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Background: Drug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option., Methods and Results: In the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6 %, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1 year., Conclusion: Data collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

Aim: We aimed at analyzing the safety of concurrent drug eluting stent (DES)/bare metal stent (BMS) placement in the same target segment using the dataset of the German Drug Eluting Stent Registry (DES.DE)., Methods and Results: In DES.DE a total of 5,296 patients either received concurrent BMS/DES (n = 526; 9.9%) or DES/DES stenting (n = 4,770; 90.1%) in the same target segment (5,407 segments). Patient and clinical characteristics were essentially similar in both groups. ACS was a positive adjusted predictor of BMS/DES concurrent stenting (OR 1.52; 95% CI 1.23-1.87) as was age (OR 1.14; 1.04-1.25). Negative predictors were in-stent stenosis (OR 0.49; 0.35-0.68), lesion length >20 mm (OR 0.62; 0.51-0.75), >85% stenosis prior to PCI (OR 0.68; 0.56-0.83) and cardiogenic shock (OR 0.29; 0.09-0.93). The in-hospital mortality in patients receiving BMS/DES concurrent stenting was higher than in those receiving DES/DES placement (OR 2.61; 95% CI 1.05-6.49). At the 12 months follow-up there were no statistical differences with respect to mortality (OR 0.94; 95% CI 0.55-1.61). However, the incidence of recurrent myocardial infarction (OR 1.86; 1.11-3.12) and target vessel revascularization (TVR) (OR 1.37; 1.06-1.76) was borderline to significantly higher in BMS/DES patients. Multivariable predictors of 1-year mortality were age, ACS, cardiogenic shock, renal insufficiency, PAD, heart failure and smoking., Conclusions: Concurrent BMS/DES stenting is associated with an increase in in-hospital but not long-term mortality. Further, there was a significant increase in recurrent myocardial infarction and TVR, but absolute differences were low.

Background: Chronic kidney disease (CKD) has an adverse impact on survival of patients with coronary artery disease and is associated with poor outcomes after percutaneous coronary intervention (PCI). Although small randomized, controlled clinical trials showed a reduced target vessel revascularization rate and a good safety profile for sirolimus-eluting coronary stents (SES), safety data need to be confirmed in clinical practice. Therefore, the data of the German DES.DE registry were evaluated to obtain acute and long-term data of this high-risk subgroup., Methods: The prospective multicenter German DES.DE registry enables to monitor the therapeutic outcome of different drug-eluting stents in the context of the German Health Care System. Baseline clinical and angiographic characteristics as well as one-year-follow-up data were recorded. From October 2005 to October 2006, 6,384 patients were enrolled at 98 DES.DE sites and stratified according to kidney disease progression: normal and impaired renal function and patients under chronic hemodialysis., Results: CKD was associated with several acute and chronic medical conditions and suffer from significantly more cardiac and cerebrovascular events after PCI as compared to patients without CKD. One-year-follow-up showed a significantly increased risk of restenosis and bleeding complications in patients with impaired renal function, especially in hemodialysis patients., Conclusions: Impaired renal function in patients undergoing DES stenting carries an independent risk factor for restenosis and bleeding.

Aims: Treatment of in-stent restenosis (ISR) was historically considered the Achilles heel of percutaneous coronary intervention (PCI) and has been associated with worse clinical outcome than PCI of de novo lesions. However, comparative data on ISR and de novo lesions using drug-eluting stents (DES) are scarce. Therefore, we aimed to assess the impact of ISR on procedural and long-term outcome in patients treated with DES., Methods and Results: We analysed data from 5,144 patients enrolled in the prospective multicentre German Drug-Eluting Stent Registry (DES.DE). The registry included 872 patients (17%) treated for ISR with follow-up data (median 12.4 months) available for 817 patients (94%). Of the ISR patients, 37.1% (n=323) presented with acute coronary syndromes. In total, 1,027 DES were used (528 sirolimus-eluting stents and 499 paclitaxel-eluting stents), with successful implantation in 97.7% of patients. In the ISR cohort, myocardial infarction (MI) during hospitalisation was observed in 1.6% of patients (n=14) and in-hospital mortality was only 0.3% (n=3). Major adverse cardiac and cerebrovascular events (MACCE) rate at follow-up (defined as a composite of death, MI and stroke) was 8.7% (n=71) versus 8.2% (n=325) in patients treated for de novo lesions (p=0.63). Target vessel revascularisation (TVR) rate was 12.7% (n=100), numerically higher than in patients with de novo lesions (10.5%, p=0.07). Ten patients (1.3%) suffered from ARC definite stent thrombosis versus 0.7% observed in patients with de novo lesions (p=0.13). After adjustment for differences in baseline characteristics, TVR rates were statistically higher in the ISR cohort (OR 1.27, 95%CI 1.01-1.61, p=0.04), while MACCE rates remained comparable (OR 1.10, 95%CI 0.83-1.44, p=0.51). The type of stent used (sirolimus vs. paclitaxel-eluting stent) did not impact the rate of MACCE, TVR or definite stent thrombosis at one year., Conclusions: Results from this large prospective multicentre registry confirm that treatment of ISR with DES is effective and safe, with similar procedural outcome but slightly higher revascularisation rates at one year compared to patients treated for de novo lesions, with no differences in outcome between sirolimus- and paclitaxel-eluting stents.

Background: Cigarette smoking strongly increases morbidity and mortality from cardiovascular causes, but the relevance of smoking in patients treated with drug-eluting stents (DES) is unknown., Aims: To assess the impact of smoking on the presentation and outcome of patients treated with DES., Methods and Results: We analyzed data from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE) and identified 1,122 patients who had never smoked and 1,052 patients who were current smokers. Smokers were younger (56.5 vs. 69.4 years, p < 0.0001), more often males, with less frequent diabetes and hypertension compared to non-smokers. Smokers presented more often with acute coronary syndromes. After a mean follow-up of 12.5 months, smokers had both higher mortality (4.6 vs. 2.7%, p < 0.05) and myocardial infarction (MI) rates (4.9 vs. 3%, p < 0.01). There was no significant difference between smokers and non-smokers in the rate of target vessel revascularization (9.8 vs. 11.4%, p = 0.26). Major adverse cardiac and cerebrovascular events (defined as the composite of death, MI and stroke, MACCE) were higher in smokers (10.6 vs. 6.1%, p < 0.001). Moreover, after adjustment for baseline clinical and angiographic variables, smoking continued to be a strong independent predictor for MACCE (OR = 2.34, 95% CI 1.49-3.68). In a subgroup analysis, we found that the increased risk of smoking was most prominent in patients presenting with stable angina pectoris (OR = 3.71, 95% CI 1.24-2.57, p < 0.05). Smoking almost doubled the risk for MACCE in acute MI patients, though this did not reach statistical significance (adjusted OR = 1.91, 95% CI 0.93-3.94, p = 0.74)., Conclusion: This large multicentre DES registry provides evidence that smokers treated with DES, despite lower incidence of predisposing risk factors for atherosclerosis, experience higher rates of death and MI compared to non-smokers, particularly in the setting of stable coronary artery disease. Smoking has only marginal effects on target vessel revascularization rates in patients treated with DES.

Background: Guidelines recommend on-site surgery backup (SB) when elective percutaneous coronary intervention (PCI) is performed. The evidence for this recommendation is however weak., Objectives: The objective of the present study was to compare clinical outcomes in patients undergoing PCI in hospitals with SB or without surgery backup (non-SB)., Methods: Prospective German PCI registry in 36 hospitals throughout Germany. Consecutive procedures were collected and analyzed centrally., Results: In 2006, a total of 23,148 patients were included; 12,465 patients (53.8%) in 11 hospitals with SB and 10,683 patients (46.2%) in 25 hospitals without on-site cardiac SB. Both patient groups were well-balanced with regard to age and gender. SB hospitals had more patients with ACS (OR 1.29; 95%CI 1.23-1.36) and less patients with stable angina (OR 0.78; 95%CI 0.74-0.82) than non-SB hospitals. There was no indication of a clinically relevant differential outcome for in-hospital death, MACE, non-fatal MI, non-fatal stroke/TIA, or emergency CABG between SB and non-SB hospitals for neither patients with ACS nor stable angina except for emergency CABG in ACS patients (more frequent in SB hospitals, OR 2.29; 95%CI 1.02-5.13)., Conclusions: There was no evidence of an excess risk associated with PCI-procedures performed in non-SB hospitals.

Background: Studies continue to identify percutaneous coronary intervention procedural volume both at the institutional level and at the operator level as being strongly correlated with outcome. High-volume centers have been defined as those that perform >400 percutaneous coronary intervention procedures per year. The relationship between drug-eluting stent procedural volume and outcome is unknown. We investigated this relationship in the German Cypher Registry., Methods and Results: The present analysis included 8201 patients treated with sirolimus-eluting stents between April 2002 and September 2005 in 51 centers. Centers that recruited >400 sirolimus-eluting stent patients in this time period were considered high-volume centers; those with 150 to 400 patients were considered intermediate-volume centers; and those with <150 patients were designated as low-volume centers. The primary end point was all death, myocardial infarction, and target-vessel revascularization at 6 months. This end point occurred in 11.3%, 12.1%, and 9.0% of patients in the low-, intermediate-, and high-volume center groups, respectively (P=0.0001). There was no difference between groups in the rate of target-vessel revascularization (P=0.2) or cerebrovascular accidents (P=0.5). The difference in death/myocardial infarction remained significant after adjustment for baseline factors (odds ratio 1.85, 95% confidence interval 1.31 to 2.59, P<0.001 for low-volume centers; odds ratio 1.69, 95% confidence interval 1.29 to 2.21, P<0.001 for intermediate-volume centers). Patient and lesion selection, procedural features, and postprocedural medications differed significantly between groups., Conclusions: The volume of sirolimus-eluting stent procedures performed on an institutional level was inversely related to death and myocardial infarction but not to target-vessel revascularization at 6-month follow-up. Safety issues are better considered in high-volume centers. These findings have important public health policy implications.

Aims: We sought to evaluate the in-hospital fate of patients with ST segment elevation myocardial infarction (STEMI) diagnosed already in the prehospital phase by physican equipped ambulances., Methods: A total of 2326 consecutive STEMI patients were included in PREMIR. For this analysis 218 patients with prehospital cardiopulmonary resuscitation were excluded., Results: The median time between symptom onset and 12-lead ECG was 85 min. The median time intervals between the diagnostic 12-lead ECG and prehospital fibrinolysis were 10 min, until inhospital fibrinolysis 52 min and until primar PCI 86min, respectively. Reperfusion therapy with prehospital fibrinolysis (24%), inhospital fibrinolysis (13%) or primary PCI (45%) was performed in 82% of the patients. Inhospital mortality was 6.0% in patients with prehospital fibrinolysis (n = 504), 5.8% in patients with inhospital fibrinolysis (n = 278), 4.5% in patients with primary percutaneous coronary intervention (n = 962) and 16.2% in patients without early reperfusion therapy (n = 377), respectively. In the multivariate propensity score analysis comparing prehospital fibrinolysis and primary PCI we observed no significant difference in the odds for in-hospital mortality (odds ratio: 1.57, 95% CI: 0.94-2.63). The final discharge diagnosis was STEMI in 90% of the patients, in patients with prehospital fibrinolysis 95%., Conclusions: In patients with STEMI already diagnosed in the prehospital phase the ischemic time is short, accuracy of the diagnosis is high and reperfusion therapy is performed in over 82%. Inhospital mortality was not different between prehospital fibrinolysis and primary PCI.

Background and Purpose: : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005., Methods: : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained., Results: : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3)., Conclusion: : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

Objectives: We assessed the effectiveness and safety of the sirolimus-eluting stent (SES) in the treatment of chronic total coronary occlusions., Background: Chronic total occlusions (CTO) of coronary vessels have an unacceptable high restenosis rate of approximately 50% after stenting. Few data exist about the performance of drug eluting stents (DES) in the treatment of CTO., Methods: All coronary interventions using the Cypher stent performed at 122 centers engaged in the German Cypher registry between April 2002 and December 2004 were analyzed; a total of 5,344 patients; 374 with and 4,970 without CTO were compared., Results: There was no significant difference between both groups regarding demographics, coronary status and left ventricular function. Patients in the CTO group had a higher level of angina symptoms, the coronary lesions were more complex and the stents used were smaller and longer than in the No-CTO group. The In-hospital outcome was similar in both groups, with importantly no difference regarding mortality and complications. Stenting was as successful in the CTO as in the No-CTO group; during a follow-up of 6.6 months we found no significant difference regarding the rate of mortality, complications, and revascularization between both groups., Conclusions: Implantation of the Cypher stent reduces the restenosis rate and seems to be a safe and effective tool for the treatment of chronic total coronary occlusions.

Background: Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary., Methods and Results: 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS)., Conclusion: The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

Background: Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery., Objective: To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry., Setting and Patients: The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point., Results: One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2)., Conclusion: Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.

Background: Patients older than 75 years undergoing percutaneous coronary interventions are at increased risk for major adverse cardiac events strongly influenced by comorbidities. In various randomized trials, sirolimus-eluting stent (SES) implantation has been shown to decrease the incidence of in-stent restenosis and to reduce repeat revascularization regardless of patient age., Methods: The present study evaluates the outcome after SES implantation in 954 patients older than 75 years compared with 5801 patients younger than 75 years enrolled in the German Cypher Registry in a routine clinical setting., Results: The elderly were at higher risk regarding renal failure, diabetes, hypertension, impaired left ventricular function, and 3-vessel disease. The SES implantation resulted in an impressive relief of angina. As expected, in-hospital and 6-month mortality rates were higher in the elderly. However, there was no difference with respect to the rate of major adverse cardiac events (death, myocardial infarction, ischemia-driven target vessel revascularization) at 6-month follow-up., Conclusions: Nonfatal complications such as myocardial infarction or repeat target vessel revascularization did not increase with age, even taking patients older than 80 years into account.

Background: Drugeluting coronary stents (DES) are increasingly used during percutaneous coronary interventions (PCI). Due to limited budgets in Germany, no special reimbursement has been given for their use and therefore they were mainly used in selected patients., Methods: In order to determine the change in indications in patients treated with a Sirolimus-eluting stent (SES) in daily clinical practice between 2002 and 2005, we analysed data from a prospective multi-centre DES registry, the German Cypher Stent Registry., Results: From April 2002 until September 2005, 11 507 patients at 132 hospitals, who received at least one SES during their PCI, were included. Between 2002 and 2005, the median age of patients increased from 63 years to 66 years (p for trend <0.0001), whereas the prevalence of prior coronary bypass surgery (p<0.0001) and prior PCI (p<0.001) significantly decreased. Initial presentation of patients was stable over time, with a small increase of patients treated for non-ST elevation myocardial infarction (p=0.05). We found a significant increase in the treatment of complex stenoses (p<0.0001) as well as an increase in the proportion of chronic total occlusions (p<0.01). There was a steady increase in the proportion of patients treated for de novo lesions (p<0.0001), which was accompanied by a relative decrease in the proportion of patients treated for in-stent restenosis (p<0.0001). Concerning interventional characteristics a significant increase in the length of SES implanted per lesion, the numbers of SES implanted per lesion as well as an increase of the proportion of patients treated for more than one stenosis during one intervention could be observed (all p<0.0001). There was a significant decrease in the use of glycoprotein II b/IIIa antagonists during the PCI (2002: 26.5 to 14.2% in 2005, p<0.0001). MACE rates until hospital discharge did not change significantly over time., Conclusions: Between 2002 and 2005 there were two trends in the use of SES: a) a significant increase in the use of SES for de novo lesions and b) a significant trend to use SES for longer lesions, smaller arteries, more complex lesions and more SES per lesion. In summary these findings indicate that still SES are mainly used in patients with lesions that are at high risk for restenosis.

Background: Involvement of the proximal LAD is considered an indication for coronary artery bypass graft (CABG) surgery due to the high restenosis rates associated with this location after percutaneous coronary interventions (PCI). This seems to be different, however, when using sirolimus-eluting stents, a finding if proven to be true could have a major impact on clinical decision making regarding the optimal revascularization strategy for these patients., Methods: We analyzed 2274 patients treated for proximal LAD stenoses using SES from the German Cypher Stent Registry. The incidence of TVR and other major clinical adverse events were determined and independent predictors of TVR were specified using a multiple logistic regression model., Results: Event-free survival was achieved in 89.5% of patients. TVR was performed in 179 patients (7.9%) and the combined incidence of all cause death, myocardial infarction and TVR was 10.5% (231 patients). Independent predictors of TVR were multivessel disease (OR 1.74, 95% CI 1.16-2.62, p = 0.008), stent diameter < or = 2.75 mm (OR 1.61, 95% CI 1.10-2.40, p = 0.02) and the administration of GP IIb/ IIIa antagonists (OR 1.60, 95% CI 1.05-2.60, p = 0.03). TVR rate was as high as 11.2% for 2.5 mm SES and as low as 4.0% for 3.5 mm SES (p < 0.001 for trend test)., Conclusion: TVR among patients treated with SES for proximal LAD stenoses is low and is related in part to operator dependent factors. Treatment with SES should be considered as an effective treatment for these patients.

Objective: To determine the predictors of time between presentation and primary angioplasty and the influence of this delay time on in-hospital mortality in clinical practice., Design: Analysis of data from the registry of percutaneous coronary interventions in acute myocardial infarction of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK)., Patients: Data of 4815 patients registered at 80 hospitals between 1994 and 2000 were analysed., Results: Mean age of the patients was 61.4 (12.5) years. Cardiogenic shock was present in 14.1%. Mean time from admission to primary angioplasty ("door to angiography" time) was 83 (122) minutes. Logistic regression analysis showed the presence of a bundle branch block (odds ratio (OR) 1.95, 95% confidence interval (CI) 1.15 to 3.29), prior coronary artery bypass grafting (OR 1.67, 95% CI 1.08 to 2.59), pre-hospital delay > 3 hours (OR 1.61, 95% CI 1.37 to 1.89), and female sex (OR 1.21, 95% CI 1.01 to 1.45) to be independently associated with longer door to angiography times, whereas a higher hospital volume of performing primary angioplasty (OR 0.53, 95% CI 0.46 to 0.62) and the year of the investigation (OR 0.96, 95% CI 0.92 to 1.00) were independently associated with shorter door to angiography times. Independent predictors of in-hospital mortality were cardiogenic shock (41.6% v 4.0% without cardiogenic shock, p < 0.0001), technical success (29.2% with TIMI (thrombolysis in myocardial infarction) flow < 3 v 6.5% with TIMI flow 3, p < 0.0001), age (16.5% > or = 70 years v 6.6% < 70, p < 0.0001), three vessel disease (16.5% v 6.8% with < 3 vessel disease, p < 0.0001), anterior location of infarction (12% v 7.4% without anterior infarction, p < 0.0001), year of inclusion (adjusted OR 0.92 per year, p = 0.011), and volume of primary angioplasty at the hospital (11% for < 20 angioplasty procedures/year v 8.3% for > or = 20/year, p = 0.027) but not the door to angiography time (adjusted OR 1.14 per tertile, p = 0.397)., Conclusions: In current clinical practice in Germany median door to angiography time is quite short (83 (122) minutes). Some patients and hospital factors are independently associated with a longer door to angiography time. Within the observed short in-hospital delays door to angiography time did not influence in-hospital mortality. However, efforts to keep them as short as possible should be continued.

Randomized trials have demonstrated the ability of drug-eluting stents to decrease the risk of restenosis after coronary stent implantation. However, the incidences of major cardiovascular/cerebral adverse events (MACCEs) and target vessel revascularization (TVR) during follow-up in a routine clinical setting remain to be determined. We analyzed data of the multicenter German Cypher Stent Registry. From April 2002 to March 2003, 1,726 patients at 93 hospitals who received >/=1 sirolimus-eluting coronary stent were included. Median follow-up was 6.7 months. During follow-up, death occurred in 1.2% of patients (20 of 1,726), nonfatal myocardial infarction in 2.5% (43 of 1,706), and nonfatal stroke in 0.5% (7 of 1,469). TVR was performed in 8.6% of patients, with percutaneous coronary intervention in 7.3% and coronary artery bypass grafting in 1.5%. The overall rate of MACCEs or TVR was 10.8% (186 of 1,726). Independent predictors of TVR were the target vessel being a bypass graft (odds ratio [OR] 2.43, 95% confidence interval [CI] 1.41 to 4.18, p = 0.001), management of >1 lesion during the same intervention (OR 1.75, 95% CI 1.04 to 2.96, p = 0.035), 2- or 3-vessel disease (OR 1.69, 95% CI 1.05 to 2.72, p = 0.030), and age (per decade; OR 0.82, 95% CI 0.69 to 0.98, p = 0.025). These data confirm the safety and effectiveness of using the sirolimus-eluting stent in daily clinical practice. The management of bypass grafts and multiple lesions in 1 session and the presence of multivessel disease were predictors of MACCEs or TVR.

Background: The ALKK registry contains about 20% of the invasive and interventional cardiological procedures performed in Germany., Methods: In 2003 a total of 82,282 consecutive diagnostic invasive and 30,689 interventional procedures from 75 hospitals were centrally collected and analyzed., Results: The main indication for an invasive diagnostic procedure was coronary artery disease in 92.5% of cases, myocardial disease in 1.6%, impaired left ventricular function in 4.0%, valve disease in 4% and other indications in 1.9%. An acute coronary syndrome was present in 25% of the patients. The rate of severe complications in patients with a lone diagnostic invasive procedure was low (<0.5%). The indication for percutaneous coronary intervention (n=30,689) was stable angina in 44.1%, ST elevation myocardial infarction in 22.3%, non ST elevation myocardial infarction in 14.8%, unstable angina in 10.0%, silent ischemia in 2.2%, prognostic in 5.2% of patients. The majority of interventions were performed directly after the diagnostic procedure (n=23,887=78.6%). The intervention was successful in 94.6% of cases. Stent implantation was performed in 77.2%, with 1 stent in 88.4%, two stents in 7.6% and 3 or more stents in 3.3%. A drug-eluting stent was implanted in 3.6% of the cases. The complication rate after PCI was influenced by the indication for the intervention. The in-hospital mortality in patients with cardiogenic shock was 33%, while in patients with stable angina, silent ischemia and prognostic indication only 0.2% died., Conclusion: There is an increase of invasive diagnostic and interventional procedures in patients with acute coronary syndromes, with 47% of PCIs performed in these patient. PCIs were performed in 75% of the cases directly after the diagnostic procedure. The rate of stent implantation seems to have reached a plateau at around 80%, while drug-eluting stents were implanted only in a minority of cases. The complication rate is mainly dependent on the clinical presentation of the patients and the indication for PCI.

Background: Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs., Methods: The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002., Results: From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs., Conclusion: In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.

Aims Acute myocardial infarction complicated by cardiogenic shock is associated with an exceedingly high mortality, even if patients are treated with early reperfusion therapy. The aim of this study was to evaluate predictors of in-hospital mortality of a large cohort of consecutive patients with cardiogenic shock treated with primary percutaneous coronary intervention (PCI). Methods and results Between July 1994 and March 2001 all interventions performed in 80 centres in Germany were prospectively entered into the primary PCI registry of the ALKK. A total of 9422 procedures were registered, of these 1333 (14.2%) were performed in patients with cardiogenic shock. Total in-hospital mortality was 46.1% and was dependent on TIMI flow grade after PCI, with mortality rates of 78.2%, 66.1% and 37.4% in patients with TIMI 0/1, TIMI 2 and TIMI 3 flow, respectively. In a multivariate analysis left main disease, TIMI <3 flow after PCI, older age, three-vessel disease and longer time-intervals between symptom onset and PCI were significant independent predictors of mortality. The relative number of PCIs performed in patients with cardiogenic shock did not change significantly from 1995-2000. There was a significant decrease in mortality over the years (P for trend 0.02). Conclusions In-hospital mortality in patients with acute myocardial infarction complicated by cardiogenic shock remains high, even with early interventional therapy. However, our data demonstrate that the PCI in these high-risk patients is feasible in a wide spectrum of community hospitals with acceptable success rates. Our results seen in connection with the results of the randomized SHOCK study advocate an early invasive approach in younger patients with cardiogenic shock, while the best strategy in elderly patients is still a matter of debate.

Objective: Patients with acute myocardial infarction complicated by cardiogenic shock have a high mortality despite the use of early reperfusion therapies with thrombolysis or percutaneous coronary intervention (PCI). Therefore, there is still need to evaluate therapy strategies in these patients., Design: The REO-SHOCK trial was a prospective, non-randomized study, aimed at evaluation of a routine strategy of early abciximab and PCI in a high-risk group of acute ST elevation myocardial infarction (STEMI) patients with cardiogenic shock., Results: Patients (n = 40) planned for coronary angioplasty or stenting received abciximab (0.25 mg/kg bolus followed by 0.125 mg/kg/minute over 12 hours), heparin and aspirin. The intervention was successful in 92.5% of the patients and achieved Thrombolysis In Myocardial Infarction (TIMI) grade 3 patency in 32 patients (80%). The primary endpoint, total mortality after 30 days, was observed in 42.5% (17/40), and was significantly different between patients aged > 75 years and patients aged 75 years (91% versus 24%, respectively; p < 0.001). Major bleeding occurred in 2 patients (5%), but stroke occurred in none., Conclusion: A strategy of abciximab with primary PCI in high-risk patients with cardiogenic shock is safe, associated with a high procedural success rate and seems to improve outcomes in patients < 75 years old.

Objective: To compare in a randomised trial the procedural and clinical outcome and long term patency of conventional angioplasty with optional stent implantation versus direct stenting without predilatation., Methods: Patients undergoing coronary intervention for symptomatic coronary artery disease were randomly assigned to conventional angioplasty with optional stenting or to direct stent implantation without predilatation. The post-stent treatment consisted of antiplatelets. Follow up angiography was performed six months after the initial procedure., Results: Between December 1998 and August 1999, 181 of 190 eligible patients were randomly assigned to either optional stenting (n = 92) or direct stenting (n = 89). The procedural success was similar in both groups (87 (97.8%) in the optional v 87 (94.6%) in direct stenting group, p = 0.88). There were five cases of crossover from the direct stenting to the optional stenting group. Six patients experienced a Q wave myocardial infarction without further complications (4 in the optional v 2 in the direct stenting group, p = 0.36). One patient in whom coronary angioplasty failed underwent elective bypass surgery. No patients required urgent bypass surgery and no patients died. The reduction in late luminal loss (mean (SD) 1.19 (0.87) mm in the optional v 0.62 (0.69) mm in the direct stenting group, p = 0.004) led to a significant improvement in minimal luminal diameter at follow up (1.87 (0.93) mm in the optional v 2.56 (0.86) mm in the direct stenting group, p = 0.002), resulting in a significant reduction in restenosis rate, defined as > 50% diameter stenosis at follow up 6.5 (2.1) months after the initial procedure (28 (30.4%) in the optional v 14 (15.7%) in the direct stenting group, p = 0.019). Direct stenting significantly reduced the overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angioplasty catheters needed. The incidence of clinical events during the six month follow up did not differ significantly between the groups. No patient died during follow up., Conclusions: Direct stent implantation without predilatation significantly reduced late luminal loss, giving a better improvement in minimal luminal diameter and restenosis rate than with optional stenting. There were five patients in whom direct stenting failed who needed predilatation followed by stent implantation. However, in most patients direct stent implantation without predilatation is a feasible treatment option with a favourable long term outcome and a low incidence of complication. The procedure may help to reduce the cost of coronary interventions by reducing overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angiography catheters needed.

Background: Coronary artery stents are used for the treatment of acute or threatening vessel occlusion complicating coronary angioplasty or for prevention of restenosis after angioplasty. The current randomized trial compared the procedural outcome and long-term patency of 2 different flexible stents in unselected lesion morphology., Methods: The study population consisted of consecutive patients undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure stent implantation. The poststent treatment consisted of antiplatelet therapy. The primary hypothesis was an assumed restenosis rate of 30% in the group receiving NIR stents (Boston Scientific Europe SPRL, Parc Industriel de Petit-Rechain, Belgium) and a reduction of the restenosis rate (defined as >50% vessel diameter at follow-up) by 50% in the group undergoing J&J Crown stent (Cordis, Johnson & Johnson Interventional Systems, Warren, NJ) implantation: the restenosis rate and minimal luminal diameter at follow-up. Follow-up angiography was performed 6 months after the initial procedure., Results: A total of 203 patients were randomized to receive either the J&J Crown stent (n = 103) or the NIR stent (n = 100). The procedural success was similar in both groups (96.1% vs 99% in the NIR stent group, respectively; P =.19). There were 4 cases of crossover from the J&J Crown to the NIR stent group. In one patient, stent implantation of either stent model did not succeed. One patient died from fulminant pulmonary embolism. Restenosis, defined as >50% diameter stenosis at follow-up 5.8 +/- 1.3 months after the initial procedure occurred in 19 patients (18.4%) in the J&J Crown stent group compared with 22 patients (22.0%) in the NIR stent group (P =.42). There was a significantly higher rate of crossover from the J&J Crown stent to the NIR stent (3.9% vs 0%, respectively, P =.047), whereas reverse crossover did not occur. The one lesion in which NIR stent implantation was not successful had an extremely tortuous proximal part. This patient underwent only balloon angioplasty. Clinical events were rare during 6 months of follow-up and the incidence did not differ between both groups (nonfatal myocardial infarction: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32; all-cause mortality: J&J Crown stent 1.0% vs 0% in the NIR stent group, P =.32)., Conclusions: There were no significant angiographic and clinical differences between the J&J Crown and NIR stents. Both stents had a similar procedural success rate, although the implantation of NIR stents was successful even in vessels in which previous attempts at J&J Crown stent placement had failed.

Background: Coronary stenting was initially designed to treat a bailout scenario. Prospective randomized trials comparing stent implantation with standard techniques, including emergency coronary artery bypass grafting, are lacking. The aim of this trial was to test the superiority of immediate stent implantation compared with standard techniques for the treatment of abrupt or threatening closure after coronary balloon angioplasty., Methods: In a prospective trial, 100 patients with abrupt vessel closure or symptomatic dissections causing objective signs of ischemia were randomly assigned to treatment with immediate placement of stents (n = 51) versus standard techniques such as prolonged dilatation or emergency bypass surgery (n = 49). The primary end point was the achievement of successful stabilization not requiring crossover to the other study group. Secondary end points included event-free survival and restenosis., Results: Successful stabilization was achieved in 94% of patients in the stent group compared with 78% of patients in the standard treatment group (P =.038). Two patients died in each group, and there was a trend toward a higher incidence of myocardial infarction (16% vs 8%; P =.163) and a significantly increased creatine phosphokinase level (245 IU/L [95% confidence interval, 217-265 IU/L] vs 179 IU/L [confidence interval 140-212 IU/L]; P =.0002) in the standard treatment group. Event-free survival after 250 days was 72% in the stent group compared with 29% in the standard treatment group (P =.001). The angiographic restenosis rate was 30% in the stent group versus 59% in the standard treatment group (P =.01)., Conclusions: Immediate stenting, if technically feasible, shows superior short- and long-term results compared with standard treatment options.

In cases with protected left main stenosis by previous bypass surgery or as an emergency intervention in patients presenting with acute myocardial infarction and cardiogenic shock, percutaneous transluminal coronary angioplasty is performed as an alternative treatment strategy to bypass surgery. A review of 262 left main angioplasties revealed a procedure-related mortality in cases without protection of the left main coronary artery of 9.1% (4/44), in cases with partially protected left main stenosis by collaterals to either left coronary artery of 4.8% (1/21) and 0.5% (1/187) in cases with nonobstructed bypass grafts to either left coronary artery. Coronary angioplasty of an unprotected left main coronary artery, had an unacceptably high procedure-related mortality rate and should therefore not be performed even in cases of emergency intervention. The risk stratification of the procedure can be evaluated by the proposed grading of left main artery protection.

We investigated a possible correlation between the serologic status concerning Cytomegalovirus (CMV), Chlamydia pneumoniae (CP) and Helicobacter pylori (HP) and the occurrence of restenosis in patients undergoing percutaneous transluminal coronary angioplasty for symptomatic coronary artery disease. Tests for anti-CMV IgG, anti-Chlamydia pneumoniae IgG and IgA and HP IgG and IgA were performed with an enzyme-linked immunosorbent assay (ELISA). Restenosis was defined as >/=50% stenosis at follow-up angiography in a vessel with less than 50% stenosis immediately after PTCA. Of 148 patients, 112 (75.7%) were seropositive for CMV, 75 (50.7%) were seropositive for CP and 78 (52.7%) were seropositive for HP. Restenosis occured in 31.8% of patients. CMV seropositivity was established in 74.5% of patients with restenosis versus 76.2% without restenosis (P=0.82), CP seropositivity was established in 44. 7% of patients with restenosis versus 53.5% without restenosis (P=0. 32), HP seropositivity was established in 53.2% of patients with restenosis versus 52.5% without restenosis (P=0.94). In contrast to some earlier studies CMV or HP seropositivity could not be found to be associated with the risk of restenosis after coronary intervention. An association between the serological status of CP and restenosis could also not be established.

The mortality of perioperative myocardial infarction is still high and according to recently published data amounts to 17 to 42%. In the seventies introduction of thrombolytic therapy has led to a dramatic reduction in mortality of non-perioperative myocardial infarction. However, in the perioperative situation thrombolytic therapy remains to be problematic in most cases because of expected severe bleeding complications. In the last 4-6 years acute-PTCA has been established in the therapy of acute myocardial infarction. Up to date no data are available concerning the effect of acute-PTCA on mortality of perioperative myocardial infarction. Nevertheless it can be assumed, that acute-PTCA will lead to a considerable reduction in mortality of perioperative myocardial infarction. Therefore, in patients with significant perioperative myocardial infarction immediate coronary angiography and, if indicated, acute-PTCA should be performed. In principle, thrombolytic therapy is considered to be contraindicated in the intra- or postoperative situation. However, if coronary angiography and PTCA are not possible, thrombolysis might be taken into consideration, in particular if the expected bleeding complications are small in relation to the expected benefit of thrombolysis. Since acute-PTCA has been shown to remarkably reduce mortality in patients with cardiogenic shock after acute myocardial infarction, this group of patients should be especially considered.

Background: Coronary artery stents are used for the treatment of acute or threatened vessel occlusion complicating coronary angioplasty or for the prevention of restenosis after angioplasty. Improvements in stent design made the stenting of complex and small vessels feasible. We prospectively evaluated the safety, efficacy and long-term patency of NIR stent (Boston Scientific, Maple Grove, Minnesota) implantation in small vessels with complex lesion morphology., Methods: The study population consisted of patients with complex (type OCO) lesions under 3 mm vessel diameter who were undergoing coronary angioplasty for symptomatic coronary artery disease followed by high-pressure NIR stent implantation and antiplatelet therapy only. Follow-up angiography was performed six months after the initial procedure., Results: Of 143 patients fulfilling the angiographic criteria and undergoing stent implantation between October 1995 and November 1997, 67 patients (46.9%) received NIR stents. In 58 patients (86.6%), angiographic 6-month follow-up was available. In one patient (1.7%), stent implantation was unsuccessful. Procedural success of the NIR stent implantation was 98.2%. Implantation of other stents failed in 12 cases. NIR stent implantation was successful in all of them. No patient required urgent bypass surgery. No patient died. Restenosis occurred 5.8 +/- 1.3 months after the initial procedure in 21 patients (36.2%)., Conclusions: Coronary high-pressure stenting of small (< 3 mm) type OCO (AHA/ACC) lesions in patients with symptomatic coronary heart disease is a feasible treatment option with a high procedural success rate and low complication rate. The new flexible NIR stent showed an acceptable restenosis rate. The implantation was successful even in vessels in which previous attempts of Palmaz-Schatz stent placement had failed.

Background: The VERAS study (VErringerung der Restenoserate nach Angioplastie durch ein Somatostatin-analogon [Prevention of Restenosis Following Angioplasty With a Somatostatin Analogue]) was a placebo-controlled trial to evaluate the effects of octreotide for the prevention of restenosis after coronary angioplasty. Octreotide is a somatostatin analogue with antiproliferative properties on smooth muscle cell growth in vitro that limits myointimal thickening of arteries in balloon injury models., Methods and Results: Patients received either octreotide or placebo, starting 1 hour before angioplasty and continued for 3 weeks. The minimal luminal diameters before and after angioplasty and at 6-month follow-up were analyzed with a digital quantitative algorithm. Of the initial 274 patients recruited, 217 (108 in the octreotide group and 109 in the placebo group) could be analyzed after a complete 6-month evaluation: the minimal luminal diameters were 1.67+/-0.57 mm in the octreotide-treated group and 1.66+/-0.64 mm in the placebo group (two-paired P=.70), and the relative losses were 0.16+/-0.22 and 0.13+/-0.21 (two-paired P=.27). The restenosis rates were also identical in both treatment groups: final diameter stenosis > or =50% (34.3% versus 33.9%, two-paired P=1.0), loss of > or =50% of the initial gain (34.3% versus 33.9%, two-paired P=1.0), and absolute reduction of minimal luminal diameter >0.72 mm (29.6% versus 24.8%, two-paired P=.45). Likewise, there was no difference with regard to the incidence of clinical events (death, myocardial infarction, bypass operations, reintervention). Octreotide was well tolerated, with the exception of gastrointestinal side effects, which were three times more common than in the placebo group., Conclusions: Octreotide did not reduce the angiographically determined restenosis rate or the incidence of major clinical events after coronary angioplasty.

Objectives: This study was designed to evaluate how elective percutaneous transluminal coronary angioplasty of the infarct-related vessel after acute myocardial infarction affects global ejection fraction and regional wall function., Background: The severity of the residual stenosis of the infarct-related artery after thrombolysis is an important predictor of changes in left ventricular function; however, the optimal time to restore complete perfusion in the infarct area has not been determined., Methods: We prospectively evaluated patients with a first myocardial infarction, postinfarction ischemia and residual high grade stenosis with reduced flow in the infarct-related artery who underwent successful coronary angioplasty. The group comprised 74 patients (61 men, 13 women with a mean age +/- SD of 55.9 +/- 9.9 years). Global ejection fraction and infarct region function (expressed as area ejection fraction) were angiographically measured before coronary angioplasty (3.9 +/- 2.1 weeks after infarction) and on routine follow-up study 6 +/- 1 months after angioplasty., Results: Restenosis with reduced flow occurred in 15 patients (20%). The global ejection fraction in patients with complete flow at follow-up increased significantly from 56.8% +/- 12% to 62.3% +/- 12.5% (p < 0.001). Regional wall motion of the infarct area increased from 12.1% to 22.5% (p = 0.001) in patients with anterior wall infarction and from 20.4% to 28.5% (p = 0.002) in those with inferior wall infarction. In patients with restenosis there was no difference at follow-up either in global ejection fraction (from 47.7% +/- 7.7% to 47.1% +/- 12.7%, p = 0.57) or in regional wall motion of the infarct area., Conclusions: Global and regional myocardial dysfunction due to postinfarction ischemia lessens significantly after successful coronary angioplasty of the infarct-related coronary artery with long-term sustained normal, complete flow. In contrast, restenosis with reduced flow prevents long-term improvement of left ventricular function.

The development of percutaneous wire-guided endoprostheses (stents) has expanded the possibilities for treating acute vascular occlusion within the field of coronary angioplasty (PTCA). A balloon-expandable Palmaz-Schatz stent was implanted in a total of 14 patients. The coronary arteries involved were the right coronary artery (seven cases), the anterior interventricular branch (five cases), and the circumflex branch (two cases). In seven cases the stent was inserted on an emergency basis to deal with treatening occlusion during PTCA, in one case of occlusion following coronary angiography, and in three cases to recanalize the infarcted vessel. Seven of these eleven patients were submitted to a follow-up angiography three months later, when none was shown to have a restenosis of more than 50%. Stent placement was followed by anticoagulation therapy comprising coumarin combined with acetylsalicylic acid. The Palmaz-Schatz stent represents an alternative to emergency bypass surgery in the treatment of acute dissection during PTCA.

According to several reports of close correlations between pulmonary artery pressure and ANF plasma levels it would be convenient to replace invasive pressure monitoring by ANF determination. Mean pulmonary artery and right atrial pressures and pulmonary artery as well as peripheral venous ANF plasma concentrations were measured in 24 patients before and after coronary angioplasty (PTCA) continuously at rest and during exercise: At rest, both pressure and ANF-values remained unchanged before and after PTCA. At exercise, there was a decrease of mean pulmonary artery pressure (from 41.3 +/- 8.6 to 31.5 +/- 7.4 mmHg, p less than 0.001), mean right atrial pressure (from 11.9 +/- 3.0 to 9.0 +/- 2.3 mmHg, p less than 0.001), pulmonary artery (282.5 +/- 191.0 to 207.3 +/- 157.2 pg/ml, p less than 0.05) and peripheral venous (112.7 +/- 48.0 to 97.1 +/- 53.2 pg/ml, n.s.) ANF concentration after PTCA. We found no correlation between PTCA-induced changes of right arterial pressures and ANF concentrations, while changes of pulmonary artery pressures were significantly correlated to changes of peripheral venous (r = 0.79, p less than 0.001) as well as pulmonary artery (r = 0.59, p less than 0.01) ANF concentrations at exercise. In 6 of the 24 patients, however there was an inverse relationship between changes of pulmonary artery pressures and ANF concentrations. - Our data demonstrate a significant correlation between changes of ANF plasma level and pulmonary artery pressure values at exercise after PTCA. In the individual case however invasive pressure monitoring cannot be replaced by determination of ANF plasma levels.

Both increasing frequency and technical improvements of percutaneous transluminal coronary angioplasty (PTCA) have focussed attention on possible applications of PTCA in elderly patients with coronary artery disease. From January 1986 to June 1989, among 1872 patients treated with PTCA in our hospital, 42 patients (2.3%) were 75 or more years old. Of these patients, 14 presented with unstable angina, 28 patients suffered from acute myocardial infarction. PTCA was performed on stenoses of left anterior descending artery (43%), circumflex coronary artery (18%), and right coronary artery (39%), respectively. In patients with unstable angina, PTCA in 81% could reduce diameter stenoses of culprit lesions to 50% or less. 43% of patients with acute myocardial infarction had received previous thrombolytic therapy with streptokinase or urokinase applied either systemically or intracoronarily. On cardiac catheterization, 39% of patients presenting with acute myocardial infarction showed total occlusion of the infarct-related vessel. In 75% of patients with acute myocardial infarction, after PTCA, patency of the infarct-related artery (diameter stenoses 50% or less) was observed. In-hospital mortality of patients with acute myocardial infarction subjected to PTCA was 10%, two patients dying in prolonged cardiogenic shock, one in septic shock. In 20% of cases, coronary dissection was observed after PTCA. Non-Q-wave infarction developed in one patient. Three patients had a peripheral vascular complication, and in one patient a transient ischemic attack was observed. No severe catheter-related complications occurred after thrombolytic therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Coronary angiography in a 55-year-old man with coronary heart disease and typical physical activity-induced angina revealed a subtotal stenosis in the middle third of the right coronary artery while left ventricular function was normal. Percutaneous transluminal coronary angioplasty (PTCA) was performed in January 1989, achieving a residual stenosis of less than 50%. However, restenosis of more than 90% developed within six months, necessitating another PTCA, followed immediately by implantation of a metal (Palmaz-Schatz) stent in the stenotic area. No stenosis was demonstrable afterwards. Maintenance medication with anticoagulants (phenprocoumon) and platelet-function inhibitors (aspirin and dipyridamole) was instituted and repeat angiography three months later demonstrated good dilatation results without any restenosis.

An emergency aorto-coronary bypass grafting operation was performed within 12 hours after the development of acute myocardial ischemia due to partial or complete vascular occlusion in 34 of 950 (3.6%) patients who had received elective percutaneous transluminal coronary angioplasty (PTCA). Of the 34 patients, three (= 8.8%) died postoperatively in irreversible cardiogenic shock. Half of the surviving patients developed a Q-wave infarction after the operation, whereas the other half remained without transmural infarct. With comparable clinical data and times of operation up to placement of the aorto-coronary bypass vessel, an adequate residual perfusion must still have been present in the cases with non Q-wave infarction. Since in many cases a myocardial necrosis is unavoidable despite relatively early operative revascularization, the decisive role will be played by the remaining perfusion of the vessel concerned and any collaterals. It follows that treatment of an early PTCA complication, occurring in the catheter laboratory, ought to be the earliest possible aorto-coronary bypass operation unless available cardiological methods can reliably assure reperfusion. Treatment of a PTCA complication occurring later, however, e.g. after hours in the intensive-care unit, should be a repeat PTCA attempt: surgery at this stage will not prevent the transmural infarction but will increase risk of lethal complications.