Percutaneous Coronary Intervention With a Bioadaptor Compared to a Contemporary Drug-Eluting Stent - INFINITY-SWEDEHEART

Oct 28, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Elixir Medical Corporation
Date Presented:
10/28/2024
Date Published:
10/28/2024
Date Updated:
10/28/2024
Original Posted Date:
09/02/2024
References

Contribution To Literature:

Highlighted text has been updated as of October 28, 2024.

The INFINITY-SWEDEHEART trial showed that in patients undergoing PCI for chronic or acute coronary syndrome, the DynamX bioadaptor resulted in less target lesion and vessel failure compared with the Resolute Onyx DES between 6 and 12 months.

Description:

The goal of the trial was to compare the efficacy of the DynamX bioadaptor, a novel coronary implantable device, to a contemporary drug-eluting stent (DES) in the treatment of coronary artery disease requiring percutaneous coronary intervention (PCI).

Study Design

  • Multicenter
  • Single-blind
  • Randomized
  • Registry-based

Patients undergoing PCI for chronic or acute coronary syndrome (CCS or ACS, respectively) were randomized in a 1:1 fashion to undergo PCI with a DynamX sirolimus-eluting bioadaptor (n = 1,201) or a Resolute Onyx zotarolimus-eluting stent (n = 1,198). Dual antiplatelet therapy was continued for at least 6 and 12 months in chronic and acute coronary syndromes, respectively.

  • Total number of enrollees: 2,399
  • Duration of follow-up: 12 months
  • Mean patient age: 68 years
  • Percentage female: 24%

Inclusion criteria:

  • Age ≥18 and ≤85 years
  • CCS or ACS undergoing indicated PCI
  • ≤3 lesions treated during index procedure, including up to 1 nontarget lesion
  • Successful pre-dilation of ≥1 target lesion

Exclusion criteria:

  • ACS with Killip class III-IV heart failure
  • Left ventricular ejection fraction <30%
  • Estimated glomerular filtration rate <30 mL/min
  • Lesions in the left main artery or venous or arterial bypass grafts
  • In-stent restenosis, chronic total occlusions, ostial disease, or bifurcation lesions requiring a two-stent strategy
  • Planned use of guide extension catheter or atherectomy

Other salient features/characteristics:

  • ACS: 77% (ST-segment elevation myocardial infarction [STEMI]: 25%)
  • ≥2 target lesions: 17%
  • Left anterior descending artery target lesion: 51%
  • Mean lesion length: 25 mm
  • Mean pre-PCI % diameter stenosis: 87%

Principal Findings:

The primary outcome, target lesion failure (TLF), a composite of cardiovascular (CV) death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR), for DynamX bioadaptor vs. Resolute Onyx DES at 1 year, was: 2.4% vs. 2.8%, difference -0.41% (95 confidence interval [CI] -1.94 to 1.11%, p for noninferiority < 0.001).

Secondary outcomes for DynamX bioadaptor vs. Resolute Onyx at 1 year:

  • CV death: 0.6% vs. 0.5%
  • TV-MI: 1.3% vs. 1.5%
  • ID-TLR: 1.3% vs. 2.1%
  • Target vessel failure (TVF), a composite of CV death, TV-MI, or target vessel revascularization: 3.0% vs. 3.5%
  • Stent thrombosis: 0.7% vs. 0.5%

Prespecified landmark analyses after 6 months for DynamX bioadaptor vs. Resolute Onyx at 1 year:

  • TLF: 0.3% vs. 1.7%, HR 0.19 (95% CI 0.06-0.65), p for superiority = 0.0079
  • TVF: 0.8% vs. 2.5%, HR 0.35 (95% CI 0.16-0.79), p for superiority = 0.011
  • TLF in patients with ACS: 0.3% vs. 1.8%, HR 0.17 (95% CI 0.04-0.74), p for superiority = 0.018

Interpretation:

The BIOADAPTOR-RCT study previously demonstrated noninferiority of the DynamX bioadaptor to contemporary DES technology with respect to TLF at 12 months in 445 patients. The current data extend these findings to a larger and clinically more complex cohort, of which over 77% notably presented with ACS including 25% with STEMI. Moreover, powered landmark analyses conducted at 6 months, when the bioadaptor helices unlock, demonstrated superiority in TLF and TVF compared to DES. This was largely driven by a plateau in TV-MI and ID-TLR compared with the steady rise in events observed in the Resolute Onyx arm.

The bioadaptor has a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore more normal vessel biology:

  • Locked phase: The bioadaptor establishes maximum flow lumen to restore blood flow.
  • Unlocked/separation phase: Unique to the bioadaptor, after 6 months, helical strands unlock and separate to allow adaptive remodeling of the vessel to maintain the established blood flow lumen.
  • Adaptive dynamic support phase: The three—now independent—helical strands continue to provide essential support as the bioadaptor re-establishes vessel hemodynamic modulation through restoration of pulsatility, compliance, and adaptive blood flow volume.

These findings suggest a promising role for the DynamX bioadaptor in PCI across a broader spectrum of coronary artery disease presentations. It currently has CE mark but not US FDA approval. Further studies, including the planned 5-year extended outcomes of this population, are warranted to understand both long-term outcomes as well as efficacy compared with other stent platforms such as everolimus-eluting durable polymer DES and biodegradable polymer DES (such as Orsiro), as well as in more complex anatomic lesions.

References:

Erlinge D, Andersson J, Fröbert O, et al. Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomized controlled trial. Lancet 2024;Oct 28:[Epub ahead of print].

Presented by Dr. David Erlinge at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 28, 2024.

Presented by Dr. David Erlinge at the European Society of Cardiology Congress, London, UK, September 2, 2024.

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

Keywords: Acute Coronary Syndrome, Coronary Artery Disease, Drug-Eluting Stents, Percutaneous Coronary Intervention, ESC Congress, ESC24, TCT24, Transcatheter Cardiovascular Therapeutics


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