A Randomized Double-Blind Placebo-Controlled Study Comparing Intracoronary Versus Intravenous Abciximab in Patients With ST-Elevation Myocardial Infarction Undergoing Transradial Rescue Percutaneous Coronary Intervention After Failed Thrombolysis.

The risk and benefit ratio of glycoprotein IIb/IIIa inhibitors with dual oral antiplatelet therapy after failed thrombolysis and rescue percutaneous coronary intervention (PCI) is unclear. Using a randomized placebo-controlled, double-blind design, we compared intravenous (IV) and intracoronary (IC) abciximab delivery in 74 patients referred for rescue transradial PCI. The primary angiographic end points were the final thrombolysis in myocardial infarction flow and myocardial blush grades. Secondary end points included acute and 6-month outcomes using angiographic parameters, platelet aggregation parameters, cardiac biomarkers, cardiac magnetic resonance measurements (CMR) and clinical end points. After rescue PCI, normal thrombolysis in myocardial infarction 3 flows were obtained in 70% in the IC group, 48% in the IV group, and 71% in the placebo group, respectively (p = 0.056). Final myocardial blush grades 2 and 3 were obtained in 43% and 39% in the IC group, 48% and 26% in the IV group, and 46% and 42% in the placebo group (p = 0.67), respectively. Acutely, peak release of cardiac biomarkers, necrosis size, myocardial perfusion and no-reflow as assessed by CMR, and clinical end points were similar between the groups and did not suggest a benefit for IC or IV abciximab compared with placebo. There was no increase in bleeding or access site-related complications with abciximab compared with placebo. Clinical, angiographic, and CMR outcomes at 6 months remained comparable between the groups. In patients with ST-elevation myocardial infarction presenting with failed thrombolysis undergoing transradial rescue PCI, IC or IV abciximab had no significant clinical impact.

Transradial experience with bioresorbable vascular scaffolds: A case-matched study with metallic drug-eluting stents.

BACKGROUND: Whether polymeric bioresorbable vascular scaffolds (BVS) implantation with transradial approach is feasible and safe is unknown. We compared the feasibility and safety of the transradial approach for BVS delivery with metallic drug-eluting stents (DES). METHODS: We identified 118 consecutive patients who underwent BVS implantation and we compared 30-days and 1-year results with 118 matched patients with DES. Patients were matched for age, sex, risk factors and clinical indication. RESULTS: Rates of transradial approach were 98% in the BVS group vs 95% in the DES group (P = 0.16) with 5Fr used in 38% and 32% (P = 0.34), respectively. The number of stents was similar in both groups, 2.6 ±â€¯1.5 vs 2.4 ±â€¯1.3 (P = 0.23). Although maximal pressure for stent deployment was identical in both groups (16 ±â€¯3 atm), more lesions were pre-dilated (83% vs 52%, P < 0.001) and post-dilated (71% vs 33%, P < 0.001) in the BVS group. Contrast volume (217 ±â€¯97 vs 175 ±â€¯108 ml, P < 0.001), fluoroscopy time (16 [10-23] vs 13 [8-21] min, P = 0.04) and procedure duration (65 ±â€¯31 vs 56 ±â€¯47 min, P = 0.045) were significantly higher in the BVS group. Major adverse cardiac events, including death, myocardial infarction and target vessel revascularization remained similar in both groups, 1.7% vs 0.8% (P = 0.56) at 30 days and 10% vs 8.5% (P = 0.66) at 1 year. At 1 year, stent thrombosis occurred in 2 (1.7%) patients in the BVS group and 1 (0.8%) patient in the DES group (P = 0.56). CONCLUSION: The use of transradial approach for BVS compared to DES implantation was feasible and safe in all-comers, although BVS implantation included more technical challenges. Outcomes up to 1-year remained comparable in both groups.

Feasibility and Safety of Early Repeat Transradial Access Within 30 Days of Previous Coronary Angiography and Intervention.

Transradial approach (TRA) is the default access site for diagnostic angiography and intervention in many centers. Repeat ipsilateral radial artery access late after index procedure has been associated with failures. It is unknown whether early (≤30 days) and very early (<24 hours) repeat radial access is technically feasible and safe. Study population consisted of consecutive patients undergoing repeat (≥2) procedures within 30 days in a high-volume TRA center. Transradial access failure and resulting femoral approach was categorized as primary (no repeat attempt) or secondary (crossover). Timing of repeat access and reasons for failure were recorded. From November 2012 to December 2014, repeat catheterization by TRA was performed twice in 573 of 626 patients (92%) (median delay 4 [2 to 9] days), 3 times in 29 of 38 (76%) patients (median delay 15 [5 to 26] days), and 4 times in 1 patient within 21 days. When repeat catheterization occurred during the first 24 hours following the index procedure, 53% and 75% of patients had second and third procedures using the same ipsilateral radial artery, respectively. Primary radial failure occurred in 5.8% for second attempt and 13% for a third attempt, whereas crossovers were noted in 2.7% and 2.6%, respectively. Main reasons for failed re-access of ipsilateral radial artery were related either to operator's reluctance to repeat attempt (primary failure) or to issues with puncture site (crossover). In a high-volume TRA center, patients who required repeat catheterization within 24 hours and within the first 30 days had the same radial artery re-accessed in the majority of cases.

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.

Prospective, multicenter, randomized, controlled pilot trial of peritoneal hypothermia in patients with ST-segment- elevation myocardial infarction.

BACKGROUND: Systemic hypothermia may reduce infarct size if established before reperfusion. The large surface area of the bowel may facilitate rapid hypothermia. We therefore examined the feasibility, safety, and efficacy of hypothermia induced by an automated peritoneal lavage system in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset were randomized to peritoneal hypothermia before and for 3 hours after percutaneous coronary intervention versus control. The primary safety end point was the 30-day composite rate of death, reinfarction, ischemia-driven target vessel revascularization, major bleeding, sepsis, pneumonia, peritonitis, severe arrhythmia, or renal failure. The primary efficacy end point was infarct size assessed by cardiac MRI on day 3 to 5. Fifty-four patients were randomized at 7 centers to hypothermia (n=28) versus control (n=26). Hypothermia was successfully initiated in 96.3% of patients, and median [interquartile range] temperature at first balloon inflation was 34.7 [34.0-34.9]°C. Median door-to-balloon times in the hypothermia and control groups were 62 [51-81] and 47 [37-55] minutes, respectively (P=0.007). The primary safety end point occurred in 6 (21.4%) and 0 (0%) patients in the hypothermia and control groups, respectively (P=0.01), including 3 versus 0 stent thrombosis events. Infarct size was 17.2% [15.1-20.6] and 16.1% [10.0-22.2] in the hypothermia and control groups, respectively (P=0.54). CONCLUSIONS: Peritoneal hypothermia is feasible and achieves rapid cooling with only a modest increase in treatment times in the setting of ST-segment-elevation myocardial infarction. However, in the present randomized trial, peritoneal hypothermia was associated with an increased rate of adverse events without reducing infarct size. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01655433.

Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions.

OBJECTIVES: This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s (FPS) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography (DCA) and percutaneous coronary intervention (PCI) via the transradial approach (TRA). BACKGROUND: TRA for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has the potential to reduce radiation exposure. METHODS: Patients undergoing TRA diagnostic angiography ± ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure. Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy. Primary endpoints were operator radiation dose (measured with dosimeter attached to the left side of the thyroid shield in µSievert [µSv]), patient radiation dose (expressed as dose-area product in Gy·cm(2)), and fluoroscopy time. RESULTS: From October 1, 2012 to August 30, 2013, from a total of 363 patients, 184 underwent DCA and 179 underwent PCI. Overall, fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose (30% relative reduction [RR], p < 0.0001); and in patient's dose-area product (19% RR; p = 0.022). When stratified by procedure type, 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA (40% RR; p < 0.0001) and PCI (28% RR; p = 0.0011). Fluoroscopy at 7.5 FPS, compared with 15 FPS, was also associated with substantial reduction in patients' dose-area product during DCA (26% RR; p = 0.0018) and during PCI (19% RR; p = 0.13). Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA (3.4 ± 2.0 min vs. 4.0 ± 4.7 min; p = 0.42) and PCI (11.9 ± 8.4 min vs. 13.3 ± 9.7 min; p = 0.57), respectively. CONCLUSIONS: Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI.

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.

Risk score, causes, and clinical impact of failure of transradial approach for percutaneous coronary interventions.

OBJECTIVES: To study the causes of and to develop a risk score for failure of transradial approach (TRA) for percutaneous coronary intervention (PCI). BACKGROUND: TRA-PCI failure has been reported in 5% to 10% of cases. METHODS: TRA-PCI failure was categorized as primary (clinical reasons) or crossover failure. Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. RESULTS: From January to June 2010, TRA-PCI was attempted in 1,609 (97.3%) consecutive patients, whereas 45 (2.7%) had primary TRA-PCI failure. Crossover TRA-PCI failure occurred in 30 (1.8%) patients. Causes of primary TRA-PCI failure included chronic radial artery occlusion (11%), previous coronary artery bypass graft (27%), and cardiogenic shock (20%). Causes for crossover TRA-PCI failure included: inadequate puncture in 17 patients (57%); radial artery spasm in 5 (17%); radial loop in 4 (13%); subclavian tortuosity in 2 (7%); and inadequate guide catheter support in 2 (7%) patients. Female sex (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.95 to 5.26, p < 0.0001), previous coronary artery bypass graft (OR: 6.1; 95% CI: 3.63 to 10.05, p < 0.0001), and cardiogenic shock (OR: 11.2; 95% CI: 2.78 to 41.2, p = 0.0011) were independent predictors of TRA-PCI failure. Risk score values from 0 to 7 predicted a TRA-PCI failure rate from 2% to 80%. CONCLUSIONS: In a high-volume radial center, 2.7% of patients undergoing PCI are excluded from initial TRA on clinical grounds, whereas crossover to femoral approach is required in only 1.8% of the cases. A new simple clinical risk score is developed to predict TRA-PCI failure.

Interaction of chronic total occlusion and chronic kidney disease in patients undergoing primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

Chronic total occlusion (CTO) in a non-infarct-related artery and chronic kidney failure (CKD) are associated with worse outcomes after primary percutaneous coronary intervention (PCI). The aim of this study was to investigate the interaction of CTO and CKD in patients who underwent primary PCI for acute ST-segment elevation myocardial infarction (STEMI). Patients with STEMIs with or without CKD, defined as an estimated glomerular filtration rate <60 ml/min/1.73 m(2), were categorized into those with single-vessel disease and those with multivessel disease with or without CTO. The primary outcomes were the incidence of 30-day and 1-year mortality. Among 1,873 consecutive patients with STEMIs included between 2006 and 2011, 336 (18%) had CKD. The prevalence of CTO in a non-infarct-related artery was 13% in patients with CKD compared with 7% in those without CKD (p = 0.0003). There was a significant interaction between CKD and CTO on 30-day mortality (p = 0.018) and 1-year mortality (p = 0.013). Independent predictors of late mortality in patients with CKD were previous myocardial infarction (hazard ratio [HR] 1.71, 95% confidence interval [CI] 1.01 to 2.79), age >75 years (HR 1.86, 95% CI 1.19 to 2.95), a left ventricular ejection fraction after primary PCI <40% (HR 2.20, 95% CI 1.36 to 3.63), left main culprit artery (HR 4.46, 95% CI 1.64 to 10.25), and shock (HR 7.44, 95% CI 4.56 to 12.31), but multivessel disease with CTO was not a predictor. In contrast, multivessel disease with CTO was an independent predictor of mortality in patients without CKD (HR 3.30, 95% CI 1.70 to 6.17). In conclusion, in patients with STEMIs who underwent primary PCI, with preexisting CKD, the prevalence of CTO in a non-infarct-related artery was twice as great. In these patients, the clinical impact of CTO seems to be overshadowed by the presence of CKD.

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.

Prevalence, predictors and clinical impact of unique and multiple chronic total occlusion in non-infarct-related artery in patients presenting with ST-elevation myocardial infarction.

OBJECTIVES: To investigate the predictors and impact on long-term survival of one chronic total occlusion (CTO) or multiple CTOs in patients presenting with ST-elevation myocardial infarction (STEMI). DESIGN: Single-centre retrospective observational study. SETTING: University-based tertiary referral centre. PATIENTS: Between 2006 and 2011, a total of 2020 consecutive patients referred with STEMI were categorised into single vessel disease, multivessel disease (MVD) without CTO, with one CTO or with multiple CTOs. INTERVENTION: Primary percutaneous coronary intervention. MAIN OUTCOME MEASURE: The primary end-point was the 1-year mortality. RESULTS: The prevalence of single vessel disease, MVD without CTO, with one CTO or with multiple CTOs was 70%, 22%, 7.2% and 0.8%, respectively. Independent clinical predictors for the presence of CTO were cardiogenic shock (OR 5.05; 95% CI 3.29 to 7.64), prior myocardial infarction (OR 2.06; 95% CI 1.35 to 3.09), age >65 years (OR 1.94; 95% CI 1.40 to 2.71) and history of angina (OR 1.94; 95% CI 1.29 to 2.87). Mortality was worse in patients with multiple CTOs (76.5%) compared with those with one CTO (28.1%) or without CTO (7.3%) (p<0.0001). After adjustment for left ventricular ejection fraction and renal function, MVD was an independent predictor for 1-year mortality (HR: 1.81; 95% CI 1.18 to 2.77, p=0.007), but CTO was not (HR: 1.07; 95% CI 0.66 to 1.73, p=0.78). CONCLUSIONS: Simple clinical factors are associated with the presence of CTO in non-infarct-related artery in patients presenting with STEMI. In these patients, long-term survival was independently associated with MVD, left ventricular ejection fraction and renal function, but not with CTO per se.

Benefit of bivalirudin versus heparin after transradial and transfemoral percutaneous coronary intervention.

Bivalirudin, a direct thrombin inhibitor, has been shown to reduce major bleeding and provide a better safety profile compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) through transfemoral access. Data pertaining to the clinical benefit of bivalirudin compared to UFH monotherapy in patients undergoing transradial PCI are lacking. The present study sought to compare the in-hospital net clinical adverse events, including death, myocardial infarction, target vessel revascularization, and bleeding, for these 2 antithrombotic regimens for all patients at a tertiary care, high-volume radial center. From April 2009 to February 2011, all patients treated with bivalirudin were matched by access site to those receiving UFH. The patients in the bivalirudin group (n = 125) were older (72 ± 13 years vs 66 ± 11 years; p <0.0001), more often had chronic kidney disease (51% vs 30%; p = 0.0012), and more often underwent primary PCI (30% vs 14%, p <0.0037) than the UFH-treated patients (n = 125). A radial approach was used in 71% of both groups. The baseline bleeding risk according to Mehran's score was similar in both groups (14 ± 9 vs 15 ± 8, p = 0.48). In-hospital mortality was 2% in both groups (p = 1.00). No difference in net clinical adverse events or ischemic or bleeding complications was detected between the 2 groups. Bivalirudin reduced both ischemic and bleeding events in femoral-treated patients, but no such clinical benefit was observed in the radial-treated patients. In conclusion, as periprocedural PCI bleeding avoidance strategies have become paramount to optimize the clinical benefit, the interaction between bivalirudin and radial approach deserves additional investigation.

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.

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.