Ricardo Czarnobai Soccol et al. Henrique Barbosa Ribeiro Ricardo Lasevitch Denise Pellegrini … Expedito Eustáquio Ribeiro da Silva Carlos Alberto Santos de Mattos Augusto Lima Filho Noriaki Takeshita Sílvio Sérgio Pontes Câmara José de Ribamar Costa Junior Leandro Zacarias Figueiredo de Freitas Marcelo Sabedotti Pablo Tomé Teixeirense Márcio Augusto Meirelles Truffa Ricardo de Gasperi Ewerton de Souza Abreu Ismael Arcari Bassani José Armando Mangione Maurício Cavalieri Gustavo Martins Pereira Alves Pedro Beraldo de Andrade Rafael Maestri Rafael Rebêlo César Cavalcanti Maria Sanali Paiva Marcelo de Oliveira Hirga José Airton de Arruda Flávio Correa Pivatelli Julia Gonçalves Zandomenico Paulo R. A. Caramori
Abstract
Background
The Inspiron™ sirolimus-eluting stent (SES) is a third-generation coronary stent featuring thin struts and an abluminal biodegradable polymer coating. Although it is widely used in Brazil, long-term real-world evidence remains limited.
Objectives
To evaluate the safety and effectiveness of the Inspiron™ SES over 24 months in an unselected population undergoing percutaneous coronary intervention (PCI).
Methods
This pooled analysis included 2,803 consecutive patients who underwent Inspiron™ SES implantation between June 2017 and January 2022 at 25 Brazilian centers. The primary endpoint was major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, MI, and target lesion revascularization (TLR) at 24 months. Kaplan-Meier survival analysis, Cox proportional hazards regression, and restricted cubic spline models were used. A two-sided p-value < 0.05 was considered statistically significant.
Results
At 24 months, the cumulative incidence of MACE was 6.7%, with rates of 5.4% for all-cause mortality, 2.3% for cardiovascular mortality, 1.2% for MI, 0.9% for TLR, and 0.6% for definite or probable stent thrombosis (ST). Patients with a vessel diameter < 2.5 mm had significantly higher rates of MACE, cardiovascular death, repeat revascularization, and ST (p = 0.022). Independent predictors of MACE included older age (p = 0.034), left main or three-vessel coronary artery disease (p = 0.024), and acute coronary syndrome as the indication for PCI (p < 0.001).
Conclusions
In this large real-world registry, the Inspiron™ SES demonstrated favorable safety and effectiveness through 24 months, with low rates of ST and repeat revascularization despite the inclusion of complex coronary lesions.