Selected CD133⁺ progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial.

RATIONALE: Refractory angina constitutes a clinical problem. OBJECTIVE: The aim of this study was to assess the safety and the feasibility of transendocardial injection of CD133(+) cells to foster angiogenesis in patients with refractory angina. METHODS AND RESULTS: In this randomized, double-blinded, multicenter controlled trial, eligible patients were treated with granulocyte colony-stimulating factor, underwent an apheresis and electromechanical mapping, and were randomized to receive treatment with CD133(+) cells or no treatment. The primary end point was the safety of transendocardial injection of CD133(+) cells, as measured by the occurrence of major adverse cardiac and cerebrovascular event at 6 months. Secondary end points analyzed the efficacy. Twenty-eight patients were included (n=19 treatment; n=9 control). At 6 months, 1 patient in each group had ventricular fibrillation and 1 patient in each group died. One patient (treatment group) had a cardiac tamponade during mapping. There were no significant differences between groups with respect to efficacy parameters; however, the comparison within groups showed a significant improvement in the number of angina episodes per month (median absolute difference, -8.5 [95% confidence interval, -15.0 to -4.0]) and in angina functional class in the treatment arm but not in the control group. At 6 months, only 1 simple-photon emission computed tomography (SPECT) parameter: summed score improved significantly in the treatment group at rest and at stress (median absolute difference, -1.0 [95% confidence interval, -1.9 to -0.1]) but not in the control arm. CONCLUSIONS: Our findings support feasibility and safety of transendocardial injection of CD133(+) cells in patients with refractory angina. The promising clinical results and favorable data observed in SPECT summed score may set up the basis to test the efficacy of cell therapy in a larger randomized trial.

Prognostic implications of atrio-ventricular block in patients undergoing primary coronary angioplasty in the stent era.

INTRODUCTION: Conduction disorders in patients with ST-segment elevation myocardial infarction (STEMI) are associated with high mortality. Previous studies have analyzed the implications of AVB in acute coronary syndrome treated with fibrinolysis. However, the implications of AVB in patients with STEMI treated with primary angioplasty have not been sufficiently studied. MATERIAL AND METHODS: 913 patients with STEMI treated with primary angioplasty. All clinical, electrocardiographic and angiographic variables were collected. RESULTS: AVB was documented in 115 patients (12.6%). On admission, AVB was present in 70 (7.7%), and persistent at hospital discharge in 36 (3.9 %). Within these, first-degree AVB was present in 29 (3.2%), second-degree in 27 (3%) and third-degree in 73 (8%). AVB was more frequent in women, elderly, hypertensive, diabetic, with worse functional class (Killip class > 2) and with higher incidence at inferior infarctions (P < 0.05). AVB in general and, more specifically, third-degree AVB was associated with a higher mortality (20.5% versus 5.7%; P < 0.001), re-infarction (8.2% versus 3.6%; P = 0.06) and a greater incidence of cardiogenic shock (33.3% versus 14%; P < 0.001). Interestingly, these events were more common in patients who had persistent AVB at hospital discharge than in those with transitory AVB or present at admission AVB. In the multivariate analysis, persistent AVB at hospital discharge proved to be an independent predictor of cardiovascular events (death and recurrent infarction), not the rest of AVB. CONCLUSIONS: AVB in patients who underwent primary angioplasty is associated with a worse prognosis while is in-hospital. This risk is particularly high in patients who had persistent AVB at hospital discharge.

Low coronary microcirculatory resistance associated with profound hypotension during intravenous adenosine infusion: implications for the functional assessment of coronary stenoses.

BACKGROUND: Intravenous adenosine infusion produces coronary and systemic vasodilatation, generally leading to systemic hypotension. However, adenosine-induced hypotension during stable hyperemia is heterogeneous, and its relevance to coronary stenoses assessment with fractional flow reserve (FFR) remains largely unknown. METHODS AND RESULTS: FFR, coronary flow reserve, and index of microcirculatory resistance were measured in 93 stenosed arteries (79 patients). Clinical and intracoronary measurements were analyzed among tertiles of the percentage degree of adenosine-induced hypotension, defined as follows: %ΔP(a)=-[100-(hyperemic aortic pressure×100/baseline aortic pressure)]. Overall, %ΔP(a) was -13.6±12.0%. Body mass index was associated with %ΔP(a) (r=0.258; P=0.025) and obesity, an independent predictor of profound adenosine-induced hypotension (tertile 3 of %ΔP(a); odds ratio, 3.95 [95% confidence interval, 1.48-10.54]; P=0.006). %ΔP(a) was associated with index of microcirculatory resistance (ρ=0.311; P=0.002), coronary flow reserve (r=-0.246; P=0.017), and marginally with FFR (r=0.203; P=0.051). However, index of microcirculatory resistance (ß=0.003; P<0.001) and not %ΔP(a) (ß=-0.001; P=0.564) was a predictor of FFR. Compared with tertiles 1 and 2 of %ΔP(a) (n=62 [66.6%]), stenoses assessed during profound adenosine-induced hypotension (n=31 [33.3%]) had lower index of microcirculatory resistance (12.4 [8.6-22.7] versus 20 [15.8-35.5]; P=0.001) and FFR values (0.77±0.13 versus 0.83±0.12; P=0.021), as well as a nonsignificant increase in coronary flow reserve (2.5±1.1 versus 2.2±0.87; P=0.170). CONCLUSIONS: The modification of systemic blood pressure during intravenous adenosine infusion is related to hyperemic microcirculatory resistance in the heart. Profound adenosine-induced hypotension is associated with obesity, lower coronary microcirculatory resistance, and lower FFR values.

Disturbed coronary hemodynamics in vessels with intermediate stenoses evaluated with fractional flow reserve: a combined analysis of epicardial and microcirculatory involvement in ischemic heart disease.

BACKGROUND: In chronic ischemic heart disease, focal stenosis, diffuse atherosclerotic narrowings, and microcirculatory dysfunction (MCD) contribute to limit myocardial flow. The prevalence of these ischemic heart disease levels in fractional flow reserve (FFR) interrogated vessels remains largely unknown. METHODS AND RESULTS: Using intracoronary measurements, 91 coronaries (78 patients) with intermediate stenoses were classified in 4 FFR and coronary flow reserve (CFR) agreement groups, using FFR>0.80 and CFR<2 as cutoffs. Index of microcirculatory resistance (IMR) and atherosclerotic burden (Gensini score) were also assessed. MCD was assumed when IMR≥29.1 (75(th) percentile). Fifty-four (59.3%) vessels had normal FFR, from which only 20 (37%) presented both normal CFR and IMR. Among vessels with FFR>0.80, most (63%) presented disturbed hemodynamics: abnormal CFR in 28 (52%) and MCD in 18 (33%). Vessels with FFR>0.80 presented higher IMR [adjusted mean 27.6 (95% confidence interval, 23.4-31.8)] than those with FFR≤0.80 [17.3 (95% confidence interval, 13.0-21.7), p=0.001]. Atherosclerotic burden was inversely correlated with CFR (r=-0.207, P=0.055), and in vessels with FFR>0.80 and CFR<2 (n=28, 39%), IMR had a wide dispersion (7-72.7 U), suggesting a combination of diffuse atherosclerotic narrowings and MCD. Vessels with FFR≤0.80 and normal CFR presented the lowest IMR, suggesting a preserved microcirculation. CONCLUSIONS: A substantial number of coronary arteries with stenoses showing an FFR>0.80 present disturbed hemodynamics. Integration of FFR, CFR, and IMR supports the existence of differentiated patterns of ischemic heart disease that combine focal and diffuse coronary narrowings with variable degrees of MCD.

Safety and efficacy of intense antithrombotic treatment and percutaneous coronary intervention deferral in patients with large intracoronary thrombus.

The optimal management of a large intracoronary thrombus in patients with acute coronary syndromes without an urgent need of revascularization is unclear. We investigated whether deferring percutaneous coronary intervention (PCI) after a course of intensive antithrombotic therapy (ATT) (glycoprotein IIb/IIIa inhibitors, enoxaparin, aspirin, and clopidogrel) improves the outcomes compared with immediate PCI. We studied 133 stable patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization at angiography. The angiographic and in-hospital outcomes of a prospective cohort of 89 patients who had undergone deferred angiography with or without PCI after ATT (d-PCI) were compared with a historical cohort of 44 patients who had undergone immediate PCI, matched for age, gender, and Thrombolysis In Myocardial Infarction thrombus grade. The absolute thrombus volume was measured before and after ATT using dual quantitative coronary angiography. All d-PCI patients remained stable during ATT (60.0 ± 30.8 hours). A significant reduction in the Thrombolysis In Myocardial Infarction thrombus grade (4, range 4 to 5, vs 3, range 2 to 4; p <0.001), thrombus volume (51.1, range 32.1 to 83, vs 38.1, range 21.7 to 50.7 mm(3); p <0.001), stenosis severity (73.8 ± 25.8% vs 60.3 ± 32.5%; p <0.001) and better Thrombolysis In Myocardial Infarction flow (2, range 0 to 3, vs 3, 1.5 to 3; p <0.001) were noted after ATT. PCI, stenting, and thrombus aspiration were performed less frequently in the d-PCI group (76.4% vs 100%, p <0.001; 70.8% vs 93.2%, p = 0.003; and 21% vs 100%, p <0.001, respectively). However, distal embolization and slow and/or no-reflow were more common during immediate PCI (31.8% vs 9%; p = 0.001). No life-threatening or severe hemorrhagic complications were observed, although the rate of mild and/or moderate bleeding was similar between the 2 groups (6.8% in immediate PCI vs 7.9% in d-PCI; p = 0.829). In conclusion, compared with immediate PCI, d-PCI after ATT in selected, stabilized patients with ACS and a large intracoronary thrombus and without an urgent need for revascularization is probably safe and associated with a reduction in thrombotic burden, angiographic complications, and the need of revascularization. These benefits were observed without an increase in hemorrhagic complications.

Sirolimus-eluting stent versus bare metal stent in diabetic patients: the final five-year follow-up of the DIABETES trial.

AIMS: The DIABETES (DIABETes and sirolimus-Eluting Stent) trial is a prospective, multicentre, randomised, controlled trial aimed at demonstrating the efficacy of sirolimus-eluting stent (SES) as compared to bare metal stent (BMS) implantation in diabetic patients. The aim of the present analysis was to assess the five-year clinical follow-up of the patients included in this trial. METHODS AND RESULTS: One hundred and sixty patients (222 lesions) were included: 80 patients were randomised to SES and 80 patients to BMS. Patients were eligible for the study if they were identified as non-insulin-dependent diabetics (NIDDM) or insulin-dependent diabetics (IDDM), with significant native coronary stenoses in ≥1 vessel. There was a sub-randomisation according to diabetes status. Clinical follow-up was extended up to five years. Five-year clinical follow-up was obtained in 96.2%. Overall, MACE at five years was significantly lower in the SES group as compared with the BMS arm, mainly due to a significant reduction in TLR. There were no significant differences in cardiac death or myocardial infarction (MI). This was also observed in both prespecified subgroups IDDM and NIDDM. In the SES group, the incidence density of definite/probable stent thrombosis was 0.53 per 100 person-years, whereas in the BMS group it was 0.8 per 100 person-years. Independent predictors of MACE were: SES implantation (p<0.001), multivessel stent implantation (p=0.04), and creatinine levels (p=0.001). CONCLUSIONS: Five-year follow-up of the DIABETES trial suggests the effect of SES in reducing TLR is similar in both IDDM and NIDDM. No major safety concerns in terms of ST, MI or mortality were observed.

Safety of lone thrombus aspiration without concomitant coronary stenting in selected patients with acute myocardial infarction.

AIMS: Although the benefit of concomitant thrombus aspiration (TA) in primary percutaneous coronary intervention (PPCI) treatment of acute ST-segment elevation myocardial infarction (STEMI) has been demonstrated, very little information is available on its safety as a lone revascularisation technique in this setting. We present our experience in a cohort of patients with STEMI treated only with TA, without concomitant interventional devices. METHODS AND RESULTS: In 28 patients with STEMI, PPCI was performed using only TA on the grounds of an excellent angiographic result and in order to avoid the potential risks associated with balloon dilatation or stenting. The patients were younger than in the overall PPCI population (n=1,737) at our institution (52±18 vs. 63±14 years, p<0.001), with a history of atrial fibrillation in six (21%), cocaine abuse in three (11%) and mechanical cardiac valves in two (7%). Twenty-eight patients (89%) presented STEMI with Killip class I, two (7%) with cardiogenic shock, and two (7%) with sudden cardiac death. A significant reduction in TIMI thrombus grade (5 [4-5] to 1 [0-1.75], p<0.001) and coronary stenosis percentage (%) (87.2±21.3 to 11.3±0.9, p<0.001) as well as an increase in final TIMI flow (0 [0-2] to 3 [3-3], p<0.001) and minimum luminal diameter (mm) (0.89±1.01 to 2.42±0.70, p<0.001) were noted after TA. Transient no-reflow phenomenon, residual intracoronary thrombus and minor distal thrombus embolisation were observed in two (7.1%), 11 (39.3%) and 10 (25.7%) patients, respectively. All but one patient remained asymptomatic during hospital admission. Scheduled control angiography was performed 6±2 days (min-max, 3-10 days) after PPCI in 11 (39%) patients, demonstrating coronary artery patency and TIMI flow grade 3 in all patients. During clinical follow-up, successfully performed in all patients at 40±23 months (min-max, six to 95 months), there was one sudden cardiac death (4%) and three (11%) non-cardiac deaths. One patient (4%) was admitted with non-STEMI (new coronary angiogram without stenosis) and the remaining 22 (78.5%) remained asymptomatic and free of cardiac events. CONCLUSIONS: Our series suggests that lone TA might be safely performed as a primary revascularisation procedure in STEMI in selected cases. Further information based on additional and larger studies is recommended to confirm our findings.

Morphological characteristics of culprit coronary lesions according to clinical presentation: insights from a multimodality imaging approach.

The aim of this study was to prospectively evaluate the morphological characteristics of culprit coronary lesions according to clinical presentation. A combined, comprehensive, multi-imaging modality protocol was systematically used. A total of 46 consecutive patients with stable angina (n = 24) or acute coronary syndromes (n = 22) were included. Culprit lesions were prospectively studied with angiography, multislice computed tomography (MSCT), intravascular ultrasound and virtual histology. MSCT showed a lower radiographic density and a higher remodeling index in culprit lesions of patients with acute coronary syndromes. Intravascular ultrasound examination demonstrated a larger remodeling index, a lower degree of calcification and a higher prevalence of soft lesions in unstable patients. Virtual histology analysis showed a lower percentage of calcium in the area of greatest stenosis and a higher prevalence of lesions with vulnerable characteristics in unstable patients. In multivariable logistic regression analysis, remodeling index by intravascular ultrasound and radiographic density in MSCT were the only independent predictors for identifying unstable culprit lesions. Our study adds further evidence on the best morphological criteria of instability in culprit lesions. Remodeling index by IVUS and low radiographic density by MSTC were the only independent predictors of unstable lesions.

Spontaneous coronary artery dissection: long-term follow-up of a large series of patients prospectively managed with a "conservative" therapeutic strategy.

OBJECTIVES: This study sought to assess the long-term clinical outcome of patients with spontaneous coronary artery dissection (SCD) managed with a conservative strategy. BACKGROUND: SCD is a rare, but challenging, clinical entity. METHODS: A prospective protocol, including a conservative management strategy, was followed. Revascularization was only considered in cases with ongoing/recurrent ischemia. Inflammatory/immunologic markers were systematically obtained. RESULTS: Forty-five consecutive patients (incidence 0.27%) were studied during a 6-year period. Of these, 27 patients (60%) had "isolated" SCD (I-SCD), and 18 had SCD associated with coronary artery disease (A-SCD). Age was 53 ± 11 years, and 26 patients were female. Most patients presented with an acute myocardial infarction. SCD had a diffuse angiographic pattern (length: 31 ± 23 mm). In 11 patients, the diagnosis was confirmed by intracoronary imaging techniques. Sixteen patients (35%) required revascularization during initial admission. One patient died after surgery, but no additional patient experienced recurrent myocardial infarction. No significant inflammatory/immunologic abnormalities were detected. At follow-up (median 730 days), only 3 patients presented with adverse events (1 died of congestive heart failure, and 2 required revascularization). No patient experienced a myocardial infarction or died suddenly. Event-free survival was similar (94% and 88%, respectively) in patients with I-SCD and A-SCD. Notably, at angiographic follow-up, spontaneous "disappearance" of the SCD image was found in 7 of 13 (54%) patients. CONCLUSIONS: In this large prospective series of consecutive patients with SCD, a "conservative" therapeutic strategy provided excellent long-term prognosis. Clinical outcome was similar in patients with I-SCD and A-SCD. The natural history of SCD includes spontaneous healing with complete resolution.

Prognosis of different types of atrial fibrillation in the primary angioplasty era.

BACKGROUND: Atrial fibrillation (AF) has been associated with a poor prognosis in patients with ST-segment elevation myocardial infarction. There is considerable controversy regarding the prognostic implications of different types of AF. METHODS AND RESULTS: We analyzed 913 patients consecutively admitted to our center with ST-segment elevation myocardial infarction undergoing a primary percutaneous coronary intervention. Clinical, ECG, and angiographic data were collected. We carried out univariate and multivariate analysis, using a combined endpoint of death, reinfarction, stroke, and clinically relevant bleeding. AF was documented in 117 patients. Among them, 25 presented AF at admission (previous AF) and 92 developed new-onset AF (66% transient, 13% persistent). Patients with AF were older, more frequently men, and had a worse Killip class, and a poorer left-ventricular ejection fraction. When analyzing the different types of AF, patients with new-onset AF (persistent and transient) had a higher Killip class and a worse left-ventricular ejection fraction. AF was associated with significantly higher in-hospital mortality and with a greater incidence of in-hospital adverse events. An increase in in-hospital mortality was recorded both for previous and for new-persistent AF, but after adjusting for confounding factors, only persistent AF was found to carry a worse short-term prognosis. CONCLUSION: In patients undergoing primary angioplasty in the stent era, AF is associated with a poor prognosis. This risk appears to be particularly high among patients with persistent AF.

Combined use of optical coherence tomography and intravascular ultrasound imaging in patients undergoing coronary interventions for stent thrombosis.

OBJECTIVE: This prospective study sought to assess the diagnostic value of optical coherence tomography (OCT) compared with intravascular ultrasound (IVUS) in patients presenting with stent thrombosis (ST). DESIGN AND SETTING: Although the role of IVUS in this setting has been described, the potential diagnostic value of OCT in patients suffering ST remains poorly defined. Catheterization Laboratory, University Hospital. PATIENTS AND INTERVENTIONS: Fifteen consecutive patients with ST undergoing rescue coronary interventions under combined IVUS/OCT imaging guidance were analysed. MEAN OUTCOME MEASURES: Analysis and comparison of OCT and IVUS findings before and after interventions. RESULTS: Before intervention, OCT visualised the responsible thrombus in all patients (thrombus area 4.7±2.5 mm(2), stent obstruction 82±14%). Minimal stent area was 4.7±2.1 mm(2) leading to severe stent underexpansion (expansion 60±21%). Although red or mixed thrombus (14 patients) induced partial strut shadowing (total length 12.3±6 mm), malapposition (six patients), inflow-outflow disease (five patients), uncovered struts (nine patients) and associated in-stent restenosis (five patients, four showing neoatherogenesis) was clearly recognised. IVUS disclosed similar findings but achieved poorer visualisation of thrombus-lumen interface and strut malapposition, and failed to recognise uncovered struts and associated neoatherosclerosis. After interventions, OCT demonstrated a reduced thrombus burden (2.4±1.6 mm(2)) and stent obstruction (24±14%) with improvements in stent area (6.8±2.9 mm(2)) and expansion (75±21%) (all p<0.05). IVUS and OCT findings proved to be complementary. CONCLUSIONS: OCT provides unique insights on the underlying substrate of ST and may be used to optimise results in these challenging interventions. In this setting, OCT and IVUS have complementary diagnostic values.

Diagnosis of spontaneous coronary artery dissection by optical coherence tomography.

OBJECTIVES: This study sought to assess the diagnostic value of optical coherence tomography (OCT) in patients with suspected spontaneous coronary artery dissection (SCAD). BACKGROUND: SCAD is a rare but challenging clinical entity. METHODS: Following a prospective protocol, OCT was performed in 17 consecutive patients with a clinical and angiographic suspicion of SCD from a total of 5,002 patients undergoing coronary angiography. A conservative management strategy was followed. RESULTS: OCT ruled out the diagnosis of SCAD in 6 patients with coronary artery disease (atherosclerotic plaques and/or intracoronary thrombus). In 11 patients (age 48 ± 9 years, 9 female), OCT confirmed the presence of SCAD. A double-lumen or intramural hematoma image was visualized in all cases. However, only 3 patients presented an intimal "flap" on angiography. OCT readily identified the intimal rupture site (n = 7), the thickness (348 ± 84 µm) and length (31 ± 9 mm) of the intimomedial membrane, the area of the true (1.1 ± 0.5 mm(2)) and false lumen (5.9 ± 2.1 mm(2)), the associated intramural hematoma (n = 9), and thrombi in the true or false lumens (n = 11). Most of these findings were angiographically silent. After stenting (n = 4), OCT disclosed adequate stent coverage, expansion, and apposition, but also residual intramural hematoma at the stented site (abluminal) and at the distal vessel. CONCLUSIONS: OCT provides unique insights in patients with SCAD that allow an early diagnosis and adequate management. Most of these findings are undetectable by angiography.

Morphometric assessment of coronary stenosis relevance with optical coherence tomography: a comparison with fractional flow reserve and intravascular ultrasound.

OBJECTIVES: The study sought to assess the diagnostic efficiency of optical coherence tomography (OCT) in identifying hemodynamically severe coronary stenoses as determined by fractional flow reserve (FFR). Concomitant OCT and intravascular ultrasound (IVUS) area measurements were performed in a subgroup of patients to compare the diagnostic efficiency of both techniques. BACKGROUND: The value of OCT to determine stenosis severity remains unsettled. METHODS: Sixty-one stenoses with intermediate angiographic severity were studied in 56 patients. Stenoses were labeled as severe if FFR ≤0.80. OCT interrogation was performed in all cases, with concomitant IVUS imaging in 47 cases. RESULTS: Angiographic stenosis severity was 50.9 ± 8% diameter stenosis with 1.28 ± 0.3 mm minimal lumen diameter. FFR was ≤0.80 in 28 (45.9%) stenoses. An overall moderate diagnostic efficiency of OCT was found (area under the curve [AUC]: 0.74; 95% confidence interval [CI]: 0.61 to 0.84), with sensitivity/specificity of 82%/63% associated with an optimal cutoff value of 1.95 mm(2). Comparison of the results in patients with simultaneous IVUS and OCT imaging revealed no significant differences in the diagnostic efficiency of OCT (AUC: 0.70; 95% CI: 0.55 to 0.83) and IVUS (AUC. 0.63; 95% CI: 0.47 to 0.77; p = 0.19). Sensitivity/specificity for IVUS was 67%/65% for an optimal cutoff value of 2.36 mm(2). In the subgroup of small vessels (reference diameter <3 mm) OCT showed a significantly better diagnostic efficiency (AUC: 0.77; 95% CI: 0.60 to 0.89) than IVUS (AUC: 0.63; 95% CI: 0.46 to 0.78) to identify functionally significant stenoses (p = 0.04). CONCLUSIONS: OCT has a moderate diagnostic efficiency in identifying hemodynamically severe coronary stenoses. Although OCT seems slightly superior to IVUS for this purpose (particularly in vessels <3 mm), its low specificity precludes its use as a substitute of FFR for functional stenosis assessment.

[Assessment of dynamic coronary plaque changes and the clinical consequences in type-II diabetic patients: a serial intracoronary ultrasound study]. / Evaluación de los cambios dinámicos de las placas coronarias y sus consecuencias clínicas en pacientes con diabetes mellitus tipo 2: un estudio de ecografía intracoronaria seriada.

INTRODUCTION AND OBJECTIVES: One of the aims of secondary prevention is to achieve plaque stabilization. This study sought to investigate the clinical consequences and predictive factors of the change in the type of plaque (CTP) as assessed by serial intracoronary ultrasound in type II diabetic patients with known coronary artery disease. METHODS: 237 segments (45 patients) from the DIABETES I, II, and III trials were included. Intracoronary ultrasound from motorized pullbacks (0.5mm/s) after index procedure and at 9-month angiographic follow-up was performed in the same coronary segment. Nontreated mild lesions (angiographic stenosis <25%) with ≥0.5mm plaque thickening and ≥5mm of length assessed by intracoronary ultrasound were included. As different types of plaques may be encountered throughout a given coronary lesion, each study lesion was divided into 3 segments for serial quantitative and qualitative analyses. Statistical adjustment by multiple lesion segments per patient (generalized estimating equations method) was performed. A CTP was defined as any qualitative change in plaque type at follow-up. At 1-year follow-up, major adverse cardiac events - death, myocardial infarction and target vessel revascularization) - were recorded. RESULTS: A CTP was observed in 48 lesions (20.2%) and occurred more frequently (52.1%) in mixed plaques. Independent predictors of CTP were glycated hemoglobin levels (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.01-1.5; P=.04); glycoprotein IIb-IIIa inhibitors (OR 0.3; 95% CI 0.1-0.7; P=.004) and statin administration (OR 0.3; 95% CI 0.1-0.8; P=.02). At 1-year follow-up CTP was associated with an increase in major adverse cardiac events rate (CTP 20.8% vs non-CTP 13.8%, P=.008; hazard ratio=1.9, 95% CI 1.3-1.9, P=.01). CONCLUSIONS: Qualitative changes in mild stenosis documented by intracoronary ultrasound in type II diabetics are associated with suboptimal secondary prevention and may have clinical consequences. Full English text available from: www.revespcardiol.org.

Findings of a mixed transfemoral aortic valve implantation program using Edwards and CoreValve devices.

INTRODUCTION AND OBJECTIVES: Transfemoral implantation of an Edwards SAPIEN (ES) or Medtronic CoreValve (MCV) aortic valve prosthesis is an alternative to surgical replacement for patients with severe aortic stenosis and a high surgical risk. The study's aim was to compare results obtained with these two devices. METHODS: Prospective observational study of transfemoral prosthesis implantation performed at our center. RESULTS: Of the 76 patients (age 83 ± 6 years, 63% female, logistic EuroSCORE 18 ± 9) included, 50 were assigned the ES and 26 the MCV device. There was no difference between the groups in age, sex, functional class, valve area, associated conditions, or EuroSCORE. Implantation was successful in 84% of the ES group and 100% of the MCV group (P = .04). There were three cases of tamponade, two aortic dissections and one valve malposition in the ES group. The two groups had similar vascular access complication rates (26% vs. 23%; P=NS), but pacemaker need was greater with the MCV (10% vs. 39%; P = .003). Mortality rates at 30 days were 12% and 20% (P = NS) in the ES and MCV groups, respectively, and at 1 year, 24% and 20% (P = NS), respectively. After a follow-up of 367 ± 266 days in the ES group and 172 ± 159 days in the MCV group, three patients died. Clinical improvement was maintained in other patients and no echocardiographic changes were observed. CONCLUSIONS: In-hospital mortality, the complication rate and medium-term outcomes were similar with the two devices. The only difference observed was a higher implantation success rate with the MCV, although at the expense of a greater frequency of atrioventricular block.