Search

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. [ABSTRACT FROM AUTHOR]

Objectives: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions.Background: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol.Methods: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up.Results: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups.Conclusions: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile. [ABSTRACT FROM AUTHOR]

Objectives: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term., Methods and Results: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278)., Conclusions: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients., (Copyright © 2018. Published by Elsevier B.V.)

Objective: Contemporary data on patients with previously undiagnosed severe aortic stenosis (AS) are scarce. We aimed to address this gap by gathering data from consecutive patients diagnosed with severe AS on echocardiography., Methods: This was a prospective, multicentre, multinational, registry in 23 tertiary care hospitals across 9 European countries. Patients with a diagnosis of severe AS were included using echocardiography (aortic valve area (AVA) <1 cm 2 , indexed AVA <0.6 cm 2 /m 2 , maximum jet-velocity (V max ) >4 m/s and/or mean transvalvular gradient >40 mm Hg)., Results: The 2171 participants had a mean age of 77.9 years and 48.0% were female. The mean AVA was 0.73 cm 2 , V max 4.3 m/s and mean gradient 47.1 mm Hg; 62.1% had left ventricular hypertrophy and 27.3% an ejection fraction (EF) <50%. 1743 patients (80.3%) were symptomatic (shortness-of-breath 91.0%; dizziness 30.2%, chest pain 28.9%). Patients had a EuroSCORE II of 4.0; 25.3% had a creatinine clearance <50 mL/min, and 3.2% had an EF <30%. Symptomatic patients were older and had more comorbidities than asymptomatic patients. Despite European Society of Cardiology 2017 valvular heart disease guideline class I recommendation, in only 76.2% a decision was made for an intervention (transcatheter 50.4%, surgical aortic valve replacement 25.8%). In asymptomatic patients, 57.7% with a class I/IIa indication were scheduled for a procedure, while 36.3% patients without an indication had their valve replaced., Conclusions: The majority of patients with severe AS presented at an advanced disease stage. Management of severe AS remained suboptimal in a significant proportion of contemporary patients with severe AS., Trial Registration Number: NCT02241447;Results., Competing Interests: Competing interests: PB is the representative of the IPPMed. NF, RPS, TKR and DM-Z have received speakers’ honoraria from Edwards Lifesciences. The institutions of these three and those of the remaining authors representing study centers have received funding from the sponsor for employing a study nurse for the duration of the study. IPPMed designed and executed the study, collected and analysed the data and drafted/revised the manuscript in collaboration with the other authors., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P =0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P =0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.

Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease., Background: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor., Methods: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined., Results: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths., Conclusions: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed., (© 2018 Wiley Periodicals, Inc.)

The transcatheter aortic valve implantation (TAVI) consist an alternative treatment in patients with severe aortic stenosis. Multimodality imaging using transthoracic echocardiography (TTE) or transesophageal echocardiography (TOE) and multislice CT (MSCT) constitute cornerstone techniques for the pre-operative management, peri-procedural guidance, follow up and recognition of possible transcatheter valve related complications. CT angiography is much more accurate regarding the total definition of aortic annulus diameter and circumferential area. Two-dimensional (2D) echocardiography, underestimates the aortic valve annulus diameter compared to 3D imaging techniques (MSCT, MRI and 3D TOE). Three-dimensional TOE imaging provides measurements of the aortic valve annulus similar to those delivered by MSCT. The pre-procedural MSCT constitutes the gold standard modality minimizing the presence of paravalvular aortic regurgitation, one of the most frequent complications. TOE/TTE and MSCT performance could predict the possibility of pacemaker implantation post-procedural. The presence of a new transient or persisting MR can be assessed well by TOE. Both TTE and TOE, consist initially the basic examination for post TAVI evaluation. In case of transcatheter heart valve failure, the MSCT could be used as additional imaging technique.

Introduction: Years after mitral valve surgery, progressive degeneration of reconstructed mitral valves or bioprostheses might lead to severe mitral valve regurgitation. Patients with significant comorbidity, or impaired left ventricular function are poor candidates for redo surgery at an acceptable risk at that later time point., Methods and Results: This study reports the first-in-man transapical valve-in-ring implantations in the mitral position of the fully repositionable Lotus valve system approved for transcatheter aortic valve replacement in Europe. Transapical valve-in-ring implantations with this valve system were successfully performed in a 64-year-old female, and a 53-year-old male patient. Both patients were NHYA class IV, and carried an unacceptably high risk of cardiac surgery due to clinical condition and comorbidity. The first patient was successfully implanted a 25 mm valve, improved to NYHA class II, and was discharged 2 weeks after the procedure. The second patient required a short episode of cardiopulmonary resuscitation after valve implantation (27 mm), and was placed on veno-venous ECMO for 24 hr to improve oxygenation. He developed stroke on day 7, and deceased from fatal, toxic rhabdomyolysis 13 days after the procedure., Conclusion: Transapical valve-in-ring implantation of the repositionable Lotus valve system in the mitral position is a feasible and promising option that merits further evaluation. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

X-ray radiation exposure is of great concern for patients undergoing structural heart interventions. In addition, a larger group of medical staff is required and exposed to radiation compared with percutaneous coronary interventions. This study aimed at quantifying radiation dose reduction with implementation of specific image noise reduction technology (NRT) in transcatheter aortic valve implantation (TAVI) procedures. We retrospectively analyzed 104 consecutive patients with TAVI procedures, 52 patients before and 52 after optimization of x-ray radiation chain, and implementation of NRT. Patients with 1-step TAVI and complex coronary intervention, or complex TAVI procedures, were excluded. Before the procedure, all patients received a multislice computed tomography scan, which was used to size aortic annulus, select the optimal implantation plane, valve type and size, and guide valve implantation using a software tool. Air kerma and kerma-area product were compared in both groups to determine patient radiation dose reduction. Baseline parameters, co-morbidity, or procedural data were comparable between groups. Mean kerma-area product was significantly lower (p <0.001) in the NRT group compared with the standard group (60 ± 39 vs 203 ± 106 Gy × cm(2), p <0.001), which corresponds to a reduction of 70%. Mean air kerma was reduced by 64% (494 ± 360 vs 1,355 ± 657 mGy, p <0.001). In conclusion, using optimized x-ray chain combined with specific image noise reduction technology has the potential to significantly reduce by 2/3 radiation dose in standard TAVI procedures without worsening image quality or prolonging procedure time., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery., Background: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation., Methods: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria., Results: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2)., Conclusions: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions., Background: The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland)., Methods: A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany., Results: Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported., Conclusions: The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications., Methods and Results: Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy. Propensity score matching (2:1) was performed except for the sheath to femoral artery ratio (SFAR). Compared to standard sheath patients, we found no significant difference in 30-day and one-year mortality (SoloPath vs. standard sheath, 9.3% vs. 3.5%; p=0.2, and 18.6% vs. 23.3%; p=0.7), major vascular complications (9.3% vs. 4.7%; p=0.3), and major bleeding (9.3% vs. 10.5%; p=0.5) in the cohort with the balloon-expandable sheath., Conclusions: The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.

To date only sparse data are available on trends and changes in indications, patient's characteristics, and clinical outcome of patients undergoing carotid artery stenting (CAS) in clinical practice. From February 1996 to December 2010, 6,116 CAS procedures were performed in 5,976 patients at 36 hospitals within the prospective, multicenter CAS registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Median age of patients was 71 years, 71.6% were men; a symptomatic stenosis was treated in 50.3% and an embolic protection device (EPD) was used in 82.5% of the patients. The overall hospital mortality or stroke rate was 3.1%. Stroke or in-hospital death occurred in 4.0% in symptomatic patients and in 2.2% in asymptomatic patients. In a logistic regression model, independent predictors of in-hospital death or stroke were heart failure (odds ratio [OR] 2.03, 95% confidence interval [CI] 1.22 to 3.36, p = 0.006), symptomatic stenosis (OR 1.52, 95% CI 1.05 to 2.18, p = 0.03), and age (OR per 10 years 1.46, 95% CI 1.17 to 1.81, p <0.001). The use of an EPD was significantly associated with a lower rate of death or stroke in the registry (OR 0.45, 95% CI 0.26 to 0.78, p = 0.004). From 1996 to 2010, mean age of patients increased by 4.1 years (p <0.001), the proportion of male patients decreased from 82.4% to 70.2% (p = 0.07), the proportion of symptomatic stenoses decreased (84.6% to 24.7%, p <0.001), and the use of EPDs increased from 1.4% to 97.2% (p <0.001). Comparing 2 periods from 1996 to 2003 and 2004 to 2010, a numeric decrease in the in-hospital stroke or death rate was seen in symptomatic (4.7% vs 3.5%, p = 0.11), and in asymptomatic patients (2.9% vs 2.1%, p = 0.27) undergoing CAS, which did not reach statistical significance. In conclusion, the proportion of symptomatic carotid artery stenoses decreased significantly; EPDs established as a standard tool and a numeric decrease of in-hospital stroke or death was seen in asymptomatic and symptomatic patients undergoing CAS in clinical practice over the last 15 years., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The Cappella Sideguard (CS) sidebranch stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions., Objective: To evaluate the mechanism of long-term lumen patency of the novel, self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel., Methods: We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel. Thirteen patients also had optical coherence tomography (OCT) at follow-up to evaluate neointimal hyperplasia and strut coverage., Results: CS stent area at the sidebranch carina increased significantly from 3.8 ± 1.2 mm(2) postintervention to 4.6 ± 1.2 mm(2) at follow-up (P < 0.001), resulting in no change in lumen area (3.8 ± 1.2 mm(2) to 3.7 ± 1.2 mm(2) , P = 0.72) despite a neointimal area at follow-up of 0.9 ± 0.8 mm(2) . Volumetric changes were similar, and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina. Change of lumen volume inversely correlated to the neointimal volume (R = -0.48, P < 0.001), but correlated positively to the change in stent volume (R = 0.52, P < 0.0001). By OCT, most CS struts were covered (100% [98.9, 100]) at the bifurcation site, whereas 61% of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima., Conclusion: Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina, the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up., (© 2014 Wiley Periodicals, Inc.)

Background: Drug-eluting stents (DES) reduce the rate of in-stent restenosis (ISR) and target vessel revascularization significantly when compared with bare metal stents (BMS). Their beneficial effects have been demonstrated in patients with acute myocardial infarction also, but the use of DES in the latter population seems to be still limited in clinical practice., Methods and Results: From January 2006 to December 2011, 25,424 patients with ST-elevation myocardial infarction were enrolled in the German ALKK PCI-registry. In 5,467 patients (21.5 %), a DES was implanted in the culprit segment, in 16,911 patients (66.5 %) a BMS, and 2,959 patients (11.6 %) received neither DES nor BMS. The rates of DES for typical subgroups were 31.7 % in patients with diabetes, 36.6 % in unprotected left main stenosis, 32.4 % in ostial lesions, 32.0 % for a stent length >15 mm, 26.2 % for a stent diameter ≤3 mm, and 58.5 % for ISR. There was a wide range in the use of DES between the different ALKK hospitals with a minimum of 2.3 % and a maximum of 58.3 % for the total study period (median 22.0 %, quartiles 14.6 and 37.5 %)., Conclusions: Despite convincing data for the use of DES in patients with STEMI, there is still an underuse of DES in this clinical setting in Germany. This is particularly worrying for the subgroups of patients and lesions with a high risk of restenosis. Further efforts are needed to reduce the skepticism about DES and to improve guideline adherent treatment.

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.

Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: We compared the mechanisms of lumen gain after Cappella Sideguard (CS) side branch (SB) bifurcation stent deployment versus a balloon-expandable stent in the corresponding main vessel (MV)., Background: The novel CS SB bifurcation stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the SB ostium., Methods: In 28 bifurcation lesions, intravascular ultrasound imaging of both the SB and the MV was performed both pre- and postintervention; vessel and lumen areas were measured every 1 mm over a 5 mm segment beginning at the carina., Results: Although minimum lumen area (MLA) within the distal 5 mm segment beginning at the carina increased from 2.8 ± 1.3 mm(2) to 3.8 ± 1.1 mm(2), P < 0.001, in the SB and from 3.4 ± 1.4 mm(2) to 6.0 ± 1.1 mm(2), P < 0.001, in the MV, stent expansion (minimum stent area/distal reference lumen area) was significantly less in the SB compared with the MV (77.8 ± 21.3% vs. 91.6 ± 18.4%, P = 0.02). Post stenting, the MLA site was located at the carina more frequently in the SB (85.7%) than in the MV (60.7%), P = 0.04. Plaque volume in the 5 mm proximal to carina in the MV tended to decrease, whereas plaque volume in the SB increased slightly with no change in overall plaque volume in the 5-mm-long segment distal to the carina in the MV, suggesting plaque shift from the proximal MV to the SB., Conclusions: Acute CS lumen gain is less than the lumen gain of a balloon-expandable stent in the MV because of less aggressive acute expansion and/or the plaque shift from the proximal MV to the SB., (Copyright © 2013 Wiley Periodicals, Inc.)

Aims: To evaluate: 1) the causes of emergency conversion from transcatheter aortic valve implantation (TAVI) to surgery, 2) procedural settings, and 3) short-term outcome of converted patients., Methods and Results: The prospective German TAVI registry was used to identify patients who underwent bail-out surgery during TAVI. Additionally, standardised questionnaires were developed and used to assess more detailed periprocedural and postprocedural data. Emergency conversion from TAVI to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Primary conversion causes were aorto-valvular complications (i.e., aortic annulus rupture, aortic perforation, or thoracic aortic dissection). This was followed by prosthesis embolisation, myocardial perforation, severe aortic regurgitation, and coronary obstructions. The mean time interval between abortions of TAVI to surgery was 19 minutes (SD ± 17 min, range 5-80 min). Four of 24 patients (16.7%) died during the initial surgery, seven of 24 (29.2%) within the first 72 hours and the 30-day mortality was 45.8%. The highest mortality was observed in patients with aortic perforation or dissection (4/5, 80%). Mortality rates for other entities were: prosthesis embolisation 40% (2/5), myocardial perforation 50% (2/4), annulus rupture 67% (2/3), severe aortic regurgitation 33% (1/3), and coronary impairment 0% (0/3)., Conclusions: Emergency conversion from TAVI to surgery is a rare event carrying a mortality of around 45% after 30 days. Outcome of converted patients with prior injury of aortic, aorto-valvular, or myocardial tissue during TAVI was poor, whereas patients with severe aortic regurgitation and those with coronary complications had a more favourable outcome after 30 days. Collected procedural and outcome data demand on-site cardiac surgery as a prerequisite for TAVI and constant process optimisation efforts regarding such emergency scenarios.

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.

Aims: The recommendation for the use of the intra-aortic balloon pump (IABP) as adjunct in patients with cardiogenic shock undergoing primary PCI in current guidelines is controversial. We sought to investigate the use and impact of the outcome of IABP in current practice of percutaneous coronary interventions in Germany., Methods and Results: Between January 2006 and December 2011, a total of 55,008 consecutive patients with acute coronary syndromes undergoing PCI in 41 hospitals were enrolled into the prospective Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte registry. Of these, 22,039 had STEMI and 32,969 had NSTEMI, and cardiogenic shock was observed in 1,435 (6.5 %) and 478 (1.4 %), respectively. Of the total of 1,913 patients with shock, 487 (25.5 %) were treated with IABP. In-hospital mortality with and without IABP was 43.5 and 37.4 %. In the multivariate analysis, the use of IABP was associated with a strong trend for an increased mortality (odds ratio 1.45, 95 % CI 1.15-1.84)., Conclusion: In the current clinical practice in Germany, IABP is used only in one quarter of patients with cardiogenic shock treated with primary PCI. We observed no benefit of IABP on outcome, which supports the findings of the randomized IABP-Shock II trial.

The combination of a giant coronary aneurysm with multiple coronary aneurysms in adults is an extremely rare entity--especially in atherosclerotic patients, since it is most commonly associated with Kawasaki disease in children. We report an interesting case of a 59-year-old male patient with multiple atherosclerotic aneurysms of the left coronary system and a giant aneurysm of the right coronary artery. The patient was admitted to our hospital because of a non-ST myocardial infarction. Diagnosis was established by echocardiography, computed tomography angiogram, and coronary angiography. In view of the clinical symptoms and the extent of the giant right coronary aneurysm, with the associated risk of rupture, the patient was successfully treated with urgent surgical intervention. We also present a review of the current literature on this anomaly and a statistical analysis of all atherosclerotic giant coronary artery aneurysms previously reported.

Objectives: To analyze age dependencies in patients currently undergoing transcatheter aortic valve implantation (TAVI) based on the German TAVI registry., Background: TAVI is a promising, less invasive treatment option for surgical high-risk patients with symptomatic aortic valve stenosis, with the majority being octogenarians treated so far. Younger patients with significant co-morbidities are now increasingly considered for this procedure, but little is known about this population., Methods: The German TAVI registry is an ongoing non-randomized national multicenter study. Consecutive patients who underwent TAVI between January 2009 and June 2010 were included in this analysis. We compared baseline characteristics, procedural characteristics, and short-term clinical outcome up to 30-day follow-up., Results: A total of 1386 patients were divided into 4 roughly equally-sized groups: group A, n = 347, mean age 73.4 ± 4.5 years; group B, n = 350, mean age 80.6 ± 1.1 years; group C, n = 382, mean age 84.5 ± 1.1 years; and group D, n = 312, mean age 88.9 ± 2.2 years. Patient characteristics varied significantly, with more co-morbidities in younger patients. Technical success rates were similar in all groups (96.6%-97.7%; P=NS). 30-day major adverse event rates were similar with an all-cause mortality rate of 7.2% (A), 7.1% (B), 9.7% (C) and 8.7% (D; P=NS). Postprocedural improvement of both New York Heart Association and self-reported health status was significant in all groups, with significantly better improvements in the categories 'mobility' and 'ability for self-care' in younger patients., Conclusion: TAVI appears to be similarly safe and effective across different age groups with currently applied enrollment criteria, but younger patients present with significantly more co-morbidities. All patient populations experience functional improvements, but this is particularly pronounced for younger patients.

Background: Carotid artery stenting (CAS) is increasingly used for treatment of severe carotid artery stenosis, but only few procedural risk factors for complications of CAS are clearly defined yet. A possible impact of the patient's gender on the outcome of patients undergoing CAS has not been investigated properly and only little information about this topic is available so far., Methods: We analysed data of the German prospective, multicenter CAS Registry of the Arbeitsgemeinschaft leitende kardiologische Krankenhausärzte., Results: From July 1996 to May 2009 5130 patients underwent CAS at 35 German hospitals and were enrolled into the prospective ALKK CAS Registry. Therefrom 1443 (28.1%) patients were female. There was no significant time-related difference in the proportion of women undergoing CAS over the years. Women undergoing CAS were significantly older than men (73 years vs. 70 years, p < 0.01) and had a longer in hospital stay in comparison to men (p < 0.01). The majority of patients treated with CAS was between 60 and 80 years of age (∼73%). No significant differences between women and men could be found regarding in-hospital events like death (0.5% vs. 0.5%, p = 0.99), major or minor stroke (1.7% vs. 1.6%, p = 0.97; 1.0% vs. 1.6%, p = 0.12), TIA (2.8% vs. 2.6%, p = 0.64), amaurosis fugax (0.3% vs. 0.5%, p = 0.25) , intracranial bleeding (0.5% vs. 0.3%, p = 0.43), myocardial infarction (0.1% vs. 0.0%, p = 0.48) or all non-fatal strokes and all death (3.0% vs. 3.4%, p = 0.47). 30 day event rates did not show gender related differences in the combined endpoint of the outcome of patients undergoing CAS, as well (♀ n = 31/882 [3.5%] vs. ♂ n = 109/2273 [4.8%], p = 0.12)., Conclusion: Our results do not suggest any gender-related differences in success rates and complications in CAS. In clinical practice approximately 30% of patients treated with CAS are women. The institutions and people who participated in the ALKK CAS Registry are listed in Zahn et al.16 The authors have no funding, financial relationships, or conflicts of interest to disclose., (© 2012 Wiley Periodicals, Inc.)

Aims: The elderly constitute an increasing proportion of all patients with acute coronary syndromes (ACS). However, increased age has been identified as an important risk factor for adverse events and complications of ACS and treatment. The purpose of this study was to investigate age-related differences in presentation and diagnostics, as well as contemporary treatment and outcome in a large series of elderly patients receiving an invasive strategy for ACS., Methods and Results: The present study is an analysis of all patients, who were enrolled in the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK) registry in 2008. To assess age-related differences, subjects were divided into three groups: (<75 yrs, 75 to 85 yrs and >85 yrs). Out of 19,708 consecutive patients who were admitted for the treatment of ACS and enrolled in the ALKK registry, 14,174 (71.9%) were <75 yrs, 4,685 (23.8%) were between 75 and 84 yrs and 849 (4.3%) patients were >85 yrs. Therapy recommendation after diagnostic angiography was conservative in 24.6% of the youngest, in 25.1% of the elderly, and in 25.3% of the very elderly patients. Interventional success rates were 95.2% in the youngest vs. 93.1% in the elderly and very elderly patient group (p<0.001). Overall in-hospital event rate increased significantly with age (3.4% vs. 7.4% vs. 8.3%, respectively; p<0.001)., Conclusions: Our analysis shows that there is a high success rate among the large proportion of elderly patients who are treated for ACS by an intervention. Complication rates increased significantly, however, with age.

Aims: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions., Methods and Results: The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.2%). Angiographic QCA and IVUS were used to measure acute gain and late loss. The Medina classification showed 35 patients (58%) had disease affecting the SB (true bifurcations) and 19 patients (32%) had disease in all three arms. The average bifurcation angulation pre-stenting was 60°±21°. Post-stenting, disconnection was performed on 90% of the stents implanted. In 18 cases, disconnection was followed by SB stenting with all SB stents successfully implanted. Post-stenting, the bifurcation angle was 51°. The primary clinical endpoint, cumulative MACE at six months, was low for DES (3.7%) but higher for BMS (27.3%) with the latter driven exclusively by clinically-driven TLR rates (3.7% vs. 24.2%). No cardiac deaths were recorded at six months and one patient had a non-Q wave infarct. The secondary angiographic endpoint of late luminal loss (LLL) was measured for both DES (paclitaxel) and BMS stents in the proximal main branch (MB), MB, distal MB as well as the SB. The values for DES were 0.39 mm, 0.42 mm, 0.40 mm and 0.16 mm, respectively. The values for BMS were 0.86 mm, 0.87 mm, 0.85 mm and 0.54 mm, respectively. Observed results using matched IVUS analysis at six months revealed an increase in mean stent area (mm²) for DES from 7.52±1.86 at baseline to 12.32±2.90 at six month follow-up (p <0.001); and for BMS from 7.95±1.40 to 11.56±2.22 (p <0.001), with no decrease in minimum lumen area (MLA) for DES (5.10 to 4.91) and a minimal decrease for BMS (5.74 to 5.15)., Conclusions: This first-in-man (FIM) study on the STENTYS® stent showed excellent procedural success and a relatively low MACE with competitively low LLL in both MB and SB at six months for the DES version and LLL comparable to other BMS for the BMS version. The disconnectable struts offered excellent "cross over" to T- stenting when necessary and the increased gains in stent area over time.

Introduction: This analysis examines the influence of age on antithrombotic therapy, success rate of percutaneous coronary intervention (PCI) and in-hospital mortality in patients with Acute Coronary Syndrome (ACS) and elective PCI., Methods: We analysed data of 26,795 unselected patients with ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable Angina (UA) and elective PCI from the ALKK-PCI Registry 2006, a German prospective, multicentre registry., Results: Elderly patients (>75) with ACS were significantly less often treated with acetylsalicylic acid intravenously and a clopidogrel loading dose of 600 mg. Moreover, the administration of GP IIb/IIIa antagonists was significantly lower in these patients. The rate of successful PCI (indicated as TIMI 3 flow) is comparable in younger and elderly patients with elective PCI, UA and NSTEMI, whereas there were more unsuccessful interventions in elderly patients with STEMI (13.2 vs. 11.0%, p < 0,033). In all indications elderly patients showed increased in-hospital mortality., Conclusion: In clinical practice, elderly patients with ACS undergoing PCI receive significantly less intensive antithrombotic treatment. In terms of successful PCI, there was no significant difference between the age groups in patients with elective PCI, UA and NSTEMI. The higher in-hospital mortality of the elderly in all patient groups is most likely due to a higher rate of comorbidities.

Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up., Methods and Results: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%., Conclusions: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.

Objectives: To evaluate feasibility and safety of MGuard based percutaneous coronary interventions (PCI) in vein grafts (VG) and native coronaries (NC)., Background: Distal embolization is a frequent complication of PCI of VG and NC during acute coronary syndromes (ACS). MGuard was a stent designed to reduce embolization., Methods: Prospective, single arm, two-center trial assessing the feasibility and safety of MGuard-based PCI with post-PCI clinical and laboratory monitoring including: cardiac biomarkers, ECG and 6-month angiography., Results: Forty-one patients with mean age of 68.2±10.1 years were enrolled. Mean VG age (n=23) was 14.4±4.3 years. All patients received heparin, clopidogrel and aspirin; while none received glycoprotein IIb/IIIa inhibitors, or embolic protection device (EPD). Device and procedural success were 100% and 95.1% respectively. Two patients (4.9%) experienced procedure-related creatinine phosphokinase rise. At 6 months one patient had myocardial infarction and 19.5% had target vessel revascularization (TLR). Late follow up (12-27 months) revealed one additional TLR., Conclusion: MGuard based PCI of NC and VG appears encouraging especially in view of unfavorable patient and lesion characteristics. Efficacy needs to be further established in larger randomized trials., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Aims: Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry., Methods and Results: Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%., Conclusion: In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

Objective: To compare characteristics and outcome of patients with re-stenoses after prior carotid artery stenting (CAS) treated with repeat carotid interventions (Re-CI) with CAS for de novo lesions., Background: The treatment of re-stenosis is a major problem in vascular interventions. Patients with re-stenoses after prior CAS treated with Re-CI are not well defined., Methods: We analyzed data from the prospective ALKK CAS Registry., Results: Out of 3,817 CAS procedures 95 were intended in 93 patients (2.5%) for a restenosis after prior CAS and 3,722 CAS in 3,655 patients (97.5%) for a de novo stenosis. There was no difference in age (p = 0.302) or distribution of gender (p = 0.545) between the two groups. Patients treated for a restenosis after CAS were less likely to be treated for a symptomatic lesion (22.7 vs. 40.1%, p = 0.001). Coronary heart disease (p = 0.017), peripheral arterial disease (p < 0.001) as well as diabetes mellitus (p = 0.004) were more prevalent in the restenosis group. Lesions were less complicated in restenosis patients, with less ulcers (7.4 vs. 19.9%, p = 0.003) and less severe calcifications (7.4 vs. 23.6%, p < 0.001). The intended interventions were more often not performed in the Re-CI group (9.5 vs. 3.3%; p = 0.001). In-hospital, the stroke or death rate was 0% in the Re-CI group as compared to 3.1% in the de novo group (p = 0.115)., Conclusions: Patients treated with Re-CI for repeat stenoses after prior CAS represent 2.5% of current CAS patients. Although representing a subgroup with more concomitant diseases, Re-CI seems to be associated with lower event rates as compared to CAS for de novo lesions.

Aims: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions., Methods and Results: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years., Conclusions: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.

Aims: Despite successful prevention of lesion recurrence by drug-eluting stents (DES), and the advancement in procedural techniques in the treatment of chronic total coronary occlusions (CTO), the number of CTOs treated by percutaneous coronary intervention (PCI) is still low as compared to their prevalence. This study aims to assess the outcome of PCI for CTOs in a contemporary survey of PCI in interventional centres in Germany., Methods and Results: The basis of this analysis is the 2006 quality assessment database of PCI conducted by the ALKK (working group of cardiology centres). Thirty-five centres contributed to this database, representing about 10% of all interventional centres of Germany. From a total of 20,502 patients, 8,882 patients with stable angina were selected. Of these 674 patients (7.6%) underwent PCI for a CTO. Their procedural characteristics and the hospital outcome were compared with patients treated for non-occlusive lesions. As compared to non-occlusive lesions, less patients underwent ad hoc PCI for a CTO. The fluoroscopy time was almost double of that in non-occlusive lesions, and contrast usage was significantly higher. The success rate was 60.1% as compared to 97.3% (p<0.001). Severe intraprocedural and in-hospital complications were similar for CTO and non-CTO lesions. Almost all patients with a CTO received a stent; DES were used in 53.4%, which was higher than the rate in non-CTO lesions (38.9%; p<0.001)., Conclusions: Although the success rate for PCI in CTOs is still well below that in non-occlusive lesions, this procedure is safe, encouraging its wider application. The low rate of DES use did not reflect the evidence for DES in CTOs.

Aims: We studied a novel sirolimus eluting stent with a bioabsorbable coating (SES) in >3 months old chronic total coronary occlusions (CTO)., Methods and Results: Ninety-five patients were randomised to either BMS (n=47) or SES (n=48). The primary endpoints were late lumen loss (LLL) and in-segment restenosis (ISR) after six months. Secondary endpoints were target vessel revascularisation after six and 24 months. Occlusion length (37.6 mm), reference diameter (2.8 mm) as well as the stented segment (45.5 mm) were similar in both groups. Up until six months no death, myocardial infarction or stent thrombosis occurred in either group. Angiographic follow-up (45BMS/46SES): LLL 1.8 mm/0.77 mm (p<0.0001), ISR 60%/17.4% (p<0.0001). In-segment re-occlusion 15.5%/0% and TVR 53.3%/10.8% (p<0.0001). After 24 months: 1 BMS, 2 SES patients died; 0 BMS, 0 SES infarction; 0 BMS, 0 SES stent thrombosis and 3 BMS, 0 SES TVR between six and 24 months. Thus total TVR after 24 months was 60% for BMS and 10.8% for SES (p<0.0001)., Conclusions: The alternative sirolimus-coated stent was shown to reduce the relative risk of restenosis after six months by 71%, and of TVR after 24 months by 82%. Between six and 24 months, neither stent thrombosis occurred, nor repeat revascularisation was required in patients who received a SES.

Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer., Methods and Results: The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR., Conclusions: This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

Objectives: The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions., Background: The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent)., Methods: In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%)., Results: The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%., Conclusions: The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728)., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Objectives: To determine the influence of the side intervened upon on outcomes during carotid artery stenting (CAS)., Background: Anatomic and technical aspects may influence the results of CAS. The value of the side intervened upon has not been analyzed yet., Methods: We analyzed data from the Carotid Artery Stent (CAS)-Registry., Results: A total of 3,165 CAS procedures, 1,613 (51%) at the left and 1,552 (49%) at the right carotid artery were included. There was a higher proportion of patients treated for symptomatic stenoses when CAS was performed at the left carotid artery (50.1% versus 45.8%, P = 0.016) and more patients already had prior carotid endarterectomy (8.5% versus 5.8%, P = 0.003). Interventions at the left side took 3 min longer than interventions at the right side (46.6 +/- 24.3 versus 43.8 +/- 23.6, P = 0.003). In patients treated at the left carotid artery amaurosis fugax (0.7% versus 0.1%, P = 0.005), ipsilateral stroke (3.1% versus 1.8%, P = 0.017), and the primary endpoint of in-hospital death or stroke (4.1% versus 2.3%, P = 0.005) occurred significantly more often. Even after adjusting for confounding parameters, CAS procedures performed at the left carotid arteries remained an independent predictor of death or stroke (OR = 1.77, 95% CI: 1.15-2.72, P = 0.009)., Conclusions: In current clinical practice, CAS is performed frequently at the right carotid artery as at the left carotid artery. CAS interventions have a higher in-hospital complication rate if performed at the left carotid artery. Technical improvements might help to overcome this situation., (Copyright 2009 Wiley-Liss, Inc.)