The SSTARS (STeroids and Stents Against Re-Stenosis) Trial: Different stent alloys and the use of peri-procedural oral corticosteroids to prevent in-segment restenosis after percutaneous coronary intervention.

BACKGROUND: Stent design and technological modifications to allow for anti-proliferative drug elution influence restenosis rates following percutaneous coronary intervention (PCI). We aimed to investigate whether peri-procedural administration of corticosteroids or the use of thinner strut cobalt alloy stents would reduce rates of binary angiographic restenosis (BAR) after PCI. METHODS: This was a two centre, mixed single and double blinded, randomised controlled trial using a factorial design. We compared (a) the use of prednisolone to placebo, starting at least six hours pre-PCI and continued for 28days post-PCI, and (b) cobalt chromium (CoCr) to stainless steel (SS) alloy stents, in patients admitted for PCI. The primary end-point was BAR at six months. RESULTS: 315 patients (359 lesions) were randomly assigned to either placebo (n=145) or prednisolone (n=170) and SS (n=160) or CoCr (n=160). The majority (58%) presented with an ACS, 11% had diabetes and 287 (91%) completed angiographic follow up. BAR occurred in 26 cases in the placebo group (19.7%) versus 31 cases in the prednisolone group (20.0%) respectively, p=1.00. For the comparison between SS and CoCr stents, BAR occurred in 32 patients (21.6%) versus 25 patients (18.0%) respectively, p=0.46. CONCLUSION: Our study showed that treating patients with a moderately high dose of prednisolone for 28days following PCI with BMS did not reduce the incidence of BAR. In addition, we showed no significant reduction in 6month restenosis rates with stents composed of CoCr alloy compared to SS (http://www.isrctn.com/ISRCTN05886349).

Primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: changing patterns of vascular access, radial versus femoral artery.

OBJECTIVE: To examine the safety and efficacy of emergency transradial primary percutaneous coronary intervention for ST-elevation myocardial infarction. DESIGN: Single-centre observational study with prospective data collection. SETTING: A regional cardiac centre, United Kingdom. PATIENTS: 1051 consecutive patients admitted with ST-elevation myocardial infarction, without cardiogenic shock, between November 2004 and October 2008. INTERVENTIONS: Percutaneous coronary interventions by radial and femoral access MAIN OUTCOME MEASURES: The primary outcome measures were procedural success, major vascular complication and failed initial access strategy. Secondary outcomes were in-hospital mortality and major adverse cardiac and cerebrovascular events, needle-to-balloon times, contrast volume used, radiation dose absorbed and time to discharge. Multiple regression analysis was used to adjust for potential differences between the groups. RESULTS: 571 patients underwent radial access and 480 femoral. A variable preference for radial access was observed among the lead operators (between 21% and 90%). Procedural success was similar between the radial and femoral groups, but major vascular complications were more frequent at the site of femoral access (0% radial versus 1.9% femoral, p = 0.001). Failure of the initial access strategy was more frequent in the radial group (7.7% versus 0.6%, p<0.001). Adjustment for other procedural and clinical predictors did not alter these findings. Needle-to-balloon time, as a measure of procedural efficiency, was equal for radial and femoral groups. CONCLUSIONS: In the setting of acute ST-elevation myocardial infarction without cardiogenic shock, transradial primary angioplasty is safe, with comparable outcomes to a femoral approach and a lower risk of vascular complications.

External validation of established risk adjustment models for procedural complications after percutaneous coronary intervention.

BACKGROUND: Workable risk models for patients undergoing percutaneous coronary intervention (PCI) are needed urgently. OBJECTIVE: To validate two proposed risk adjustment models (Mayo Clinic Risk Score (MC), USA and North West Quality Improvement Programme (NWQIP), UK models) for in-hospital PCI complications on an independent dataset of relatively high risk patients undergoing PCI. SETTING: Tertiary centre in northern England. METHODS: Between September 2002 and August 2006, 5034 consecutive PCI procedures (validation set) were performed on a patient group characterised by a high incidence of acute myocardial infarction (MI; 16.1%) and cardiogenic shock (1.7%). Two external models-the NWQIP model and the MC model-were externally validated. MAIN OUTCOME MEASURE: Major adverse cardiovascular and cerebrovascular events: in-hospital mortality, Q-wave MI, emergency coronary artery bypass grafting and cerebrovascular accidents. RESULTS: An overall in-hospital complication rate of 2% was observed. Multivariate regression analysis identified risk factors for in-hospital complications that were similar to the risk factors identified by the two external models. When fitted to the dataset, both external models had an area under the receiver operating characteristic curve >or=0.85 (c index (95% CI), NWQIP 0.86 (0.82 to 0.9); MC 0.87(0.84 to 0.9)), indicating overall excellent model discrimination and calibration (Hosmer-Lemeshow test, p>0.05). The NWQIP model was accurate in predicting in-hospital complications in different patient subgroups. CONCLUSIONS: Both models were externally validated. Both predictive models yield comparable results that provide excellent model discrimination and calibration when applied to patient groups in a different geographic population other than that in which the original model was developed.

One year results of the Middlesbrough early revascularisation to limit infarction (MERLIN) trial.

OBJECTIVE: To report one year results of the MERLIN (Middlesbrough early revascularisation to limit infarction) trial, a prospective randomised trial comparing the strategy of coronary angiography and urgent revascularisation with conservative treatment in patients with failed fibrinolysis complicating ST segment elevation myocardial infarction (STEMI). The 30 day results have recently been published. At the planning stage of the trial, it was determined that follow up of trial patients would continue annually to three years to determine whether late benefit occurred. SUBJECTS: 307 patients who received a fibrinolytic for STEMI but failed to reperfuse early according to previously described ECG criteria and did not develop cardiogenic shock. METHODS: Patients were randomly assigned to receive either emergency coronary angiography with a view to proceeding to urgent revascularisation (rescue percutaneous coronary intervention (rPCI) arm) or continued medical treatment (conservative arm). The primary end point was all cause mortality at 30 days. The secondary end points included the composite end point of death, reinfarction, stroke, unplanned revascularisation, or heart failure at 30 days. The same end points were evaluated at one year and these results are presented. RESULTS: All cause mortality at one year was similar in the conservative arm and the rPCI arm (13.0% v 14.4%, p = 0.7, risk difference (RD) -1.4%, 95% confidence interval (CI) -9.3 to 6.4). The incidence of the composite secondary end point of death, reinfarction, stroke, unplanned revascularisation, or heart failure was significantly higher in the conservative arm (57.8% v 43.1%, p = 0.01, RD 14.7%, 95% CI 3.5% to 25.5%). This was driven almost exclusively by a significantly higher incidence of subsequent unplanned revascularisation in the conservative arm (29.9% v 12.4%, p < 0.001, RD 17.5%, 95% CI 8.5% to 26.4%). Reinfarction and clinical heart failure were numerically, but not statistically, more common in the conservative arm (14.3% v 10.5%, p = 0.3, RD 3.8%, 95% CI -3.7 to 11.4, and 31.2% v 26.1%, p = 0.3, RD 5.0%, 95% CI -5.1 to 15.1). There was a strong trend towards fewer strokes in the conservative arm (1.3% v 5.2%, p = 0.06, RD -3.9%, 95% CI -8.9 to 0.06). CONCLUSION: At one year of follow up, there was no survival advantage in the rPCI arm compared with the conservative arm. The incidence of the composite secondary end point was significantly lower in the rPCI arm, but this was driven almost entirely by a highly significant reduction in the incidence of further revascularisation.

Predictors of outcome after percutaneous treatment for cardiogenic shock.

OBJECTIVES: To determine predictors of outcome after percutaneous coronary intervention (PCI) in patients with cardiogenic shock complicating acute myocardial infarction. METHODS: Retrospective analysis of a cohort of 113 patients undergoing emergency coronary angiography and attempted PCI for cardiogenic shock complicating acute myocardial infarction in a regional cardiothoracic unit. RESULTS: In-hospital mortality was 51% (58 patients). Adverse outcome was associated with previous myocardial infarction, age over 70 years, cardiogenic shock complicating failure to respond to thrombolytic treatment (failed thrombolysis), and multivessel coronary artery disease. Multivariate logistic regression analysis showed that the first three factors were independent predictors of in-hospital death with odds ratios of 5.21 (95% confidence interval (CI) 1.85 to 14.69), 4.02 (95% CI 1.14 to 14.12), and 3.78 (95% CI 1.43 to 9.96), respectively. CONCLUSION: About 50% of patients with cardiogenic shock undergoing a strategy of urgent coronary angiography and PCI survive to hospital discharge. Survivors do well in the subsequent six months. Emergency PCI for cardiogenic shock reduces mortality from an expected 80% to about 50%. Clinical features can help determine which patients are most likely to gain from urgent coronary angiography and attempted PCI. Alternative strategies are needed to improve the outcome of patients who fare badly.

Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization.

GOAL: To investigate the incidence of early (< 24 hours) and late (> 24 hours to 7 days) reactions to 3 contrast agents commonly used in cardiac catheterization. METHODS AND RESULTS: A total of 2,108 patients undergoing cardiac catheterization in a Regional Cardiothoracic Unit were randomly assigned to receive 1 of 3 commonly used contrast agents in a prospective, double-blind study. The contrast agents were iopamidol 340 (Niopam ), a nonionic monomer; iomeprol 350 (Iomeron ), a nonionic dimer; and iodixanol 320 (Visipaque ), a nonionic dimer. The main outcome measures were the incidence of early (< 24 hours) reactions following catheterization and the incidence of late (24 hours to 7 days) reactions. Early reactions, excluding patients with heat on left ventriculography as the sole symptom, were relatively common (7.4%), but there was no significant difference between the 3 agents (p = 0.35). Late skin reactions, excluding reactions solely at the site of the arterial puncture and continuations of early urticarial reactions, were also relatively common (5.4%), but the incidence differed between the 3 agents. Such reactions occurred in 2.7% of those receiving iopamidol 340 (Niopam ), 3.5% of those receiving iomeprol 350 (Iomeron ) and 10.4% of those receiving iodixanol 320 (Visipaque ) (p < 0.01). CONCLUSION: The incidence of early adverse reactions is similar with these 3 contrast agents. However, late skin reactions are significantly more common with iodixanol 320 (Visipaque ) than with the other 2 agents. Although such reactions were rarely troublesome, patients should be advised accordingly.

Early and late reactions after the use of iopamidol 340, ioxaglate 320, and iodixanol 320 in cardiac catheterization.

BACKGROUND: Although modern contrast agents have tolerability superior to older agents, significant differences remain between the agents currently in use. METHODS: To investigate the incidence of early (<24 hours) and late (>24 hours to 7 days) reactions to 3 contrast agents commonly used in cardiac catheterization, we performed a randomized, prospective, double-blind trial in which 2001 patients received one of the following agents: iopamidol 340, a nonionic monomer; ioxaglate 320, an ionic dimer; and iodixanol 320, a nonionic dimer. Possible reactions to contrast were recorded during the hospital admission and after discharge by means of a questionnaire, telephone follow-up, or both. RESULTS: Early reactions occurred in 22.2% of those receiving ioxaglate, 7.6% of those receiving iodixanol, and 8.8% of those receiving iopamidol (P <.0001). Late skin reactions occurred in 12.2% of those receiving iodixanol, 4.3% of those receiving ioxaglate, and 4.2% of those receiving iopamidol (P <.0001). CONCLUSIONS: The early side effect profile of certain ionic contrast agents suggests that these agents should no longer be used routinely in cardiac catheterization. The use of nonionic agents, however, is associated with late skin reactions, but there are notable differences between the monomeric and dimeric compounds. Although the skin reactions are generally benign, this is not always the case. Patients should be advised accordingly.

Reappraising the role of immediate intervention following thrombolytic recanalization in acute myocardial infarction.

Early studies indicated that after successful thrombolytic recanalization, adjunctive percutaneous transluminal coronary angioplasty (PTCA) was not appropriate, even when a significant residual stenosis was present. The aim of this study was to assess in-hospital clinical outcomes of patients with acute myocardial infarction (AMI) who underwent successful recanalization after thrombolytic therapy. The relation between repeat AMI/unstable angina and the severity of the stenosis, as well as other angiographic and clinical features was also examined. One hundred patients with AMI of <10 hours underwent coronary angiography 2 hours after receiving thrombolytic therapy. Salvage PTCA +/- stenting was performed if recanalization was unsuccessful (Thrombolysis In Myocardial Infarction [TIMI] trial grade 0 to 2), and no PTCA was undertaken if there was brisk anterograde flow (TIMI 3). Angiographic analysis was performed to assess the severity of the residual lesion, as well as the presence or absence of thrombus. Forty patients had unsuccessful recanalization, and of these, 36 underwent attempted PTCA. Of the 60 patients with TIMI 3 flow, 15 required repeat angiography and PTCA after repeat AMI (n = 13) or unstable angina (n = 2) within 5 days. Receiver-operating characteristic analysis indicated an optimum percent diameter stenosis predictor of 85% for repeat AMI/unstable angina. There was no additional relation to age, gender, time to thrombolysis, the infarct-related artery, or the presence of culprit lesion thrombus. After recanalization, a high-grade stenosis >85% is common (n = 25, 42.4%). This is associated with a 54% repeat AMI/unstable angina risk-a ninefold increase in the incidence of such events than in patients with lesions <85%. Thus, patients with narrowings >85% may benefit from early intervention rather than a conservative approach. Narrowings <85% have a 94% probability of no repeat AMI/unstable angina and do not require early intervention.

Failure of thrombolysis by streptokinase: detection with a simple electrocardiographic method.

OBJECTIVE: To determine whether simple, readily applicable ECG criteria will allow early prediction of inadequate (< TIMI 3) flow in the infarct related vessel in patients receiving thrombolytic treatment for acute myocardial infarction; and to determine the success of streptokinase in achieving adequate antegrade flow in the infarct related vessel two hours after starting treatment. DESIGN: Cohort study. SETTING: Regional cardiothoracic unit. PATIENTS: 100 sequential patients with acute myocardial infarction. INTERVENTIONS: Coronary angiography two hours after the initiation of thrombolytic treatment, proceeding to rescue angioplasty for inadequate flow in the infarct related vessel where appropriate. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of six ECG criteria for the detection of inadequate antegrade flow in the infarct related vessel. RESULTS: The ECG test that performed best as a positive test for < TIMI 3 flow in the infarct related vessel was < 50% resolution of the ST segment elevation in the worst lead and no accelerated idioventricular rhythm. This had a sensitivity of 81%, specificity of 88%, positive predictive value of 87%, negative predictive value of 83%, and overall accuracy of 85%. CONCLUSIONS: Sensitive, specific, and simple ECG criteria are defined for diagnosing failure of thrombolytic treatment with streptokinase. These allow the early detection of patients at high risk of further adverse events from a persistently occluded vessel. They may be used without recourse to sophisticated equipment or complex analyses. Such patients can then be considered for alternative treatments or enrollment into appropriate research protocols.

Failure of thrombolysis: experience with a policy of early angiography and rescue angioplasty for electrocardiographic evidence of failed thrombolysis.

OBJECTIVE: To assess the outcome of a policy of emergency coronary angiography with or without rescue angioplasty in patients with acute myocardial infarction and ECG evidence of failed reperfusion after thrombolysis. DESIGN: A cohort study. SETTING: Regional cardiothoracic unit. PATIENTS: 197 patients with acute myocardial infarction fulfilling a simple ECG criterion of failed reperfusion. INTERVENTIONS: Emergency coronary angiography proceeding to rescue angioplasty for inadequate antegrade flow. MAIN OUTCOME MEASURES: Hospital mortality for all 197 patients; incidence of successful and failed rescue angioplasty; need for additional revascularisation in those receiving rescue angioplasty compared with those not treated in this way. RESULTS: 197 patients had emergency angiography for ECG evidence of failed reperfusion; 156 patients received immediate rescue angioplasty. Overall hospital mortality for those undergoing rescue angioplasty was 11.5%. Rescue angioplasty achieved TIMI 2 (11) or TIMI 3 (124) in 135 patients, who had a hospital mortality of 5.9%. Failure to achieve at least TIMI 2 flow following rescue angioplasty occurred in 21 patients, with a hospital mortality of 48%. In the 41 patients in whom immediate rescue angioplasty was not performed, reinfarction or requirement for revascularisation occurred in 37%. Reinfarction occurred in three patients (1.9%) who had immediate rescue angioplasty. Hospital mortality for the whole cohort was 10.7%. CONCLUSIONS: A policy of emergency coronary angiography proceeding to rescue angioplasty where appropriate reduces mortality in a high risk group to a level less than expected for patients with acute myocardial infarction and ECG evidence of failed reperfusion. Unsuccessful rescue angioplasty is associated with a high mortality.

Type A dissection of the ascending thoracic aorta during percutaneous coronary intervention.

Retrograde dissection of the aorta is extremely rare during percutaneous coronary intervention (PCI), but is a recognized and potentially life-threatening complication. We describe a case in which retrograde dissection of the aorta, necessitating urgent surgical repair, occurred during an attempt to open a chronically occluded right coronary artery. Initially localized, the dissection extended during an attempt to seal the right coronary ostium. Our experience suggests that if localized aortic retrograde dissection occurs, the management will depend on the stability of the distal coronary vessel. If stable, a conservative approach may be preferable to an attempt to seal the dissection.

The use of atropine for facilitation of direct current cardioversion from atrial fibrillation--results of a pilot study.

BACKGROUND: The importance of the role of the autonomic nervous system (ANS) in the initiation and propagation of atrial fibrillation has been demonstrated in the condition of paroxysmal atrial fibrillation. However, the role of the ANS in patients with chronic atrial fibrillation is less clear. Some patients with chronic atrial fibrillation are resistant to the standard techniques of direct current (DC) cardioversion. HYPOTHESIS: We sought to investigate whether excessive vagal tone might prevent the restoration of sinus rhythm and to establish that the abolition of vagal tone using intravenous atropine will facilitate DC cardioversion in patients with atrial fibrillation who are resistant to the standard cardioversion techniques. METHODS: Beginning in August 1994, a change in the protocol for elective DC cardioversion of atrial fibrillation was made to include the use of intravenous atropine for patients resistant to the standard techniques of DC cardioversion. RESULTS: Over a 2-year period, 140 elective cardioversions were performed for atrial fibrillation. Sinus rhythm could not be restored on 31 occasions. Intravenous atropine prior to a further 360 J shock with paddles in the anteroposterior position allowed sinus rhythm to be restored on nine occasions. Patients with successful cardioversion after atropine had significantly better left ventricular function than those who remained in atrial fibrillation (p = 0.001) as well as a tendency toward a smaller left atrium. CONCLUSION: This study suggests that high vagal tone, which is dominant in patients with structurally normal hearts, may prevent the termination of atrial fibrillation by standard techniques of DC cardioversion, and that the abolition of high vagal tone by atropine facilitates the restoration of sinus rhythm.

Simultaneous onset of idiopathic dilated cardiomyopathy in identical middle-aged twins.

Idiopathic dilated cardiomyopathy is a primary myocardial disease which is characterised by left ventricular, or biventricular, dilatation and impaired contractility. The precise aetiology is unknown and the relative contribution of genetic and environmental factors is debated. We report two identical male twins of Caucasian origin with idiopathic dilated cardiomyopathy who presented within a few months of each other.

Erosion of the left ventricle by the epicardial patch of an automatic implantable cardioverter defibrillator.

A 56 year old man with an implantable cardioverter defibrillator was admitted with chest pain and collapse. Erosion of the left ventricle by an epicardial patch was confirmed by thoracotomy, but surgical repair was impossible. This rare complication should be considered in patients with a history of cardioverter defibrillators implanted by thoracotomy.

Acute myocardial infarction: failed thrombolysis revisited.

The prognosis following acute myocardial infarction is dependent upon the presence of adequate blood flow in the infarct-related vessel. All too often, this is not achieved by thrombolytic therapy ('failed thrombolysis'). Diagnosis of failed thrombolysis is difficult and the optimum management is currently unclear.