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Objectives: The aim was to investigate whether a strategy of direct drug-eluting stent (DES) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting (PS)., Background: Previous studies were performed comparing direct stenting (DS) with conventional stenting (CS) after pre-dilation; however, none of these in the DES era. Therefore, the STRESSED (direct Stenting To reduce REStenosis in Stent Era with Drug elution) study was designed and carried out., Methods: A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS, CS, or PS strategy. The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography. Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events (MACE), and MACE at 9-month and 2-year follow-up., Results: Stent implantation in the DS group was 98%, 99% in the CS group, and 77% in the PS group. Percutaneous coronary intervention success was 99% in all groups. The minimal lumen diameter at 9-month follow-up was 2.12 ± 0.58 mm (DS), 2.17 ± 0.67 mm (CS), and 1.99 ± 0.69 mm (PS), p = 0.556 for comparison of DS with CS, p = 0.073 for comparison of DS with PS. The absolute difference was -0.05 (DS to CS), 95% confidence interval: -0.19 to -0.09, p = 0.48 and 0.13 (DS to PS), confidence interval: -0.02 to -0.27, p = 0.087. Restenosis was found in 3.4% (DS), 6.7% (CS), and 11.5% (PS), p = 0.025. At 9-month and 2-year follow-up, MACE occurred in 6.8% and 11.5% (DS), 4.6% and 10.3% (CS), and 7.6% and 13.8% (PS) (p = 0.439 and 0.536), respectively., Conclusions: Direct DES implantation compared with conventional DES implantation did not reduce restenosis. Provisional stenting, however, was associated with a higher rate of restenosis. This did not translate into a difference in the rate of MACE. (STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution; ISRCTN41213536)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The aging congenital heart disease (CHD) population is prone to develop a variety of sequelae, including pulmonary arterial hypertension (PAH). Previous prevalence estimates are limited in applicability due to the use of tertiary centers, or database encoding only. We aimed to investigate the contemporary prevalence of PAH in adult CHD patients, using a nationwide population., Methods: A cross-sectional study was performed, using the population-based Dutch CONgenital CORvitia (CONCOR) registry. All patients born with a systemic-to-pulmonary shunt, thereby at risk of developing PAH, were identified. From this cohort, a random sample was obtained and carefully reviewed., Results: Of 12,624 registered adults with CHD alive in 2011, 5,487 (44%) were at risk of PAH. The random sample consisted of 1,814 patients (mean age 40 ± 15 years) and 135 PAH cases were observed. PAH prevalence in patients born with a systemic-to-pulmonary shunt was 7.4%. The prevalence of PAH after corrective cardiac surgery was remarkably high (5.7%). Furthermore, PAH prevalence increased with age, from 2.5% under 30 years until 35% in the eldest. PAH prevalence in the entire CHD population was 3.2%. Based on 3000 per million adult CHD patients in the general population, we can assume that PAH-CHD is present in 100 per million., Conclusions: This new approach using a nationwide CHD population reports a PAH prevalence of 3.2% in CHD patients, and 100 per million in the general adult population. Especially in patients after shunt closure and the elderly, physicians should be aware of PAH-CHD, to provide optimal therapeutic and clinical care., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Myocardial necrosis is a time-dependent event. Nevertheless, clinical studies on association between ischemic time and left ventricle function showed inconsistent findings. Aim of current study is to evaluate the association between ischemic time and the post-infarction left ventricular function in ST-elevation myocardial infarction treated with primary PCI., Methods: In 2529 patients treated with primary PCI, left ventricular ejection fraction (LVEF) was measured before discharge (median day 4) by radionuclide ventriculography or by echocardiography if patients had atrial fibrillation. Ischemic time was calculated from symptom onset to first balloon inflation., Results: The correlation between ischemic time as continuous variable and LVEF was significant but weak (P=0.002, r=-0.062). The LVEF of patients in ischemic time intervals of >6, >3-6, and ≤3 h was 45.1±11.7%, 44.6±11.9%, and 43.2±12.2%, respectively (P=0.029). Adjusted odds ratio of the ischemic time intervals for LVEF<40% was 1.14 (95% CI 1.00-1.30). TIMI flow 0 before and TIMI flow 3 after PCI were related with both longer ischemic time and low LVEF., Conclusion: Ischemic time was associated with post infarction LVEF in patients treated with primary PCI, although this association was weak. Initial TIMI flow and post-PCI TIMI flow played important role in impact of the ischemic time on the LVEF., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: No randomized comparisons are yet available evaluating the effect of pre-hospital high dose tirofiban on the incidence of early stent thrombosis after primary percutaneous coronary intervention (PCI)., Objectives: The aim of this analysis was to evaluate whether routine pre-hospital administration of high-dose tirofiban in ST-segment elevation myocardial infarction (STEMI) decreases the incidence of early stent thrombosis after primary PCI., Patients/methods: The Ongoing Tirofiban in Myocardial Evaluation (On-TIME) 2 trial was a prospective multicenter study of consecutive STEMI patients referred for primary PCI in which patients were randomized to pre-hospital no high-dose tirofiban/placebo. We examined the incidence of Academic Research Consortium definite and probable early stent thrombosis and determined predictors and outcome of early stent thrombosis., Results: Primary PCI was performed in 1203 out of 1398 patients (86.1%). In 1073 patients (89.2%) a coronary stent was placed. Early stent thrombosis occurred in 39 patients (3.6%). Pre-hospital initiation of high-dose tirofiban significantly reduced early stent thrombosis (2.1% vs. 5.2%, P = 0.006) and was associated with a lower incidence of urgent repeat PCI (1.9% vs. 5.2%, P = 0.005). Early stent thrombosis, as well as pre-hospital initiation of high-dose tirofiban, was independently associated with 30-day mortality., Conclusions: Pre-hospital initiation of high-dose tirofiban reduces the 30-day incidence of stent thrombosis in STEMI patients treated with primary PCI and stenting. Early stent thrombosis and pre-hospital initiation of high-dose tirofiban were independent predictors of 30-day mortality.

Background: More than 10 years ago, survival benefit of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) was demonstrated in several randomized trials. Since then, primary PCI has been implemented in routine daily practice and is in the guidelines of the preferred reperfusion therapy for patients with STEMI. We aimed to assess time-dependent changes in baseline characteristics, concomitant treatment and prognosis in patients with STEMI treated with primary PCI., Methods: Individual patient data from all 4732 patients admitted for primary PCI for STEMI between 1994 and 2004 in our hospital were recorded. Patient characteristics, concomitant treatment and one-year outcome were evaluated., Results: During the 11-year period, mean age and proportion of female were increasing, whereas door to balloon time decreased. Stent implantation rates increased from 2% to 84%. At discharge, prescription of aspirin, beta-blockers, statins, and ADP receptor blockers increased significantly. From 1994 to 2004, hospital stay shortened from 10.4 to 4.5 days p<0.001. Hospital and one-year mortality decreased, from 6.7% to 1.4% and 9% to 4.9% (both p<0.001), respectively., Conclusions: Between 1994 and 2004, utilization of stents and recommended pharmacotherapies increased remarkably. Hospital stay and both hospital and one-year mortality decreased significantly.

Background: The prognostic importance of elevated cardiac enzymes after elective percutaneous coronary intervention has been debated. Therefore, we performed a prospective observational study to evaluate the prognostic value of postprocedural rise of troponin T and creatine kinase., Methods: Troponin T (cut-off value 0.05 ng/ml) and creatine kinase (cut-off value 180 IU/l with muscle-brain fraction >4%) were measured 12 h after elective percutaneous coronary intervention in 713 consecutive patients without elevated troponin before the procedure. Primary endpoint was the combined incidence of death, myocardial infarction, stroke, repeat angiography or re-admission because of anginal symptoms during the follow-up period., Results: Troponin was elevated after the procedure in 150 patients (21%) and creatine kinase in 66 pts (9%), with a strong association between increased troponin and creatine kinase. After a mean follow-up of 10.9 months, mortality was low (1%) and not associated with increased troponin or creatine kinase. There was, however, a strong relation between postprocedural troponin and re-admission for angina (p=0.001) or myocardial infarction (p=0.001). Furthermore, troponin rise was significantly associated with an increased risk of the primary endpoint (relative risk 1.55 95% confidence interval 1.01-2.38). After multivariate analysis, troponin elevation but not increased creatine kinase was associated with an increased risk of the primary endpoint (relative risk 1.59 95% confidence interval 1.02-2.47 for troponin elevation versus 1.16 95% confidence interval 0.62-2.15 for increased creatine kinase)., Conclusion: Increase of troponin T after elective percutaneous coronary intervention has stronger prognostic implication when compared to increased creatine kinase.

Background: Coronary stenting has been shown to improve clinical outcome in comparison with balloon angioplasty in patients with ST-segment elevation myocardial infarction (STEMI). However, few data have been reported so far in the elderly. Thus, the aim of the current study was to evaluate the benefits from routine stenting in this high-risk subset of patients., Methods: In the Zwolle-6 randomized trial a total of 1683 consecutive patients with STEMI was randomized to stenting or balloon angioplasty without any exclusion criteria. One year follow-up data were available from all patients., Results: Among a total of 143 patients older than 75 years, 73 were randomized to stent and 67 to balloon angioplasty. No difference was observed in 1-year mortality (17.1% vs 11.9%, p=NS), reinfarction (9.2% vs 11.9%, p=NS), target vessel revascularization (15.8% vs 14.9%, p=NS) or major adverse cardiac events (28.9% vs 26.9%, p=NS) between the groups at 1-year follow-up., Conclusion: In conclusion, our study showed that as compared to balloon angioplasty, the clinical benefits of routine coronary stenting in the setting of acute myocardial infarction may not be necessarily applicable to elderly patients.

Background: Optimal epicardial recanalization does not guarantee optimal myocardial perfusion. The aim of the current study was to evaluate angiographic and electrocardiographic markers of reperfusion in the prediction of infarct size in patients with STEMI undergoing successful primary angioplasty., Methods: Our population is represented by 270 STEMI patients with ST successful primary angioplasty (postprocedural TIMI 3 flow and residual stenosis <50%) with available corrected TIMI frame count (cTFC), myocardial blush grade (MBG), ST-segment resolution and enzymatic infarct size (peak CK-MB) analyses., Results: A significant linear relationship with enzymatic infarct size was observed for all markers of reperfusion, except for ST-segment resolution. These data were confirmed even when analyzed as continuous variables in case of cTFC (r=0.13, p=0.035), postprocedural residual cumulative ST-segment elevation (r=0.41, p<0.0001) and deviation (r=0.45, p<0.0001). At multivariate analysis applied to postprocedural angiographic and electrocardiographic markers of reperfusion, cumulative residual ST-segment deviation, myocardial blush grade, and corrected TIMI frame count were independent predictors of enzymatic infarct size., Conclusions: This study showed that, among patients with STEMI treated by primary angioplasty, cTFC, MBG and cumulative residual ST-segment deviation are independent predictors of infarct size. Therefore, angiography and electrocardiography may provide complementary information in the evaluation of myocardial perfusion.

Background: Statin therapy can reduce long-term mortality in several subgroups of patients with coronary artery disease, but the benefits after primary angioplasty for ST-segment elevation myocardial infarction (STEMI) have yet to be established. The aim of the current study was to determine whether statin therapy is associated with a reduction in mortality in patients with STEMI treated with primary angioplasty., Methods: Our population is represented by a total of 1513 consecutive in-hospital survivors treated with primary angioplasty for STEMI between April 1997 and October 2001. Patients were divided in two groups according to statin therapy (statin group, n=893; control group, n=620) at discharge. Clinical follow-up was performed at 1 year. A propensity score, built on the basis of variables independently associated with statin prescription, was used to investigate the benefits from statin therapy in subgroups of patients that were homogeneous in terms of baseline clinical and angiographic characteristics., Results: At 1-year follow-up statin therapy was associated with a significantly lower mortality (1.2% versus 7.1%, R(2) [95% CI]=0.16 [0.09-0.32], p<0.0001). These benefits were confirmed in all subgroups according to the propensity score, and at multivariate analysis (adjusted R(2) [95% CI]=0.24 [0.12-0.47], p<0.0001)., Conclusions: Statin therapy at discharge was associated with a significant reduction in 1-year mortality after primary angioplasty for STEMI. Therefore, the use of statins is highly recommended in these patients.

Background: Elevated white blood cell (WBC) count on admission in patients with ST segment elevation myocardial infarction (STEMI) has been associated with an adverse prognosis. Whether successful reperfusion by primary percutaneous coronary intervention (PCI) is associated with a decrease in WBC count is unknown., Methods: In this subanalysis of the On-TIME trial, WBC count was measured on admission and 6 h and 24 h after primary PCI for STEMI (n = 364). Angiographic measurements of reperfusion, including TIMI-flow and myocardial blush grade, were compared with changes in WBC count., Results: Restoration of TIMI 3 flow by primary PCI was associated with a significant decrease in median WBC count (11.5 (9.7-14.2), 10.7 (9.0-12.5), 9.9 (8.5-11.5) at baseline, 6 h and 24 h), whereas after unsuccessful PCI (TIMI < 3 flow) WBC count remained elevated (12.5 (9.5-14.6), 12.1 (9.9-14.4), and 11.4 (9.2-15.2)). Improved myocardial blush was also related to a decrease in WBC count. After multivariate analysis, improved myocardial perfusion (TIMI 3 flow and myocardial blush grade 3) was an independent predictor of a decrease of WBC count after PCI., Conclusion: Impaired myocardial reperfusion after primary PCI for STEMI is associated with persistent WBC elevation.

Background: There are scarce and sometimes contradictory data about ventricular fibrillation (VF) during the acute phase of MI. In-hospital VF most often occurs with inferior MI, when treated with fibrinolytics. Out-of-hospital VF seems to be associated with anterior MI. We studied characteristics of patients with VF during reperfusion therapy by primary angioplasty (PCI) versus patients with VF before PCI., Methods: From January 1995 until December 2001, we treated 2826 patients for acute MI and reviewed clinical records of all patients who developed VF and classified the patients according to the first episode of VF: either before or during the angioplasty procedure., Results: VF developed in 219 (8%) patients. Patients with VF during reperfusion therapy (n=74, 3%) were older (p=0.03), more frequently female (0.04), less often had heart failure (p=0.04), when compared with patient with VF before PCI (n=145, 5%). Patients with VF during PCI experienced more often preinfarction angina (p=0.009) and suffered more often from inferior MI (p=0.001), when compared with patients with VF before PCI., Conclusions: Patients with early VF before reperfusion have different characteristics when compared with patients with VF during reperfusion. Infarct location is a major determinant of timing of VF, when both groups are compared (p<0.001).