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BACKGROUND: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. AIMS: We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon. METHODS: In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon. CONCLUSIONS: In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. VISUAL SUMMARY: A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.

Aims: Aitken several studies have shown positive outcomes after the use of drug-coated balloons (DCB) for in-stmt restenosis (ISR), data on randomised controlled trials versus latest-generation drug-eluting stents (DES) are limited. Therefore, in this randomised trial, we sought to evaluate whether a butyryltri-hexyl citrate (BTHC)-based paclitaxel DCB is non-inferior to a biodegradable polymer sirolimus-eluting stem (BP-SFS) therapy in patients with ISR in either a bare metal stent (BMS) or DES. Methods and results: A total of 229 patients with ISR in BMS or DES from 13 German centres and one Latvian centre were 2:1 randomly allocated to DCB (n=157) or DES (n=72). The primary efficacy endpoint was defined as in-stent late lumen loss (LLL) at six months, and the primary safety endpoint was target lesion failure (TLF) at 12 months. LLL in the DCB arm was 0.03 +/- 0.40 mm compared to 0.20 +/- 0.70 mm in the DES arm (p=0.40). DCB proved to be non-inferior to DES (Delta=-0.17 +/- 0.52 mm, 97.5% CI -infinity;-0.01];p

Aims Long-term results of transcatheter aortic valve implantation (TAVI), in particular the incidence of bioprosthetic valve failure (BVF), are uncertain. This study presents data derived from a long-term, structured follow-up programme of the self-expanding CoreValve device utilising standardised definitions and core lab adjudication of valve performance. Methods and results The study prospectively included all 152 patients who had undergone TAVI with the self-expanding CoreValve up to December 2011 at the Heart Center, Bad Segeberg, Germany. Late BVF (>30 days) was defined as either: 1) severe structural valve deterioration (transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation), OR 2) bioprosthetic valve dysfunction leading to death or reintervention. Echocardiographic follow-up at 6.3±1.0 years (range: 5.0-8.9 years) was 88% complete (60 out of 68 survivors beyond five years) and all echocardiograms were analysed by an independent core laboratory. The all-cause mortality rate at 1, 2, 5, 6, 7 and 8 years was 14%, 20%, 50%, 60%, 65%, and 73%, respectively. Among survivors beyond five years, effective orifice area was 1.60±0.46 cm2, and transvalvular mean pressure gradient was 6.7±3.1 mmHg; no cases showed evidence of structural valve deterioration. Five patients (3.3%) had undergone redo TAVI (n=4) or surgery (n=1) 0.6 to 5.2 years after the index procedure, all due to paravalvular leakage. The estimated rate of BVF at eight years was 7.9% for the actuarial and 4.5% for the actual analysis. Conclusions Long-term follow-up up to 8.9 years after TAVI documents favourable performance of the self-expanding CoreValve with low rates of BVF.

AIMS The LEADERS FREE trial has demonstrated that a polymer-free Biolimus A9-coated stent (BA9-DCS) is superior to a bare metal stent (BMS) for high bleeding risk (HBR) patients when treated with one month of dual antiplatelet therapy (DAPT). This analysis aimed to determine the impact of PCI procedure complexity on the two-year results. METHODS AND RESULTS Six hundred and sixty-seven (667) patients enrolled in the LEADERS FREE (BA9-DCS 346, BMS 321) underwent a complex PCI, defined by one or more of eight characteristics: total stent length ≥60 mm, ≥3 vessels or lesions treated, ≥3 stents implanted, bifurcation lesion treated with ≥2 stents, chronically occluded, restenotic or saphenous vein graft lesion. Patients undergoing complex PCI were older, more often male, and presented with more ACS, diabetes, renal insufficiency, anaemia and multivessel disease. They derived major benefit from DCS over BMS for safety (16.2% vs. 21.7%, HR 0.70 [0.49-0.99], p

Aims The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

AIMS The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). METHODS AND RESULTS A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. CONCLUSIONS GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

AIMS The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. METHODS AND RESULTS This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p

Aims: In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality. Methods and results: From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p

Aims We aimed to assess the safety and performance of a novel sirolimus-eluting stent with biodegradable polymer under real-world conditions. Methods and results This prospective, multicentre, observational, all-comers registry enrolled 1,356 patients. The primary endpoint was target lesion failure at 12 months: it occurred in 5.1% (95% CI: 4.0-6.4) of patients in the overall population and in 7.7% (95% CI: 5.5-10.9), 5.8% (95% CI: 4.2-8.1), 1.8% (95% CI: 0.2-11.8) and 7.2% (95% CI: 5.1-10.0) of patients with diabetes mellitus, small vessels, chronic total occlusion and acute myocardial infarction, respectively. Conclusions This novel stent platform demonstrated good clinical outcomes in an all-comers population, even in predefined high-risk groups. ClinialTrials.gov identifier: NCT01553526

Over the last decade, transcatheter aortic valve implantation (TAVI) has gained widespread acceptance for the treatment of high surgical risk or inoperable patients with severe aortic stenosis. Spurred on by initial success and an ever-growing body of supporting data, TAVI has undergone rapid technological advancements in recent years with a focus on procedural simplification and limiting complications associated with the early devices. In this article, we provide a brief overview of the past, current and newer devices for transfemoral (TF) TAVI and their post-procedural outcomes.

AIMS To analyse patient characteristics, decision-making processes, and outcomes of TAVI performed in hospitals with versus those without on-site cardiac surgery (CS). METHODS AND RESULTS Current guidelines mandate transcatheter aortic valve implantation (TAVI) to be performed at hospitals with both cardiology and on-site CS departments. Some hospitals in Germany perform TAVI without CS departments in-house. We analysed the data of 1,432 patients enrolled in the German TAVI registry at 27 hospitals between January 2009 and June 2010. Nineteen of these had on-site CS (group 1), while eight centres performed TAVI with no CS department at their institution (group 2). Patients in group 2 (n=178, 12% of the overall study population) were older than in group 1 (mean age 82.6±6.3 years vs. 81.6±6.2 years) with similar logistic EuroSCORE (average: 21%). Patients in group 2 were haemodynamically more stable (higher blood pressures, better ejection fraction, less low-flow or low-gradient aortic stenosis, and less urgent procedures). Procedure times and use of contrast were higher in group 2. The procedural success rate was higher in group 1 (98% vs. 95%). Post-procedural complications were similar in the two groups with 30-day mortality of 6.2% in group 2 compared with 8.3% in group 1 patients. CONCLUSIONS Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.

Transcatheter aortic valve implantation (TAVI) has developed rapidly in the past few years and is expected to expand further in the near future. A reasonable number of large multicentre registries and randomised clinical trials have been performed, which have provided a considerable quality of evidence necessary to ensure optimal use and optimal patient outcomes. Currently, a large number of different valves have been approved in Europe, with a varying amount of supporting evidence, which complicates the process of valve type selection. This article reviews the evolution and fundamental aspects of prosthesis type selection in patients undergoing TAVI, and summarises the most relevant clinical studies in this context.

Aims Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients. Methods and results Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months. Conclusions Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).

Background Despite the technical advancements of the transcatheter aortic valve implantation (TAVI) procedure, valve embolisation into the left ventricle remains a challenging situation requiring expedited management through the Heart Team. Investigation The advantages and pitfalls of an interventional transfemoral approach, a transapical extraction of the dislocated prosthesis or the conversion to open heart surgery have to be balanced depending on the overall situation and the specific characteristics of the patient. Diagnosis A transfemoral approach would be the first choice for most TAVI implanters. We discuss the different options and present an elegant solution solving this challenging situation, leading to a good immediate and long-term outcome. Management Attempts at pulling the prosthesis out of the ventricle using a balloon remained unsuccessful. After grasping of the prosthesis with a goose-neck snare, the valve was pulled into the annulus. A second SAPIEN XT prosthesis was implanted and fixed the first prosthesis within the annulus. After post-dilatation, there was a good result without relevant gradient and minimal aortic regurgitation.

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.

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

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