About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Liberal post-dilatation strategy during PCI
BehavioralA 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
All cause mortality
all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.
Target vessel revascularization
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
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.
Sponsors and contacts
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Cathreine BV
Lead sponsor
Medtronic
Collaborator