Gerard Devlin

Sex-related differences in the presentation, treatment and outcomes among patients with acute coronary syndromes: the Global Registry of Acute Coronary Events

Objective: To assess whether sex differences exist in the angiographic severity, management and outcomes of acute coronary syndromes (ACS). Methods: The study comprised 7638 women and 19 117 men with ACS who underwent coronary angiography and were included in GRACE (Global Registry of Acute Coronary Events) from 1999–2006. Normal vessels/mild disease was defined as <50% stenosis in all epicardial vessels; advanced disease was defined as ⩾one vessel with ⩾50% stenosis. Results: Women were older than men and had higher rates of cardiovascular risk factors. Men and women presented equally with chest pain; however, jaw pain and nausea were more frequent among women. Women were more likely to have normal/mild disease (12% vs 6%, p<0.001) and less likely to have left-main and three-vessel disease (27% vs 32%, p<0.001) or undergo percutaneous coronary intervention (65% vs 68%, p<0.001). Women and men with normal and mild disease were treated less aggressively than those with advanced disease. Women with advanced disease had a higher risk of death (4% vs 3%, p<0.01). After adjustment for age and extent of disease, women were more likely to have adverse outcomes (death, myocardial infarction, stroke and rehospitalisation) at six months compared to men (odds ratio 1.24, 95% confidence interval 1.14 to 1.34); however, sex differences in mortality were no longer statistically significant. Conclusions: Women with ACS were more likely to have cardiovascular disease risk factors and atypical symptoms such as nausea compared with men, but were more likely to have normal/mild angiographic coronary artery disease. Further study regarding sex differences related to disease severity is warranted.

Management and 6-month outcomes in elderly and very elderly patients with high-risk non-ST-elevation acute coronary syndromes: The Global Registry of Acute Coronary Events

AIMS To test the hypothesis that increasing age in patients presenting with high-risk non-ST-segment elevation acute coronary syndromes (NSTE-ACS) does not adversely influence the benefit of an early invasive strategy on major adverse events at 6 months. METHODS AND RESULTS We report clinical outcomes in young (<70), elderly (70-80), and very elderly (>80 years) patients with high-risk NSTE-ACS enrolled in GRACE between 1999 and 2006. Six month data were available in 18 466 patients (27% elderly, 16% very elderly). Elderly and very elderly patients were less likely to receive evidence-based treatments at discharge and had a longer hospital stay (6 vs. 5 days). Angiography was performed more frequently in younger patients (67 vs. 33% in very elderly, 55% in elderly; P < 0.0001). Multiple logistic regression analysis confirmed the benefit of revascularization on the primary study endpoint (6-month stroke, death, myocardial infarction) in young [odds ratio (OR) 0.69, 95% confidence interval (CI) 0.56-0.86], elderly (0.60, 0.47-0.76), and very elderly (0.72, 0.54-0.95) patients. Revascularization was associated with reductions in 6-month mortality (OR 0.52, 95% CI 0.37-0.72 in young; 0.38, 0.26-0.54 in elderly; 0.68, 0.49-0.95 in very elderly). Stroke risk in hospital or at 6 months was not increased by revascularization. CONCLUSION Following presentation with high-risk NSTE-ACS, an evidence-based approach to management was noted less frequently with advancing patient age. Angiography, in particular, was less likely to be undertaken. Revascularization, however, when performed, was associated with significant benefits at 6 months, independent of age, and did not increase risk of stroke.

A randomized study of direct coronary stent delivery compared with stenting after predilatation: The NIR future trial

This randomized trial compared a strategy of direct stenting without predilatation (n = 39) with conventional stenting with predilatation (n = 42) in patients with suitable lesions in native vessels ≥ 2.5‐mm diameter to be covered by either a 9‐ or 16‐mm‐length NIR Primo stent. Equipment cost [mean (median) ± SD] was less in those with direct stenting [

Delay to angiography and outcomes following presentation with high-risk, non-ST-elevation acute coronary syndromes: results from the Global Registry of Acute Coronary Events

1,199 (979) ± 526] than in those with predilatation [

Quality of Life after Late Invasive Therapy for Occluded Arteries

1,455 (1,285) ± 401, P < 0.001]. There was no significant difference in contrast use or fluoroscopy time. Procedural time was shorter in the direct stenting group. The clinical outcome at 1 month was satisfactory in both groups. In selected patients, a strategy of direct stenting is feasible, costs less, and is quicker to perform than the conventional strategy of stenting following predilatation. Cathet. Cardiovasc. Intervent. 50:377–381, 2000.

Primary percutaneous balloon pericardiotomy for malignant pericardial effusion

Objective: To test if delay-to-angiography (>72 hours from admission) in patients presenting with high-risk non-ST-elevation acute coronary syndromes (NSTE-ACS) is associated with adverse outcomes. Design: GRACE (Global Registry of Acute Coronary Events) is a multinational registry of patients admitted with NSTE-ACS. Setting: 14 countries with varying healthcare systems. Patients: 23 396 high-risk NSTE-ACS patients with complete initial data collection entered into GRACE between 1999 and 2006 were analysed. Interventions: Data were analysed according to delay-to-angiography and subsequent in-hospital or post-discharge adverse outcomes. Main outcome measures: Outcomes recorded included death, myocardial infarction, recurrent ischaemia, stroke, new heart failure and composite major adverse cardiovascular event (MACE) comprising death, cerebrovascular accident and myocardial infarction. Revascularisation procedures were recorded. Results: 10 089 (43.1%) had no in-hospital angiography. Median delay-to-angiography was 46 hours; 3680 (34%) patients waited >72 hours. 9.3% waited >7 days before angiography. Patients waiting longest were more often older, diabetic, women and had a history of heart failure, previous myocardial infarction or hypertension. Recurrent in-hospital ischaemia (33% vs 22%), reinfarction (8.4% vs 5.0%) and heart failure (14% vs 9.1%) were more common with delayed angiography. Delayed angiography was associated with better outcomes than no angiography (MACE 18.9% vs 22.2%, p = 0.015). MACE rates within six months of admission were higher with longer delay-to-angiography and highest of all with no angiography. Conclusions: High-risk NSTE-ACS is suboptimally managed with 43% not undergoing angiography. One-third of those undergoing angiography are delayed >72 hours. Longer delays were more likely with higher risk, sicker patients. These delays were associated with adverse outcomes at six months. Very long delay was associated with lower MACE, but not mortality, compared to conservative management.

Percutaneous coronary intervention with bivalirudin anticoagulation, immediate sheath removal, and early ambulation: A feasibility study with implications for day-stay procedures

BACKGROUND The open-artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction will improve clinical outcomes. We evaluated the quality-of-life and economic outcomes associated with the use of this strategy. METHODS We compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in high-risk patients in stable condition who had a totally occluded infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44% of those eligible), we assessed quality of life by means of a battery of tests that included two principal outcome measures, the Duke Activity Status Index (DASI) (which measures cardiac physical function on a scale from 0 to 58, with higher scores indicating better function) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being). Structured quality-of-life interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment were assessed for 458 of 469 patients in the United States (98%), and 2-year cost-effectiveness was estimated. RESULTS At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically marginal decrease of 3.4 points in the DASI score (P=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. For the 469 patients in the United States, cumulative 2-year costs were approximately

Trends and predictors of rehospitalisation following an acute coronary syndrome: report from the Australian and New Zealand population of the Global Registry of Acute Coronary Events (GRACE)

7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival was marginally longer in the medical-therapy group. CONCLUSIONS PCI was associated with a marginal advantage in cardiac physical function at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and was associated with marginally longer quality-adjusted survival. (ClinicalTrials.gov number, NCT00004562.)

Six-Month Angiographic and 12-Month Clinical Follow-Up of MultiLink Long (25 to 35 mm) Stents for Long Coronary Narrowings in Patients With Angina Pectoris

Objectives: Pericardial effusion associated with malignancy is a life‐threatening complication of late‐stage disease. While simple drainage is effective in relieving the symptoms, reaccumulation of effusion may cause further symptomatic episodes, often during a period when overall patient management is focused on improving the quality of remaining life. Over a 16‐year period, we have adopted a strategy of managing such patients with balloon pericardiotomy as the initial preferred treatment. The results are described and compared to alternative management strategies. Methods: A retrospective analysis of patients who presented with symptomatic, malignant pericardial effusion, their management, procedural complication rates, and the need for further therapy for the same condition was made. Survival, reaccumulation rates, and readmissions after the index procedure were recorded and compared. Results: Forty‐three patients were treated for malignant pericardial effusion. Balloon pericardiotomy was the primary treatment in 27/43 patients, simple drainage in 14/43, and surgery in 2/43. Reaccumulation rates between balloon pericardiotomy and simple aspiration (7.4% vs. 14.3%, respectively, P = 0.48) and complication rates (7.4% vs. 7.1%, respectively, P = 0.98) were not statistically different. Survival following intervention was driven by the underlying pathology and was poor, with overall median survival of 56 days. Conclusions: Balloon pericardiotomy, as initial management of symptomatic malignant pericardial effusions, allows a definitive procedure to be performed at presentation. This can be achieved with low complication rates, similar to treatment by simple drainage.

Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial.

We assessed the feasibility and safety of a strategy of transfemoral percutaneous coronary intervention (PCI) with bivalirudin anticoagulation, immediate sheath removal, early ambulation, and, where possible, same‐day discharge in 100 consecutive patients. Ambulation was achieved by 2 hr 30 min in 85% of patients and same‐day discharge in 26%. PCI was angiographically successful in 97%. In hospital, there were no deaths or Q‐wave myocardial infarctions. One patient suffered a non–Q‐wave infarction, another in‐hospital surgical revascularization and one required blood transfusion for rectal bleeding. Femoral access site hematoma > 5 cm diameter occurred in two patients. In addition, by 1 month there had been one death (at 10 days) and one pseudoaneurysm treated nonsurgically. In this preliminary study, the strategy of bivalirudin bolus anticoagulation, immediate sheath removal, and 2‐hr ambulation after PCI appeared safe, with same‐day discharge possible in 26% of unselected patients with stable or unstable angina. Cathet Cardiovasc Intervent 2002;55:289–293.