Improved Drug-Eluting stent for All-comers Left Main - IDEAL-LM

Sep 26, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
09/26/2019
Date Updated:
09/26/2019
Original Posted Date:
09/26/2019
References

Contribution To Literature:

The IDEAL-LM trial showed that using 4 months of DAPT post-Synergy stent implantation is noninferior to 12 months of DAPT post-Xience stent implantation among patients undergoing unprotected LM PCI.

Description:

The goal of the trial was to compare the safety and efficacy of Synergy stent implantation followed by short-duration dual antiplatelet therapy (DAPT) (4 months) compared with Xience stent implantation followed by 12 months among patients undergoing unprotected left main (LM) percutaneous coronary intervention (PCI).

Study Design

Eligible patients were randomized in a 1:1 fashion to either Synergy stent implantation followed by DAPT for 4 months (n = 410) or Xience drug-eluting stent (DES) implantation followed by DAPT for 12 months (n = 408).

  • Total number of enrollees: 818
  • Duration of follow-up: 2 years
  • Mean patient age: 66.4 years
  • Percentage female: 20%

Inclusion criteria:

  • Unprotected LM PCI based on heart team decision

Other salient features/characteristics:

  • Previous PCI: 33%
  • Acute coronary syndrome presentation: 37%
  • Low SYNTAX score: 58%

Principal Findings:

The primary outcome for Synergy vs. Xience, major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target lesion revascularization [TLR]), was 14.6% vs. 11.4% (p for noninferiority < 0.05; p for superiority = 0.17).

  • All-cause mortality: 5.2% vs. 5.3% (p = 1.0)
  • MI: 6.0% vs. 3.5% (p = 0.13)
  • Ischemia-driven TLR: 6.0% vs. 4.6% (p = 0.43)

Secondary outcomes for Synergy vs. Xience:

  • Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding: 2.7% vs. 0.5% (p = 0.02)

Interpretation:

The results of this trial indicate that using 4 months of DAPT post-Synergy stent implantation is noninferior to 12 months of DAPT post-Xience stent implantation among patients undergoing unprotected LM PCI. Event rates for ischemic events were numerically higher in the Synergy arm, driven by higher MI and ischemia-driven TLR rates. Surprisingly, bleeding was higher with the shorter DAPT duration strategy. Synergy is a DES that has thinner struts and a biodegradable polymer compared with Xience, which is a durable polymer stent with slightly thicker struts (81 vs. 74 µ).

References:

Presented by Dr. Robert-Jan van Geuns at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 26, 2019.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: Acute Coronary Syndrome, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Polymers, Stents, Transcatheter Cardiovascular Therapeutics, TCT19


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