:346–52. 10.1097/MCA.0000000000000483
    1. Kitahara H, Okada K, Kimura T, et al. . Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in de novo coronary lesions. Circ Cardiovasc Interv 2017;10:e004795 10.1161/CIRCINTERVENTIONS.116.004795
    1. Raja Y, Routledge HC, Doshi SN. A noncompliant, high pressure balloon to manage undilatable coronary lesions. Catheter Cardiovasc Interv 2010;75:NA–73. 10.1002/ccd.22430
    1. Hong S-J, Ahn C-M, Shin D-H, et al. . Effect of adjunct balloon dilation after long everolimus-eluting stent deployment on major adverse cardiac events. Korean Circ J 2017;47:694–704. 10.4070/kcj.2017.0016

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi