Trials comparing drug-eluting stent (DES) with CABG in diabetic subjects
| Trial | Patients | Primary endpoint | Intervention | Results |
|---|---|---|---|---|
| ARTS II27 | Diabetic patients treated with SES. Multivessel disease that included treatment of the left anterior descending artery and at least one other significant lesion (50% diameter stenosis) in another major epicardial coronary artery | MACCE | Three-year clinical outcome was compared with that of the historical diabetic and non-diabetic arms of the randomised ARTS-I trial | In patients with diabetes, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR 0.67, 95% CI 0.27 to 1.65) and was similar to that of ARTS-I CABG |
| CARDIA37 | Diabetes. Multivessel CAD (two or more stenotic coronary or one in which PCI suitability is unclear. Consensus between a cardiologist and surgeon that adequate revascularisation can be achieved | Death, non-fatal MI or stroke within 1 year | Optimal PCI includes the use of aspirin, clopidogrel, abciximab and SESs in all patients. Modern CABG: defined as one or more arterial conduit with a LIMA graft for the anterior native vessels and off-pump bypass at the surgical team’s discretion | Composite rate of death, MI and stroke: 10.5% in the CABG group and 13.0% in the PCI group (HR 1.25, p=0.39), all-cause mortality rates: 3.2% and 3.2%. Rates of death, MI, stroke or repeat revascularisation were 11.3% and 19.3% (HR 1.77, p=0.02). CABG when compared with drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR 0.93, p=0.82). Could not prove PCI non-inferiority |
| PRECOMBAT38 | Inclusion: LMCA stenosis ≥50% (visual estimate); angina or documented ischaemia amenable to both PCI or CABG; lesions outside LMCA amenable to both PCI or CABG. Exclusion: previous PCI (≥12 months); previous LMCA PCI; previous CABG; LVEF ≤20%; NYHA heart failure class III or IV | All-cause mortality, MI and stroke at 2 years | Randomisation CABG vs PCI (30% diabetics) | Primary end point: 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs 8.1%; hazard ratio with PCI, 1.50; 95% CI 0.90 to 2.52; p=0.12). Ischaemia-driven target-vessel revascularisation: 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs 4.2%; HR, 2.18; 95% CI 1.10 to 4.32; p=0.02) |
| FREEDOM39 | Diabetes. Multivessel CAD (two or more lesions in major arteries), amenable to either PCI with DES or surgical revascularisation. | All-cause mortality, MI and stroke | Compared multivessel stenting using SESs with CABG superiority trial | Primary composite end point: PCI 26.6% vs CABG 18.7%, p value=0.005 Death from any cause: PCI 16.3% vs CABG 10.9%, p value=0.049 Myocardial infarction: PCI 13.9% vs CABG 6.0%, p value <0.001 Stroke: PCI 2.4% vs CABG 5.2%, p value=0.03 Cardiovascular death: PCI 10.9% vs CABG 6.8%, p value=0.12 |
ARTS, Arterial Revascularization Therapies Study; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CVA, cerebrovascular accident; LVEF, left ventricular ejection fraction; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary interventions; SES, sirolimus-eluting stent.