Analysis Conducted of Abbott's Xience V Everolimus-Eluting Stent for Treatment of Very Long Lesions

October 4, 2016—A patient-level pooled analysis of 13,266 patients from the SPIRIT and XIENCE V USA prospective multicenter trials evaluated the clinical outcomes after percutaneous coronary intervention (PCI) for very long lesions with the Xience V everolimus-eluting coronary stent system (Abbott Vascular). Georgios Bouras, MD, et al published the findings online ahead of print in Catheterization and Cardiovascular Interventions (CCI).

The investigators stated that the background of the study is that lesion length has been an important factor in predicting a worse outcome after PCI; however, the safety and efficacy of second-generation drug-eluting stents in very long coronary lesions have not been validated in large-scale randomized controlled trials.

As summarized in CCI, the investigators performed an analysis of patients undergoing planned overlapping stent treatment of very long coronary lesions with the Xience V system from six trials evaluating the device (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 mm and < 35 mm). The primary outcome measures were target lesion failure (TLF), major adverse cardiac events (MACE), and Academic Research Consortium–defined definite and probable stent thrombosis at 1 year.

The investigators reported that 2.4% of the 13,266 patients (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 composed of 3.6% of the cohort (482 patients with 500 total lesions) with a 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 = .63), MACE (9.2% vs 10%; P = .74), or stent thrombosis (1.6% vs 1.5%; P = .92) at 1 year.

The Xience V stent appears as safe and effective for PCI in the treatment of very long coronary lesions, concluded the investigators in CCI.