Platelet reactivity and cardiovascular events after percutaneous coronary intervention in patients with stable coronary artery disease: the Stent Thrombosis In Belgium (STIB) trial.

AIMS: The Stent Thrombosis In Belgium (STIB) trial aimed to determine whether assessing platelet reactivity (PR) in patients with stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI) could predict the risk of ischaemic complications and adverse clinical events up to 30 days post PCI. METHODS AND RESULTS: PR before intervention was determined in 891 patients undergoing PCI for stable angina pectoris. Twelve to 24 hours before PCI, all patients received a 600 mg clopidogrel dose followed by 75 mg daily, and 500 mg of aspirin followed by 80-100 mg daily. Residual PR was assessed by VerifyNow point-of-care aspirin and P2Y12 assay before PCI. "Non-responders" to antiplatelet therapy were defined as aspirin reaction unit (ARU) >550 and as P2Y12 reaction unit (PRU) >230. The endpoint of the study was the composite of periprocedural myonecrosis, stent thrombosis, non-fatal myocardial infarction (MI), stroke and death at 30 days in patients with or without high PR. The endpoint was observed in 180 patients: four deaths, one stroke, 11 Q-wave MI, three non-Q-wave MI and 161 periprocedural myonecroses. At multivariate analysis, the endpoint was predicted by total stent length (OR: 1.020), GFR <60 ml/min (OR: 1.87), history of PCI (OR: 0.58), white blood cell count (OR: 1.95) and diabetes (OR: 1.83). No significant association was found between residual PR and the primary endpoint or any of its components. CONCLUSIONS: PR measured before PCI in stable patients undergoing elective PCI who are preloaded with 500 mg of aspirin and 600 mg of clopidogrel is not predictive of periprocedural myocardial injury or adverse ischaemic complications up to 30 days.

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).

Reperfusion therapy and mortality in octogenarian STEMI patients: results from the Belgian STEMI registry.

BACKGROUND: Treatment strategies and outcome of ST-elevation myocardial infarction (STEMI) have been mainly studied in middle-aged patients. With increasing lifetime expectancy, the proportion of octogenarians will substantially increase. We aimed to evaluate whether the benefit of currently recommended reperfusion strategies is maintained in octogenarians. METHODS: Reperfusion therapy and in-hospital mortality were evaluated in 1,092 octogenarians and compared with 7,984 STEMI patients <80 years old based on data from the prospective Belgian STEMI registry. RESULTS: The octogenarian STEMI group had more cardiovascular comorbidities, contained more female patients and presented more frequently with cardiac failure (Killip class >1, 40 vs. 20 %) compared with their younger counterparts (all p < 0.05). Although the rate of thrombolysis was similar (9.2 vs. 9.9 %) between both groups, a conservative approach was chosen more frequently (13.8 vs. 4.7 %), while PCI was performed less frequently (76.9 vs. 85.4 %) in octogenarians (p < 0.001). Moreover, ischemic time and door-to-needle/balloon time were longer for octogenarians. In-hospital mortality for octogenarians was 17.8 vs. 5.5 % in the younger group [adjusted OR 2.43(1.92-3.08)]. In haemodynamically stable octogenarians, PCI seemed to improve outcome compared with thrombolysis or conservative treatment (5.7 vs. 12.7 vs. 8.5 %, p = 0.09). In octogenarians with cardiac failure, in-hospital mortality was extremely high independent of the chosen reperfusion therapy (34.6 vs. 31.6 vs. 36.3 %, p = 0.88). CONCLUSIONS: In-hospital mortality in octogenarian STEMI patients was high and related to a high prevalence of cardiac failure. Less PCI was performed in the octogenarian group compared with the younger patients, although mortality benefit of PCI was maintained in haemodynamically stable octogenarians.

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.

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.

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.

Usefulness of remote monitoring in cardiac implantable device follow-up.

The conventional approach to cardiac implantable device follow-up involves patients attending regularly scheduled in-clinic visits to verify the functionality and safety of the implanted devices. Due to increasing patient volumes, as well as the time, capital, and human resources required, such routine device follow-up contributes a significant resource burden to already overstrained clinics and electrophysiology departments, as well as to patients and caregivers in terms of travel and time. Continuous device status monitoring via remote means (i.e., remote device monitoring) allows clinics the ability to immediately be aware of changes in device functionality to proactively respond to actionable events, and may represent a safe, effective, and cost-saving alternative to conventional in-clinic follow-up programs. The currently available systems to remotely transmit device data combine leading medical and information technology using Web-based networks that promptly provide physicians with data comparable to in-clinic follow-up visits and offer patients a high level of convenience.

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 < or = 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 ms(2)) 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.

3-year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions).

OBJECTIVES: This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study. BACKGROUND: The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile. METHODS: The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days. RESULTS: At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%). CONCLUSIONS: The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Clinical performance of a ventricular automatic capture verification algorithm.

BACKGROUND: This study was conducted to evaluate the clinical performance of the ventricular automatic capture feature as implemented in the Insignia I Ultra pacemaker system (Guidant) utilizing a variety of ventricular leads. Currently, the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). The ability of a pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s and is only available today in conjunction with a specific low polarization lead system. METHODS: One hundred and five patients were enrolled from 17 European centers utilizing 31 different types of ventricular leads were followed through their 3-month follow-up visit. There were no restrictions on the type of ventricular leads used. RESULTS: The average mean difference between the commanded autothreshold test (0.652 + 0.335 V) and the manual threshold test (0.651 + 0.335 V) was 0.001 + 0.49 (P < 0.0001). The average mean difference between the ambulatory autothreshold test (0.696 + 0.322 V) and the commanded autothreshold test (0.682 + 0.315 V) was 0.002 + 0.74 (P < 0.0001). Holter recordings confirmed that there were no loss of capture incidences without a backup pulse being delivered. In addition, the mean number of backup pulses delivered in a 24-hour period was less than 0.1% of the total number of paced beats. CONCLUSIONS: This study provided that the automatic capture feature while using a variety of leads accurately determines the ventricular stimulation threshold and safely delivers a backup pulse when required.

Electrocardiographic findings in cardiogenic shock, risk prediction, and the effects of emergency revascularization: results from the SHOCK trial.

OBJECTIVES: To evaluate electrocardiographic (ECG) parameters as predictors of 1-year mortality in patients developing cardiogenic shock after acute myocardial infarction (AMI), and to document associations between these ECG parameters and the survival benefit of emergency revascularization versus initial medical stabilization. BACKGROUND: Emergency revascularization reduces the risk of mortality in patients developing cardiogenic shock after AMI. The prognostic value of ECG parameters in such patients is unclear, and it is uncertain whether emergency revascularization reduces the mortality risk denoted by ECG parameters. METHODS: In a prospective substudy of 198 SHOCK (SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK) trial patients, ECGs recorded within 12 hours of shock were interpreted by personnel blinded to the patients' treatment assignment and outcome. RESULTS: The baseline heart rate was higher in non-survivors than in survivors (106 +/- 20 versus 95 +/- 24 beats/minute, P = .001). There was a significant association between the QRS duration and 1-year mortality in medically stabilized patients (115 +/- 28 ms in non-survivors versus 99 +/- 23 ms in survivors, P = .012), but not in emergently revascularized patients (110 +/- 31 versus 116 +/- 27 ms respectively, P = .343). The interaction between the QRS duration, mortality and treatment assignment was significant (P = .009). Among patients with inferior AMI, a greater sum of ST depression was associated with higher 1-year mortality in medically stabilized patients (P = .029), but not in emergently revascularized patients (P = .613, treatment interaction P = .025). On multivariate analysis, the independent mortality predictors were increasing age, elevated pulmonary capillary wedge pressure, heart rate, sum of ST depression in medically stabilized patients, and interaction (P = .016) between a prolonged QRS duration and treatment assignment. The adjusted hazard ratio for 1-year mortality per 20 ms increase in the QRS duration was 1.19 (95% CI 0.98-1.46) in medically stabilized patients and 0.81 (95% CI 0.63-1.03) in emergently revascularized patients. CONCLUSION: ECG parameters identified patients with cardiogenic shock who were at high risk. Emergency revascularization eliminated the incremental mortality risk associated with cardiogenic shock in patients with a prolonged QRS duration, or inferior AMI accompanied by precordial ST depression. Prospective assessments of the magnitude of the treatment effect based on ECG parameters are required.

A dose-finding study of fondaparinux in patients with non-ST-segment elevation acute coronary syndromes: the Pentasaccharide in Unstable Angina (PENTUA) Study.

OBJECTIVES: In this dose-finding study, we sought to compare fondaparinux with enoxaparin in patients with acute coronary syndromes (ACS). BACKGROUND: Fondaparinux is a synthetic pentasaccharide that selectively inhibits activated clotting factor X. It has been demonstrated as effective in preventing thromboembolic complications in orthopedic surgery. METHODS: Four doses fondaparinux (2.5, 4, 8, or 12 mg once daily) and enoxaparin (1 mg/kg twice daily) were compared, both given for three to seven days, in patients with ACS without persistent ST-segment elevation. RESULTS: The rates of the combined primary end point of death, myocardial infarction, or recurrent ischemia after nine days were 27.9%, 35.9%, 34.7%, 30.3%, and 35.7% in patients allocated to fondaparinux doses of 2.5, 4, 8, and 12 mg and enoxaparin, respectively (p = NS). In the per-protocol analysis (929 patients who received adequate study drug and had adequate ST-segment monitoring), these figures were 30.0%, 43.5%, 41.0%, 34.8%, and 40.2%. Again, no dose response was observed. The lowest event rates were observed in the 2.5-mg fondaparinux group, which had significantly lower rates than the enoxaparin group as well as for 4 and 8 mg fondaparinux in the per-protocol analysis (p < 0.05). Bleeding rates were low and not different among the patient groups. No differences were observed in fondaparinux concentrations in patients with or without death, myocardial infarction, recurrent ischemia, or bleeding events. CONCLUSIONS: This dose-finding study revealed no dose response for different fondaparinux doses ranging from 2.5 to 12 mg subcutaneously and suggests that the efficacy and safety of fondaparinux may be similar to that of enoxaparin. Further studies with fondaparinux in ACS might include the lowest dose (2.5 mg) investigated in this study.

Benefits of direct angioplasty for women and men with acute myocardial infarction: results of the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B) Angioplasty Substudy.

BACKGROUND: Direct angioplasty (PTCA) and thrombolytic therapy are the chief therapies for treating an ST-segment elevation myocardial infarction (MI). OBJECTIVE: This study was designed to evaluate sex differences in the relative benefit of direct PTCA versus thrombolytic therapy among patients enrolled in the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B PTCA) Substudy. METHODS: Women and men presenting with an acute ST-segment elevation MI were randomized to receive either direct PTCA or accelerated tissue plasminogen activator (t-PA). Patients were then randomized to treatment with either heparin or bivalirudin. A gender analysis of outcome was performed. RESULTS: Women were older than men (68.6 +/- 11.5 vs 59.5 +/- 12.0 years, P <.001) and were more likely to have diabetes (22.5% vs 13.5%, P <.0001) and hypertension (53.3% vs 34.8%, P =.001). After adjusting for differences in baseline variables, the odds ratio (OR) for reaching a 30-day clinical end point (death, nonfatal infarction, or nonfatal disabling stroke) was similar for women and men (1.35, 95% CI 0.88-2.08). The OR for reaching a clinical end point at 30 days for the PTCA-treated women compared with the t-PA-treated women was 0.685 (95% CI 0.36-1.32) and similar to the OR in men, 0.565 (95% CI 0.35-0.91), P for interaction =.535. Because women had a higher event rate than men, the absolute number of major events prevented when treating women with direct PTCA was higher than men (56 events/1000 women treated with PTCA vs 42 events per 1000 men treated with PTCA). CONCLUSIONS: Although the relative benefit of direct PTCA to t-PA for the treatment of an acute MI appears to be similar in women and men, women may derive a larger absolute benefit from direct PTCA.

Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial.

BACKGROUND: The enhancement of diastolic coronary blood flow by the combination of thrombolytic therapy (TT) and intra-aortic balloon counterpulsation (IABP) in experimental studies provides a rationale for their combined use in acute myocardial infarction (MI) complicated by cardiogenic shock. We examined the relation between TT (with and without IABP) and 12-month survival in the SHould We Emergently Revascularize Occluded Coronaries for Cardiogenic ShocK (SHOCK) Trial. METHODS AND RESULTS: Among 302 patients with myocardial infarction and cardiogenic shock who were randomized in the SHOCK Trial, 16 had absolute contraindications to TT. Among 150 patients randomly assigned to initial medical stabilization (IMS), 63% received TT, as recommended per protocol, compared with 49% of 152 patients randomly assigned to emergency revascularization, in whom TT was not recommended if immediate angiography was available. IABP deployment, which was protocol-recommended, was used in 86% of patients. The rate of severe bleeding was similar in patients receiving TT and in those not receiving TT (31% vs 26%, P =.37). Among patients randomly assigned to IMS, TT was associated with improved 12-month survival (unadjusted mortality hazard ratio, 0.59; P =.01; mortality hazard ratio adjusted for age and prior MI, 0.62; P =.02). TT was not associated with improved 12-month survival among patients randomly assigned to emergency revascularization (unadjusted mortality hazard ratio, 0.93; P =.76; mortality hazard ratio adjusted for age and prior MI, 1.06, P =.81). The test for interaction of TT and randomization group P value was.16, and there was insufficient statistical power to demonstrate a differential effect of TT on 12-month survival by treatment group assignment. CONCLUSIONS: Among patients randomly assigned to IMS in the SHOCK Trial, TT was associated with improved 12-month survival and did not significantly increase the risk of severe bleeding.

Correlates of one-year survival inpatients with cardiogenic shock complicating acute myocardial infarction: angiographic findings from the SHOCK trial.

OBJECTIVES: The goal of this study was to describe the core laboratory angiographic findings of "SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK" (SHOCK) trial participants and to determine the relationship of angiographic parameters to one-year survival. BACKGROUND: In the SHOCK trial, emergency revascularization improved one-year survival of patients with cardiogenic shock compared with initial medical stabilization including thrombolysis and intraaortic balloon counterpulsation. METHODS: Coronary angiography was performed by protocol in 147 of 152 (97%) patients in the emergency revascularization (ERV) group and by clinical selection in 100 of 150 (67%) patients in the initial medical stabilization (IMS) group. Of the other 50 IMS patients, 45 of 50 (90%) died rapidly and did not undergo angiography. RESULTS: Left ventricular ejection fraction was correlated with one-year survival in both treatment groups (p < 0.001). In the IMS group, the hazard ratio for death was 2.59 (95% confidence interval 1.47 to 4.58, p = 0.001) per diseased vessel (0/1 vs. 2 vs. 3). In the ERV group, the hazard ratio for death per diseased vessel was 1.11 (95% confidence interval 0.79 to 1.56, p = 0.559). Multivariate analysis of the angiography cohort (without regard for left ventriculogram measurements) identified initial Thrombolysis in Myocardial Infarction flow grade (p = 0.032), number of diseased vessels (for IMS patients only, p = 0.024), and culprit vessel (p = 0.004) as independent correlates of one-year survival, even after adjustment for key clinical factors. In the smaller cohort with left ventricular ejection fraction measured (n = 97), ejection fraction and culprit vessel remained independently correlated with survival. CONCLUSIONS: For patients in cardiogenic shock, left ventricular function and culprit vessel were independent correlates of one-year survival.

Percutaneous coronary intervention for cardiogenic shock in the SHOCK trial.

OBJECTIVES: We examined the clinical, angiographic, and procedural characteristics determining survival after percutaneous coronary intervention (PCI) for cardiogenic shock. BACKGROUND: The SHOCK (SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK?) trial prospectively enrolled patients with shock complicating acute myocardial infarction (MI). Patients were randomized to a strategy of early revascularization or initial medical stabilization. METHODS: Patients randomized to early revascularization underwent PCI or bypass surgery on the basis of predefined clinical criteria. Patients randomized to early revascularization who underwent PCI and had angiographic films available for analysis are the subject of this report (n = 82). RESULTS: The median time from MI to PCI was 11 h. The majority of patients had occluded culprit arteries (Thrombolysis In Myocardial Infarction [TIMI] grade 0 or 1 flow in 62%) and multivessel disease (81%). One-year mortality in PCI patients was 50%. Mortality was 39% if PCI was successful but 85% if unsuccessful (p < 0.001). Mortality was 38% if TIMI flow grade 3 was achieved, 55% with TIMI grade 2 flow, and 100% with TIMI grade 0 or 1 flow (p < 0.001). Mortality was 67% if severe mitral regurgitation was documented. Independent correlates of mortality were as follows: increasing age (p < 0.001), lower systolic blood pressure (p = 0.009), increasing time from randomization to PCI (p = 0.019), lower post-PCI TIMI flow (0/1 vs. 2/3) (p < 0.001), and multivessel PCI (p = 0.040). CONCLUSIONS: Restoration of coronary blood flow is a major predictor of survival in cardiogenic shock. Benefit appears to extend beyond the generally accepted 12-h post-infarction window. Surgery should be considered in shock patients with severe mitral insufficiency or multivessel disease not amenable to relatively complete percutaneous revascularization.

Cardiogenic shock caused by right ventricular infarction: a report from the SHOCK registry.

OBJECTIVES: The purpose of this study was to determine the characteristics and outcomes of patients with acute myocardial infarction (MI) complicated by cardiogenic shock due to predominant right ventricular (RV) infarction. BACKGROUND: Although RV infarction has been shown to have favorable long-term outcomes, the influence of RV infarction on mortality in cardiogenic shock is unknown. METHODS: We evaluated 933 patients in cardiogenic shock due to predominant RV (n = 49) or left ventricular (LV) failure (n = 884) in the SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK? (SHOCK) trial registry. RESULTS: Patients with predominant RV shock were younger, with a lower prevalence of previous MI (25.5 vs. 40.1%, p = 0.047), anterior MI, and multivessel disease (34.8 vs. 77.8%, p < 0.001) and a shorter median time between the index MI and the diagnosis of shock (2.9 vs. 6.2 h, p = 0.003) in comparison to patients with LV shock. In-hospital mortality was 53.1% versus 60.8% (p = 0.296) for patients with predominant RV and LV shock, respectively, and the influence of revascularization on mortality was not different between groups. Multivariate analysis revealed that RV shock was not an independent predictor of lower in-hospital mortality (odds ratio 1.07, 95% confidence interval 0.54 to 2.13). CONCLUSIONS: Despite the younger age, lower rate of anterior MI, and higher prevalence of single-vessel coronary disease of RV compared with LV shock patients, and their similar benefit from revascularization, mortality is unexpectedly high in patients with predominant RV shock and similar to patients with LV shock.

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 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 cardiac-event-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.