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CARDIOVASCULAR DISEASE RISK PREVENTION

  • FOURIER. N Engl J Med 2017;376(18):1713-1722.

    • - Randomized, double-blind, placebo-controlled trial that included 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg/dL or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (PCSK9 inhibitor, either 140 mg every 2 weeks or 420 mg monthly) or placebo. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. Relative to placebo, evolocumab treatment significantly reduced the risk of the composite primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]).

CORONARY ARTERY DISEASE (CAD)

  • FAME-2. N Engl J Med 2012;367(11):991–1001.

    • - In this trial, 888 patients with stable CAD for whom PCI was being considered underwent fractional flow reserve (FFR) testing to measure the percentage of functionally significant stenosis. Patients with at least one functionally significant lesion were randomly assigned to FFR-guided PCI plus best medical therapy vs. best medical therapy alone. This trial demonstrated that FFR-guided PCI reduced the composite endpoint of death, nonfatal MI, and urgent recatheterization in patients with stable CAD compared to best medical therapy alone.

  • SYNTAX. N Engl J Med 2009;360:961–972.

    • - This trial randomized 1800 patients with previously untreated three-vessel or left main coronary artery disease (or both) to undergo coronary artery bypass graft (CABG) vs. PCI. In this trial, rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P = 0.002). Therefore, CABG remains the standard of care for patients with three-vessel or left main coronary artery disease.

  • ISCHEMIA. N Engl J Med 2020;382:1395–1407.

    • - This trial randomized 5179 patients with moderate to severe stable coronary disease to conservative strategy (medical management) vs. early interventional strategy (revascularization). There was no significant difference in ischemic cardiovascular events or death over a median of 3.2 yr.

  • ORBITA. The Lancet 2017;391:31–40.

    • - This trial randomized 230 patients with stable coronary artery disease and ischemic symptoms to revascularization of flow-limiting lesions vs. a placebo procedure. There was no difference in exercise time or symptom scores at 6 weeks follow up.

ACUTE CORONARY SYNDROME (ACS) AND POST-ACS CARE

  • CAPRICORN. The Lancet 2001;357(9266):1385–1390.]

    • - This trial randomized 1959 patients who had had a hemodynamically stable MI with reduced LVEF of ≤40% who were already on an ACE inhibitor (unless proven intolerance) to receive carvedilol or placebo. Treatment with carvedilol was associated with decreased all-cause mortality (12% vs. 15% in placebo group).

  • MIRACL. JAMA 2001;285(13):1711–1718.

    • - This trial randomized 3086 patients who were hospitalized for unstable angina/NSTEMI to receive either atorvastatin 80 mg or placebo daily. The early initiation of atorvastatin reduced the combined endpoint of death, nonfatal MI, cardiac arrest, and ACS requiring hospitalization at 16 weeks.

  • IMPROVE-IT. N Engl J Med 2015;375(25):2387–2397.

    • - This trial ...

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