Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing PCI With Angiography Guidance Alone - SMART-CASE
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%).
Conservative revascularization would be noninferior to aggressive revascularization.
- 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%
- Cardiogenic shock
- Left main stenosis
- ≥2 chronic total occlusions
- 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
- Death, myocardial infarction, or any revascularization within 12 months
- All-cause death
- Myocardial infarction
- Death or myocardial infarction
- Any revascularization
- Target vessel failure
- Stent thrombosis
Patients undergoing PCI with an everolimus-eluting stent were randomized to a conservative revascularization strategy (n = 449) versus an aggressive revascularization strategy (n = 450).
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
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.
Presented by Hyeon-Cheol Gwon at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 30, 2013.
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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