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Maarten L Simoons

Publications and source records attributed to Maarten L Simoons.

87 records · Page 5Linked to original sources
PubMed2003

Prehospital thrombolysis with reteplase: the Nijmegen/Rotterdam study.

OBJECTIVE: The objective of this observational study was to assess time from electrocardiogram diagnosis to treatment and time from pain onset to treatment with double bolus reteplase compared to current therapy with streptokinase or bolus anistreplase in 2 cities (Rotterdam and Nijmegen) in the Netherlands, where prehospital thrombolysis is an established way of treatment of acute myocardial infarction. METHODS: Prehospital thrombolysis is performed using electrocardiogram diagnosis by the ambulance service as well as bolus anistreplase for treatment in Nijmegen, and streptokinase infusion in Rotterdam. Reteplase or anistreplase/streptokinase was assigned open label to patients according to order of presentation on a 1-to-1 basis. All patients were treated with nitrates sublingually and aspirin orally. Time intervals were recorded by the ambulance staff. RESULTS: In total, 250 patients were treated between April 1, 1999 and August 1, 2000. Reteplase was used in 120 patients and anistreplase/streptokinase in 130 patients. Using double bolus reteplase resulted in a significantly shorter time to treatment: a median of 81 minutes compared to a median of 104 minutes with the established therapy (P <.0001). There were no differences in mortality, aborted myocardial infarction, hemorrhagic stroke or the need for rescue angioplasty between the groups. CONCLUSION: In prehospital thrombolysis, double bolus reteplase is associated with a shorter time to treatment than bolus anistreplase or infusion of streptokinase.

Aged↗
PubMed2003

Frequency, patient characteristics, and outcomes of mild-to-moderate heart failure complicating ST-segment elevation acute myocardial infarction: lessons from 4 international fibrinolytic therapy trials.

BACKGROUND: There is a paucity of data on the incidence of mild-to-moderate heart failure (HF) complicating ST-segment elevation acute myocardial infarction (MI) and its impact on short-term outcomes. Our objective was to determine the incidence, timing, and consequences of mild-to-moderate HF complicating acute MI. METHODS: We examined the occurrence of death or death/recurrent MI (re-MI) in patients enrolled in the Global Utilization of Streptokinase and Tissue-Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I), the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO IIb), the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO-III), and Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-II) trials, which examined different fibrinolytic therapies for MI. We excluded patients who had cardiogenic shock (n = 2994) or unknown HF status at all time points (n = 13,716). Of the remaining 61,041 patients, 17,949 patients (29.4%) had HF, 1566 (8.7%) only at baseline, 10,339 (57.6%) only after admission, and 6044 (33.7%) at baseline and after. RESULTS: The incidence of HF was 32.5% in the United States and 26.9% elsewhere. At 30 days, death and death/re-MI occurred in 2% and 4% of patients without HF and 8% and 12% of patients with HF, respectively (2% and 4% of patients with HF only at baseline, 7% and 13% of patients with HF only after baseline, and 10% and 13% of patients with HF at baseline and later). By use of multivariable analyses, the presence of HF was associated with 1.55 times greater risk of dying at 30 days (95% CI 1.38-1.74) and 2.15 times greater risk of death/re-MI (95% CI 1.96-2.36). CONCLUSION: Mild-to-moderate HF is a frequent and ominous complication of MI, especially when it does not resolve or develops after admission.

Clinical Trials as Topic↗
PubMed2002

Sustained ventricular arrhythmias among patients with acute coronary syndromes with no ST-segment elevation: incidence, predictors, and outcomes.

BACKGROUND: The prognosis of ventricular arrhythmias among patients with non-ST-elevation acute coronary syndromes is unknown. We studied the incidence, predictors, and outcomes of sustained ventricular arrhythmias in 4 large randomized trials of such patients. METHODS AND RESULTS: We pooled the datasets of the Global Use of Streptokinase and tPA for Occluded Arteries (GUSTO)-IIb, Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT), Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network (PARAGON)-A, and PARAGON-B trials (n=26 416). We identified independent predictors of ventricular fibrillation (VF) and ventricular tachycardia (VT) and compared the 30-day and 6-month mortality rates of patients who did (n=552) and did not (n=25 864) develop these arrhythmias during the index hospitalization. Independent predictors of in-hospital VF included prior hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, and ST-segment changes at presentation. Except for hypertension, these variables also independently predicted in-hospital VT. In Cox proportional-hazards modeling, in-hospital VF and VT were independently associated with 30-day mortality (hazard ratio [HR], 23.2 [95% CI, 18.1 to 29.8] for VF and HR, 7.6 [95% CI, 5.5 to 10.4] for VT) and 6-month mortality (HR, 14.8 [95% CI, 12.1 to 18.3] for VF and HR, 5.0 [95% CI, 3.8 to 6.5] for VT). These differences remained significant after excluding patients with heart failure or cardiogenic shock and those who died <24 hours after enrollment. CONCLUSIONS: Despite the use of effective therapies for non-ST-elevation acute coronary syndromes, ventricular arrhythmias in this setting are associated with increased 30-day and 6-month mortality. More effective therapies are needed to improve the survival of patients with these arrhythmias.

Acute Disease↗
PubMed2002

Troponin T levels in patients with acute coronary syndromes, with or without renal dysfunction.

BACKGROUND: Among patients with suspected acute coronary syndromes, cardiac troponin T levels have prognostic value. However, there is concern that renal dysfunction may impair the prognostic value, because cardiac troponin T may be cleared by the kidney. METHODS: We analyzed the outcomes in 7033 patients enrolled in the Global Use of Strategies to Open Occluded Coronary Arteries IV trial who had complete base-line data on troponin T levels and creatinine clearance rates. The troponin T level was considered abnormal if it was 0.1 ng per milliliter or higher, and creatinine clearance was assessed in quartiles. The primary end point was a composite of death or myocardial infarction within 30 days. RESULTS: Death or myocardial infarction occurred in 581 patients. Among patients with a creatinine clearance above the 25th percentile value of 58.4 ml per minute, an abnormally elevated troponin T level was predictive of an increased risk of myocardial infarction or death (7 percent vs. 5 percent; adjusted odds ratio, 1.7; 95 percent confidence interval, 1.3 to 2.2; P<0.001). Among patients with a creatinine clearance in the lowest quartile, an elevated troponin T level was similarly predictive of increased risk (20 percent vs. 9 percent; adjusted odds ratio, 2.5; 95 percent confidence interval, 1.8 to 3.3; P<0.001). When the creatinine clearance rate was considered as a continuous variable and age, sex, ST-segment depression, heart failure, previous revascularization, diabetes mellitus, and other confounders had been accounted for, elevation of the troponin T level was independently predictive of risk across the entire spectrum of renal function. CONCLUSIONS: Cardiac troponin T levels predict short-term prognosis in patients with acute coronary syndromes regardless of their level of creatinine clearance.

Abciximab↗
PubMed2002

Early angioplasty in acute coronary syndromes without persistent ST-segment elevation improves outcome but increases the need for six-month repeat revascularization: an analysis of the PURSUIT Trial. Platelet glycoprotein IIB/IIIA in Unstable angina: Receptor Suppression Using Integrilin Therapy.

OBJECTIVES: We explored the effect of timing of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) without persistent ST-segment elevation on the need for repeat revascularization, and we related this effect to other events. BACKGROUND: Percutaneous coronary intervention is widely used to treat ACS without persistent ST-segment elevation. Moreover, restenosis and subsequent revascularization after PCI are more frequent in ACS than in stable angina. The optimal timing of PCI in ACS without persistent ST-segment elevation is unknown. METHODS: In the Platelet glycoprotein IIB/IIIA in Unstable angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) database, patients were stratified by the time of PCI. In the PURSUIT trial, 9,461 patients received a platelet glycoprotein IIb/IIIa inhibitor, eptifibatide or placebo for 72 h. The investigators decided on other treatments. RESULTS: A total of 2,430 patients underwent PCI within 30 days. Repeat revascularization (during 165 days) was notably higher for PCI within 24 h of enrollment (n = 620 [19%]) than for PCI at 24 to 72 h (n = 624 [16.7%]), 3 to 7 days (n = 614 [13.2%]), or 8 to 30 days (n = 561 [7.7%]; p < 0.001), regardless of eptifibatide use. This gradual reduction in the revascularization rate for later PCI was also observed after multivariate analysis correcting for baseline characteristics and with time as a continuous variable. CONCLUSIONS: Percutaneous coronary intervention within 24 is associated with improved outcome (other analysis) but more repeat revascularization. Prospective analyses are needed to test the hypothesis that rapid PCI in ACS with a platelet glycoprotein IIb/IIIa receptor antagonist reduces myocardial infarction (and possibly death) and is therefore most suited for patients at highest risk of infarction, despite a higher need for repeat revascularization.

Aged↗
PubMed2002

Minor myocardial damage and prognosis: are spontaneous and percutaneous coronary intervention-related events different?

BACKGROUND: The relevance of the adverse prognostic implications of CK-MB elevation after percutaneous coronary intervention (PCI) remains controversial. Therefore, we compared the relationship between the level of postprocedural CK-MB elevation and 6-month mortality in patients undergoing PCI with the relationship between the level of spontaneous, non-PCI-related CK-MB elevation and 6-month mortality in patients with acute coronary syndromes (ACS) treated medically. METHODS AND RESULTS: In the PURSUIT trial, 5583 of 9461 patients who presented with a non-ST-elevation ACS did not undergo PCI or CABG and had at least 1 CK-MB sample collected during index-hospitalization. There was a gradual increase in 6-month mortality with higher CK-MB levels: 4.1%, 8.6%, 9.0%, 14.3%, 15.5% for CK-MB ratios 0 to 1, >1 to 3, >3 to 5, >5 to 10, and >10 times the upper limit of normal. A combined analysis in 8838 patients undergoing PCI in 5 large, clinical trials revealed a proportional relationship between postprocedural CK-MB levels (</= 48 hours after PCI) and 6-month mortality. In patients with CK-MB ratios 0 to 1, >1 to 3, >3 to 5, >5 to 10, and >10, the risk of death was 1.3%, 2.0%, 2.3%, 4.3%, and 7.4%, respectively. The absolute mortality rates were lower after procedure-related infarcts compared with spontaneous infarcts. Yet, the relative increase in 6-month mortality with each increase in peak CK-MB level was similar for PCI-related myocardial necrosis and spontaneous myocardial necrosis, as all tests for heterogeneity of the odds ratios were nonsignificant. CONCLUSIONS: The present analysis indicates that the adverse prognostic implications of periprocedural myocardial necrosis should be considered similar to the adverse consequences of spontaneous myocardial necrosis.

Angioplasty, Balloon, Coronary↗
PubMed2002

Outcomes of patients with acute coronary syndromes and prior coronary artery bypass grafting: results from the platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial.

BACKGROUND: Patients with prior CABG with a subsequent non-ST-segment elevation acute coronary syndrome (ACS) pose an increasingly important clinical problem. Although GP IIb/IIIa inhibitors have improved the outcome of patients with ACS, their efficacy in patients with prior CABG has not been previously evaluated. Methods and Results- We analyzed the 30- and 180-day outcomes of patients with prior CABG enrolled in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial. In this trial, which evaluated the efficacy of eptifibatide in patients with ACS, 1134 patients (12%) with prior CABG and 8321 without prior CABG were enrolled. After adjusting for differences in baseline characteristics and treatment, patients with prior CABG had a significantly higher mortality rates at 30 days (hazard ratio [HR], 1.45 [95% CI, 1.06 to 1.98]; P=0.019) and at 180 days (HR, 1.32 [95% CI, 1.04 to 1.67]; P=0.021). At 30 days, there was a similar effect on the primary end point of death or myocardial infarction in the eptifibatide group versus the placebo group in prior CABG patients (unadjusted HR, 0.90 [95% CI, 0.67 to 1.20]) and in patients without a history of CABG (unadjusted HR, 0.89 [95% CI, 0.80 to 0.99]). CONCLUSIONS: Patients with prior CABG with non-ST-segment elevation ACS have a significantly worse prognosis than do patients without a history of CABG. The treatment effect of eptifibatide in the prior CABG group was similar to the effect seen in patients without prior CABG.

Acute Disease↗
PubMed2002

Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials.

BACKGROUND: Platelet glycoprotein IIb/IIIa inhibitors have been shown to reduce cardiac complications in patients undergoing percutaneous coronary intervention. The clinical efficacy of these drugs in acute coronary syndromes, however, is still unclear. We did a meta-analysis of all large randomised trials designed to study the clinical efficacy and safety of glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes who were not routinely scheduled to undergo early coronary revascularisation. METHODS: Inclusion criteria were: randomisation of patients with acute coronary syndromes but without persistent ST elevation; comparison of a glycoprotein IIb/IIIa inhibitor with placebo or control therapy; non-recommendation of early coronary revascularisation during study-drug infusion; and enrollment of at least 1000 patients. Data on individual patients were obtained from all participants in these trials. FINDINGS: Six trials, enrolling 31402 patients, fulfilled the inclusion criteria. 30 days after randomisation, 3530 (11.2%) patients died or developed a myocardial infarction. At 30 days, a 9% reduction in the odds of death or myocardial infarction was seen with glycoprotein IIb/IIIa inhibitors compared with placebo or control (10.8% [1980/18297] vs 11.8% [1550/13105] events; odds ratio 0.91 [95% CI 0.84-0.98]; p=0.015). The relative treatment benefit was similar in subgroups of patients according to important clinical baseline characteristics; hence, the absolute treatment benefit was largest in high-risk patients. An unexpected and significant interaction was seen between sex and allocated treatment, with a treatment benefit in men (0.81 [0.75-0.89] but not in women (1.15 [1.01-1.30]). However, once patients were stratified according to troponin concentration, there was no evidence of a sex difference in treatment response, and a risk reduction was seen in men and women with raised troponin concentrations. Major bleeding complications were increased by glycoprotein IIb/IIIa inhibitors (2.4% [445/18297] vs 1.4% [180/13105]; p<0.0001), but intracranial bleeding was not (16 [0.09%] vs 8 [0.06%]; p=0.40). INTERPRETATION: Glycoprotein IIb/IIIa inhibitors reduce the occurrence of death or myocardial infarction in patients with acute coronary syndromes not routinely scheduled for early revascularisation. The event reduction is greatest in patients at high risk of thrombotic complications. Treatment with a glycoprotein IIb/IIIa inhibitor might therefore be considered especially in such patients early after admission, and continued until a decision about early coronary revascularisation has been made.

Aged↗
PubMed2002

Contribution of nursing to risk factor management as perceived by patients with established coronary heart disease.

BACKGROUND: Guidelines stress the importance of risk factor management in patients with coronary heart disease (CHD). AIMS: To evaluate whether guidelines on patient education in risk factor management are followed in clinical practice and to assess the contribution of nursing to risk factor management as perceived by patients with established CHD. METHODS: Within three Dutch hospitals consecutive patients were identified after a first coronary-artery bypass graft, a first percutaneous transluminal coronary angioplasty or hospital admission for acute myocardial infarction or ischaemia (n=357). Data were collected through patient interviews at least 6 months after hospital admission. RESULTS: Among smokers, overweight patients, patients with hypertension, high cholesterol, and sedentary lifestyle, respectively 75, 36, 67, 61 and 49% reported that information on presence or management of these risk factors was provided. The proportion of patients informed by nurses ranged from 14% (lowering cholesterol) to 23% (increasing physical activity), while 55% (lowering cholesterol) to 71% (stop smoking) were informed by physicians. CONCLUSION: Many patients with established CHD and cardiovascular risk factors do not remember ever having received information about management of their risk factors. Clearly, there is a substantial potential to improve professionals' compliance to guidelines on risk factor management, including those on patient education. The perceived contribution of nurses to risk factor management is small compared to that of physicians and other caregivers. If risk factor management is felt to be a main responsibility of nurses, current nursing activities in this area should be reconsidered within an improved organisational structure.

Coronary Disease↗
PubMed2002

Characteristics, treatment and outcome of patients with non-ST-elevation acute coronary syndromes and multivessel coronary artery disease: observations from PURSUIT (platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrelin therapy).

BACKGROUND: The 6-month clinical outcome of patients with multivessel disease enrolled in PURSUIT (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy) is described. Patients with complete angiography data were included; multivessel disease was stratified according to the treatment strategy applied early during hospitalization, i.e. medical treatment, percutaneous coronary intervention (PCI) (balloon), PCI (stent), or coronary artery bypass grafting (CABG). METHODS: Patients were divided into three groups according to the treatment strategy applied during the first 30 days of enrolment. Patients who did not undergo a percutaneous or surgical coronary intervention were classified as medically treated. Patients who underwent a PCI (prior to a possible CABG) were separated from those who underwent a CABG (prior to a possible PCI). The PCI group was further subdivided: patients receiving >/=1 coronary stents were separated from those in whom no stents were used. RESULTS: The mortality rate at 30 days was 6.7, 3.9, 2.4 and 4.8% for the medical treatment, PCI (balloon), PCI (stent) and CABG groups, respectively (p value = 0.002). Differences as observed at 30 days were still present at 6-month follow-up with 11.1, 5.8, 5.5 and 6.5% mortality event rates for the aforementioned groups (p value = 0.002). The 30-day myocardial infarction (MI) rate according to the opinion of the Clinical Events Committee was lower among medically than non-medically treated patients, with the highest event rate observed in the CABG group (27.7%). Approximately half of the MIs in the PCI and CABG subgroups occurred within 48 h after the procedure. CONCLUSIONS: The observed differences in clinical outcomes are explained by an imbalance in baseline characteristics and comorbid conditions between the analyzed groups of patients.

Acute Disease↗
PubMed2001

Systematic adjudication of myocardial infarction end-points in an international clinical trial.

BACKGROUND: Clinical events committees (CEC) are used routinely to adjudicate suspected end-points in cardiovascular trials, but little information has been published about the various processes used. We reviewed results of the CEC process used to identify and adjudicate suspected end-point (post-enrolment) myocardial infarction (MI) in the large Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial. METHODS: The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. A central adjudication process was established prospectively to identify all suspected MIs and adjudicate events based on protocol definitions of MI. Suspected MIs were identified by systematic review of data collection forms, cardiac enzyme results, and electrocardiograms. Two physicians independently reviewed all suspected events. If they disagreed whether a MI had occurred, a committee of cardiologists adjudicated the case. RESULTS: The CEC identified 5005 patients with suspected infarction (46%), of which 1415 (28%) were adjudicated as end-point infarctions. As expected, the process identified more end-point events than did the site investigators. Absolute and relative treatment effects of eptifibatide were smaller when using CEC-determined MI rates rather than site investigator-determined rates. The site-investigator reporting of MI and the CEC assessment of MI disagreed in 20% of the cases reviewed by the CEC. CONCLUSIONS: End-point adjudication by a CEC is important, to provide standardised, systematic, independent, and unbiased assessment of end-points, particularly in trials that span geographic regions and clinical practice settings. Understanding the CEC process used is important in the interpretation of trial results and event rates.

Journal Article↗
PubMed2001

Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study.

BACKGROUND: Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs) reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial and those adjudicated by a central clinical events committee (CEC) to determine the reasons for differences in event rates. METHODS: The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. The primary end-point was death or post-enrolment MI at 30 days as assessed by the CEC; this end-point was also constructed using site-reported events. The CEC identified suspected MIs by systematic review of clinical, cardiac enzyme, and electrocardiographic data. RESULTS: The CEC identified 5005 (46%) suspected events, of which 1415 (28%) were adjudicated as MI. The site investigator and CEC assessments of whether a MI had occurred disagreed in 983 (20%) of the 5005 patients with suspected MI, mostly reflecting site misclassification of post-enrolment MIs (as enrolment MIs) or underreported periprocedural MIs. Patients for whom the CEC and site investigator agreed that no end-point MI had occurred had the lowest mortality at 30 days and between 30 days and 6 months, and those with agreement that a MI had occurred had the highest mortality. CONCLUSION: CEC adjudication provides a standard, systematic, independent, and unbiased assessment of end-points, particularly for trials that span geographic regions and clinical practice settings. Understanding the review process and reasons for disagreement between CEC and site investigator assessments of MI is important to design future trials and interpret event rates between trials.

Journal Article↗