Prediction and impact of failure of transradial approach for primary percutaneous coronary intervention.

OBJECTIVES: To determine predictors of failure of transradial approach (TRA) in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and develop a novel score specific for this population. METHODS: Consecutive patients with STEMI undergoing primary PCI in a tertiary care high-volume radial centre were included. TRA-PCI failure was categorised as primary (primary transfemoral approach (TFA)) or crossover (from TRA to TFA). Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Clinical outcomes up to 1 year were assessed. RESULTS: From January 2006 to January 2011, 2020 patients were studied. Primary TRA-PCI failure occurred in 111 (5%) patients and crossover to TFA in 44 (2.2%) patients. Independent predictors of TRA-PCI failure were: weight ≤65 kg (OR: 3.0; 95% CI 1.9 to 4.8, p<0.0001), physician with ≤5% TFA conversion (OR: 0.45; 95% CI 0.2 to 0.9, p=0.033), and physician with ≥10% conversion to TFA (OR: 2.2; 95% CI 1.2 to 3.7, p=0.005), intra-aortic balloon pump (OR: 2.0; 95% CI 0.9 to 4.3, p=0.066), cardiogenic shock (OR: 2.8; 95% CI 1.4 to 5.6, p=0.0035), endotracheal intubation (OR: 107; 95% CI 42 to 339, p<0.0001), creatinine >133 µmol/L (OR: 3.6; 95% CI 1.9 to 6.8, p<0.0001), age ≥75 (OR: 1.7; 95% CI 1.0 to 2.9, p=0.031), prior PCI (OR: 2.6; 95% CI 1.5 to 4.5, p=0.0009), hypertension (OR: 1.8; 95% CI 1.2 to 2.9, p=0.009). An integer risk score ranging from -1 to 12 was developed, and predicted TRA-PCI failure from 0% to 100% (c-statistic of 0.868; 95% CI 0.866 to 0.869). Mortality at 1 year remained significantly higher after TRA-PCI failure (adjusted OR 2.2; 95% CI 1.2 to 3.9, p=0.011). CONCLUSIONS: In a high-volume radial centre, the incidence of TRA-PCI failure is low and can be accurately predicted using a 9-variables risk score. Since outcomes after TRA-PCI failure remained inferior, further effort to maximise the use of radial approach for primary PCI should be investigated.

Changes in CYP2C19 enzyme activity evaluated by the [(13)C]-pantoprazole breath test after co-administration of clopidogrel and proton pump inhibitors following percutaneous coronary intervention and correlation to platelet reactivity.

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is used for the prevention of cardiovascular events following percutaneous coronary intervention (PCI). These agents increase the risk of gastrointestinal bleeding. To prevent these events, proton pump inhibitors (PPI) are routinely prescribed. It has been reported that with the exception of pantoprazole and dexlanzoprazole, PPIs can impede conversion of clopidogrel by cytochrome P450 2C19 (CYP2C19) to its active metabolite, a critical step required for clopidogrel efficacy. Changes in CYP2C19 enzyme activity (phenotype) and its correlation with platelet reactivity following PPI therapy has not yet been fully described. In this study we attempted to determine if the [ (13)C]-pantoprazole breath test (Ptz-BT) can evaluate changes in CYP2C19 enzyme activity (phenoconversion) following the administration of PPI in coronary artery disease (CAD) patients treated with DAPT after PCI. Thirty (30) days after successful PCI with stent placement, 59 patients enrolled in the Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects (SPICE) trial (ClinicalTrials.gov Identifier: NCT00930670) were recruited to participate in this sub study. Patients were randomized to one of 4 antacid therapies (omeprazole, esomeprazole. pantoprazole or ranitidine). Subjects were administered the Ptz-BT and platelet function was evaluated by vasodilator-stimulated phosphoprotein (VASP) phosphorylation and light transmittance aggregometry before and 30 d after treatment with antacid therapy. Patients randomized to esomeprazole and omeprazole had greater high on-treatment platelet reactivity and lowering of CYP2C19 enzyme activity at Day 60 after 30 d of PPI therapy. Patients randomized to ranitidine and pantoprazole did not show any changes in platelet activity or CYP 2C19 enzyme activity. In patients treated with esomeprazole and omeprazole, changes in CYP2C19 enzyme activity (phenoconversion) correlated well with changes in platelet reactivity. Co-administration of omeprazole or esomeprazole in patients treated with clopidogrel results in lower CYP2C19 enzyme activity and increased platelet reactivity as measured by VASP phosphorylation test while patients given pantoprazole or ranitidine did not show any significant changes in CYP2C19 enzyme activity and platelet reactivity.

Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial.

BACKGROUND: Very few data exist on the long-term follow-up of patients with intermediate nonobstructive saphenous vein graft (SVG) lesions. The purpose of this study was to evaluate the 5-year clinical outcomes of the patients enrolled in the Moderate Vein Graft Lesion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) and the factors associated with SVG disease progression and outcomes. METHODS: Patients with ≥ 1 intermediate SVG lesion (30%-60% diameter stenosis) were randomized to either stenting the SVG lesion with a paclitaxel-eluting stent (PES group, n = 30) or to medical treatment alone (MT group, n = 27). All patients were followed yearly up to 5 years. RESULTS: Major adverse cardiac events (MACEs) (cardiac death, myocardial infarction [MI], revascularization) related to the target SVG lesion tended to be lower in the PES group (17% vs 33%; P = 0.146) due to a lower lesion revascularization rate (13% vs 33%; P = 0.072), with no difference in cardiac death or MI between groups. MACEs related to the target SVG and global MACEs were similar between groups (P > 0.20 for both). A higher cholesterol level at baseline was the only independent predictive factor of MACEs related to the target SVG (P = 0.016). CONCLUSIONS: Over a 5-year period, one third of intermediate lesions in old SVGs progressed, leading to a cardiac event. Stenting these lesions with PESs tended to improve clinical outcomes by reducing lesion progression but not SVG failure. Higher cholesterol levels were associated with SVG disease progression and clinical events. This pilot study provides the basis for a larger trial to determine the efficacy of intermediate SVG lesion plaque sealing.

Successive transradial access for coronary procedures: experience of Quebec Heart-Lung Institute.

BACKGROUND: Transradial approach (TRA) for cardiac catheterizations and interventions improves clinical outcomes compared with transfemoral access, and its use is increasing worldwide. However, there are limited data on successive use of same artery for repeat procedures. METHODS: Between May 2010 and May 2011, all consecutive patients undergoing a repeat TRA procedure (≥2) were retrospectively identified. Success rates and reasons for failure to use ipsilateral radial artery for repeat access were identified. RESULTS: A total of 519 patients underwent 1,420 procedures. In 480 patients (92%), right radial artery was used as initial access, and left radial artery, in 39 patients. All patients underwent ≥2 procedures; 218 patients, ≥3; 87 patients, ≥4; 39 patients, ≥5; 19 patients, ≥6; 11 patients, ≥7; and 5 patients, ≥8 procedures. Two patients had, respectively, 9 and 10 procedures. The success rate for second attempt was 93%, 81% for third, and declining to 60% for ≥8. Linear regression analysis estimated a 5% failure rate for each repeat attempt (R(2) = 0.87, P = .007). The main reason for failure was related to clinical radial artery occlusion (RAO) including absent or faint pulse, poor oximetry, and failed puncture. All patients with clinical RAO were asymptomatic. By multivariate analysis, female gender (odds ratio [OR] 3.08, 95% CI 1.78-5.39, P < .0001), prior coronary artery bypass graft (OR 5.26, 95% CI 2.67-10.42, P < .0001), and repeat radial access (OR 2.14, 95% CI 1.70-2.76, P < .0001) were independent predictors of radial access failure. CONCLUSION: Successive TRA is both feasible and safe in most cases for up to 10 procedures. However, failure rate for TRA increases with successive procedures, primarily due to clinical RAO. Strategies to minimize the risks of chronic clinical RAO and allow repeat use of ipsilateral radial artery need to be further defined.

Telephone contact to improve adherence to dual antiplatelet therapy after drug-eluting stent implantation.

BACKGROUND: Many patients delay or interrupt dual antiplatelet therapy (DAT) after drug-eluting stent (DES) implantation, which increases the risk of stent thrombosis and death. OBJECTIVE: To test the hypothesis that simple telephone contact made by nurses would improve adherence to and persistence of DAT. DESIGN: Randomised controlled trial. PATIENTS AND INTERVENTION: A total of 300 patients (mean±SD 64±10 years, 73% male) were recruited immediately after DES implantation performed between June 2009 and June 2010. The last patient recruited reached the 1-year follow-up time point in June 2011. Patients were randomised to one of two groups: intervention, with four telephone follow-ups, versus a control group. In the intervention group, phone calls were made within 7 days of the DES implantation and at 1, 6 and 9 months to support drug adherence. Control patients were followed as per usual clinical practice. Pharmacy data were collected to assess drug prescription filling and refill. SETTING: Tertiary care university cardiovascular centre and community. MAIN OUTCOME MEASURES: The primary end point was the proportion of days covered with aspirin and clopidogrel over the year after discharge as assessed by pharmacy refill data. Secondary outcome measures included persistence of aspirin and clopidogrel treatment, defined as no gaps longer than 14 days during follow-up. RESULTS: Most patients (73%) underwent DES implantation in the context of an acute coronary syndrome. All patients had drug insurance cover, either from the public plan (59%) or through private plans (41%). Complete pharmacy follow-up data were available for 96% of the cohort. At 12 months, median scores (25th-75th centile) for adherence to aspirin and clopidogrel were 99.2% (97.5-100%) and 99.3% (97.5-100%), respectively, in the intervention group compared with 90.2% (84.2-95.4%) and 91.5% (85.1-96.0%), respectively, in the control group (p<0.0001 for aspirin and clopidogrel). Patients in the intervention group were significantly more persistent in the aspirin and clopidogrel treatment than those in the control group. For clopidogrel, 87.2% of patients in the intervention group were still persistent at 12 months compared with only 43.1% in the control group (p<0.0001). CONCLUSIONS: A simple approach of four telephone calls to patients after DES implantation significantly improved 1-year drug adherence to near-perfect scores. Persistence of DAT was also significantly improved by the intervention.

Effect on door-to-balloon time of immediate transradial percutaneous coronary intervention on culprit lesion in ST-elevation myocardial infarction compared to diagnostic angiography followed by primary percutaneous coronary intervention.

Door-to-balloon (DTB) time is an important metric in primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction to optimize clinical outcomes. The aim of this study was to compare the impact of immediate PCI on culprit lesions in patients with ST-segment elevation myocardial infarctions versus diagnostic angiography followed by PCI on DTB times and procedural data at a high-volume tertiary care radial center. All patients who underwent primary PCI <12 hours after symptom onset were studied. Procedural data and all-cause mortality were assessed in all patients. The primary outcome was DTB time. From January 2006 to June 2011, 1,900 patients were included and divided into 2 groups: 562 patients (30%) underwent primary PCI followed by contralateral diagnostic angiography, and 1,338 patients (70%) underwent diagnostic angiography before primary PCI. No significant differences were observed in baseline characteristics. Left anterior descending coronary artery-related ST-segment elevation myocardial infarctions were more often found in patients who underwent PCI first (54% vs 34%, p <0.0001). Overall, there was a reduction of 8 minutes in DTB time between patients who underwent PCI first and those who underwent angiography first (32 minutes [interquartile range 24 to 52] vs 40 minutes [interquartile range 30 to 69], respectively, p <0.0001). After adjustment, immediate PCI remained an independent predictor of DTB time ≤90 minutes (odds ratio 2.42, 95% confidence interval 1.70 to 3.52, p <0.0001). There were no differences in early and late clinical outcomes. In conclusion, a strategy of transradial direct PCI of the infarct-related artery in selected patients before complete coronary angiography was associated with a benefit of 8 minutes in DTB time. Further study is required to determine whether this strategy can favorably affect clinical outcomes.

Deadly association of cardiogenic shock and chronic total occlusion in acute ST-elevation myocardial infarction.

BACKGROUND: The association between cardiogenic shock and 1 or >1 chronic total occlusion (CTO) in unselected patients presenting with ST-elevation myocardial infarction (MI) (STEMI) has not been characterized. METHODS: Patients with STEMI referred with or without cardiogenic shock were categorized into no CTO, 1 CTO, and >1 CTO. The primary end point was the 30-day mortality. RESULTS: Between 2006 and 2011, 2,020 consecutive patients were included. A total of 141 patients (7%) presented with cardiogenic shock on admission. The prevalence of 1 CTO and >1 CTO in a non-infarct-related artery was 23% and 5%, respectively, among patients with shock compared with 6% and 0.5% in patients without shock (P < .0001). Independent predictors of cardiogenic shock included left main-related MI (odds ratio [OR] 6.55, 95% CI 1.39-26.82, P = .019), CTO (OR 4.20, 95% CI 2.64-6.57, P < .001), creatinine clearance <60 mL/min (OR 3.41, 95% CI 2.32-4.99, P < .0001), and left anterior descending-related MI (OR 2.20, 95% CI 1.51-3.23, P < .0001). Thirty-day mortality was 100% in shock patients with >1 CTO, 65.6% with 1 CTO, and 40.2% in patients without CTO (P < .0001). After adjustment for left ventricular ejection fraction and renal function, CTO remained an independent predictor for 30-day mortality (hazard ratio [HR] 1.83; 95% CI 1.10-3.01, P = .02). CONCLUSION: In patients with STEMI, CTO was strongly associated with cardiogenic shock on admission. In this setting, mortality was substantially higher in patients with 1 CTO and exceedingly high in those with >1 CTO. The presence of CTO was an independent predictor of early mortality.

Importance of diffuse atherosclerosis in the functional evaluation of coronary stenosis in the proximal-mid segment of a coronary artery by myocardial fractional flow reserve measurements.

The objective of this study was to evaluate the impact of diffuse coronary atherosclerosis on the functional evaluation of moderate coronary lesions in the proximal-mid segment of a coronary artery and its clinical implications. This was a prospective study including 100 consecutive patients with a moderate lesion (45 ± 9% diameter stenosis) in the proximal-mid coronary segment who were evaluated with fractional flow reserve (FFR) measurement. No patient had any other angiographic stenosis distal to the evaluated coronary stenosis. FFR measurements were obtained just distal (~2 to 3 cm) to the lesion (FFR proximal measurement [FFR-PM]) and as distally as possible in the artery (FFR distal measurement [FFR-DM]) after administration of the same dose of intracoronary adenosine. Thirty-nine patients underwent dipyridamole or exercise myocardial single-photon emission computed tomography within 3 months of the FFR study. Mean FFR-PM was significantly higher compared to FFR-DM (0.84 ± 0.08 vs 0.78 ± 0.09, median gradient 0.06, 25th to 75th interquartile range 0.02 to 0.10, p <0.0001). FFR-DM was <0.75 in 33% of patients with FFR-PM ≥0.75, leading to the decision of revascularization in these patients. Performing FFR measurement in the left main/left anterior descending artery predicted a higher gradient between FFR-DM and FFR-PM (odds ratio 4.58, 95% confidence interval 1.4 to 15.03, p = 0.007). FFR-DM exhibited a better correlation with results of myocardial single-photon emission computed tomography compared to FFR-PM (kappa 0.33 vs 0.22, p <0.0001). In conclusion, significant differences between FFR-DM and FFR-PM were observed in patients with moderate coronary stenosis in the proximal-mid segment of a coronary artery, with FFR-DM exhibiting a better correlation with results of noninvasive functional tests. These differences influenced the treatment decision in about 1/3 of patients and highlight the potential clinical relevance of coronary pressure wire positioning for functional evaluation of lesions in the proximal-mid segment of the coronary arteries.

Right coronary artery from the left sinus of valsalva: Multislice CT and transradial PCI.

A 42-year-old-woman presented with de novo crescendo angina. Thallium-scintigraphy showed inferior ischemia. Coronary angiogram revealed a right coronary artery (RCA), originating from the left sinus of Valsalva with a severe proximal systolic compression. She underwent successful transradial percutaneous coronary intervention with stent implantation. Multislice-computed tomography (MSCT) is usually used to evaluate coronary artery anomalies and can effectively show the anomalous RCA and the inter-arterial trajectory between the aorta and pulmonary arteries. Anomalies of the origin of the coronary arteries are rare, but can produce specific clinicopathological entities that should be diagnosed with accuracy. This case report illustrates the role of MSCT in the detailed description of an abnormal coronary artery and the use of stenting for symptoms relief.

Effects of aspiration thrombectomy on necrosis size and ejection fraction after transradial percutaneous coronary intervention in acute ST-elevation myocardial infarction.

BACKGROUND: The use of routine aspiration thrombectomy in primary percutaneous coronary intervention (PCI) remains controversial. METHODS: Patients in the EArly Discharge after Transradial Stenting of CoronarY Arteries in Acute Myocardial Infarction (n = 105) study were treated with aspirin, clopidogrel, and abciximab within 6 hr of symptoms onset. Operators were allowed to use 6 Fr Export aspiration catheter at their discretion. In this observational analysis, we compared acute and late results in patients treated with and without thrombectomy using cardiac biomarkers, angiographic, cardiovascular magnetic resonance (CMR), and clinical parameters. RESULTS: Patients in the thrombectomy group (n = 44) had longer symptoms to balloon time (196 ± 86 min vs. 164 ± 62, P = 0.039) and higher incidence of preprocedural TIMI flow grade 0 or 1 (84% vs. 64%, P = 0.028). Following PCI, both groups had similar incidence of TIMI flow grade 3 (93 vs. 92%, P = 0.73) and myocardial blush grade 2 or 3 (80 vs. 77%, P = 0.86), respectively. Patients in thrombectomy group had significantly higher post-PCI maximum values of creatine kinase-MB (P = 0.0007) and troponin T (P = 0.0010). Accordingly, post-PCI myocardial necrosis by CMR was higher (P = 0.0030) in patients in the thrombectomy group. At 6-month follow-up, necrosis size remained higher (20.7% ± 13.3% vs. 13.5% ± 11.1%, P = 0.012) in the thrombectomy group. Ejection fraction at 6 months was 65% ± 9% in patients in thrombectomy group compared to 70% ± 11% in patients without (P = 0.070). Results were not affected by initial TIMI flow or symptoms to balloon time. Clinical events remained comparable in both groups at 12 months follow-up. CONCLUSION: In patients with ST-segment elevation myocardial infarction presenting within 6 hr of symptoms and undergoing primary angioplasty with maximal antiplatelet therapy, acute and late results did not suggest significant benefit for additional aspiration thrombectomy, irrespective of initial TIMI flow or total ischemic time.

Impact of thrombus aspiration on angiographic and clinical outcomes in patients with ST-elevation myocardial infarction.

BACKGROUND: Primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) may be limited by thrombus embolization. Export aspiration catheter (EAC) is a thrombectomy device which may enhance angiographic results, but its impact on clinical outcomes is unclear. This trial objective was to assess the impact of EAC on angiographic and clinical outcomes in patients with STEMI. METHODS: All STEMI patients undergoing primary or rescue PCI in a tertiary care center were included. Patients were divided in two groups according to the use of the EAC. Patients were followed up prospectively for death, reinfarction, revascularization, or stroke. Thrombolysis In Myocardial Infarction (TIMI) flow in the culprit vessel was assessed before and after PCI. RESULTS: Included in the analysis were 535 patients. EAC was used in 165 patients before angioplasty (Group 1) and 370 patients underwent PCI without thrombus aspiration (Group 2). More patients in Group 1 had initial TIMI flow 0-1 compared to Group 2 (88% vs. 62%, P<.001). Proportion of patients with a final TIMI flow 3 was the same in both groups (89.1% vs. 87.6% for Groups 1 and 2, respectively; P=.67). An analysis restricted to patients with initial TIMI flow 0-1 yielded similar results. No difference in clinical outcomes was observed between the two groups (P=.70). CONCLUSIONS: Selective use of the EAC based on the judgment of operators results in excellent angiographic and clinical results. Further clinical investigation is needed to definitely answer whether thromboaspiration needs to be performed in all STEMI patients undergoing primary PCI.

Incidence, range, and clinical effect of hemoglobin changes within 24 hours after transradial coronary stenting.

Anemia and major bleeding are independent predictors of outcomes after acute coronary syndromes and percutaneous coronary intervention (PCI). Although the transradial approach reduces the incidence of bleeding, the hemoglobin changes after transradial PCI have not been defined. We serially assessed the hemoglobin values before and after transradial PCI and evaluated the effect of hemoglobin changes on outcomes. In the EArly Discharge After Transradial Stenting of CoronarY Arteries (EASY) trial, 1,348 patients underwent transradial PCI. All patients received aspirin, clopidogrel, and a bolus of abciximab before PCI. The hemoglobin values were assessed immediately before and 4 to 6 hours and 12 to 24 hours after PCI. The major adverse cardiac events (death, myocardial infarction, and target vessel revascularization) were assessed < or =3 years after PCI. According to the World Health Organization classification, 206 patients (15%) had anemia before PCI and 410 (30%) developed anemia within 24 hours after PCI. A mean hemoglobin decrease of 0.6 +/- 1.0 g/dl occurred within 24 hours after PCI. At 30 days, the major adverse cardiac events were significantly increased when the hemoglobin decrease within 24 hours after PCI was >3 g/dl (p = 0.0002). Patients with anemia within 24 hours after PCI had significantly more major adverse cardiac events at 30 days, 6 months, 1 year, and 3 years than patients without anemia (log-rank p = 0.0044). After adjustment for differences in the baseline characteristics, anemia within 24 hours after PCI remained an independent predictor of major averse cardiac events at 3 years (hazard ratio 1.30, 95% confidence interval 1.01 to 1.67, p = 0.045). In conclusion, within 24 hours after transradial PCI with maximal antiplatelet therapy, only a mild hemoglobin decrease was observed. The choice of a hemoglobin decrease >3 g/dl after PCI as a cutoff value for current definitions of major bleeding in modern PCI trials appears reasonable. Measures to prevent anemia and blood loss during PCI remain to be further studied.

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=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.

Improving myocardial salvage in late presentation acute ST-elevation myocardial infarction with proximal embolic protection.

BACKGROUND: Late-presenting ST-elevation myocardial infarction (STEMI) patients possess larger, more organized coronary thrombus leading to greater ventricular remodeling and arrhythmia despite angioplasty and pharmacological therapies. We hypothesized that myocardial injury would be reduced in late STEMI by proximal embolic protection (PEP). METHODS: 31 patients with first STEMI 12-24 hr after pain onset and TIMI 0-1 flow were treated with or without PEP (cohort design matched for age, gender, and infarct-related artery). Contrast-enhanced magnetic resonance determined myocardial function, area at risk, necrosis, salvaged myocardium, and arrythmogenic peri-infarct region. Clinical follow-up was performed. RESULTS: Pain to balloon time was 18 hr (95% CI 15.5-21.2 h), and Q waves were present in 87%. Angioplasty was performed with PEP in 15 and without in 16. Left ventricular (LV) volumes and ejection fraction were similar (EF 46.9% vs. 49.0% without PEP, P = 0.9). Although myocardial necrosis was similar (32.5 vs. 37.3% of LV, P = 0.3), PEP improved microvascular obstruction (8.7 vs. 11.2% of LV, P = 0.02) salvaged myocardium (39.6% vs. 29.6% of area at risk, P = 0.001), and the peri-infarct region (20.9 vs. 29.6% of infarct, P < 0.0001). On multivariate analysis, the use of PEP was an independent predictor of decreased arrythmogenic peri-infarct region and greater myocardial salvage. CONCLUSION: In this pilot study, PEP improved myocardial salvage and the arrythmogenic peri-infarct region in late-presentation STEMI. Randomized trials are required to assess the clinical impact of improving salvaged myocardium and the peri-infarct region with PEP.

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.

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 mm(2); 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 mm(2) 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.

Impact of final activated clotting time after transradial coronary stenting with maximal antiplatelet therapy.

The optimal value of activated clotting time (ACT) during percutaneous coronary intervention (PCI) with unfractionated heparin remains controversial. No data are available on the relation between the ACT at the end of the procedure (final ACT) and the clinical outcomes after transradial PCI and maximal antiplatelet therapy. By dividing the final ACT values in tertiles, we analyzed the ischemic and bleeding events in 1,234 consecutive patients with acute coronary syndrome recruited in the EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) trial. All patients were pretreated with aspirin and clopidogrel. After radial sheath insertion, patients received 70 IU/kg unfractionated heparin. Abciximab was given before the first balloon inflation. The median final ACT value was 312 seconds (interquartile range 279 to 344). At 30 days, the rate of major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization, from the lower to upper tertiles was 4%, 4%, and 2%, respectively (p = 0.16), and the rate of major bleeding was 2%, 1% and 0.7%, respectively (p = 0.20). During the 3 years of follow-up, the incidence of myocardial infarction was less in the tertile with the greatest ACT value (>330 seconds) than in the other 2 tertiles (4%, 8%, and 8%, respectively; p = 0.038). Troponin-T and creatine kinase-MB release after PCI indicated that the effect was related to periprocedural myonecrosis protection. After adjustment for baseline and procedural differences, a final ACT of >330 seconds remained associated with a 47% relative reduction in myocardial infarction (odds ratio 0.53, 95% confidence interval 0.29 to 0.93, p = 0.024). Death and target vessel revascularization remained similar in all tertiles for < or =3 years. In conclusion, with the combination of aspirin, clopidogrel pretreatment, and abciximab, a final ACT value of >330 seconds appears protective against peri-PCI myonecrosis, and this benefit was maintained for < or =3 years. With a transradial approach and maximal antiplatelet therapy, greater ACT values did not correlate with an increased risk of bleeding.

Comparison of outcomes in patients > or =70 years versus <70 years after transradial coronary stenting with maximal antiplatelet therapy for acute coronary syndrome.

Elderly patients are at a higher risk for complications after percutaneous coronary intervention (PCI) when performed through the femoral approach. The impact of age on complications in patients treated using the transradial approach is not known. The bleeding and ischemic outcomes at 30 days, 6 months, 1 year, and 3 years after transradial PCI and maximal antiplatelet therapy were compared in 1,348 patients aged <70 or > or =70 years with acute coronary syndromes. All patients received aspirin and clopidogrel before catheterization, followed by abciximab at the time of PCI. Patients aged > or =70 years (n = 259 [19%]) had more hypertension, dyslipidemia, family histories, and previous coronary artery bypass grafting. Older patients had lower baseline hemoglobin, platelet, and creatinine clearance values, and they also more often had 2- or 3-vessel syndrome (p = 0.001), as well as longer procedure durations (p = 0.024). At 30 days, the rates of major adverse cardiac events and major bleeding were similar in older and younger patients. Only the incidence of gastrointestinal bleeding (p = 0.021) and mild to moderate access-site hematoma were higher in older patients (p = 0.036). The rates of major adverse cardiac events were also similar in the 2 age groups at 6 months (6% vs 9%, p = 0.08), 1 year (10% vs 13%, p = 0.22), and 3 years (19% vs 20%, p = 0.73), but mortality was significantly higher at 3 years in patients aged > or =70 years (p = 0.0031). In conclusion, age per se is not a predictor of major adverse cardiac events or major bleeding after transradial PCI with maximal antiplatelet therapy. However, older patients remain more prone to gastrointestinal bleeding and local hematoma compared to younger patients, and preventive measures need to be further investigated.