scholarly journals Συγκριτική μελέτη της κλινικής αποτελεσματικότητας επικαλυμμένων και μη επικαλυμμένων ενδοστεφανιαίων προθέσεων

2020 ◽  
Author(s):  
Ιωάννης Ματσούκης
Keyword(s):  
De Novo ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Target Lesion Failure

Στην παρούσα διατριβή συγκρίθηκαν σε 600 ασθενείς οι μακροπρόθεσμες εκβάσεις χρόνιας σταθερής στηθάγχης και μονήρους de-novo βλάβης στο εγγύς τμήμα του προσθίου κατιόντα που υποβλήθηκαν σε διαδερμική στεφανιαία παρέμβαση με επικαλυμμένα stents εκλυτικής ουσίας zotarolimus (E-ZES) (Ν=180) με εκείνες ασθενών ιδίου προβλήματος και αντιμετώπισης με εκλυτική ουσία everolimus (EES) (Ν=420), με μέση κλινική παρακολούθηση τους 54,9 + 25,6 μήνες. Το πρωταρχικό τελικό σημείο της μελέτης ήταν η «αποτυχία» της βλάβης στόχου (Target Lesion Failure- TLF), ένας σύνθετος δείκτης, που καθορίζεται με ιεραρχική σειρά από: καρδιακό θάνατο, μη θανατηφόρο έμφραγμα του μυοκαρδίου που δεν αποδίδεται σαφώς σε αγγείο άλλο από το αγγείο στόχο και την κλινικά κατευθυνόμενη επαναγγείωση της βλάβης στόχου (Target Lesion Revascularization-TLR). Τα δευτερεύοντα καταληκτικά σημεία ήταν εκβάσεις σχετιζόμενες με τον ασθενή (PRO-σύνθετος δείκτης που απαρτίζουν η ολική θνησιμότητα, το έμφραγμα του μυοκαρδίου σε οποιοσδήποτε αγγείο, η επαναγγείωση σε οποιοδήποτε αγγείο), η θρόμβωση του stent και τα επιμέρους συστατικά του TLF (καρδιακός θάνατος, μη θανατηφόρο έμφραγμα του μυοκαρδίου και TLR). Η χρήση των EES σε μονήρεις de-novo βλάβες του LAD, οδήγησε σε στατιστικά σημαντική μείωση των κλινικών συμβαμάτων σε σύγκριση με τα E-ZES. Στα 5 χρόνια κλινικής παρακολούθησης, παρατηρήθηκαν στατιστικά σημαντικές διαφορές στη σωρευτική πιθανότητα εμφάνισης συμβαμάτων στην ομάδα ασθενών που έλαβαν E-ZES έναντι της ομάδας των ασθενών που έλαβαν EES μόνον αναφορικά με TLF (13,8% στην ομάδα E-ZES έναντι 7,5% στην ομάδα EES, p=0,025) και TLR (10% στην ομάδα E-ZES έναντι 3,3% στην ομάδα EES, p=0,003). Για όλες τις άλλες εκβάσεις δεν παρατηρήθηκαν διαφορές. Οι διαφορές μεταξύ των ενδοπροθέσεων ως προς το πρωτογενές καταληκτικό σημείο αυξήθηκαν μετά από 30 μήνες. Οι προγνωστικοί δείκτες του προτυπωμένου για τον τύπο του stent TLF ήταν ο σακχαρώδης διαβήτης και ο επηρεασμένος εκτιμώμενος ρυθμός σπειραματικής διήθησης (eGFR). Επιπλέον σε 631 ασθενείς με PCI-DES και 379 ασθενείς με CABG συγκρίθηκαν τα μακροπρόθεσμα αποτελέσματα της διαδερμικής στεφανιαίας παρέμβασης με δεύτερης γενιάς επικαλυμμένες ενδοπροθέσεις και της επέμβασης αορτοστεφανιαίας παράκαμψης με χρήση της αριστερής έσω μαστικής αρτηρίας σε ασθενείς με σταθερή στηθάγχη με μονήρη βλάβη στο εγγύς τμήμα του προσθίου κατιόντα. Το κύριο καταληκτικό σημείο της δεύτερης μελέτης ήταν η εμφάνιση σύνθετου δείκτη MACEs (καρδιακός θάνατος, έμφραγμα μυοκαρδίου που δεν αποδίδεται σαφώς σε αγγείο άλλο από το αγγείο στόχο και επαναγγείωση της βλάβης στόχου με χρήση διαδερμικής ή χειρουργικής τεχνικής. Δευτερεύοντα τελικά σημεία ήταν εκβάσεις σχετιζόμενες με τον ασθενή (PRO), καθώς και επιμέρους εκβάσεις των MACEs, επανεμφάνιση σταθερής ή ασταθούς στηθάγχης ή εμφάνιση μη θανατηφόρου αρρυθμίας, διάρκεια νοσηλείας, οποιαδήποτε επιπλοκή (περιεπεμβατική ή ενδονοσοκομειακή) και εξέλιξη της νόσου σε άλλα τμήματα (έμφραγμα μυοκαρδίου σε αγγείο άλλο από το αγγείο στόχο, νέα εμφάνιση σταθερής στηθάγχης που αποδίδεται σε αγγείο ή σε τμήμα αγγείου άλλο από το υπό μελέτη και που προσδιορίζεται με δοκιμασία ισχαιμίας-καρδιακό σπινθηρογράφημα ή/και αγγειογραφία). Υπολογίστηκαν οι μη προτυπωμένες και στη συνέχεια προτυπωμένες αναλογίες κινδύνου (HR) για τα υπό εξέταση κύρια συμβάματα. Το κύριο εύρημα ήταν ότι τα μακροπρόθεσμα ποσοστά MACE ήταν συγκρίσιμα μεταξύ των δύο ομάδων, παρά τον οριακά στατιστικά σημαντικό μικρότερο κίνδυνο της επαναγγείωσης στην ομάδα CABG από ό,τι στην ομάδα PCI. Συγκεκριμένα, δεν παρατηρήθηκε σημαντική διαφορά μεταξύ των δύο ομάδων κατά τη διάρκεια της κλινικής παρακολούθησης σχετικά με τα MACEs, το PRO, τον καρδιακό θάνατο και το έμφραγμα του μυοκαρδίου. Σε σύγκριση με το CABG, η PCI με δεύτερης γενιάς DES παρουσίασε σημαντικά μεγαλύτερο κίνδυνο επαναγγείωσης (HR PCI:1,99, 95% CI:1,00-3,94, p=0,05 και HR PCI:1,95, 95% CI:0,98-3,9, p=0,06). Ο κίνδυνος για την επανεμφάνιση σταθερής στηθάγχης ήταν σημαντικά αυξημένος στην ομάδα PCI σε σύγκριση με την ομάδα CABG (p <0,001), αλλά ο κίνδυνος εμφάνισης μη θανατηφόρας αρρυθμίας (κολπική μαρμαρυγή, κολπικός πτερυγισμός ή μη εμμένουσα κοιλιακή ταχυκαρδία) ήταν μεγαλύτερος στην ομάδα χειρουργικής επέμβασης από ό,τι στην ομάδα PCI (p=0,02). Η χειρουργική προσέγγιση συσχετίστηκε με υψηλότερα ποσοστά ενδονοσοκομειακών επιπλοκών (p <0,001) και μεγαλύτερης διάρκειας νοσηλεία (p <0,001) σε σύγκριση με εκείνα στην ομάδα PCI. Συμπερασματικά, και οι δύο τύποι stents, EES και E-ZES, επέδειξαν ένα ευνοϊκό προφίλ ασφαλείας. Η χρήση των EES φάνηκε στη μελέτη μας να έχει ελαφρώς καλύτερη αποτελεσματικότητα σε ορισμένους δείκτες (TLF, TLR). Οι μακροπρόθεσμες κλινικές εκβάσεις της δεύτερης γενιάς PCI-DES και του CABG σε ασθενείς με σταθερή στηθάγχη και μονήρη βλάβη στον pLAD ήταν συγκρίσιμες, υπογραμμίζοντας τα εξαιρετικά μακροπρόθεσμα αποτελέσματα τόσο της χειρουργικής όσο και της DES-PCI προσεγγίσεως. Τα παρόμοια ποσοστά καρδιακής θνησιμότητας και ο παραπλήσιος κίνδυνος του εμφράγματος του μυοκαρδίου μπορούν ελαφρώς να αντισταθμιστούν από τον αυξημένο κίνδυνο επανεπέμβασης στην ομάδα ασθενών που υποβλήθησαν σε PCI στον pLAD με δεύτερης γενιάς DES, αν και τα συνολικά MACEs ήταν παρόμοια.

scholarly journals Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Botey Katamu Benjamin ◽  
Wenjie Lu ◽  
Zhanying Han ◽  
Liang Pan ◽  
Xi Wang ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Independent Predictor ◽  
Coronary Vessels ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Vessel Disease ◽  
One Year ◽  
Target Lesion Failure ◽  
Drug Coated Balloon

Background. The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease. Methods. A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events. Results. There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P = 0.006 ], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P = 0.014 ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, P = 0.011 ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, P = 0.033 ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P = 0.110 ) and MACE [19 (4.4%) vs. 21 (2.7%), P = 0.120 ]. Conclusion. Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year.

scholarly journals Treatment of de novo coronary artery lesions with paclitaxel drug coated balloons (DCB) in diabetic and non-diabetic patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
De Novo ◽  
Target Lesion ◽  
Diabetic Group ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Coronary Artery Lesions ◽  
Artery Disease

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None

scholarly journals Association between in-stent neointimal characteristics and native coronary artery disease progression

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0247359
Author(s):  
Hae Won Jung ◽  
Chewan Lim ◽  
Han Joon Bae ◽  
Jung-Hee Lee ◽  
Yong-Joon Lee ◽  
...  
Keyword(s):  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Atherosclerosis Progression ◽  
Drug Eluting ◽  
Artery Disease ◽  
N 93 ◽  
Target Lesion Failure ◽  
Relationship Of ◽  
The Relationship

Background and aims The prognosis of stented lesions differs according to in-stent neointimal characteristics on optical coherence tomography (OCT). In particular, patients who show in-stent heterogeneous neointima are associated with a higher incidence of target lesion revascularization (TLR) compared with those who show in-stent non-heterogeneous neointima. However, the relationship between in-stent neointimal characteristics and native coronary atherosclerosis progression has not been clearly elucidated. The study aimed to investigate the relationship between in-stent neointimal characteristics and progression of native atherosclerosis. Methods The neointimal characteristics of 377 patients with 377 drug-eluting stents (DESs) were quantitatively and qualitatively assessed using OCT. The OCT-based neointima was categorized as homogeneous (n = 207), heterogeneous (n = 93), and layered (n = 77). The relationship of non-target lesion revascularization (non-TLR) with neointimal characteristics was evaluated after OCT examination of the stents. Results After a median follow-up duration of 40.0 months, patients with heterogeneous neointima showed significantly higher non-TLR rates than those with homogeneous neointima and tended to have higher non-TLR rates than those with layered neointima (heterogeneous vs. homogeneous:14.0% vs. 8.7%, p = 0.046; heterogeneous vs. layered neointima:14.0% vs. 7.8%, p = 0.152). Multivariate analysis showed that the independent determinants for non-TLR were heterogeneous neointima (HR: 2.237, 95% CI: 1.023–4.890, p = 0.044) and chronic kidney disease (hazard ratio [HR]: 8.730, 95% CI: 2.175–35.036, p = 0.002). Conclusions The heterogeneous neointima in DES-treated lesions was associated with a higher incidence of non-TLR and target lesion failure. This finding suggests that the neointimal pattern may reflect the progression of the native lesion.

Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results

2021 ◽  
pp. 152660282110570
Author(s):  
Jean-Baptiste Dexpert ◽  
Daniel Hayoz ◽  
Rolf P. Engelberger ◽  
Caroline Krieger ◽  
Marie-Antoinette Rey Meyer ◽  
...  
Keyword(s):  
De Novo ◽  
Arterial Disease ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Stent Restenosis ◽  
Stent Length ◽  
Peripheral Arterial ◽  
Vessel Preparation

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

scholarly journals Association of Side-Branch Treatment and Patient Factors in Left Anterior Descending Artery True Bifurcation Lesions: Analysis from the GRAND-DES Pooled Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Gyu Chul Oh ◽  
Kyung Woo Park ◽  
Jeehoon Kang ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Target Lesion ◽  
Side Branch ◽  
Target Lesion Revascularization ◽  
Baseline Risk ◽  
2Nd Generation ◽  
Significant Difference ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
The Difference ◽  
Target Lesion Failure

Background and Objectives. In most bifurcation lesions, keeping the procedure simple by not treating the side-branch (SB) lesion when possible is considered the best method. However, because of improvements with 2nd generation drug-eluting stents (DESs), it remains unknown whether treatment of the SB may improve outcomes in certain subgroups, especially when exclusively using 2nd generation DESs. We report the outcome of SB treatment in a group of patients exclusively receiving newer generation DES for bifurcation PCI. Methods. Patients undergoing PCI to left anterior descending (LAD) bifurcation lesions with contemporary DES were analyzed from a nationwide registry. Baseline risk was assessed using the Age, Creatinine, and Ejection Fraction (ACEF) score. Target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization, was assessed at 3 years. Results. Among 1,089 patients with LAD bifurcation lesions, 548 (50.3%) patients underwent SB treatment. The SB treatment group showed a nonsignificant, but numerically lower rate of 3-year TLF (6.6% vs. 9.2%, HR 0.75, 95%CI 0.44–1.28, p  = 0.29). In patients with low pretreatment risk (ACEF<1.22), SB treatment was associated with a lower rate of 3-year TLF (HR 0.43, 95%CI 0.19–0.96, p  = 0.04), while no significant difference was observed in patients with high risk (ACEF≥1.22). The difference in the low risk group was mostly driven by target lesion revascularization (HR 0.24, 95%CI 0.08–0.75, p  = 0.01). Conclusions. SB treatment for LAD bifurcation lesions showed favorable long-term outcomes compared with main-branch-only intervention, especially in patients with low pretreatment risk.

scholarly journals Randomized Clinical Comparison of the Dual Therapy CD34 Antibody-Covered Sirolimus-Eluting Combo Stent with the Sirolimus-Eluting Orsiro Stent in Patients Treated with Percutaneous Coronary Intervention: The SORT OUT X Trial

Circulation ◽  
2021 ◽  
Author(s):  
Lars Jakobsen ◽  
Evald H. Christiansen ◽  
Phillip Freeman ◽  
Johnny Kahlert ◽  
Karsten Veien ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Primary Endpoint ◽  
Cardiac Death ◽  
Large Scale ◽  
Dual Therapy ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Intention To Treat ◽  
Increased Risk ◽  
Target Lesion Failure

Background: Target lesion failure remains an issue with contemporary drug eluting stents. Thus, the dual therapy sirolimus-eluting and CD34+ antibody coated Combo stent (DTS) was designed to further improve early healing. The aim of this study was to investigate whether the DTS is non-inferior to the sirolimus-eluting Orsiro stent (SES) in an all-comers patient population. Methods: The SORT OUT X trial, was a large-scale randomized, multicenter, single-blind, two-arm, non-inferiority trial with registry-based follow-up. The primary endpoint target lesion failure (TLF) was a composite of cardiac death, myocardial infarction or target lesion revascularization within 12 months, analyzed using intention to treat. The trial was powered for assessing TLF non-inferiority of the DTS compared with the SES with a predetermined non-inferiority margin of 0.021. Results: 3,146 patients were randomized to treatment with the DTS (1,578 patients, 2,008 lesions) or the SES (1,568 patients 1,982 lesions). At 12 months, intention-to-treat analysis showed that 100 patients (6.3%), who were assigned the DTS, and 58 patients (3.7%), who were assigned the SES, met the primary endpoint (absolute risk difference 2.6% [upper limit of one-sided 95% confidence interval (CI) 4.1%]; p(non-inferiority)=0.76). The SES was superior to the DTS (Incidence rate ratios (IRR) for target lesion failure=1.74 [95% CI, 1.26-2.41]; P=0.00086). The difference was mainly explained by a higher incidence of target lesion revascularization in the DTS group compared to the SES group (53 [3.4%] vs 24 [1.5%], IRR=2.22 [95% CI, 1.37-3.61]; P=0.0012). Conclusions: The DTS did not confirm non-inferiority to the SES for target lesion failure at 12 months in an all-comer population. The SES was superior to the DTS mainly because the DTS was associated with an increased risk of target lesion revascularization. However, rates of death, cardiac death, and myocardial infarction at 12 months did not differ significantly between the two stent groups. Clinical Trial Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03216733.

scholarly journals A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hang Ouyang ◽  
Xuehui Zeng ◽  
Chunlei Zhang ◽  
Linli Song ◽  
Jiarui Xu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Controlled Trials ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Late Luminal Loss

Abstract Objective We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. Methods A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. Results EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001). Conclusion Among those three types of stents, EES should be the first recommended stent for DM patients.

scholarly journals Two-year clinical performance of Absorb BVS compared to Xience EES in ST-segment elevation myocardial infarction: a pooled analysis of AIDA and COMPARE-ABSORB trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.S.M Kerkmeijer ◽  
G Chao ◽  
R Tijssen ◽  
T Gori ◽  
R.P Kraak ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Target Lesion ◽  
Pooled Analysis ◽  
St Segment Elevation ◽  
Patient Level ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Absorb Bvs ◽  
Target Lesion Failure

Abstract Introduction Bioresorbable vascular scaffolds (BVS) use appears theoretically attractive in patients presenting with ST-segment elevation myocardial infarction (STEMI) as acute lesions are generally composed of soft plaques, in which optimal BVS deployment and expansion is easier to achieve. Furthermore, those patients are generally younger and would benefit longer from the promise of vascular restoration therapy. Purpose In this patient level pooled analysis of two clinical trials, we evaluated the clinical outcomes of Absorb BVS versus Xience everolimus-eluting stent (EES) in STEMI patients at 2-year follow-up. Methods We performed an individual patient-level pooled analysis of the AIDA and COMPARE-ABSORB trials in which 3515 patient were randomly assigned to Absorb BVS (n=1772) or Xience EES (n=1743). Clinical outcomes in STEMI patients were analyzed by randomized treatment assignment cumulative through 2 years. The primary efficacy outcomes measure was target lesion failure (cardiac death, target-vessel myocardial infarction or target lesion revascularization), and the primary safety outcome measure was device thrombosis at 2-year follow-up. Results 350 (19.8%) STEMI patients were allocated to Absorb BVS versus 328 (18.8%) to Xience EES. The mean age of patient presenting with STEMI was 60 years old, 76.0% were males and 15.3% had diabetes mellitus. At 2-years target lesion failure occurred in 8.4% of BVS STEMI patients and 6.2% of EES STEMI patients (p=0.253). The 2-year rates of cardiac death (2.6% vs 1.6%, p=0.332), TV-MI (4.7% vs 2.5%) and TLR (6.8% vs 4.1%) were not significantly different. The 2-year incidence of definite device thrombosis was 4.7% in Absorb BVS versus 1.8% in Xience EES (p=0.045). Conclusion In the present patient-level pooled analysis of the AIDA and COMPARE-Absorb trials, BVS was associated with increased rates of device thrombosis in STEMI patients compared to Xience EES. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott

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