AIMS: Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. METHODS AND RESULTS: The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02–1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58–1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71–1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53–1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80–2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. CONCLUSIONS: In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

• Klíčová slova
• Clinical Trials, Drug-coated balloon, Drug-eluting stent, In-stent restenosis, Meta-analysis, Mortality, Paclitaxel, Percutaneous coronary intervention,
• MeSH
• balónková angioplastika * MeSH
• koronární angiografie MeSH
• koronární restenóza * terapie   MeSH
• léčivé přípravky * MeSH
• lidé MeSH
• paclitaxel MeSH
• protézy - design MeSH
• randomizované kontrolované studie jako téma MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• práce podpořená grantem MeSH
• Názvy látek
• léčivé přípravky * MeSH
• paclitaxel MeSH

BACKGROUND: In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). OBJECTIVES: This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR. METHODS: The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. RESULTS: A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. CONCLUSIONS: At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.

• Klíčová slova
• drug-coated balloon, drug-eluting stent, in-stent restenosis, individual patient data, percutaneous coronary intervention, randomized clinical trial, restenosis,
• MeSH
• balónková koronární angioplastika mortalita   MeSH
• koronární restenóza terapie   MeSH
• lidé MeSH
• randomizované kontrolované studie jako téma MeSH
• stenty uvolňující léky * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

BACKGROUND: The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. OBJECTIVES: We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. METHODS: We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group). RESULTS: The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270). CONCLUSIONS: At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

• Klíčová slova
• everolimus-eluting stent, in-stent restenosis, paclitaxel-eluting balloon,
• MeSH
• balónková koronární angioplastika škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• biokompatibilní potahované materiály * MeSH
• časové faktory MeSH
• doba přežití bez progrese choroby MeSH
• everolimus aplikace a dávkování   škodlivé účinky   MeSH
• kardiovaskulární látky aplikace a dávkování   škodlivé účinky   MeSH
• koronární angioplastika škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• koronární restenóza diagnostické zobrazování   etiologie   mortalita   terapie   MeSH
• kovy * MeSH
• lidé středního věku MeSH
• lidé MeSH
• opakovaná terapie MeSH
• paclitaxel aplikace a dávkování   škodlivé účinky   MeSH
• prospektivní studie MeSH
• protézy - design MeSH
• rizikové faktory MeSH
• senioři MeSH
• srdeční katétry * MeSH
• stenty uvolňující léky * MeSH
• stenty * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• biokompatibilní potahované materiály * MeSH
• everolimus MeSH
• kardiovaskulární látky MeSH
• kovy * MeSH
• paclitaxel MeSH

Coronary stent implantation has significantly improved percutaneous coronary intervention and enabled the management of early complications of plain balloon angioplasty. However, a new complication has accompanied these improvements: in-stent restenosis (ISR) arising from neointimal hyperplasia. ISR after coronary angioplasty is currently one of the main limitations of this method, leading to the recurrence of exertional angina pectoris or acute coronary syndromes. The clinical incidence of ISR after bare-metal stent (BMS) implantation is approximately 20%-35%. The use of drug-eluting stents (DES) has led to a further decrease in the occurrence of ISR to 5%-10%. Evidence resulting from controlled clinical studies suggests that DES and drug-eluting balloon catheters (DEB) provide the best clinical and angiographic results in the treatment of ISR. We undertook a systematic review of the pathophysiology, diagnostics and treatment options for BMS- and DES-ISR. We discuss recent randomised studies, comparing different DES or DEB used for BMS or DES-ISR treatment, as well as the use of new biovascular scafolds and the topic of scafold restenosis.

• Klíčová slova
• Drug-eluting balloon, Drug-eluting stent, In-stent restenosis,
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

BACKGROUND: Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR). METHODS: We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE). RESULTS: Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p < 0.0001), repeated binary restenosis (28.12% vs. 8.7%; p = 0.012), 12-month MACE (26.98% vs. 10.29%; p = 0.003), and target vessel revascularization (TVR; 20.63% vs. 7.35%; p = 0.009). Compared to EES, no significant differences were found in the 12-month LLL (0.30 vs. 0.19 mm; p = 1.000), repeated binary restenosis (28.12% vs. 19.12%; p = 0.666), 12-month MACE (26.98% vs. 19.12%; p = 0.102) or TVR (20.63% vs. 16.18%; p = 0.360). CONCLUSION: BMS-ISR treatment using seal-wing PEB led to significantly higher 12-month LLL, repeated binary restenosis, MACE, and TVR compared to iopromide-coated PEB. However, no significant differences were found in comparison with EES. TRIAL REGISTRATION: ClinicalTrials.gov; NCT01735825.

• Klíčová slova
• Drug-eluting stent, In-stent restenosis, Paclitaxel-elution balloon,
• MeSH
• balónková koronární angioplastika škodlivé účinky   přístrojové vybavení   MeSH
• biokompatibilní potahované materiály * MeSH
• časové faktory MeSH
• Kaplanův-Meierův odhad MeSH
• kardiovaskulární látky aplikace a dávkování   škodlivé účinky   MeSH
• koronární angiografie MeSH
• koronární angioplastika škodlivé účinky   přístrojové vybavení   MeSH
• koronární restenóza diagnostické zobrazování   etiologie   terapie   MeSH
• kovy * MeSH
• lidé středního věku MeSH
• lidé MeSH
• logistické modely MeSH
• nemoci koronárních tepen diagnostické zobrazování   terapie   MeSH
• odds ratio MeSH
• paclitaxel aplikace a dávkování   škodlivé účinky   MeSH
• přežití po terapii bez příznaků nemoci MeSH
• prospektivní studie MeSH
• protézy - design MeSH
• randomizované kontrolované studie jako téma MeSH
• recidiva MeSH
• rizikové faktory MeSH
• senioři MeSH
• srdeční katétry * MeSH
• stenty uvolňující léky MeSH
• stenty * MeSH
• studie případů a kontrol 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
• práce podpořená grantem MeSH
• Názvy látek
• biokompatibilní potahované materiály * MeSH
• kardiovaskulární látky MeSH
• kovy * MeSH
• paclitaxel MeSH

• MeSH
• balónková koronární angioplastika MeSH
• everolimus * MeSH
• koronární angiografie MeSH
• koronární restenóza MeSH
• lidé MeSH
• paclitaxel * MeSH
• sirolimus MeSH
• stenty uvolňující léky MeSH
• stenty MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• dopisy MeSH
• komentáře MeSH
• Názvy látek
• everolimus * MeSH
• paclitaxel * MeSH
• sirolimus MeSH

BACKGROUND: The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxel-eluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis. METHODS AND RESULTS: A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004). The difference in the incidence of repeated binary restenosis (8.7% versus 19.12%; P=0.078) and 12-month major adverse cardiac events (10.29% versus 19.12%; P=0.213) was not significant. The 12-month LLL was significantly less in the PEB group and also in subgroups with in-stent restenosis >10 mm (0.05 versus 0.26 mm; P=0.0002) and artery diameter <3 mm (0.05 versus 0.16 mm; P=0.003) compared with the EES groups, but not in the subgroup of patients with diabetes mellitus (P=0.254). In the EES group, repetitive binary restenosis had a significantly greater chance of occurring (odds ratio=3.132; 95% confidence interval, 1.058-9.269; P=0.039), even when adjusting for other risk factors. CONCLUSIONS: Treatment of bare metal stent restenosis using PEB led to significantly less 12-month LLL than the implantation of second-generation EES. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01735825.

• Klíčová slova
• coronary restenosis, diabetes mellitus, drug-eluting stents, paclitaxel, stents,
• MeSH
• biokompatibilní potahované materiály * MeSH
• časové faktory MeSH
• cévní přístupy * MeSH
• everolimus aplikace a dávkování   MeSH
• Kaplanův-Meierův odhad MeSH
• kardiovaskulární látky aplikace a dávkování   MeSH
• koronární angioplastika škodlivé účinky   přístrojové vybavení   MeSH
• koronární restenóza diagnostické zobrazování   etiologie   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• logistické modely MeSH
• nemoci koronárních tepen diagnostické zobrazování   terapie   MeSH
• odds ratio MeSH
• paclitaxel aplikace a dávkování   MeSH
• přežití po terapii bez příznaků nemoci MeSH
• prospektivní studie MeSH
• protézy - design MeSH
• rizikové faktory MeSH
• rozdělení chí kvadrát MeSH
• senioři 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
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• biokompatibilní potahované materiály * MeSH
• everolimus MeSH
• kardiovaskulární látky MeSH
• paclitaxel MeSH

AIMS: We sought to identify biochemical predictors that indicate susceptibility to in-stent restenosis (ISR) after coronary artery bare-metal stenting. METHODS: A total of 111 consecutive patients with post-percutaneous coronary intervention (PCI) in-stent restenosis of a target lesion within 12 months were matched for age, sex, vessel diameter, and diabetes with 111 controls without post-PCI ISR. Plasma or serum levels of biochemical markers were measured: matrix metalloproteinases (MMP) 2, 3, 9; myeloperoxidase (MPO); asymmetric dimethylarginine (ADMA); lipoprotein (a) (Lp[a]); apolipoproteins E and D (ApoE and D); and lecitin-cholesterol acyltransferase (LCAT). Multivariable logistic regression association tests were performed. RESULTS: Increased plasma MMP-3 (OR: 1.013; 95% CI: 1.004-1.023; P = 0.005), MMP-9 (OR: 1.014; 95% CI: 1.008-1.020; P < 0.0001) or MPO (OR: 1,003; 95% CI: 1.001-1.005; P = 0.002) was significantly associated with increased risk of ISR. Increased levels of ADMA (OR: 0.212; 95% CI: 0.054-0.827; P = 0.026), ApoE (OR: 0.924; 95% CI: 0.899-0.951; P < 0.0001), ApoD (OR: 0.919; 95% CI: 0.880-0.959; P = 0.0001), or LCAT (OR: 0.927; 95% CI: 0.902-0.952; P < 0.0001) was associated with risk reduction. No correlation was found between plasma MMP-2 or Lp (a) and ISR risk. CONCLUSIONS: Increased levels of MMP-3, MMP-9, and MPO represent predictors of ISR after bare-metal stent implantation. In contrast, increased ADMA, LCAT, and Apo E and D indicate a decreased in-stent restenosis occurrence.

• Klíčová slova
• apolipoproteins D, apolipoproteins E, asymmetric dimethylarginine, in-stent restenosis, lecitin-cholesterol acyltransferase, matrix metalloproteinases, myeloperoxidase,
• MeSH
• apolipoproteiny D metabolismus   MeSH
• apolipoproteiny E metabolismus   MeSH
• arginin analogy a deriváty   metabolismus   MeSH
• biologické markery metabolismus   MeSH
• koronární angioplastika MeSH
• koronární restenóza diagnóza   patofyziologie   MeSH
• lecitincholesterolacyltransferasa metabolismus   MeSH
• lidé středního věku MeSH
• lidé MeSH
• lipoprotein (a) metabolismus   MeSH
• matrixová metaloproteinasa 3 metabolismus   MeSH
• matrixová metaloproteinasa 9 metabolismus   MeSH
• okluze cévního štěpu diagnóza   patofyziologie   MeSH
• peroxidasa metabolismus   MeSH
• průchodnost cév fyziologie   MeSH
• senioři MeSH
• stenty * MeSH
• studie případů a kontrol MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• apolipoproteiny D MeSH
• apolipoproteiny E MeSH
• arginin MeSH
• biologické markery MeSH
• lecitincholesterolacyltransferasa MeSH
• lipoprotein (a) MeSH
• matrixová metaloproteinasa 3 MeSH
• matrixová metaloproteinasa 9 MeSH
• N,N-dimethylarginine MeSH Prohlížeč
• peroxidasa MeSH

AIM: The purpose of this study was to access and compare the prognostic effects of different types of cardiac rehabilitation (CR) in patients with chronic coronary artery disease. METHODS: One hundred fifty-two patients were retrospectively divided into 4 groups according to their adherence to physical activity recommendations. Patients in groups 1 and 2 participated in the guided 3-month exercise programme. Patients in group 1 then continued with individual exercise training, while patients in the group 2 stopped exercising after finishing the guide exercise programme. Patients in group 3 participated only in individual exercise training throughout the whole follow-up period, and patients in group 4 declined all exercise recommendations and did not exercise. The prognostic outcome of different types of cardiac rehabilitation was compared among the groups. In addition, patients who participated in individual exercise training according to recommendations (cohort IT+) were compared with patients who declined these activities (cohort IT-). RESULTS: During a median follow-up of 94 months, 33 deaths occurred: 17 cardiovascular and 16 non-cardiac deaths. A Kaplan-Meier survival analysis demonstrated significantly better survival rates for patients who followed a long-term aerobic exercise training (IT+) than for those who did not participate or who had only a short-term exercise programme (IT-) (P = 0.009). CONCLUSION: In our study, long-term exercise training had a higher impact on patient survival than short-term guided CR.

• MeSH
• cvičení fyziologie   MeSH
• elektrokardiografie MeSH
• lidé středního věku MeSH
• lidé MeSH
• míra přežití trendy   MeSH
• následné studie MeSH
• nemoci koronárních tepen mortalita   patofyziologie   rehabilitace   MeSH
• prognóza MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• senioři MeSH
• terapie cvičením metody   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH