Safety and efficacy of biolimus-eluting stent with biodegradable polymer: insights from EINSTEIN (Evaluation of Next-generation drug-eluting STEnt IN patients with coronary artery disease) Registry

Einstein (Sao Paulo). 2013 Jul-Sep;11(3):350-6. doi: 10.1590/s1679-45082013000300015.
[Article in English, Portuguese]

Abstract

Objective: To evaluate the incidence of major adverse cardiac events (cardiac death, or acute myocardial infarct, or target vessel revascularization) at one year in "real world" patients.

Methods: The EINSTEIN registry is an observational, prospective, single center study that consecutively included 103 patients (152 lesions) treated with the BiomatrixTM stent, a biolimus A9-eluting stent with biodegradable polymer.

Results: The mean age was 65.0±12.4 years; male gender represented 83.5% of the patients; and 37.9% of them were diabetic. At one-year, major adverse cardiac events occurred in 11.7% of the patients, including 2.9% of cardiac death, 4.9% of with non ST- segment elevation acute myocardial infarction, and 3.9% of target vessel revascularization. Stent thrombosis occurred in only 1% (1 patient) at one-yearfollow-up.

Conclusion: The present Registry suggests that new generation biolimus A9 drug-eluting stents are safe and effective in a "real world", all-comers patients, showing low rates of major cardiac adverse events on long-term follow-up.

objetivo:: Avaliar a incidência de eventos adversos cardíacos maiores (morte cardíaca, infarto agudo do miocárdio ou necessidade de nova revascularização do vaso-alvo) em 1 ano em pacientes do “mundo real”.

Métodos:: O registro EINSTEIN é um estudo observacional prospectivo, unicêntrico, que incluiu consecutivamente 103 pacientes (152 lesões) tratados com o stent Biomatrix™, eluidor de biolimus A9 e polímero biodegradável.

Resultados:: A média das idades foi de 65,0±12,4 anos; o gênero masculino representou 83,5% dos pacientes; e 37,9% deles eram diabéticos. Em 1 ano, eventos adversos cardíacos maiores ocorreram em 11,7% dos pacientes, incluindo 2,9% de morte cardíaca, 4,9% de infarto agudo do miocárdio sem supradesnivelamento do segmento ST e 3,9% de revascularização do vaso-alvo. Trombose de stent esteve presente em apenas 1% (1 paciente) após o seguimento clínico de 1 ano.

Conclusão:: O presente registro sugere que os novos stents farmacológicos eluidores de biolimus A9 com polímero biodegradável são seguros e eficazes em pacientes da prática clínica diária, com baixas taxas de eventos adversos cardíacos maiores no longo prazo.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants* / adverse effects
  • Aged
  • Coronary Artery Disease / surgery*
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Polymers / administration & dosage*
  • Prospective Studies
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Time Factors
  • Treatment Outcome

Substances

  • Polymers
  • umirolimus
  • Sirolimus