J. Boland

Randomized Multicenter Comparison of Conventional Anticoagulation Versus Antiplatelet Therapy in Unplanned and Elective Coronary Stenting The Full Anticoagulation Versus Aspirin and Ticlopidine (FANTASTIC) Study

BACKGROUND Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated. METHODS Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization. RESULTS In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of 111, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3+/-3.6 versus 6. 4+/-3.7 days, P=0.0001). CONCLUSIONS Antiplatelet therapy after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.

Prediction of fatal or near-fatal cardiac arrhythmia events in patients with depressed left ventricular function after an acute myocardial infarction †

Aims To determine whether risk stratification tests can predict serious arrhythmic events after acute myocardial infarction (AMI) in patients with reduced left ventricular ejection fraction (LVEF ≤ 0.40). Methods and results A total of 5869 consecutive patients were screened in 10 European centres, and 312 patients (age 65 ± 11 years) with a mean LVEF of 31 ± 6% were included in the study. Heart rate variability/turbulence, ambient arrhythmias, signal-averaged electrocardiogram (SAECG), T-wave alternans, and programmed electrical stimulation (PES) were performed 6 weeks after AMI. The primary endpoint was ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT). To document these arrhythmic events, the patients received an implantable ECG loop-recorder. There were 25 primary endpoints (8.0%) during the follow-up of 2 years. The strongest predictors of primary endpoint were measures of heart rate variability, e.g. hazard ratio (HR) for reduced very-low frequency component (<5.7 ln ms2) adjusted for clinical variables was 7.0 (95% CI: 2.4–20.3, P < 0.001). Induction of sustained monomorphic VT during PES (adjusted HR = 4.8, 95% CI, 1.7–13.4, P = 0.003) also predicted the primary endpoint. Conclusion Fatal or near-fatal arrhythmias can be predicted by many risk stratification methods, especially by heart rate variability, in patients with reduced LVEF after AMI.

Contemporary mortality differences between primary percutaneous coronary intervention and thrombolysis in ST-segment elevation myocardial infarction.

BACKGROUND Current ST-segment elevation myocardial infarction guidelines regarding reperfusion strategy are based on trials conducted before the application of routine invasive evaluation after thrombolysis. Modern thrombolysis may affect the previously observed mortality difference between primary percutaneous coronary intervention (PPCI) and thrombolysis. METHODS In-hospital mortality was prospectively assessed in 5295 patients with ST-segment elevation myocardial infarction admitted to 73 Belgian hospitals from July 1, 2007, through December 31, 2009. A total of 4574 patients (86.4%) were treated with PPCI and 721 (13.6%) received thrombolysis; of these thrombolysis patients, 603 (83.6%) underwent subsequent invasive evaluation. The Thrombolysis in Myocardial Infarction risk score was used to stratify the study population by low (n = 1934), intermediate (n = 2382), and high (n = 979) risk. RESULTS In-hospital mortality in the PPCI patients was 5.9% vs 6.6% in the thrombolysis patients. After adjustment for differences in baseline risk profile, a significant mortality benefit was only present in the high-risk groups: 23.7% in the PPCI patients vs 30.6% in the thrombolysis patients. For patients not at high risk, the mortality difference was marginal. For low-risk patients, mortality was 0.3% in the PPCI patients vs 0.4% in the thrombolysis patients. For intermediate-risk patients, mortality was 2.9% in the PPCI patients vs 3.1% in the thrombolysis patients. Subgroup analysis revealed that the mortality benefit of PPCI compared with early thrombolysis (door-to-needle time <30 minutes) was offset if the door-to-balloon time exceeded 60 minutes. CONCLUSIONS Modern thrombolytic strategies have substantially attenuated the absolute mortality benefit of PPCI over thrombolysis, particularly in patients not at high risk. Our study findings suggest that target door-to-balloon time should be less than 60 minutes to maintain the lowest mortality rates.

Gender, TIMI risk score and in-hospital mortality in STEMI patients undergoing primary PCI: results from the Belgian STEMI registry

AIMS The relationship between the predictive performance of the TIMI risk score for STEMI and gender has not been evaluated in the setting of primary PCI (pPCI). Here, we compared in-hospital mortality and predictive performance of the TIMI risk score between Belgian women and men undergoing pPCI. METHODS AND RESULTS In-hospital mortality was analysed in 8,073 (1,920 [23.8%] female and 6,153 [76.2%] male patients) consecutive pPCI-treated STEMI patients, included in the prospective, observational Belgian STEMI registry (January 2007 to February 2011). A multivariable logistic regression model, including TIMI risk score variables and gender, evaluated differences in in-hospital mortality between men and women. The predictive performance of the TIMI risk score according to gender was evaluated in terms of discrimination and calibration. Mortality rates for TIMI scores in women and men were compared. Female patients were older, had more comorbidities and longer ischaemic times. Crude in-hospital mortality was 10.1% in women vs. 4.9% in men (OR 2.2; 95% CI: 1.82-2.66, p<0.001). When adjusting for TIMI risk score variables, mortality remained higher in women (OR 1.47, 95% CI: 1.15-1.87, p=0.002). The TIMI risk score provided a good predictive discrimination and calibration in women as well as in men (c-statistic=0.84 [95% CI: 0.809-0.866], goodness-of-fit p=0.53 and c-statistic=0.89 [95% CI: 0.873-0.907], goodness-of-fit p=0.13, respectively), but mortality prediction for TIMI scores was better in men (p=0.02 for TIMI score x gender interaction). CONCLUSIONS In the Belgian STEMI registry, pPCI-treated women had a higher in-hospital mortality rate even after correcting for TIMI risk score variables. The TIMI risk score was effective in predicting in-hospital mortality but performed slightly better in men. The database was registered with clinicaltrials.gov (NCT00727623).

Risk markers of late high-degree atrioventricular block in patients with left ventricular dysfunction after an acute myocardial infarction: a CARISMA substudy

AIMS High-degree atrioventricular block (HAVB) after acute myocardial infarction (AMI) is associated with increased risk of mortality. Risk markers and predictors of HAVB occurring after AMI are largely unknown. The aim of this study was to assess the predictive value of risk markers derived from a series of non-invasive and invasive tests for the development of HAVB documented by an implantable loop recorder (ILR) in late convalescent phases of an AMI. METHODS AND RESULTS The study included 292 patients with AMI and subsequent left ventricular dysfunction without prior HAVB or implanted pacemaker. An ILR was implanted for continuous arrhythmia surveillance. Risk stratification testing was performed at inclusion and 6 weeks after AMI. The tests included echocardiography, electrocardiogram (ECG), 24 h Holter monitoring, and an invasive electrophysiological study. High-degree atrioventricular block was documented in 28 (10%) patients during a median follow-up of 2.0 (0.4-2.0) years. Heart rate variability (HRV) measures and non-sustained ventricular tachycardia occurring at the week 6 Holter monitoring were highly predictive of HAVB. Power law slope <-1.5 ms(2)/Hz was the most powerful HRV parameter (HR = 6.02 [2.08-17.41], P < 0.001). CONCLUSION Late HAVB development in post-AMI patients with left ventricular dysfunction can be predicted by risk stratification tests. Measures of HRV reflecting autonomic dysfunction revealed the highest predictive capabilities.

STEMI mortality in community hospitals versus PCI-capable hospitals: results from a nationwide STEMI network programme:

Aims: Reports examining local ST elevation myocardial infarction (STEMI) networks focused mainly on percutaneous coronary intervention (PCI)-related time issues and outcomes. To validate the concept of STEMI networks in a real-world context, more data are needed on management and outcome of an unselected community based STEMI population. Methods and results: The current study evaluated reperfusion strategies and in-hospital mortality in 8500 unselected STEMI patients admitted to 47 community hospitals (n=3053) and 25 PCI-capable hospitals (n=5447) in the context of a nationwide STEMI network programme that started in 2007 in Belgium. The distance between the hub and spoke hospitals ranged from 2.2 to 47 km (median 15 km). A propensity score was used to adjust for differences in baseline characteristics. Reperfusion strategy was significantly different with a predominant use of primary PCI (pPCI) in PCI-capable hospitals (93%), compared to a mixed use of pPCI (71%) and thrombolysis (20%) in community hospitals. A door-to-balloon time <120 min was achieved in 83% of community hospitals and in 91% of PCI-capable hospitals (p<0.0001). In-hospital mortality was 7.0% in community hospitals versus 6.7% in PCI-capable hospitals with an adjusted odds ratio of 1.1 (95% confidence interval: 0.8–1.4). Between the periods 2007–2008 and 2009–2010, the pPCI rate in community hospitals increased from 60% to 80%, whereas the proportion of conservatively managed patients decreased from 11.1% to 7.9%. Conclusion: In a STEMI network with >70% use of pPCI, in-hospital mortality was comparable between community hospitals and PCI-capable hospitals. Participation in the STEMI network programme was associated with an increased adherence to reperfusion guidelines over time.

Clinical and angiographic results with the beStent: the Registry for Optimal beStent Evaluation (ROSE) trial

BACKGROUND: Although safety and efficacy of the beStent (Medtronic Inc., Santa Rosa, CA, USA) have been described, the long-term angiographic and clinical outcomes have yet to be investigated. The ROSE (Registry for Optimal beStent Evaluation) trial was designed to assess the procedural safety of single 15 mm beStent implantation, and the six-month angiographic and 12-month clinical outcomes of patients treated with this novel coronary stent. METHODS: Patients with angina and a single de novo lesion in a native coronary artery ≥83 of 2.75 mm diameter were included in this multicenter, prospective, observational trial. Clinical follow-up was obtained at one, six and 12 months. Angiography was performed before and after the stent implantation and at six months. The primary end-point included major adverse cardiac events (death, myocardial infarction and target lesion revascularization), major bleeding complications, and thrombotic occlusions at one-month follow-up. Secondary end-points were major cardiacevent-free survival at six- and 12-month follow-up and angiographic restenosis at six months. A total of 120 patients (80% male, mean age 58.6 +/- 10.6 years) with stable (48%) or unstable (44%) angina pectoris were allocated. The target vessel reference diameter pre-procedure was 2.85 +/- 0.52 mm. RESULTS: Minimal lumen diameter pre/post and at follow-up was 0.97 +/- 0.28 mm, 2.53 +/- 0.40 mm and 1.86 +/- 0.63 mm, respectively. Restenosis rate according to the >50% diameter stenosis criterion at six-month follow-up was 21.5%. At 12 months, the event-free survival rate was 75% (no deaths, two Q-wave and seven non-Q-wave infarctions, five bypass surgery interventions and 16 target lesion revascularizations), whilst 87% of the patients were free of angina pectoris. CONCLUSION: Despite the relatively high percentage of small vessels, the outcome of the ROSE trial is comparable to those observed in previous stent trials, indicating that the coronary beStent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with (un)stable angina pectoris. (Int J Cardiovasc Intervent 2000; 3:21–28)

Guidelines for percutaneous coronary intervention by the Belgian Working Group on Invasive Cardiology

More than 20.000 percutaneous coronary interventions (PCI) procedures are performed yearly in Belgium. The success of new coronary devices as well as the expanded indications, notably in acute coronary syndromes, suggest a continuous increase in percutaneous revascularization procedures during the following years. Consequently, this increasing need for PCI has encouraged many hospitals to have an interventional programme. In addition, recent trials showing the superiority of PCI for the treatment of AMI, suggest that easy access to primary PCI for all patients would have the greatest potential to salvage the myocardium and reduce mortality. Although urgent surgical back-up is now exceptional thanks to the refinement of PCI materials and adjunctive treatment, performance of PCI still deserves optimal environmental conditions and physician expertise to be carried out with the expected efficacy. Considering the recent developments in interventional cardiology and the Belgian health care system, this document aims to define updated guidelines for the practice of PCI in Belgium.

Inter-hospital variation in length of hospital stay after ST-elevation myocardial infarction: results from the Belgian STEMI registry.

OBJECTIVE The aim of this paper was to assess the determinants of and variations in length of hospital stay (LOS) in Belgium after ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS Data on LOS were collected from 2079 STEMI patients who were discharged alive from 33 Belgian hospitals (21 with PCI facilities) during 2010-201 1. Early discharge was defined as hospital discharge within 4 days after admission, and the hospitals were clustered according to their LOS for low-risk patients. Determinants of LOS were calculated by means of a negative binomial regression model. LOS was, on average, 6.5 days with a median of 5 days (IQR 4). Baseline risk profiles and reperfusion treatment explained only 13% of the LOS variation. Additional analysis revealed major in-hospital variations independent of the case mix of patients. For comparable baseline risk profiles, the average LOS in a cluster of 11 hospitals with short discharge policies was 5.3 + 5.6 days, with an early discharge rate of 58%, while in the cluster of 11 hospitals with long discharge policies, the average LOS was 7.9 + 8.5 days with an early discharge rate of 22% (P <0.0001). Among the clustered hospitals, there were no differences with regard to logistics (PCI facility, academic affiliation) or volume of STEMI patients. The 1-month mortality rate was less than 0.5% in the different clusters of hospitals (p = NS). CONCLUSIONS Length of hospital stay is not only determined by baseline risk profiles of patients but is also highly dependent on hospital discharge policy, which seems to be unrelated to medical or logistical factors.

Safety and Efficacy of the cobalt chromium PRO-Kinetik coronary stent system: Results of the MULTIBENE study☆ , ☆☆ ,★

BACKGROUND The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions. METHODS AND MATERIALS This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n=72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). RESULTS At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66±0.61mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup. CONCLUSION Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.