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).

Oxygen use for chest pain in coronary care units across the UK.

AIM: To quantify the adherence to national guidance for the use of oxygen in patients presenting with chest pain to coronary care units (CCUs) across the UK. DESIGN: Prospective survey. METHODS: A total of 307 hospitals were contacted by telephone between August 2010 and October 2010. Of these, 48 had no CCUs, 10 units refused to take part and 18 hospitals were contacted on 2 occasions but were unable to provide the information due to paucity of time owing to heavy clinical workload. Overall 231 hospitals participated in the audit questionnaire. RESULTS: A total of 30% of the units used oxygen titrated to saturations in accordance with national guidelines. There was no difference between units that had on-site availability of percutaneous coronary intervention and those that did not. Those hospitals where there was a policy for routine oxygen prescription were as unlikely to comply with the guidelines on oxygen use as hospitals where oxygen was not routinely prescribed. CONCLUSION: Only one-third of CCUs in the UK reported adherence to guidelines with regards to oxygen delivery in patients presenting with chest pain. Despite this figure seeming rather low, this is consistent with practice through a range of specialties and guidelines. The evidence base for the oxygen guidance remains insecure. Additional research is required but in the meantime we recommend oxygen is prescribed according to current guidelines.

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.

Strain rate imaging pre- and post-percutaneous coronary intervention: a potential role in the objective detection of ischaemia in exercise stress echocardiography.

AIMS: To determine the feasibility of strain rate imaging (SRI) in the objective detection of exercise-induced ischaemia. METHODS AND RESULTS: Sixteen patients undergoing elective percutaneous coronary intervention (PCI) underwent treadmill exercise stress echocardiography (ESE) pre- and post-PCI. Measurement of systolic SRI parameters was attempted in all myocardial segments at baseline, peak stress, and in recovery. Segments were divided into those supplied by target (Group 1) and non-target vessels (Group 2). Percutaneous coronary intervention was successful in all patients. In Group 1, there was no significant difference in post-systolic strain rate (SRps) at baseline or at peak stress but there was significantly greater SRps pre-PCI compared with post-PCI at 30 min into recovery (-0.37 +/- 0.53 vs. -0.07 +/- 0.44 s(-1), P = 0.004). There were similar findings with the SRps index [ratio of SRps:peak systolic strain rate (SRsys)]. Group 2 segments did not demonstrate any significant differences in SRI parameters pre- and post-PCI. At peak exercise pre-PCI, Group 1 segments had significantly delayed time to SRsys compared with Group 2 (0.12 +/- 0.05 vs. 0.09 +/- 0.05 s, P = 0.013), a difference that was abolished post-PCI. CONCLUSION: This suggests a potential role for SRI in the objective detection of exercise-induced ischaemia by echocardiography at peak stress and during recovery at the time of improved image quality.

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.

Acute rheumatic fever mimicking an acute coronary syndrome.

An elevated troponin measurement does not always reflect myocardial ischaemia secondary to obstructive coronary artery disease. Troponin levels can also be elevated in other disease states including pulmonary emboli, myo-pericarditis, acute rheumatic fever, and in the critically ill. Thus, patients presenting with chest pain and electrocardiological and biochemical evidence of myocardial necrosis are not always suffering from an acute coronary syndrome.

Prospective, randomised, controlled trial to study the effect of intracoronary injection of verapamil and adenosine on coronary blood flow during percutaneous coronary intervention in patients with acute coronary syndromes.

OBJECTIVES: To study the impact of injection of verapamil and adenosine in the coronary arteries on TIMI (Thrombolysis in Myocardial Infarction) frame count (TFC) after percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome (ACS). METHODS: Prospective, randomised, controlled study of the intracoronary administration of normal saline versus verapamil versus adenosine in patients undergoing PCI in the setting of an ACS, even when flow is visually established to be normal or near normal. Patients were randomised to receive verapamil (n = 49), adenosine (n = 51) or normal saline (n = 50) after PCI. Quantitative angiography, TIMI flow grade (TFG), TFC and myocardial blush grade were assessed before PCI, after PCI and after drugs were given. Wall motion index (WMI) was measured at days 1 and 30. RESULTS: 9 patients in the verapamil group developed transient heart block, not seen with adenosine (p

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.

The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design.

BACKGROUND: Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary intervention (PCI)--is limited, mainly confined to a subanalysis of the Bypass Angioplasty Revascularization (BARI) trial, suggesting a mortality benefit of CABG over PCI. No prospective trial has specifically compared these modes of revascularization in patients with diabetes. OBJECTIVE: The Coronary Artery Revascularisation in Diabetes (CARDia) trial is designed to address the hypothesis that optimal PCI is not inferior to modern CABG as a revascularization strategy for diabetics with multivessel or complex single-vessel coronary disease. The primary end point is a composite of death, nonfatal myocardial infarction, and cerebrovascular accident at 1 year. METHOD: A total of 600 patients with diabetes are to be randomized to either PCI or CABG, with few protocol restrictions on operative techniques or use of new technology. This gives a power of 80% to detect non-inferiority of PCI assuming that the PCI 1-year event rate is 9%. A cardiac surgeon and a cardiologist must agree that a patient is suitable for revascularization by either technique prior to recruitment into the study. Twenty-one centers in the United Kingdom and Ireland are recruiting patients. Data on cost effectiveness, quality of life, and neurocognitive function are being collected. Long-term (3-5 year) follow-up data will also be collected.

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.

Selective use of abciximab in coronary stenting: overall outcomes can still be equivalent to those in the EPISTENT treatment group.

BACKGROUND: The EPISTENT trial reported improved early outcomes with routine use of abciximab after coronary stenting. Increasing use of stents means that routine abciximab adds significantly to costs of percutaneous coronary intervention (PCI). This paper reports the results of a protocol encouraging restriction of abciximab therapy to high-risk patients only. METHODS: Data were collected prospectively over a 34-month period for patients undergoing PCI with stenting. In addition to those who fulfilled criteria for inclusion in the EPISTENT trial, patients treated in the setting of acute myocardial infarction (AMI) were studied. Demographic data, procedural details and early clinical outcomes were recorded. RESULTS: Of 808 patients studied, 601 fulfilled EPISTENT inclusion criteria and comprised 367 patients (45%) treated for stable angina and 234 (30%) treated for unstable or post-infarct angina. The additional 207 patients (25%) were treated during AMI. The 808 patients received a total of 981 stents. Abciximab was given in only 88 cases (10.9%). Major adverse clinical events occurred in 39 patients (4.8%). CONCLUSION: Selective use of abciximab for patients undergoing coronary stenting can be associated with outcomes equivalent to those reported for routine use, but with significant cost savings.

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.