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The primary objective is to evaluate whether a standard pre- and postdilatation (PSP strategy) of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease. The secondary clinical objective is to evaluate clinical cardiovascular outcomes in patients with stable coronary artery disease treated with the PSP strategy.
Rationale: Historically, when coronary stents were initially introduced, the standard and mandatory treatment of a significant stenosis was with pre-dilation prior to stent placement. In the 2000s, several studies found no significant difference in clinical outcome between the two different stent implantation techniques: direct stenting (DS) versus the conventional stenting after pre-dilation (CS). Consequently, the stent implantation technique has become "unprotocolarised", i.e. each operator has their own, individual set of reasons for applying or avoiding pre- and post-dilation in specific conditions. However, these trials do not apply to the current/modern clinical practice of coronary stenting. The current patient population undergoing percutaneous coronary intervention (PCI) cannot be compared to the population that was treated in the early 2000s. The same applies for stent design. Stents have undergone several major transformations in the last 20 years. Furthermore, the events rates after PCI have significantly decreased within the last decades due to better stent design and improved background pharmacological therapy.
Imaging studies have revealed that an optimal stent result is not achieved in a high percentage of stent implantations. Post-hoc studies have demonstrated that the optimization of the implantation technique could reduce adverse cardiac events over time. As a result of these findings, the PSP concept: Pre-dilation, Sizing and Post-dilation was introduced. Whether routine pre- and postdilatation compared to DS also results in optimal stent implantation in contemporary drug-eluting stents (DES) has not been investigated and, hence is currently unknown.
Objective: The primary objective is to evaluate whether a standard pre- and postdilatation (PSP strategy) of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease. The secondary clinical objective is to evaluate clinical cardiovascular outcomes in patients with stable coronary artery disease treated with the PSP strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSP technique | Experimental | The definitions of the PSP technique are:
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| Direct Stenting | Active Comparator | • The DES is directly placed without any lesion preparation and deployed at a pressure at the discretion of the operator. Ideally a pressure would be achieved in which angiographic expansion of the DES is complete (without significant dog-boning) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | percutaneous coronary intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Suboptimal stent results which is defined as a composite of major stent underexpansion and major edge dissection measured by OCT at lesion level directly after completion of the stent implantation according to the protocol | Stent malapposition (categorical variable) is defined as:
Edge dissections (categorical variable) will be presented as: • Dissections on OCT of ≥60 degrees of the circumference of the vessel at the site of dissection and ≥3 mm in length | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal stent area (MSA) (mm^2) | During procedure | |
| Acute recoil (percent) | assessed on coronary angiography | During procedure |
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Inclusion Criteria:
Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating operator.
The use of fractional flow reserve (FFR) or resting indices like iFR and RFR to assess lesion severity is encouraged.
Subject must be at least 18 years of age
Written consent to participate in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selina Vlieger, MSc | Contact | 0786541492 | s.vlieger@asz.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rohit Oemrawsingh, MD, PhD | Albert Schweitzer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Schweitzer hospital | Recruiting | Dordrecht | Netherlands |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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single-center, prospective, single blinded randomized clinical trial
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| Stent malapposition (percent) |
defined as frequency of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). |
| During procedure |
| Mean stent expansion (percent): | mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100 | During procedure |
| Intra-stent plaque protrusion and thrombus | defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut | During procedure |
| Post OCT stent result optimalization (percent) | composite of additional post-dilation and/or stent placements after OCT | During procedure |
| MACE | a composite of time- to-first event rate of cardiac death, target vessel MI, ischemia-driven target vessel revascularization (TVR) | 1-,3- and 5-year follow-up |
| Target Lesion Failure (TLF) | defined as cardiac death, target vessel- myocardial infarction and clinically indicated target lesion revascularization) | 1-,3- and 5-year follow-up |
| Target Vessel Failure (TVF) | defined as cardiac death, target vessel- myocardial infarction and clinically indicated target vessel revascularization | 1-,3- and 5-year follow-up |
| All cause mortality | 1-,3- and 5-year follow-up |
| Stent Thrombosis | definite or probable; Academic Research Consortium (ARC) definition | 1-,3- and 5-year follow-up |
| Cost-effectiveness analysis | total number of stent, balloons, wires and repeat hospitalizations due to MACE | 1-,3- and 5-year follow-up |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |