Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus

Abstract

Background: Diabetes mellitus (DM) is a well-known risk factor for adverse cardiovascular events in patients receiving percutaneous coronary intervention (PCI). Limited data are available on the relative performance of different types of contemporary drug-eluting stents (DES) for diabetic patients.

Objectives: The authors investigated the effectiveness and safety profiles of several contemporary DES in patients with DM in a "real-world" clinical setting.

Methods: Among 24,516 patients enrolled in a multicenter, prospective registry, 7,823 patients with DM were treated with 4 contemporary DES: 2,877 with a cobalt chromium everolimus-eluting stent (EES), 789 with a biodegradable polymer biolimus-eluting stent, 2,286 with a platinum chromium-EES, and 1,871 with a Resolute zotarolimus-eluting stent. The primary outcome was target vessel failure (TVF) (a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization).

Results: The median follow-up duration was 2.9 years. Observed 3-year rates of TVF were not significantly different according to different DES types. On multigroup propensity-score analysis, the adjusted HRs for TVF were similar in between-group comparisons: biodegradable polymer biolimus-eluting stent (HR: 0.94; 95% CI: 0.76-1.16; P = 0.57), platinum chromium-EES (HR: 0.94; 95% CI: 0.81-1.09; P = 0.41), and Resolute zotarolimus-eluting stent (HR: 1.01; 95% CI: 0.86-1.18; P = 0.93) compared with the cobalt chromium-EES (reference). This trend was maintained in patients with non-insulin- and insulin-treated DM.

Conclusions: In this multicenter clinical-practice PCI registry, no significant between-group differences were found for a 3-year risk of TVF in patients with DM undergoing PCI with various types of contemporary DES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Keywords: DES, drug-eluting stent(s); DM, diabetes mellitus; HbA1c, glycosylated hemoglobin; MACE, major adverse cardiovascular event(s); MI, myocardial infarction; PCI, percutaneous coronary intervention; PES, paclitaxel-eluting stent(s); SES, sirolimus-eluting stent(s); TVF, target vessel failure; TVR, target vessel revascularization; coronary artery disease; diabetes mellitus; drug-eluting stent; percutaneous coronary intervention.

Conflict of interest statement

This study was partly supported by the CardioVascular Research Foundation (Seoul, Republic of Korea). The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. 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

Flow Diagram BP-BES = biodegradable polymer biolimus-eluting stents; CoCr-EES = cobalt chromium everolimus-eluting stents; DES = drug-eluting stents; DM = diabetes mellitus; IRIS-DES = Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents registry; PtCr-EES = platinum chromium everolimus-eluting stents; Re-ZES = Resolute zotarolimus-eluting stents.

Figure 2

Unadjusted Curves for the TVF and its Components Crude cumulative-incidence curves for primary composite outcome of target vessel failure (TVF) (A) and its individual components: cardiac death (B), target vessel myocardial infarction (C), and target vessel revascularization (D). P values were calculated using the log-rank test. Target vessel failure was defined as death from cardiac causes, target vessel myocardial infarction (MI), or target vessel revascularization. Abbreviations as in Figure 1.

Figure 3

Adjusted Curves for the TVF and Its Components Adjusted cumulative-incidence curves for primary composite outcome of target vessel failure (A) and its individual components: cardiac death (B), target vessel myocardial infarction (C), and target vessel revascularization (D). P values were calculated using the adjusted log-rank test. Target vessel failure was defined as death from cardiac causes, target vessel myocardial infarction, or target vessel revascularization. Abbreviations as in Figure 1.

Central Illustration

Adjusted Risks for Device-Oriented and Patient-Oriented Clinical Events Comparing Contemporary Drug-Eluting Stents (A) Adjusted HR using multigroup propensity-score analyses are given for different types of stent compared with the CoCr-EES. (B) Unadjusted Kaplan-Meier curves for cumulative incidence of secondary outcomes of (a) major adverse cardiac events, (b) all-cause mortality, (c) any myocardial infarction, and (d) any revascularization. BP-BES = biodegradable polymer biolimus-eluting stents; CoCr-EES = cobalt chromium everolimus-eluting stents; DM = diabetes mellitus; HR = hazard ratio; PtCr-EES = platinum chromium everolimus-eluting stents; Re-ZES = Resolute zotarolimus-eluting stents.

Figure 4

Adjusted HRs for TVF According to Insulin Use Adjusted HRs using multigroup propensity-score analyses are given for different types of stents compared with the CoCr-EES in in patients with non–insulin- or insulin-treated diabetes mellitus. Abbreviations as in Figure 1.