Clinical outcome following second-generation drug-eluting stent use for off-label versus on-label indications: insights from the two-year outcome of the TWENTE trial

Abstract

Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.

Complex patients treated with zotarolimus‐eluting resolute and everolimus‐eluting xience V stents in the randomized TWENTE trial: Comparison of 2‐year clinical outcome

“…As recently reported in a pooled analysis of all patients of the TWENTE trial, complex patients (i.e., patients with “off‐label” indications for DES use) had significantly more diabetes (23% vs. 18%), previous MI (36% vs. 22%), type B2/C lesions (85% vs. 63%), and acute coronary syndromes at presentation (58% vs. 33%) compared with the non‐complex patients. At 2‐year follow‐up, the rate of target vessel‐related MI was significantly higher in the complex patients (6.4% vs. 2.8%; P = 0.01) . Our present study adds to those findings by showing that complex patients treated with ZES versus EES do not differ in target vessel‐related MI (6.0% vs. 6.7%; P = 0.65) .…”

“…At 2‐year follow‐up, the rate of target vessel‐related MI was significantly higher in the complex patients (6.4% vs. 2.8%; P = 0.01) . Our present study adds to those findings by showing that complex patients treated with ZES versus EES do not differ in target vessel‐related MI (6.0% vs. 6.7%; P = 0.65) .…”

Three-year clinical outcome of patients with bifurcation treatment with second-generation Resolute and Xience V stents in the randomized TWENTE trial

“…24 Overall, Xience V and Resolute have shown favorable results in various patient populations that included patients with bifurcation lesions. [5][6][7]16,21,25,26 A recent analysis that pooled both stent arms of the RESOLUTE All Comers trial, which used the same DES as the TWENTE trial (and thus our present substudy), showed similar clinical outcomes for patients treated for bifurcated versus nonbifurcated lesions at 2-year follow-up. 13 In the study reported by Diletti et al 13 as well as in our present study, there was a higher incidence of PMI in patients with bifurcation lesions.…”