Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPCI
percutaneous coronary intervention
Sponsors
Albert Schweitzer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
single-center, prospective, single blinded randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease 2. 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. 3. Subject must be at least 18 years of age 4. Written consent to participate in the study
Exclusion criteria
1. Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions 2. Culprit lesions of acute coronary syndrome cannot be randomized to the trial. After successful treatment of the ACS culprit lesion, patients however can be randomized in the trial in case of remaining stable non-culprit lesions that thought to be stented directly of during a staged procedure. 3. Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass grafts or tortuous anatomy 4. Treatment for in-stent restenosis 5. Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned. 6. Treatment of coronary artery bypass grafts 7. Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) 8. Known hypersensitivity or allergy for cobalt chromium 9. Known comorbidity associated with a life expectancy \< 1 year 10. Unable to understand and follow study-related instructions or unable to comply with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During procedure | Stent malapposition (categorical variable) is defined as: * Unacceptable stent expansion: The minimal stent area (MSA) of the proximal segment is \<90% of the proximal lumen area, and/or the MSA of the distal segment is \<90% of the distal reference lumen area on OCT OR * Presence of incompletely apposed stent struts on OCT more than 3mm long (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch: i.e. the Prati criterium) 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute recoil (percent) | During procedure | assessed on coronary angiography |
| Stent malapposition (percent) | During procedure | 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). |
| Mean stent expansion (percent): | During procedure | mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100 |
| Intra-stent plaque protrusion and thrombus | During procedure | defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut |
| Post OCT stent result optimalization (percent) | During procedure | composite of additional post-dilation and/or stent placements after OCT |
| Minimal stent area (MSA) (mm^2) | During procedure | — |
| Target Lesion Failure (TLF) | 1-,3- and 5-year follow-up | defined as cardiac death, target vessel- myocardial infarction and clinically indicated target lesion revascularization) |
| Target Vessel Failure (TVF) | 1-,3- and 5-year follow-up | defined as cardiac death, target vessel- myocardial infarction and clinically indicated target vessel revascularization |
| All cause mortality | 1-,3- and 5-year follow-up | — |
| Stent Thrombosis | 1-,3- and 5-year follow-up | definite or probable; Academic Research Consortium (ARC) definition |
| Cost-effectiveness analysis | 1-,3- and 5-year follow-up | total number of stent, balloons, wires and repeat hospitalizations due to MACE |
| MACE | 1-,3- and 5-year follow-up | a composite of time- to-first event rate of cardiac death, target vessel MI, ischemia-driven target vessel revascularization (TVR) |
Countries
Netherlands
Contacts
Primary ContactSelina Vlieger, MSc
Outcome results
None listed