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

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.

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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