Rapid Aspirin Desensitization is Safe and Feasible in Patients With Stable and Unstable Coronary Artery Disease: A Single-Center Experience.

AIMS: There are limited data on aspirin (ASA) desensitization for patients with coronary disease. We present our experience with a rapid nurse-led oral desensitization regimen in patients with aspirin sensitivity undergoing coronary angiography. METHODS: This single-center retrospective observational study includes patients with a history of ASA sensitivity undergoing coronary angiography with intent to perform percutaneous coronary intervention (PCI). RESULTS: Between January 2012 and January 2017, 24 patients undergoing coronary angiography for stable coronary disease (7 cases) or acute coronary syndromes (non-ST-segment myocardial infarction [NSTEMI; 8 cases], STEMI [9 cases]) underwent aspirin desensitization having reported previous reactions to aspirin. At initial presentation, previous sensitivity reactions were reported as: mucocutaneous reactions in 17 patients (urticaria in 3 [13%], nonurticarial rash in 6 [25%], angio-oedema in 8 [33%]), respiratory sensitivity in 4 (17%), and systemic anaphylactoid reactions in 3 (13%). Seventeen (71%) patients underwent PCI. Desensitization was acutely successful in 22 (92%) patients and unsuccessful in 2 (8%) patients who both had a single short-lived episode of acute bronchospasm treated successfully with nebulized salbutamol. Fifteen successfully desensitized patients completed 12 months of aspirin; no patient had recurrent hypersensitivity reaction. Aspirin was stopped prior to 12 months in 7 patients (replaced by warfarin [1 case], no antiplatelet or single antiplatelet clinically indicated and clopidogrel chosen [4 cases], patient choice without evidence of recurrent hypersensitivity [1 case], and death due to cardiogenic shock following STEMI [1 case]). CONCLUSION: A rapid aspirin desensitization protocol is safe and effective across a broad spectrum of hypersensitivity reactions and clinical presentations.

Outcomes after culprit-only percutaneous coronary intervention for multivessel disease during ST-segment elevation myocardial infarction: a comparison of registry and clinical trial outcomes.

BACKGROUND: The PRAMI and CvLPRIT trials support preventive percutaneous coronary intervention (PCI) for multivessel coronary disease found during ST-segment elevation myocardial infarction (STEMI). We assess our real-world experience of the management of multivessel disease identified during primary PCI (PPCI) in a large UK regional centre. PATIENTS AND METHODS: All STEMI patients who underwent culprit-only PPCI during the study period (August 2011 to August 2013) were retrospectively assessed for eligibility to each trial. The two resulting groups were designated as the 'observational' cohorts. Primary outcomes were then determined and compared with the culprit-only revascularisation cohorts from the respective published randomized controlled trials (RCTs). RESULTS: A total of 1143 consecutive cases were presented during the study period. Of these, 343 would have been suitable for inclusion to PRAMI and were included in the 'observational PRAMI' cohort; 196 patients were included in the 'observational CvLPRIT' cohort.The 'observational PRAMI' cohort experienced fewer primary outcome events (13.1 vs. 22.9%), cardiac deaths (0.6 vs. 4.3%) and nonfatal myocardial infarctions (3.5 vs. 8.7%) than the culprit-only PCI PRAMI cohort (n=231); there were significantly more diabetics (P=0.022) and anterior STEMI initial presentations in the culprit-only PCI PRAMI cohort. Primary outcomes were comparable to those of the preventive PCI PRAMI cohort.The 'observational CvLPRIT' cohort showed no significant difference in primary outcomes over 12 months (16.8 vs. 21.2%), but significantly lower all-cause mortality (2 vs. 6.9%) than the culprit-only PCI CvPLRIT cohort (n=146). The 30-day event rates were similar to the preventive PCI arm; the 12-month events were better than the nonpreventive, but not as good as the preventive RCT cohorts. CONCLUSION: Outcomes from culprit-only primary PCI for multivessel disease in patients selected by the RCT criteria from an all-comers population representing real-life experience are better than those published in the two main RCTs. The RCTs may have selected a high-risk population for study exaggerating the benefits of preventive PCI.

Impact of implementation of evidence-based strategies to reduce door-to-balloon time in patients presenting with STEMI: continuous data analysis and feedback using a statistical process control plot.

BACKGROUND: Strategies to reduce DTB (door-to-balloon) time have been previously described. However, there is no well-established data-monitoring system that can be used for prompt feedback. The aims of this study were to use statistical process control (SPC) methodology to measure current processes, to provide real-time feedback on the impact of a change in service delivery and to identify individual outliers for specific investigation. METHODS: A prospective study was conducted in a tertiary centre in North England. Data were collected for 841 consecutive STEMI patients from the local district undergoing PPCI. The impact on median DTB time after changes in protocols were prospectively determined. RESULTS: Median DTB times fell significantly as a result of changes in protocol. The upper control limit (UCL) decreased from 209 to 86 min and narrower control limits indicated improved performance. The main outliers included patients presenting to the Accident and Emergency department and patients who developed STEMI while being treated in non-cardiology wards for other reasons (18.3% of the study population). CONCLUSIONS: SPC provides a statistically robust mechanism for assessing the effect of process redesign interventions, and in this context provides a clear visual representation of DTB times for individual patients. Identification of significant outliers allows investigation of any variation with a special cause. It allows a unit to identify when a system of service delivery, albeit stable, is inadequate and needs redesign and can monitor the impact of changes in protocol.

Cumulative funnel plots for the early detection of interoperator variation: retrospective database analysis of observed versus predicted results of percutaneous coronary intervention.

OBJECTIVE: To use funnel plots and cumulative funnel plots to compare in-hospital outcome data for operators undertaking percutaneous coronary interventions with predicted results derived from a validated risk score to allow for early detection of variation in performance. DESIGN: Analysis of prospectively collected data. SETTING: Tertiary centre NHS hospital in the north east of England. PARTICIPANTS: Five cardiologists carrying out percutaneous coronary interventions between January 2003 and December 2006. MAIN OUTCOME MEASURES: In-hospital major adverse cardiovascular and cerebrovascular events (in-hospital death, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accident) analysed against the logistic north west quality improvement programme predicted risk, for each operator. Results are displayed as funnel plots summarising overall performance for each operator and cumulative funnel plots for an individual operator's performance on a case series basis. RESULTS: The funnel plots for 5198 patients undergoing percutaneous coronary interventions showed an average observed rate for major adverse cardiovascular and cerebrovascular events of 1.96% overall. This was below the predicted risk of 2.06% by the logistic north west quality improvement programme risk score. Rates of in-hospital major adverse cardiovascular and cerebrovascular events for all operators were within the 3sigma upper control limit of 2.75% and 2sigma upper warning limit of 2.49%. CONCLUSION: The overall in-hospital major adverse cardiovascular and cerebrovascular events rates were under the predicted event rate. In-hospital rates after percutaneous coronary intervention procedure can be monitored successfully using funnel and cumulative funnel plots with 3sigma control limits to display and publish each operator's outcomes. The upper warning limit (2sigma control limit) could be used for internal monitoring. The main advantage of these charts is their transparency, as they show observed and predicted events separately. By this approach individual operators can monitor their own performance, using the predicted risk for their patients but in a way that is compatible with benchmarking to colleagues, encapsulated by the funnel plot. This methodology is applicable regardless of variations in individual operator case volume and case mix.

Rescue angioplasty after failed fibrinolysis for acute myocardial infarction: predictors of a failed procedure and 1-year mortality.

BACKGROUND: Rescue angioplasty (rPCI) for failed fibrinolysis is associated with a low mortality if successful, but a high mortality if it fails. The latter may reflect a high-risk group or harm in some patients. Predictors of success or failure of rPCI may aid selection of patients to be treated. METHODS: Unselected patients referred for rPCI from March 1994 to March 2005 were studied to determine the predictors of a failed procedure and 1-year mortality. RESULTS: Of 440 patients undergoing emergency coronary angiography for failed fibrinolysis (1-year mortality 18%), 101 had thrombolysis in myocardial infarction flow grade (TFG) 3 in the infarct-related vessel. rPCI was attempted in 318 of 339 patients with 75 years, shock, and final TFG < 3 were independent predictors of 1-year mortality. CONCLUSIONS: Cardiogenic shock is an independent predictor of a failed rPCI. Age group >75 years and shock were the only independent clinical predictors of 1-year mortality. These clinical variables may help in selecting patients for either a strategy of rescue angioplasty after failed fibrinolysis, or in selecting specific patients who might do better with a policy of primary angioplasty.

The impact of chronically diseased coronary arteries and stenting on the corrected TIMI frame count in elective coronary angiography and percutaneous coronary intervention procedures.

UNLABELLED: The impact of chronic coronary obstructions on resting blood flow in stable cardiac patients and the response to percutaneous coronary intervention (PCI) using the TIMI frame count method has not been well documented. We studied the impact of coronary artery stenosis severity on the corrected TIMI frame count (cTFC) in chronically stenosed coronary arteries. We prospectively and quantitatively determined the impact of stenting on the cTFC during elective PCI. METHODS: In substudy 1, analysis was performed to obtain the mean cTFC for arteries with <50% stenosis (Group A), 51-75% stenosis (Group B), 76-85% stenosis (Group C1), 86-95% stenosis (Group C2) and 96-99% stenosis (Group C3). In substudy 2, the cTFC and quantitative coronary angiography were performed pre- and post-PCI. RESULTS: In substudy 1, the cTFC increased exponentially beyond a diameter stenosis of 75% (P < 0.01). However there was no significant difference in the cTFC for coronary arteries with <75% stenosis. In substudy 2, the overall pre- and poststenting cTFC was 17.1 +/- 11.7 and 7.8 +/- 2.7 (P < 0.01) and the TFC index [calculated by dividing the mean cTFC for the relevant artery by the mean cTFC for the corresponding coronary artery in a previously derived control group in our laboratory] was 1.6 +/- 1 and 0.7 +/- 0.2 (P = < 0.01), respectively. CONCLUSION: We have demonstrated that there was a significant increase in the cTFC when the coronary artery stenosis was more than 75% reflecting significant flow abnormalities at this degree of stenosis in chronically diseased coronary arteries. Following stenting there is a significant improvement in the cTFC, which is better than the cTFC for arteries with normal flow, suggesting early hyperaemia.

Should patients in cardiogenic shock undergo rescue angioplasty after failed fibrinolysis: comparison of primary versus rescue angioplasty in cardiogenic shock patients.

BACKGROUND: Trials of rescue angioplasty (rPCI) following failed fibrinolysis have excluded patients with cardiogenic shock and the benefit of rPCI in this setting is unknown. We compared the clinical, angiographic characteristics, 30-day and 1-year outcomes of cardiogenic shock patients undergoing rPCI with those undergoing primary percutaneous coronary intervention (PPCI). METHODS: Of the 171 patients undergoing PCI for cardiogenic shock between 1994 and 2005 at our institution, the indication was for PPCI in 65 and rPCI in 59 patients. Clinical, procedural, 30- day and 1-year mortality data were compared. RESULTS: There were no differences between the cohorts with regard to clinical and pre-PCI angiographic variables, except that patients who underwent rPCI were more likely to be interhospital transfers (64% vs. 43%; p = 0.02) and had a longer door-to-balloon time (median 298 [IQR 395 to 180] minutes in the rPCI group vs. 131 [IQR 215 to 90] minutes in the PPCI group; p <0.01). Glycoprotein IIb/IIIa inhibitors were used less often (20% vs. 42%; p = 0.01), but use of stents was similar in both groups. Patients undergoing rPCI had a lower rate of final TIMI 3 flow grade (56% vs. 74%; p = 0.04) and a higher 1-year mortality (71% vs. 49%; p = 0.01). In the patients with final TIMI flow 3, 1-year mortality was higher in the rPCI group (61% vs. 37%; p = 0.04). In patients with successful procedures (survived procedure, no emergency CABG, TIMI 3 flow), 1-year mortality was higher in the rPCI group (59% vs. 33%; p = 0.02). One-year mortality was 85% in both groups if the procedure was unsuccessful. One-year mortality in patients >70 years old with cardiogenic shock undergoing rPCI was 100% (n = 15) and 70% (n = 14) with PPCI. Rescue angioplasty, anterior myocardial infarction, multivessel disease and postprocedure TIMI flow grade <3 were found to be independent predictors of mortality at 30 days. CONCLUSIONS: In the setting of cardiogenic shock, rPCI patients were treated later than those undergoing PPCI. They had a lower final TIMI 3 flow and higher 1-year mortality. Even patients with a successful rPCI procedure had a higher 1-year mortality than those with a successful PPCI. Rescue angioplasty in the setting of cardiogenic shock was found be an independent predictor of mortality. Rescue angioplasty in elderly patients in cardiogenic shock (>75 years) may be a futile treatment. Efforts should be made to improve reperfusion and survival in these patients, possibly by either adopting PPCI for all patients presenting with ST-elevation acute myocardial infarction or, if this is not logistically possible, adopting PPCI for selected high-risk patients or early referral for rPCI in high-risk groups receiving fibrinolysis.

Early invasive versus conservative treatment in patients with failed fibrinolysis--no late survival benefit: the final analysis of the Middlesbrough Early Revascularisation to Limit Infarction (MERLIN) randomized trial.

BACKGROUND: Early (30 days) and midterm (6 months) clinical outcomes in trials comparing rescue angioplasty (rescue percutaneous coronary intervention [rPCI]) with conservative treatment of failed fibrinolysis complicating ST-segment elevation myocardial infarction have shown variable results. Whether early rPCI confers late (up to 3 years) clinical benefits is not known. METHODS: The MERLIN trial compared rPCI and a conservative strategy in patients with failed fibrinolysis complicating ST-segment elevation myocardial infarction. Three hundred seven patients with electrocardiographic evidence of failure to reperfuse at 60 minutes were included. Patients in cardiogenic shock were excluded. Thirty-day and 1-year results have been reported. Results of 3 years of follow-up are presented. RESULTS: Three-year mortality in the conservative arm and rPCI, respectively, was 16.9% versus 17.6% (P = .9, relative difference [RD] -0.8, 95% CI [-9.3 to 7.8]). Death rates were similar (3.9% vs 3.2%) between 1- and 3-year follow-up, respectively. The incidence of the composite secondary end point of death, reinfarction, stroke, unplanned revascularization, or heart failure was significantly higher in the conservative arm (64.3% vs 49%, P = .01, RD 15.3, 95% CI [4.2-26]). There was no significant difference in the rate of reinfarction (0.7% vs 0.7%) or heart failure (1.3% vs 2.7%) between 1 and 3 years between the conservative and rPCI arms, respectively. The incidence of subsequent unplanned revascularization at 3 years was significantly higher in the conservative arm (33.8% vs 14.4%, P < .01, RD 19.4, 95% CI [10-28.7]), most of which occurred within 1 year; the rates between 1 and 3 years were 3.9% in the conservative arm versus 2% in the rPCI arm. There was a trend toward fewer strokes in the conservative arm at 3 years (conservative arm 2.6% vs rPCI 6.5%, P = .1, RD -3.9%, 95% CI [-9.4 to 0.8]), with similar stroke rates (1.3% vs 1.3%) between 1- and 3-year follow-up. CONCLUSIONS: Rescue angioplasty did not confer a late survival advantage at 3 years. The composite end point occurred less often in the rPCI arm mainly because of fewer unplanned revascularization procedures in the early phase of follow-up. The highest risk of clinical events in patients with failed reperfusion is in the first year, beyond which the rate of clinical events is low.

Successful thrombus extraction with the Rescue thrombus management system during acute percutaneous coronary intervention improves flow but does not necessarily restore optimal myocardial tissue perfusion.

UNLABELLED: We determined the effectiveness of the Rescue device in restoring flow and achieving optimal tissue perfusion during percutaneous coronary intervention (PCI) in thrombus-laden coronary arteries. METHODS: A total of 30 patients with an acute coronary syndrome underwent PCI using the Rescue device. RESULTS: The mean age was 65.5 +/- 9.8 years. Although the Rescue device could not be passed across the lesion in 6 (20%) cases, debris was aspirated in 26 (87%). The uncorrected TIMI frame count improved following the use of the Rescue device and improved further at the completion of PCI (92.2 +/- 23.9 pre-PCI vs. 38.7 +/- 31.3 post-Rescue vs. 21.96 +/- 24 post-PCI, P < 0.0001). The thrombus score improved from 4 +/- 0 to 2.2 +/- 1.29 to 0.86 +/- 1.4 (P < 0.0001). TIMI flow grade (TFG) 3 was restored in 60% of cases following the Rescue device and in 87% after PCI. Myocardial blush grade 3 occurred in only 13% of patients following the Rescue device and 37% of patients after PCI. CONCLUSION: These data suggest that the Rescue device can aspirate considerable amounts of debris in the majority of patients and significantly improves the angiographic epicardial coronary blood flow. How effective such a device is in improving tissue perfusion and, thereby, clinical outcomes for patients remains to be seen.

A randomized trial of rescue angioplasty versus a conservative approach for failed fibrinolysis in ST-segment elevation myocardial infarction: the Middlesbrough Early Revascularization to Limit INfarction (MERLIN) trial.

OBJECTIVES: We sought to compare emergency coronary angiography with or without rescue percutaneous coronary intervention (PCI) with conservative treatment in patients with failed fibrinolysis complicating ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Most patients with STEMI receive fibrinolytic therapy and aspirin. The management of failed fibrinolysis is unclear. METHODS: A total of 307 patients with STEMI and failed fibrinolysis were randomized to emergency coronary angiography with or without rescue PCI or conservative treatment. RESULTS: Thirty-day all-cause mortality was similar in the rescue and conservative groups (9.8% vs. 11%, p = 0.7, risk difference [RD] 1.2%, 95% confidence interval [CI] -5.8 to 8.3). The composite secondary end point of death/re-infarction/stroke/subsequent revascularization/heart failure occurred less frequently in the rescue group (37.3% vs. 50%, p = 0.02, RD 12.7%, 95% CI 1.6 to 23.5), driven by less subsequent revascularization (6.5% vs. 20.1%, p < 0.01, RD 13.6%, 95% CI 6.2 to 21.4). Re-infarction and clinical heart failure were less common in the rescue group (7.2% vs. 10.4%, p = 0.3, RD 3.2%, 95% CI -3.3 to 9.9; and 24.2% vs. 29.2%, p = 0.3, RD 5.7%, 95% CI -4.3 to 15.6, respectively). Strokes and transfusions were more common in the rescue group (4.6% vs. 0.6%, p = 0.03, RD 3.9%, 95% CI 0.5 to 8.6; and 11.1% vs. 1.3%, p < 0.001, RD 9.8%, 95% CI 4.9 to 19.9, respectively). Left ventricular function at 30 days was the same in the two groups. CONCLUSIONS: Rescue angioplasty did not improve survival by 30 days, but improved event-free survival, almost completely due to a reduction in subsequent revascularization. Rescue angioplasty was associated with more strokes and more transfusions and did not result in preservation of left ventricular systolic function at 30 days.

A randomized prospective trial of ioxaglate 320 (Hexabrix) vs. iodixanol 320 (Visipaque) in patients undergoing percutaneous coronary intervention.

We performed a randomized, prospective, double blind trial comparing the use of the ionic dimer contrast agent ioxaglate 320 (Hexabrix) with the nonionic dimer contrast agent iodixanol 320 (Visipaque) in 618 patients undergoing percutaneous coronary intervention (PCI) for stable or unstable coronary artery syndromes. The aim was to determine whether the different anticoagulant and antiplatelet properties of these two contrast agents resulted in a significant difference in the incidence of a combined endpoint comprising the major complications of PCI. Procedural success rates were marginally higher in the Visipaque group compared to the Hexabrix group, although this did not reach statistical significance (96.7% vs. 93.9%; P = 0.09). There was a borderline statistically significant higher requirement for bailout stenting in the Visipaque group compared to the Hexabrix group (6.8% vs. 3.2%; P = 0.05), although this was not a predefined endpoint. The incidence of the combined primary endpoint of failed catheter laboratory outcome/requirement for bailout stenting/requirement for abciximab/myocardial infarction/death before hospital discharge was higher in the Visipaque group compared to the Hexabrix group (17.9% vs. 14.8%), although this did not reach statistical significance (P = 0.29). When subgroup analysis was performed, the incidence of the combined endpoint in patients with stable coronary artery disease randomized to receive either Visipaque or Hexabrix was identical (13.7%). In patients with an acute coronary syndrome, there was a trend toward a reduced incidence of the combined endpoint in the Hexabrix compared to the Visipaque group, although this did not reach statistical significance (17.2% vs. 24.8%; P = 0.17). More adverse reactions occurred in the Hexabrix group compared to the Visipaque group (8.7% vs. 4.9%; P = 0.06). We conclude that there is no clear advantage with the use of an ionic contrast agent in a large population of patients undergoing PCI for both stable and unstable coronary artery disease. Although the study was underpowered to detect significant differences with the use of either agent when patients with either stable or unstable coronary disease were studied, it is highly unlikely that the ionicity of the contrast agent confers any advantage for patients with stable coronary disease. There remains a possibility that ionic agents do have advantages for patients with unstable coronary artery disease undergoing PCI, although a larger study than ours would be required to confirm or refute this.