Propensity score matched all comers population treated with ultra‐thin strut bare metal and sirolimus‐probucol coated drug‐eluting stents of identical stent architecture

Krackhardt, Florian; Rosli, Mohd Ali; Leschke, Matthias; Schneider, André; Sperling, Christian; Heang, Tay Mok; Pons, Maxime; Sousa, Pedro Jerónimo; Kherad, Behrouz; Waliszewski, Matthias

doi:10.1002/ccd.27306

Cited by 6 publications

(8 citation statements)

References 19 publications

(26 reference statements)

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“…All-comers studies with polymer-free sirolimus-eluting stents (PF-SES) have demonstrated safety and efficacy in Asian and European patients [8,9]. The objective of this clinical assessment in a real-world PF-SES population was to investigate whether there are ethnic or geographical differences in terms of baseline characteristics, clinical outcomes and DAPT preferences (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214).…”

Section: Introductionmentioning

confidence: 99%

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

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BackgroundThe objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe. MethodsTwo all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months. ResultsOf the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were

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Section: Introductionmentioning

confidence: 99%

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

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“…One alternative analysis to overcome this statistical dilemma is the use of propensity score (PS) matching, which was recently used to study the effect of a stent coating in otherwise identical stent platforms. Krackhardt and co-workers [ 24 ] studied a PF-SES and compared the clinical results to those of its bare-metal stent analogue. The study revealed the efficacy of the stent coating (reduction in MACE by 5.5%, p = 0.001), and the ST rate was also lower in the PF-SES group.…”

Section: Discussionmentioning

confidence: 99%

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

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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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“…Details on the study database were previously published by Krackhardt et al [ 13 – 16 ] Briefly, the ISAR 2000 all-comers registry (ClinicalTrials.gov Identifier NCT02629575 and NCT02905214), prospectively enrolled patients in 43 European and 39 Asian cardiac centers. All relevant ethics committee votes were obtained prior to patient recruitment.…”

Section: Methodsmentioning

confidence: 99%

“…A PF-SES (Coroflex © ISAR, Coroflex © ISAR Neo B.Braun Melsungen AG, Germany) previously studied by Krackhardt et al [ 13 – 16 ] was used in this study. Its sirolimus matrix coating was extensively investigated in the ISAR-TEST 5 trial with very favorable clinical outcomes up to 5 years.…”

Section: Methodsmentioning

confidence: 99%

“…[ 11 ] Recently, new stent coating technologies using bioabsorbable polymers or non-polymer coating have been developed aiming to shorten dual antiplatelet therapy with the hypothesized reduced risk of bleeding due to a lower thrombogenic stimulus. [ 12 ] Patients on hemodialysis with high risk of hemoconcentration and blood volume reduction during treatment and more compromised coronary arteries, may gain a higher benefit from a polymer-free sirolimus eluting stent (PF-SES) [ 13 – 16 ] as compared to bare metal stents (BMS) [ 17 ] and earlier DES generations. This would help to reduce the negative gap in terms of clinical outcomes currently present between patients with CKD, those on dialysis as compared to patients with NRF.…”

Section: Introductionmentioning

confidence: 99%

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Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients

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Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function. Large-scale, international, single-armed, multicenter, ‘all comers’ observational studies (ClinicalTrials.gov Identifier: NCT02629575 and NCT02905214) were used for this post-hoc subgroup analysis to compare the clinical outcomes in patients with normal renal function (NRF) to those with renal insufficiency (CKD, dialysis dependence). The accumulated target lesion revascularization rate was the primary endpoint at 9 to 12 months whereas the accumulated major adverse cardiac event, stent thrombosis (ST) and procedural success rates were part of the secondary endpoints. There were 6791 patients with NRF, whereas 369 patients had CKD and 83 patients were dialysis dependent. The target lesion revascularization rate at 9 to 12 months was significantly higher in dialysis patients (2.1% vs 3.3% vs 6.7%, P = .011). The accumulated major adverse cardiac events rates in the dialysis and in the CKD group were significantly higher as compared to patients with NRF (13.3% vs 4.0%, P < .001; 6.5% vs 4.0%, P = .024). Finally, ST rates (NRF: 0.7%, CKD: 0.6%, dialysis: 1.3%) were not statistically different between subgroups ( P = .768). All-cause cumulative mortality rates were 3.3% (CKD) and 4.0% (dialysis) respectively. Percutaneous coronary interventions with polymer-free, ultra-thin strut sirolimus-eluting stents have comparable revascularization rates in CKD and dialysis dependent patients as compared to percutaneous coronary interventions with other 2nd generation drug-eluting stents. ST and all-cause mortality rates were low as compared to available literature references.

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Propensity score matched all comers population treated with ultra‐thin strut bare metal and sirolimus‐probucol coated drug‐eluting stents of identical stent architecture

Cited by 6 publications

References 19 publications

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

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

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

Clinical outcomes following polymer-free sirolimus-eluting stent implantations in unselected patients

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