Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions

Study Overview
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Brief Summary
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The DR vs DK trial is designed to elucidate the benefits of Double Rewire crush technique (DR-Crush) over Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

Detailed Description
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DR vs DK is a multicentre, randomized, prospective, non-inferiority clinical trial designed to evaluate the efficacy and safety of DR crush over DK crush for patients with ULMb. More than 12 tertiary centres from Spain will participate including patients. Subjects with Medina 1,1,1 ULMb will be randomized in a 1:1 fashion to DR or DK crush. In order to avoid bias, the Sirolimus coronary stent will be used in all patients (UltimasterTM TanseiTM). The use of Intracoronary imaging techniques are recommended. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary end-point, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2022 and will be completed in January 2024; 180 patients will be randomized.

Official Title
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Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: DK crush
* Procedure: DR crush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18-90 years of age. Patients who gave written informed consent for participation in the trial. Lesions are eligible for percutaneous coronary intervention (PCI). Patient has stable/unstable angina or myocardial infarction (MI): all-comers. ULMb (Medina 1,1,1) with/without left main ostial/shaft lesions. Downstream lesions in LAD or LCX could be covered by two stents. Severe calcification needing rotational atherectomy, orbital atherectomy or Laser are included. Diameter stenosis in LAD/LM and LCX ≥ 50% by visual estimation or minimal luminal area by IVUS in LM ≤6 mm2. Exclusion Criteria: Restenotic lesions. Patient was allergic to the study stent or protocol-required concomitant medications. Patient is intolerable to dual anti-platelet therapy. Patient has any other serious medical illness that may reduce life expectancy to <12 months. Patient is a woman who is pregnant or nursing. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Patient is participating in another clinical trial. Patients in shock.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DR crush technique<br> | Procedure: DR crush<br>* Double Rewire crush technique (DR-Crush) in patients with Unprotected Left Main Bifurcation lesions (ULMb).<br>|
| Experimental: DK crush technique<br> | Procedure: DK crush<br>* Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of target vessel failure | as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR. | 12 months | 
| Rate of stent thrombosis | The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MACE | as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization | 1 month | 
| Rate of MACE | as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization | 12 months |