Interventional treatment and outcome in elderly patients with stable coronary artery disease. Results from the German ALKK registry.

BACKGROUND: The number of elderly and very elderly patients undergoing percutaneous coronary interventions (PCI) is increasing. We therefore analyzed data from the German ALKK registry (Arbeitsgemeinschaft Leitende Krankenhausärzte; Working Group of Hospital Cardiologists) to determine differences in procedural features, antithrombotic treatment, and in-hospital outcome in patients with coronary artery disease (CAD) according to age in a large series of patients. METHODS AND RESULTS: The present analysis was based on the data of 35,534 consecutive patients undergoing elective PCI who were enrolled in the ALKK registry. Of these 27,145 (76.4 %) were younger than 75 years, 7,645 (21.5 %) were aged between 75 and 84 years, and 744 (2.1 %) patients were older than 85 years. Mean age was 68.5 years (60.9-74.5 years), and 25,784 patients (72.6 %) were male. Overall intraprocedural events were very low (1.1 %) and there was no significant difference between the three age groups [< 75 years (1.1 %); 75-< 85 years (1.2 %); ≥ 85 years (0.5 %) (p = not significant)]. Rates of in-hospital death, stroke and transient ischemic attack (TIA), as well as the combined endpoint in-hospital major adverse cardiac and cerebrovascular events (MACCE) were also very low (0.6 % vs. 0.9 % vs. 0.9 %; p < 0.001) but significantly higher in elderly patients with no further increase in the very elderly patient group. CONCLUSION: We found no differences in this registry in intraprocedural complications during elective PCI between younger and elderly patients. Although in-hospital MACCE were somewhat higher in the elderly, the overall event rate was low and thus elderly patients should not be deprived from this therapy because of age alone.

Impact of coronary artery disease on in-hospital mortality in patients with aortic valve disease. Results from the German ALKK registry.

OBJECTIVE: Although aortic valve disease (AVD) is frequently associated with coronary artery disease (CAD), little is known about the impact of significant coronary artery disease on mortality after diagnostic cardiac catheterization in patients with AVD. METHODS: We analyzed data of the coronary angiography registry of the "Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte" (ALKK) in Germany. The primary endpoint was in-hospital mortality. RESULTS: A total of 1427 consecutive patients with AVD (438 patients with CAD versus 989 patients without CAD) underwent diagnostic catheterization in 2006 in 42 hospitals. All cause in-hospital mortality was more than threefold higher in patients with CAD (16/438; 3.7%) as compared to patients without CAD (12/989; 1.2%; p < 0.01; OR 3.09, 95% CI 1.45-6.58). Even after adjustment for age, sex, presence of diabetes mellitus and renal insufficiency, in-hospital all cause mortality remained statistically significant different between the two groups (OR 2.4; 95% CI 1.09-5.28; p < 0.01). Several factors, such as transient ischemic attack/stroke, volume of contrast agent, and left heart catheter-associated complications could not be identified as possible causes for the increase in mortality. CONCLUSION: This analysis in patients with the leading diagnosis of AVD shows a significantly higher in-hospital mortality after diagnostic cardiac catheterization in case of an accompanying CAD. However, further studies are necessary to identify the driving force for the increase in mortality.

Volume-outcome relation for contemporary percutaneous coronary interventions (PCI) in daily clinical practice: is it limited to high-risk patients? Results from the Registry of Percutaneous Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).

OBJECTIVE: The formerly observed volume-outcome relation for percutaneous coronary interventions (PCIs) has recently been questioned. DESIGN: We analysed data of the PCI registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. PATIENTS: In 2003 a total of 27 965 patients at 67 hospitals were included. RESULTS: The median PCI volume per hospital was 327. In-hospital mortality was 1.85% in hospitals belonging to the lowest PCI volume quartile and 1.21% in the highest quartile (p for trend <0.001). Two groups of patients were then compared according to their treatment at hospitals with either <325 PCIs (n = 5754) or >325 PCIs (n = 22 211) per year. Logistic regression analysis showed that a PCI performed at hospitals with a volume of >325 PCI/year was independently associated with a lower hospital mortality (OR = 0.67, 95% CI: 0.52 to 0.87; p = 0.002). If PCI was performed in patients with acute myocardial infarction there was a significant decline in mortality with increasing volume (p for trend = 0.004); however, there was no association in patients without a myocardial infarction. CONCLUSIONS: This analysis of contemporary PCI in clinical practice shows a small but significant volume-outcome relation for in-hospital mortality. However, this relation was only apparent in high-risk subgroups, such as patients presenting with acute myocardial infarction.

The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.

OBJECTIVE: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. BACKGROUND: The Mynx device is an extra-arterial vascular closure technology utilizing a water-soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. METHODS: The Mynx study was a prospective, multicenter, single-arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (+/-7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. RESULTS: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device-precipitated complications associated with serious clinical sequelae were reported. Mean (+/- standard deviation) times to hemostasis and ambulation were 1.3 +/- 2.3 min and 2.6 +/- 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). CONCLUSIONS: The initial experience with the extra-arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures.

Glycoprotein IIb/IIIa antagonists during carotid artery stenting: results from the carotid artery stenting (CAS) registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

BACKGROUND: Glycoprotein II b/IIIa antagonists (GPII b/IIIa-A) lower the periprocedural rate of ischemic events during high risk percutaneous coronary interventions. Their clinical impact on carotid artery stenting (CAS) remains to be determined. METHODS: We analyzed data from the Carotid Artery Stent (CAS) Registry. RESULTS: From 01/ 2000 to 06/2005 1322 CAS interventions were registered. In 94 (7.1%) procedures a GPII b/IIIa-A was used: abciximab in 8 cases (8.6%), tirofiban in 53 cases (57%) and eptifibatide in 32 cases (34.4%). The use of a GPII b/IIIa-A during CAS decreased significantly over time: from 17.6% in 2000 to 3% in 2005, p for trend <0.0001. The mean use of a GPII b/IIIa-A at the hospitals was 5.2%. More than 50% of the hospitals never used a GPII b/IIIa-A. There were no significant differences in baseline characteristics and concomitant diseases in CAS patients treated with GPII b/IIIa-A compared to those without GPII b/IIIa-A. A bilateral intervention was performed more often in patients treated with GPII b/IIIa-A (2.1 vs 0.2%, p = 0.04), a thrombus was more often visible (27 vs 12.4%, p <0.001) and an ulcer more frequently diagnosed (50 vs 37.5%, p = 0.03). There was no significant difference in the combined death or stroke rate between the two groups (5.3 vs 3.0%, p = 0.22, OR = 1.81, 95% CI: 0.69-4.72), which was confirmed by logistic regression analysis after adjusting for possible confounders (OR = 1.67, 95% CI: 0.62-4.46, p = 0.31). CONCLUSIONS: Our data neither demonstrate a significant benefit nor a significant risk with the use of GPIIb/IIIa-A during CAS. However, only an adequately sized randomized controlled clinical trial could establish the real value of GPII b/IIIa-A during CAS. Until then, considering the potential increase in cerebral hemorrhage, we should not use GPII b/ IIIa-A routinely during CAS.

Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis.

PURPOSE: Carotid artery stent placement may be limited by the embolization of atheromatous material. We evaluated the safety and feasibility of the Medtronic Self-Expanding Carotid Stent (Exponent) in combination with the Medtronic Interceptor Carotid Filter System for the treatment of carotid stenosis among patients at high risk for carotid endarterectomy. METHODS: Patients at high risk for carotid endarterectomy but amenable to percutaneous treatment with stent placement were enrolled. Clinical follow-up was performed at 30 days and 6 and 12 months postprocedure. The National Institutes of Health Stroke Scale was assessed before and within 3 days postprocedure and at 30 days and 6 months postprocedure. Angiography was performed pre- and postprocedure, and carotid duplex scans were performed at baseline and at 30 days and 6 months. RESULTS: Fifty-two carotid procedures were performed in 51 patients (mean age, 69 years; 84% of patients were men). The major adverse event (MAE) rate (death, stroke, and myocardial infarction [MI]) at 30 days was 5.9%: 2 strokes and a single death from periprocedural MI. MAE rates after 6 and 12 months were 5.9% and 11.8%, respectively. The delivery success rate was 94.2% (49/52) for the Interceptor Filter System and 95.9% (47/49) for the Exponent Stent. The mean diameter stenosis of the target lesion was reduced from 62.4% preprocedure to 21.2% postprocedure. CONCLUSION: High delivery success rates were achieved with a low rate of MAE (death, stroke, or MI) in a high-risk population. Treatment of carotid artery disease with the Exponent Carotid Stent combined with distal protection from the Interceptor Filter System is effective and safe.

Carotid artery stenting in clinical practice results from the Carotid Artery Stenting (CAS)-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).

BACKGROUND: Carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis seems to be on the doorstep of more widespread use. However, its feasibility and safety in clinical practice at a broad spectrum of hospitals needs to be determined. METHODS: We analyzed data of the prospective multi-centre Carotid Artery Stenting (CAS) Registry of the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK). RESULTS: From 7/1996 to 5/2004 1888 patients from 28 hospitals were included in the CAS Registry. The median hospital stay from CAS until hospital discharge was 3 days (quartiles: 2-6 days). Median patients age was 70 years (quartiles: 64-76 years) with 72.1% males. CAS for symptomatic stenosis was performed in 55% of cases. Patients treated with CAS suffered from coronary artery disease in 66.5%, had arterial hypertension in 91.7%, hyperlipidemia in 86.3% and 34.2% were diabetics. The intended CAS procedure was completed in 98.1% of cases. A stent was implanted in 97.3% of completed cases. The median intervention time was 43 min (quartiles: 30-60 min). During the hospital stay death rate was 0.3% (5/1888) and the rate of ipsilateral stroke 3.2% (58/1840). A contralateral ischemic event occurred in 1.4% (26/ 1840) of patients. The combined rate of all death or strokes was 3.8% (70/1841). Between 1996 and 2004 there was a steady increase in the use of protection devices during CAS (0% in 1996 and 97.9% in 2004; p for trend <0.0001). There was also an increase in the proportion of patients treated for asymptomatic stenoses (p for trend <0.0001). We observed a decrease of the combined endpoint of death or stroke from 6.3% in 1996 to 1.9% in 2004 (p for trend=0.021). CONCLUSION: The multi-centre ALKK CAS Registry data confirm the feasibility and shot-term safety of CAS even in daily clinical practice. There was a rapid penetration of the use of embolic protection devices, an increase in treatment of asymptomatic carotid stenoses and a decrease in acute complication rates from 1996 to 2004.

The NUGGET study: NIR ultra gold-gilded equivalency trial.

This study should clarify whether the gold-coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08-0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = -24.7 to -9.3) for NIR/NIROYAL. The 6-month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = -7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months.

[Long-term follow-up of patients with acute myocardial infarction treated with primary angioplasty or thrombolysis. Results of the MITRA trial]. / Langzeitverlauf bei Patienten mit akutem Myokardinfarkt, die mittels Primär-Dilatation oder Thrombolyse behandelt wurden. Ergebnisse der MITRA-Studie.

Long-term follow-up after treatment with primary angioplasty compared to treatment with thrombolysis in patients with acute myocardial infarction (AMI) remains still to be determined. We therefore analyzed the data of the "Maximal Individual Therapy" in Acute Myocardial Infarction (MITRA-1) Registry. Follow-up data for a median of 17 months after discharge were available in 2090 out of 2195 (95%) AMI patients treated with thrombolysis, as well as 293 out of 312 patients (94%) treated with primary angioplasty. There were only small differences in patient characteristics between the two treatment groups. Compared to patients treated with thrombolysis, those treated with primary angioplasty had a higher prevalence of prior myocardial infarction (16.4% versus 12.2%, p = 0.04), longer prehospital delay: 10 minutes (130 minutes versus 120 minutes, p = 0.002), and a longer door-to-treatment time: 45 minutes (p < 0.001). Primary angioplasty patients were more likely to be treated with beta-blockers (primary angioplasty 79.8% versus thrombolysis 66.2%, p < 0.001) or statins (24.5% versus 16.5%, p < 0.001). There was no difference between the treatment groups for total mortality (p = 0.90) nor for the combined endpoint of death or re-infarction (p = 0.85). However, the combined endpoint of death, re-infarction or percutaneous coronary intervention or coronary bypass surgery was significantly lower in the primary angioplasty group (primary angioplasty 25.6% versus thrombolysis 32.3%, univariate odds ratio 0.72, 95% CI: 0.55-0.95, p = 0.02). This result was confirmed by multivariate analysis after adjusting for confounding parameters (multivariate odds ratio: 0.62, 95% CI: 0.42-0.91). The beneficial effect of primary angioplasty compared to thrombolysis achieved during the hospital stay after an AMI is maintained during a 17 month follow-up. AMI patients treated with thrombolysis were more likely to be treated with either percutaneous coronary intervention or coronary bypass surgery after discharge.

Determinants of mortality after cardiac surgery: results of the registry of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK) on 10 525 patients.

BACKGROUND: Mortality from cardiac surgery is an essential indicator of quality and forms the basis of treatment strategy decisions in eligible patients. No contemporary complete data on unselected adult cardiac surgery patients are available in Germany. METHODS AND RESULTS: A registry was started in June 1997 of all patients referred to surgery from 85 cardiology centres in Germany. The registry was intended to include 10 000 patients and this number was reached in March 1998. Follow-up of the patients was by simple questionnaire, reporting the date of surgery, major complications, and symptomatic improvement. If the questionnaire was not returned, a reminder letter was sent and, if necessary, further telephone investigations were performed. This resulted in 99.9% complete data. Of 10 525 patients operated on, 3.91% had died by 30 days after surgery. The overall operative mortality was 4.57%, which included 69 patients who died after more than 30 days from complications related to surgery. By multivariate analysis, the following predictors of mortality were identified: previous surgery, emergency or complex operation; age >75 years, female gender, cardiac failure, angina CCS class IV, and three-vessel coronary disease. An integral part of the registry was a pre-operative prediction of surgical risk in five categories. This risk estimate revealed a surprisingly correct prediction of the mortality observed. CONCLUSIONS: In a representative unselected group of cardiac surgery patients, operative mortality was 4.57%. Several procedural and clinical parameters were significantly correlated with mortality, but the risk increment by each of these factors was small. Unstructured clinical judgement reliably predicted the operative risk.

Daytime and nighttime differences in patterns of performance of primary angioplasty in the treatment of patients with acute myocardial infarction. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

BACKGROUND: Concern exists regarding the results of primary angioplasty for acute myocardial infarction when the procedure is performed during night hours. METHODS AND RESULTS: Between June 1994 and January 1997, 491 patients with acute myocardial infarction who underwent primary angioplasty procedures were consecutive registered in the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Three hundred seventy-eight patients (77%) were treated during the day and 113 (23%) at night. Baseline characteristics showed no major differences between the 2 groups. Prehospital delay time was 60 minutes shorter during the night (median value 180 minutes for day, 120 minutes for night, P =.005), and in-hospital time to treatment was 9 minutes longer (median value 85 minutes day, 94 minutes night, P =.037). Patients treated during the night more often received angiotensin-converting enzyme blockers (61.4% day, 76.1% night, P =.004) and the so-called optimal adjunctive therapy (54% day, 64.6% night, P =.045). There were no differences concerning clinical events between the 2 groups. Hospital mortality was 8.7% during the day and 5.3% during the night (univariate analysis P =.238; logistic regression P =.653). CONCLUSIONS: In a clinical setting, primary angioplasty for acute myocardial infarction can be performed safely during the night with a clinically insignificant prolongation of in-hospital time to reperfusion compared with practice during the day.

[30-day mortality after heart surgery: a pilot project of the Working Party of Directors of Hospital Cardiology Departments]. / 30-Tage-Sterblichkeit nach Herzoperation. Ein Modellprojekt der Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte.

BACKGROUND AND OBJECTIVE: 30-day mortality after operation is generally accepted as a central standard of quality, especially in regard to cardiac operations. The Working Party of Directors of Hospital Cardiology Departments (Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte, ALKK) in Germany set up a pilot project to analyse whether by direct communication with patients by a database centre the expenditure incurred in collecting complete data can be decisively reduced and full documentation of outcome can in this way be obtained even for a large multi-centre patient cohort. PATIENTS AND METHODS: Between 1.6.1997 and 31.3.1998, data were consecutively collected by questionnaire on all patients registered for a cardiac operation at 85 of the 135 ALKK centres. The questionnaire included data about each patient and the indication for operation as well as the estimate of operative risk, assigned to one of five risk categories by the referring cardiologist either alone or in conjunction with the cardiac surgeon. RESULTS: Until 30.9.1998, the data were obtained on 11,349 patients who had given informed consent (response rate 99.99%), including survival figures. 824 (7.3%) patients had not undergone the planned cardiac surgery, 134 having died before the data of operation. The 30-day postoperative mortality, obtained in 99.99% of the 10,525 patients, was 3.92%. The operative mortality was lowest, at 3.73%, for aortocoronary bypass only (n = 7932), highest for aortocoronary bypass plus valvular operation (n = 785), at 8.04%. There was good agreement between the cardiologists' preoperative risk assessment and the observed mortality. CONCLUSIONS: The 30-day mortality after cardiac operation can be obtained almost completely and with reasonable expenditure even for a large patient cohort. The results confirm that hospital mortality data definitely understate the overall operative risk. The methodology used in this pilot project, namely the inclusion of information from the patients by questionnaire, can also be applied to clinical results in other areas.

Spectrum of reperfusion strategies and factors influencing the use of primary angioplasty in patients with acute myocardial infarction admitted to hospitals with the facilities to perform primary angioplasty. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

OBJECTIVE: To determine the frequency of the use of primary angioplasty in patients with acute myocardial infarction and the factors influencing its indications in hospitals with the facilities to perform this treatment. DESIGN: Data from the maximal individual therapy in acute myocardial infarction (MITRA) trial were analysed, concerning the effects of the decisions of individual hospitals, the time of admission of patients, and the effects of patient characteristics on the selection of reperfusion treatment. PATIENTS: Between June 1994 and January 1997 eight hospitals treated 1532 patients with acute myocardial infarction. 418 (27.3%) were treated conservatively, 641 (41.8%) were treated using intravenous thrombolysis, 387 (25.3%) were treated using primary angioplasty, and 86 (5.6%) received a combination of thrombolysis and angioplasty. RESULTS: The proportion of patients treated with primary angioplasty varied from 1.8% to 57.7% among the eight hospitals. The use of primary angioplasty during non-office hours also showed wide variation, ranging from 20% to 54% between centres. The use of thrombolysis was comparatively evenly distributed during the non-office hours, ranging from 50-69%. Four hospitals with a primary angioplasty use rate > 30% showed no difference in the proportion of patients with contraindications for thrombolysis, high risk patients, or a combination of both, when compared with four hospitals with a lower rate of primary angioplasty use (98/322 (30.4%) v 19/65 (29. 2%), respectively, p = 0.847). CONCLUSIONS: In hospitals with the facilities for performing primary angioplasty the most important factors influencing its use were the discretion of the individual hospital and the time of patient admission. Characteristics of patients did not influence the choice of reperfusion treatment

[Primary dilatation versus thrombolysis in patients with acute myocardial infarct, not included in randomized studies. Results of the MITRA Study. Maximal Individual Optimized Therapy for Acute Myocardial Infarct]. / Primär-Dilatation versus Thrombolyse bei Patienten mit akutem Myokardinfarkt, die nicht in randomisierte Studien eingeschlossen wurden. Ergebnisse aus der MITRA-Studie. Maximale Individuelle Therapie beim Akuten Myokardinfarkt (MITRA) -Studiengruppe.

There have been some prospective randomized studies which compared primary angioplasty with intravenous thrombolysis in patients with an acute myocardial infarction (AMI). However, a substantial number of patients with AMI who would not have been included in those trials are treated with one of these two therapeutic options. To describe the proportions, characteristics, and outcome of these patients treated with primary angioplasty or thrombolysis we analyzed the data of the prospective "Maximal Individual Optimized Therapy for Acute Myocardial Infarction" (MITRA) trial. Out of 3308 patients treated with primary angioplasty or thrombolysis, 737 (22.3%) belonged to one of the following groups, not included in current randomized trials: Left bundle branch block, non-diagnostic first ECG, pre-hospital delay > 12 hours or unknown pre-hospital delay. Primary angioplasty was performed in 158/737 (21.4%) and thrombolysis received 579/737 (78.6%) of the patients. There were only minor differences regarding patients' characteristics and concomitant diseases between the two groups. Patients treated with primary angioplasty were 3 years younger (62 years median versus 65 years median (p < 0.036). They also more often showed overt heart failure at admission compared to patients treated with thrombolysis (primary angioplasty: 3.2% versus thrombolysis: 8.9%, OR = 0.34, 95% CI: 0.13-0.86). In-hospital time to intervention was 1 1/2 hours longer in patients treated with primary angioplasty (156 minutes median versus 47 minutes median, p = 0.001). beta-blockers were more often used with primary angioplasty compared to thrombolysis (70.31% versus 55.9%; OR = 1.87, 95% CI: 1.28-2.72), as well as ACE inhibitors (62% versus 49.9%; OR = 1.64, 95% CI: 1.14-2.35). Hospital mortality (8.2% versus 16.4%; OR = 0.46, 95% CI: 0.25-0.84), as well as a combined endpoint of death, reinfarction, postinfarction angina, advanced heart failure, and stroke (24.1% versus 42.3%, OR = 0.43, 95% CI: 0.29-0.64) were lower in patients treated with primary angioplasty compared to those treated with thrombolysis. Logistic regression analysis showed primary angioplasty to be independently associated with a lower rate of the combined endpoint (OR = 0.73, 95% CI: 0.59-0.91), after adjusting for confounding parameters. All subgroups showed a more favorable outcome in patients treated with primary angioplasty. In clinical practice, patients with AMI, not included in current randomized trials comparing primary angioplasty with thrombolysis, account for 22% of all patients with AMI treated with one of those two therapies. Primary angioplasty seems to be associated with a lower event rate compared to thrombolysis in these patients. This has to be confirmed by a prospective randomized trial.

Primary percutaneous transluminal coronary angioplasty for acute myocardial infarction in patients not included in randomized studies. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of > 12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates.

Comparison of primary angioplasty with conservative therapy in patients with acute myocardial infarction and contraindications for thrombolytic therapy. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

The benefit of primary angioplasty in patients with acute myocardial infarction (AMI) and contraindications for thrombolysis compared to a conservative regimen is still unclear. Out of 5,869 patients with AMI registered by the MITRA trial, 337 (5.7%) patients had at least one strong contraindication for thrombolytic therapy. Out of these 337 patients 46 (13.6%) were treated with primary angioplasty and 276 (86.4%) were treated conservatively. Patients treated conservatively were older (70 years vs. 60 years; P=0.001), had a higher rate of a history with chronic heart failure (14.8% vs. 4.4%; P=0.053), a higher heart rate at admission (86 beats/min vs. 74 beats/min; P=0.001), and a higher prevalence of diabetes mellitus (27.1% vs. 12.8%; P=0.056). Patients treated with primary angioplasty received more often aspirin (91.3% vs. 74.6%; P=0.012), beta-blockers (60.9% vs. 46.1%; P = 0.062), angiotensin converting enzyme (ACE) inhibitors (71.7% vs. 44%; P=0.001), and the so-called optimal adjunctive medication (54.4% vs. 32.3%; P=0.004). Hospital mortality was significantly lower in patients who received primary angioplasty (univariate: 2.2% vs. 24.7%; P=0.001; multivariate: OR=0.46; P=0.0230). In patients with AMI and contraindications for thrombolytic therapy, primary angioplasty was associated with a significantly lower mortality compared to conservative treatment. Therefore, hospitals without the facilities to perform primary angioplasty should try to refer such patients to centers with the facilities for such a service, if this is possible in an acceptable time.

Differences in patients with acute myocardial infarction treated with primary angioplasty or thrombolytic therapy. Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) Study Group.

BACKGROUND: Little is known about the differences in patients with acute myocardial infarction (AMI) treated with primary angioplasty or intravenous thrombolysis in clinical practice. METHODS: In all, 5,906 patients with AMI were registered by the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study. Of these, 491 (8.3%) patients were treated with primary angioplasty and 2,817 (47.7%) with intravenous thrombolysis. RESULTS: There were only minor differences in baseline characteristics between the two groups. Prehospital delay time (median) was longer in the angioplasty group than in the thrombolysis group (161 vs. 120, p = 0.001), as was door-to-treatment time (88 vs. 30 min; p = 0.001). Patients treated with primary angioplasty more often had contraindications for thrombolytic therapy (12.9 vs. 6%, p = 0.001) and received beta blockers (65 vs. 58.1%, p = 0.004), heparin (98.2 vs. 91.6%, p = 0.001), angiotensin-converting enzyme (ACE) inhibitors (64.8 vs. 50%, p = 0.001) and "optimal" concomitant medication (56.4 vs. 42.9%, p = 0.001) more often. Univariate analysis showed a significant lower incidence of heart failure (5.3 vs. 16.5%, p = 0.001), postinfarct angina (7.3 vs. 16.4%, p = 0.001), in-hospital death (7.9 vs. 11.7%, p = 0.015) and the combined end point (21.6 vs. 40.3%, p = 0.001) in these patients. Stepwise logistic regression analysis revealed optimal concomitant medication [odds ratio (OR) = 0.94, 95% confidence interval (CI): 0.89-0.98) and the type of revascularization (OR = 0.65, 95% CI: 0.58-0.73) to be associated with a significant reduction in the incidence of the combined end point. Similar results were obtained in all predefined subgroups. CONCLUSIONS: In clinical practice, patients treated with primary angioplasty are more often treated with beta blockers and ACE inhibitors than patients treated with intravenous thrombolysis. Thus, the selection of patients and the type of revascularization contributes to the reduction in mortality, overt heart failure, and postinfarct angina in these patients.

Primary angioplasty in acute myocardial infarction: differences between referred patients and those treated in hospitals with on-site facilities?

BACKGROUND: Primary angioplasty for acute myocardial infarction (AMI) can only be performed in a limited number of centers. Therefore, some patients will be referred for this procedure. DESIGN: We analyzed the data of the prospective observational MITRA trial, which took place at 54 hospitals in southwest Germany, to describe current practices and outcomes in referred patients compared to patients treated on-site. RESULTS: Out of 491 patients treated with primary angioplasty, 63 (12.8%) were referred. Out of 46 hospitals without facilities to perform primary angioplasty, 29 (63%) never referred patients. Referred patients were less often male (60.3% versus 75.9%; p = 0.013), suffered more often from anterior wall infarction (62.9% versus 45.8%; p = 0.014), and more often had absolute contraindications against thrombolysis (11.1% versus 2.8%; p = 0.006). In-hospital time to treatment was 80 minutes in patients treated on-site compared to 190 minutes in referred patients (p = 0.001). There was a non-significant difference of in-hospital mortality between the two groups (11.1% for referred versus 7.5% on-site; p = 0.319). Referred patients had a higher hospital morbidity as expressed by a higher proportion of post-infarction angina (28.6% versus 4.2%; p = 0.001), a more frequent need for urgent revascularization (43.8% versus 16.4%; p = 0.001) and a higher proportion of advanced heart failure (11.1% versus 4.4%; p = 0.062). CONCLUSIONS: Referral of patients with AMI for primary angioplasty is used only in a minority of hospitals. The referred patients represent a selected, more ill subgroup, resulting in a higher hospital morbidity compared to patients treated on-site. Continuous efforts should be undertaken to decrease the time delay from admission at the initial hospital to the beginning of revascularization.