Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.

BACKGROUND: The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. METHODS: Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. RESULTS: The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). CONCLUSIONS: Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.

Myocardial perfusion imaging evidence of functionally complete revascularization by minimally invasive direct coronary artery bypass in 2-vessel coronary artery disease.

BACKGROUND: Whether patency of a second diseased vessel still impacts myocardial perfusion when complete revascularization of the left anterior descending coronary artery (LAD) territory has been achieved is currently undetermined. In patients with 2-vessel coronary artery disease and complex LAD lesions, we evaluated the impact of single LAD or integrated revascularization on single photon emission computed tomography-assessed reversible myocardial ischemia. METHODS AND RESULTS: Thirty-five candidates for revascularization with double-vessel disease including the LAD and a preoperative stress single photon emission computed tomography study were studied. Revascularization was performed by minimally invasive direct coronary artery bypass (MIDCAB) alone (n = 15) or by an integrated procedure with second-vessel angioplasty, either soon after surgery (n = 13) or at 2 months (n = 7), according to the extent of reversible perfusion defects in the second vessel territory. At 1 year, the total ischemic area decreased from 9.3 +/- 5.1 to 0.8 +/- 1.5 in MIDCAB-only patients and from 8.2 +/- 4.9 to 1.6 +/- 2.9 in the integrated group (P = .87 for treatment and P < .001 for time). The ischemic area in the second vessel territory similarly decreased in both groups (P = .81 for treatment and P < .001 for time). CONCLUSIONS: In 2-vessel coronary artery disease involving the LAD, MIDCAB alone achieves, in a substantial proportion of patients, functionally complete revascularization even in the nonrevascularized second vessel territory.

The Virtual histology In CaroTids Observational RegistrY (VICTORY) study: a European prospective registry to assess the feasibility and safety of intravascular ultrasound and virtual histology during carotid interventions.

BACKGROUND: Carotid occlusive disease is the most common determinant of thromboembolic stroke. However, limited insights in vivo into the pathophysiology and pathology of carotid plaques are available. We designed a prospective multicenter registry to appraise the safety and feasibility of intravascular ultrasound (IVUS) and IVUS-virtual histology (IVUS-VH) imaging before and immediately after carotid stenting. METHODS: Symptomatic and asymptomatic patients scheduled for carotid stenting were included. IVUS-VH pullbacks were performed before and after stenting. Angiographic, IVUS and IVUS-VH analyses were performed. The primary objective was to appraise feasibility and safety of IVUS-VH, and secondary objectives were to correlate plaque composition and plaque type derived from IVUS-VH with acute and 30-day complications. RESULTS: A total of 119 patients were enrolled. IVUS-VH could be performed in all cases (100%), with additional runs after completion of the stenting procedure in 85%. Most plaques were stable by IVUS-VH, with vulnerable ones at minimum lumen area in 7%. Conversely, vulnerable plaques were significantly more common elsewhere in the internal carotid artery (ICA, 24% of patients, p<0.001). Acute and 30-day adverse events were uncommon (2 strokes, 1 transient ischemic attack), with no significant association between these and IVUS-VH features. CONCLUSIONS: IVUS and IVUS-VH examinations during carotid interventions are feasible and safe, and provide important insights on qualitative and quantitative compositions of carotid plaques. Whether carotid IVUS-VH can predict clinical events remains uncertain, awaiting long-term follow-up of the VICTORY study and additional clinical trials.