Differential Long-Term Effects of First- and Second-Generation DES in Patients With Bifurcation Lesions Undergoing PCI

Abstract

Background: There is a paucity of data regarding the long-term clinical outcomes of first- versus second-generation drug-eluting stent (DES), especially when used to treat complex lesions such as bifurcation lesions.

Objectives: The current study compares the efficacy and safety of first- versus second-generation DES at the 5-year follow-up in patients who underwent bifurcation percutaneous coronary intervention (PCI).

Methods: A total of 5,498 patients with a bifurcation lesion who underwent PCI were pooled at a single patient level from COBIS (Coronary Bifurcation Stenting) registries II and III. Five-year target lesion failure (TLF) (the composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and cardiac death or MI were compared between the use of first-generation DES (n = 2,436) and second-generation DES (n = 3,062) during PCI. Propensity score matching was performed to reduce selection bias.

Results: After a 1:1 propensity score matching procedure was conducted, the cohort consisted of 1,702 matched pairs. Patients treated with second-generation DES had a significantly lower risk of TLF at 5 years than those treated with first-generation DES in both overall and propensity-matched populations (matched hazard ratio [HRmatched]: 0.576; 95% confidence interval [CI]: 0.456 to 0.727; p <0.001). There were no significant differences in risk of a composite of cardiac death or MI between the 2 groups (HRmatched: 0.782; 95% CI: 0.539 to 1.133, P = 0.193). However, among patients who required a 2-stent technique, use of the second-generation DES reduced cardiac death or MI (HRmatched:0.422; 95% CI: 0.209 to 0.851, P = 0.016). On the other hand, among patients who required a one-stent technique, the risk of a composite of cardiac death or MI was similar between the 2 groups (HRmatched: 1.046; 95% CI: 0.664 to 1.650, P = 0.845). There was a significant interaction between stent generation and treatment strategy for cardiac death or MI (interaction P = 0.029).

Conclusions: In patients treated with PCI for a bifurcation lesion, the use of second-generation DES was associated with a significantly reduced risk of 5-year TLF than the use of first-generation DES. (Korean Coronary Bifurcation Stenting Registry II [NCT01642992]; COBIS II) (Korean Coronary Bifurcation Stenting Registry III [NCT03068494] COBIS III).

Keywords: BMS, bare-metal stent(s); DES, drug-eluting stent(s); MI, myocardial infarction; MV, main vessel; PCI, percutaneous coronary intervention; QCA, quantitative coronary angiography; SB, side branch; TLF, target lesion failure; TLR, target lesion revascularization; bifurcation; drug-eluting stents; outcomes; percutaneous coronary intervention.

Conflict of interest statement

Supported by the Korean Bifurcation Club (COBIS III) and Korean Society of Interventional Cardiology (COBIS II and III). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

© 2021 The Authors.

Figures

Graphical abstract

Figure 1

Study Flow Study flowchart of pooled data from COBIS II and III (COronary BIfurcation Stenting) registries are shown. DES = drug-eluting stent(s); PCI = percutaneous coronary intervention.

Figure 2

Comparison of 5-Year Clinical Outcomes According to Stent Generation in a Propensity-Matched Population Kaplan-Meier curves were used to compare the risks of target lesion failure (A), cardiac death, or myocardial infarction (B), and target lesion revascularization (C) between first- and second-generation drug-eluting stent (DES) patient groups who underwent percutaneous coronary intervention (PCI) for bifurcation lesions.

Figure 3

Locations of In-Stent Restenosis in the First- and Second-Generation DES Groups Bar graphs show the proportion of in-stent restenosis during follow-up in the parent vessel, main branch, and side branch in first-generation drug-eluting stent (DES) (blue bars) and second-generation DES (red bars) groups.

Figure 4

Subgroup Analysis in the Propensity-Matched Population Comparative hazard ratios of target lesion failure (A) and cardiovascular death or myocardial infarction (B) at 5 years for various subgroups in the propensity-matched population who underwent percutaneous coronary intervention (PCI) for bifurcation lesions. Red text denotes statistically significant differences. CI = confidence interval; HR = hazard ratio.

Central Illustration

Benefits of Second-Generation DES in Patients Treated With PCI for Bifurcation Lesion This study compared the long-term efficacy and safety of the first- versus the second-generation drug-eluting stent (DES) in patients with a bifurcation lesion who underwent percutaneous coronary intervention (PCI), using patient-pooled data from the COBIS II and III (COronary BIfurcation Stenting ) registries. The use of second-generation DES was associated with a 40% risk reduction of target lesion failure (TLF) compared with the use of first-generation DES. However, there were no significant differences in hard endpoints such as cardiac death or myocardial infarction (MI), between the 2 groups. After stratifying into the stent technique, the risk of cardiac death or MI was only significantly lower in patients treated with the 2-stent technique with second-generation DES than in those with first-generation DES. There was a significant interaction between the type of DES and stent strategies for cardiac death or MI (interaction P = 0.029).