Aims: To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) for in-stent restenosis (ISR) in an unselected patient population. Implantation of bare metal stents in native coronary vessels can result in ISR rates exceeding 50%. PES significantly reduces ISR-lesion restenosis and improves event-free survival versus vascular brachytherapy.
Methods and results: The 7,492-patient ARRIVE registry enrolled patients receiving ≥1 TAXUS Express stent at procedure initiation with no inclusion/exclusion criteria, including 489 patients with ISR. Endpoints were independently adjudicated. All major cardiac events were monitored plus a 10%-20% sample per site. ISR patient 2-year follow-up was 94% complete (462/489). Compared to simple-use patients undergoing native coronary intervention (N=2698) or other, non-ISR expanded-use cases (N=4305), ISR patients had significantly more baseline comorbidities/complex disease. They had higher 2-year rates for mortality (8.6% vs. 4.2%, P<0.001), myocardial infarction (5.0% vs. 2.2%, P<0.001), definite/probable stent thrombosis (4.0% vs. 1.4%, P<0.001), and target lesion revascularisation (12.3% vs. 5.4%, P<0.001) versus simple-use. Safety outcomes were comparable between the ISR and non-ISR expanded-use subgroups but target vessel revascularisation (TVR) was significantly higher for ISR (16.0% vs. 10.9%, P=0.003). ISR was independently associated with increased risk for TVR (1.4-fold).
Conclusions: ARRIVE ISR, one of the largest studied cohorts of patients receiving DES for ISR, had higher risk for clinical events versus simple-use patients but comparable safety outcomes versus other expanded-use patients except for significantly higher revascularisation. ARRIVE provides a detailed estimate of 2-year outcomes in these real-world patients.