Optimization of Percutaenous Coronary Intervention with Liberal Use of Post-dilatation
- Conditions
- Coronary Artery Disease
- Interventions
- Behavioral: Liberal post-dilatation strategy during PCI
- Registration Number
- NCT06558474
- Lead Sponsor
- Cathreine BV
- 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.
- Detailed Description
The Netherlands Heart Registration (NHR) is an independent organization in which Dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including PCI. Data provided to the NHR are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. Multiple audits are conducted annually by the NHR for data validation and verification. A waiver for informed consent for analysis with the data of the NHR data registry is obtained.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12000
- 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
- If a patient has multiple PCIs within 365 days, only the first procedure is included.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post-intervention/implementation cohort Liberal post-dilatation strategy during PCI 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 MACE.
- Primary Outcome Measures
Name Time Method Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality 30 day The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.
- Secondary Outcome Measures
Name Time Method All cause mortality 30 days, 1 year all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.
Target vessel revascularization 30 days and 1 year Target vessel revascularization, defined as a revascularization by percutaneous coronary intervention or coronary artery bypass grafting in the same vessel(s) that had been treated at the index procedure, excluding staged procedures.
Myocardial infarction 30 day Myocardial infarction, defined as an increase and/or decrease in one or more cardiac biomarkers by at least one value above the 99th percentile of the upper limit where at least one of the following symptoms is present: 1) symptoms appropriate to ischemia, 2) new significant ST-segment or T-wave abnormalities or bundle branch block, 3) development of pathological Q-waves on the electrocardiogram (ECG), 4) imaging demonstrated new loss of viable myocardial tissue or new wall motion abnormalities, 5) identification of intracoronary thrombus on angiography or autopsy.
Trial Locations
- Locations (1)
Catharina Hospital
🇳🇱Eindhoven, North- Brabant, Netherlands