BACKGROUND: Current therapy for in-stent restenosis (ISR) is based on drug-eluting stents (DES) or drug-eluting balloon catheters. This prospective randomized study compared the efficacy of a novel sirolimus-eluting balloon (SEB) catheter to that of a paclitaxel-eluting balloon (PEB) catheter for the treatment of bare-metal stent (BMS-ISR) or DES-ISR. METHODS: A total of 145 patients with 158 BMS or DES-ISR lesions were randomly assigned to the treatment with either SEB or PEB. The in-segment late lumen loss at 12 months, the 12-month incidence of binary ISR, and major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) were compared between groups. RESULTS: The noninferiority of SEB compared with PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not demonstrated (Δlate lumen loss, -0.024 mm [95% CI, -0.277 to 0.229]; for a noninferiority margin of 0.20 mm), except in the post hoc subanalysis for the BMS-ISR group (-0.203 mm [95% CI, -0.584 to 0.178]). No significant differences in the incidence of repeated binary ISR (31.6% versus 30.4%, P=0.906) or 12-month major adverse cardiac events (31% for both; P>0.999) between the SEB and PEB groups were observed. CONCLUSIONS: The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03667313.
- Klíčová slova
- angioplasty, balloon, coronary, coronary restenosis, paclitaxel, sirolimus,
- MeSH
- balónková koronární angioplastika * škodlivé účinky přístrojové vybavení mortalita MeSH
- biokompatibilní potahované materiály * MeSH
- časové faktory MeSH
- kardiovaskulární látky * aplikace a dávkování škodlivé účinky MeSH
- koronární angioplastika * škodlivé účinky přístrojové vybavení mortalita MeSH
- koronární restenóza * diagnostické zobrazování terapie mortalita etiologie MeSH
- kovy MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnostické zobrazování terapie mortalita MeSH
- paclitaxel * aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- senioři MeSH
- sirolimus * aplikace a dávkování škodlivé účinky MeSH
- srdeční katétry * MeSH
- stenty uvolňující léky MeSH
- stenty * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- biokompatibilní potahované materiály * MeSH
- kardiovaskulární látky * MeSH
- kovy MeSH
- paclitaxel * MeSH
- sirolimus * MeSH
BACKGROUND: Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years. METHODS: FAME 3 was a multicentre, randomised trial comparing FFR-guided PCI using current-generation zotarolimus-eluting stents versus CABG in patients with three-vessel coronary artery disease not involving the left main coronary artery. 48 hospitals in Europe, USA and Canada, Australia, and Asia participated in the trial. Patients (aged ≥21 years with no cardiogenic shock, no recent ST segment elevation myocardial infarction, no severe left ventricular dysfunction, and no previous CABG) were randomly assigned to either PCI or CABG using a web-based system. At 1 year, FFR-guided PCI did not meet the prespecified threshold for non-inferiority for the outcome of death, stroke, myocardial infarction, or repeat revascularisation versus CABG. The primary endpoint for this intention-to-treat analysis was the 5-year incidence of the prespecified composite outcome of death, stroke, or myocardial infarction. The trial was registered at ClinicalTrials.gov, NCT02100722, and is completed; this is the final report. FINDINGS: Between Aug 25, 2014 and Nov 28, 2019, 757 of 1500 participants were assigned to PCI and 743 to CABG. 5-year follow-up was achieved in 724 (96%) patients assigned to PCI and 696 (94%) assigned to CABG. At 5 years, there was no significant difference in the composite of death, stroke, or myocardial infarction between the two groups, with 119 (16%) events in the PCI group and 101 (14%) in the CABG group (hazard ratio 1·16 [95% CI 0·89-1·52]; p=0·27). There were no differences in the rates of death (53 [7%] vs 51 [7%]; 0·99 [0·67-1·46]) or stroke (14 [2%] vs 21 [3%], 0·65 [0·33-1·28]), but myocardial infarction was higher in the PCI group than in the CABG group (60 [8%] vs 38 [5%], 1·57 [1·04-2·36]), as was repeat revascularisation (112 [16%] vs 55 [8%], 2·02 [1·46-2·79]). INTERPRETATION: At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients. FUNDING: Medtronic and Abbott Vascular.
- MeSH
- frakční průtoková rezerva myokardu * MeSH
- infarkt myokardu epidemiologie MeSH
- koronární angiografie MeSH
- koronární angioplastika * metody MeSH
- koronární bypass * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- nemoci koronárních tepen * chirurgie mortalita MeSH
- senioři MeSH
- sirolimus analogy a deriváty aplikace a dávkování MeSH
- stenty uvolňující léky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- sirolimus MeSH
- zotarolimus MeSH Prohlížeč
PURPOSE: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). RESULTS: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. CONCLUSIONS: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.
- Klíčová slova
- Acute coronary syndrome, Anti-CD34, Dual therapy stent, Endothelial progenitor cell capture, Percutaneous coronary intervention,
- MeSH
- akutní koronární syndrom klasifikace komplikace mortalita chirurgie MeSH
- časové faktory MeSH
- endoteliální progenitorové buňky metabolismus MeSH
- infarkt myokardu klasifikace komplikace MeSH
- koronární angioplastika metody MeSH
- koronární trombóza epidemiologie MeSH
- lidé MeSH
- nestabilní angina pectoris komplikace MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- sirolimus aplikace a dávkování MeSH
- stenty uvolňující léky škodlivé účinky statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- sirolimus MeSH
OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.
- Klíčová slova
- Clopidogrel, Dual antiplatelet therapy, Polymer-free, Sirolimus-eluting stent, Ticagrelor,
- MeSH
- časové faktory MeSH
- dodržování směrnic MeSH
- duální protidestičková léčba * škodlivé účinky mortalita MeSH
- hodnocení rizik MeSH
- inhibitory agregace trombocytů aplikace a dávkování škodlivé účinky MeSH
- kardiovaskulární látky aplikace a dávkování škodlivé účinky MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- koronární trombóza etiologie prevence a kontrola MeSH
- krvácení chemicky indukované MeSH
- lékařská praxe - způsoby provádění MeSH
- lidé středního věku MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- nemoci koronárních tepen diagnostické zobrazování mortalita terapie MeSH
- pozorovací studie jako téma MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sirolimus aplikace a dávkování škodlivé účinky MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- stenty uvolňující léky * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- inhibitory agregace trombocytů MeSH
- kardiovaskulární látky MeSH
- sirolimus MeSH
- MeSH
- adenin analogy a deriváty MeSH
- lidé MeSH
- lymfom z plášťových buněk farmakoterapie patologie MeSH
- mezinárodní agentury MeSH
- míra přežití MeSH
- následné studie MeSH
- piperidiny MeSH
- prognóza MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- pyrazoly aplikace a dávkování MeSH
- pyrimidiny aplikace a dávkování MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- záchranná terapie * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- adenin MeSH
- ibrutinib MeSH Prohlížeč
- piperidiny MeSH
- pyrazoly MeSH
- pyrimidiny MeSH
- sirolimus MeSH
- temsirolimus MeSH Prohlížeč
Temsirolimus 175 mg once-weekly for 3 weeks, followed by 75 mg once-weekly intravenously dosed (175/75 mg) is approved in the European Union for treatment of relapsed/refractory mantle cell lymphoma (MCL). A phase IV study explored whether similar efficacy, but improved safety could be achieved with 75 mg without 175 mg loading doses (ClinicaTrials.gov: NCT01180049). Patients with relapsed/refractory MCL were randomized to once-weekly temsirolimus 175/75 mg (n = 47) or 75 mg (n = 42). Treatment continued until objective disease progression. Primary endpoint: progression-free survival (PFS). Secondary endpoints included overall survival (OS) and adverse events (AEs). Median PFS was 4.3 versus 4.5 months (hazard ratio [HR] 0.731; 80% confidence interval [CI], 0.520-1.027), and median OS 18.7 versus 11.0 months (HR 0.681; 80% CI, 0.472-0.982) with 175/75 mg versus 75 mg. There were fewer patients with serious AEs, dose reduction, or death with 175/75 mg (57.4%, 48.9%, and 48.9%) versus 75 mg (73.8%, 64.3%, and 65.1%). Temsirolimus 175/75 mg remains the preferred dosing regimen for relapsed/refractory MCL.
- Klíčová slova
- Temsirolimus, mantle cell lymphoma, overall survival, progression-free survival, safety,
- MeSH
- chemorezistence účinky léků MeSH
- injekce intravenózní MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie patologie MeSH
- lymfom z plášťových buněk farmakoterapie patologie MeSH
- míra přežití MeSH
- následné studie MeSH
- prognóza MeSH
- protinádorové látky aplikace a dávkování MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- záchranná terapie * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- protinádorové látky MeSH
- sirolimus MeSH
- temsirolimus MeSH Prohlížeč
OBJECTIVE: To evaluate the long-term follow-up of the unrestricted use of a biodegradable polymer-coated drug-eluting stent in patients undergoing percutaneous coronary intervention (PCI). METHODS: The Nobori 2 study was a prospective, multicentre, observational registry evaluating the safety and the efficacy of the biodegradable polymer biolimus-eluting stent (BP-BES) among 3067 patients recruited at 125 international sites. The primary combined endpoint was a composite of cardiac death, myocardial infarction and target-lesion revascularisation (TLR). RESULTS: Five-year follow-up was available in 2738 (89.3%) patients. The combined endpoint occurred in 268 patients (10%, 95% CIs 8.9% to 11.3%) at 5 years, with 3.9% of events during the first year and 6.2% during years 1-5 of follow-up. Cumulative rates of TLR and definite/probable stent thrombosis were 5.3% (95% CI 4.5% to 6.3%) and 1.1% (95% CI 0.8% to 1.6%), respectively. Between 1 and 5 years, TLR and very late stent thrombosis rates were 3.5% (95% CI 2.8% to 4.4%) and 0.6% (95% CI 0.3% to 1.1%), respectively. Previous PCI (HR, 2.05, 95% CI 1.68 to 2.50), moderate-to-severe renal disease (HR, 1.89, 95% CI 1.30 to 2.74) and peripheral vascular disease (HR, 1.86, 95% CI 1.38 to 2.52) were the three most powerful independent predictors of the combined endpoint at 5 years. CONCLUSIONS: The final 5-year follow-up of the Nobori 2 registry demonstrates the safety and effectiveness of the BP-BES in an unselected, broadly inclusive cohort of PCI patients, highlighting the excellent performance of this coronary stent technology after polymer biodegradation. TRIAL REGISTRATION NUMBER: ISRCTN81649913; Results.
- MeSH
- imunosupresiva aplikace a dávkování MeSH
- Kaplanův-Meierův odhad MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení metody MeSH
- koronární trombóza epidemiologie etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- nemoci ledvin epidemiologie etiologie MeSH
- onemocnění periferních cév epidemiologie etiologie MeSH
- opakovaná terapie statistika a číselné údaje MeSH
- polymery MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- registrace MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- stenty uvolňující léky * škodlivé účinky MeSH
- vstřebatelné implantáty * škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- imunosupresiva MeSH
- polymery MeSH
- sirolimus MeSH
- umirolimus MeSH Prohlížeč
AIMS: To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program. METHODS: This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients). RESULTS: After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later). CONCLUSIONS: Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.
- Klíčová slova
- aged, drug-eluting stents, hemorrhage, myocardial infarction, percutaneous coronary intervention,
- MeSH
- časové faktory MeSH
- infarkt myokardu etiologie MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární látky aplikace a dávkování MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- krvácení etiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- multivariační analýza MeSH
- nemoci koronárních tepen diagnóza mortalita terapie MeSH
- pozorovací studie jako téma MeSH
- protézy - design MeSH
- randomizované kontrolované studie jako téma MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- stenty uvolňující léky * MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- kardiovaskulární látky MeSH
- sirolimus MeSH
- zotarolimus MeSH Prohlížeč
BACKGROUND: Although trastuzumab-containing therapies prolong survival in patients with metastatic breast cancer (MBC), most tumors develop trastuzumab resistance, potentially mediated by aberrant phosphatidylinositide 3-kinase (PI3K)/AKT signaling. Ridaforolimus (a mammalian target of rapamycin [mTOR] inhibitor) may overcome trastuzumab resistance by inhibiting PI3K signaling. METHODS: A single-arm, phase IIb trial was conducted to evaluate the efficacy and safety of ridaforolimus-trastuzumab in human epidermal growth factor receptor 2-positive (HER2(+)) trastuzumab-refractory MBC (NCT00736970). Ridaforolimus was administered orally (40 mg daily) for 5 d/wk plus weekly trastuzumab. The primary end point was objective response (OR). RESULTS: Thirty-four patients were enrolled (91% had received 1 or 2 previous trastuzumab-based therapies, whereas 9% had received 3 previous therapies). The most common reasons for discontinuation were disease progression (62%) and adverse events (AEs; 24%). Three patients died; 1 because of bowel perforation, which was possibly ridaforolimus related. Partial response was observed in 5 patients (15%). Median duration of response was 19.1 weeks (range, 15.9-80.1 weeks). Fourteen patients (41%) achieved stable disease (SD); 7 patients (21%) maintained SD for ≥ 24 weeks. The clinical benefit response (CBR) rate was 34.3%. Median progression-free survival (PFS) and overall survival (OS) were 5.4 months (range, 0-20.3 months; 95% confidence interval [CI], 2.0-7.4) and 17.7 months (range, 0-25.9 months; 95% CI, 8.8-20.8), respectively. PFS rate at 6 months was 37%. The most common treatment-related AEs were stomatitis (59%), diarrhea (27%), and rash (27%). CONCLUSION: Ridaforolimus-trastuzumab was well tolerated and demonstrated antitumor activity in trastuzumab-resistant HER2(+) MBC.
- Klíčová slova
- Breast cancer, HER2, Ridaforolimus, Trastuzumab, mTOR inhibitor,
- MeSH
- analýza přežití MeSH
- aplikace orální MeSH
- chemorezistence účinky léků MeSH
- dospělí MeSH
- duktální karcinom prsu farmakoterapie mortalita patologie MeSH
- humanizované monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- nádory prsu farmakoterapie mortalita patologie MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky MeSH
- receptor erbB-2 metabolismus MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sirolimus aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- trastuzumab MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- Názvy látek
- ERBB2 protein, human MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- receptor erbB-2 MeSH
- ridaforolimus MeSH Prohlížeč
- sirolimus MeSH
- trastuzumab MeSH
OBJECTIVES: The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients. BACKGROUND: The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients. METHODS: This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated. RESULTS: The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS. CONCLUSIONS: At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.
- Klíčová slova
- ABSORB, STEMI, everolimus-eluting stent,
- MeSH
- časové faktory MeSH
- databáze faktografické MeSH
- dospělí MeSH
- everolimus MeSH
- infarkt myokardu diagnóza mortalita terapie MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární látky aplikace a dávkování MeSH
- koronární angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- koronární trombóza etiologie MeSH
- kovy * MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- proporcionální rizikové modely MeSH
- protézy - design MeSH
- recidiva MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- sirolimus aplikace a dávkování analogy a deriváty MeSH
- stenty uvolňující léky * MeSH
- tendenční skóre MeSH
- vstřebatelné implantáty * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Názvy látek
- everolimus MeSH
- kardiovaskulární látky MeSH
- kovy * MeSH
- sirolimus MeSH