Louis Roy

A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation

Background— Systematic use of coronary stents and optimized platelet aggregation inhibition has greatly improved the short-term results of percutaneous coronary interventions. Transradial percutaneous coronary interventions have been associated with a low risk of bleeding complications. It is unknown whether moderate- and high-risk patients can be discharged safely the same day after uncomplicated transradial percutaneous coronary interventions. Methods and Results— We randomized 1005 patients after a bolus of abciximab and uncomplicated transradial percutaneous coronary stent implantation either to same-day home discharge and no infusion of abciximab (group 1, n=504) or to overnight hospitalization and a standard 12-hour infusion of abciximab (group 2, n=501). The primary composite end point of the study was the 30-day incidence of any of the following events: death, myocardial infarction, urgent revascularization, major bleeding, repeat hospitalization, access site complications, and severe thrombocytopenia. The noninferiority of same-day home discharge and bolus of abciximab only compared with overnight hospitalization and abciximab bolus and infusion was evaluated. Two thirds of patients presented with unstable angina and ≈20% presented with high-risk acute coronary syndrome prior to the procedure. The incidence of the primary end point was 20.4% in group 1 and 18.2% in group 2 (P=0.017 for noninferiority) with a troponin T–based definition of myocardial infarction; the incidence of the primary end point was 11.1% in group 1 and 9.6% in group 2 (P=0.0004 for noninferiority) with a creatinine kinase myocardial band–based definition of myocardial infarction. No death occurred. Rate of major bleeding in both groups was extremely low at 0.8% and 0.2%, respectively. From 504 patients randomized in group 1, 88% were discharged home the same day. Conclusion— Our data suggest that same-day home discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day home discharge after uncomplicated coronary intervention.

Increased Formation of the Isoprostanes IPF2α-I and 8-Epi-Prostaglandin F2α in Acute Coronary Angioplasty Evidence for Oxidant Stress During Coronary Reperfusion in Humans

Background The role of oxidant stress in cardiac ischemia/reperfusion injury in humans remains controversial. This is due, in part, to the limitations of available indices of oxidant stress in vivo. Isoprostanes are stable, free radical–catalyzed products of arachidonic acid. We assessed their formation in patients undergoing coronary reperfusion via percutaneous transluminal coronary angioplasty (PTCA). Methods and Results We developed specific, mass spectrometry assays for two structurally distinct F2 isoprostanes, 8-epi-PGF2α and IPF2α-I. Urine samples for isoprostane determination were collected in patients undergoing coronary arteriography (n=11), elective PTCA (n=15), and angiography after thrombolysis for acute myocardial infarction (MI) (n=10). Urinary levels (pmol/mmol creatinine) of both isoprostanes were markedly increased from baseline in the first 6 hours after PTCA for acute MI (105±17.8 versus 230±66 for 8-epi-PGF2α [P=.009] and 466±91 versus 833±153 for IPF2α-I [P=.001]) and returned towar...

Predicting Late Myocardial Recovery and Outcomes in the Early Hours of ST-Segment Elevation Myocardial Infarction : Traditional Measures Compared With Microvascular Obstruction, Salvaged Myocardium, and Necrosis Characteristics by Cardiovascular Magnetic Resonance

OBJECTIVES The aim of this study was to determine whether a very early imaging strategy improves the prediction of late systolic dysfunction and poor outcomes in ST-segment elevation myocardial infarction (STEMI) compared with traditional predictors. BACKGROUND Earlier prediction of poor outcomes after STEMI is desirable, because it will allow tailored therapy at the earliest possible time, when benefits might be greatest. METHODS One hundred and three patients with acute STEMI were studied by contrast-enhanced cardiovascular magnetic resonance within 12 h of primary angioplasty and at 6 months and followed >2 years. The primary end point was left ventricular (LV) dysfunction, whereas poor outcomes were a key secondary end point. RESULTS Traditional risk factors were only modest predictors of late LV dysfunction. Late gadolinium enhancement (LGE) volume maintained a stronger association to LV ejection fraction change than infarct transmurality, microvascular obstruction, or myocardial salvage during STEMI (p = 0.02). Multivariable logistic regression identified LGE volume during STEMI as the best predictor of late LV dysfunction (odds ratio: 1.36, p = 0.03). An LGE >or=23% of LV during STEMI accurately predicted late LV dysfunction (sensitivity 89%, specificity 74%). The LGE volume provided important incremental benefit for predicting late dysfunction (area under the curve = 0.92, p <or= 0.03 vs. traditional risk factors). Twenty-three patients developed poor outcomes (1 death, 2 myocardial infarctions, 5 malignant arrhythmias, 4 severe LV dysfunction <35%, 11 hospital stays for heart failure) over 2.6 +/- 0.9 years; LGE volume remained a strong independent predictor of poor outcomes, whereas LGE >or=23% carried a hazard ratio of 6.1 for adverse events (p < 0.0001). CONCLUSIONS During the hyperacute phase of STEMI, LGE volume provides the strongest association and incremental predictive value for late systolic dysfunction and discerns poor late outcomes.

Nonrandomized Comparison of Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention for the Treatment of Unprotected Left Main Coronary Artery Disease in Octogenarians

Background— The objective of the present study was to compare the midterm follow-up results of percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG) for the treatment of unprotected left main coronary artery disease in octogenarians. Methods and Results— A total of 249 consecutive patients ≥80 years of age diagnosed with left main coronary artery disease underwent coronary revascularization in our center between January 2002 and January 2008; 145 patients underwent CABG, and 104 patients had PCI. Major adverse cardiac and cerebrovascular events (MACCE [cardiac death, myocardial infarction, cerebrovascular event, revascularization]) were evaluated at a mean follow-up of 23±16 months. Patients who underwent PCI were older; had higher creatinine levels, lower ejection fraction, and higher EuroSCORE; and presented more frequently with an acute coronary syndrome. Drug-eluting stents were used in 48% of PCI patients. A propensity score analysis was performed to adjust for baseline differences between the 2 groups. Survival free of cardiac death or myocardial infarction (PCI, 65.4%; CABG, 69.7%) and MACCE-free survival (PCI, 56.7%; CABG, 64.8%) at follow-up were similar between the groups (adjusted hazard ratio for survival free of cardiac death or myocardial infarction, 1.28; 95% CI, 0.64 to 2.56; P=0.47; adjusted hazard ratio for MACCE-free survival, 1.11; 95% CI, 0.59 to 2.0; P=0.73). The EuroSCORE value was an independent predictor of MACCE regardless of the type of revascularization (hazard ratio, 1.17 for each EuroSCORE increase of 1 point; 95% CI, 1.09 to 1.25; P<0.0001). Conclusions— In this single-center, nonrandomized study, there were no significant differences in cardiac death or myocardial infarction and MACCE between CABG and PCI for the treatment of left main coronary artery disease in octogenarians after a mean follow-up of 2 years. Baseline EuroSCORE was the most important predictor of MACCE regardless of the type of revascularization. Randomized studies comparing both revascularization strategies in this high-risk coronary population are warranted.

Double-blind, randomized, controlled trial of fish oil supplements in prevention of recurrence of stenosis after coronary angioplasty.

BackgroundPrevious studies suggest that recurrence of coronary stenosis after percutaneous transluminal coronary angioplasty (PTCA) might be prevented with dietary supplements rich in ω-3 fatty acids. The purpose of the present study was to evaluate this hypothesis. In addition, the relation between usual dietary consumption of ω-3 fatty acids and restenosis was assessed. Methods and ResultsA double-blind, randomized, controlled trial was conducted in which 205 patients undergoing a first PTCA received 15 capsules per day containing 1 g of either fish oil (2.7 g/day of eicosapentaenoic acid, 1.8 g/day of docosahexaenoic acid) or olive oil. The treatment was started 3 weeks before PTCA and continued for 6 months thereafter. Dietary intake was assessed by food frequency questionnaire. At 6 months after PTCA, patients underwent a control angiography. All angiographic lesions were measured by quantitative computer analysis. Four criteria were used to define restenosis. Restenosis occurred less often in the fish oil group (22.0–35.6% depending on the definition) than in the control group (40.0–53.3%). After controlling for other risk factors of restenosis, the association of fish oil supplementation with a lower frequency of restenosis was statistically significant (p = 0.03) for three of four definitions. After adjustment, a dietary intake of ω-3 fatty acids of more than 0.15 g/day was also associated with a lower frequency of restenosis (p≤0.03). ConclusionsThis trial documented the protective effect of fish oil supplements on the recurrence of coronary stenosis 6 months after PTCA. The study results suggest that a dietary intervention could be useful in preventing restenosis.

Chronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents Comparison With Bare Metal Stents by Serial Intravascular Ultrasound Analyses: Data From the Randomized TAXUS-II Trial

Background—Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial. Methods and Results—TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA−SA) were measured. NIHA was significantly reduced in SR (0.7±0.9 mm2, P <0.001) and MR (0.6±0.8 mm2, P <0.001) compared with BMS (1.9±1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5±1.7, 1.0±1.8, and 1.4±2.0 mm2, respectively; P <0.001). The increase in peristent area was directly correlated with increases in VA. Conclusions—Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.

Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy

BACKGROUND Bleeding has recently emerged as predictor of early and late mortality after percutaneous coronary intervention (PCI) using femoral approach. Transradial PCI is associated with a lower risk of access-site complications than femoral approach. We evaluated the predictors of bleeding and the impact of major bleeding on death and major adverse cardiac events (MACE) after transradial PCI and maximal antiplatelet therapy. METHODS In the EASY (EArly discharge after transradial Stenting of coronarY arteries) trial, 1,348 patients with acute coronary syndrome were enrolled and underwent transradial PCI. All patients received clopidogrel (90% > or =12 hours pre-PCI) and a bolus of abciximab before first balloon inflation. Univariate and multivariate analyses to identify predictors and prognostic impact of major bleeding on death and MACE (death, myocardial infarction, and target vessel revascularization) were performed. RESULTS From the study population, 19 (1.4%) patients presented major bleeding. Patients with bleeding were older, had lower creatinine clearance, more often had 3-vessel disease and > or =3 dilated sites, and had longer procedures. Independent predictors of bleeding were creatinine clearance <60 mL/min (odds ratio [OR] 3.26, 95% confidence interval [CI] 1.10-8.67, P = .022), procedure duration (OR 2.95, 95% CI 1.12-8.31, P = .032), and sheath size (OR 5.34, 95% CI 1.44-34.65, P = .029). In patients with major bleeding, the incidence of MACE was higher at 30 days (37% vs 3%), 6 months (42% vs 8%), and 12 months (53% vs 12%; P < .0001 for all comparisons). By multivariate analysis, major bleeding was an independent predictive factor of 1-year mortality and MACE. CONCLUSION After transradial PCI and maximal antiplatelet therapy, the incidence of major bleeding remains low. Major bleeding is an independent predictive factor of adverse acute and 1-year outcomes, regardless of the access site.

Impact of female gender and transradial coronary stenting with maximal antiplatelet therapy on bleeding and ischemic outcomes

BACKGROUND Female gender has been associated with poorer outcomes after percutaneous coronary intervention (PCI) and femoral approach. However, no data are available on the impact of gender and transradial PCI with maximal antiplatelet therapy on bleeding and ischemic outcomes. METHODS In the EArly discharge after Stenting of coronarY arteries (EASY) trial, 1,348 patients with acute coronary syndrome underwent transradial PCI. All patients were pretreated with aspirin and clopidogrel. After sheath insertion, 70 U/kg heparin was administered and a bolus of abciximab was given before first balloon inflation. Major adverse cardiac events including death, myocardial infarction, and target vessel revascularization; major bleeding; and local hematomas were evaluated at 30 days, 6 months, and 12 months. RESULTS Women (n = 298, 22%) were older, had more hypertension, more family history, and less previous PCI than men. Weight, baseline hemoglobin, and creatinine clearance were significantly lower in women. The number of dilated sites, complex lesions, and procedure duration was similar, but 5F sheath size was more frequent in women. Major adverse cardiac events remained similar at 30 days (3.4% vs 3.9%, P = .86), at 6 months (11.5% vs 7.8%, P = .06), and at 1 year (14.1% vs 12.6%) in both groups. There was no significant difference in the incidence of major bleeding between the 2 groups, but female gender was the only independent predictor of hematomas (odds ratio 4.40, 95% confidence interval 2.49-7.81, P < .0001). CONCLUSION Despite more comorbidities, female gender was not a predictor of adverse clinical outcomes after transradial PCI with maximal antiplatelet therapy. Still, female gender remained associated with a higher risk of local hematomas. Efforts should continue to identify modifiable factors to reduce procedural bleeding in women, regardless of the access site.

Comparison of Plaque Sealing With Paclitaxel-Eluting Stents Versus Medical Therapy for the Treatment of Moderate Nonsignificant Saphenous Vein Graft Lesions: The Moderate VEin Graft LEsion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) Pilot Trial

Background— The presence of moderate saphenous vein graft (SVG) lesions is a major predictor of cardiac events late after coronary artery bypass grafting. We determined the effects of sealing moderate nonsignificant SVG lesions with paclitaxel-eluting stents (PES) on the prevention of SVG atherosclerosis progression. Methods and Results— Patients with at least 1 moderate SVG lesion (30% to 60% diameter stenosis) were randomized either to stenting the moderate SVG lesion with a PES (n=30, PES group) or to medical treatment alone (n=27, medical treatment group). Patients had an angiographic and intravascular ultrasound evaluation of the SVG at baseline and at 12-month follow-up. The primary end points were (1) the ultrasound SVG minimal lumen area at follow-up and (2) the changes in ultrasound atheroma volume in an angiographically nondiseased SVG segment. Mean time from coronary artery bypass grafting was 12±6 years, and mean low-density lipoprotein cholesterol level was 73±31 mg/dL. A total of 70 moderate SVG lesions (39±7% diameter stenosis) were evaluated. Significant disease progression occurred in the medical treatment group at the level of the moderate SVG lesion (decrease in minimal lumen area from 6.3±3.0 to 5.6±3.1 mm2; P<0.001), leading to a severe flow-limiting lesion or SVG occlusion in 22% of the patients compared with none in the PES group (P=0.014). In the PES group, mean minimal lumen area increased (P<0.001) from 6.1±2.2 to 8.6±2.9 mm2 at follow-up (P=0.001 compared with the medical treatment group at 12 months). There were no cases of restenosis or stent thrombosis. No significant atherosclerosis progression occurred at the nonstented SVG segments. At 12-month follow-up, the cumulative incidence of major adverse cardiac events related to the target SVG was 19% in the medical treatment group versus 3% in the PES group (P=0.091). Conclusions— Stenting moderate nonsignificant lesions in old SVGs with PES was associated with a lower rate of SVG disease progression and a trend toward a lower incidence of major adverse cardiac events at 1-year follow-up compared with medical treatment alone, despite very low low-density lipoprotein cholesterol values. This pilot study supports further investigation into the role of plaque sealing in SVGs. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT002289835.

Intracoronary compared to intravenous Abciximab and high-dose bolus compared to standard dose in patients with ST-segment elevation myocardial infarction undergoing transradial primary percutaneous coronary intervention: a two-by-two factorial placebo-controlled randomized study.

Platelet aggregation inhibition (PAI) of > or =95% has been associated with improved outcomes after percutaneous coronary intervention (PCI) and glycoprotein IIb/IIIa inhibitor treatment. A greater thrombotic burden in acute ST-segment elevation myocardial infarction (STEMI) might require higher doses and/or intracoronary delivery of glycoprotein IIb/IIIa inhibitors to achieve optimal PAI. Using a 2 x 2 factorial placebo-controlled design, 105 patients with STEMI who had been referred for primary PCI within 6 hours of symptom onset were randomized to intracoronary (IC) or intravenous (IV) delivery of an abciximab bolus at a standard dose (0.25 mg/kg) or high dose (> or =0.30 mg/kg) of abciximab. The primary end point was PAI measured at 10 minutes after the bolus of abciximab. Secondary end points included the acute and 6-month outcomes using angiographic parameters, cardiac biomarkers, cardiovascular magnetic resonance imaging, and clinical end points. At 10 minutes after the bolus, the proportion of patients with > or =95% PAI was not different between the IC and IV groups (53% vs 54%, p = 1.00) nor between the high-dose and standard-dose bolus groups (56% vs 51%, p = 0.70). Acutely, the angiographic myocardial blush grades, peak release of cardiac biomarkers, necrosis size, myocardial perfusion, and no reflow as assessed by magnetic resonance imaging, and clinical end points were similar between the groups and did not suggest a benefit for IC compared to IV or high-dose versus standard-dose bolus of abciximab. No increase occurred in bleeding complications with the high-dose bolus or IC delivery. The clinical, angiographic and cardiac magnetic resonance imaging outcomes at 6 and 12 months were similar between the 4 groups. In conclusion, in patients with STEMI presenting with symptom onset <6 hours and undergoing transradial primary PCI, PAI remained suboptimal, despite a higher dose bolus of abciximab. A higher dose bolus or IC delivery of abciximab bolus was not associated with improved acute or late results compared to the standard IV dosing and administration.