[Show abstract][Hide abstract]ABSTRACT: Background
There is limited data on prognosis after percutaneous coronary intervention (PCI) for coronary chronic total occlusions (CTO) in the era of drug-eluting stents (DES).
This study investigates the specific contribution of CTO recanalization to the survival benefit of complete revascularization.
Consecutive patients who underwent PCI of a CTO at our center between 01/2005 and 12/2013 were followed for a median of 2.6 years (interquartile range 1.1–3.1 years). All-cause mortality was compared between patients with successful and failed PCI of CTO without and with adjustment for pertinent co-variables by the Cox models.
The study comprised 2002 patients with attempted PCI of CTO (mean age 65.2 ± 11 years, 17 % female), 82 % had multivessel disease. The CTO PCI was successful in 1662 (83 %) patients with a DES rate of 94 %. All-cause mortality was significantly lower in patients with successful PCI of CTO compared to failed PCI of CTO (15.3 vs. 25.9 % at 4 years; P < 0.001). In the multivariable model, both successful CTO PCI and complete revascularization were strong independent predictors of reduced long-term mortality (adjusted hazard ratio (HR) 0.72; 95 % confidence interval (CI) 0.53–0.97; P = 0.03 and adjusted HR 0.59; 95 % CI 0.42–0.82; P = 0.002). Also within the subset of incomplete revascularization, successful PCI of CTO was associated with reduced mortality (adjusted HR: 0.67; 95 % CI: 0.50–0.92; P = 0.012).
Successful CTO recanalization is an independent predictor for improved long-term survival. Persistent CTO lesions are associated with significantly worse survival than persistent non-occlusive coronary lesions.
Full-text Article · Jun 2016 · Clinical Research in Cardiology
[Show abstract][Hide abstract]ABSTRACT: Aims:
To investigate the prognostic relevance of elevated Troponin T (cTnT) levels in patients with ST-segment elevation myocardial infarction (STEMI) without significant creatine kinase (CK) elevation on admission.
Methods and results:
From January 1, 2002 to December 31, 2006 patients with STEMI without significant CK elevation (<2-fold) on admission treated with percutaneous coronary intervention (PCI) were included and stratified according to cTnT plasma levels. Univariate and multivariate regression analyses were used to find independent predictors for mortality. During the 5-year period 514 patients with STEMI and normal CK plasma levels were included. 308 (59.9 %) patients had cTnT levels <0.1 μg/l and 206 (40.1 %) patients had cTnT levels ≥0.1 μg/l. Multivariate logistic regression analysis identified cTnT levels ≥0.1 μg/l and 3-vessel disease as positive, and hemoglobin levels as negative independent predictors for long-term mortality. Discordantly elevated cTnT plasma levels independently predicted higher mortality rates in the first year (HR 3.9, 95 % CI 1.7-9.1, p = 0.002) and during 5 years (HR 2.3, 95 % CI 1.4-3.9, p = 0.002) after PCI for STEMI.
Discordant elevation of cTnT in the presence of normal CK plasma levels on admission is associated with increased mortality in STEMI patients undergoing primary PCI. This may be due to preceding microembolization.
Article · Nov 2015 · Clinical Research in Cardiology
[Show abstract][Hide abstract]ABSTRACT: There is increasing evidence that various types of drug-eluting stents (DES) may differ regarding the long-term safety and efficacy, particularly in complex lesion subsets.
In a cohort of consecutive patients undergoing bifurcation stenting, we sought to compare the 1-year efficacy and safety of the first-generation paclitaxel-eluting stents (PES), the first-generation sirolimus-eluting (SES) and the second-generation everolimus- or zotarolimus-eluting stents (EES/ZES).
We treated 2197 patients (mean age 67.5 years, 75.4 % male) with provisional T-stenting for de novo coronary bifurcation lesions using PES, SES or EES/ZES. Primary endpoint (MACE) was the composite of death from any cause, myocardial infarction (MI) and target lesion revascularisation (TLR).
Side branch stenting was found to be clinically indicated in 793 patients (36.1 %). The cumulative 1-year incidence of MACE was 18.8 % after PES, 13.1 % after PCI with SES and 12.2 % after EES/ZES (p = 0.003), the combined endpoint death and MI occurred in 6.6, 5.6 and 8.3 % (p = 0.253) and death in 4.3, 5.2 and 5.3 % (p = 0.581), respectively. After adjustment for co-variables the type of DES was a significant (p = 0.008) predictor of MACE [HR (95 % confidence interval) PES vs SES 1.34 (1.04-1.71), PES vs. EES/ZES 1.75 (1.19-2.57), EES/ZES vs. SES 0.762 (0.531-1.095)], but not of death (p = 0.581), death and MI (p = 0.077) or stent thrombosis (ST) (p = 0.925).
In de novo coronary bifurcation lesions treated with provisional T-stenting, SES and EES/ZES achieved better outcomes than PES by reducing the need for reintervention.
Article · Sep 2015 · Clinical Research in Cardiology
[Show abstract][Hide abstract]ABSTRACT: Aims: Bivalirudin has emerged as a meaningful alternative to heparin in patients undergoing percutaneous coronary intervention (PCI). To date, it is unclear whether bivalirudin has advantages in patients undergoing rotational atherectomy (RA). Methods and results: The current subgroup analysis of the ROTAXUS trial compared patients receiving bivalirudin (n=129) to those receiving unfractionated heparin (UFH) (n=111). Efficacy was assessed by the frequency of periprocedural myocardial infarction (MI) and safety by the frequency of major access-site bleeding (ASB). Baseline characteristics were similar. Periprocedural MI occurred less frequently in the bivalirudin group (22% vs. 37.5%, p=0.02), while ASB did not differ significantly (2.3% vs. 5.5%, p=0.20). This effect was larger in the RA group, where bivalirudin significantly reduced periprocedural MI (15.7% vs. 38.7%, p=0.01) with a trend towards reduced major ASB (2.9% vs. 10.2%, p=0.09). In the control group without RA, bivalirudin was not superior to UFH regarding periprocedural MI (28.6% vs. 36.6%, p=0.42) and major ASB (1.7% vs. 1.7%, p=0.99). Conclusions: This analysis suggests a differential benefit of bivalirudin in patients treated with RA. Patients receiving bivalirudin during RA showed significantly less periprocedural MI and fewer ASB compared to patients treated with UFH.
Article · Aug 2014 · EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
[Show abstract][Hide abstract]ABSTRACT: Background: High-sensitivity troponin T (hsTnT) can improve risk prediction in stable patients. However, it is unknown if this is due to the detection of underlying cardiac diseases that are not diagnosed so far or if this prognostic value is independent of overt cardiac disease. The aim of the present analysis was to evaluate the use of hsTnT for risk prediction in subjects with or without cardiac disease.
Methods: Stable patients with full cardiac assessment including ECG, echocardiography and elective coronary angiography were enrolled (n=2046). HsTnT and risk scores for adjustment (Framingham Risk Score and the SCORE) were determined before diagnostic procedures. Patients were followed for up to seven years. Primary endpoint was all-cause mortality or non-fatal myocardial infarction. All endpoints were adjudicated by independent physicians.
Results: Out of the 2046 subjects enrolled, 1406 (69%) had significant heart disease defined diagnosis of obstructive coronary heart disease during index angiography and/or reduced left ventricular ejection fraction. The use of hsTnT in addition to clinical risk scores significantly improved the reclassification of the primary endpoint (Framingham: NRI=0.631, P<0.001; SCORE: NRI=0.656, P<0.001). Discrimination of risk scores for the primary endpoint did not show any significant differences between subjects with and without significant heart disease (Framingham: c-statistic=0.612 vs. 0.628, P=0.68; SCORE: c-statistic=0.593 vs. 0.650, P=0.10).
Full-text Article · Aug 2014 · European Heart Journal
[Show abstract][Hide abstract]ABSTRACT: Objectives
This study sought to assess aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the self-expandable Medtronic CoreValve (MCV) (Medtronic Inc., Minneapolis, Minnesota) versus balloon-expandable Edwards Sapien XT valve (ESV) (Edwards Lifesciences, Irvine, California).
AR after TAVI has been associated with poor survival, but limited data exist comparing MCV with ESV.
We pooled the prospective TAVI databases of 2 German centers. The primary endpoint was more-than-mild post-TAVI AR assessed by echocardiography. We also assessed device success and survival within 1 year. Endpoints were adjudicated according to the Valve Academic Research Consortium criteria and analyzed by unadjusted and propensity-score–adjusted models.
A total of 394 patients were included, 276 treated with MCV and 118 with ESV. More-than-mild AR was significantly higher with MCV than with ESV (12.7% vs. 2.6%, p = 0.002). This difference remained significant after propensity adjustment (adjusted odds ratio [OR]: 4.59, 95% confidence interval [CI]: 1.03 to 20.44). The occurrence of any degree of AR was also higher with MCV (71.6% vs. 56.9%, p = 0.004). Device success was mainly influenced by the occurrence of AR and was consequently higher with ESV (95.8% vs. 86.6%, p = 0.007), but this was not significant after propensity adjustment (adjusted OR: 0.34, 95% CI: 0.11 to 1.03, p = 0.06). At 1 year, survival was comparable between both valve types (83.8% MCV vs. 88.2% ESV, p = 0.42), but was significantly worse in patients with more-than-mild AR (69.8% vs. 87.4%, p = 0.004) and in those with device failure (65.6% vs. 87.4%, p < 0.001).
More-than-mild AR after TAVI was more frequent with MCV than with ESV. This finding deserves consideration, as more-than-mild AR was associated with higher mortality at 1 year.
Article · Mar 2014 · JACC Cardiovascular Interventions
[Show abstract][Hide abstract]ABSTRACT: Purpose: There is limited data on prognosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTOs) in multi-vessel disease.
Methods: Between 01/2005 and 12/2011 we performed elective PCI of a CTO in 1642 consecutive patients. Median follow-up was 3.0 (1.1,3.8) years. CTO patients were assigned to coronary one/two vessel disease (1+2VD) or three vessel disease (3VD). Procedural success was defined as <30% residual diameter stenosis of the CTO lesion after drug eluting stent implantation. All-cause mortality was assessed with adjusted Cox proportional hazard models.
Results: Of the CTO patients 757 (46%) had 1+2VD and 885 (54%) had 3VD. Patients with 3VD compared to 1+2VD were older (67.3±11 vs. 64.0±11; p<0.001), had higher serum creatinine (1.10±0.6 vs. 1.03±0.6; p=0.033), more often diabetes (33.5% vs. 25.8%; p<0.001), left ventricular ejection fraction (LVEF) <40% (25.2% vs. 16.7%; p<0.001), previous myocardial infarction (25.9% vs. 17.8%; p<0.001) or coronary bypass operation (19.1% vs. 2.6%; p<0.001). Procedural success was lower in 3VD compared to 1+2VD (70.9% vs. 78.5%; p<0.001). Total long-term mortality for 3VD and 1+2VD was (21.4% and 15.6%; p=0.003). After multivariable adjustment for relevant covariates (age, serum creatinine, LVEF <40%) procedural success remained an independent predictor for reduced long-term mortality in patients in 3VD (adjusted HR 0.50; 95% CI 0.31-0.81; p=0.004) but not in patients in 1+2VD (adjusted HR 0.71; 95% CI 0.37-1.35; p=0.3) [Figure].
[Show abstract][Hide abstract]ABSTRACT: Purpose: Despite advancements in recanalization technique there is limited data on prognosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTOs) in the era of drug-eluting stents (DES).
Methods: We evaluated long-term mortality in 1642 consecutive patients who underwent elective PCI of a CTO in our center between 01/2005 and 12/2011. Median follow-up was 3.0 years (interquartile range 1.1–3.8 years). Procedural success was defined as <30% residual diameter stenosis of the CTO lesion after DES implantation. Survival was assessed with unadjusted and adjusted Cox proportional hazard models.
Results: Mean age was 65.8±11 years, 18% were female, 28% diabetics, 17% had a serum creatinin >1.3mg/dl, 11% a prior coronary bypass operation, 24% a previous myocardial infarction and 17% a left ventricular ejection fraction <40%. Procedural success was obtained in 1216 (74.1%) patients with a stent rate of 96.2%. Of the stents implanted 92% were DES. Patients with procedural success compared to failure were younger and had less often a previous coronary bypass operation. After multivariable adjustment procedural success was independently predictive for reduced long-term mortality (adjusted HR 0.56; 95% CI 0.38–0.81; p=0.003). Figure shows adjusted 3-years mortality from any cause.
[Show abstract][Hide abstract]ABSTRACT: Background: Levels of high-sensitivity troponin T (hsTnT) are detectable in a significant proportion of stable patients undergoing elective coronary assessment and are prognostic for clinical outcome. Some factors such as renal function have been described to be associated with levels of hsTnT. The aim of the present analysis was to identify independent predictors for hsTnT and to evaluate the strength of association of these factors with levels of hsTnT.
Methods: Stable patients undergoing echocardiography and elective coronary angiography were enrolled (n=2046). HsTnT was determined before diagnostic procedures. A multivariable linear regression model for levels of hsTnT at presentation was created to identify independent predictors for hsTnT and to determine their strength of association with levels of hsTnT.
Results: Out of the 2046 subjects enrolled, 1422 (69.5%) had detectable levels of hsTnT (≥3ng/L) and 313 (15.3%) showed levels above the 99%-percentile of a healthy reference population (14ng/L). Several variables showed an association with levels of hsTnT in univariable analyses (Figure shows only a selection of variables). Multivariable analysis identified age, sex, smoking, arterial hypertension, diabetes, hemoglobin, renal function (GFR), use of β-blockers and ACE inhibitors, left ventricular ejection fraction, NYHA class, and results of coronary angiography as independent predictors of hsTnT. The five variables with highest strength of association with levels of hsTnT were age, sex, renal function, left ventricular ejection fraction, and results of coronary angiography.
Full-text Article · Aug 2013 · European Heart Journal
[Show abstract][Hide abstract]ABSTRACT: Background: For patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) current guidelines recommend antithrombotic therapy with new P2Y12 receptor antagonists (prasugrel and ticagrelor) as well as bivalirudin. Currently, there is limited long term experience with the combination of these 2 therapeutic options.
Methods: Between May 2010 and November 2011, we identified 359 consecutive patients with ACS undergoing PCI, who were preloaded with either prasugrel or ticagrelor and received bivalirudin during PCI. Patients were preloaded as soon as possible before coronary angiography and PCI. The loading dose for prasugrel was 60 mg and for ticagrelor 180 mg. Immediately before PCI patients were treated with bivalirudin loading dose and with infusion during the PCI. Post PCI dual antiplatelet therapy was continued for 12 months independent of type of implanted stent. The 1 year incidences of death from any cause, the composite of death and myocardial infarction (MI) and of target vessel revascularisation (TVR) were analyzed.
Results: One year follow-up was complete in all patients. Patients were 65 + 12 years old (patients with ticagrelor were in average 11 years older), 22% of patients were diabetic. STEMI patients were more frequent (70.8%) than NSTEMI patients (29.2%). With prasugrel were treated 87.0% of STEMI patients and with ticagrelor 71.4% of NSTEMI patients. Bail-out GP IIbIIIa –inhibitors were needed in 8.3%. The 1 year incidence of TVR was 16.1% in the prasugrel group and 13.9% in the ticagrelor group, those of death and MI 7.3% and 10.6% and those of death 6.5% and 8.6%, respectively. There was no case of subacute stent thrombosis. TIMI major bleeding occurred in 0.8% and only 1.1% of the patients needed blood transfusion. There were no significant differences between ticagrelor and prasugrel in any of the event rates.
Conclusions: In patients with ACS undergoing PCI the combination of new generation P2Y12-selective inhibitors (prasugrel or ticagrelor) and bivalirudin is associated with low rates of severe bleeding complications and similar clinical outcome during 1 year follow-up between in the prasugrel and ticagrelor treatment group.
[Show abstract][Hide abstract]ABSTRACT: Background: Rotablation is mostly used to enable stent implantation in severely calcified coronary lesions. There is a lack of long term data regarding the outcome after rotablation in severe calcified lesions with either failed balloon crossing or in case of failed balloon expansion.
Methods: To assess the 1-year outcome of rotabloation in this setting, we analyzed 210 consecutive patients undergoing rotablation required for preparation of stent implantation in severely calcified coronary lesions. Complete 1-year follow-up data was available for all patients.
Results: Patients were on average 71 years old. The reasons for rotablation were in 42% inability to cross the lesion with the balloon and in 58% inability to expand the balloon in severe calcified lesion. Sixteen % of patients needed rotablation during PCI for acute coronary syndrom (ACS). The procedural success was 99,5%. Drug eluting stents (DES) were implanted in 88%. The majority of patients received initial rotablation with 1,5 mm burr. Elevated troponin a day post rotablation was measured in 38% of patients and elevated creatine kinase (CK) in 12%. Target vessel revascularisation (TVR) after 1 year post index PCI was performed in 13,2% of patients. The combined endpoint of death and myocardial infarction (MI) as marker for safety was reached by 14,4%. Death during 1-year follow-up occurred in 10,4%.
Conclusions: Rotablation as a part of lesion preparation for stent implantation in otherwise untreatable severe calcified coronary lesions is associated with high procedural success rate. One-year event rates, however, indicate that patients in need for bail-out rotablation represent a high risk subset.
[Show abstract][Hide abstract]ABSTRACT: Objectives:
The SYNTAX score (Ssc) assessing the complexity of coronary anatomy predicts survival after percutaneous coronary intervention (PCI). We tested the hypothesis that the newly developed euroSCORE II (eSC2) can improve the prediction of outcome after complex PCI by the Ssc.
Methods and results:
Our study comprised 1262 consecutive patients with triple vessel disease or left main stenosis, who were contacted 3 years after elective PCI with drug-eluting stents. We calculated eSC2, Ssc, logistic euroSCORE, and ACEF score. Prediction of 3-year all-cause mortality by these scores was assessed by Cox proportional hazard models. Models were compared by the Hosmer-Lemeshow test for calibration (HL), the C-statistics (AUC) for discrimination and by net reclassification indices (NRI). eSC2 and Ssc were significant predictors of 3-year mortality (unadjusted hazard ratios [95%-confidence limits], 1.050 [1.033-1.067], 1.180 [1.146-1.215], respectively, P<0.001). The predictive value of eSC2 was improved by logarithmic transformation. Adding eSC2 to the model with Ssc improved calibration (HL 7.4 vs. 11.1) and discrimination (increase in AUC [95%-confidence limits] 0.12 [0.07 to 0.17]) and yielded a significant NRI of 0.38 (95%-confidence limits 0.28 to 0.47). The absolute difference in 3-year mortality between strata of Ssc (≤22, >22-32, >32) was smaller with eSC2<1% (1.4%, 3.4%, 9.7%, respectively), than with eSC2>1.6% (11.2%, 20.2%, 30.6%, respectively). The predictive ability of eSC2 was similar to that of the other clinical scores.
eSC2 predicts 3-year mortality after complex PCI and modifies the impact of angiographic complexity on outcome.
Article · May 2013 · International journal of cardiology
[Show abstract][Hide abstract]ABSTRACT: Objectives:
This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness.
DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown.
The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months.
Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups.
Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.
Article · Dec 2012 · JACC. Cardiovascular Interventions