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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Rate of target vessel failure
as the composite of cardiac death, target vessel myocardial infarction (TVMI), and clinically driven TVR.
Time frame: 12 months
Rate of stent thrombosis
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Time frame: 12 months
Rate of MACE
as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization
Time frame: 1 month
Rate of MACE
as the composite of cardiac death, non-fatal target vessel myocardial infarction (TVMI), and unplaned target vessel revascularization
Time frame: 12 months
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