Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study)

Abstract

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.

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study

“…The recent DAEDALUS study in patients treated with DCB or DES for in-stent re-stenosis showed that there was no significant difference in late mortality associated with DCB. This conclusion is limited however, by the fact that followup was limited to 3 years and thus might have missed a true late effect [19]. In addition, it is difficult to draw definitive conclusions from that study for late mortality relating to paclitaxel, as this was a subgroup analysis and the patient groups were heterogeneous given the previous stent implantations including bare metal stents and paclitaxel DES.…”

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study

“…Calcified lesion modification with this device, as measured by optical coherence tomography, was favorably rated in previous observational studies [ 18 ]. Given the fact that there is no class effect for DCB devices [ 4 ] the iopromide–paclitaxel-coated DCB was used (SeQuent ® Please NEO, B.Braun Melsungen AG). As compared to the predecessor device (SeQuent ® Please, B.Braun Melsungen AG), a hydrophilic coating of the distal shaft was introduced for enhanced lesion crossability.…”

“…Lumen gain prior to DCB angioplasty may be of paramount importance in the absence of stent or scaffold implantations due to elastic recoil and/or dissections. However, pivotal studies for DCB angioplasty were primarily conducted to treat in-stent restenotic (ISR) lesions with documented high restenosis [ 4 ]. Numerous studies provided sufficient evidence for a renewed class I recommendation by the European Society of Cardiology for in-stent restenosis with an evidence level A [ 5 ].…”

The year in cardiovascular medicine 2020: interventional cardiology

“…In the field of restenosis, the DAEDALUS study, a patient-level meta-analysis including 10 RCT, showed that treatment of in-stent restenosis (ISR) with DCB was associated with a higher risk of TLR at 3 years, with no differences in the safety outcome (death, MI, or target lesion thrombosis). 60 A sub-analysis of this study, comparing BMS-ISR and DES-ISR, demonstrated that both treatment strategies (DCB and new DES implantation) were similarly effective and safe in patients with BMS-ISR. However, in patients with DES-ISR, treatment with DCB was associated with a higher rate of TLR at 3 years and non-significant differences in safety outcomes.…”