Comparative Safety of Bioabsorbable Polymer Everolimus-Eluting, Durable Polymer Everolimus-Eluting, and Durable Polymer Zotarolimus-Eluting Stents in Contemporary Clinical Practice

Author(s):  
Nadia R. Sutton ◽  
Milan Seth ◽  
Ryan D. Madder ◽  
Devraj Sukul ◽  
Simon R. Dixon ◽  
...  

Background: Uncertainty exists over whether stents commonly used for percutaneous coronary intervention have comparable short- and long-term safety. The objective of this study was to determine the outcomes of patients treated with bioabsorbable polymer everolimus-eluting (BP-EES; Synergy, Boston Scientific), durable polymer everolimus-eluting (DP-EES; XIENCE, Abbott Vascular), or durable polymer zotarolimus-eluting (DP-ZES; Resolute, Medtronic) stents in routine clinical practice. Methods: All percutaneous coronary intervention cases from 48 hospitals performed after the introduction of the BP-EES stent in 2015 until the first quarter of 2018 were included. Propensity-matched multivariable analysis was used to adjust for differences in baseline characteristics and procedural variables. After matching, we performed pair-wise comparisons between DP-EES and BP-EES, DP-EES and DP-ZES, and BP-EES and DP-ZES for in-hospital postpercutaneous coronary intervention outcomes. We also evaluated 2-year postdischarge mortality in a subset of patients who could be matched to Medicare data. Results: During the study period, 53 724 percutaneous coronary intervention cases were performed. A total of 59% of patients were treated with DP-EES stents, 14% with BP-EES stents, and 27% with DP-ZES stents. Although baseline characteristics of patients differed between stent types, these differences were attenuated after matching. In the matched cohort, there was no difference in in-hospital mortality, stent thrombosis, or postprocedural stroke (a falsification end point) between BP-EES, DP-EES, and DP-ZES. After matching, there was no difference in 2-year postdischarge mortality (DP-EES versus BP-EES hazard ratio 0.91, P =0.50; DP-EES versus DP-ZES hazard ratio 1.03, P =0.77; BP-EES versus DP-ZES hazard ratio 1.20, P =0.29). Conclusions: Our data suggest similar risk-adjusted in-hospital outcomes among drug-eluting stent platforms commonly used in clinical practice. The absence of a difference in 2-year mortality between BP-EES, DP-EES, and DP-ZES suggests that stent choice decisions could be made based on other factors, including durability, availability, and cost.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Okuno ◽  
T Ishihara ◽  
O Iida ◽  
M Asai ◽  
M Masuda ◽  
...  

Abstract Background Biodegradable polymer drug-eluting stent (BP-DES) has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) for patients presenting coronary artery disease (CAD). Although BP-DES showed non-inferior safety and efficacy to durable polymer DES (DP-DES) in several randomized clinical trials, hemodialysis (HD) patients, who have been well known as high risk population for adverse events, were excluded in the most of trials. Therefore, there are limited data comparing the clinical outcomes between BP-DES and DP-DES in HD patients with CAD after PCI. Purpose The purpose of this study was to investigate clinical outcomes in HD patients after BP-DES implantation compared with those after DP-DES implantation. Methods We retrospectively analyzed 234 HD patients (male 74%, mean age 71±10 years) undergoing PCI for 404 lesions with 472 DESs (71 patients for 138 lesions with 170 BP-DESs [91 Ultimaster and 79 Synergy] and 163 HD patients for 266 lesions with 302 DP-DESs [219 Xience, 53 Promus and 30 Resolute]) from 2011 to 2017. Two-year clinical outcomes were compared between BP-DES group and DP-DES group. The primary outcome measure was the incidence of target lesion revascularization (TLR), while the secondary outcome measures were the occurrence of cardiac death (CD), stent thrombosis (ST), myocardial infraction (MI), target vessel revascularization (TVR), non-TVR and major adverse cardiac event (MACE) defined as a composite of CD, MI, and TVR. Outcome measures were estimated by the Kaplan-Meier method and the differences between BP-DES group and DP-DES group were assessed by the log-rank test. We also conducted Cox's proportional hazard model to identify predictors for TLR occurrence. Results Baseline patient and lesion characteristics were similar between the two groups. The two-year incidence of TLR was not significantly different between BP-DES group and DP-DES group (14.1% vs. 22.2%, p=0.391). The two-year incidences of CD (17.3% vs. 17.5%, p=0.381), ST (0% vs. 3.9%, p=0.133), MI (4.2% vs. 5.8%, p=0.965), TVR (21.3% vs. 27.5%, p=0.586), non-TVR (26.1% vs. 31.3%, p=0.439) and MACE (41.1% vs. 42.6%, p=0.526) were also not different between the two groups. After multivariate analysis, diabetes mellitus (hazard ratio 1.97; 95% confidence interval 1.03–3.78, p=0.004) was independently associated with TLR occurrence in HD patients. Two-year clinical outcomes of HD patient Conclusions At two-year follow-up after PCI, BP-DES had comparable safety and efficacy profiles to DP-DES in HD patients presenting CAD. Acknowledgement/Funding None


2014 ◽  
Vol 6 (2) ◽  
pp. 107-111
Author(s):  
S Munwar ◽  
AHMW Islam ◽  
S Talukder ◽  
AQM Reza ◽  
T Ahmed ◽  
...  

Background: Aim of the study was to evaluate the primary procedural success of percutaneous coronary intervention of unprotected left main coronary artery stenosis using either Bare-metal stents or drug eluting stent. Methods: Total 33 patients were enrolled in this very preliminary non-randomized prospective cohort study. Among them, Male: 25 and Female: 8. Total 35 stents were deployed. Mean age were for Male: 59 yrs, for Female: 62 yrs. Associated coronary artery diseases risk factors were dyslipidemia, High Blood pressure, Diabetes Mellitus, Positive family history for coronary artery diseases and smoking. Results: Among the study group; 26 (78%) were Dyslipidemic, 24(70%) were hypertensive; 17 (51.5%) patients were Diabetic, 11(33%) were smoker and 7(21%) patients had family history of Ischaemic heart disease. Female patients were more obese (BMI M 26: F 27) and developed coronary artery diseases in advance age. Common stented territory were left main: 20 (60%), Left main to left anterior descending artery 7 (22%) and Left main to left circumflex artery 6 (18%). Average length and diameter of stent was 3.5 and 18 mm respectively. Stent used: Bare Metal Stent 5 (15%), Drug Eluting Stent: 28 (85%). Among the different Drug Eluting Stents, Everolimus eluting stents were 11 (39.3%), Sirolimus eluting 10(35.7%), Paclitaxel eluting 3 (10.7%), Biolimus eluting 3 (10.7%) and Zotarolimus eluting1 (3.6%). In the present study, overall survival outcome was 94% (31 patient), mortality of cardiac cause 3% (1 patient) and 1 patient (3%) died of hepatocellular carcinoma. Conclusion: Our study has shown that percutaneous coronary intervention of the unprotected left main is a safe and effective alternative to Coronary Artery Bypass Graft (CABG). DOI: http://dx.doi.org/10.3329/cardio.v6i2.18349 Cardiovasc. j. 2014; 6(2): 107-111


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Van Veelen ◽  
J Elias ◽  
I.M Van Dongen ◽  
J.P.S Henriques ◽  
P Knaapen

Abstract Background Females comprise a minority of patients with chronic total occlusions (CTO). It is known that men have a greater benefit from CTO percutaneous coronary intervention (PCI) than women. We aimed to determine gender-based differences in baseline characteristics and outcomes after PCI in patients with CTO. Methods The Netherlands Heart Registration (NHR) is a nationwide registry that registers outcomes of cardiac interventions. For the purpose of this analysis, the data of all patients undergoing PCI from inception of the NHR to December 2018 were selected, that included PCI with at least one CTO in one of the treated coronary arteries. We compared baseline characteristics and the outcomes 1 year mortality, 30 day myocardial infarction (MI) and target vessel revascularization (TVR) <1 year between men and women. Results A total of 7560 patients were identified that underwent PCI between January 1, 2015 and December 31, 2018 with at least 1 CTO in the treated vessel. A total of 5850 was male (77.4%) and 1710 was female (22.6%). Women were older (68.5±10.6 versus 64.7±10.6 years old, p<0.001), and more frequently had diabetes (29.4% [n=529] versus 25.0% [n=1602], p<0.001) and kidney disease (4.5% [n=529] versus 2.2% [n=142], p<0.001). However, men had more extensive cardiovascular disease, i.e. multi-vessel disease (56.0% [n=3584] versus 50.4% [n=912], p<0.001), previous MI (39.7% [n=2527] versus 31.0% [n=555], p<0.001), previous PCI (48.2% [n=1967] versus 40.2% [n=455], p<0.001) and previous coronary artery bypass grafting (16.8% [n=1085] versus 10.5% [n=191], p<0.001) and more frequently presented with an out-of-hospital cardiac arrest, compared to women (2.1% [n=136] versus 1.1% [n=20], p=0.004). The 1-year mortality was higher in women (10.3% versus 7.5%, p<0.001), as well as the 30-day MI (0.9% versus 0.4%, p=0.043), but men had higher risk for TVR<1 year (11.7% versus 9.5%, p=0.044). Corrected for age and comorbidities, female gender was an independent predictor for mortality (Figure 1; odds ratio 1.83, 95% confidence interval 1.08–3.11, p=0.025). Conclusion In this nationwide registry comprising 7560 CTO patients undergoing PCI, significant gender-based differences were found. Males were found to have more extensive cardiovascular disease. However, females were at higher risk of mortality, possibly due to higher age and higher prevalence of concomitant comorbidities. Figure 1. Survival curve Funding Acknowledgement Type of funding source: None


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