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Randomized Controlled Trial
. 2022 Dec 2;18(11):e910-e919.
doi: 10.4244/EIJ-D-22-00372.

Durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial

Doyeon Hwang  1 , Hong-Seok Lim  2 , Kyung Woo Park  1 , Won-Yong Shin  3 , Jeehoon Kang  1 , Jung-Kyu Han  1 , Han-Mo Yang  1 , Hyun-Jae Kang  1 , Bon-Kwon Koo  1 , Yun-Kyeong Cho  4 , Soon Jun Hong  5 , Sanghyun Kim  6 , Sang-Ho Jo  7 , Yong Hoon Kim  8 , Weon Kim  9 , Sung Yun Lee  10 , Seok Kyu Oh  11 , Dong-Bin Kim  12 , Hyo-Soo Kim  1
Affiliations
Randomized Controlled Trial

Durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial

Doyeon Hwang et al. EuroIntervention. .

Abstract

Background: Comparative data of durable polymer (DP) versus biodegradable polymer (BP) drug-eluting stents (DES) are limited in patients presenting with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI).

Aims: We sought to evaluate the efficacy and safety of DP-DES and BP-DES in ACS patients receiving complex PCI.

Methods: This study was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomly assigned 1:1 to DP-DES or BP-DES in the HOST-REDUCE-POLYTECH-ACS trial. Complex PCI was defined as having at least 1 of the following features: ≥3 stents implanted, ≥3 lesions treated, total stent length ≥60 mm, bifurcation PCI with 2 stents, left main PCI, or heavy calcification. Patient-oriented (POCO, a composite of all-cause death, non-fatal myocardial infarction, and any repeat revascularisation) and device-oriented composite outcomes (DOCO, a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularisation) were evaluated at 12 months.

Results: Among 3,301 patients for whom full procedural data were available, 1,140 patients received complex PCI. Complex PCI was associated with higher risks of POCO and DOCO. The risks of POCO were comparable between DP-DES and BP-DES in both the complex (HR 0.87, 95% confidence interval [CI]: 0.57-1.33; p=0.522) and non-complex (HR 0.83, 95% CI: 0.56-1.24; p=0.368; p for interaction=0.884) PCI groups. DOCO was also not significantly different between DP-DES and BP-DES in both the complex (HR 0.74, 95% CI: 0.43-1.27; p=0.278) and non-complex (HR 0.67, 95% CI: 0.38-1.19; p=0.175; p for interaction=0.814) PCI groups.

Conclusions: In ACS patients, DP-DES and BP-DES showed similar clinical outcomes irrespective of PCI complexity.

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Conflict of interest statement

H-S. Kim has received research grants or speaker's fees from Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, and Dio, as well as Medtronic, Abbott Vascular, Edwards Lifesciences, Amgen, and Boehringer Ingelheim. B-K. Koo has received institutional research grants from Abbott Vascular and Philips. K. W. Park reports speaker’s fees from Daiichi Sankyo, Sanofi, Bristol-Myers Squibb, Bayer, Pfizer, InnoN Pharmaceutical, DaeWoong Pharmaceutical, and JW Pharmaceutical, outside of the submitted work. The other authors have no conflicts of interest to declare relevant to the submitted work.

Figures

Figure 1
Figure 1. Rates of BARC bleeding at 1 year after randomisation by prior CABG status and treatment arm.
Kaplan-Meier curves with bleeding rates at 1 year of (A) BARC 2, 3 or 5 bleeding, and (B) BARC 3 or 5 bleeding for ticagrelor plus placebo versus ticagrelor plus aspirin in patients with and without prior CABG. BARC: Bleeding Academic Research Consortium; CABG: coronary artery bypass graft; CI: confidence interval; HR: hazard ratio; Tica: ticagrelor
Figure 2
Figure 2. Bleeding events by prior CABG status at 1 year after randomisation.
Forest plot illustrating outcomes of ticagrelor plus placebo versus ticagrelor plus aspirin according to prior CABG status. The interaction p-value is for the interaction test between randomised treatment assignment and prior CABG status. *Bleeding events were analysed in intention-to-treat cohort.ASA: aspirin; BARC: Bleeding Academic Research Consortium; CABG: coronary artery bypass graft; CI: confidence interval; GUSTO: Global Utilization of Streptokinase and TPA for Occluded Arteries; HR: hazard ratio; ISTH: International Society on Thrombosis and Haemostasis; Tica: ticagrelor; TIMI: Thrombolysis in Myocardial Infarction; TPA: tissue plasminogen activator
Figure 3
Figure 3. Rates of all-cause death, MI or stroke, and cardiovascular death, MI or ischaemic stroke at 1 year after randomisation by prior CABG status and treatment arm.
Kaplan-Meier curves with ischaemic rates at 1 year of (A) death, MI, or ischaemic stroke, and (B) cardiovascular death, MI, or ischaemic stroke for ticagrelor plus placebo versus ticagrelor plus aspirin in patients with and without prior CABG. CABG: coronary artery bypass graft; CI: confidence interval; HR: hazard ratio; MI: myocardial infarction; Tica: ticagrelor
Figure 4
Figure 4. Ischaemic events by prior CABG status at 1 year after randomisation.
Forest plot illustrating outcomes of ticagrelor plus placebo versus ticagrelor plus aspirin according to prior CABG status. The interaction p-value is for the interaction test between randomised treatment assignment and prior CABG status. *Ischaemic events were analysed in per-protocol cohort. ASA: aspirin; CABG: coronary artery bypass graft; CI: confidence interval; CV: cardiovascular; HR: hazard ratio; MI: myocardial infarction; ST: stent thrombosis; Tica: ticagrelor
Central Illustration
Central Illustration. Ticagrelor with or without aspirin after PCI in patients with a previous CABG surgery.
Prior CABG patients who were event-free after 3 months after PCI with DES and adherent to DAPT with ticagrelor were randomised to ticagrelor plus placebo or ticagrelor plus aspirin. At 12 months after randomisation, prior CABG patients suffered significantly more bleeding and ischaemic events. However, patients receiving ticagrelor monotherapy, compared with ticagrelor plus aspirin, significantly reduced clinically relevant Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding outcomes without increasing ischaemic events of all-cause death, MI, or stroke. CABG: coronary artery bypass graft; CI: confidence interval; DAPT: dual antiplatelet therapy; DES: drug-eluting stent(s); HR: hazard ratio; MI: myocardial infarction; PCI: percutaneous coronary intervention
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