Table 4.
Examples of contemporary clinical trials using revascularization as an endpoint
| Trial name | Key inclusion criteria and sample size | Intervention versus control | Primary endpoint | Primary results | Definition of revascularization and use of an adjudication committee | Events, n |
|---|---|---|---|---|---|---|
| FAME–3 [52] | Patients with three-vessel CAD (n = 1,500) | FFR-guided PCI versus CABG | A composite of death from any cause, Ml, stroke, or repeat revascularization | FFR-guided PC1 10.6% versus CABG 6.9%. (HR 1.50; 95% CI: 1.10–2.20, p = 0.350 for noninferiority of FFR-guided PCI) | Urgent revascularization is defined as an unplanned hospitalization for an ACS with at least one of the following: electrocardiographic changes, biomarker elevation, or new perfusion/wall motion abnormalities to document ischemia and which results in revascularization during the hospitalization. Repeat revascularization is defined as any unplanned (elective or urgent) revascularization, whether PCI or CABG. Planned staged PCI procedures do not qualify. Use of an adjudication committee: yes | Revasc.: n = 74 Total: n= 131 Revasc./total: 56.4% |
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| STEP [53] | Patients 60–80 years of age with hypertension (n = 9,624) | SBP target of 110–130 mm Hg (intensive treatment) versus 130–150 mm Hg (standard treatment) | A composite of stroke, ACS (acute Ml and UA), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes | Intensive-treatment group 3.5% versus standard-treatment group 4.6%. (HR 0.74; 95% CI: 0.60–0.92; p = 0.007) | Coronary revascularization defined as PCI or CABG. Not further specified. Use of an adjudication committee: yes |
Revasc.: n = 54 Total: n = 342 Revasc./total:15.8% |
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| FLOWER–Ml [54] |
Patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery (n = 1,163) | FFR versus angiography guided revascularization | A composite of death from any cause, nonfatal Ml, or unplanned hospitalization leading to urgent revascularization | FFR-guided 5.5% versus angiography-guided group 4.2% (HR 1.32; 95% CI: 0.78–2.23; p = 0.310) | Patient admitted to the hospital with persistent or increasing chest pain and the revascularization procedure (PCI or CABG surgery) performed during the same hospitalization. Use of an adjudication committee: yes | Revasc.: n = 26 Total: n = 56 Revasc./total: 46.4% |
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| MR-INFORM [55] |
Patients with typical angina and cardiovascular risk factors or a positive exercise treadmill test (n = 918) | Myocardial-perfusion cardiovascular MRI strategy versus invasive angiography and measurement of FFR strategy | A composite of death, nonfatal Ml, or target-vessel revascularization within 1 year | Cardiovascular-MRI group 3.6% versus the FFR group 3.7% (risk difference, −0.2 percentage points; 95% CI: −2.7 to 2.4) | Target vessel revascularization was defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as 5 mm within the revascularized segment. Use of an adjudication committee: yes | Revasc.: n = 10 Total: n = 31 Revasc./total: 32.3% |
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| NOBLE [56] | Patients with left main CAD, stable angina, UA, or NSTEMI (n = 1,201) | PCI versus CABG for treatment of left main CAD | A composite of all-cause mortality, nonprocedural Ml, any repeat coronary revascularization, and stroke | PCI 29.0% versus CABG 19.0% (HR 1.48, 95% CI: 1.11 −1.96, p = 0.007) | Repeat revascularizations were categorized as target lesion revascularization, left main coronary artery target lesion revascularization, or de-novo lesion revascularization. Use of an adjudication committee: yes |
Revasc.: n = 118 Total: n = 202 Revasc./total: 58.4% |
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| FAME-2 [57] | Patients with stable CAD for whom PCI was being considered and in whom at least one stenosis was functionally significant (n = 1,220) | PCI versus medical therapy | A composite of death, Ml, or urgent revascularization | PCI 4.3% versus medical therapy 12.7% (HR with PCI 0.32; 95% CI: 0.19–0.53; p < 0.001) | Defined as unexpectedly hospitalization because of persisting or increasing complaints of chest pain (with or without ST-T changes, with or without elevated biomarkers) AND revascularization is performed within the same hospitalization. Use of an adjudication committee: yes | Revasc.: n = 56 Total: n = 75 Revasc./total: 74.7% |
ACS, acute coronary syndromes; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CI, confidence interval; CV, cardiovascular; FFR, fractional flow reserve; HR, hazard ratio; MRI, magnetic resonance imaging; NSTEMI, non-ST-elevation myocardial infarction; PCI, percutaneous coronary intervention; Revasc, revascularization; SBP, systolic blood pressure; STEMI, ST-elevation myocardial infarction; UA, unstable angina.