New clinical trial shows second generation drug-eluting stents are safe and effective

April 26, 2018, Society for Cardiovascular Angiography and Interventions

Results of the PERSPECTIVE trial were presented today as late-breaking clinical science at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions. The PERSPECTIVE study is a prospective, single-center rigorously performed clinical trial and reports on one-year outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) treated with Zotarolimus-Eluting Stents (ZES). The ZES included in the study were manufactured by Medtronic and represent a modern, newer generation drug-eluting stent (DES).

CTO is a complete blockage of one or more coronary arteries that has been present for at least three months and occurs in 20 percent of with coronary artery disease (UVA Health). CTO PCI has become the preferred treatment option for complex, high-risk patients due to improvements in equipment and novel procedural techniques. There is limited data on procedural and long-term safety and efficacy of CTO revascularization applying modern techniques with newer generation DES.

The PERSPECTIVE 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, and target lesion revascularization. In a pre-specified cohort of prospectively followed patients, quality of life was measured at baseline and one-year. A one-year MACE analysis of patients treated with ZES was compared to a pooled analysis of historical DES trials.

The study included 183 patients with successful CTO recanalization and treatment with ZES. Successful guidewire achievement of at least TIMI 2 flow was observed in 93.4 percent of patients. Compared with performance goals from prior CTO DES trials (1-year MACE, 25.2 percent), treatment with ZES was associated with significantly lower occurrence of adverse events (7.6 percent). One-year rates of myocardial infarction and target lesion revascularization were 3.5 percent and 1.7 percent, respectively. Patients reported significant improvement to quality of life from baseline to one-year (Seattle Angina Questionnaire, 72.3 ± 26.3 versus 96.3 ± 10.2).

"Our study is the most comprehensive review of the safety, efficacy and durability of contemporary stent techniques with ZES for a high-lesion, complex patient population," said lead author David Kandzari, MD, Piedmont Heart Institute in Atlanta, GA. "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."

The authors of the study note the FDA is currently reviewing this study data for a potential expanded label indication for the ZES (Medtronic).

Explore further: Results from the BIONICS trial reported

More information: "Late-Breaking Clinical Science I: Procedural, Clinical and Health Status Outcomes in Chronic Total Coronary Occlusion Revascularization with Zotarolimus-Eluting Stents: Results from the PERSPECTIVE Trial" [April 26, 2018, 11:00 a.m. - 12:00 p.m. PDT, Seaport DE]

Related Stories

Results from the BIONICS trial reported

October 31, 2016
The large multinational randomized BIONICS study found that a novel ridaforolimus-eluting stent (BioNIR) was non-inferior to a zotarolimus-eluting stent (Resolute) for one-year clinical outcomes in a broad, less selected ...

Results of the SORT-OUT VI trial presented

October 30, 2013
A new study found that both drug-eluting stents (DES) with biocompatible polymers and DES with biodegradable polymers were associated with low major adverse coronary events, demonstrating the non-inferiority of the biocompatible ...

Two-year results of the COLOR trial presented

November 1, 2016
Two-year results from COLOR, the first large-scale multicenter prospective study of its kind, found that PCI on coronary artery lipid-rich plaque (LRP) detected by near infrared spectroscopy (NIRS) was not associated with ...

Study compares outcomes for different methods of drug-releasing stent implantation

November 10, 2015
Myeong-Ki Hong, M.D., Ph.D., of the Yonsei University College of Medicine, Seoul, Korea and colleagues randomly assigned 1,400 patients with long coronary lesions to receive intravascular ultrasound-guided (n = 700) or angiography-guided ...

MACE risk similar for white men, women, minorities after PCI

October 19, 2017
(HealthDay)—Women and minorities undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents have a risk of major adverse cardiac events (MACE) that is similar to that of white men, according to a ...

First European randomized trial of PCI vs. optimized medical therapy in CTO

May 18, 2017
Revascularization with percutaneous coronary intervention (PCI) achieves a high success rate with low procedural risk in patients with coronary chronic total occlusion, show results reported at EuroPCR 2017 from the first ...

Recommended for you

No sweat required: Team finds hypertension treatment that mimics effect of exercise

October 16, 2018
Couch potatoes rejoice—there might be a way to get the blood pressure lowering benefits of exercise in pill form.

New model suggests cuffless, non-invasive blood pressure monitoring possible using pulse waves

October 16, 2018
A large team of researchers from several institutions in China and the U.S. has developed a model that suggests it should be possible to create a cuffless, non-invasive blood pressure monitor based on measuring pulse waves. ...

Why heart contractions are weaker in those with hypertrophic cardiomyopathy

October 16, 2018
When a young athlete suddenly dies of a heart attack, chances are high that they suffer from familial hypertrophic cardiomyopathy (HCM). Itis the most common genetic heart disease in the US and affects an estimated 1 in 500 ...

Novel genetic study sheds new light on risk of heart attack

October 12, 2018
Loss of a protein that regulates mitochondrial function can greatly increase the risk of myocardial infarction (heart attack), Vanderbilt scientists reported Oct. 3 in the journal eLife.

Researchers say ritual for orthodox Jewish men may offer heart benefits

October 11, 2018
A pilot study led by researchers at the University of Cincinnati (UC) College of Medicine suggests Jewish men who practice wearing tefillin, which involves the tight wrapping of an arm with leather banding as part of daily ...

Markers of dairy fat consumption linked to lower risk of type two diabetes

October 10, 2018
Higher levels of biomarkers of dairy fat consumption are associated with a lower risk of developing type 2 diabetes, according to new research published today in PLOS Medicine. The study, in more than 60,000 adults, was undertaken ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.