Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials.

BACKGROUND: Lesion length has been an important factor in predicting a worse outcome after percutaneous coronary interventions (PCI); however, the safety and efficacy of second-generation drug eluting stents in very long coronary lesions has not been validated in large scale randomized controlled trials. METHODS: We performed a patient level pooled analysis of 13,266 patients undergoing planned overlapping stent treatment of very long coronary lesions with the XIENCE V everolimus eluting coronary stent system from 6 trials evaluating the XIENCE V stent (Spirit II, III, IV, V, Spirit Small Vessel and XIENCE V USA). Patients were divided into two cohorts, a very long lesion (VLL) group (lesions ≥35 mm) and a control group (lesions >24 to <35 mm). The primary outcome measures were Target Lesion Failure (TLF), Major Adverse Cardiac Events (MACE), and Academic Research Consortium (ARC) defined definite and probable stent thrombosis at 1 year. RESULTS: A total of 13,266 patients were included in the pooled analysis of which 2.4% (323 patients with 328 total lesions) had a mean lesion length of 47.1 ± 13.7 mm in the VLL group which were compared to controls comprised of 3.6% of the cohort (482 patients with 500 total lesions) with mean lesion length of 28.1 ± 2.4 mm.There was no significant difference in the rates of TLF between the VVL and control groups (8.9 vs. 10%, P = 0.63), MACE (9.2 vs. 10%, P = 0.74) or stent thrombosis (1.6 vs. 1.5%, P = 0.92) at 1 year. CONCLUSIONS: In the treatment of very long coronary lesions, the XIENCE V stent appears as safe and effective as percutaneous coronary interventions for long lesions. © 2016 Wiley Periodicals, Inc.