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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Catharina Hospital
RECRUITING
Eindhoven
Contact Information
Primary
K Teeuwen, MD, PhD
koen.teeuwen@catharinaziekenhuis.nl
+ 31 040 239 9111
Backup
K.A.J. Beek, MD
konrad.v.beek@catharinaziekenhuis.nl
+ 31 040 239 9111
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 12000
Treatments
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.
Sponsors
Leads: Cathreine BV
Collaborators: Medtronic

This content was sourced from clinicaltrials.gov