The Xience V drug-eluting stent (DES) was no less effective for very long lesions versus shorter ones, pooled data from previous trials indicated.
With overlapping stents to cover diffuse blockages, adverse events at 1-year follow-up were no more likely for those with lesions longer than 35 mm compared to lesions in the 24-35 mm range:
- Target lesion failure (cardiac death, target vessel myocardial infarction, target lesion revascularization; 8.9% versus 10.%, HR 1.12, 95% CI 0.70-1.79)
- Major adverse cardiac events (cardiac death, all-cause myocardial infarction, target lesion revascularization; 9.2% versus 10%, HR 1.08, 95% CI 0.68-1.72)
- Definite or probable stent thrombosis (1.6% versus 1.5%, HR 0.94, 95% CI 0.30-2.96)
None of the individual compoments of the composite outcomes occurred at rates showing a difference between groups, either, reported a team of researchers led by Alexandra J. Lansky, MD, of Yale University Medical Center in New Haven, Conn., in a study published online in Catheterization and Cardiovascular Interventions. Several co-authors were employees of the stent’s manufacturer, Abbott Vascular.
“In the treatment of very long coronary lesions, the Xience V stent appears as safe and effective as percutaneous coronary interventions for long lesions,” they concluded.
Lansky and colleagues called the outcomes “acceptable” for newer-generation stenting in diffuse lesions, which have been linked to worse outcomes after percutaneous coronary interventions of years past.
“With bare metal stents, failure rates were high, and with first generation DES, concern over high doses of antiproliferative drug dose, overlapping metal and polymer layer and higher injury at the site of overlap were associated with higher restenosis and rates of very late stent thrombosis due to delayed endothelial coverage and chronic local inflammation,” the authors noted.
“Our results are consistent with the findings of … previous studies done on second generations DES and add to the growing body of evidence concerning the safety and efficacy of the cobalt-chromium everolimus-eluting stent with thin struts, a biocompatible and thromboresistant fluoropolymer and an optimal dose of everolimus.”
The popular, conventional Xience stent is a thin-strut (81 μm) device, which some have argued is an advantage over the Absorb bioresorbable vascular scaffold’s current 157-μm strut thickness.
Lansky and her colleagues pooled data from the SPIRIT studies (Spirit II, III, IV, V, Spirit Small Vessel) and the XIENCE V USA trial for their analysis, taking into account the records of 13,266 patients.
Very long lesions were observed in 2.4% of patients (average lesion length 47.1 mm); lesions less than 35 mm but more than 24 mm were recorded for 3.6% of the cohort (average length 28.1 mm).
A total of 805 patients received planned PCI with at least two overlapping stents, 40% of them in the very long lesion group and 60% their shorter lesion counterparts.
Patients with lesions beyond 35 mm were more likely to have at baseline:
- A history of dyslipidemia (85.3% versus 73.3% for patients with less diffuse blockages, P<0.0001)
- Hypertension (90.3% versus 80.6%, P=0.0002)
- Prior cardiac intervention in the target vessels (27.1% versus 17.8%, P=0.004)
- Greater pre-procedure diameter stenosis (87.3% versus 82.4%, P<0.0001)
- Chronic total occlusion (13.9% versus 6.3%, P=0.0013)
“Baseline characteristics of coronary lesions, such as lesion length and percent stenosis, were based upon visual estimations from study investigators, which are known to have some degree of variability between operators,” the investigators admitted.
Another limitation to their study, they wrote, was that the post hoc analysis selected participants from non-prespecificed subgroups. As such, “the findings should be considered hypothesis generating,” they suggested.
Lansky and colleagues added that the short clinical follow-up in their data precludes any conclusions about the risk of very late stent thrombosis.
The SPIRIT and XIENCE V USA trials were sponsored by Abbott Vascular.
Lansky disclosed no relevant conflicts of interest.
Several co-authors were employees of Abbott Vascular.
Catheterization and Cardiovascular Interventions
Bouras G, et al “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” Catheter Cardiovasc Interv 2016; DOI: 10.1002/ccd.26711.