Acceptance and safety of femoral versus radial access for percutaneous coronary intervention (PCI): results from a large monitor-controlled German registry (QuIK).

BACKGROUND: In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry. METHODS: The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization. RESULTS: From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009). CONCLUSION: Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention.

Oral anticoagulation in heart failure complicated by atrial fibrillation: A nationwide routine data study.

BACKGROUND: This nationwide routine data analysis evaluates if oral anticoagulant (OAC) use in patients with heart failure (HF) and atrial fibrillation (AF) leads to a lower mortality and reduced readmission rate. Superiority of new oral anticoagulants (NOACs), compared to vitamin K antagonists (VKA), was analyzed for these endpoints. METHODS: Anonymous data of patients with a health insurance at the Allgemeine Ortskrankenkasse and a claims record for hospitalization with the main diagnosis of HF and secondary diagnosis of AF (2017-2019) were included. A hospital stay in the previous year was an exclusion criterion. Mortality and readmission for all-cause and stroke/intracranial bleeding (ICB) were analyzed 91-365 days after the index hospitalization. Kaplan-Meier survival curves and multivariable Cox regression models were used to evaluate the impact of medication on outcome. RESULTS: 180,316 cases were included [81 years (IQR 76-86), 55.6% female, CHA2DS2-VASc score ≥ 2 (96.81%)]. In 80.6%, OACs were prescribed (VKA: 21.7%; direct factor Xa inhibitors (FXaI): 60.0%; direct thrombin inhibitors (DTI): 3.4%; with multiple prescriptions per patient included). Mortality rate was 19.1%, readmission rate was 29.9% and stroke/ICB occurred in 1.9%. Risk of death was lower with any OAC (HR 0.77, 95% CI [0.75-0.79]) but without significant differences in OAC type (VKA: HR 0.73, [0.71-0.76]; FXaI: HR 0.77, [0.75-0.78]; DTI: HR 0.71, [0.66-0.77]). The total readmission rate (HR 0.97, [0.94 to 0.99]) and readmission for stroke/ICB (HR 0.71, [0.65-0.77]) was lower with OAC. CONCLUSIONS: Nationwide data confirm a reduction in mortality and readmission rate in HF-AF patients taking OACs, without NOAC superiority.

Sirolimus-eluting stent treatment at high-volume centers confers lower mortality at 6-month follow-up: results from the prospective multicenter German Cypher Registry.

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

Coronary stenting with the sirolimus-eluting stent in clinical practice: final results from the prospective multicenter German Cypher Stent Registry.

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: two- or 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.

Prognostic value of the modified American College of Cardiology/American Heart Association lesion morphology classification for clinical outcome after sirolimus-eluting stent placement (results of the prospective multicenter German Cypher Registry).

The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.

Implantation of sirolimus-eluting stents in saphenous vein grafts is associated with high clinical follow-up event rates compared with treatment of native vessels.

AIMS: The clinical effectiveness of sirolimus-eluting stents (SES) for treatment of patients with saphenous vein graft disease is not well defined. This analysis sought to evaluate the clinical follow-up after treatment of stenotic saphenous vein grafts using SES in a large patient registry. Patients treated with SES for saphenous vein graft disease were compared with patients receiving SES in native vessel disease. METHOD: This is a subanalysis from the prospective multicenter German Cypher Stent Registry. Only patients with completed 6 months clinical follow-up were included. The analysis comprises 344 patients with 353 lesions in saphenous vein grafts treated with 400 SES (Cypher, Cordis Inc., Cordis Corp., Warren, New Jersey, USA) and 6411 patients with 7607 native coronary artery lesions treated with 8725 SES. RESULTS: Mean SES length per lesion was 22.6+/-11.7 mm and mean stent diameter 3.0+/-0.3 mm in saphenous vein graft lesions. Target vessel revascularization rate was 18.1% and major adverse cardiovascular events (MACE) rate was 23.8% at 6-month follow-up after SES implantation for saphenous vein graft lesions. Even after adjustment for different baseline characteristics, target vessel failure and MACE rate were significantly higher after SES implantation for saphenous vein graft lesions than for native coronary vessel stenosis [odds ratio: 2.10 (95% confidence interval: 1.40-3.13), P<0.001] and [odds ratio: 2.15 (95% confidence interval: 1.49-3.09), P<0.001], respectively. CONCLUSION: Treatment of saphenous vein graft disease is associated with high target vessel revascularization and MACE rates also with the use of SES if applied to unselected patients. Target vessel revascularization and MACE rates remain significantly higher after SES for saphenous vein graft lesions than after SES in native vessel disease.

High adherence to therapy and low cardiac mortality and morbidity in patients after acute coronary syndrome systematically managed by office-based cardiologists in Germany: 1-year outcomes of the ProAcor Study.

We aimed to assess patient acceptance and effectiveness of a 12-month structured management program in patients after an acute coronary syndrome (ACS) event who were treated in a special setting of office-based cardiologists. The program comprised patient documentation with a specific tool (Bundesverband Niedergelassener Kardiologen [German Federation of Office-Based Cardiologists] cardiac pass with visit scheduling) shared by the hospital physician and the office-based cardiologist, the definition of individual treatment targets, and the systematic information of patients in order to optimize adherence to therapy. Participating centers (36 hospitals, 60 office-based cardiologists) included a total of 1,003 patients with ACS (ST-segment elevation myocardial infarction [STEMI] 44.3%, non-ST-segment elevation myocardial infarction [NSTEMI] 39.5%, unstable angina pectoris [UA] 15.2%, and unspecified 1.0%). During follow-up, treatment rates with cardiac medication remained high in all groups, with dual antiplatelet therapy in 91.0% at 3 months, 90.0% at 6 months, and 82.8% at 12 months, respectively. Twelve months after the inclusion, a total of 798 patients (79.6%) still participated in the program. Eighteen patients (1.8%) had died after discharge from hospital (6 in the STEMI, 12 in the NSTEMI group), while for 58 the status was unknown (5.8%). Based on a conservative approach that considered patients with unknown status as dead, 1-year mortality was 7.6%. Recurrent cardiac events were noted in 14.9% at 1 year, with an about equal distribution across STEMI and NSTEMI patients. In conclusion, patients' acceptance of the ProAcor program as determined by adherence rates over time was high. Treatment rates of recommended medications used for patients with coronary heart disease were excellent. The 1-year mortality rate was comparatively low.

Drug-eluting stents in clinical routine: a 1-year follow-up analysis based on German health insurance administrative data from 2008 to 2014.

OBJECTIVES: To describe the use of drug-eluting stents (DESs) in the largest population of statutory health insurance members in Germany, including newly developed bio-resorbable vascular scaffolds (BVSs), and to evaluate 1-year complication rates of DES as compared with bare metal stents (BMSs) in this cohort. DESIGN: Routine data analysis of statutory health insurance claims data from the years 2008 to 2014. SETTING: The German healthcare insurance Allgemeine Ortskrankenkasse covers approximately 30% of the German population and is the largest nationwide provider of statutory healthcare insurance in Germany. PARTICIPANTS AND INTERVENTIONS: We included all patients with a claims record for a percutaneous coronary intervention (PCI) with either DES or BMS and additionally, from 2013, BVS. Patients with acute myocardial infarction (AMI) were excluded. MAIN OUTCOME MEASURE: major adverse cerebrovascular and cardiovascular event (MACCE, defined as mortality, AMI, stroke and transient ischaemic attack), bypass surgery, PCI and coronary angiography) at 1 year after the intervention. RESULTS: A total of 243 581 PCI cases were included (DES excluding BVS: 143 765; BVS: 1440; BMS: 98 376). The 1-year MACCE rate was 7.42% in the DES subgroup excluding BVS and 11.29% in the BMS subgroup. The adjusted OR for MACCE was 0.72 (95% CI 0.70 to 0.75) in patients with DES excluding BVS as compared with patients with BMS. In the BVS group, the proportion of 1-year MACCE was 5.0%. CONCLUSION: The analyses demonstrate a lower MACCE rate for PCI with DES. BVSs are used in clinical routine in selected cases and seem to provide a high degree of safety, but data are still sparse.

Predictors of death or myocardial infarction during follow-up after coronary stenting with the sirolimus-eluting stent. Results from the prospective multicenter German Cypher Stent Registry.

BACKGROUND: Drug-eluting coronary stents are the most recent "breakthrough" technology in interventional cardiology. Whereas risk factors influencing restenosis and need for target vessel revascularization are well known, risk factors for dying or developing a myocardial infarction (MI) after drug-eluting coronary stent implantation need to be evaluated yet. METHODS: We evaluated data from the German Cypher Stent Registry. RESULTS: From April 2002 to December 2004, 7445 patients at 122 hospitals, who received at least one sirolimus-eluting stent during percutaneous coronary intervention, were included. Complete follow-up at a median of 6.6 months (quartiles 6.1-8.1 months) was available in 6755 patients (91%). Death occurred in 1.8% (120/6755) of patients, nonfatal MI in 2.3% (156/6635), and death or MI in 4.1% (276/6755) of patients. Independent predictors of death or MI were initial presentation with ST-elevation MI or non-ST-elevation MI (OR [odds ratio] 2.21, 95% CI 1.66-2.95, P < .0001), cardiogenic shock (OR 3.05, 95% CI 1.67-5.55, P = .0003), renal insufficiency (OR 1.74, 95% CI 1.24-2.44, P = .0017), reduced left ventricular function (OR 1.74, 95% CI 1.21-2.50, P = .0027), age (per decade) (OR 1.19, 95% CI 1.05-1.36, P = .0058), diabetes mellitus (OR 1.39, 95% CI 1.05-1.84, P = .0183), 3-vessel disease (OR 1.32, 95% CI 0.99-1.77, P = .043), and prior MI (OR 1.35, 95% CI 1.01-1.80, P = .0468), whereas interventional and lesion characteristics showed no significant association. CONCLUSIONS: These results demonstrate that the most powerful predictors of death or MI after sirolimus-eluting stent implantation during percutaneous coronary intervention are presentation with an acute coronary syndrome, impaired left ventricular ejection fraction, and conventional risk factors for coronary heart disease. Interventional and lesion characteristics do not play a major role.

Transcatheter aortic valve implantation in obese patients: Overcoming technical challenges and maintaining adequate hemodynamic performance using new generation prostheses.

BACKGROUND: Second-generation TAVI prostheses may enhance the procedure reducing operative time and complications rate, maintaining adequate valve hemodynamic performance. We present our results with 2 new generation trans-catheter aortic valve (TAVI) prostheses in obese patients. METHODS: A series of 172 patients underwent trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, and LOTUS®). Two groups were identified according to body mass index (BMI): group NO (125) BMI<30kg/m(2) and group O (47) BMI≥30kg/m(2). RESULTS: Trans-femoral approach was possible in all patients without conversion to conventional surgery/cardiopulmonary bypass. Operative/fluoroscopy time and contrast use were comparable. Vascular and bleeding complications were also equally represented in the 2 groups. Thirty-day mortality was 7.2% in group NO and 6.4% in group O (p=0.9). At discharge, aortic regurgitation was absent/mild in 96% of group NO and in all patients in group O (p=0.3). Mild prosthetic stenosis was reported in 3.8% of the patients in group NO and 2.2% in group O. No moderate/severe prosthetic stenosis was reported. Estimated 1-year survival was 93.1% in group NO and 83.2% in group O (p=0.6). Estimated 1-year freedom from MACCE was 74.7% in group NO and 62.8% in group O (p=0.4). At follow-up echocardiography no significant differences were noticed in the 2 groups. CONCLUSIONS: Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient's body habitus, agile prosthesis placement will lead to optimized hemodynamics. Valve and clinical performance are confirmed at follow-up.

Revascularisation of patients with end-stage renal disease on chronic haemodialysis: bypass surgery versus PCI-analysis of routine statutory health insurance data.

OBJECTIVES: We aimed to analyse the short-term and long-term outcome of patients with end-stage renal disease (ESRD) undergoing percutaneous intervention (PCI) as compared to coronary artery bypass surgery (CABG) to evaluate the optimal coronary revascularisation strategy. DESIGN: Retrospective analysis of routine statutory health insurance data between 2010 and 2012. MAIN OUTCOME MEASURES: Primary outcome was adjusted all-cause mortality after 30 days and major adverse cardiovascular and cerebrovascular events at 1 year. Secondary outcomes were repeat revascularisation at 30 days and 1 year and bleeding events within 7 days. RESULTS: The total number of cases was n=4123 (PCI; n=3417), median age was 71 (IQR 62-77), 30.4% were women. The adjusted OR for death within 30 days was 0.59 (95% CI 0.43 to 0.81) for patients undergoing PCI versus CABG. At 1 year, the adjusted OR for major adverse cardiac and cerebrovascular events (MACCE) was 1.58 (1.32 to 1.89) for PCI versus CABG and 1.47 (1.23 to 1.75) for all-cause death. In the subgroup of patients with acute myocardial infarction (AMI), adjusted all-cause mortality at 30 days did not differ significantly between both groups (OR 0.75 (0.47 to 1.20)), whereas in patients without AMI the OR for 30-day mortality was 0.44 (0.28 to 0.68) for PCI versus CABG. At 1 year, the adjusted OR for MACCE in patients with AMI was 1.40 (1.06 to 1.85) for PCI versus CABG and 1.47 (1.08 to 1.99) for mortality. CONCLUSIONS: In this cohort of unselected patients with ESRD undergoing revascularisation, the 1-year outcome was better for CABG in patients with and without AMI. The 30-day mortality was higher in non-AMI patients with CABG reflecting an early hazard with surgery. In cases where the patient's characteristics and risk profile make it difficult to decide on a revascularisation strategy, CABG could be the preferred option.

Incidence and predictors of target vessel revascularization and clinical event rates of the sirolimus-eluting coronary stent (results from the prospective multicenter German Cypher Stent Registry).

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

Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group.

AIMS: Drug-coated balloon catheters (DCB) are a new clinical treatment modality for coronary and peripheral artery disease. The goal of the consensus group is to develop recommendations for the clinical use of DCB based on randomized clinical trials and the best available clinical evidence. The present paper gives an update on the recommendations against the background of a variety of new data published since the first paper was presented. METHODS AND RESULTS: The general concept of our recommendations for the coronary use of DCB includes the preparation of the lesion to facilitate drug delivery and to estimate the need for stent implantation, especially after relevant dissections. Lesion preparation includes conventional angioplasty. In more complex lesions, additional treatments and imaging or functional measurements are helpful. In case of no flow-limiting dissection and an acceptable but not stent-like primary result, DCB use without additional stent implantation may be considered. The proposed advantages of the DCB only concept over a direct stent approach include reduced restenosis rates in indications where DES show limited efficacy, the reduction of DAPT especially in patients with contraindications for prolonged DAPT, and the option of leaving no foreign object behind resulting in vascular restoration with potentially plaque regression instead of neo-atherosclerosis. CONCLUSIONS: DCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.

Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry.

AIMS: To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR). METHODS AND RESULTS: Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1 years was obtained in 5,247 patients (88.2 %). During the follow-up, death occurred in 9.2 % of patients, nonfatal myocardial infarction in 5.9 %, nonfatal stroke in 2.2 % and MACCE (death/myocardial infarction/stroke) in 16.3 %. Any TVR was performed in 20.3 %. Independent predictors of MACCE were: older age (p < 0.0001), renal insufficiency (p < 0.0001), prior myocardial infarction (p < 0.0001), diabetes mellitus (p < 0.0001), cardiogenic shock (p = 0.0002), three-vessel disease (p = 0.0012), reduced left ventricular function (p = 0.0048), target vessel = bypass graft (p = 0.0122), indication for treatment = ACS (p = 0.0181) and PCI before implantation (p = 0.0308). Independent predictors of TVR were target vessel = coronary bypass (<0.0001), two- or three-vessel disease (p < 0.0001), ostial lesions (p < 0.0001), total length of SES implanted (p = 0.0012) and older age being a protective factor (p = 0.0187). CONCLUSIONS: Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3 % and TVR rate of 20.3 %.

Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry.

BACKGROUND: Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting stents (SES) in this setting may be an option to be evaluated. METHODS AND RESULTS: We analysed the prospective multicentre SES registry, the German Cypher Stent Registry. 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% (P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients. CONCLUSIONS: The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.

Combined assessment of myocardial perfusion and late gadolinium enhancement in patients after percutaneous coronary intervention or bypass grafts: a multicenter study of an integrated cardiovascular magnetic resonance protocol.

OBJECTIVES: We sought to assess the accuracy of an integrated cardiac magnetic resonance (CMR) protocol for the diagnosis of relevant coronary artery or bypass graft stenosis in patients with suspected coronary artery disease (CAD) or with previously performed percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG). BACKGROUND: CMR is suitable for diagnosing inducible myocardial ischemia in patients with suspected CAD and has been proven to be a helpful diagnostic tool for decision of further treatment. However, little is known about its diagnostic accuracy in patients with known CAD who previously were treated by PCI or CABG. METHODS: A total of 477 patients with suspected CAD, 236 with previous PCI, and 110 after CABG referred for coronary X-ray angiography (CXA) underwent an integrated CMR examination before CXA. Myocardial ischemia was assessed using first-pass perfusion after vasodilator stress with adenosine (140 microg/kg/min for 3 min) using gadolinium-based contrast agents (0.1 mmol/kg). Late gadolinium enhancement (LGE) was assessed 10 min after a second contrast bolus. RESULTS: CXA demonstrated a relevant coronary vessel stenosis (> or =70% luminal reduction) in 313 (38%) patients using quantitative coronary analysis. The combination of CMR perfusion and LGE assessment for detecting a relevant coronary stenosis in patients with suspected CAD yielded sensitivity and specificity of 0.94 and 0.87, in PCI patients 0.91 and 0.90, and in CABG patients 0.79 and 0.77, respectively. CONCLUSIONS: A combined CMR protocol for the assessment of myocardial perfusion and LGE is feasible for the detection of relevant coronary vessel stenosis even in patients who previously were treated by PCI or CAG in a routine clinical setting. However, diagnostic accuracy is reduced in patients with CABG. This could be due to different flow and perfusion kinetic. Further studies are needed to optimize the clinical protocols especially in post-surgical patients.

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry.

AIMS: Drug-eluting stents have been reported to effectively reduce in-stent restenosis (ISR). However, the effectiveness and safety have yet been investigated only in small trials or case series. The aim of this prospective large scale registry was to show that treatment of ISR with sirolimus eluting stents (SES) is safe, effective and feasible in daily routine. METHODS AND RESULTS: The German Cypher registry prospectively enrolled 6,555 patients undergoing implantation with SES for various indications, including 1,533 patients treated for ISR. Follow-up data (median 6.6 months) of this cohort was available for 1,531 patients (99.8%). Of these patients 75.8% were male. Of these patients 36.5% (n = 552) presented with acute coronary syndromes. In total, 1,932 SES were used with successful implantation in 98.9%. MI during hospitalization was observed in 0.7% (n = 11) while in-hospital mortality was only 0.1% (n = 2). MACE-rate at follow-up was 13.8% (n = 211) including a mortality of 1.3% (n = 20) and MI in 1.9% (n = 29). Total revascularization procedures including CABG (1.7%) were necessary in 12.3% (n = 186). Target vessel revascularization (TVR) rate was 9.3% (n = 139) and thus similar to patients with de novo lesions (8.1%, P = 0.69). Ten patients (0.65%) suffered from subacute stent thrombosis Vs. 0.24% observed in patients with de novo lesions (P = 0.03). CONCLUSION: This large registry confirms that treatment of ISR with sirolimus-eluting-stents is effective and save with good clinical results at index procedure and follow-up. TVR was not different from de novo lesions.

Detection of cardiac small vessel disease by adenosine-stress magnetic resonance.

BACKGROUND: Patients testing positive for myocardial ischemia but without significant coronary artery (CA) stenosis in coronary angiography (CXA) are characterized as having "small vessel disease" (SVD). The aim of our study was to identify these patients by stress perfusion cardiac magnetic resonance (CMR). METHODS: 317 patients with suspected myocardial ischemia and clinical indication for CXA were scanned < 72 h before CXA in a whole-body 1.5T scanner. After 3 min of adenosine infusion (140 microg/kg/min), a myocardial first-pass perfusion sequence in 4-5 contiguous short-axis orientations using a Gadolinium-based contrast agent (0.1 mmol/kg) was performed. Images were analyzed qualitatively by two independent and blinded investigators. RESULTS: Perfusion deficits were detected in 93% of our patients. In 78% of patients with relevant perfusion delay, perfusion deficits extended to > 1/3 of the wall thickness in > or = 2 myocardial segments, persisted for > 5 heartbeats and were regarded as relevant coronary macroangiopathy. All of these patients had significant CA stenosis (60% had luminal narrowing > 70% and 18% had 50-70%). 22% of the patients had perfusion deficits affecting < or = 1/3 of wall thickness with persistence for < or = 5 heartbeats and were regarded as having SVD. None of these patients had a CA stenosis of > 50% or received CA revascularization. These patients more frequently had hypertension (p<0.0001), diabetes (p<0.05) and circumferential perfusion deficits (p<0.0001) than other patients. CONCLUSION: Stress perfusion CMR allows non-invasive differentiation between patients with significant CA stenosis and patients with SVD caused by hypertension and/or diabetes based on the temporal and spatial extent of perfusion deficits. Patients with SVD more often have diffuse perfusion deficits with shorter persistence than patients with significant CA disease.

Incidence and predictors of target vessel revascularization after sirolimus-eluting stent treatment for proximal left anterior descending artery stenoses among 2274 patients from the prospective multicenter German Cypher Stent Registry.

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