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DELIVER was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES). In-hospital clinical outcomes and resource utilization following radial and femoral access implantations are compared in a post-hoc analysis.
Patients undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers. The primary endpoint of the study was delivery success when R-ZES was used as the primary stent. Delivery success was defined as complete passage of the stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. In-hospital clinical outcomes, procedural details, and resource utilization were collected. Target lesion failure (TLF) was the composite of cardiac death, target vessel myocardial infarction (MI), and clinically-driven target lesion revascularization. Procedural and in-hospital outcome comparisons of radial vs. femoral approach were adjusted using propensity scores.
A high proportion of the population (n=7740 patients) had complex disease (71%; n=5490/7739), and the approach was radial in 46% (n=3564) and femoral in 53% (n=4128) of patients. The femoral group had significantly more patients who were female or had a prior MI, a prior coronary artery bypass graft, diabetes, renal insufficiency, or a history of hypertension (all p<0.001). The femoral group was also characterized by more complex lesion characteristics. Primary delivery success was high (98.9%, n=10617/10733 stents) and did not differ by approach (adjusted p=0.880). In-hospital clinical outcomes were low (TLF: 1.6%, n=122/7740) and did not differ by approach (adjusted p=0.275). Radial access was associated with lower hospital length of stay and procedure duration (both adjusted p<0.001), less contrast used (p=0.003), and fewer balloons and catheters used (adjusted p=0.010 and p<0.001).
R-ZES was found to be highly deliverable in a complex, all-comers, international population. DELIVER was not intended to compare R-ZES implantation access methods. The radial approach, however, was associated with lower resource utilization than the femoral approach after adjustment for differences in baseline characteristics.