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Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a mainstay of the prevention of stent thrombosis following percutaneous coronary intervention (PCI). In the 2015 European guidelines for the management of acute coronary syndrome (ACS), prasugrel (PRA) and ticagrelor (TICA) combined with aspirin are recommended as first-line therapy. Clopidogrel (CLO) is recommended as an alternative medication for patients with contradictions to these new drugs. This single-center study analyzed the platelet function of 809 ACS patients undergoing PCI and treatment with DAPT. The platelet response to ADP was determined using Multiplate® analyzer at a median of 3 days after PCI in 254 patients treated with PRA (loading dose [LD] 60 mg, 10 mg qd), 162 patients receiving TICA (LD 180 mg, D 90 mg bid), and 393 CLO-treated patients (LD 600 mg, 75 mg qd). An aggregation >468 arbitrary units (AU)*min was defined as "high on-treatment platelet reactivity" (HPR)

Aims: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented. Methods and results: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length

Objective To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the L imus E luted from A D urable versus ER odable Stent (LEADERS) coating trial at the final 5-year follow-up. Methods The LEADERS trial is a multicentre all-comer study, where patients (n=1707) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer. Out of 1707 patients enrolled in this trial, 573 patients had percutaneous coronary intervention for AMI (BES=280, SES=293) and were included in the current analysis. Patient-oriented composite endpoint (POCE, including all death, all myocardial infarction (MI) and all revascularisations), major adverse cardiac events (MACE, including cardiac death, MI and clinically indicated target vessel revascularisation) and stent thrombosis were assessed at 5-year follow-up. Results The baseline clinical, angiographic and procedural characteristics were well matched between BES and SES groups. In all patients with AMI, coronary intervention with a BES, compared with SES, significantly reduced POCE (28.9% vs 42.3%; relative risk (RR) 0.61, 95% CI 0.47 to 0.82, p=0.001) at 5-year follow-up. There was also a reduction in MACE rate in the BES group (18.2% vs 25.9%; RR 0.67, 95% CI 0.47 to 0.95, p=0.025); however, there was no difference in cardiac death and stent thrombosis. In patients with ST-elevation MI (STEMI), coronary intervention with BES significantly reduced POCE (24.4% vs 39.3%; RR 0.55, 95% CI 0.36 to 0.85, p=0.006), MACE (12.6% vs 25.0%; RR 0.47, 95% CI 0.26 to 0.83, p=0.008) and cardiac death (3.0% vs 11.4%; RR 0.25, 95% CI 0.08 to 0.75, p=0.007), along with a trend towards reduction in definite stent thrombosis (3.7% vs 8.6%; RR 0.41, 95% CI 0.15 to 1.18, p=0.088), compared with SES. Conclusions BES, compared with SES, significantly improved safety and efficacy outcomes in patients with AMI, especially those with STEMI, at 5-year follow-up. Trial registration number NCT 00389220.

Prospective data on the usage of 3-dimensional imaging based annulus sizing on the outcome of TAVI is not available yet and there is general uncertainty about the optimal degree of oversizing. In the current study we therefore assessed a 3-D MSCT guided over-sizing approach and evaluated the clinical outcome of different degrees of oversizing.TAVI-size-selection was done using systolic MSCT-annulus cross-sectional-area (CSA) measurements in 107 patients with severe aortic stenosis with the goal to oversize the 3rd generation balloon expandable Edwards Sapien XT (ESTV) device in relation to the native aortic annulus CSA.Among different degrees of oversizing there were no differences in the occurrence of stroke, myocardial infarction and death. No aortic injuries were observed. The overall rate ofmild postprocedural aortic regurgitation (PAR) was 7.6%. Increasing oversizing ratios are associated with lower rates ofmild PAR (r = -0.236, p0.02) with the lowest rate ofmild PAR in patients with area based oversizing ratios25% and the highest rate in patients with oversizing ratios15% (0% vs. 15.8%, p0.02). The rate of postprocedural permanent pacemakers tended to be lower in patients with15% oversizing compared to those with25% oversizing (5.3 vs. 16.7%, p0.23).MSCT guided ESTV-device sizing is safe and is associated with significantly lower than previously reported rates for PAR. A device/annulus oversizing ratio of 15-25% based on area and 7-12% based on mean diameter appears to provide the best risk-benefit ratio in terms of PAR reduction and conduction disorders.

TAVI is a novel treatment option for patients at too high risk for surgery. Risk scores for surgical valve replacement failed to accurately predict outcomes after TAVI and alternative risk parameters are lacking so far.We evaluated the CT-derived aortic valve calcification score as a predictor for outcome during and after TAVI.Transfemoral TAVI using the CoreValve device was performed in 68 patients, in whom the aortic valve calcium score was determined from preprocedural 64-sclice ECG gated CT-scans.30-day MACE rate (death, stroke, MI) was 10.3%, 1-year mortality was 11.8%. Using linear regression analysis the aortic valve calcium score was the only significant predictor for 30-day MACE and for 1-year mortality and was also associated with the incidence and severity of post procedural aortic regurgitation (r=0.33, p0.05). Patients withvalve calcium scores750 had a significant lower 1-year survival rate compared to patients with scores750 (58% vs. 98%, p0.05). The aortic valve calcium score is also inversely associated with the absolute improvement of NYHA-class after TAVI (regression coefficient=-0.43, p0.02).The degree of aortic valve calcification is associated with post procedural aortic regurgitation, procedural complications, 1-year mortality and with the degree of functional improvement of patients who underwent TAVI using the CoreValve device. Due to the fact that the aortic valve calcium score can be determined from CT-datasets that are used for preprocedural planning, this parameter may be incorporated in the general work up and may be used for risk stratification and patient selection.

The aim of this study was to evaluate the rate of bleeding, thromboembolic complications, and the rate of stent thrombosis or restenosis in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). In this retrospective analysis, we included patients with AF who underwent PCI with stent implantation from 2003 to 2006. Combinations of aspirin, clopidogrel, and oral anticoagulation with phenprocoumon (OAC) were used for antithrombotic management. Follow-up was performed by telephone interview. Adverse events (AEs) were defined as major bleedings, stroke/transient ischaemic attack, peripheral embolism, stent thrombosis, or restenosis. One hundred and seventeen patients (85 men, mean age 72.0 +/- 8.2 years) were included in the study. Fifty-five patients (47%) received drug-eluting stents, 62 patients (53%) bare-metal stents. After coronary intervention, 53 patients (45.3%) received a combination of aspirin, clopidogrel, and OAC, 64 (54.7%) patients received other antithrombotic regimens. Eighteen patients died during follow-up, 11 patients presumably of cardiac and 7 patients of non-cardiac causes. In total, 26 AEs occurred in 24 of 113 patients (21.2%) during follow-up: 13 major bleedings, 6 cardioembolic complications, 3 stent thromboses, and 4 restenoses. The present study demonstrates an 11.5% rate of major bleedings, a 5.3% rate of thromboembolic events, and a 2.7% rate of stent thromboses in the high-risk group of patients with AF and coronary stent implantation. The decision on different antithrombotic treatment regimens needs to be based on the patients' individual risk until further prospective studies have evaluated the risk-benefit profile of a standardized approach of triple therapy in this high-risk patient group.

Background: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SES). Methods: Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36). The primary endpoint was the occurrence of major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI) and clinically-indicated target vessel revascularization (TVR). Results: At 5 years, the rate of MACE was numerically higher in the CTO group than in the non-CTO group (29.6% vs. 23.3%; p = 0.173), with a significant increase in the incidence of target lesion revascularization (TLR) (21.0 vs. 12.6; p = 0.033), but no difference in stent thrombosis (ST). Patients with CTO receiving a BES demonstrated a lower incidence of MACE (22.2% vs. 38.9%; p = 0.147) with a significant reduction in TLR compared to patients receiving a SES (11.1% vs. 33.3%, p = 0.0214) with an incidence similar to that observed in the non-CTO group treated with BES (11.6%). Definite ST at 5 years nearly halved in the BES group (4.4% vs. 8.3%, p = 0.478) with no ST in the BES group after the first year (0% vs. 8.3%, p for interaction = 0.009). Conclusions: The use of a BES showed a reduction in MACE, TVR, TLR, and ST over time in the CTO subset with similar outcome as for non-CTO lesions.

Objectives: Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Methods: We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints. Results: A total of 100 patients (SXT, n=50 versus CoV, n=50) were analyzed. Both SXT and CoV showed good device success rates (98% versus 90%, p=0.20). SXT versus CoV reduced the occurrence of paravalvular regurgitation after TAVR (26% versus 90%, p0.99), life-threatening bleedings (2% versus 4%, p>0.99), stroke (4% versus 6%, p>0.99) and death (6% versus 2%, p>0.99) did not differ between SXT and CoV. However, safety endpoints favored SXT (17% versus 34.6%, p=0.01), due to a numerically higher incidence of ischemic stroke and Acute Kidney Injury Stage 3 after CoV. At multivariate analysis, TAVR with SXT (odds ratio=0.21, 95% confidence intervals [0.05-0.84], p=0.03) was predictive of fewer adverse events. Conclusions: Transcatheter valve implantation with Edwards SAPIEN XT was associated with lower VARC-combined safety endpoints as compared with Medtronic CoreValve. More extensive cohorts are needed to confirm these results.

Aims To assess image quality and diagnostic performance of 3.0 Tesla (3T) cardiac magnetic resonance (CMR) myocardial perfusion imaging with a dual radiofrequency source to detect functional relevant coronary artery disease (CAD), using coronary angiography and invasive pressure-derived fractional flow reserve (FFR) as reference standard. Methods and results We included 116 patients with suspected or known CAD, who underwent 3T adenosine myocardial perfusion CMR (resolution 2.97 × 2.97 mm) and coronary angiography plus FFR measurements in intermediate lesions. Image quality of myocardial perfusion CMR was graded on a 4-point scale (1 = poor to 4 = excellent). Diagnostic accuracy was assessed by ROC analyses using a 16-myocardial segment-based summed perfusion score (0 = normal to 3 = transmural perfusion defect) and by determining sensitivity, specificity, positive and negative predictive value on the coronary vessel territory and the patient level. Diagnostic image quality was achieved for all stress myocardial perfusion CMR studies with an average quality score of 2.5, 3.1, and 3.0 for LAD, LCX, and RCA territories. The ability of the myocardial perfusion CMR perfusion score to detect significant coronary artery stenosis yielded an area under the curve of 0.93 on ROC analysis. Values for sensitivity, specificity, positive and negative predictive value on a vessel territory level and the patient level were 89, 95, 87, 96% and 85, 87, 77, 92%, respectively. Conclusion In patients with suspected or known significant CAD, 3T myocardial perfusion CMR with standard perfusion protocols provides consistently high image quality and an excellent diagnostic performance.

Background The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers. Methods We did a multicentre, assessor-masked, non-inferiority trial. Between Nov 27, 2006, and May 18, 2007, patients aged 18 years or older with coronary artery disease were randomly allocated with a computer-generated sequence to receive either biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stents (SES; 1:1 ratio). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation (TVR); patients were followed-up for 4 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389220. Findings 1707 patients with 2472 lesions were randomly allocated to receive either biodegradable polymer BES (857 patients, 1257 lesions) or durable polymer SES (850 patients, 1215 lesions). At 4 years, biodegradable polymer BES were non-inferior to durable polymer SES for the primary endpoint: 160 (18·7%) patients versus 192 (22·6%) patients (rate ratios [RR] 0·81, 95% CI 0·66–1·00, p for non-inferiority

We appreciate the comments by Dr Alfonso and colleagues on the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II (PEPCAD II) trial. Intracoronary radiation was the first successful treatment option for in-stent restenosis avoiding the stent-in-stent approach. However, implantation of a second (drug-eluting) stent has since become the first treatment option for in-stent restenosis. The implantation of a drug-eluting stent in a restenotic stent results in better acute lumen gain and lower restenosis rates compared with conventional balloon angioplasty or brachytherapy.1,2 The main determinant of restenosis after coronary stent implantation is neointimal hyperplasia. Other factors such as elastic vessel recoil and negative remodeling have no relevant impact on this scenario. Therefore, late lumen loss has been accepted as the most important …

Background— Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care. Methods and Results— One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 μg/mm 2 ) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of ≥70% and ≤22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38±0.61 mm in the drug-eluting stent group versus 0.17±0.42 mm ( P =0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P =0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively ( P =0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group ( P =0.15). Conclusions— Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.

Angiotensin-converting enzyme (ACE) inhibitors can improve cardiovascular outcome in patients with type 2 diabetes mellitus (T2DM). Myocardial diastolic function (Ve) is a known marker of cardiovascular prognosis. It could potentially indicate the effects of preventive therapy if evaluated by tissue Doppler. We tested the hypothesis that treatment with the ACE inhibitor ramipril has beneficial effects on Ve. In this study, 16 subjects on insulin therapy (eight receiving 10 mg ramipril/day compared to eight matched controls who were not treated with an ACE inhibitor) were followed up for a period of nine months. Myocardial and vascular function were assessed by tissue Doppler and ultrasound. In the ramipril group, Ve improved significantly after nine months of treatment (7.8±0.9 cm/s to 8.6±0.9 cm/s, p In conclusion, the observed improvement of myocardial diastolic function with ramipril in patients with T2DM is an encouraging result. It might contribute to the overall improvement that has been observed with hard cardiovascular end points.

Left ventricular (LV) hypertrophy is a common finding in patients with resistant hypertension and is associated with an impaired intramyocardial perfusion. Renal sympathetic denervation (RDN) has been shown to reduce blood pressure (BP) and sympathetic tone. In this pilot study we aimed to

The effectiveness of 1st generation durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis. The Biolimus A9™ eluting stent platform (BES) releases biolimus from an abluminal biodegradable polymer, fully