Nordic Bifurcation Study - Nordic Bifurcation Study

Description:

The goal of the trial was to evaluate stenting of the main vessel and side branch compared with a strategy of stenting of the main vessel and optional stenting of side branch among patients with angina pectoris and a bifurcation lesion.

Contribution to the Literature: The Nordic Bifurcation Study (NORDIC I) showed that stenting of the main vessel and side branch was associated with no difference in MACE at 6 months, but an increase in periprocedural MI compared with a strategy of stenting of the main vessel and optional stenting of side branch.

Study Design

Patients Enrolled: 413
Mean Follow-Up: 8 months
Mean Patient Age: Mean age 63 years
Female: 22%

Patient Populations:

Angina pectoris patients with a bifurcation lesion ≥2.5 mm diameter in the main vessel and ≥2.0 mm in the side branch

Primary Endpoints:

Major adverse cardiac events (MACE) at 6 months, defined as cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), or stent thrombosis of index lesion

Drug/Procedures Used:

Patients were randomized to stenting of the main vessel and side branch (MV+SB; n = 206) or stenting of the main vessel and optional stenting of side branch (MV; n = 207). Following main vessel stenting, the side branch was dilated in patients in the MV+SB group if TIMI flow grade was <3. If TIMI flow grade was 0 after dilation, the side branch was then stented. Repeat angiography was performed at 8 months.

Principal Findings:

Stenting of the side branch was performed in 95.1% of the MV+SB group and 4.3% of the MV group. Duration of the procedure (76 minutes vs. 62 minutes) and fluoroscopy time (21 minutes vs. 15 minutes) were increased in the MV+SB group, as was use of contrast (283 ml vs. 233 ml, p < 0.001 for all). Glycoprotein IIb/IIIa inhibitors were used in 51% of patients. Treatment success was similar in both groups (94% in the MV+SB group and 97% in MV group, p = NS).

There was no difference in the primary endpoint of MACE at 6 months (3.4% in the MV+SB group vs. 2.9% in the MV group, p = NS). Procedure-related MI, defined as a threefold elevation of biochemical markers, occurred more often in the MV+SB group (18% vs. 8%, p = 0.01). There was no difference in 6-month cardiac death (1.0% each), clinical MI (0% for MV and 0.5% for MV+SB), or TLR (1.9% for MV vs. 1.0% for MV+SB). Stent thrombosis occurred in 0.5% of the MV group and 0% of the MV+SB group (p = NS).

Repeat angiography at 8 months was performed in 86% of patients (n = 307). Binary stenosis >50% across the entire bifurcation lesion was present in 22.5% of the MV group and 16.0% of the MV+SB group (p = 0.15). There was no difference in binary stenosis in the main vessel (4.6% for MV vs. 5.1% for MV+SB, p = NS), but binary stenosis in the side branch trended higher in the MV group (19.2% vs. 11.5%, p = 0.062). There was only one side branch occlusion in the MV group.

Five-year clinical outcomes (combined NORDIC I and BBC ONE data sets): All-cause mortality for complex vs. simple strategy: 7.0% vs. 3.8%, p = 0.04 (NORDIC I: 10.4% vs. 5.9%; BBC ONE: 5.9% vs. 2.9%;  p = 0.1).

Interpretation:

Among patients with angina pectoris and a bifurcation lesion, stenting of the main vessel and side branch was associated with no difference in MACE at 6 months, but an increase in periprocedural MI compared with a strategy of stenting of the main vessel and optional stenting of side branch.

Angiographic follow-up showed only one patient had side branch occlusion at 8-month follow-up in the MV group, and overall rates of binary stenosis were similar between the groups. Given the lack of clinical benefit and the increase in periprocedural MI, routine side-branch stenting of bifurcation lesions does not appear to be a valid initial treatment strategy.

Long-term (5-year) mortality appears to be lower with a single-stent approach, although the mechanism for this (lower TLR, lower target vessel MI) is unknown.

References:

Behan MW, Holm NR, de Belder AJ, et al. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J 2016;37:1923-8.

Steigen TK, Maeng M, Wiseth R, et al. Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions: The Nordic Bifurcation Study. Circulation 2006;114:1955-61.

Presented by Dr. Andrejs Englis at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Presented by Dr. Terje K. Steigen at the March 2006 ACC Annual Scientific Session, Atlanta, GA.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Coronary Artery Disease, Interventions and Imaging, Nuclear Imaging

Keywords: Coronary Artery Disease, Myocardial Infarction, Fluoroscopy, Biological Markers, Thrombosis, Constriction, Pathologic, Stents


< Back to Listings