Timm Bauer

Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina

BACKGROUND The percentage of elderly treated with percutaneous coronary intervention (PCI) has been increasing year by year. Little is known about predictors of hospital mortality in elderly undergoing PCI for acute coronary syndromes (ACS) and stable angina. METHODS Between 2005 and 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the EHS Programme. For the present analysis patients were divided into four categories: ACS patients ≥ 75 (n=4,943) and < 75 years (n=19,446), and patients with stable angina ≥ 75 (n=3,393) and < 75 years (n=19,625). A multiple logistic regression analysis was conducted to detect independent predictors of mortality in patients ≥ 75 years undergoing PCI. In addition, differences in clinical characteristics, procedural details and in-hospital outcomes between the subgroups were evaluated. RESULTS Patients ≥ 75 years had more co-morbidities, and more severe coronary pathology. The use of guideline-recommended adjunctive therapy and procedural success was high in all groups. The incidence of in-hospital death was highest in ACS patients ≥ 75 years (5.2%) and < 75 years (1.7%), followed by patients with stable angina ≥ 75 (0.5%) and < 75 years (0.2%). Haemodynamic instability and acute ST-elevation myocardial infarction were the strongest determinants of hospital mortality among patients ≥ 75 years with ACS, whereas interventional complications were the most meaningful predictors of death in older patients undergoing elective PCI. CONCLUSIONS Patients ≥ 75 years undergoing PCI face a relatively low risk of hospital death. However, complication rates were significantly higher compared to younger patients, strongly influenced by clinical, angiographic and interventional variables.

Use and impact of intra-aortic balloon pump on mortality in patients with acute myocardial infarction complicated by cardiogenic shock: results of the Euro Heart Survey on PCI.

AIMS The intra-aortic balloon pump (IABP) is recommended by current guidelines as adjunct in patients with cardiogenic shock, despite the lack of larger clinical trials. We sought to investigate the use and impact on mortality of IABP in current practice of percutaneous coronary interventions in Europe. METHODS AND RESULTS Between May 2005 and April 2008 a total of 47,407 consecutive patients undergoing percutaneous coronary intervention (PCI) in 176 centres in 33 countries in Europe and the Mediterranean basin were enrolled into the registry. From these, 8,102 had ST-elevation myocardial infarction and 7,999 non-ST elevation myocardial infarction and cardiogenic shock was observed in 7.9% and 2.1%, respectively. Of the 653 patients with cardiogenic shock 25% were treated with an IABP. In-hospital mortality, with and without IABP, was 56.9% and 36.1%. In the multivariate analysis the use of IABP was not associated with an improved survival (odds ratio 1.47; 95% CI 0.97-2.21, p=0.07). CONCLUSIONS In current clinical practice in Europe, IABP is used only in one quarter of patients with cardiogenic shock treated with primary PCI. However, there was no hint of a beneficial effect of IABP on outcome. Therefore, a large randomised clinical trial is urgently needed to define the role of IABP in patients with PCI for shock.

Efficacy and safety of enoxaparin in unselected patients with ST-segment elevation myocardial infarction.

In randomized clinical trials the low-molecular-weight heparin enoxaparin has been shown to reduce ischemic complications in patients with acute ST elevation myocardial infarction (STEMI) treated with fibrinolysis. Little is known about the use and efficacy of enoxaparin in unselected patients with STEMI in clinical practice. In a retrospective analysis of the prospective ACOS registry we compared the outcomes of patients with STEMI treated with enoxaparin or unfractionated heparin. A total of 6,299 patients with STEMI < 12 hours were included in this analysis, 609 (10%) were treated with enoxaparin and 5,690 (90%) with unfractionated heparin. In the multivariable propensity score analysis enoxaparin was associated with a reduction in the combined endpoint of death and non-fatal reinfarction in the entire group (odds ratio 0.59; 95% CI 0.43-0.80) and the subgroups of patients treated without early reperfusion (odds ratio 0.65, 95% CI 0.43-0.97), fibrinolysis (odds ratio 0.64; 95% CI 0.33-1.26) and primary percutaneous coronary intervention (odds ratio 0.33; 95% CI 0.15-0.72). There was no significant increase in severe bleeding complications with enoxaparin (6.5% versus 5.5%, p = 0.4). In clinical practice in unselected patients with STEMI treated with or without early reperfusion therapy early treatment with enoxaparin compared to unfractionated heparin is associated with a significant reduction of the combined endpoint of inhospital death and reinfarction without a significant increase in severe bleeding complications.

Effects of a secondary prevention combination therapy with an aspirin, an ACE inhibitor and a statin on 1-year mortality of patients with acute myocardial infarction treated with a beta-blocker. Support for a polypill approach

Abstract Objective: Large randomized clinical trials have shown the efficacy of aspirin, ACE (angiotensin converting enzyme) inhibitors and statins as secondary prevention measures in patients after an acute coronary syndrome with and without ST elevations. Therefore we aimed to determine the effect of a combination therapy with these three drugs on 1-year mortality after acute myocardial infarction (AMI). Methods: We prospectively followed 9998 survivors of acute myocardial infarction treated with a beta-blocker for 1 year. Patients were divided into three groups according to their therapy with aspirin, ACE inhibitors and statins: 3 drugs, 2 drugs or 0–1 drug. Results: The majority of patients (n = 6260, 62.6%) were treated with 3 drugs, 2986 (29.9%) with 2 drugs and 752 (7.5%) with 0–1 drug. In the univariate analysis 1-year mortality was 4.9%, 9.7% and 13.6%, respectively. After adjusting for confounding factors in the propensity score analysis the odds ratios for 1-year mortality were significantly increased with 0–1 drug (odds ratio 1.67, 95% CI 1.24–2.27) and with 2 drugs (odds ratio 1.54, 95% CI 1.26–1.87) in comparison with the group treated with all 3 drugs. However, in the ACOS registry the treatment was left to the discretion of the physician. This could lead to a selection bias, which cannot be fully eliminated by using multiple regression analysis. Conclusions: A combination therapy with aspirin, an ACE inhibitor and a statin reduces 1-year mortality in patients after AMI. Therefore a polypill approach with these three agents should be considered to increase drug compliance and reduce mortality after acute myocardial infarction.

Guideline-recommended secondary prevention drug therapy after acute myocardial infarction: predictors and outcomes of nonadherence:

Background Guideline-recommended pharmacotherapy after myocardial infarction (MI) has been shown to reduce cardiovascular morbidity and mortality. Our objectives were to determine factors of, and to measure outcomes associated with nonadherence after MI. Design Multicentre, prospective, observational study (Acute Coronary Syndromes Registry). Methods We analyzed data of 11 823 consecutive hospital survivors of acute MI and evaluated their discharge medication with the five following drugs: acetyl salicylic acid, clopidogrel, β-blocker, angiotensin-converting enzyme inhibitor/sartan and statin. Patients receiving less than four drugs (group 1, n = 3439, 29.1%) were compared with those receiving 4–5 drugs (group 2, n = 8384, 70.9%). The impact of clinical, demographic and treatment factors on not prescribing each of these five drugs at discharge was investigated by using multiple logistic regression models. Results Patients of group 1 were older, had more comorbidities, more frequently suffered a nonST elevation MI and less often received reperfusion therapy. In the multivariate analysis, group 1 was associated with an increased risk for death at 1-year follow-up [odds ratio (OR): 1.6, 95% confidence interval (CI): 1.4–1.9]. After adjustment for confounding variables chronic oral anticoagulation was the strongest predictor for not receiving acetyl salicylic acid (OR: 19.6, 95% CI: 15.9–24.0) at discharge, no percutaneous coronary intervention within 48 h for not receiving statin (OR: 2.1, 95% CI: 1.9–2.4) and clopidogrel (OR: 10.4,95% CI: 9.4–11.5), chronic obstructive lung disease for not receiving β-blocker (OR: 4.2,95% CI: 3.6–4.9) and chronic renal insufficiency for not receiving angiotensin-converting enzyme inhibitor/sartan (OR: 2.8, 95% CI: 2.2–3.5). Conclusion In clinical practice guideline-adherent secondary prevention drug therapy is linked with an improved 1-year survival. Comorbidities and no interventional treatment were strong negative predictors for guideline-adherent discharge medication.

Efficacy and safety of enoxaparin in combination with and without GP IIb/IIIa inhibitors in unselected patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention

AIMS We sought to determine the efficacy of enoxaparin in unselected patients with STEMI treated with primary percutaneous coronary intervention in clinical practice. METHODS AND RESULTS In a retrospective analysis of the prospective MITRA-plus registry we compared the outcomes of patients with primary PCI and either enoxaparin or unfractionated heparin. A total of 2,655 patients with STEMI < 12 hours were included in this analysis, 374 (14%) were treated with enoxaparin and 2,281 (86%) with unfractionated heparin. In the univariate analysis enoxaparin reduced mortality (1.6% versus 6.0%, < 0.001), fewer non-fatal reinfarctions (1.9% versus 3.8%, p = 0.05) and no significant difference in major bleeding (5.6% versus 7.2%, p = 0.2) was observed. In the multivariable propensity score analysis enoxaparin was associated with a reduction in the combined endpoint of death and non-fatal reinfarction (odds ratio 0.42; 95% CI 0.2-0.8). This advantage was observed both in subgroups without (odds ratio 0.33 95% CI 0.1-0.8) and with GP IIb/IIIa inhibitors (odds ratio 0.44, 95% CI 0.2-1.0). CONCLUSIONS Our data suggest that in unselected patients with STEMI treated with primary PCI enoxaparin compared to unfractionated heparin reduces the combined endpoint of in-hospital death and reinfarction and does not increase severe bleeding complications.

Clopidogrel in addition to aspirin reduces in-hospital major cardiac and cerebrovascular events in unselected patients with acute ST segment elevation myocardial

We sought to assess the effect of clopidogrel on in-hospital events in unselected patients with acute ST elevation myocardial infarction (STEMI). In a retrospective analysis of consecutive patients enrolled in the Acute Coronary Syndromes (ACOS) registry with acute STEMI we compared outcomes of either adjunctive therapy with aspirin alone or aspirin plus clopidogrel within 24 hours after admission.A total of 7,559 patients were included in this analysis, of whom 3,541 were treated with aspirin alone, and 4,018 with dual antiplatelet therapy. The multivariable analysis with adjustment for baseline characteristics and treatments showed that the rate of in-hospital MACCE (death, non-fatal reinfarction, non-fatal stroke) was significantly lower in the aspirin plus clopidogrel group,compared to the aspirin alone group in the entire cohort and all three reperfusion strategy groups (entire group odds ratio 0.60, 95% CI 0.49-0.72 , no reperfusion OR 0.69,95% CI 0.51-0.94,fibrinolysis OR 0.62,95% CI 0.44-0.88, primary PCI OR 0.54, 95% CI 0.39-0.74). There was a significant increase in major bleeding complications with clopidogrel (7.1% vs. 3.4%, p<0.001). In clinical practice early adjunctive therapy with clopidogrel in addition to aspirin in patients with STEMI is associated with a significant reduction of in-hospital MACCE regardless of the initial reperfusion strategy. This advantage was associated with an increase in major bleeding complications.

Incidence and Clinical Impact of Stroke Complicating Percutaneous Coronary Intervention Results of the Euro Heart Survey Percutaneous Coronary Interventions Registry

Background—Stroke is a rare but serious complication of percutaneous coronary interventions (PCIs). So far, scant information is available about the incidence and outcome of patients developing stroke after PCI for stable angina or acute coronary syndrome (ACS) in daily clinical practice in Europe today. Methods and Results—Between 2005 and 2008, 46 888 patients undergoing PCI were enrolled into the PCI Registry of the Euro Heart Survey Programme (176 centers in 33 European countries) to document patient’s characteristics, PCI details, and hospital complications in different PCI indications. Stroke was observed in 0.4% of the procedures in the total population, in 0.3% of PCIs in elective patients, and in 0.6% in PCIs performed for ACS. The overall in-hospital mortality was 19.2% for patients who developed stroke (elective PCIs, 10.0%; PCI for ACS, 23.2%) compared with 1.3% for those without stroke (elective PCIs, 0.2%; PCI for ACS, 2.3%). In multivariate analysis hemodynamic instability, age ≥75 years, history of stroke, and congestive heart failure were found to be independent predictors for periprocedural stroke in ACS, whereas only PCI of a bypass graft and renal failure could be identified as independent predictors for stroke in elective patients. Conclusions—Stroke as complication of PCI occurs rarely (0.4%) in clinical practice in Europe today. However, peri-interventional stroke is still associated with an exceedingly high in-hospital mortality rate. Most predictors for periprocedural stroke are not modifiable and cannot be diminished before PCI. Therefore, treatment of patients with stroke after PCI needs further research.

Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion

OBJECTIVE This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. BACKGROUND Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. METHODS Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. RESULTS A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54-85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1-30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5-214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. CONCLUSION These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases.

Clinical Benefit of Early Reperfusion Therapy in Patients With ST-Elevation Myocardial Infarction Usually Excluded from Randomized Clinical Trials (Results from the Maximal Individual Therapy in Acute Myocardial Infarction Plus [MITRA Plus] Registry)

Randomized clinical trials (RCTs) usually enroll selected patient populations that may not be representative for patients seen in everyday practice. Therefore, concerns have been raised regarding their external validity. For the present study we evaluated the MITRA Plus registry and included 20,175 patients with ST-elevation myocardial infarction. We defined RCT-ineligible patients as patients fulfilling >or=1 of the following criteria: age >or=75 years, prehospital delay >12 hours, prehospital cardiopulmonary resuscitation, cardiogenic shock, impaired renal function, and previous stroke. Those patients (n = 9,369, 46.4%) were compared to patients eligible for enrollment in RCTs (n = 11,806, 53.6%). Ineligible patients were older (p <0.0001), more often were women (p <0.0001), and more often had concomitant diseases (p <0.0001). Ineligible patients less often received early reperfusion therapy (p <0.0001), aspirin (p <0.0001), clopidogrel (p <0.0001), and statins (p <0.0001). Ineligible patients had a higher hospital mortality (20.1% vs 4.9%; p <0.0001) and a higher rate of nonfatal strokes (1.5% vs 0.4%, p <0.0001) compared to eligible patients. Early reperfusion therapy (thrombolysis and/or percutaneous coronary intervention [PCI]) in ineligible patients was associated with a significant decrease of hospital mortality (odds ratio 0.62, 95% confidence interval 0.49 to 0.79), with primary PCI being more effective than thrombolytic therapy (odds ratio 0.52, 95% confidence interval 0.41 to 0.65). In conclusion, about 50% of patients with ST-elevation myocardial infarction seen in clinical practice are usually excluded from RCTs. Hospital mortality in those patients is very high. Primary PCI improves the prognosis and is therefore the preferred reperfusion strategy in these patients.