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Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial.

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Intensive medical management (IMM) significantly improved blood pressure and LDL cholesterol in patients with asymptomatic carotid stenosis. This approach enables comparison with revascularization for stroke prevention.

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Area of Science:

  • Cardiovascular Medicine
  • Neurology
  • Clinical Trials

Background:

  • The CREST2 trial investigates intensive medical management (IMM) for asymptomatic carotid stenosis.
  • IMM is compared against IMM plus revascularization (carotid endarterectomy or stenting) to prevent stroke or death.
  • Limited data exists for IMM outcomes, making it the experimental treatment in CREST2.

Purpose of the Study:

  • To describe the intensive medical management (IMM) protocol used in the CREST2 trial.
  • To report interim risk factor data for patients undergoing IMM.
  • To assess the effectiveness of IMM in controlling risk factors for stroke in asymptomatic carotid stenosis.

Main Methods:

  • IMM includes aspirin 325 mg/day and intensive risk factor management.
  • Primary targets: systolic blood pressure <130 mm Hg and LDL cholesterol <70 mg/dL.
  • Secondary targets: smoking, non-HDL, HbA1c, physical activity, and weight, managed via site personnel and telephone coaching.

Main Results:

  • Mean LDL cholesterol improved from 80.5 to 66.7 mg/dL.
  • Mean systolic blood pressure improved from 139.7 to 130.3 mm Hg.
  • Proportion of patients at target increased significantly for both systolic blood pressure (43% to 61%) and LDL cholesterol (45% to 67%).

Conclusions:

  • The CREST2 trial's multimodal approach significantly improved risk factor control.
  • These improvements allow for a robust comparison between IMM and revascularization.
  • The findings support the rigorous management of stroke risk factors in asymptomatic carotid stenosis.