[Show abstract][Hide abstract] ABSTRACT: Background Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. Methods In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. Results We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). Conclusions Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180 .).
Full-text · Article · Oct 2015 · New England Journal of Medicine
[Show abstract][Hide abstract] ABSTRACT: Background:
Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects.
The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years).
Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.
Full-text · Article · Oct 2015 · Cardiovascular revascularization medicine: including molecular interventions
[Show abstract][Hide abstract] ABSTRACT: We aimed to evaluate the long-term safety and efficacy of the STENTYS self-apposing paclitaxel-eluting stent (STENTYS-PES) in bifurcation lesions in routine clinical practice.
The primary endpoint of the study was the composite major adverse cardiac events (MACE: cardiac death, myocardial infarction, clinically driven target lesion revascularisation, or emergent bypass surgery) assessed at six months after enrolment. This was reported in 21 patients (10.1%), mainly due to clinically driven target lesion revascularisation (TLR). At 12 months, 27 patients experienced MACE (13.0%).
The long-term results of OPEN II show that the STENTYS-PES is safe and effective in the treatment of all-comers with coronary bifurcation lesions.
Full-text · Article · Jun 2015 · EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
[Show abstract][Hide abstract] ABSTRACT: The prognostic relevance of direct contrast toxicity in patients treated with transcatheter aortic valve implantation (TAVI) remains unclear because of the confounding hemodynamic effect of acute left ventricular ejection fraction (LVEF) impairment on kidney function estimation. In addition, different definitions of contrast-induced acute kidney injury (CI-AKI) may have different prognostic stratification potential. In the present study, 240 consecutive patients who underwent TAVI were prospectively enrolled. CI-AKI was defined (1) according to the postprocedural creatinine increase of ≥0.3 mg/dl or (2) according to the postprocedural decrease of the creatinine clearance of at least 25%. Primary end point of the study was 1-year all-cause mortality. At a mean follow-up of 1.7 ± 1.4 years, all-cause mortality was significantly higher in the CI-AKI patient group, using both CI-AKI definitions (for (1) and (2) p = 0.025 and p <0.001, respectively). In the Cox regression multivariate analysis, CI-AKI was an independent predictor of mortality (hazard ratio 2.244, 95% CI 1.064 to 4.732, p = 0.034), along with LVEF (hazard ratio 0.974, 95% CI 0.946 to 0.993, p = 0.012). Although LVEF and creatinine values at admission were not significantly associated with CI-AKI, their interaction term significantly defined CI-AKI (p = 0.033). The prognostic accuracy of definition (2) was higher (area under the curve 0.704; p <0.001) as with respect to definition (1) (area under the curve 0.602; p = 0.037) for the primary end point of 1-year mortality. In conclusion, in a nonselected patient population who underwent TAVI, CI-AKI was confirmed as an independent predictor of clinical outcome. Only the interaction between LVEF and baseline creatinine values was found to determine CI-AKI. Definition of CI-AKI based to creatinine clearance values had higher prognostic accuracy in comparison with the CI-AKI definition based on creatinine absolute value changes.
Full-text · Article · May 2015 · The American Journal of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Background/objectives:
Non-ST segment elevation myocardial infarction (MI) poses similar detrimental long-term prognosis as ST-segment elevation MI. No marker on ECG is established to predict successful reperfusion in NSTEMI. QT dispersion is increased by myocardial ischemia and reduced by successful restoration of epicardial blood flow by PCI. Whether QT dispersion reduction translates to smaller infarcts and thus indicates successful reperfusion is unknown. We hypothesized that the relative reduction of QT dispersion (QTD-Rrel ) on a standard ECG in acutely reperfused NSTEMI is related to infarct size and infarct transmurality as assessed by delayed enhancement CMR (DE-CMR).
Methods and results:
69 patients with a first acute NSTEMI were included. QTD-Rrel was stratified according to LV function and volumes, infarct transmurality and size as assessed by DE-CMR. Extensive myocardial infarction was defined as above median infarct size. LV function and end-systolic volume were only mildly related to QTD-Rrel . QTD-Rrel was inversely related to infarct size (r=-0.506,p=0.001) and infarct transmurality (r=-0.415, p=0.001). QTD-Rrel was associated with extensive myocardial infarction in univariate analysis (odds ratio (OR) 0.958, CI 0.935-0.982; p=0.001). Compared to clinical and angiographic data QTD-Rrel remained the only independent predictor of non-transmural infarcts (OR 1.110, CI 1.055-1.167; p=0.049).
In patients with acute Non-ST-Segment Myocardial infarction QTd-Rrel calculated on a surface ECG prior and post PCI for restoration of epicardial blood flow detects small, non-transmural infarcts as assessed by delayed enhancement CMR. Thus, QTd-Rrel can indicate successful reperfusion therapy.
No preview · Article · May 2015 · International journal of medical sciences
[Show abstract][Hide abstract] ABSTRACT: During primary percutaneous coronary intervention (PCI), manual thrombectomy may reduce distal embolization and thus improve microvascular perfusion. Small trials have suggested that thrombectomy improves surrogate and clinical outcomes, but a larger trial has reported conflicting results.
We randomly assigned 10,732 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI to a strategy of routine upfront manual thrombectomy versus PCI alone. The primary outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within 180 days. The key safety outcome was stroke within 30 days.
The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P=0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P=0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P=0.02).
In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.).
Full-text · Article · Mar 2015 · New England Journal of Medicine
[Show abstract][Hide abstract] ABSTRACT: Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. Methods and results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.
Full-text · Article · Jan 2015 · EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Aims. To compare 30-day performance of three different type of transcatheter aortic valve implantation (TAVI) prosthesis: Direct Flow Medical (DFM), Medtronic Corevalve (MCV), and Edwards Sapien XT (ES).Methods and results. Forty consecutive patients treated with DFM for severe aortic stenosis were matched to an equal sample of patients undergoing TAVI with MCV and ES (1:1:1 propensity score-matching). Primary end-point was 30-day safety, defined according to the valve academic research consortium (VARC-2) criteria. Secondary end-points were: (i) immediate post-TAVI transaortic gradient reduction, (ii) device success and (iii) thirty-day mortality. Patients treated with DFM had higher 30-day safety rate compared to MCV and ES (respectively: 95.0% vs. 67.5% vs. 82.5%; p=0.006). Immediate post-TAVI transaortic gradient reduction was similar for DFM, MCV and ES subgroups (respectively: 8.3 ± 5.2 mmHg vs. 5.3 ± 3.7 mmHg vs. 5.6 ± 5.1 mmHg; p=0.15); likewise, device success did not differ significantly (respectively: 100% vs. 92.5% vs. 92.5%; p=0.19). Mortality rates were also similar (respectively: 0% vs. 7.5% vs. 7.5%; p=0.190). In the pooled binary logistic regression analysis blood transfusion was associated to 30-day safety (HR 0.156, 95%CI 0.049-0.500, p=0.002), while a significant trend was observed for the vascular closure device type (favoring Proglide vs. Prostar: HR 0.239, 95% CI 0.049 – 1.160, p=0.076).Conclusions. In high-risk patients with aortic stenosis undergoing TAVI, device success and short-term mortality were comparable between DFM, MCV and ES. In contrast, the 30-day VARC-defined safety primary end-point was met significantly more frequently in patients treated with DFM. This result was mainly driven by differences in major vascular complications, associated to differences in vascular closure devices between the different valve subgroups. This article is protected by copyright. All rights reserved.
No preview · Article · Jan 2015 · Catheterization and Cardiovascular Interventions
[Show abstract][Hide abstract] ABSTRACT: Aims: Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. Methods and results: Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. Conclusions: One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.
No preview · Article · Dec 2014 · EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
[Show abstract][Hide abstract] ABSTRACT: -Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear.
-To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES.
-In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.