Rolf Michels

Randomized, Double-Blind Study Comparing Saruplase With Streptokinase Therapy in Acute Myocardial Infarction: The COMPASS Equivalence Trial

Abstract Objectives. This study sought to demonstrate the equivalence of saruplase and streptokinase in terms of 30-day mortality. Background. The use of thrombolytic agents in the treatment of acute myocardial infarction is well established and has been shown to substantially reduce post-myocardial infarction mortality. Methods. Three thousand eighty-nine patients with symptoms compatible with those of acute myocardial infarction for Results. Death of any cause up to 30 days after randomization occurred in 88 (5.7%) of 1,542 patients randomized to receive saruplase and 104 (6.7%) of 1,547 patients randomized to receive streptokinase (odds ratio 0.84, p Conclusions. Saruplase is a clinically safe and effective thrombolytic medication. This profile ranks saruplase favorably among the currently available thrombolytic agents.

Percutaneous transluminal angioplasty of stenosed aortocoronary bypass grafts.

During the period between October 1980 and December 1982, percutaneous transluminal angioplasty of stenosed aortocoronary bypass grafts was attempted 44 times in 31 patients who had developed disabling angina pectoris four months to seven years after coronary bypass surgery. The primary success rate was 93%. Two (4.5%) patients developed myocardial infarction related to the procedure. No emergency aortocoronary bypass surgery was required and there was no mortality. Although the primary success rate was high, the incidence of recurrence after one or more angioplasties was 50%. Despite this recurrence rate the condition of 10 of the first 16 (62%) patients was clinically improved after a mean follow up of 26 months.

Comparison of Saruplase and Alteplase in Acute Myocardial Infarction

Four hundred seventy-three patients with acute myocardial infarction (AMI) were treated with either saruplase (80 mg/hour, n = 236) or alteplase (100 mg every 3 hours, n = 237). Comedication included heparin and acetylsalicylic acid. Angiography was performed at 45 and 60 minutes after the start of thrombolytic therapy. When flow was insufficient, angiography was repeated at 90 minutes. Coronary angioplasty was then performed if Thrombolysis In Myocardial Infarction (TIMI) trial 0 to 1 flow was seen. Control angiography was at 24 to 40 hours. Baseline characteristics were similar. Angiography showed comparable and remarkably high early patency rates (TIMI 2 or 3 flow) in both treatment groups: at 45 minutes, 74.6% versus 68.9% (p = 0.22); and at 60 minutes 79.9% versus 75.3% (p = 0.26). Patency rates at 90 minutes before additional interventions were also comparable (79.9% and 81.4%). Angiographic reocclusion rates were not significantly different: 1.2% versus 2.4% (p = 0.68). After rescue angioplasty, angiographic reocclusion rates of 22.0% and 15.0% were observed. Safety data were similar for both groups. Thus, (1) early patency rates were high for saruplase and alteplase treatment, (2) reocclusion rates for both drugs were remarkably low, and (3) complication rates were similar. Thus, saruplase seems to be as safe and effective as alteplase.

Gender differences in long-term outcome after primary percutaneous intervention for ST-segment elevation myocardial infarction

Previous studies on gender differences in outcome in patients with ST segment elevation myocardial infarction (STEMI) have been performed, but most of those are from before the current era of PCI technique and medical therapy and have a short duration of follow‐up. The objective of our study is to assess the influence of gender on long‐term outcome in patients with STEMI who underwent primary percutaneous intervention (PCI) between January 2006 and May 2008.

Usefulness of the rescue pt catheter to remove fresh thrombus from coronary arteries and bypass grafts in acute myocardial infarction

I the setting of an acute myocardial infarction (AMI), thrombolytic therapy has proved to reduce mortality and improve left ventricular function.1–3 A good or even better alternative is primary angioplasty.4–6 Several devices have been developed to remove thrombus material. The disadvantages of most of these devices are that they are complicated, and difficult to handle in the acute setting for interventionalists who are not experienced with these devices. We describe the clinical experience with a simple thrombectomy system using a catheter that can be handled like a balloon. This study evaluates the safety and efficacy of the Rescue percutaneous thrombectomy (PT) system (Boston Scientific, Maple Grove, Minnesota) in the setting of AMI or unstable angina pectoris. • • • The thrombectomy system consists of a very flexible, 4.5Fr polyethylene catheter that can be advanced over a standard 0.014-in guidewire through a 7Fr guiding catheter using a monorail system. The catheter has an oblique tip to facilitate passage through the lesion and a marker to improve visibility during fluoroscopy (Figure 1). The proximal end has an extension tube connected to a vacuum pump (0.8 bar) with a collection bottle. The removed thrombus material is collected on a filter in the collection bottle. While the catheter is advanced and pulled back through the thrombus, continuous suction is applied. When necessary, several runs can be performed. In case of distal embolization, the catheter can be advanced distally over the guidewire to remove the embolized material. Thrombectomy using the Rescue PT system was considered when a coronary angiogram recorded in the setting of an AMI raised the suspicion of a considerable amount of thrombus in a venous coronary artery bypass graft or native coronary artery. At the beginning of the procedure 10,000 IU of heparin was administered to the patients not pretreated with a thrombolytic agent. A coronary angiogram was performed before and after guidewire placement, after every passage of the Rescue PT catheter, and when applicable after additional coronary intervention. Coronary flow was classified according to the Thrombolysis In Myocardial Infarction (TIMI) trial.7 Angiographic analysis was performed to evaluate presence and removal of the thrombus and distal embolization. The removal of thrombus was also determined by the material on the filter in the collection bottle. The use of additional medication and coronary intervention, including stent placement, were at the discretion of the operator. Fifty-one lesions were treated in 50 patients (8 women and 42 men). One patient had a thrombus in the left anterior descending (LAD) artery and first diagonal branch because of distal embolization of thrombus from the proximal LAD artery after treatment with a thrombolytic agent. In 30 patients (60%) thrombectomy was performed after failed thrombolysis. In 43 patients (86%) the estimated age of the thrombus was ,6 hours, in 7 patients, thrombus age was 6 to 10 hours, and in 2 patients, it was .10 hours. In 45 patients thrombectomy was performed in a native coronary artery and in the remaining 5 patients in a venous coronary artery bypass graft (graft age range 13 to 18 years). The lesion could be reached in all vessels and thrombus material was removed from 48 of the 51 From the Department of Cardiology, University Hospital Maastricht, Maastricht; and Department of Cardiology, Catharina Ziekenhuis, Eindhoven, The Netherlands. Dr. van Ommen’s address is: Department of Cardiology, University Hospital Maastricht, PO Box 5800, 6202 Maastricht, The Netherlands. E-mail: vvo@scar.azm.nl. Manuscript received October 20, 2000; revised manuscript received and accepted February 27, 2001. FIGURE 1. Photograph of the tip of the Rescue PT system showing the oblique tip and the marker band.

Comparison of drug-eluting and Bare-metal stents for primary percutaneous coronary intervention with or without Abciximab in ST-segment elevation myocardial infarction DEBATER : the Eindhoven Reperfusion Study

OBJECTIVES The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI). BACKGROUND Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established. METHODS Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 × 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm). RESULTS At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03). CONCLUSIONS Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050).

Variation of Cardiac Troponin I and T Measured with Sensitive Assays in Emergency Department Patients with Noncardiac Chest Pain

BACKGROUND New-generation high-sensitivity assays for cardiac troponin have lower detection limits and less imprecision than earlier assays. Reference 99th-percentile cutoff values for these new assays are also lower, leading to higher frequencies of positive test results. When cardiac troponin concentrations are minimally increased, serial testing allows discrimination of myocardial infarction from other causes of increased cardiac troponin. We assessed various measures of short-term variation, including absolute concentration changes, reference change values (RCVs), and indices of individuality (II) for 2 cardiac troponin assays in emergency department (ED) patients. METHODS We collected blood from patients presenting with cardiac chest pain upon arrival in the ED and 2, 6, and 12 h later. Cardiac troponin was measured with the high-sensitivity cardiac troponin T (hs-cTnT) assay (Roche Diagnostics) and a sensitive cTnI assay (Siemens Diagnostics). Cardiac troponin results from 67 patients without acute coronary syndrome or stable angina were used in calculating absolute changes in cardiac troponin, RCVs, and II. RESULTS The 95th percentiles for absolute change in cardiac troponin were 8.3 ng/L for hs-cTnT and 28 ng/L for cTnI. Within-individual and total CVs were 11% and 14% for hs-cTnT and 18% and 21% for cTnI, respectively. RCVs were 38% (hs-cTnT) and 57% (cTnI). The corresponding log-normal RCVs were +46%/-32% for hs-cTnT and +76%/-43% for cTnI. II values were 0.31 (cTnI) and 0.12 (hs-cTnT). CONCLUSIONS The short-term variations and IIs of cardiac troponin were low in ED patients free of ischemic myocardial necrosis. The detection of cardiac troponin variation exceeding reference thresholds can help to identify ED patients with acute myocardial necrosis whereas variation within these limits renders acute coronary syndrome unlikely.

Initial and long-term results of coronary angioplasty and coronary bypass surgery in patients of 75 or older.

OBJECTIVE--To evaluate clinical outcome after percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) in patients of 75 or older who underwent either procedure between 1980 and 1987. SUBJECTS--93 patients aged 75-89 with angina pectoris class III-IV (Canadian Cardiovascular Society) who underwent PTCA and 81 patients aged 75-84 with angina class III-IV who underwent CABG. Follow up was 8.2 years in the PTCA group and 8.3 years in the CABG group. MAIN OUTCOME MEASURES--In-hospital complications and survival at follow up. RESULTS--Primary success rate for PTCA was 84% (78/93). Two patients died, two had emergency CABG, three had a myocardial infarction, and one had a cerebrovascular accident. PTCA failed in seven patients (five underwent elective CABG and two were treated conservatively). Median hospital stay was 4.3 days. Primary success rate for CABG was 63% (53/81). Six patients died, two had a cerebrovascular accident, eight had a myocardial infarction, 10 had a rethoracotomy, and four the adult respiratory distress syndrome. Median hospital stay was 14.2 days. In the PTCA group during follow up eight patients died, three had a non-fatal myocardial infarction, two had elective CABG, 10 had repeat PTCA, and four had recurrence of angina. Sixty four patients were free of angina (69%). In the CABG group during follow up eight patients died, one had a non-fatal myocardial infarction, six had PTCA, and three had recurrence of angina. Fifty seven patients were free of angina AP (70%). Actuarial survival after 10 years was 92% for PTCA and 91% for CABG. CONCLUSIONS--PTCA is safe in elderly patients. The complication rate is lower and hospital stay significantly shorter compared with CABG (p < 0.05). Long-term follow up showed no significant difference between PTCA and CABG.

Rapid Detection of Myocardial Infarction With a Sensitive Troponin Test

Rapid identification and treatment of patients with a myocardial infarction (MI) is mandatory. We studied the diagnostic capacities of a sensitive troponin assay for detection of MI in emergency department patients within 2 hours after arrival. The study included 157 patients suspected of having non-ST-elevation acute coronary syndrome. Blood was drawn on arrival (T0) and 2 (T2), 6, and 12 hours later. At T2, a troponin concentration above the MI cutoff is 87% sensitive and 100% specific for MI detection (positive predictive value [PPV], 100%; negative predictive value [NPV], 96%). If a difference of more than 30% between the troponin measurements at T0 and T2 in the absence of an absolute troponin increase above the 99th percentile of a reference population is also considered indicative of MI, the sensitivity increases to 100% and specificity decreases to 87% (PPV, 70%; NPV, 100%). Sensitivity and specificity of creatine kinase-MB and myoglobin are lower than those of troponin. By using a sensitive troponin assay and simple algorithms, the diagnosis of MI can be determined within 2 hours after arrival at the emergency department. Measurement of myoglobin and creatine kinase-MB has no added value.

Catheter induced spasm in aortocoronary vein grafts.

Catheter induced spasm in venous bypass grafts was observed in two patients. In the first, it resolved 10 minutes after intravenous administration of 100 ,ug glyceryl trinitrate and 0-2 mg nifedipine. The second patient showed what was presumably spasm during angiography, for when the graft was visualised six weeks later, after receiving 10 mg nifedipine and 0 5 mg glyceryl trinitrate sublingually, the narrowed segment seen at the initial examination had disappeared. Our observation that spasm can occur in vein grafts and can be relieved by glyceryl trinitrate and nifedipine may have therapeutic consequences.