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PCB Angioplasty vs. DES Implantation for In-Stent Restenosis
Study Questions:
What are the outcomes with angioplasty with paclitaxel-coated balloon (PCB) versus repeat stenting with drug-eluting stent (DES) in patients undergoing treatment for in-stent restenosis (ISR)?
Methods:
The investigators conducted 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, in the DAEDALUS (Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis) study. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1,976 patients enrolled, 1,033 assigned to PCB, and 943 to DES. A two-stage meta-analysis with individual trial risk estimates extraction by Cox proportional hazards regression and subsequent pooling by fixed- and random-effects models was conducted as sensitivity analysis for each outcome.
Results:
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% confidence interval [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 prespecified 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:
The authors concluded that 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.
Perspective:
This individual patient data meta-analysis of patients undergoing treatment for coronary ISR study reports that angioplasty with PCB is moderately less effective than repeat stenting with DES in terms of the primary efficacy endpoint of TLR. Of note, the rates of all-cause death, cardiac death, and noncardiac death were similar between treatments, and PCB use in the setting of coronary artery disease does not increase long-term mortality compared with non–paclitaxel-based DES. Overall, the results of this analysis support the use of both PCB and DES in patients with coronary ISR. The moderate advantage with repeat DES should be considered against the potential advantages with PCB of avoiding additional layers of stent and the absence of significant differences in terms of safety.
Keywords: Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Artery Disease, Coronary Restenosis, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Paclitaxel, Secondary Prevention, Stents, Thrombosis
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