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

NCT06558474 | Recruiting

• 1 other identifier: CathreineBV
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; coronary artery disease; stent optimization; post-dilatation

Outcome Measures

Primary Outcomes (1)

• Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality

  The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.

  30 day

Secondary Outcomes (3)

• All cause mortality

  30 days, 1 year

• Target vessel revascularization

  30 days and 1 year

• Myocardial infarction

  30 day

Study Arms (2)

Pre-intervention/implementation cohort

In the first phase, data additional to the national PCI registry will be analyzed retrospectively from all patients receiving PCI from January 2021 to January 2022. Data on the percentage of use of post-dilatation using high-pressure non-compliant (HPNC) balloon by the individual interventional cardiologist will be collected. This will establish a benchmark from which individual interventional cardiologists must increase their use of post-dilatation.

Post-intervention/implementation cohort

During this implementation phase, all individual PCI operators of the participating centres will be informed to liberally use post-dilatation for stent optimization during PCI. Operators are requested to increase their use of post-dilatation with at least 20% or use post-diltation in at least 85% of the PCI's. Throughout the project, individual participating operators will receive individual feedback on the percentage use of post-dilatation with prospective data collection after 2, 4, 6, 9 and 12 months. Based on this result, the implementation process will be refined as necessary. The duration of this phase will be approximately 1 year per centre. Eventually a retrospective observational anlaysis, comparing the two cohorts, will be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.

Behavioral: Liberal post-dilatation strategy during PCI

Interventions

Liberal post-dilatation strategy during PCI BEHAVIORAL

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

Post-intervention/implementation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population exists of patients registered in our national PCI registration of the Netherlands Heart Registration after receiving PCI. All indications are included (ACS and non-ACS, OHCA, cardiogenic shock), resulting in an all-comer population

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cathreine BV: lead
• Medtronic: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

Related Publications (2)

• van Beek KAJ, Timmermans MJC, Derks L, Cheng JM, Kraaijeveld AO, Arkenbout EK, Schotborgh CE, Brouwer J, Claessen BE, Lipsic E, Polad J, van Nunen LX, Sjauw K, van Veghel D, Tonino PA, Teeuwen K; 'on behalf of the PCI registration committee of The Netherlands Heart Registration'. Contemporary Use of Post-Dilatation for Stent Optimization During Percutaneous Coronary Intervention; Results From the Netherlands Heart Registration. Catheter Cardiovasc Interv. 2025 Mar;105(4):870-877. doi: 10.1002/ccd.31404. Epub 2025 Jan 8.

  PMID: 39777867 BACKGROUND

• Slingerland SR, van Beek KAJ, Schulz DN, van Steenbergen GJ, Brouwer T, Stoel M, Vlaar PJ, Tonino PA, Dekker L, van Nunen LX, Teeuwen K, van Veghel D. Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes? Hellenic J Cardiol. 2025 Mar-Apr;82:26-33. doi: 10.1016/j.hjc.2023.11.004. Epub 2023 Nov 16.

  PMID: 37979617 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

K Teeuwen, MD, PhD

CONTACT

+ 31 040 239 9111; koen.teeuwen@catharinaziekenhuis.nl

K.A.J. Beek, MD

CONTACT

+ 31 040 239 9111; konrad.v.beek@catharinaziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

NL (1)