RecruitingNCT06558474

Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation

Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice


Sponsor

Cathreine BV

Enrollment

12,000 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment. Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear. For this reason, the OPTIMIZE PCI was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • All patients >18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project

Exclusion Criteria1

  • \- If a patient has multiple PCIs within 365 days, only the first procedure is included.

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Interventions

BEHAVIORALLiberal post-dilatation strategy during PCI

A liberal post-dilatation strategy for stent optimization during PCI will be implemented in multiple centers in the Netherlands. This include an increase of post-dilatation use of at least 20% per operator, or a percentage of post-dilatation of at least 85%. Operators will be asked to enforce a very low threshold for post-dilatation in general, with a mandatory HPNC post-dilatation for the following indications: * In case of any calcification * Delta of ≥ 0.5mm between the distal and proximal reference diameter of the treated coronary segment * Stent length \>24 mm * Signs of incomplete stentframe-deployment on angiography or StentBoost * In case of CTO * In case of bifurcation PCI (Left main and non-left main) * Proximal Optimisation Technique (POT) with NC balloon * Final Kissing Balloon dilatation (FKB) with preferentially first sequential high-pressure inflations and final low pressure kiss both with NC balloons


Locations(1)

Catharina Hospital

Eindhoven, North Brabant, Netherlands

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NCT06558474


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