Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography.

BACKGROUND: Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months. METHODS: A total of 20 patients were randomly assigned to stenting with BP-SES (n=11) or EES (n=9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach. RESULTS: Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p=0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p=0.97). No difference in percent neointimal volume (14.1±8.2% vs. 11.4±6.4%, p=0.56) was observed. CONCLUSIONS: Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.

Clopidogrel pre-treatment is associated with reduced in-hospital mortality in primary percutaneous coronary intervention for acute ST-elevation myocardial infarction.

AIMS Pre-treatment with clopidogrel results in a reduction of ischaemic events in non-ST-elevation acute coronary syndromes. Data on upstream clopidogrel in the setting of primary percutaneous coronary intervention (PCI) are limited. The aim of this study was to investigate whether clopidogrel loading before arrival at the PCI centre may result in an improved outcome of primary PCI for ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS In a multicentre registry of acute PCI, 5955 patients undergoing primary PCI in Austria between January 2005 and December 2009 were prospectively enrolled. The patients consisted of two groups, a clopidogrel pre-treatment group (n = 1635 patients) receiving clopidogrel before arrival at the PCI centre and a peri-interventional clopidogrel group (n = 4320 patients) receiving clopidogrel at a later stage. Multiple logistic regression analysis including major confounding factors stratified by the participating centres was applied to investigate the effect of pre-treatment with clopidogrel on the in-hospital mortality. Additionally, two subgroups, with or without the use of GP IIb/IIIa antagonist therapy in the catheterization laboratory, were analysed. On univariate analysis, clopidogrel pre-treatment was associated with a reduced in-hospital mortality (3.4 vs. 6.1%, P< 0.01) after primary PCI. On multivariate analysis, clopidogrel pre-treatment remained an independent predictor of in-hospital mortality [odds ratio (OR) = 0.60, 95% confidence interval (CI) 0.35-0.99; P =0.048], especially in patients receiving additional GP IIb/IIIa antagonist therapy in the catheterization laboratory (OR = 0.40, 95% CI 0.19-0.83; P =0.01). CONCLUSION Clopidogrel pre-treatment before arrival at the PCI centre is associated with reduced mortality in a real world setting of primary PCI. These results strongly support the recommendation of clopidogrel treatment 'as soon as possible' in patients with STEMI undergoing pimary PCI.

Primary percutaneous intervention of ST-elevation myocardial infarction in Austria: Results from the Austrian acute PCI registry 2005-2007.

BACKGROUND: Primary percutaneous coronary intervention (PPCI) has become the preferred reperfusion strategy in ST-elevation myocardial infarction (STEMI). Implementation of networks of care and registries providing continuous quality assessment are key components for optimal management in patients with STEMI. AIM: To analyze procedural success and in-hospital outcome of interventional therapy of STEMI in Austria. METHODS: We evaluated a total number of 4016 consecutive STEMI patients registered in the first three years after implementation of the Austrian acute PCI registry in January 2005. RESULTS: The rate of PPCI as an indication for acute coronary intervention increased from 83.5% in 2005 to 92.4% in 2007 (P < 0.0001). During this period the median door-to-balloon time decreased from 60.0 (40.0-90.0) min to 53.0 (30.0-80.0) min (P = 0.012). The percentage of patients receiving adequate adjunctive antithrombotic therapy with ASA/heparin and clopidogrel significantly increased (78.8-85.1% and 67.8-90.3%, respectively; P < 0.001). Overall in-hospital mortality was 9.6% in rescue PCI, 6.4% in facilitated PCI and 5.1% in PPCI. On multivariate analysis, cardiogenic shock (OR: 20.21, 95% CI: 12.21-33.44, P < 0.001), resuscitation (OR: 2.62, 95% CI: 1.47-4.69, P = 0.01), age (OR: 1.04, 95% CI: 1.02-1.06, P < 0.001) and angiographic success (OR: 5.93, 95% CI: 3.33-10.57, P < 0.001) were independent predictors of in-hospital death. CONCLUSION: Continuous nationwide efforts to establish regional networks for STEMI treatment in the years 2005-2007 led to a decrease in door-to-balloon time, improved adjunctive antithrombotic therapy and an in-hospital mortality of 5%. Results of interventional STEMI treatment in Austria are in accordance with current guidelines and with other contemporary registries.

2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study.

OBJECTIVES: The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. BACKGROUND: The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. METHODS: Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. RESULTS: Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). CONCLUSIONS: With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

Gender-related outcome following percutaneous coronary intervention for ST-elevation myocardial infarction: data from the Austrian acute PCI registry.

AIMS: Whether or not primary percutaneous coronary intervention (P-PCI) is equally effective and safe in women and men in a real world setting is still a matter of debate. The aim of this study was to evaluate the effect of gender on in-hospital outcome after P-PCI for ST-elevation myocardial infarction (STEMI) in a prospective national registry. METHODS AND RESULTS: This registry includes in-hospital outcome data from 19 PCI-performing hospitals. During 12 months, 1087 patients with STEMI were registered (mean age 62 +/- 13 years; 27% women). Women were older than men (67 +/- 13 vs. 60 +/- 13 years; p < 0.001) and more often had diabetes mellitus (21% vs. 13%; p < 0.001) or cardiogenic shock (15% vs. 9%; p=0.004). PCI was performed in 1004 patients (92.4%) and more frequently in men than in women (93.9 vs. 88.3%, p=0.002), whereas conservative treatment was more often decided in women (9.3% vs 4.3%; p=0.002). No differences were found between women and men in primary success rate (TIMI 2+3 flow, 92.9% vs. 93%; p=0.96). On univariate analysis, in-hospital mortality was higher in women than in men (13.7% vs. 7.2%; p=0.001). On multivariable analysis age, shock, diabetes and TIMI flow before PCI remained associated with mortality. CONCLUSIONS: Women have higher in-hospital mortality following PCI for STEMI. On multivariate analysis age, shock, diabetes and TIMI flow, but not gender, were associated with mortality in this national register. Older age and more comorbidity are likely to explain the higher mortality in female patients undergoing P-PCI.

Small vessel stenting with cobalt-chromium stents (Arthos Pico) in a real world setting.

BACKGROUND: In current clinical practice, 35-67% of significant coronary artery lesions are located in small (<3.0 mm) vessels, a setting with poor short- and long-term results after percutaneous coronary interventions. OBJECTIVES: The aim of the present Arthos Pico Austria Multicenter Registry is to demonstrate the safety and efficacy of the Arthos Pico (cobalt-chromium alloy) stent implantation in small coronary arteries in a real world setting. METHODS: Two hundred and three patients (mean age, 67+/-12 years; 63% male) were included in the Registry; 199 patients (98%) were controlled clinically (including noninvasive stress tests) 6 and 12 months after stent implantation. Clinically driven angiographic controls were performed in 37 patients (18.2%) at mean 6 months after stenting. The primary endpoint of the study was the 6-month rate of major adverse cardiac events (as target vessel revascularization, all cause death, and acute myocardial infarction), the secondary endpoints were the intervention complications, and the occurrence of acute and subacute stent thrombosis. RESULTS: The procedural success was 99%. The rates of acute and subacute stent thrombosis were 0.5 and 1.5%, respectively. During the 6-month clinical follow-up, primary endpoint events (major adverse cardiac events) were recorded in 13% of the clinically controlled patients: four patients (2%) with acute myocardial infarction; 12 patients (6%) with target vessel revascularization; and 10 patients died (5%), resulting in an event-free survival rate of 87%. Between the 6- and 12-month follow-up, additional target vessel revascularization was performed in three patients, acute myocardial infarction and death occurred in one patient each, respectively. Thus, the 12-month major adverse cardiac event-free survival rate was 85%. Patients who died had older age (76+/-7 years) and a high proportion of type C lesions (50%) at the initial angiography. Multivariate analysis revealed older age (P=0.026) and type C lesions (P=0.016) as significant predictors for all causes of death. CONCLUSION: In conclusion, stenting of small arteries with Arthos Pico is safe and effective in the prevention of major adverse cardiac events during 6- and 12-month follow-up.