Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by longitudinal sequential optical coherence tomography assessments: the EGO-BIOFREEDOM study.

AIMS: This study aimed to establish the early healing and neointimal transformation profile of the new polymer-free BioFreedom stent through sequential optical coherence tomography (OCT) within the first nine months following stent implantation. METHODS AND RESULTS: We randomly assigned 104 BFS recipients to one of five groups with angiography and OCT follow-up at 1, 2, 3, 4, or 5 months, together with another follow-up for all at nine months. The primary endpoint was the degree of OCT-detected strut coverage at nine months. From 1, 2, 3, 4, and 5 months, median neointimal strut coverage increased from 85.8, 87.0, 88.6, 96.8 to 97.1%, respectively, to 99.6% (IQR 98.2-99.9) at nine months. At nine months, median percent neointimal volume was 13.0% and angiographic late lumen loss was 0.21±0.30 mm. Major adverse cardiac events (MACE) were limited to one non-cardiac death, one non-ST-elevation myocardial infarction not related to BFS, and two target lesion revascularisations without stent thrombosis (MACE rate 4.0%). CONCLUSIONS: Neointimal strut coverage of the BFS was rapid and the BFS was shown to be clinically safe and effective.

Long-term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention: an observational single-centre registry follow-up.

OBJECTIVES: There are few data evaluating the long-term effect of femoral vascular closure devices (FCDs) on patients' clinical outcome. We aim to evaluate the incidence of peripheral vascular disease (PVD) in patients who received FCD following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures. DESIGN AND SETTING: Observational study of a single-centre registry. PARTICIPANTS: From June 2000 to September 2004, 265 patients who received FCD after coronary angiography and PCIs were enrolled on the study. OUTCOME MEASURES: Clinical follow-up (using Rutherford's categories of claudication), ankle brachial index (ABI) and duplex ultrasound of femoral arteries (using the non-accessed side as control) were performed to evaluate the presence of PVD. RESULTS: The mean follow-up interval was 3320±628 days. 1 patient (0.4%) suffered from grade 2 claudication and another (0.4%) suffered from grade 1 claudication. The mean ABIs of the accessed side and non-accessed side were 1.06±0.13 and 1.08±0.11, respectively (p=0.17). For duplex ultrasound, the mean common femoral artery peak systolic velocities of the accessed side and non-accessed side were 87.4±22.3 and 87.7±22.1 cm/s, respectively (p=0.73); the mean superficial femoral artery peak systolic velocities of the accessed side and non-accessed side were 81.4±20.1 and 81.31±17.8 cm/s, respectively (p=0.19). CONCLUSIONS: The use of FCD after a coronary angiogram and PCI is safe and does not increase the long-term risk of PVD.

Virtual histology findings and effects of varying doses of atorvastatin on coronary plaque volume and composition in statin-naive patients: the VENUS study.

BACKGROUND: While statin induces plaque regression, its effects, particularly with different doses on plaque virtual histology composition, remain unknown. METHODS AND RESULTS: In this prospective, randomized, double-blinded study, 40 consecutive statin-naive patients with stable angina requiring percutaneous coronary intervention (PCI) were randomized to 2 arms (20 patients each) receiving 6 months of atorvastatin 10 mg or 40 mg daily. The primary end-point was (VH-IVUS) changes from baseline to 6 months, as assessed by a core laboratory. Fifty-four VH-IVUS lesions were analyzed from the 10 mg group and 57 from the 40 mg group. Overall, plaque volume was reduced by 4.28% (-5.10±14.93 mm(3), P<0.001), absolute VH-IVUS fibrous volume by 10.54% (-4.87±10.74 mm(3), P<0.001), and relative percentage fibrous component by 3.29±7.84% (P<0.001), while relative percentage dense calcium increased by 1.50±3.08% (P<0.001), and necrotic core by 3.19±7.82% (P<0.001). Beneficial changes were more substantial in the higher dose (40 mg) group, with significantly more percentage plaque volume regression (-1.50±3.85% vs. 0.38±4.05% increase in the 10 mg group, P=0.014), less relative percentage necrotic core expansion (1.68±7.57% vs. 4.78±7.82% in the 10 mg group, P=0.037), and without occurrence of major adverse cardiac events (vs. 6 patients in the 10 mg group, P=0.020). CONCLUSIONS: In statin-naive patients requiring PCI, 6 months of atorvastatin induced a significant percentage of plaque volume reduction and substantial modification of VH-IVUS composition. In addition, these effects appeared to vary with different doses of atorvastatin, showing significantly better limitation of relative percentage necrotic core expansion at a higher dose.

Acute and 16-month outcomes of a new stent: the first-in-man evaluation of the Medtronic S9 (integrity) stent.

OBJECTIVE: A first-in-man evaluation of the safety, feasibility, deliverability, and efficacy of the new Medtronic S9 (Integrity) bare metal stent (BMS) in complex coronary diseases. BACKGROUND: Excellent deliverability remains an unmet clinical need among stents especially in complex lesions. The S9 (Integrity) BMS utilizes a new, continuous sinusoidal manufacturing technology to enhance stent flexibility and deliverability, without sacrificing radial strength. METHODS: This is a first-in-man, open label observational study in 15 patients treated with S9 (Integrity) BMS. Device success during implantation, clinical outcomes, 30-day and 12-month device-oriented and patient-oriented composite efficacy end-points, and 16-month angiographic restudy were evaluated (with amended protocols). RESULTS: Thirty-four stents were deployed to treat 30 complex lesions. Mean lesion length was 22.93 ± 11.78 mm, and mean percentage diameter stenosis was 78.59% ± 9.01%. Mean stent delivery time was 125 ± 68.3 sec. Acute device, lesion, and procedure success, as defined, were 100%. Device-oriented and patient-oriented composite end-points were zero at 30 days. Two patients had ischemic driven revascularization before 12 months. One patient had non-cardiac death at 13 months; all remaining 12 patients received 16 months angiographic restudy and only one had angiographic restenosis. The mean diameter of stenosis was 27.0% ± 18.3%, and mean late loss was 0.73 ± 0.50 mm. Total target vessel failure rate was 21.4% (3/14) at 16 months. CONCLUSION: The new S9 (Integrity) BMS exhibited excellent deliverability, flexibility, and conformability, contributing to good acute and 16 months outcomes in complex cases.

Side differences of carotid intima-media thickness in predicting cardiovascular events among patients with coronary artery disease.

Population-based studies have demonstrated differences in intima-media thickness (IMT) measured from the left and right common carotid arteries (CCAs). However, its prognostic implications among patients with established coronary artery disease (CAD) remain unknown. Correlations between the left and right CCAs and the composite end point of cardiac death or nonfatal acute coronary syndrome among 149 patients with angiographically confirmed stable CAD were studied. A total of 22 patients had cardiovascular events during the 32.1 ± 10.9 months follow-up. Multivariate analysis revealed that prior ischemic stroke (hazard ratio [HR]: 15.36, 95% confidence interval [CI]: 4.49-52.59, P < .001), extent of CAD (HR: 1.56, 95%CI: 1.01-2.42, P = .046), and right CCA IMT (HR: 17.07, 95%CI: 2.16-134.69, P = .007) but not the left CCA IMT, independently predicted cardiovascular events. The right CCA IMT independently predicted event-free survival among patients with established CAD, suggesting that the left and right CCA may exhibit different prognostic values in our population.

Long term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention.

BACKGROUND: We evaluated the long term clinical outcomes of femoral vascular closure devices following its deployment in coronary angiography and percutaneous coronary intervention (PCI) procedures. METHODS: From June 2000 to September 2004, 265 patients who received femoral vascular closure devices after coronary angiography and PCIs were enrolled into the study. Patients' medical records were reviewed and vascular complications within 1 year of follow-up period were recorded. Rutherford's categories of claudication were used to quantify different degrees of claudication and leg ischaemia. Duplex ultrasonography of both femoral arteries (using the nonaccessed site as control) was performed at 1 year after deployment of vascular closure devices. Vessel diameter and flow velocities for both common femoral arteries were obtained. RESULTS: There was no occurrence of late vascular complications like arteriovenous fistula, pseudoaneurysm, surgical repair of access site complications, late groin bleeding and infection. By Rutherford categories of claudication, 99.2% of patients had grade 0 claudication while the remaining 0.8% was in grade 1. By arterial Duplex ultrasonography, the peak systolic velocity of the accessed femoral artery (predominantly right side) was nonsignificantly higher, 94.9 + or - 26.0 cm/s when compared to 91.5 + or - 24.8 cm/s in the control site (P = 0.12). As for vessel diameter, no significant difference was found in the mean end-diastolic vessel diameter 8.8 + or - 1.3 mm (puncture site) versus 8.7 + or - 4.4 mm (control site) (P = 0.72). CONCLUSION: We found that the use of femoral closure devices was safe and it was not associated with any adverse long term vascular complications.

Angiographic and clinical implications of combined ST-segment elevation in anterior and inferior leads in acute myocardial infarction.

BACKGROUND: The clinical and angiographic findings of patients suffered from acute myocardial infarction (MI) and presented with combined ST elevation in both anterior and inferior leads remain unclear. HYPOTHESIS: These patients might have >/= 1 coronary arteries occluded. METHODS: From January 2002 to December 2006, 49 consecutive patients were found to have ST elevation in both anterior and inferior leads during myocardial infarction. Patients who had left circumflex artery occlusion (acute or chronic) were excluded. These patients were divided into 4 types according to the infarct-related artery (IRA) and status of the contralateral vessel patency: left anterior descending artery (LAD) as the IRA with a patent right coronary artery (RCA) (type 1A, n = 25); LAD as IRA with an occluded RCA (type 1B, n = 1); RCA as IRA with a patent LAD (type 2A, n = 19); and RCA as IRA with an occluded LAD (type 2B, n = 4). RESULTS: Single vessel occlusion (type A angiographic pattern) was found in 90% of patients. Type 1A patients had a larger infarct size than that of 2A. ST elevation in V(2) >/= V(3) identified RCA as the IRA with a high specificity (92%) and sensitivity (74%). Type 2B patients (2-vessel occlusion) had a larger infarct size than that of 2A; however, no electrocardiogram (ECG) criteria could reliably differentiate them. CONCLUSION: In a real world situation, single vessel occlusion is found in the majority of cases of combined ST elevation in anterior and inferior leads. ST elevation in V(2) >/= V(3) distinguishes RCA against LAD as the IRA with high accuracy.

Electrocardiographic characteristics of patients with inferior myocardial infarction but angiographically normal coronary arteries.

Normal coronary arteries were found in 22 (5.8%) of 379 patients presented with acute inferior myocardial infarction. These patients were significantly younger, had less cardiovascular risk factors, better systolic heart function, and lower cardiac enzymes level. Electrocardiography significantly showed more (1) ratio of ST-segment elevation in II/ III>or=1; (2) isoelectric ST-segment in I; (3) ST-segment elevation in I; and less (4) paroxysmal atrial fibrillation; (5) ST-segment depression in I; and (6) ST-segment elevation in V4R. In conclusion, this subset of patients had clinical features suggestive of smaller infarct size compared with those suffering from atherosclerotic disease. They may have more left circumflex artery involvement and distal right coronary artery occlusion, as deduced from electrocardiography.

Comparison of intensive and low-dose atorvastatin therapy in the reduction of carotid intimal-medial thickness in patients with coronary heart disease.

BACKGROUND: Intensive statin therapy has been shown to improve prognosis in patients with coronary heart disease (CHD). It is unknown whether such benefit is mediated through the reduction of atherosclerotic plaque burden. AIM: To examine the efficacy of high-dose atorvastatin in the reduction of carotid intimal-medial thickness (IMT) and inflammatory markers in patients with CHD. DESIGN: Randomised trial. SETTING: Single centre. PATIENTS: 112 patients with angiographic evidence of CHD. INTERVENTIONS: A high dose (80 mg daily) or low dose (10 mg daily) of atorvastatin was given for 26 weeks. MAIN OUTCOME MEASURES: Carotid IMT, C-reactive protein (CRP) and proinflammatory cytokine levels were assessed before and after therapy. RESULTS: The carotid IMT was reduced significantly in the high-dose group (left: mean (SD), 1.24 (0.48) vs 1.15 (0.35) mm, p = 0.02; right: 1.12 (0.41) vs 1.01 (0.26) mm, p = 0.01), but was unchanged in the low-dose group (left: 1.25 (0.55) vs 1.20 (0.51) mm, p = NS; right: 1.18 (0.54) vs 1.15 (0.41) mm, p = NS). The CRP levels were reduced only in the high-dose group (from 3.92 (6.59) to 1.35 (1.83) mg/l, p = 0.01), but not in the low-dose group (from 2.25 (1.84) to 3.36 (6.15) mg/l, p = NS). A modest correlation was observed between the changes in carotid IMT and CRP (r = 0.21, p = 0.03). CONCLUSIONS: In patients with CHD, intensive atorvastatin therapy results in regression of carotid atherosclerotic disease, which is associated with reduction in CRP levels. On the other hand, a low-dose regimen only prevents progression of the disease.

Value of ST-segment depression in lead V4R in predicting proximal against distal left circumflex artery occlusion in acute inferoposterior myocardial infarction.

BACKGROUND: Lead V(4R) faces the right ventricular free wall; it also reflects ischemia in the posterolateral wall lying opposite and manifests as ST-segment depression. HYPOTHESIS: The aim of this study was to evaluate the usefulness of V(4R) ST-segment depression in distinguishing proximal from distal left circumflex artery occlusion in acute inferoposterior wall myocardial infarction. METHODS: We retrospectively analyzed 239 patients who had first acute inferoposterior myocardial infarction, were admitted within 6 h from onset of symptom, and had coronary angiography performed within 4 weeks. Patients who had bundle-branch block or concomitant significant stenoses in the proximal and distal segments of the same vessel or of both vessels were excluded. The electrocardiographic and angiographic findings were reviewed by two independent groups of investigators. RESULTS: V(4R) ST-segment depression > or =1.0 mm was found in 8 of 46 patients (17.4%) with left circumflex artery occlusion but none (0%) with right coronary artery occlusion. Among the group with left circumflex artery occlusion, the mean magnitude of V(4R) ST-segment depression was greater in proximal than distal occlusion (0.82 +/- 0.65 vs. 0.03 +/- 0.12 mm, p < 0.0001). V(4R)ST-segment depression > or =1.0 mm was found in 8 of 14 patients (57.1%) with proximal occlusion but none (0%) in 32 patients with distal occlusion. The sensitivity and specificity to predict proximal occlusion were 57.1 and 100%, respectively. CONCLUSIONS: V(4R) ST-segment depression > or =1.0 mm was not useful for differentiating left circumflex and right coronary artery occlusion because of its low sensitivity. It is a fairly sensitive and very specific sign of proximal left circumflex artery occlusion.

Prognostic implications of PR-segment depression in inferior leads in acute inferior myocardial infarction.

BACKGROUND: Concurrent atrial ischemia is usually overlooked in acute myocardial infarction (MI) due to its subtle electrocardiographic (ECG) changes, lack of clear-cut clinical picture, and prognostic significance. PR-segment depression in the inferior leads is a simplified ECG sign for detecting possible underlying atrial ischemia. HYPOTHESIS: The purpose of this study was to document the incidence, clinical characteristics, and prognostic implications of this ECG sign in the setting of acute inferior MI. METHODS: Demographics, clinical characteristics, and outcomes of 463 consecutive patients presenting with acute inferior MI were reviewed. The in-hospital ECG was examined by two independent reviewers. The results were then compared between those with and without ECG sign. RESULTS: Profound PR-segment depression > or = 1.2 mm in inferior leads was found in 9 of 463 (1.9%) patients. Patients with atrial ischemia tended to present earlier (2.4 +/- 2.6 vs. 7.0 +/- 8.2 h, p = 0.000) and had a higher frequency of first-degree atrioventricular block (77.8 vs. 30.6%, p = 0.028) and supraventricular arrhythmias (55.5 vs. 20.2%, p = 0.022). Of greater importance, it was significantly associated with an increased rate of cardiac free-wall rupture (33.3 vs. 2.0%, p = 0.001) and in-hospital mortality (44.4 vs. 11.7%, p = 0.015). CONCLUSION: Profound PR-segment depression > or = 1.2 mm in inferior leads was associated with a complicated hospital course and poor short-term outcome in acute inferior MI. These patients were at high risk for the development of atrioventricular block, supraventricular arrhythmias, and cardiac free-wall rupture.

Relation of aspirin resistance to coronary flow reserve in patients undergoing elective percutaneous coronary intervention.

Previous studies have shown that more complete platelet inhibition improves the coronary flow reserve (CFR), a measure of microvascular integrity, in patients undergoing percutaneous coronary intervention (PCI). We hypothesized that patients with aspirin resistance would have impaired CFR after elective PCI. We used VerifyNow Aspirin to determine the response to aspirin in 117 consecutive patients who underwent elective single-lesion PCI. The assay results are expressed quantitatively in Aspirin Reaction Units based on the degree of platelet aggregation. All patients received a 300-mg loading dose of clopidogrel >12 hours before and a 75-mg maintenance dose the morning of PCI. CFR was estimated using the Thrombolysis In Myocardial Infarction frame count method. Of the 117 patients, 22 (18.8%) were aspirin resistant. The clinical, angiographic, and procedural characteristics of the aspirin-sensitive and -resistant patients were balanced. All patients underwent successful PCI with <50% residual diameter stenosis and Thrombolysis In Myocardial Infarction grade 3 flow after PCI. Aspirin-resistant patients had a lower CFR than the aspirin-sensitive patients (1.42 +/- 0.35 vs 1.80 +/- 0.64, p = 0.018). Univariate correlates of CFR included the Aspirin Reaction Unit (r = -0.227, p = 0.014) and post-PCI creatine kinase-MB elevation (p = 0.048). Multivariate linear regression analysis revealed the Aspirin Reaction Unit to be the only independent determinant of CFR after PCI (r2 = 0.051, p = 0.014). Thus, aspirin resistance was associated with impaired CFR in patients who underwent elective PCI, implicating insufficient aspirin-induced platelet inhibition as a cause of microvascular dysfunction by distal atherothrombotic embolization and/or spasm.

Anomalous origin of right coronary artery from the left coronary sinus: incidence, characteristics, and a systematic approach for rapid diagnosis.

Twenty-three patients were found to have anomalous origin of right coronary artery from the left coronary sinus (LCS) from January 2000 to October 2003. The mean age was 58.6+/-14.3 years with male predominance (56.5%). Cardiovascular risk factors were found in 18 (78.3%) patients while coronary artery disease was seen in 13 (56.5%) patients. Among the coronary artery disease patients, the left anterior descending artery was the most commonly involved, followed by the right coronary artery and the left circumflex artery. Right coronary artery dominance was seen in 19 (82.6%) patients. The anomalous right coronary artery originates within the left coronary sinus in 17 (73.9%) patients while from the left aortic wall above the sinus in 6 (26.1%) patients only. Congenital heart disease and acquired valvular heart disease were the most common associated conditions. The author will share his experience and suggest a four-step approach of early recognition and selection of the anomalous right coronary artery ostium. Using the suggested strategy, most of the anomalous right coronary artery could be opacified with a left amplatz 1 catheter. Aortogram was needed only in 47.8% of cases.

Anomalous origin of the right coronary artery from the left coronary sinus is associated with early development of coronary artery disease.

BACKGROUND: Anomalous origin of the right coronary artery (RCA) from the left coronary sinus can cause sudden cardiac death. Whether this unique anatomical defect also predisposes to early development of coronary artery disease (CAD) remains uncertain. METHODS: Demography, cardiovascular risk factor profiles and coronary angiograms were reviewed in 1,532 consecutive patients over the past 3 years. RESULTS: Thirteen patients (0.8%) had anomalous RCA from the left coronary sinus, while the rest had normal origin from the right coronary sinus. CAD was found in 9/13 anomalous RCA patients (group A) and in 795/1,519 patients with normal RCA origin (group B). There were no differences in the distributions of age, sex or cardiovascular risk factors between the two groups. The distribution of critical lesions among the 3 major coronary arteries showed no significant differences either. However, among the patients with RCA involvement, the anomalous RCA group was significantly younger (54.8 +/- 4.8 years versus 64.9 +/- 10.1 years; p = 0.022). CONCLUSION: The anomalous RCA from left coronary sinus is associated with early development of CAD. The affected patients are 10 years younger.

Transient giant R-wave, right axis deviation, and intraventricular conduction delay during exercise treadmill testing: a case report.

A 53 year old man complained of chest pain during an exercise treadmill test. Electrocardiogram revealed transient giant R-wave, right-axis deviation, intraventricular conduction delay, and ST-segment elevation in the inferolateral leads. Subsequent coronary angiography showed an 80% lesion in mid part of a nondominant left circumflex artery, whereas the other coronary arteries had mild atherosclerosis only. Percutaneous coronary intervention and stenting was performed on the left circumflex artery lesion. A follow-up exercise thallium scan 3 months later still showed an intermediate-sized, mild reversible perfusion defect in the inferior and lateral wall but the giant R-wave ECG pattern was not inducible anymore. Restudy coronary angiography showed no in-stent restenosis, but there was disease progression in the midpart of the right coronary artery. The initial electrocardiographic pattern is typical of the "giant R-wave syndrome." Severe coronary spasm superimposed on the underlying mild atherosclerotic lesion of the right coronary artery is hypothesized to be the cause of the initial event. Ad hoc direct stenting was performed on the right coronary artery lesion. The patient remained symptom-free with a normal thallium scan 9 months later.

Localized bronchiectasis is a definite association of coronaro-bronchial artery fistula.

An 81-year-old smoker presented with acute coronary syndrome. Coronary angiography revealed severe double-vessel disease, as well as the incidental finding of a coronaro-bronchial artery fistula that arose from the left circumflex artery. Percutaneous coronary intervention was performed on the culprit lesion in the left anterior descending artery. A subsequent high-resolution computed tomography of the thorax revealed mild bronchiectic change in the corresponding area supplied by the coronaro-bronchial artery fistula. The patient had a normal lung function test and never had any chest symptoms. From the literature, the association of the coronaro-bronchial artery fistula and localized bronchiectasis is very definite, but the pathophysiology is still controversial.