Coronary Intervention Trials

By Steven Lome

ASCERT Trial

Evaluated percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in a retrospective manner with a primary endpoint of all cause mortality. CABG reduced all cause mortality at 4 years compared to PCI. At 1 year there was no difference in all cause mortality. More detail

BARI-2D Trial

Evaluated percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) with a medical therapy control arm in a randomized fashion in patients with diabetes mellitus type II and severe coronary disease. Revascularization (either by PCI or CABG) did not reduce mortality or cardiovascular events compared to medical therapy. CABG reduced cardiovascular events while PCI did not reduce the primary endpoint (mortality) or the secondary endpoint (composite rate of death, MI or stroke). More detail

COMPARE Trial

Evaluated everolimus stents (2nd generation) versus paclitaxel stents (1st generation) in patients with coronary disease undergoing percutaneous coronary intervention (PCI). The primary composite endpoint of major adverse cardiac events (including cardiac death, nonfatal MI, and target vessel revascularization) was reduced by everolimus stents. There was less in-stent thrombosis with everolimus stents even though fewer patients in this arm were on dual antiplatelet therapy. More detail

COURAGE Trial

Evaluated percutaneous coronary intervention (PCI) using bare metal stents versus optimal medical therapy in patients with stable coronary artery disease or Canadian Cardiovascular Society (CCS) class IV anginal symptoms. The primary endpoint of composite all-cause mortality and nonfatal MI was not different in the two groups. There was no difference in hospitalization for acute coronary syndromes. PCI resulted in better symptom relief compared to medical therapy at 24 months, however this disappeared at 36 months likely from progression of the coronary disease. PCI was not found to be cost-effective compared to medical therapy. More detail

FAME TRIAL

Evaluated using fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) versus standard therapy in patients with at least 2 stenosis of 50% or greater in major coronary vessels. The primary composite endpoint of all-cause mortality, nonfatal MI or coronary artery bypass grafting or repeat PCI was significantly reduced in the FFR guided PCI group. More detail

FAME-2 Trial

Evaluated using fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) versus best medical therapy. The primary endpoint of composite all-cause mortality, nonfatal MI or unplanned hospitalization leading to urgent PCI was significantly reduced in the FFR guided PCI group. More detail

FREEDOM Trial

Evaluated coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in diabetic patients with 3-vessel coronary disease. The primary composite endpoint of all cause mortality, non-fatal MI and non-fatal stroke was  reduced with CABG, but not PCI at 5 years. There was decreased mortality and MI in CABG patients, however increased stroke. More detail

HORIZONS-AMI

Evaluated bivalirudin versus unfractionated heparin with abciximab during ST elevation MI at 30 days. Bivalirudin had fewer adverse events, less major bleeding and reduced death from cardiac causes. There was no difference in major adverse cardiac events (MACE) or stent thrombosis at 30 days. Subsequent follow-up confirmed at 1 and 3 years the benefit of bivalirudin. Paclitaxel stent versus bare metal stent was also evaluated for efficacy. Paclitaxel stents had significantly reduced ischemia driven revascularization at 1 and 3 years compared to bare metal stents. There is no mortality benefit and no difference in stent thrombosis. More detail

NORDISTEMI Trial

Patients with delayed presentation of MI (symptoms for at least 6 hours) treated with immediate percutaneous coronary intervention (PCI) versus thrombolysis with possible rescue PCI if clinically indicated. Primary endpoint of composite death, reinfarction, stroke or new ischemia at 30 days was reduced, but not at 12 months. Secondary endpoint of composite death, stroke and reinfarction was reduced at 12 months, but not 30 days. There was no difference in bleeding in both groups. More detail

PARTNER Trial

Evaluated transcatheter aortic valve replacement (TAVR or TAVI) versus standard surgical aortic valve replacement. The primary endpoint of all-cause mortality was the same in both groups. Symptoms and stroke risk the same. There was a decrease in mortality in a subgroup of patients who were not candidates for surgical intervention, but underwent TAVR. More detail

PRODIGY Trial

Evaluated 6 months versus 24 months of dual antiplatelet therapy in patients undergoing coronary stenting. The primary composite endpoint of all-cause mortality, MI or stent thrombosis was not different (24 months of dual antiplatelet therapy non-superior) regardless of stent type (drug eluting or bare metal). More detail

RAVEL Trial

Evaluated sirolimus versus bare metal stents. The primary endpoint of major adverse cardiac events (cardiovascular death, nonfatal MI and target vessel revascularization) was reduced with sirolimus stents. There was reduced angiographic stenosis at 1 year. More detail

RIVAL Trial

Evaluated radial access versus femoral access during coronary angiography. The primary composite endpoint of death, MI, stroke, or non-CABG related bleeding at 30 days was not different in the two groups. There were fewer vascular complications with radial access. More detail

SYNTAX Trial

Evaluated coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI). The primary endpoint of composite death from any cause, stroke, MI or repeat revascularization at 12 months was not different in the two groups, however PCI had higher cardiovascular death and revascularization rates than CABG. More detail

TACTICS TIMI-18 Trial

Patients with unstable angina and non-ST elevation myocardial infarction (NSTEMI) were randomized to early invasive versus initial conservative strategies. The early invasive strategy reduced the primary endpoint of composite death, nonfatal MI and rehospitalization for an acute coronary syndrome only in the patients that were troponin positive. The troponin negative patients did not receive benefit from an early invasive strategy. When the TIMI risk score was utilized, those with a score > 3 had the most benefit from an early invasive strategy. If the TIMI risk score was < 2, then there was no difference between early invasive and initial conservative management in terms of the primary endpoint. More detail

TAPAS Trial

Patients with ST elevation MI were randomized to thrombus aspiration versus conventional percutaneous coronary intervention (PCI). The primary endpoint of postprocedure myocardial blush grade 0 or 1 was reduced with thrombus aspiration. Reduced mortality at 30 days and 1 year was seen with thrombus aspiration. More detail

TAXUS-IV Trial

Evaluated paclitaxel stents versus bare-metal stents. The primary endpoint of ischemia driven target vessel revascularization at 9 months was significantly reduced with paclitaxel stents. More detail