Two-Stent vs. Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions - DEFINITION II

Jul 13, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Science Foundation of China
Date Published:
06/26/2020
Original Posted Date:
07/13/2020
References

Contribution To Literature:

The DEFINITION II trial showed that a two-stent strategy was superior to provisional stenting for complex bifurcation lesions. 

Description:

The goal of the trial was to evaluate a two-stent approach compared with provisional stenting for treatment of complex bifurcation lesions.


Study Design

  • Randomized
  • Parallel

Patients undergoing revascularization of a complex bifurcation lesion were randomized to a two-stent (n = 331) versus provisional stenting strategy (n = 329).

In the two-stent strategy, the DK-crush (or culotte technique) was strongly encouraged. For the DK-crush technique, the side branch was stented with approximately 2 mm protrusion into the main vessel, balloon crush performed, rewiring of the side branch from a proximal cell, first kissing balloon inflation, main vessel stenting with proximal optimization technique, final kissing balloon inflation, and final proximal optimization technique.

In the provisional strategy, both vessels were wired (pre-dilatation of the side branch was discouraged), the main vessel stented, and the side branch dilated/stented only if there was significant dissection or compromised flow.

  • Total number of enrollees: 660
  • Duration of follow-up: 1 year
  • Mean patient age: 63 years
  • Percentage female: 22%
  • Percentage with diabetes: 34%

Inclusion criteria:

  • ≥18 years of age
  • Percutaneous coronary intervention for silent ischemia, stable/unstable angina, or myocardial infarction >24 hours prior to treatment
  • Bifurcation lesion (Medina 1,1,1 or 0,1,1), side branch reference vessel diameter ≥2.5 mm, and DEFINITION criteria for complex lesion defined as side branch lesion length ≥10 mm, and side branch diameter stenosis ≥70% for distal left main lesions or ≥90% for nonleft main lesions
  • ≥2 of the following: moderate to severe calcification, multiple lesions, bifurcation angle <45° or >70°, reference diameter of the main vessel <2.5 mm, thrombus, or main vessel lesion length ≥25 mm

Exclusion criteria:

  • Life expectancy <12 months
  • Anticipated use of three stents
  • Need for cessation of antiplatelet therapy within 6 months
  • Chronic anticoagulation therapy
  • Pregnant or breastfeeding women

Other salient features/characteristics:

  • Transradial approach: 79%
  • Intravascular ultrasound: 24%

In the provisional stenting group, 8.6% of side branches became occluded during the procedure and 11% of these remained permanently occluded. A total of 22.5% of patients required a side branch stent.

In the two-stent group, a side branch stent was not performed in 7.9%. DK-crush was performed in 78% and culotte in 18%.

Principal Findings:

The primary outcome was target lesion failure at 12 months, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and occurred in 6.1% of the two-stent group compared with 11.4% of the provisional stent group (p = 0.019).

Secondary outcomes:

  • Definite or probable stent thrombosis at 12 months: 1.2% of the two-stent group vs. 2.5% of the provisional stent group
  • Cardiac death: 2.1% of the two-stent group vs. 2.5% of the provisional stent group
  • Target vessel myocardial infarction: 3.0% of the two-stent group vs. 7.1% of the provisional stent group
  • Clinically driven target lesion revascularization: 2.4% of the two-stent group vs. 5.5% of the provisional stent group

Interpretation:

Among patients with a complex bifurcation lesion undergoing revascularization, a two-stent strategy was superior to provisional stenting. The two-stent strategy was mostly represented by the DK-crush technique. The two-stent strategy was associated with a reduction in target lesion failure at 12 months. Benefit was due to reductions in target vessel myocardial infarction and target lesion revascularization. There was a numerical reduction in definite/probable stent thrombosis with the two-stent vs. provisional strategy.

Prior to the introduction of the DK-crush technique, a two-stent strategy was associated with inferior outcomes compared with provisional stenting. Accumulating data support DK-crush as the preferred technique for revascularization of complex bifurcation lesions. For simple bifurcation lesions, provisional stenting may still be considered.

References:

Zhang JJ, Ye F, Xu K, et al. Multicenter, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J 2020;Jun 26:[Epub ahead of print].

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Imaging, Echocardiography/Ultrasound, Chronic Angina

Keywords: Acute Coronary Syndrome, Angina, Stable, Angina, Unstable, Coronary Occlusion, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Thrombosis, Ultrasonography, Interventional


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