Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes

Krackhardt, Florian; Waliszewski, Matthias; Ahmad, Wan Azman Wan; Kočka, Viktor; Toušek, Petr; Janek, Bronislav; Trenčan, Milan; Krajči, Peter; Lozano, Fernando; Roman, Koldobika Garcia-San; Irurueta, Imanol Otaegui; Blanco, Bruno García del; Wachowiak, Lucie; Vilalta, Victòria; Nofrerías, Eduard Fernandez; Cho, Jeong Gwan; Jung, Byung-Chun; Han, Kyu-Rock; Piot, Christophe; Sebagh, Laurent; Rischner, Jérôme; Pansiéri, Michel; Leschke, Matthias; Ahn, Tae Hoon

doi:10.1371/journal.pone.0226606

Cited by 6 publications

(9 citation statements)

References 24 publications

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“…The decreasing use of ticagrelor in ACS patients with second-generation PF-SES is noteworthy. As previously reported by Krackhardt et al [18], independent of the patients' presentation at baseline, the DAPT duration in Malaysia is close to 12 months, with 11.6 ± 1.7 months for first-generation PF-SES versus 11.9 ± 1.0 months (p = 0.045) for the secondgeneration PF-SES.…”

Section: Co-medicationsupporting

confidence: 78%

“…Nevertheless, we need to point out that the event rates were quite low, with an overall MACE rate of 1.8%, which makes it difficult to conduct a properly powered randomized controlled trial. One reason for these low event rates may be the 12-month DAPT recommendation in Malaysia even in stable coronary artery disease patients [ 18 ]. However, due to the observational character of this study, event underreporting may have occurred equally in both groups, which would still allow a comparison of these two stent generations.…”

Section: Discussionmentioning

confidence: 99%

“…The two PF-SES’s have an identical polymer-free stent coating, which was intensively studied in the ISAR-TEST 5 trial with a 10-year clinical follow-up [ 6 ]. The devices were studied in different ethnic subpopulations [ 18 ], in lesion morphological subgroups [ 8 ] and dialyzed patients [ 19 ], and were investigated with a focus on real-world dual-antiplatelet therapy (DAPT) [ 20 ].…”

Section: Methodsmentioning

confidence: 99%

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Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

et al. 2020

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Introduction The objective of this study was to compare the accumulated clinical outcomes of two Malaysian all-comers populations, each treated with different polymer-free sirolimus-eluting stents (PF-SES) of similar stent design. Methods The Malaysian subpopulation of two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined and compared to a Malaysian-only cohort which was treated with a later-generation PF-SES. The PF-SES’s used differed only in their bare-metal backbone architecture, with otherwise identical sirolimus coating. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 12 months. The rates of major adverse cardiac events (MACE), stent thrombosis (ST) and myocardial infarction (MI) were part of the secondary endpoints. Results A total of 643 patients were treated with either the first-generation PF-SES (413 patients) or second-generation PF-SES (230 patients). Patient demographics were similar in terms of age ( p = 0.744), male gender (0.987), diabetes mellitus ( p = 0.293), hypertension ( p = 0.905) and acute coronary syndrome (ACS, 44.8% vs. 46.1%, p = 0.752) between groups. There were no differences between treatment groups in terms of lesion length (20.8 ± 7.3 mm vs. 22.9 ± 7.9, p = 0.111) or vessel diameter (2.87 ± 0.39 vs. 2.93 ± 0.40, p = 0.052) despite numerically smaller diameters in the first-generation PF-SES group. The second-generation PF-SES tended to have more complex lesions as characterized by calcification (10.3% vs. 16.2%, p = 0.022), severe tortuosity (3.5% vs. 6.9%, p = 0.041) and B2/C lesions (49.2% vs. 62.8%, p < 0.001). The accumulated TLR rates did not differ significantly between the first- and second-generation PF-SES (0.8% vs. 0.9%, p = 0.891). The accumulated MACE rates were not significantly different ( p = 0.561), at 1.5% (6/413) and 2.2% (5/230), respectively. Conclusions Modifications in coronary stent architecture which enhance the radial strength and radiopacity without gross changes in strut thickness and design do not seem to impact clinical outcomes. Clinical Trial Registration ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214.

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Section: Co-medicationsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

et al. 2020

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“…In the e-HEALING worldwide registry substudy by Klomp M et al, differences in cardiovascular risk factors and clinical outcomes were evaluated between Western European and Southeast Asian patients treated with the Genous Bio-engineered R stent (OrbusNeich Medical Technologies). 11 The primary study outcome was target-vessel failure (TVF), which is the composite of cardiac death or MI and TVR, at 12 age 57.4 ± 9.9 versus 65.9 ± 11.2 years, p<0.01), with fewer women (15% versus 25%, p<0.01). Southeast Asian patients also had a higher incidence of type 2 diabetes (36.0% versus 24%, p<0.01) and a lower prevalence of MI or revascularisation history.…”

Section: Discussionmentioning

confidence: 99%

“…A more recent study by Krackhardt et al 12 assessed the regional and ethnic differences in an unselected patient population treated with newer-generation DES (polymer-free sirolimus-eluting stents) in Asia and Europe. Of the 7,190 eligible patients, 3,186 (44.0%), 2,317 (32.0%), 1,274 (17.6%) and 413 (5.7%) were from the Mediterranean region, Central Europe, South Korea and Malaysia, respectively.…”

Section: Discussionmentioning

confidence: 99%

Are There Differences in the Demographics and Clinical Outcomes Between Asian and European Patients Treated With the COMBO Dual Therapy Stent in the REDUCE Trial Populations?

Ahmad

Benit

Camaro

et al. 2022

J Asian Pac Soc Cardiol

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Background: This study aimed to assess differences in clinical characteristics and outcomes between Asian and European patients treated with the COMBO dual therapy stent in the REDUCE trial. Methods: In the REDUCE trial, 1,496 patients who underwent successful COMBO stent implantation were randomised to 3- or 12-month dual antiplatelet therapy groups. Of these, 449 (30%) were Asian and 1,047 (70%) were European. Given that no significant differences were observed between the 3- and 12-month dual antiplatelet therapy cohorts for both sites, the overall data of Asian patients were compared with those of European patients in terms of clinical characteristics and outcomes. Results: The Asian cohort was younger and comprised fewer women than the European cohort. They also had more cases of type 2 diabetes (33.0% versus 15.1%), hypercholesterolaemia (54.6% versus 41.7%) and hypertension (55.7% versus 48.5%) but had fewer previous interventions compared with European patients. Regarding procedures, Asian patients had more cases of infarct-related vessel in the left anterior descending artery. The primary endpoint indices among Asian patients at 90, 180, 360 and 720 days were lower than those among European patients, which can be attributed to the lower number of cases of target-vessel revascularisation, bleeding (Bleeding Academic Research Consortium classification II, III or V) and MI among the Asian cohort. Conclusion: Despite having a higher incidence of cardiovascular risk factors, more ST-elevation MI cases and more cases of culprit lesion located at the proximal left anterior descending artery, Asian patients in the REDUCE trial showed lower trends of target-vessel revascularisation, bleeding and MI than European patients in the REDUCE trial.

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Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials

Ploumen,

Semedo,

Doggen

et al. 2024

Neth Heart J

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Background Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients’ ethnic background. Aims To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention. Methods In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients’ self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year. Results Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38–1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates. Conclusions Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

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Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes

Cited by 6 publications

References 24 publications

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

Impact of Coronary Stent Architecture on Clinical Outcomes: Do Minor Changes in Stent Architecture Really Matter?

Are There Differences in the Demographics and Clinical Outcomes Between Asian and European Patients Treated With the COMBO Dual Therapy Stent in the REDUCE Trial Populations?

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials

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