Background
A large trial established the favorable profile of a new polymer‐free biolimus A9‐eluting stent (PF‐BES) with a 1‐month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) ...patients. This is the first study comparing outcomes for a 1‐month versus longer DAPT strategies following PF‐BES‐percutaneous coronary intervention (PCI).
Methods
All patients undergoing PF‐BES‐PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1‐month vs. planned >1‐month). Primary outcomes were the 390‐day estimates of a patient‐oriented and of a device‐oriented composite endpoints (POCE: death, myocardial infarction MI or target vessel revascularization; DOCE: cardiac death, target vessel‐MI or ischemia‐driven target lesion revascularization). Landmark analyses from 1‐month post‐PCI were carried.
Results
Following PF‐BES‐PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1‐month and longer DAPT (12 months 6–12), respectively. Patients with a previous or index MI were less likely to be discharged on 1‐month DAPT. Patients prescribed with 1‐month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between‐groups differences in the primary outcomes (planned 1‐month vs. planned >1‐month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted‐hazard ratio adj‐HR 1.26, 95%CI 0.74–2.13; DOCE: adj‐HR 1.00, 95%CI 0.49–1.99). Landmark analyses showed similar results.
Conclusions
In a large all‐comers registry of PF‐BES PCI, no interaction of planned DAPT strategy (1‐month vs. >1‐month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).
The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, ...Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS).
This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events.
Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure.
This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.
El estudio PEACE (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investiga por primera vez si un balón recubierto de sirolimus (BRS) (Magic Touch, Concept Medical, India) deriva en resultados diferentes según se utilice en síndromes coronarios agudos (SCA) o crónicos (SCC).
Este es un análisis post-hoc del registro EASTBOURNE (NCT03085823). De los 2.083 pacientes inscritos, se utilizó un BRS para tratar a 968 (46,5%) pacientes con SCA y a 1.115 (53,5%) con SCC. El objetivo primario es la revascularización de la lesión diana a los 12 meses; las variables secundarias son el éxito angiográfico y los eventos cardiovasculares adversos mayores.
Las características demográficas iniciales, el diámetro medio del vaso de referencia y la longitud media de la lesión son similares en ambos grupos. Es importante destacar que la predilatación se realiza con mayor frecuencia en SCA que en SCC (p=0,007). Los BRS se inflan a una presión estándar en ambos grupos, con una ligera tendencia hacia un tiempo de inflado más largo en SCA. El éxito angiográfico es alto en ambos grupos (el 97,4% en SCA frente al 97,7% en SCC; p=0,820) con un limitado uso de stents de rescate, y a los 12 meses la incidencia acumulada de revascularización de la lesión diana es similar en SCA y SCC (el 6,6% en SCA frente al 5,2% en SCC; p=0,258). Por el contrario, los eventos cardiovasculares adversos mayores son más frecuentes en SCA (el 10,4% frente al 8,3% en SCC; p=0,009) debido a su mayor número de recaídas. La reestenosis intrastent muestra una mayor proporción de revascularización de la lesión diana y eventos cardiovasculares adversos mayores que las lesiones nuevas, independientemente del tipo de presentación en el procedimiento inicial.
Este BRS muestra buenos resultados agudos y a un año, independientemente de la presentación clínica.
Abstract Aims radial strength of bioresorbable vascular scaffolds (BVS) implanted in coronary arteries is still under debate. Moreover, their final shape patterns, when implanted in an all-comer, ...unselected population, has not yet been completely correlated with clinical outcome and should be better investigated. Methods and results a multicenter collaborative analysis was performed on all consecutive patients with native coronary artery disease undergoing PCI with intravascular imaging–guided BVS implantation. The BVS was arbitrarily categorized as having a final “oval shape” through intravascular imaging, if maximal lumen diameter was longer than 150% of minimal lumen diameter at the target lesion. Primary study-endpoint was device-oriented major adverse events (DOCE) at mid-term follow-up. Sixty-seven consecutive patients were evaluated at 6 european centres. Mean patient age was 58 ± 11 years, and 12 patients (18%) had diabetes. Mean percent diameter stenosis was 79 ± 12.5%. Average lesion length was 24.4 ± 13.8 mm and 66% of lesions were AHA/ACC type B2/C. Postdilation rate was 91% and all BVS resulted well apposed to the vessel wall. Procedural success was achieved in all patients and 10 (14.9%) had an “oval shape” at intravascular imaging. This occurrence was not associated with an increase in periprocedural myocardial infarction (p = 0.37) or DOCE during hospitalization (p = 0.65). Seven-month DOCE occurred in 3 patients (5.6%) of the oval shape group, they were target-vessel revascularization and did not differ significantly between patients with vs. without final “oval shape” (p = 0.34). We did not register episodes of scaffold thromboses. Conclusions in an all-comer population with complex coronary lesions treated with BVS, a final oval shape after postdilation was not rare and not associated with immediate and medium term adverse events.
Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment ...of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data.
Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required.
We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3 ± 7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR.
This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.
Objectives
With this prospective study we aim at investigating the long‐term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation.
...Background
It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome.
Methods
Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow‐up. After a run‐in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high‐pressure post‐dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1‐year angiographic follow‐up and ischemia‐driven target‐lesion revascularization (ID‐TLR) at 2‐year clinical follow‐up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years.
Results
A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow‐up LLL was 0.38 ± 0.9. At 2‐year clinical follow‐up, ID‐TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR.
Conclusions
In a complex, all‐comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid‐term angiographic and long‐term clinical outcome.
Statins are able to reduce cardiovascular morbility and mortality mainly through their hypocholesterolemic effect. Beyond the inhibition of cholesterol synthesis, the identification of “ancillary” ...mechanisms has motivated studies evaluating the relationship between the use of statins and the modification of bone mineral density (BMD). To date, clinical trials have provided discordant results. The aim of our study was to evaluate whether simvastatin treatment (40 mg/d) could modify BMD in hypercholesterolemic women (n = 40) after a 2-year treatment as compared with a control group treated only with diet (n = 20) and matched by gender, age, body mass index (BMI), lipids, menopausal age, and BMD and the number of osteopenic, osteoporotic, and normal women (on the basis of T-score value). Exclusion criteria were secondary hyperlipemias and osteoporosis and current or previous therapy with statins, bisphosphonates, and estrogens. The BMD was measured at the lumbar spine and hip by dual energy x-ray absorpiometry (DEXA). In the group treated by simvastatin, BMD, both on the spine and femoral hip, showed a significant increase after 8 and 24 months, respectively (0.878 ± 0.133
v 0.893 ± 0.130 and 0.907 ± 0.132; 0.840 ± 0.101
v 0.854 ± 0.101; and 0.863 ± 0.10,
P < .001); there was a percentage increase of 1.7% after 8 months and 3.3% after 24 months at the spine; at the femoral hip, BMD increased 1.6% after 8 months and 2.7% after 24 months. The group treated only with hypolipidic diet demonstrated after 8 and 24 months a slight decrease in BMD both on the spine and femoral hip (respectively, 0.884 ± 0.175
v 0.872 ± 0.174 and 0.861 ± 0.164; 0.860 ± 0.110
v 0.853 ± 0.096 and 0.847 ± 0.095;
P < .05). In conclusion, as partly suggested by retrospective or observational data, this longitudinal study indicates that simvastatin treatment exerts a beneficial effect on BMD.
In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers ...an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease.
MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348±52days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late.
A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.
•Recently LM PCI has gained a precise role;•A self-expandable stent, with its property to adapt to tapered vessel, is promising for LM PCI;•In a real world, high risk population, this device showed good immediate procedural results with low rates of adverse events at mid-term follow-up.
Treatment of saphenous vein graft (SVG) disease is still a matter of debate given the uncertainty of the available conflicting data. Our aim was to assess, by means of a meta-analytic approach, the ...risk/benefit profile of drug eluting stents (DES) versus bare metal stents (BMS) in the treatment of SVG disease.
A search of relevant studies in several databases was performed. The endpoints of interest such as: major adverse events (MAE) (the combination of overall death and non-fatal myocardial infarction AMI), target vessel revascularisation (TVR), and target lesion revascularisation (TLR) have been calculated in-hospital and at the longest follow-up. Single endpoints and the rate of stent thrombosis (ST) were also assessed. Three randomised controlled trials and 15 registry studies were appraised, totalling 3,294 patients. During hospitalisation, there was no difference in the risk of MAE, overall death, AMI and TVR. No data were available to calculate the TLR rate. At a mean follow-up of 19.8 months, no significant differences were found in the risk of MAE and AMI. BMS were associated with a trend towards a higher risk of overall death (OR 1.32 1,00-1.74, p=0.05, number needed to treat NNT=55). DES showed superiority in terms of TVR (OR 1.86 1.33-2.61, p=0.0003, NNT=16), and TLR (OR 1.77 1.27-2.48, p<0.0001, NNT=25). According to pre-specified subgroup analyses, these effects seem less evident at the long-term follow-up. DES were not associated with an increased risk of ST.
Use of DES in SVG substantially reduces both TVR and TLR. These data also demonstrate that using DES in SVG is safe and contradict previous reports of potential risks.
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