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

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 bez známek 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