The purpose of this study is to investigate whether baseline V-RESOLVE score guided intervention is associated with significant reduction of side branch occlusion rates compared to angiography guided intervention in patients with coronary bifurcation lesions.
A number of 1104 patients scheduled for elective percutaneous coronary intervention (PCI) with native coronary bifurcation lesions suitable for stent implantation are included in the present study. This study will be conducted in two stages with 552 patients each. In the first stage, all patients receive angiography-guided PCI. In the second stage, all patients receive PCI under the guidance of baseline V-RESOLVE score.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,104
Jailed wire technique (JWT): Both main vessel (MV) and side branch (SB) are wired. The MV is stented with wire protection in SB. If suboptimal results exist, the SB would be rewired and a kissing balloon inflation (KBI) is undertaken. Jailed balloon technique: A monorail balloon is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB. Provisional two-stent strategy: Lesion preparation and MV stenting are consistent with JWT. Provisional SB stenting could be undertaken when suboptimal results occur after SB rewiring and a KBI is undertaken. Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which usually stenting SB before MV stenting.
The choice of interventional strategy was left to the discretion of experienced interventionists based on the coronary angiogram.
Fuwai Hospital
Beijing, Beijing Municipality, China
side branch occlusion after main vessel stenting
The primary endpoint is side branch occlusion, which is defined as any decrease in TIMI flow grade or absence of flow in side branch after main vessel stent well opposed.
Time frame: Immediately after the main vessel
The elevation of biomarkers of periprocedural myocardial injury [Creatine Kinase-Myocardial Band (CK-MB) and Troponin I].
Periprocedural Myocardial Infarction (MI) is defined by the Society for Cardiovascular Angiography and Interventions criteria.
Time frame: 48h after Percutaneous Coronary Intervention (PCI)
Major adverse cardiac events (MACE)
Including all cause death, all myocardial infarction (MI) and target vessel revascularization
Time frame: 12-month follow-up
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