STRATEGY for Left Main Coronary Bifurcation Lesion II (STRATEGY-II)

A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion

In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: One stent technique alone; Device: One stent technique + Elective FKB; Procedure: Provisional approach; Device: Elective 2-stent

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥20 years
2. Left main bifurcation lesion on coronary angiography
3. Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis > 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
4. Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
2. Patients who have received DES implantation in the target lesion prior to enrollment

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One stent technique alone; One stent technique alone for non-true LM bifurcation	Device: One stent technique alone; One stent technique alone with drug-eluting stent
Experimental: One stent technique + Elective FKB; One stent technique + Elective FKB for non-true LM bifurcation	Device: One stent technique + Elective FKB; One stent technique + Elective FKB with drug-eluting stents + balloon
Experimental: Provisional approach; Provisional approach for true LM bifurcation	Procedure: Provisional approach; Provisional approach with drung-eluting stents
Experimental: Elective 2-stent; Elective 2-stent for true LM bifurcation	Device: Elective 2-stent; Elective 2-stent with drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	All deaths were considered cardiac unless a definite non-cardiac cause could be established.	12-month
Angiographic in-segment restenosis rate	as measured by 9-month quantitative coronary analysis	9 months
Target vessel revascularization (TVR)	TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.	12-month
Stent thrombosis	Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.	12-month
Myocardial infarction (MI)	MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.	12-month
Target lesion revascularization (TLR)	TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.	12-month
Periprocedural CK-MB elevation	Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.	the first 48 hours after PCI
Procedure success rate		the first 48 hours after PCI
Procedure time		immediate after PCI
Amount of contrast dye		immediate after PCI

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2013
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 29, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Angioplasty; Transluminal; Percutaneous Coronary
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2012-12-039