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Objectives This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness. Background DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown. Methods The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months. Results Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups. Conclusions Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation. (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial [ROTAXUS]; NCT00380809)

The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.Limited data exists on clinical or manifest transcatheter heart valve thrombosis. Prior studies have focused on subclinical thrombosis.A retrospective analysis was conducted of prospectively collected data from a single-center registry that included 642 consecutive patients who underwent transcatheter aortic valve replacement between 2007 and 2015 (305 patients had self-expanding valves; balloon-expandable, n = 281; mechanically expanding, n = 56). Long-term oral anticoagulation (OAC) was indicated in 261 patients, while 377 patients received dual-antiplatelet therapy post-procedure. All patients underwent scheduled clinical and echocardiographic follow-up.The overall incidence of clinical valve thrombosis was 2.8% (n = 18). No patient on OAC developed thrombosis. Of the detected thrombosis cases, 13 patients had balloon-expandable, 3 had self-expanding, and 2 had mechanically expanding valves. Thrombosis occurred significantly more often with balloon-expandable valves (odds ratio: 3.45; 95% confidence interval: 1.22 to 9.81; p = 0.01) and following valve-in-valve procedures (odds ratio: 5.93; 95% confidence interval: 2.01 to 17.51; p = 0.005). Median time to diagnosis of valve thrombosis was 181 days. The median N-terminal pro-brain natriuretic peptide level was 1,318 pg/ml (interquartile range: 606 to 1,676 pg/ml). The mean transvalvular gradient and valve area were 34 ± 14 mm Hg and 1.0 ± 0.46 cmClinical transcatheter heart valve thrombosis is more common than previously considered, characterized by imaging abnormalities and increased gradients and N-terminal pro-brain natriuretic peptide levels. It occurred more commonly after balloon-expandable transcatheter aortic valve replacement and valve-in-valve procedures. OAC appeared to be effective in the prevention and treatment of valve thrombosis. Randomized control trials are needed to define optimal antithrombotic therapy after transcatheter aortic valve replacement.

AIMS The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.

Background The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions. Methods and Materials This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n = 72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). Results At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66 ± 0.61 mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup. Conclusion Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.

A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P = 0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P = 0.51), peripheral ischemic complications (4.3% and 3.4%, P = 0.53), sepsis (15.7% and 20.5%, P = 0.15), and stroke (0.7% and 1.7%, P = 0.28). Conclusions The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.)

ObjectiveTo evaluate a vasculitis centre based management strategy for eosinophilic granulomatosis and polyangiitis (Churg-Strauss, EGPA).MethodsA retrospective cohort study at a vasculitis referral centre was performed. All EGPA patients admitted from 1990 to 2009 were included. A structured interdisciplinary work-up for proof of diagnosis, Disease Extent Index and Birmingham Vasculitis Activity Score was performed. Immunosuppressive therapy was initiated and regularly adapted. Treatment targets were induction and maintenance of remission according to definitions given by the European League Against Rheumatism and the European Vasculitis Study Group. Outcomes were mortality, rate of remission, relapses, adverse events and prednisolone-dose.ResultsOut of 269 patients with suspected EGPA 150 fulfilled the inclusion criteria. Of those, 104 had more than one follow-up visit resulting in a mean follow up of 53±4.9 months. By using additional data sources the follow-up concerning survival was extended to 92±5 month. Severe organ manifestations occurred at heart (46%), kidney (18%) and lungs (10%). Cyclophosphamide was used in 107 patients (71%). The prednisolone-doses of all patients were within the targeted range (i.e. ≤7.5mg) in 69% of the total follow-up time; the median dose at end of follow-up was 5mg/d. The 10-year survival rate was 89% resulting in mortality comparable to the general population (SMR 1.29). Only patients with cardiac failure associated with EGPA had an increased mortality (SMR 3.06).ConclusionsRegular re-evaluation and target-orientated adaption of therapy may lead to normalization of life expectancy and attenuation of disease progression. Continued centre based interdisciplinary treatment should be standard of care.

Objectives This study sought to investigate the efficacy, safety, and antiplatelet effect of prasugrel as compared with clopidogrel in patients with high on-treatment platelet reactivity (HTPR) after elective percutaneous coronary intervention (PCI). Background The extent to which prasugrel can correct HTPR and improve clinical outcomes in patients undergoing elective PCI is unknown. Methods Stable coronary artery disease (CAD) patients with HTPR (>208 P2Y12 reaction units [PRU] by the VerifyNow test) after elective PCI with at least 1 drug-eluting stent (DES) were randomly assigned to either prasugrel 10 mg daily or clopidogrel 75 mg daily. Platelet reactivity of the patients on the study drug was reassessed at 3 and 6 months. The study was stopped prematurely for futility because of a lower than expected incidence of the primary endpoint. Results In 212 patients assigned to prasugrel, PRU decreased from 245 (225 to 273) (median [interquartile range]) at baseline to 80 (42 to 124) at 3 months, whereas in 211 patients assigned to clopidogrel, PRU decreased from 249 (225 to 277) to 241 (194 to 275) (p Conclusions Switching from clopidogrel to prasugrel in patients with HTPR afforded effective platelet inhibition. However, given the low rate of adverse ischemic events after PCI with contemporary DES in stable CAD, the clinical utility of this strategy could not be demonstrated. (Testing platelet Reactivity In patients underGoing elective stent placement on clopidogrel to Guide alternative thErapy with pRasugrel [TRIGGER-PCI]; NCT00910299)

Objectives Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. Background Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. Methods We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. Results Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. Conclusions Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly. © 2012 Wiley Periodicals, Inc.

Rotational atherectomy has been regaining interest over the last couple of years after it almost has disappeared from most interventional catheterization laboratories for several years due to failure to prove its original concept of improving long term results of percutaneous coronary interventions (PCI) as was repeatedly shown in studies in the 1990s. Its revival coupled the introduction of drug-eluting stents (DES); these devices have led to treating much more complex lesions and high-risk patients by PCI. However, real-world experience suggested that off-label use of DES is associated with a higher rate of early and late stent thrombosis. Therefore, more attention is now being paid to the initial implantation technique of DES including aggressive lesion preparation to facilitate stent delivery and expansion. The limited studies with rot-ablation and DES showed promising results with no long term safety concerns. In these studies, a subtle observation was made suggesting that rot-ablation prior to DES implantation in such lesions may have an add-on effect on long term outcome compared to DES alone. An ongoing multicenter study is investigating such effect among complex calcified coronary lesions. Even if this additive benefit does not prove true, rot-ablation remains an efficient tool for preparing certain lesions to facilitate effective and safe DES implantation. Therefore, interventional training programs should focus on this difficult technique to bridge the gap of experience which resulted from neglecting it for several years. In this regard, dedicated courses at experienced sites as well as medical simulation may be appropriate.

Aims Expansive vessel wall remodeling has been previously reported after implantation of drug-eluting stents. These abnormal vessel wall reactions (AVWR), though uncommon may be associated with serious clinical events. We report on a series of patients in whom symptoms developed despite patent stents. Methods and results We report a series of 10 consecutive patients with evidence of AVWR on angiography and/or intravascular ultrasonography after implantation of sirolimus-eluting stents (age 39-90 years, 4 females) during a period of 4 years. All patients were symptomatic despite patent stents in coronary angiographies done because of persistent chest pain. Four patients subsequently developed very late stent thrombosis (VLST). These 4 patients were only on aspirin monotherapy prior to the VLST. Of the remaining 6 patients, 3 patients underwent coronary interventions (with or without stenting) while the remaining 3 patients were managed conservatively. All 6 were advised for life-long dual antiplatelet therapy. Conclusion Though uncommon, AVWR might precede VLST. In our series, all patients were symptomatic despite patent stents. Additional studies are required to identify patients at risk and to determine the best treatment modality for this challenging new entity. Until further data become available, these patients should stay on dual antiplatelet therapy after an AVWR has been identified.

Background— The Bleeding Academic Research Consortium (BARC) has recently proposed a unified definition of bleeding in patients receiving antithrombotic therapy. We investigated the relationship between bleeding events as defined by BARC and 1-year mortality in patients undergoing percutaneous coronary intervention (PCI) and assessed whether the BARC bleeding definition is superior to existing bleeding definitions in regard to mortality prediction in patients after PCI procedures. Methods and Results— This study represents a patient-level pooled analysis of 12 459 patients recruited in 6 randomized trials of patients undergoing PCI. Bleeding events were assessed with the use of BARC, Thrombolysis in Myocardial Infarction (TIMI), and Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial criteria. The primary outcome was 1-year mortality. Bleeding occurred in 1233 patients (9.9%) according to BARC (679 patients or 5.4% with BARC class ≥2 bleeding), in 374 patients (3.0%) according to TIMI, and in 491 patients (3.9%) according to REPLACE-2 criteria. There were 340 deaths (2.7%) over the first year after PCI. BARC class ≥2 bleeding was associated with a significant increase in 1-year mortality (adjusted hazard ratio 2.72; 95% confidence interval, 2.03–3.63). The predictivity of a multivariable model for 1-year mortality was significantly improved after inclusion of bleeding defined according to BARC to an extent comparable to that provided by TIMI and REPLACE-2 criteria. Conclusions— The present study demonstrated a close association between bleeding events defined according to BARC and 1-year mortality after PCI.

Background: Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug-eluting stents (DES). We sought to investigate 1-year outcome of the treatment of bifurcation lesions using DES in a large “real-world” cohort. Methods and Results: Among 5,126 patients enrolled in phase I of the multicenter German Drug-Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1-year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum-defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively). Conclusion: In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1-year outcomes after DES implantation. The outcomes for SES and PES were similar. (J Interven Cardiol 2012;25:344–352)

Coronary artery disease negatively affects the outcome of patients undergoing surgical aortic valve replacement and practice guidelines recommend revascularization at time of surgery. In patients undergoing transcatheter aortic valve implantation (TAVI), the impact of preprocedural percutaneous coronary intervention (PCI) on TAVI outcome has not been examined. We aimed in the present study to assess the feasibility and safety of performing PCI before TAVI and to evaluate procedural, 30-day, and 6-month clinical outcomes. We retrospectively analyzed 125 patients who underwent successful TAVI at a single institution and divided them into an isolated TAVI and a PCI + TAVI group. During the study period, a strategy of preprocedural PCI of all significant (>50%) lesions in major epicardial vessels was adopted. Study end points were adjudicated in accordance with the Valve Academic Research Consortium consensus on event definition. All patients were treated with the Medtronic CoreValve prosthesis (n = 55 with PCI + TAVI and n = 70 with isolated TAVI). Thirty-day mortality was 2% versus 6% for patients treated with PCI + TAVI versus isolated TAVI, respectively (p = 0.27). Neither periprocedural nor spontaneous myocardial infarction occurred in either group. Rates of 30-day stroke, major bleeding, major vascular complications, and the Valve Academic Research Consortium–defined combined safety end point (11% vs 13%, p = 0.74) did not differ between the 2 groups. Patients' symptoms significantly improved in the first month after TAVI, and extent of improvement did not differ between groups. Adverse events at 6 months were comparable. In conclusion, PCI before TAVI appears feasible and safe. Based on these early results revascularization should become an important consideration in patients with coronary artery disease undergoing TAVI.

Angioplasty with drug-coated balloons (DCB) is recommended for treatment of coronary in-stent restenosis (ISR) in European clinical practice guidelines. However there is a paucity of study data comparing different DCB devices. Our aim was to compare the performance of two widely-used paclitaxel

Bypass-graft intervention was associated with worse outcomes in the bare-metal stent era. Without sufficiently powered data from subgroup analyses, and in absence of randomized controlled trials targeting clinical endpoints, controversy is ongoing over safety and efficacy of drug-eluting stents (DES) in saphenous vein graft (SVG) lesions. Between October 2005 and October 2006, 5,183 patients receiving DES in SVG (n = 251) or native coronary arteries (NCA) (n = 4,932) were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target-vessel revascularization (TVR) were defined as primary endpoints. Baseline clinical and descriptive morphology of coronary artery disease revealed more severe lesions and comorbidities in the SVG group. At 1-year follow-up, the SVG group suffered from higher rates of overall death (6.6 vs. 2.5%; p

Objectives This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year. Background A “pro-healing” approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions. Methods We undertook an international, clinical trial in 26 centers planning to randomize 1,300 patients with stable coronary artery disease and with a high risk of restenosis between treatment, with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was higher and treatment of new patients with an ECS would be unreasonable. Results At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority). Conclusions Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression.

Aims: Treatment of in-stent restenosis (ISR) was historically considered the Achilles heel of percutaneous coronary intervention (PCI) and has been associated with worse clinical outcome than PCI of de novo lesions. However, comparative data on ISR and de novo lesions using drug-eluting stents (DES) are scarce. Therefore, we aimed to assess the impact of ISR on procedural and long-term outcome in patients treated with DES. Methods and results: We analysed data from 5,144 patients enrolled in the prospective multicentre German Drug-Eluting Stent Registry (DES.DE). The registry included 872 patients (17) treated for ISR with follow-up data (median 12.4 months) available for 817 patients (94). Of the ISR patients, 37.1 (n=323) presented with acute coronary syndromes. In total, 1,027 DES were used (528 sirolimus-eluting stents and 499 paclitaxel-eluting steins), with successful implantation in 97.7 of patients. In the ISR cohort, myocardial infarction (MI) during hospitalisation was observed in 1.6 of patients (n=14) and in-hospital mortality was only 0.3 (n=3). Major adverse cardiac and cerebrovascular events (MACCE) rate at follow-up (defined as a composite of death, MI and stroke) was 8.7 (n=71) versus 8.2 (n=325) in patients treated for de novo lesions (p=0.63). Target vessel revascularisation (TVR) rate was 12.7 (n=100), numerically higher than in patients with de novo,0 lesions (10.5, p=0.07). Ten patients (1.3) suffered from ARC definite stent thrombosis versus 0.7 observed in patients with de novo lesions (p=0.13). After adjustment for differences in baseline characteristics, TVR rates were statistically higher in the ISR cohort (OR 1.27, 95CI 1.01-1.61, p=0.04), while MACCE rates remained comparable (OR 1.10, 95CI 0.83-1.44, p=0.51). The type of stent used (sirolimus vs. paclitaxel-eluting stent) did not impact the rate of MACCE, TVR or definite stent thrombosis at one year. Conclusions: Results from this large prospective multicentre registry confirm that treatment of ISR with DES is effective and safe, with similar procedural outcome but slightly higher revascularisation rates at one year compared to patients treated for de novo lesions, with no differences in outcome between sirolimus- and paclitaxel-eluting stents.

Objectives The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES). Background Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients. Methods Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into “complex” and “simple.” Results Of 2,292 patients, 1,520 (66.3%) were complex and treated with ZES (n = 764) or EES (n = 756). Event rates were higher among complex patients, and results did not differ between ZES and EES, regardless of complexity. At 1 year, target lesion failure was 8.9% in ZES- and 9.7% in EES-treated complex patients (p = 0.66) and 6.8% in ZES- and 5.7% in EES-treated simple patients (p = 0.55). Rates of cardiac death (1.3% vs. 2.2%, p = 0.24), target-vessel myocardial infarction (4.3% vs. 4.4%, p = 0.90), and clinically indicated target lesion revascularization (4.4% vs. 4.0%, p = 0.80) were similar for both stent types among complex patients. Definite or probable stent thrombosis occurred in 20 (1.3%) complex patients with no difference between ZES (1.7%) and EES (0.9%, p = 0.26). Angiographic follow-up showed similar results for ZES and EES in terms of in-stent percentage diameter stenosis (22.2 ± 15.4% vs. 21.4 ± 15.8%, p = 0.67) and in-segment binary restenosis (6.6% vs. 8.0%, p = 0.82) in the complex group. Conclusions In this all-comers randomized trial, major adverse cardiovascular events were more frequent among complex than simple patients. The newer-generation ZES and EES proved to be safe and effective, regardless of complexity, with similar clinical and angiographic outcomes for both stent types through 1 year. (RESOLUTE-III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084 )

Objectives This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents. Background The SXscore can identify patients treated with PCI who are at highest risk of adverse events. Methods The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscoreLOW ≤9 (n = 698), 9 17 (n = 659). Results At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscoreHIGH tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p Conclusions The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084)

Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited.We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter 2.5 or 3.5 mm.Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62-1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78-1.42).In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.

Objective: To determine whether statin therapy influences the efficacy of thrombin inhibitor bivalirudin or unfractionated heparin (UFH) during PCI. Setting and patients: The post-hoc analysis of the ISAR-REACT 3 Trial included 4,570 patients: 3,106 patients were on statin therapy and 1,464 patients were not on statin therapy at the time of PCI procedure. Main outcome measures: The primary outcome of this analysis was the 30-day composite of death, myocardial infarction, target vessel revascularization (TVR) or major bleeding. Results: The primary outcome occurred in 7.9% patients (n=246) in the statin group versus 9.8% (n=143) in the non-statin group (P=0.036). There was an interaction in univariate (P=0.028) and multivariable (P=0.026) analysis between pre-PCI statin therapy and the type of antithrombotic therapy regarding myocardial infarction. In the statin group, bivalirudin significantly reduced the incidence of major bleeding (2.6 vs. 4.3%, P=0.013) with no significant difference in the incidence of myocardial infarction (4.9 vs. 5.2%; P=0.73) compared with UFH. In the non-statin group, bivalirudin was inferior to UFH regarding the incidence of myocardial infarction (7.1 vs. 4.1%, P=0.013), yet major bleeding remained lower among bivalirudin-treated patients (4.0 vs. 5.2%, P=0.25). Conclusion: This post-hoc analysis suggests the existence of an interaction between statin therapy before PCI and antithrombotic therapy during PCI. Patients receiving bivalirudin therapy at the time of PCI showed less periprocedural myocardial infarction when on pre-PCI statin therapy which has to be investigated in further studies

Cigarette smoking strongly increases morbidity and mortality from cardiovascular causes, but the relevance of smoking in patients treated with drug-eluting stents (DES) is unknown. To assess the impact of smoking on the presentation and outcome of patients treated with DES. We analyzed data from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE) and identified 1,122 patients who had never smoked and 1,052 patients who were current smokers. Smokers were younger (56.5 vs. 69.4 years, p

The aminosteroid 1-[6-({17beta-3-methoxyestra-1,3,5(10)-trien-17-yl}amino)hexyl]-1H-pyrrole-2,5-dione (U73122) has been extensively used as a pharmacologic inhibitor of phospholipase C (PLC). The inhibitory effect of U73122 on PLC activity is most likely the result of decreased availability of phosphatidylinositol 4,5-bisphosphate (PIP2), the substrate of the PLC signal transduction pathway, rather than direct inhibition of the enzyme. PIP2 is a phospholipid with pleiotropic cellular functions, including a pivotal role in regulating cardiac phospholipase D (PLD) signal transduction. Here, we hypothesized that U73122 acts as an inhibitor of cardiac PLD activity by interference with PIP2. U73122 concentration-dependently inhibited PLD activity in rat myocardial membranes. The inhibitory effect of U73122 was significantly attenuated when assayed on solubilized PLD activity and was completely restored if solubilized PLD activity was assayed in the presence of PIP2. U73122 had no inhibitory effect on purified PLD indicating that the substance does not interact with PLD directly. These data highlight a mechanism of action of U73122 as an inhibitor of myocardial PLD by interaction with PIP2 as a cofactor for optimal PLD activity. Hence, studies using U73122 as a specific inhibitor of PLC have to take into account that PLD may be involved in some of the effects ascribed to PLC.

Patients with diabetes mellitus are known to be at increased risk for acute cardiovascular events. We used intravascular ultrasound virtual histology (IVUS-VH) to examine whether nonobstructive coronary artery lesions of diabetic patients have distinct plaque composition and morphology compared with nondiabetic patients.A total of 41 patients (13 diabetic and 28 nondiabetic) with proximally located angiographically nonobstructive coronary lesions were prospectively enrolled. In addition to plaque geometry, IVUS-VH lesion evaluation of the fibrous, fibro-fatty, necrotic core and calcified plaque components was performed. An IVUS-derived thin-cap fibroatheroma (IDTCFA) was defined as a lesion with a confluent necrotic core of at least 10% lumen cross-sectional area without evident overlying fibrous tissue and a plaque atheroma volume of at least 40% in at least three consecutive frames.Coronary artery lesions of diabetic and nondiabetic patients had similar plaque geometry. Lesions of diabetic patients were more likely to be positively remodeled than those of nondiabetic patients (67 vs. 27%, respectively, P = 0.02). Plaques of diabetic patients had significantly higher necrotic core percentages (23.3 +/- 6.1 vs. 17.1 +/- 8.7%, P = 0.03) and lower fibro-fatty tissue percentages (8 +/- 5 vs. 14.2 +/- 7.5%, P = 0.01) than those of nondiabetic patients. In addition, IDTCFAs were significantly more prevalent at the minimal lumen area site of diabetic patients compared to nondiabetic patients (92 vs. 54%, respectively, P = 0.02). After adjustment for various confounders, diabetes mellitus remained as the only independent clinical predictor of IDTCFAs at the minimal lumen area site [odds ratio (OR) 9.43, 95% confidence interval (CI) 1.06-84.04, P = 0.04].Nonobstructive coronary artery lesions of diabetic patients have distinct compositional and morphological features, suggesting that these differences may explain the increased likelihood of coronary events in diabetic patients.

Aims: Assessment of health related quality-of-life (HRQL) has become increasingly important as not only the clinician's view of the technical success, but also the patient's perception is being measured. We evaluated the HRQL following sirolimus-eluting coronary stent (SES) (CYPHER®; Cordis, Johnson & Johnson, Warren, NJ, USA) implantation in patients with multivessel disease, comparing the outcomes with the historical surgical and bare metal stent (BMS) arms of the ARTS-I study. Methods and results: The HRQL outcomes were compared to the outcome of the historical cohorts of the randomised ARTS-I trial using the same inclusion and exclusion criteria. HRQL was evaluated at baseline, at one month and at 6, 12 and 36 months after revascularisation using the SF-36 in patients treated with SES (n=585), BMS (n=483) or coronary artery bypass graft (CABG) (n=492). The HRQL compliance rates varied from 100% at baseline to 92% at 36 months. Both stenting and CABG resulted in significant improvement of HRQL and anginal status. There was a trend towards better HRQL after CABG than BMS beyond six months. Already from the first month up to three years, SES patients had, on average, 10% significantly better HRQL than BMS patients on the HRQL subscales physical functioning, role physical functioning, role emotional functioning and mental health (p

Recent trials in multivessel STEMI patients show that a strategy of complete revascularization in the acute or sub-acute phase guided by angiography (PRAMI, CvLPRIT) or FFR (PRIMULTI, COMPARE-ACUTE) improves the composite endpoint of MACE in comparison to an infarct related artery (IRA) only

Udgivelsesdato: 2010-Mar-19 Background: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. Results: The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

atsklinikum, Kardiologie, Rostock Aims: Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent “off-label” use data from “real life,” registries are necessary to monitor indications and outcome of DES in daily clinical practice. Methods and Results: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 ± 0.41 SES were implanted with a mean length of 21.1 ± 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: twoor three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery. Conclusions: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters. (J Interven Cardiol 2009; ∗∗ :1–8)

BACKGROUND New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. METHODS In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. RESULTS At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P

The prospective multicenter German Drug-Eluting Stent (DES.DE) registry is an observational study to analyze and evaluate the therapeutic principle of the differential drug-eluting stents (sirolimus- and paclitaxel-eluting stents) and bare metal stents under real world conditions in the context of the German healthcare system. The baseline clinical and angiographic characteristics and follow-up events for 1 year were recorded for all enrolled patients. In addition, a health economics assessment was performed at 3, 6, 9, and 12 months after initial stent placement. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, and target vessel revascularization were used as the primary objectives. From October 2005 to October 2006, 6,384 patients were enrolled (sirolimus-eluting stents, n = 2,137; paclitaxel-eluting stents, n = 2,740; bare metal stents, n = 485) at 98 Deutsches Drug-Eluting Stent Register sites. With similar baseline clinical and descriptive morphology of coronary artery disease between both drug-eluting stent groups, no differences were present at 1 year of follow-up in the rates of overall mortality (3.8% vs 4.1%), target vessel revascularization (10.4% vs 10.4%), overall stent thrombosis (3.6% vs 3.8%), and major adverse cardiac and cerebrovascular events (8.1% vs 8.0%). Compared with the bare metal stent group, patients treated with drug-eluting stents had significantly lower rates of myocardial infarction (3.2% vs 6.0%; p

The development of less invasive percutaneous techniques for aortic valve replacement to treat high-risk patients with severe aortic stenosis is a new challenge for cardiovascular therapists. Currently, there are two catheter-based treatment systems in clinical application (the Edwards SAPIEN aortic valve and the CoreValve ReValving System) utilizing either a balloon-expandable or a self-expanding stent platform, respectively. The immediate outcome and the midterm follow-up results available for both techniques confirm the safety and the applicability of these treatment modalities.

Aims The aim of this study was to identify a subset of patients at high risk of bleeding or myocardial infarction from a percutaneous coronary intervention and to investigate whether such high-risk subsets derive preferential benefit from heparin or bivalirudin. Methods and results This study included 4570 patients with coronary artery disease enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment trial and randomized to receive bivalirudin or heparin. Primary outcomes were in-hospital incidence of major bleeding and 30-day incidence of myocardial infarction. Major bleeding, myocardial infarction, and bleeding plus myocardial infarction occurred in 140, 204, and 34 patients, respectively. Older age, female sex, lower body weight, low cholesterol, multi-lesion intervention, complex lesions, and heparin therapy were independent correlates of increased risk of bleeding. Multi-lesion intervention, unstable angina, and lower body weight correlated independently with increased risks of myocardial infarction. Compared with heparin, bivalirudin was associated with a reduction in major bleeding (3.1 vs. 4.6%, P = 0.008), but mostly in low-risk patients. A reduction in the bleeding risk inversely correlated with an increase in the risk of myocardial infarction with bivalirudin ( R = −0.61). Conclusion Bivalirudin and unfractionated heparin have a differential effect on risk of bleeding and myocardial infarction across various subsets of patients.

The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs ( 2 ), 289 were overweight (≥25 and ≤30 kg/m 2 ), and 142 were obese (>30 kg/m 2 ). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II.

Phosphatidic acid phosphohydrolase (PAP) catalyzes the dephosphorylation of phosphatidic acid (PA) to diacylglycerol, the second messenger responsible for activation of protein kinase C. Despite the crucial role of PAP lipid signaling, there are no data on PAP signaling function in the human heart. Here we present a nonradioactive assay for the investigation of PAP activity in human myocardium using a fluorescent derivative of PA, 2-(4,4-difluoro-5,7-dimethyl-4-bora-3a,4a-diaza-s-indacene-3-pentanoyl)-1-hexadecanoyl-sn-glycero-3-phosphate (BODIPY-PA), as substrate in an in vitro PAP-catalyzed reaction. Unreacted BODIPY-PA was resolved from the PAP products by a binary gradient HPLC system and BODIPY-diacylglycerol was detected by fluorimetry. The reaction proceeded at a linear rate for up to 60 min and increased linearly with increasing amounts of cardiac protein in a range of 0.25 to 8.0 microg. This assay proved to be sensitive for accurate quantitation of total PAP activity, PAP-1 activity, and PAP-2 activity in human atrial tissue and right ventricular endomyocardial biopsies. Total PAP activity was approximately fourfold higher in ventricular myocardium than in atrial tissue. There was negligible PAP-1 activity in atrial myocardium compared with ventricular myocardium, indicating regional differences in activities and distribution pattern of PAP-1 and PAP-2 in the human heart.

AIMS Identification of subclinical high-risk plaques is potentially important because they may have greater likelihood for rupture and thrombosis. The aim of this study was to assess the relationship between in vivo coronary artery plaque composition using intravascular ultrasound virtual histology (IVUS-VH) and cardiovascular risk as predicted by clinical risk scores in patients with non-obstructive stable coronary artery disease. METHODS AND RESULTS Forty patients undergoing elective coronary angiography revealing

Aims: Late stent thrombosis has been documented in on- and off-label populations. Stent thrombosis is more frequently in higher risk patients and there is still scarce data about the impact on late adverse cardiac events. The aim therefore is to determine the 3-year safety and effectiveness of Sirolimus-Eluting Stent (SES) (Cypher®) implantation in patients with multivessel disease and to compare outcomes with the historical results of the two arms of the Arterial Revascularisation Therapies Study (ARTS-I). Methods and results: ARTS-II is a 45 centre, 607 patient single-arm study. Three years outcomes were compared to the outcome of the historical cohorts of ARTS-I using the same inclusion and exclusion criteria and major adverse cardiac and cerebrovascular events (MACCE) definitions. Patients were stratified by clinical site to ensure that at least 1/3 had 3-vessel disease to achieve a number of treated lesions per patient comparable to ARTS-I. Stent thrombosis was re-adjudicated using the ARC definitions. An angiographic coronary score to characterise lesion complexity was applied to allow the identification of patients who might benefit the most from multivessel stenting. In ARTS-II, 46.6% of the patients underwent 3-vessel treatment as compared to 18.0% in ARTS-1 percutaneous coronary intervention (PCI) (n=600) with bare metal stents (BMS). Diabetes was present in 26.2% in ARTS-II as compared to 17.3% in ARTS-I. In ARTS-II, patients received on average 3.7 stents resulting in a mean total stented length of 72.5 mm. The 3-year survival rate in ARTS-II was 97.0%, comparable to the 95.6% and 96.0% of the historical surgical (n=605) and PCI cohorts of ARTS-I. The death/cerebrovascular accident (CVA)/myocardial infarction (Ml) event free survival rate in ARTS-II was 91.7%, versus 89.1% (p=0.1) and 87.2% (p=0.007) in ARTS-I coronary artery bypass graft (CABG) and PCI cohorts, respectively. Freedom from revascularisation in ARTS-II was 85.5%, lower than in ARTS-I CABG (93.4%; p

Summary Patients with established coronary artery disease (CAD) were recruited in 11 hospitals and randomized to an intervention (telemedicine system; n = 752) or a control group (usual medical care; n = 748). On the day before discharge, patients in the intervention group were equipped with a 12-lead event recorder and trained to use the device. Whenever they had symptoms, they could contact the call centre, transmit an ECG (without redialling) and consult a physician. During a 12-month study, 171 patients (23%) in the intervention group contacted the call centre, a total of 269 times. The main reasons for calling were chest pain and radiating pain. Pathological changes were seen in 24% of the transmitted ECGs. Only 23% of the calls were made in the first hour after onset of symptoms and a further 12% in the subsequent hour, suggesting that patients should be encouraged to use ECG transmission at an earlier stage. At follow-up, 157 patients (21%) had had at least one recurrent cardiac event (myocardial infarction, cardiac hospital stay, re-vascularization). The proportion was significantly higher in telemedicine users (35%) than in non-users (17%), P < 0.001. Regardless of utilization, the majority of the intervention patients considered that the telemedicine system was helpful (users = 93%, non-users = 89%; P = 0.095).

Die koronare Revaskularisation durch perkutane Koronarintervention (PCI) hat in den vergangenen 2 Jahrzehnten eine rasante Entwicklung erfahren und kann aufgrund technischer und medikamentoser Fortschritte oftmals sogar eine Bypassoperation ersetzen. Mit dem Einsatz Medikamente freisetzender Stents (DES) haben sich in den letzten Jahren die klassischen Bypassindikationen aufgelost, und die Grenzen verschieben sich zugunsten der Koronarintervention – wobei eine kritische Abwagung prozeduraler und patientenindividueller Risiken wichtig bleibt. Therapieentscheidungen konnen durch invasive Masnahmen wie intravaskularen Ultraschall oder Druckdraht lasionsspezifisch und sofort getroffen werden. Der Uberblick soll das aktuelle Potential der Koronarintervention zusammenfassen, so dass auch der nicht interventionell tatige Arzt durch Kenntnis von Moglichkeiten und Grenzen seinen Patienten beraten und die geeignete Behandlung bahnen kann.

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

In this retrospective study we reviewed our results of secondary surgery for complications after emergency placement of aortic stents for acute type B dissection. From October 2000 to June 2006, endovascular stent-grafting (ESG) was performed in 13 patients as an emergency procedure for acute type B dissection. Self-expanding nitinol stents (mean diameter 39.8+/-4.7 mm) were placed into the descending aorta distal to the left subclavian artery. In-hospital mortality was 15.4% (2/13) and related to persistent visceral malperfusion. Three patients (23%) required consecutive open surgery of the thoracic aorta after emergency endovascular stent-grafting for acute type B dissection. Indications for surgery included acute development of retrograde type A aortic dissection and acute stent dislocation by fractured wires and secondary leakage. Elective surgery was necessary in one patient 6 months after stent-grafting for late formation of an aneurysm of the descending aorta. There were no deaths or major morbidity after surgery of the thoracic aorta early or during follow-up. Mean follow-up was 38.0+/-13.9 months (range 1-70 months) and complete. We conclude from our study that stent-grafting of the descending aorta is a feasible, relatively safe and effective approach even in the emergency treatment of patients with complicated acute type B dissection. However, in a relevant number of patients emergency stent-grafting for acute type B aortic dissection results in complications that require secondary surgical treatment.

Relaxation techniques are established in managing of cardiac patients during rehabilitation aiming to reduce future adverse cardiac events. It has been hypothesized that relaxation-training programs may significantly improve cardiac autonomic nervous tone. However, this has not been proven for all available relaxation techniques. We tested this assumption by investigating cardiac vagal modulation during yoga.We examined 11 healthy yoga practitioners (7 women and 4 men, mean age: 43 ± 11; range: 26–58 years). Each individual was subjected to training units of 90 min once a week over five successive weeks. During two sessions, they practiced a yoga program developed for cardiac patients by B.K.S. Iyengar. On three sessions, they practiced a placebo program of relaxation. On each training day they underwent ambulatory 24 h Holter monitoring. The group of yoga practitioners was compared to a matched group of healthy individuals not practicing any relaxation techniques. Parameters of heart rate variability (HRV) were determined hourly by a blinded observer. Mean RR interval (interval between two R-waves of the ECG) was significantly higher during the time of yoga intervention compared to placebo and to control (P< 0.001 for both). The increase in HRV parameters was significantly higher during yoga exercise than during placebo and control especially for the parameters associated with vagal tone, i.e. mean standard deviation of NN (Normal Beat to Normal Beat of the ECG) intervals for all 5-min intervals (SDNNi,P< 0.001 for both) and root mean square successive difference (rMSSD,P< 0.01 for both). In conclusion, relaxation by yoga training is associated with a significant increase of cardiac vagal modulation. Since this method is easy to apply with no side effects, it could be a suitable intervention in cardiac rehabilitation programs.

In myocardial infarction without cardiogenic shock (CS), the affected coronary vessel has significant influence on the final infarct size and patient prognosis. CS data on this relation are scarce. The objective of this study was to determine the prognostic relevance of the culprit lesion location in patients with CS complicating acute myocardial infarction. In the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial patients with CS were randomized to therapy with intraaortic balloon pump or control. Additional CS patients not eligible for the randomized trial were included in a registry. We compared the location of the culprit lesions in these patients with regard to the affected coronary vessel [left main (LM), left anterior descending (LAD), left circumflex (LCX) and right coronary artery (RCA)] and location within the vessel (proximal, mid or distal) regarding short- and long-term outcome. Of 758 patients, the majority had the culprit lesion in the LAD (44 %) compared to RCA (27 %), LCX (19 %) or LM (10 %). Proximal lesions were more frequent than mid or distal culprit lesions (60 vs. 27 vs. 13 %, p

Aims: The aim of this post hoc subgroup analysis of the Intraaortic Balloon Pump in Cardiogenic Shock II trial was to compare the clinical outcome of patients treated with either clopidogrel or the newer, more potent P2Y 12 receptor inhibitors prasugrel or ticagrelor. Methods and results: The primary endpoint was one-year mortality with respect to different P2Y(12) receptor inhibitors. Secondary safety endpoints were GUSTO bleedings until hospital discharge. After exclusion of 117 patients (patients who died before or during PCI, patients with unavailable information on P2Y(12) receptor inhibitor treatment, patients not receiving or receiving a combination of different P2Y(12) receptor inhibitors as acute antiplatelet therapy), 483 patients were analysed. Of these, 373 patients (77.2%) received clopidogrel and 110 patients (22.8%) either prasugrel or ticagrelor as acute antiplatelet therapy. The adjusted rate of mortality did not differ between prasugrel/ticagrelor and clopidogrel treated patients (HR: 0.83, 95% CI: 0.59-1.19, p(adj) = 0.31). GUSTO bleedings did not differ between groups (14.3% for prasugrel/ ticagrelor and 16.4% for clopidogrel, HR: 0.91, 95% CI: 0.55-1.5, p(adj) = 0.7). Conclusions: This IABP-SHOCK II trial subgroup analysis shows that the use of potent P2Y 12 receptor inhibitors like prasugrel or ticagrelor is feasible and might not be harmful in selected patients with cardiogenic shock complicating acute myocardial infarction. However, the superiority in comparison to clopidogrel remains to be proven.

Background: Everolimus-eluting bioresorbable scaffolds (BRS) have thick struts, which could influence shear stress and neointimal formation. According to a previous report, the implantation of overlapping BRS has been associated with delayed coverage at 28-days after BRS implantaion. The aim of the present study was to investigate the relationship between BRS overlap and neointimal formation at long-term, using optical coherence tomography (OCT). Method: 32 patients (35 lesions) treated with overlapping BRS underwent follow-up OCT at 11.8±3.0 months after percutaneous coronary intervention. Neointimal area and %uncovered strut were analyzed by OCT at the overlapping BRS site (OBS), non-overlapping proximal and distal BRS sites (NOPBS and NODBS, respectively). Neointimal area was defined as scaffold area - [lumen area + black box (strut)]. %neointimal area was defined as the neointimal areaх100/ scaffold area. In addition, we evaluated the frequency of inter-strut invaginations (hollows) at OBS and non-overlapping sites, which have been suggested as a marker of abnormal vascular reactions to the eluted drug and/or the polymer. Hollows were counted if they exsisted in-between and outside apposed BRS struts. Result: Mean stent diameter and length of overlapped distal BRS and proximal BRS were 2.96±0.39 and 23.1±6.4mm, and 3.11±0.39 and 19.5±6.4mm, respectively. Mean overlap length of BRS was 2.5±1.3mm. At follow-up, %neointimal area was significantly higher at OBS compared to NODBS and NOPBS (35.1±7.8 vs. 20.1±6.2 vs. 21.3±7.6%, respectively, p=0.01). No correlation was observed between the overlap length and %neointimal area. Additionally, %uncovered strut of NODBS and NOPBS was similar to that of OBS. However, the frequency of hollows in OBS was significantly higher than in both NODBS and NOPBS (0.54±0.52 vs. 0.14±0.18 vs. 0.15±0.28/cross-section, respectively, p=0.02). Conclusion: The site of BRS overlap is associated with increased neointimal proliferation one year after implantation, which could be particularly important in patients with small vessels or diffuse coronary disease. Signs of abnormal vascular reactions might be more frequently observed at the site of overlapping BRS compared to non-overlapping site.

Background: Previous studies have described different patterns of neointimal coverage between the outer wall and inner wall at coronary bifurcations lesions (BL) treated with metallic drug-eluting stents (DES) due to endothelial shear stress. Everolimus-eluting bioresorbable scaffolds (BRS) have thicker struts and could therefore have a stronger influence on endothelial shear stress compared to DES. However, the neointimal coverage of BL treated with BRS has not been adequately studied. We sought to evaluate the vascular response to BRS struts deployed at BL using optical coherence tomography (OCT). Methods: 50 patients (64 lesions) underwent follow-up OCT 11.0 ± 2.1 months after BRS implantation. Cross-sectional area of BL with a side branch more than 1mm using OCT was analyzed every 200μm. All images were divided into 3 regions according to shear stress: the 1/2 circumference of the vessel opposite to the ostium (OO), side branch ostium (SO), and the vessel wall adjacent to the ostium (AO). %uncovered strut of all struts and the averaged neointimal thickness (NIT) in 3 regions were evaluated. Additionally, to assess the impact of the side branch size on neointimal proliferation in BL, we calculated the ratio of the diameter of side branch ostium (Ds) to the diameter of main branch (Dm) (Ds/Dm) and divided patients into two groups based on median value of Ds/Dm of 0.318 as follow: large ratio side branch group (LRSB, n=32) and small ratio side branch group (SRSB, n=32). Results: Mean BRS diameter and length were 3.01±0.37 and 20.7±5.5mm. Mean diameter of all side branches was 1.69±0.51mm. In all patients, there was a significant difference in NIT among 3 regions (OO, 121±66 vs. AO, 96±32 vs. SO, 82±43μm, p=0.03). A significant difference was shown in %uncovered strut among 3 regions (OO, 0.45 vs. AO, 1.5 vs. SO, 4.7%, p=0.03). Further, in LRSB group, there was a significant difference in NIT among 3 regions (OO, 130±63 vs. AO, 92±38 vs. SO, 75±39 μm, p=0.01), and a significant difference was shown in %uncovered strut among 3 regions (OO, 0.37 vs. AO, 2.0 vs. SO, 8.8%, p=0.01). Conclusion: Different patterns of neointimal coverage are observed between the outer wall and inner wall of BL treated with BRS. Neointimal coverage is least at and adjacent to large side branches.

Objects: Peri-strut low intensity areas (PLIA) surrounding stent struts on optical coherence tomography (OCT) images has been histologically related to the delayed healing and inflammation, and have been previously associated with neointimal proliferation particularly in first generation drug-eluting stent era. However, the relationship between PLIA and bioresorbable vascular scaffolds (BRS) implantation remains to be clarified. Methods: Of 149 patients treated with the everolimus-eluting BRS at a single institution and followed-up for at least 6 months, 38 patients (50 lesions) underwent follow-up coronary angiography including OCT 11.0 ± 2.1 months after BRS implantation. All patients were prescribed lifelong aspirin (100mg/d) and prasugrel (10mg/d) for at least 6 months. The mean- and percent- neointimal area were evaluated by OCT. PLIA was defined as a peri-strut region with a homogenous lower intensity appearance than the surrounding tissue on OCT images without significant signal attenuation and was graded as follows:grade 0, no PLIA; grade 1, Results: The frequency of any PLIA within the scaffold segment was 70.0% (35/50 scaffolds). Mean PLIA grade score was 0.72± 0.77 [Median value (interquartile range), 0.51 (0, 1.07)]. There were significant positive correlations between PLIA score and both mean- (R=0.55,p2 , p< 0.01 and 24.0±7.0 vs. 17.4±3.6 %, p< 0.01, respectively).Furthermore, when lesions were divided in 3 groups (group of PLIA score 0, N=15; group of 0< PLIA score, N=15), mean- and percent- neointima area were different among 3 groups (1.51±0.27 vs.1.66±0.39 vs.2.39±0.73 mm 2 , p Conclusion: The presence and extent of PLIA after BRS implantation on OCT imaging appeared to be significantly associated with neointimal formation.