Providing Regional Observations to Study Predictors of Events in the Coronary Tree II study combined with a randomized, controlled, intervention trial - PROSPECT ABSORB

Oct 14, 2020
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott Vascular, Infraredx Inc., and The Medicines Company
Date Presented:
10/14/2020
Date Published:
10/14/2020
Date Updated:
10/14/2020
Original Posted Date:
10/14/2020
References

Contribution To Literature:

PCI of proximal non–flow-limiting stenosis with angiographic stenosis <70%, FFR/iFR negative, and plaque burden on IVUS ≥65% with Absorb BVS resulted in a larger MLA on IVUS follow-up, with no difference in clinical endpoints at 24 months.

Description:

The goal of the trial was to assess the safety and efficacy of percutaneous coronary intervention (PCI) of non–flow-limiting stenosis with Absorb bioresorbable vascular scaffold (BVS) compared with control, using near-infrared spectroscopy–intravascular ultrasound (NIRS-IVUS) to understand plaque burden.

Study Design

Eligible patients were randomized in a 1:1 fashion to either PCI with Absorb BVS (n = 93) or control (n = 89). Both arms got optimal guideline-directed medical therapy (GDMT).

  • Total number of enrollees: 182
  • Duration of follow-up:  4.1 years
  • Mean patient age: 64 years
  • Percentage female: 18%
  • Percentage with diabetes: 11%

Inclusion criteria:

  • Successful PCI of all flow-limiting lesions
  • Angiographic diameter stenosis <70% (with negative fractional flow reserve [FFR] or instantaneous wave-free ratio [iFR] required if diameter stenosis was >40%)
  • Reference vessel diameter 2.5-4.0 mm
  • Lesion length ≤50 mm
  • IVUS plaque burden ≥65%

Other salient features/characteristics:

  • Prior PCI: 11%
  • Presentation – ST-segment elevation myocardial infarction (STEMI): 30%, non-STEMI: 70%
  • Baseline low-density lipoprotein: 130 mg/dl
  • Maximal plaque burden: 74%
  • Baseline minimal lumen area (MLA): 3.1 mm2; lesions with MLA ≤4 mm2: 82%

Principal Findings:

The primary endpoint, MLA on IVUS, for PCI + GDMT vs. GDMT alone, was 6.9 vs. 3.0 mm2 (p < 0.0001).

  • Across the entire lesion (including 5 mm margins): 5.2 vs. 2.9 mm2 (p < 0.0001)

Secondary endpoints for IVUS, for PCI + GDMT vs. GDMT alone:

  • Target lesion failure: 4.3% vs. 4.5% (p = 0.96)
  • Target vessel myocardial infarction (TV-MI): 3.3% vs. 1.1%
  • Lesion-related major adverse cardiac events (MACE): 4.3% vs. 10.7% (p = 0.12)
  • Scaffold thrombosis: 1.1% vs. 0%

Interpretation:

The results of this pilot trial indicate that PCI of proximal non–flow-limiting stenosis with angiographic stenosis <70%, FFR/iFR negative, and plaque burden on IVUS ≥65% with Absorb BVS resulted in a larger MLA on IVUS follow-up, with no difference in clinical endpoints at 24 months. MACE rates were numerically lower with Absorb BVS PCI, while TV-MI rates were slightly higher.

References:

Stone GW, Maehara A, Ali ZA, et al, on behalf of the PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol 2020;Oct 14:[Epub ahead of print].

Presented by Dr. Gregg Stone at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 14, 2020.

Clinical Topics: Acute Coronary Syndromes, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Vascular Medicine, Lipid Metabolism, Interventions and ACS, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Echocardiography/Ultrasound, Nuclear Imaging, Chronic Angina

Keywords: Acute Coronary Syndrome, Atherosclerosis, Absorbable Implants, Constriction, Pathologic, Coronary Angiography, Fractional Flow Reserve, Myocardial, Lipoproteins, LDL, Myocardial Infarction, Percutaneous Coronary Intervention, Plaque, Atherosclerotic, Spectroscopy, Near-Infrared, ST Elevation Myocardial Infarction, Stents, TCT20, Thrombosis, Transcatheter Cardiovascular Therapeutics, Ultrasonography, Interventional


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