PERSPECTIVE Trial Evaluates Medtronic's Zotarolimus-Eluting Stents
May 4, 2018—The Society for Cardiovascular Angiography and Interventions (SCAI) announced that results of the PERSPECTIVE trial were presented at the SCAI 2018 scientific sessions held April 25–28 in San Diego, California.
The prospective, single-center PERSPECTIVE clinical trial reported on 1-year outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) treated with Medtronic's new-generation zotarolimus-eluting stents (ZESs). The investigators advised that the US Food and Drug Administration is currently reviewing the PERSPECTIVE data for a potential expanded label indication for Medtronic's ZESs.
According to SCAI, the rigorously performed trial examined procedural, clinical, and health status outcomes using contemporary methods and was reviewed by an independent core laboratory and events committee.
Among consecutive patients undergoing attempted CTO PCI, procedural and in-hospital clinical outcomes were examined in addition to major adverse cardiac events (MACE; death, myocardial infarction, and target lesion revascularization).
In a prespecified cohort of prospectively followed patients, quality of life was measured at baseline and 1 year. A 1-year MACE analysis of patients treated with ZESs was compared to a pooled analysis of historical drug-eluting stent (DES) trials.
As summarized by SCAI, the study included 183 patients with successful CTO recanalization and treatment with ZESs. Successful guidewire achievement of at least thrombolysis in myocardial infarction 2 flow was observed in 93.4% of patients.
Compared with performance goals from previous CTO DES trials (1-year MACE, 25.2%), treatment with ZESs was associated with significantly lower occurrence of adverse events (7.6%). One-year rates of myocardial infarction and target lesion revascularization were 3.5% and 1.7%, respectively. Additionally, patients reported significant improvement of quality of life from baseline to 1 year (Seattle Angina Questionnaire, 72.3 ± 26.3 vs 96.3 ± 10.2).
PERSPECTIVE lead investigator David Kandzari, MD, commented in the SCAI announcement, “Our study is the most comprehensive review of the safety, efficacy, and durability of contemporary stent techniques with ZESs for a high-lesion, complex patient population. Not only were the success rates favorable, but we were also able to demonstrate that patients reported an improved quality of life, which should be considered one of the most important outcomes of any procedure.”