Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing PCI With Angiography Guidance Alone - SMART-CASE

Description:

The goal of the trial was to evaluate a conservative revascularization strategy (percutaneous coronary intervention [PCI] for lesions >70%) compared with an aggressive revascularization strategy (PCI for lesions >50%).

Hypothesis:

Conservative revascularization would be noninferior to aggressive revascularization.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • Patients undergoing PCI of a 2.25- to 4.25-mm vessel

    Number of enrollees: 899
    Duration of follow-up: 12 months
    Mean patient age: 64 years
    Percentage female: 36%
    Ejection fraction: 62%

Exclusions:

  • Cardiogenic shock
  • Left main stenosis
  • ≥2 chronic total occlusions
  • Thrombocytopenia
  • Limited life expectancy
  • Myocardial infarction within last 48 hours
  • Prior drug-eluting stent implantation
  • Bleeding abnormality
  • Major surgery within the last 2 months
  • Planned surgery within the next 6 months

Primary Endpoints:

  • Death, myocardial infarction, or any revascularization within 12 months

Secondary Endpoints:

  • All-cause death
  • Myocardial infarction
  • Death or myocardial infarction
  • Any revascularization
  • Target vessel failure
  • Stent thrombosis

Drug/Procedures Used:

Patients undergoing PCI with an everolimus-eluting stent were randomized to a conservative revascularization strategy (n = 449) versus an aggressive revascularization strategy (n = 450).

Principal Findings:

Overall, 899 patients were randomized. The mean age was 64 years, 64% were men, 32% had diabetes, and 66% had stable ischemic heart disease. The number of stents implanted per patient in the conservative group was 0.7 vs. 1.8 in the aggressive group (p < 0.001), and the total stent length per patient was 15.6 mm vs. 39.3 mm (p < 0.001), respectively.

The primary outcome of all-cause death, myocardial infarction, or any revascularization at 1 year occurred in 7.3% of the conservative group versus 6.8% of the aggressive group (p = 0.86). This met the criteria for noninferiority. Among numerous tested subgroups, a conservative strategy appeared especially beneficial among those ≥65 years of age.

- All-cause death: 0.5% vs. 2.1% (p = 0.06), respectively, for conservative vs. aggressive groups

- Myocardial infarction: 0.9% vs. 0.9% (p = 0.99), respectively

- Any revascularization: 6.8% vs. 4.8% (p = 0.23), respectively

- Target vessel failure: 5.9% vs. 4.5% (p = 0.42), respectively

- Stent thrombosis: 0.2% vs. 0.4% (p = 0.57), respectively

Interpretation:

Among patients undergoing revascularization with drug-eluting stents, a conservative strategy (PCI for lesions >70%) was noninferior to an aggressive strategy (PCI for lesions >50%). The limitations of utilizing coronary stenosis (i.e., anatomical information) as a surrogate for myocardial ischemia are widely known. Unfortunately, this study did not examine functional information (i.e., fractional flow reserve), which might have better defined conservative versus aggressive strategies.

References:

Presented by Hyeon-Cheol Gwon at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 30, 2013.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Pyridinolcarbamate, Coronary Stenosis, Thrombosis, Drug-Eluting Stents, Sirolimus, Diabetes Mellitus, Percutaneous Coronary Intervention


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