Ultrathin drug eluting stents (60 µm) had been shown beneficial vs. thin-strut stents in terms of target lesion failure (TLF) at 2, 3 and 5 years in randomized studies, but they had not been yet assessed in “real world” patients.
The BIOFLOW VII is a prospective, multicenter study including 556 “real world”patients with a total 690 lesions. The study used the ORSIRO, an ultrathin bioresorbable polymer sirolimus-eluting stent.
Primary end point was defined as TLF, a composite of cardiac death, target vessel MI and ischemia driven target vessel revascularization.
Patient mean age was 65, 65% were men, 80% were hypertensive, 35% diabetic (with 13% kidney failure), 37% had experienced prior MI, 20% prior PCI, 4% CABG and 7% had peripheral vascular disease.
51.4% presented unstable angina, 37.2% stable angina and 11.3% silent ischemia. Among unstable syndromes, 24% were NSTEMI.
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The most frequently stented arteries were the anterior descending (AD), followed by the right coronary (RC) and the circumflex (CX). Mean stent length was 20 mm, and on average they used 1.3 stents per patient. Procedural success was 99.1%.
At one year followup, primary end point was observed in 1.7% of patients, with no cardiac deaths; 1.3% saw target vessel MI, 0.9% ischemia driven target vessel revascularization and 0.4% definite thrombosis.
Conclusion
In sum, this study’s results at one year followup on ultrathin bioresorbable sirolimus eluting stents indicate that clinical evolution is consistent with prior findings in terms of safety and efficacy for this kind of ultrathin stents.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Reference: David E. Kandzari, et al.
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