Prospective, Randomized Evaluation of Sirolimus-Eluting Coronary Stents With Fixed-Wire and Rapid-Exchange Delivery Systems and a Novel Bioresorbable Drug Carrier - OPTIMIZE IDE

Oct 17, 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:
Svelte Medical Systems
Date Presented:
10/17/2020
Date Updated:
10/17/2020
Original Posted Date:
10/17/2020
References

Contribution To Literature:

The OPTIMIZE IDE trial failed to show that the Svelte drug-eluting stent was noninferior to a control drug-eluting stent at preventing target lesion failure.

Description:

The goal of the OPTIMIZE IDE trial was to evaluate a drug-eluting stent/fixed-wire device compared with a conventional rapid exchange drug-eluting stent among patients undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel

Patients undergoing primary PCI were randomized to the Svelte drug-eluting stent group (n = 827) versus control drug-eluting stent (n = 812). After randomization, operators in the Svelte drug-eluting stent group could choose between the Svelte IDE or the Svelte Rx device. The Svelte is designed to facilitate transradial access with direct stenting.

  • Total number of enrollees: 1,639
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 29%
  • Percentage with diabetes: 31%

Inclusion criteria:

  • ≤3 native coronary artery lesions in ≤2 major epicardial vessels
  • Objective ischemia
  • Reference vessel diameter ≥2.25 mm to ≤4.0 mm
  • Lesion length ≤34 mm
  • % diameter stenosis ≥50 to <100%
  • Angulation ≤90◦
  • Mild to moderate calcium density

Exclusion criteria:

  • Left main, chronic total occlusion, saphenous vein graft, in-stent restenosis or ST-segment elevation myocardial infarction (STEMI)
  • Planned cardiac intervention (for example, TAVR)
  • Need for anticoagulation

Other salient features/characteristics:

  • Transradial approach: 78%
  • Direct stent strategy: 95%
  • Post-dilatation: 52%
  • Mean reference vessel diameter: 2.8 mm
  • Mean lesion length: 14 mm

Principal Findings:

The primary outcome, 12-month target lesion failure, defined as cardiac death, target vessel MI, or clinically driven target lesion revascularization, occurred in 10.3% of the Svelte group compared with 9.5% of the control group (p for noninferiority = not significant).

Secondary outcomes:

  • Target lesion revascularization: 1.9% of the Svelte group compared with 1.5% of the control group (p = 0.57)
  • Target vessel MI: 8.2% of the Svelte group compared with 9.3% of the control group (p = 0.49)
  • Stent thrombosis at 12 months: 0.38% of the Svelte group compared with 0.51% of the control group (p = 0.72)

Interpretation:

Among patients undergoing PCI, the Svelte drug-eluting stent did not meet the threshold for noninferiority with respect to the composite outcome of target lesion failure.

References:

Presented by Dr. Dean Kereiakes at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 17, 2020.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, SCD/Ventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias

Keywords: Constriction, Pathologic, Death, Sudden, Cardiac, Dilatation, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Sirolimus, Stents, TCT20, Thrombosis, Transcatheter Cardiovascular Therapeutics


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