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The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN)

What was known?

Patients with non-left-main (LM) coronary bifurcation lesions are usually treated with a provisional stepwise single stent strategy. However, the DKCRUSH-V study found that an upfront, systematic dual stent strategy gave better outcomes.

Objective(s):

The aim of this study was to evaluate clinical outcomes in patients with distal bifurcation LM stem lesions undergoing percutaneous intervention (PCI) with either a provisional single-stent strategy or a systematic dual stenting strategy.

What this study adds:

No difference was seen in clinical outcomes between the provisional single stenting and the upfront use of two-stent techniques.

Clinical implications:

The 2018 European Society of Cardiology (ESC) Guidelines recommended an upfront two-stent approach in true LM bifurcations, but this study provides evidence to contradict this recommendation, particularly since upfront two-stent techniques have been associated with a higher long-term mortality risk than a single-stent strategy.

Study design:

The European Bifurcation Club Left Main Coronary Stent Study (EBC MAIN) study (NCT02497014) was an investigator-led prospective randomised multicentre trial. A total of 467 patients were randomly allocated to PCI using the stepwise provisional strategy (n=230) or the upfront, systematic dual stenting approach (n=237), with the technique left to the discretion of the operator. The OnyxTM zotarolimus eluting coronary stent (Medtronic) was used in the study. The 6-month follow-up assessed patient symptoms and wellbeing, while the 1-year follow-up assessed symptoms, angina index, adverse events, and study endpoints.

Primary endpoint:

Composite of all-cause death, myocardial infarction, and target lesion revascularisation at 12 months.

Secondary endpoints:

  • Individual components of the primary endpoint
  • Angina status
  • Angina medication
  • Adjudicated stent thrombosis

Inclusion criteria:

  • ‘True’ unprotected bifurcation LM stem coronary artery disease in which both vessel reference diameters were ≥ 2.75mm.
  • Either ischaemic symptoms, positive non-invasive imaging for ischaemia, a positive fractional flow reserve or a left main stem intravascular ultrasound (IVUS)-derived minimum luminal area of <6 mm2.
  • Patients with ≤ 2 additional coronary lesions could be included in the study   
  • Age ≥18 years

Notable exclusion criteria:

  • STEMI <72 hours prior to intervention
  • Cardiogenic shock
  • Chronic total occlusion of either vessel
  • >2 other coronary lesions planned for treatment
  • SYNTAX score for planned lesions to be treated >32

Findings:

  • The mean age was 71 ± 10 years, 77 % were male and 28 % were diabetic
  • The primary endpoint occurred in 14.7% and 17.7% of the stepwise provisional and systematic dual groups, respectively (hazard ratio, 0.8; 95% confidence interval, 0.5-1.3; p=0.34)
  • There was no significant difference in secondary endpoints between the two groups: death (3 % vs. 4.2 %), MI (10 % vs. 10.1 %), TLR (6.1 % vs. 9.3 %) or stent thrombosis (1.7 % vs. 1.3 %)

Interpretation:

There was no significant difference in outcomes between the stepwise provisional and systematic dual stent strategies, and the majority (78%) of patients in the provisional single stent group did not require a second stent. A systematic dual stent strategy involves a more complex procedure than a provisional single-stent approach. A pooled analysis of the BBC ONE and NORDIC trials, found that upfront two-stent techniques had a higher long-term mortality risk compared with an initial single-stent strategy. The investigators concluded that the stepwise provisional strategy should remain the treatment of choice for distal LM true bifurcation procedures.

Limitations:

  • Only 1-year follow up reported at present but the study will proceed to 3-year follow-up
  • The open-label design could have led to theoretical bias in interpreting outcomes
  • Event rates were lower than anticipated and therefore the study was underpowered to detect clinical differences between the two groups

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