In this paper, we analyze the nonlinear thermoelastic plates, with Fourier heat conduction, and consider a polynomial-type nonlinearity. We first develop a theoretical analysis of the corresponding ...linear system to derive time decay estimates in
$ L^{\infty }(\mathbb {R}^n) $
L
∞
(
R
n
)
and
$ H^s(\mathbb {R}^n) $
H
s
(
R
n
)
. Then, using that set of decay estimates and controlling the nonlinearity, we prove the existence and uniqueness of local solutions with initial data
$ (u(0),u_t(0),\theta (0))=(u_0,\Delta u_1,\Delta \theta _1) $
(
u
(
0
)
,
u
t
(
0
)
,
θ
(
0
)
)
=
(
u
0
,
Δ
u
1
,
Δ
θ
1
)
, with
$ u_0\in H^s $
u
0
∈
H
s
, and
$ u_1,\theta _1\in H^{s+1} $
u
1
,
θ
1
∈
H
s
+
1
, for
$ s \gt \frac {n}{2}+1 $
s
>
n
2
+
1
.
The aims of this study were: i) to assess fragility indices (FIs) of individual randomized controlled trials (RCTs) that compared paclitaxel-based drug-coated balloons (DCBs) or drug-eluting stents ...(DESs) versus standard endovascular devices, and ii) to meta-analyze mid-term and long-term safety and efficacy outcomes from available RCT data while also estimating the FI of pooled results.
This systematic review has been registered in the PROSPERO public database (CRD42022304326 http://www.crd.york.ac.uk/PROSPERO). A query of PubMed (Medline), EMBASE (Excerpta Medical Database), Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) databases was performed to identify eligible RCTs. Rates of primary patency (PP) and target lesion revascularization (TLR) were assessed as efficacy outcomes, while lower limb amputation (LLA) consisting of major amputation that is. below or above the knee and all-cause mortality were estimated as safety outcomes. All outcomes were pooled with a random effects model to account for any clinical and study design heterogeneity. The analyses were performed by dividing the RCTs according to their maximal follow-up length (mid-term was defined as results up to 2-3 years, while long-term was defined as results up to 4-5 years). For each individual outcome, the FI and reverse fragility index (RFI) were calculated according to whether the outcome results were statistically significant or not, respectively. The fragility quotient (FQ) and reverse fragility quotient (RFQ), which are the FI or RFI divided by the sample size, were also calculated.
A total of 2,337 patients were included in the systematic review and meta-analysis. There were 2 RCTs examining DES devices and 14 RCTs evaluating different DCBs. For efficacy outcomes, there was evidence that paclitaxel-based endovascular therapy increased the PP rate and reduced the TLR rate at mid-term, with a calculated pooled risk ratio (RR) of 1.66 for patency (95% CI, 1.55-1.86; P < 0.001), with a corresponding number needed-to-treat (NNT) of 3 patients (95% CI, 2.9-3.8) and RR of 0.44 for TLR (95% CI, 0.35-0.54; P = 0.027), respectively. Similarly, there was evidence that paclitaxel-based endovascular therapy both increased PP and decreased TLR rates at long-term, with calculated pooled RR values of 1.73 (95% CI, 1.12-2.61; P = 0.004) and 0.53 (95% CI, 0.45-0.62; P = 0.82), respectively. For safety outcomes, there was evidence that paclitaxel-based endovascular therapy increased all-cause mortality at mid-term, with a calculated pooled RR of 2.05 (95% CI, 1.21-3.24). However, there was no difference between treatment arms in LLA at mid-term (95% CI, 0.1-2.7; P = 0.68). Similarly, neither all-cause mortality nor LLA at long-term differed between treatment arms, with a calculated pooled RR of 0.66, 1.02 (95% CI, 0.31-3.42) and 1.02 (95% CI, 0.30-5.21; P = 0.22), respectively. The pooled estimates of PP at mid-term were robust (FI = 28 and FQ = 1.9%) as were pooled rates of TLR (FI = 18 and FQ = 0.9%). However, when safety outcomes were analyzed, the robustness of the meta-analysis decreased significantly. In fact, the relationship between the use of paclitaxel-coated devices and all-cause mortality at mid-term showed very low robustness (FI = 4 and FQ = 0.2%). At 5 years, only the benefit of paclitaxel-based devices to reduce TLR remained robust, with an FI of 32 and an FQ of 3.1%.
The data supporting clinical efficacy endpoints of RCTs that examined paclitaxel-based devices in the treatment of femoral-popliteal arterial occlusive disease were robust; however, the pooled safety endpoints were highly fragile and prone to bias due to loss of patient follow-up in the original studies. These findings should be considered in the ongoing debate concerning the safety of paclitaxel-based devices.
Simultaneous carotid artery stenosis (CS) and coronary artery disease (CAD) is a common condition among patients with several cardiovascular risk factors; however, its optimal management still ...remains under investigation, such as the assumption that carotid disease is causally related to perioperative stroke and that preventive carotid revascularization decrease the risk of this complication. Synchronous surgical approach to both conditions, performing carotid endarterectomy (CEA) before coronary artery bypass graft (CABG) during the same procedure, should still be considered in selective patients, in order to reduce the risk of perioperative stroke during coronary cardiac surgery. For the same purpose, staged approaches, such as CEA followed by CABG or CABG followed by CEA during the same hospitalization or a few weeks later have been described. Hybrid approach with carotid artery stenting (CAS) and CABG can also be an option in selected cases, offering a minimally invasive procedure to treat CS among patients whom CABG cannot be postponed. When carotid intervention is indicated in patients with concomitant CAD requiring CABG, a personalized and tailored approach is mandatory, especially in asymptomatic patients, in order to define the ideal surgical strategy. The aim of this paper is to summarize the current “state of the art” of the different approaches to carotid artery diseases in patients undergoing CABG.
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