Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: Final five-year results of the patient-level pooled analysis from the TARGET I and TARGET II trials.

Abstract

OBJECTIVES:

The study reports the final 5-year safety and effectiveness outcomes of the novel abluminal groove-filled biodegradable polymer-coated FIREHAWK sirolimus-eluting stent in a large patient cohort.

BACKGROUND:

The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long-term safety and efficacy data from three TARGET trials for greater statistical power to analyze low-frequency events.

METHODS:

Patient-level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n = 227), TARGET I long lesion cohort (n = 50), and TARGET II registry (n = 730) were prospectively collected and analyzed. The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven indicated target lesion revascularization (ID-TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.

RESULTS:

Among 947 patients (94.0%) who completed the 5-year clinical follow-up, the 5-year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV-MIs, and 33 ID-TLRs. Only four (0.4%) very late probable or definite stent thrombosis events were observed beyond 1 year after stent implantation. In the subgroup analysis, lesion length ≥ 30 mm was associated with higher long-term TLF incidence, while the use of a predilation-sizing-postdilation technique showed no significant effect on long-term outcomes.

CONCLUSIONS:

Five-year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.

• Authors: Chongjian Li, Changdong Guan, Ruiyan Zhang, Yuejin Yang, Changsheng Ma, Hui Li, Shaoliang Chen, Yaling Han, Bo Xu, Runlin Gao, TARGET Investigators
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 93 Issue S1 Pg. 818-824 (02 15 2019) ISSN: 1522-726X [Electronic] United States
• PMID: 30565397 (Publication Type: Journal Article)
• Copyright: © 2018 Wiley Periodicals, Inc.

Chemical References

• Cardiovascular Agents
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Cardiovascular Agents (administration & dosage, adverse effects)
• China (epidemiology)
• Coronary Artery Disease (diagnostic imaging, mortality, therapy)
• Coronary Thrombosis (epidemiology)
• Drug-Eluting Stents
• Female
• Humans
• Incidence
• Male
• Middle Aged
• Myocardial Infarction (epidemiology)
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Prospective Studies
• Prosthesis Design
• Randomized Controlled Trials as Topic
• Registries
• Risk Factors
• Sirolimus (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome