Predictors of outcomes in medically treated patients with acute coronary syndromes after angiographic triage: an Acute Catheterization And Urgent Intervention Triage Strategy (ACUITY) substudy.

BACKGROUND: Outcomes of patients presenting with acute coronary syndromes are improved with an early invasive approach; however, approximately one third of these patients are treated medically after angiographic screening. We sought to assess the predictors of adverse cardiac events in patients with acute coronary syndrome assigned to medical management. METHODS AND RESULTS: This substudy of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial included 4491 acute coronary syndrome patients treated medically after angiographic triage. Rates of bleeding and composite ischemia (death, myocardial infarction, revascularization) were compared among the 3 antithrombotic treatment arms. Composite ischemia occurred in 399 patients (9.5%) at 1 year. Treatment with bivalirudin glycoprotein IIb/IIIa inhibitors significantly reduced major bleeding at 30 days (2.5% bivalirudin monotherapy; P=0.005, 2.0% bivalirudin plus glycoprotein IIb/IIIa inhibitors; P=0.0002 versus 4.4% heparin with glycoprotein IIb/IIIa inhibitors). Composite ischemic events at 1 year were not significantly different in the 3 groups (bivalirudin monotherapy, 9.6%; bivalirudin plus glycoprotein IIb/IIIa inhibitors, 9.7%; heparin plus glycoprotein IIb/IIIa inhibitors, 9.1%). Independent predictors of composite ischemia were mostly angiographic factors at 30 days, including jeopardy score and coronary ectasia, and at 1 year, including previous percutaneous coronary intervention, jeopardy score, coronary ectasia, and increasing number of diseased vessels. CONCLUSIONS: Among the ACUITY acute coronary syndrome patients treated medically after angiographic triage, bivalirudin therapy significantly reduced bleeding complications compared with heparin without any negative impact on ischemic outcomes at 1 year. The most powerful predictors of ischemic outcomes were angiographic rather than traditional clinical parameters, supporting the early use of angiographic screening in the moderate- and high-risk but medically treated acute coronary syndrome population. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158.

Quantitative angiographic methods for bifurcation lesions: a consensus statement from the European Bifurcation Group.

The treatment of bifurcation lesions is complex and increasingly common. A growing number of dedicated bifurcation devices are under clinical evaluation, but no standardized methodology exists. Specifically, the angiographic analysis of bifurcation lesions is not standardized and current QCA packages are not designed for bifurcation lesions. This consensus statement outlines the limitations of conventional QCA in the bifurcation application, and outlines a new standard approach for the analysis and reporting of the angiographic results of the bifurcation lesion allowing for future trial and device comparisons and mechanistic insight into location and modes of treatment failure.

Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.

BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85+/-57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The in-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P=0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.

BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART Stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART Stents and 18 patients received uncoated SMART Stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The instent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P = 0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P = 0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART Stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.

Combined NIRS and IVUS imaging detects vulnerable plaque using a single catheter system: a head-to-head comparison with OCT.

AIMS: The presence of thin-cap fibroatheromas (TCFA) is associated with high risk of acute coronary syndrome, hence their early detection may identify high-risk patients. In the present study we investigated the ability of a combined imaging catheter with near-infrared spectroscopy (NIRS) plus intravascular ultrasound (IVUS) to detect TCFA in patients with stable coronary artery disease. METHODS AND RESULTS: Optical coherence tomography (OCT) and combined NIRS-IVUS assessment were performed on identical coronary segments. IVUS analysis provided per-segment minimal cross-sectional area (CSA), plaque length (PL), plaque burden (PB), plaque volume (PV), and remodelling index (RI). OCT was used as the gold-standard reference to define TCFA (fibrous cap thickness <65 µm). Plaque lipid content was estimated by NIRS (lipid core burden index [LCBI]). OCT-defined TCFA was present in 18 of 76 segments. IVUS revealed that OCT-defined TCFA were positively remodelled lesions with greater PB and PV, smaller CSA, and longer PL, while NIRS revealed greater LCBI per 2 mm segment (LCBI2mm) (all p<0.001). Greatest accuracy for OCT-defined TCFA detection was achieved using LCBI2mm >315 with RI >1.046 as a combined criterion value. CONCLUSIONS: OCT-defined TCFA are characterised by positive vessel remodelling, high plaque burden and greater lipid core burden as assessed by dual NIRS-IVUS imaging.

Relationship between ST-segment recovery and clinical outcomes after primary percutaneous coronary intervention: the HORIZONS-AMI ECG substudy report.

BACKGROUND: In patients with ST-segment elevation myocardial infarction undergoing thrombolytic therapy, the degree of ST-segment resolution (STR) correlates with long-term cardiovascular mortality. The long-term predictive value of STR after primary percutaneous coronary intervention (PCI) is less well understood. We sought to determine the long-term prognostic value of STR after primary PCI in ST-segment-elevation myocardial infarction. METHODS AND RESULTS: In a formal substudy from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, 2484 patients with ST-segment-elevation myocardial infarction undergoing primary PCI with interpretable baseline and 60-minute post-PCI electrocardiograms had at least 1 mm of baseline ST-segment elevation in ≥2 contiguous leads. Patients were categorized by the degree of STR at 60 minutes: (1) complete (>70%); (2) partial (30%-70%); and (3) absent (<30%). Absent, incomplete, and complete STR were achieved in 514 (20.7%), 712 (28.7%), and 1258 (50.5%) patients, respectively. STR <30% was associated with a greater likelihood of hypertension, diabetes mellitus, longer symptom onset to balloon time, lower left ventricular ejection fraction, and final thrombolysis in myocardial infarction flow <3. At 3 years, patients with STR<30% experienced a higher rate of major adverse cardiovascular events (death, reinfarction, ischemia-driven target vessel revascularization or stroke; 29.9% versus 20.1% versus 19.6%; P<0.0001), ischemia-driven target vessel revascularization (20.4% versus 14.0% versus 11.7%; P<0.001), and mortality (8.4% versus 5.0% versus 5.6%; P=0.03) than those with partial and complete STR, respectively. By multivariable analysis, STR<30% was an independent predictor of 3-year major adverse cardiovascular events (hazard ratio, 1.58; 95% confidence interval, 1.24-2.00; P=0.0002) and 3-year ischemia-driven target vessel revascularization (hazard ratio, 1.87; 95% confidence interval, 1.41-2.48; P<0.0001). CONCLUSIONS: In this large international study, absent STR 60 minutes after primary PCI was present in ≈1 in 5 patients with ST-segment-elevation myocardial infarction and was a significant independent predictor of major adverse cardiovascular events and target vessel revascularization at 3 years.

Impact of gender and antithrombin strategy on early and late clinical outcomes in patients with non-ST-elevation acute coronary syndromes (from the ACUITY trial).

Women with non-ST-elevation acute coronary syndrome are at increased risk for ischemic and bleeding complications compared with men. We examined the impact of gender and antithrombotic therapy for non-ST-elevation acute coronary syndrome on outcomes in patients in the ACUITY trial. Patients were randomized to heparin (unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin alone. We compared major bleeding unconnected to coronary artery bypass grafting, composite ischemia (death, myocardial infarction, or revascularization), and net clinical outcome (composite ischemia or bleeding) in (1) men versus women overall and undergoing percutaneous coronary intervention (PCI) and (2) women overall and undergoing PCI by antithrombotic strategy. Of 13,819 patients enrolled, 4,157 were women (30.1%). Women had similar 30-day composite ischemia (7% vs 8%, p = 0.07) but greater 30-day rates of major bleeding (8% vs 3% p <0.0001) and net clinical outcomes (13% vs 10% p <0.0001) than men. One-year composite ischemia and mortality was similar. In women, bivalirudin compared with heparin + GPI resulted in less 30-day major bleeding (5% vs 10%, p <0.0001) but similar composite ischemia (7% vs 6%, p = 0.15). No differences were observed in rates of 1-year composite ischemia or mortality in women who received bivalirudin versus heparin + GPI. Results were similar in women undergoing PCI. In conclusion, women had similar 30-day mortality and composite ischemia but higher net clinical adverse events due to more bleeding complications than men; 1-year mortality was similar for men and women. In women, bivalirudin monotherapy compared with a GPI-based strategy resulted in significantly decreased bleeding but similar rates of 1-year composite ischemia and mortality.