Randomized Comparison of Provisional Side Branch Stenting Versus a Two-Stent Strategy for Treatment of True Coronary Bifurcation Lesions Involving a Large Side Branch - Nordic-Baltic Bifurcation Study IV

Description:

The goal of the trial was to evaluate treatment with a 2-stent strategy compared with a 1-stent strategy for bifurcation lesions involving a large side branch.

Hypothesis:

A 2-stent strategy will reduce adverse cardiovascular events.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients ≥18 years of age with stable angina, unstable angina, or non-ST-segment elevation MI (NSTEMI) due to a bifurcation lesion
  • Main branch required to be ≥3.0 mm
  • Side branch required to be ≥2.75 mm

    Number of enrollees: 450 patients
    Duration of follow-up: 6 months
    Mean patient age: 64 years

Exclusions:

  • STEMI
  • Cardiogenic shock or other critical illness
  • Renal insufficiency
  • Side branch lesion length >15 mm

Primary Endpoints:

  • Composite of cardiac death, nonindex procedure-related MI, target lesion revascularization, or definite stent thrombosis

Secondary Endpoints:

  • All-cause death
  • Cardiac death
  • Nonindex procedure-related MI
  • Target lesion revascularization
  • Target vessel revascularization
  • Definite stent thrombosis
  • Procedure-related MI

Drug/Procedures Used:

Patients with a bifurcation lesion involving a large side branch were randomized to a 2-stent strategy (n = 229) versus a 1-stent strategy with provisional stenting of the side branch (n = 221).

Sirolimus-eluting stents were used for the first 225 patients and everolimus-eluting stents were used for the last 225 patients.

In the 2-stent group, the main vessel and side branch was wired, and both segments to be stented were predilated. Culotte stenting and kissing balloon dilatation were recommended.

In the 1-stent group, the main vessel and side branch were wired, and both segments were predilated. The main vessel was stented, and the side branch was provisionally dilated if there was poor flow or a severe residual stenosis. If there was still poor flow after kissing balloon dilatation, the side branch could be stented (T or Culotte was recommended).

Principal Findings:

Overall, 450 patients were randomized. The mean age was 64 years, 16% had diabetes, and left anterior descending artery/diagonal lesions were present in 74%. In the 1-stent group, the side branch was stented in 3.7%.

- Creatine kinase-myocardial band >3x upper limit of normal: 6.1% with 2-stent versus 6.0% with 1-stent group (p = NS)

- Procedure time: 93 minutes with 2-stent vs. 74 minutes with 1-stent group (p < 0.0001)

- The primary outcome of cardiac death, nonindex procedure-related myocardial infarction (MI), target lesion revascularization, or definite stent thrombosis at 6 months, occurred in 1.8% of the 2-stent vs. 4.6% of the 1-stent group (p = 0.09).

- Nonprocedure MI: 0.9% with 2-stents vs. 1.8% with 1-stents (p = 0.50)

- Target lesion revascularization: 1.3% vs. 3.2% (p = 0.18)

Interpretation:

Among patients with a bifurcation lesion involving a large side branch, a 2-stent strategy did not reduce adverse cardiac events; however, there was a suggestion of benefit from this approach. A planned 2-stent strategy significantly increased procedure time. At the present time, a 1-stent strategy with provisional stenting of the side branch for bifurcation lesions remains preferential.

References:

Presented by Dr. Indulis Kumsars at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 30, 2013.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Angina, Stable, Immunosuppressive Agents, Creatine Kinase, MB Form, Dilatation, Constriction, Pathologic, Sirolimus, Stents, Thrombosis, Coronary Vessels, Diabetes Mellitus


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