October 17, 2020
DES With Durable Polymers Are Noninferior to Biodegradable DES in HOST-REDUCE-POLYTECH-ACS Trial
October 17, 2020—An investigator-initiated randomized clinical trial (RCT) found that drug-eluting stents (DES) with durable polymers are noninferior to DES with biodegradable polymers in patients with acute coronary syndrome (ACS).
The HOST-REDUCE-POLYTECH-ACS RCT was sponsored by Seoul National University Hospital in Seoul, Republic of Korea. Study chair Hyo-Soo Kim, MD, who is Director, Coronary Intervention and Transcatheter Aortic Valve Implantation, and Professor, Department of Internal Medicine at Seoul National University Hospital, presented the HOST-REDUCE-POLYTECH-ACS findings at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
As noted in the TCT Connect announcement, newer DES have significantly improved outcomes among patients undergoing percutaneous coronary intervention (PCI). However, the polymers used in first-generation DES were seen as the cause of a chronic inflammatory response that lead to stent-oriented adverse clinical outcomes, such as stent thrombosis. Biocompatible durable polymers and biodegradable polymers were developed to help mitigate this adverse effect.The comparison of these two polymer technologies in patients with ACS, who have a heightened risk of thrombosis and delayed vascular healing after PCI, has not been previously examined in a large-scale randomized trial.
The aim of the HOST-REDUCE-POLYTECH-ACS trial was to investigate the efficacy and safety of a durable polymer DES versus a 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 1:1 fashion to durable polymer or biodegradable polymer DES.
TCT Connect reported that the open-label, multicenter trial enrolled 3,413 ACS patients with 4,713 lesions at 35 centers who were randomized to the durable polymer DES group (1,713 patients, 2,367 lesions) or the absorbable polymer DES group (1,700 patients, 2,346 lesions).
The primary endpoint was a patient-oriented composite outcome (POCO; defined as a composite of all-cause death, nonfatal myocardial infarction, stent thrombosis, and any repeat revascularization) at 12 months.
The investigators found that the rate of POCO was 5.2% in the durable polymer DES versus 6.4% in the biodegradable polymer DES group (hazard ratio, 0.81; 95% CI, 0.61-1.08; P =.146).
The key secondary endpoint was a device-oriented composite endpoint (DOCO; a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). The rate of DOCO was slightly higher in the biodegradable polymer group (2.6% vs 3.9%; hazard ratio, 0.67; 95% CI, 0.46-0.98; P = .038).
In the TCT Connect announcement, Dr. Kim stated, “In ACS patients who had a significant coronary stenosis and were eligible for stent implantation, durable polymer DES was noninferior to biodegradable polymer DES, in terms of 1-year patient oriented composite outcomes. Regarding the device oriented composite outcome, we observed a sign of higher clinical events in the biodegradable polymer DES. More research is needed to assess the effect of polymer technology on clinical outcomes greater than 1-year post PCI.”