Drug-eluting stents (DES) with durable polymers are non-inferior to DES with biodegradable polymers in patients with acute coronary syndrome (ACS) in terms of patient-oriented adverse events at 1 year, according to study results presented Saturday at the TCT Connect virtual conference.
Hyo-Soo Kim, MD, PhD, Seoul National University Hospital presented the results of the HOST-REDUCE-POLYTECH-ACS trial.
DES have significantly improved outcomes amount patients undergoing percutaneous coronary intervention (PCI); however, the polymers used in first-generation DES were blamed as the cause of a chronic inflammatory response that leads to stent-oriented adverse clinical outcomes, such as stent thrombosis.
Furthermore, biocompatible durable polymers and biodegradable polymers (which dissolve over time) were developed to help mitigate this adverse effect. The comparison of the two polymer technologies in patients with ACS (who have a heightened risk of thrombosis and delayed vascular healing after PCI) has not been previously performed in a large scale randomized trial.
The aim of the HOST-REDUCE-POLYTECH-ACS (Harmonizing Optima Strategy for Treatment of coronary artery diseases – Comparison of Reduction of prasugrel or Polymer technology in ACS patients) trial was to investigate the efficacy and safety of durable-polymer DES versus biodegradable polymer DES in patients with ACS undergoing PCI.
Patients with a culprit lesion in a native coronary artery or a graft vessel with significant stenosis eligible for stent implantation were randomized in a 1-to-1 fashion to durable-polymer or biodegradable-polymer DES. The primary endpoint was a patient-oriented composite outcome (POCO), consisting of all-cause death, nonfatal myocardial infarction (MI), stent thrombosis and any repeat revascularization at 12 months. The key secondary endpoint was a device-oriented composite outcome (DOCO), consisting of cardiac death, target vessel MI, or target lesion revascularization.
In this investigator-initiated, randomized, open-label, multicenter trial, 3,413 ACS patients with 4,713 lesions from 35 centers were randomized to the durable-polymer DES group (1,713 patients, 2,367 lesions) or the biodegradable-polymer DES group (1,700 patients, 2,346 lesions).
The rate of POCO was 5.2% in the durable-polymer DES group and 6.4% in the biodegradable-polymer DES group (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.61-1.08; p=0.146). The rate of DOCO was higher in the biodegradable-polymer group (durable polymer 2.6% vs. biodegradable polymer 3.9%; HR, 0.67, 95% CI, 0.46-0.98; p=0.038).
The investigators concluded that durable polymer DES was non-inferior to biodegradable polymer DES, in terms of 1-year POCO. Regarding DOCO, they observed a sign of higher clinical events in the biodegradable than durable polymer DES.
In his presentation, Kim commented: “Most clinicians and industrial companies believe that biodegradable polymer DES would be better than durable polymer DES. But, such belief is not confirmed by this study. On the other hand, the beneficial role of durable polymer, such as thrombo-resistance, may be real.”
Robert W. Yeh, MD, MBA, Beth Israel Deaconess Medical Center, Boston, who was not involved in the study, noted during a press conference announcing the results that each arm of the study included multiple stents, which differs from previous studies comparing one stent directly to another stent.
Ori Ben-Yehuda, MD, who also was not involved in the study but presented it during the press conference, added that the study did not provide the definition of periprocedural MI, which also might have affected the results.
The HOST-REDUCE-POLYTECH-ACS trial was sponsored by Seoul National University Hospital and received research funds from Biotronik, Boston Scientific, Daiichi Sankyo, Dio, Qualitech Korea Ltd., and Terumo.