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Current Cardiology Reviews 05/2013;
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Tobias Rutz,
Stefano F de Marchi,
Patrizia Roelli,
Steffen Gloekler,
Tobias Traupe,
Hélène Steck,
Parham Eshtehardi,
Stéphane Cook,
Rolf Vogel,
Paul Mohacsi, Christian Seiler
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ABSTRACT: BACKGROUND: Chronic heart transplant rejection, i.e. cardiac allograft vasculopathy (CAV) is a major adverse prognostic factor after heart transplantation (HTx). This study tested the hypothesis that the relative myocardial blood volume (rBV) as quantified by myocardial contrast echocardiography accurately detects severe CAV as defined by coronary intravascular ultrasound (IVUS). METHODS AND RESULTS: Forty-five HTx patients underwent a total of 50 quantitative IVUS measurements for intima thickness assessment (>1 mm = severe CAV; the reference method). Simultaneously, the two factors constituting myocardial perfusion (mL/min/g) were obtained by transthoracic contrast echocardiography at rest: rBV (the test method), a measure of microvascular density (mL/mL), and its exchange rate β (1/s; a measure of coronary conductance) after mechanical contrast bubble disruption.Sixty-nine per cent (31 of 45) of the HTx patients showed severe CAV. rBV at rest was equal to 0.17 ± 0.05 in the group without severe CAV, and it was equal to 0.12 ± 0.07 in the group with severe CAV (P = 0.0157). Conversely, β amounted to 6.4 ± 4.5 in the former and to 10.3 ± 6.2 in the latter group (P = 0.0410), thus, maintaining normal resting myocardial perfusion at 1 mL/min/g. IVUS determined intima thickness correlated significantly and inversely with rBV at rest. An rBV value at rest <0.14 accurately detected severe CAV (intima thickness >1 mm): area under the receiver operating characteristics curve = 0.844, P = 0.004, sensitivity = 0.90, specificity = 0.75. CONCLUSION: Severe CAV can be detected using the non-invasive method of quantitative myocardial contrast echocardiography. rBV at rest amounting to <14% of the surrounding tissue accurately detects coronary intima thickness >1 mm as determined invasively by IVUS.Clinical trial number: NCT00414895.
European heart journal cardiovascular Imaging. 04/2013;
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ABSTRACT: Aims: Recent data have demonstrated the feasibility of therapeutic induction of coronary collateral growth (arteriogenesis); however, mechanisms of action of such therapeutic collateral stimulation in humans are unknown. The aim of this study was to evaluate potential mechanisms, especially the involvement of arteriogenesis-relevant genes. Methods and Results: A total of 52 patients were randomized into two groups: subcutaneous G-CSF (10μg/kg; n=26) or placebo (n=26). Before and after this 2-week treatment, collateral-flow index (CFI) was determined by simultaneous measurement of mean aortic, distal coronary occlusive and central venous pressure. CD34+ endothelial progenitor cells (EPC) and monocytes were quantified before, during and after treatment; gene-expression analysis of monocytes was performed with real-time polymerase chain reaction (RT-PCR). G-CSF lead to a significant increase of EPC and monocytes (4.8 and 2.6 fold, p < 0.05); for both cell types, the extent of increase correlated with CFI increase (r=0.23 and 0.14, p < 0.05). G-CSF also induced a change in gene expression of pro-and anti-arteriogenic genes in monocytes. Among nine assessed genes, three were found to be differentially regulated (IL8, JAK2, and PNPLa4; p < 0.05). Conclusions: The mechanism of induction of collateral growth by G-CSF is related to an increase of EPC and of peripheral monocytes. It also leads to a change toward a pro-arteriogenic gene expression in peripheral monocytes.
Current Vascular Pharmacology 01/2013; 11(1):38-46. · 2.90 Impact Factor
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ABSTRACT: In adults with congenital heart disease and a systemic right ventricle, subaortic ventricular systolic dysfunction is common. Echocardiographic assessment of systolic right ventricular (RV) function in these patients is important but challenging. The aim of the present study was to assess the reliability of conventional echocardiographic RV functional parameters to quantify the systolic performance of a subaortic right ventricle. We compared 56 contemporary echocardiograms and cardiac magnetic resonance studies in 37 adults, aged 26.9 ± 7.4 years, with complete transposition and a subaortic right ventricle. The fractional area change (FAC), lateral tricuspid annular plane systolic excursion, lateral RV systolic motion velocities by tissue Doppler, RV myocardial performance index, and the rate of systolic RV pressure increase (dp/dt) measured across the tricuspid regurgitant jet were assessed by echocardiography and correlated with the cardiac magnetic resonance-derived RV ejection fraction (EF). The mean RVEF was 48.0 ± 7.8%. FAC (r(2) = 0.206, p = 0.001) and dp/dt (r(2) = 0.173, p = 0.009) significantly correlated with RVEF, and the other nongeometric echocardiographic parameters failed to show a significant correlation with RVEF by linear regression analysis. FAC <33% and dp/dt <1,000 mm Hg/s identified a RVEF of <50% with a sensitivity of 77% and 69% and a specificity of 58% and 87%, respectively. In conclusion, in patients with a systemic right ventricle, routine nongeometric echocardiographic parameters of RV function correlated weakly with cardiac magnetic resonance-derived EF. RV FAC and the measurement of the rate of systolic RV pressure increase (dp/dt) should be preferentially used to assess systemic systolic function in adult patients with a subaortic right ventricle.
The American journal of cardiology 12/2012; · 3.58 Impact Factor
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Heart (British Cardiac Society) 12/2012; · 4.22 Impact Factor
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ABSTRACT: The aim of this study was to test the hypothesis that ear oximetry immediately after the release of a sustained Valsalva maneuver accurately detects patent foramen ovale (PFO). One hundred sixty-five scuba divers underwent transesophageal echocardiography (TEE; reference method) for PFO assessment. Ear oximetry of the right earlobe was performed in a different room within a time frame of 2 hours before or after TEE. The subject and the oximetry operator were unaware of the results of TEE. Oxygen saturation (SO(2)) measurements were obtained at baseline and during the release phase of 4 Valsalva maneuvers within 10 minutes, and the average SO(2) change (SO(2) at baseline minus SO(2) at Valsalva release) was determined as the primary study end point. One hundred seventeen divers had no PFO, and 48 (29%) had PFO by TEE (mean age 39 ± 8 years). The average SO(2) change was 0.79 ± 1.13% (i.e., a slight absolute SO(2) decrease in response to the Valsalva maneuver) in the group without PFO and 1.67 ± 1.19% in the PFO group (p <0.0001). Using receiver-operating characteristic curve analysis, a PFO as defined by TEE could be detected at a threshold of a Valsalva-induced decrease in SO(2) of ≥0.825 percentage points in comparison to baseline (sensitivity 0.756, specificity 0.706, area under the receiver-operating characteristic curve 0.763, p <0.0001, negative predictive value 0.882). In conclusion, the entirely noninvasive method of ear oximetry in response to repetitive Valsalva maneuvers is accurate and useful as a screening method for the detection of a PFO, as shown in this study of divers.
The American journal of cardiology 10/2012; · 3.58 Impact Factor
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ABSTRACT: The prognostic relevance of quantitative an intracoronary occlusive electrocardiographic (ECG) ST-segment shift and its determinants have not been investigated in humans. In 765 patients with chronic stable coronary artery disease, the following simultaneous quantitative measurements were obtained during a 1-minute coronary balloon occlusion: intracoronary ECG ST-segment shift (recorded by angioplasty guidewire), mean aortic pressure, mean distal coronary pressure, and mean central venous pressure (CVP). Collateral flow index (CFI) was calculated as follows: (mean distal coronary pressure minus CVP)/(mean aortic pressure minus CVP). During an average follow-up duration of 50 ± 34 months, the cumulative mortality rate from all causes was significantly lower in the group with an ST-segment shift <0.1 mV (n = 89) than in the group with an ST-segment shift ≥0.1 mV (n = 676, p = 0.0211). Factors independently related to intracoronary occlusive ECG ST-segment shift <0.1 mV (r(2) = 0.189, p <0.0001) were high CFI (p <0.0001), intracoronary occlusive RR interval (p = 0.0467), right coronary artery as the ischemic region (p <0.0001), and absence of arterial hypertension (p = 0.0132). "High" CFI according to receiver operating characteristics analysis was ≥0.217 (area under receiver operating characteristics curve 0.647, p <0.0001). In conclusion, absence of ECG ST-segment shift during brief coronary occlusion in patients with chronic coronary artery disease conveys a decreased mortality and is directly influenced by a well-developed collateral supply to the right versus left coronary ischemic region and by the absence of systemic hypertension in a patient's history.
The American journal of cardiology 07/2012; 110(9):1234-9. · 3.58 Impact Factor
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ABSTRACT: The benefit of the coronary collateral circulation (natural bypass network) on survival is well established. However, data derived from smaller studies indicates that coronary collaterals may increase the risk for restenosis after percutaneous coronary interventions. The purpose of this systematic review and meta-analysis of observational studies was to explore the impact of the collateral circulation on the risk for restenosis.
We searched the MEDLINE, EMBASE and ISI Web of Science databases (2001 to 15 July 2011). Random effects models were used to calculate summary risk ratios (RR) for restenosis. The primary endpoint was angiographic restenosis > 50%.
A total of 7 studies enrolling 1,425 subjects were integrated in this analysis. On average across studies, the presence of a good collateralization was predictive for restenosis (risk ratio (RR) 1.40 (95% CI 1.09 to 1.80); P = 0.009). This risk ratio was consistent in the subgroup analyses where collateralization was assessed with intracoronary pressure measurements (RR 1.37 (95% CI 1.03 to 1.83); P = 0.038) versus visual assessment (RR 1.41 (95% CI 1.00 to 1.99); P = 0.049). For the subgroup of patients with stable coronary artery disease (CAD), the RR for restenosis with 'good collaterals' was 1.64 (95% CI 1.14 to 2.35) compared to 'poor collaterals' (P = 0.008). For patients with acute myocardial infarction, however, the RR for restenosis with 'good collateralization' was only 1.23 (95% CI 0.89 to 1.69); P = 0.212.
The risk of restenosis after percutaneous coronary intervention (PCI) is increased in patients with good coronary collateralization. Assessment of the coronary collateral circulation before PCI may be useful for risk stratification and for the choice of antiproliferative measures (drug-eluting stent instead bare-metal stent, cilostazol).
BMC Medicine 06/2012; 10:62. · 6.03 Impact Factor
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ABSTRACT: The coronary collateral circulation as an alternative source of blood supply has shown benefits regarding several clinical endpoints in patients with myocardial infarction (MI) such as infarct size and left ventricular remodelling. However, its impact on hard endpoints such as mortality and its impact in patients with stable coronary artery disease (CAD) is more controversial. The purpose of this systematic review and meta-analysis was to explore the impact of collateral circulation on all-cause mortality.
We searched MEDLINE, EMBASE, ISI Web of Science (2001 to 25 April 2011), and conference proceedings for studies evaluating the effect of coronary collaterals on mortality. Random-effect models were used to calculate summary risk ratios (RR). A total of 12 studies enrolling 6529 participants were included in this analysis. Patients with high collateralization showed a reduced mortality compared with those with low collateralization [RR 0.64 (95% confidence interval 0.45-0.91); P= 0.012]. The RR for 'high collateralization' in patients with stable CAD was 0.59 [0.39-0.89], P= 0.012, in patients with subacute MI it was 0.53 [0.15-1.92]; P= 0.335, and for patients with acute MI it was 0.63 [0.29-1.39]; P= 0.257.
In patients with CAD, the coronary collateralization has a relevant protective effect. Patients with a high collateralization have a 36% reduced mortality risk compared with patients with low collateralization.
European Heart Journal 03/2012; 33(5):614-21. · 10.48 Impact Factor
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Stéphane Cook,
Parham Eshtehardi,
Bindu Kalesan,
Lorenz Räber,
Peter Wenaweser,
Mario Togni,
Aris Moschovitis,
Rolf Vogel, Christian Seiler,
Franz R Eberli,
Thomas Lüscher,
Bernhard Meier,
Peter Jüni,
Stephan Windecker
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ABSTRACT: Late acquired incomplete stent apposition (ISA) is more common after drug-eluting stent (DES) than bare metal stent (BMS) implantation and has been associated with vascular hypersensitivity and stent thrombosis (ST). We investigated the impact of incidentally discovered ISA as assessed by intravascular ultrasound (IVUS) 8 months after DES implantation on the long-term clinical outcome.
A total of 194 patients with 221 lesions were prospectively followed through 5 years. At 8 months, IVUS showed evidence of ISA among 37 patients with 39 lesions (18%) (mean ISA(max) 4.7 ± 5.0 mm(2)), whereas no ISA was observed among 157 patients with 182 lesions. Incomplete stent apposition was more prevalent among segments treated with sirolimus-eluting (n = 103) than paclitaxel-eluting stents (n = 118) (27 vs. 9%, P = 0.001). Between IVUS investigation at the 8-month and 5-year follow-up, major adverse cardiac events occurred more frequently in patients with (18.9%, n = 7) than without ISA (7.0%, n = 11) (HR = 2.71, 95% CI: 1.05-6.96, P = 0.031). While there were no differences with respect to death, the rate of myocardial infarction was higher among patients with (13.5%, n = 5) than without ISA (1.9%, n = 3) (HR = 7.53, 95% CI: 1.79-31.6, P = 0.001). Very late ST was more common among patients with than without ISA [Academic Research Consortium-definite ST:13.5% (n = 5) vs. 0.6% (n = 1) HR = 23.2, 95% CI: 2.65-203, P < 0.001].
In the present study, the presence of ISA as assessed by IVUS 8 months after DES implantation was associated with a higher rate of myocardial infarction and very late stent thrombosis during long-term follow-up. The prognostic impact of ISA on long-term clinical outcomes requires further investigation.
European Heart Journal 01/2012; 33(11):1334-43. · 10.48 Impact Factor
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ABSTRACT: Iatrogenic free wall cardiac perforation is a rare but serious complication encountered during percutaneous cardiac procedures, which usually leads to tamponade and death. Septal occluder devices have been developed for sealing intracardiac shunts but may be also used in this emergency setting.
We report a small series of five consecutive cases of iatrogenic heart perforations that were treated with implantation of Amplatzer Septal Occluders (ASO). In the first case, iatrogenic left ventricle (LV) perforation occurred during LV biopsy and could be closed up with a 4 mm ASO. In the second case, a 4 mm ASO was used for sealing of a right atrial perforation allocated to Port-a-Cath dislodgment. The third case happened during transseptal puncture for implantation of a TandemHeart bVAD device in a patient suffering cardiogenic shock and was treated by implantation of a 5 mm ASO. The fourth patient was transferred to our facilities for percutaneous closure of an acute post-infarct VSD after anteroseptal myocardial infarction. This procedure was complicated by perforation of the posterolateral free wall and led to the deployment of 12 mm ASO. The last patient suffered from free LV wall perforation during investigation of a severe aortic stenosis and was treated by implantation of 4 mm ASO. All patients were alive after 24 hrs but the last patient died during the in-hospital stay of a right ventricular infarction complicated by multiple organ failure.
Percutaneous device occlusion of iatrogenic heart perforation seems to be a safe and efficient method to treat iatrogenic heart perforation. In order to perform this elegant method, it is however imperative not to prematurely withdraw the perforating catheter to maintain access to the hole for closure.
Catheterization and Cardiovascular Interventions 11/2011; 79(2):263-70. · 2.29 Impact Factor
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Christian Seiler
European Journal of Clinical Investigation 11/2011; 41(11):1259-60. · 3.02 Impact Factor
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ABSTRACT: To test the effect of patent foramen ovale (PFO) closure on neurological events in divers.
Prospective, non-randomised, longitudinal three-arm study.
Tertiary referral centre.
104 scuba divers with a history of major decompression illness (DCI). INTERVENTIon: Transcutaneous PFO closure.
Baseline and three follow-up examinations with a questionnaire about health status and diving habits/accidents, transoesophageal echocardiography at baseline for PFO grading, cerebral MRI at all examinations.
39 divers had no PFO, 26 had a PFO and chose to undergo percutaneous closure and 39 had a PFO, but decided not to undergo closure. The total number of dives, including those performed before baseline and those during long-term follow-up, was 81,654; 18,394 dives during the follow-up period of 5.3 ± 0.3 years, during which there were a total of five major neurological DCI events-namely 0 in the no PFO group, 0.5 ± 2.5/10⁴ dives in the PFO closure group and 35.8 ± 102.5/10⁴ dives in the PFO no closure group (four events; p = 0.045 between the PFO groups). In the groups, no PFO, PFO closure and PFO no closure, there were 1.1 ± 2.6, 0.8 ± 1.4, 3.3 ± 6.9 ischaemic brain lesions, respectively, at follow-up (p = 0.039 between the PFO groups)-that is, 16 ± 42/10⁴ dives in the no PFO group, 6 ± 13/10⁴ dives in the PFO closure group and 104 ± 246/10⁴ dives in the PFO no closure group (overall p = 0.042; p = 0.024 between the PFO groups).
PFO closure in continuing divers appears to prevent symptomatic (major DCI) and asymptomatic (ischaemic brain lesions) neurological events during long-term follow-up.
Heart (British Cardiac Society) 09/2011; 97(23):1932-7. · 4.22 Impact Factor
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ABSTRACT: Right ventricular (RV) systolic function is prognostically important, but its assessment by echocardiography remains challenging, in part because of the multitude of available measurement methods. The purpose of this prospective study was to rank these methods against the reference of RV ejection fraction (EF) as obtained in a broad clinical population by magnetic resonance imaging (MRI).
Two hundred and twenty-three individuals were included in the study. The following seven Doppler echocardiographic parameters were tested using receiver operating characteristic (ROC) analysis for their accuracy to distinguish between normal and moderately impaired RVEF by MRI (RVEF cut-off 50%), respectively, between moderately and severely reduced RVEF (cut-off 30%): RV fractional area and fractional long-axis change (FLC), RV myocardial performance index (MPI), tricuspid annular peak systolic excursion, Doppler tissue imaging-derived isovolumic acceleration and peak systolic velocity (S') at the lateral tricuspid annulus, and strain at the lateral free wall as obtained by speckle-tracking echocardiography. Survival analysis was performed. All seven Doppler echocardiographic parameters correlated significantly with RVEF by MRI (range between 5 and 85%). RVEF <50% was best detected by S' < 11 cm/s: area under the ROC curve 0.779 (95% confidence interval 0.716-0.843), sensitivity 0.740, and specificity 0.753. RVEF ≤30% was best detected by MPI > 0.50: area under the ROC curve 0.948 (95% confidence interval 0.906-0.991), sensitivity 0.947, and specificity 0.852. The Kaplan-Meier analysis revealed reduced cumulative survival among patients with RVEF ≤30% (P = 0.0003).
A systolic long-axis peak velocity of <11 cm/s at the lateral tricuspid annulus most accurately detects moderately impaired RVEF as obtained by MRI; severely reduced RVEF ≤30% is best detected by RV MPI at a value of >0.50.
European Heart Journal – Cardiovascular Imaging 09/2011; 12(11):871-80. · 2.32 Impact Factor
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Andreas Wahl,
Fabien Praz,
Markus Schwerzmann,
Harald Bonel,
Simon C Koestner,
Roger Hullin,
Jean-Paul Schmid,
Thomas Stuber,
Etienne Delacrétaz,
Otto M Hess,
Bernhard Meier, Christian Seiler
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ABSTRACT: Systolic right ventricular (RV) function is an important predictor in the course of various congenital and acquired heart diseases. Its practical determination by echocardiography remains challenging. We compared routine assessment of lateral tricuspid annular systolic motion velocity (TV(lat), cm/s) using pulsed-wave tissue Doppler imaging from the apical 4-chamber view with cardiac magnetic resonance (CMR) as reference method.
254 individuals (43 ± 18 years) underwent both CMR (contiguous short axis slices; retrogated cine steady state free precession technique; manual contour tracing) and echocardiography within 2 ± 2 months. Seventy-five had coronary artery disease, 87 congenital heart disease, 17 dilated cardiomyopathy, 15 pulmonary artery hypertension, and 47 normal findings. RV ejection fraction (EF) by CMR was 51 ± 12% (range 17-78%). There was a linear correlation between RVEF and TV(lat) (r=0.60; p<0.0001). A TV(lat) cut-off of 12 cm/s identified patients with normal EF (≥50%) with 81% sensitivity and 68% specificity, and a threshold of TV(lat) <9 cm/s identified patients with severely reduced RVEF (<30%) with 82% sensitivity and 86% specificity.
Systolic long-axis velocity measurements of the lateral tricuspid annulus allow a reliable assessment of RVEF in clinical routine. A threshold of TV(lat)<9 cm/s identifies patients with severely reduced RVEF (<30%) with high sensitivity and specificity.
International journal of cardiology 08/2011; 151(1):58-62. · 7.08 Impact Factor
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ABSTRACT: Coronary collaterals protect myocardium jeopardized by coronary artery disease (CAD). Promotion of collateral circulation is desirable before myocardial damage occurs. Therefore, determinants of collateral preformation in patients without CAD should be elucidated.
In 106 patients undergoing coronary angiography who were free of coronary stenoses, a total of 39 clinical test variables were collected. The coronary collateral flow index (CFI) was measured. Stepwise multiple linear regression analysis was performed after choosing a restricted number of candidates emerging from univariate testing. Separate multiple regression analyses were performed in patients with and without beta-blocker therapy.
Nine parameters were found to be possible determinants of CFI by univariate analysis: arterial hypertension (aHT), dyslipidemia, statins, diuretics, age, height, heart rate (HR), pulse pressure amplitude, and left ventricular end-diastolic pressure (LVEDP). After multiple regression analysis, a low HR, absence of aHT, and elevated LVEDP were significantly related to CFI (F = 5.31, p = 0.002, adjusted r(2) = 0.12). In patients without beta-blockers, a low HR and absence of aHT were independent predictors of CFI (F = 8.03, p < 0.001, n = 50, adjusted r(2) = 0.30).
A low HR and absence of aHT are both related to collateral preformation in humans. We suppose that bradycardia favors fluid shear stress in coronary arteries, thus triggering collateral growth.
Cardiology 06/2011; 118(3):198-206. · 1.71 Impact Factor
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Lorenz Räber,
Lea Wohlwend,
Mathias Wigger,
Mario Togni,
Simon Wandel,
Peter Wenaweser,
Stéphane Cook,
Aris Moschovitis,
Rolf Vogel,
Bindu Kalesan, Christian Seiler,
Franz Eberli,
Thomas F Lüscher,
Bernhard Meier,
Peter Jüni,
Stephan Windecker
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ABSTRACT: Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) LATE study.
A total of 1012 patients were randomly assigned to SES or PES. Repeat angiography was completed in 444 of 1012 patients (43.8%) at 5 years. Major adverse cardiac events occurred in 19.7% of SES- and 21.4% of PES-treated patients (hazard ratio, 0.89; 95% confidence interval, 0.68 to 1.17; P=0.39) at 5 years. There were no differences between SES and PES in terms of cardiac death (5.8% versus 5.7%; P=0.35), myocardial infarction (6.6% versus 6.9%; P=0.51), and target lesion revascularization (13.1% versus 15.1%; P=0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37 ± 0.73 mm for SES and 0.29 ± 0.59 mm for PES (P=0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES (P=0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%).
Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents.
Circulation 06/2011; 123(24):2819-28, 6 p following 2828. · 14.74 Impact Factor
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Circulation 06/2011; 123(23):e631. · 14.74 Impact Factor
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Thomas Pilgrim,
Lorenz Räber,
Andreas Limacher,
Lukas Löffel,
Peter Wenaweser,
Stéphane Cook,
Jean-Christophe Stauffer,
Mario Togni,
Rolf Vogel,
Ali Garachemani,
Aris Moschovitis,
Ahmed A Khattab, Christian Seiler,
Bernhard Meier,
Peter Jüni,
Stephan Windecker
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ABSTRACT: This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota).
Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies.
In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat.
Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; p(noninferiority) = 0.54), and subsequent superiority testing was in favor of ZES (p(superiority) = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; p(superiority) = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; p(interaction) = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year.
Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908).
06/2011; 4(6):672-82. · 1.07 Impact Factor
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Lorenz Räber,
Peter Jüni,
Eveline Nüesch,
Bindu Kalesan,
Peter Wenaweser,
Aris Moschovitis,
Ahmed A Khattab,
Maryam Bahlo,
Mario Togni,
Stéphane Cook,
Rolf Vogel, Christian Seiler,
Bernhard Meier,
Stephan Windecker
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ABSTRACT: This study sought to compare the unrestricted use of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention.
It is unclear whether there are differences in safety and efficacy between EES and SES during long-term follow-up.
Using propensity score matching, clinical outcome was compared among 1,342 propensity score-matched pairs of patients treated with EES and SES. The primary outcome was a composite of death, MI, and target vessel revascularization.
The median follow-up was 1.5 years with a maximum of 3 years. The primary outcome occurred in 14.9% of EES- and 18.0% of SES-treated patients up to 3 years (hazard ratio [HR]: 0.83, 95% confidence interval [CI]: 0.68 to 1.00, p = 0.056). All-cause mortality (6.0% vs. 6.5%, HR: 0.92, 95% CI: 0.68 to 1.25, p = 0.59) was similar, risks of myocardial infarction (MI) (3.3% vs. 5.0%, HR: 0.62, 95% CI: 0.42 to 0.92, p = 0.017), and target vessel revascularization (7.0% vs. 9.6%, HR: 0.75, 95% CI: 0.57 to 0.99, p = 0.039) were lower with EES than SES. Definite stent thrombosis (ST) (HR: 0.30, 95% CI: 0.12 to 0.75, p = 0.01) was less frequent among patients treated with EES. The reduced rate of MI with EES was explained in part by the lower risk of definite ST and the corresponding decrease in events associated with ST (HR: 0.25, 95% CI: 0.08 to 0.75, p = 0.013).
The unrestricted use of EES appears to be associated with improved clinical long-term outcome compared with SES. Differences in favor of EES are driven in part by a lower risk of MI associated with ST.
Journal of the American College of Cardiology 05/2011; 57(21):2143-51. · 14.16 Impact Factor