Very Long-Term Outcome of the PRISON-IV Trial: 5-Year Clinical Follow-Up of Ultra-Thin Struts in CTO-PCI

Wilgenhof, Adriaan; Zivelonghi, Carlo; Teeuwen, Koen; Schaaf, René J. van der; Henriques, José P.S.; Vermeersch, Paul; Bosschaert, Mike A.R.; Agostoni, Pierfrancesco; Suttorp, Maarten J.

doi:10.1016/j.carrev.2022.08.013

Cited by 3 publications

(1 citation statement)

References 4 publications

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“…7 Although the ultrathin-strut durable-polymer Sirolimus-eluting stent (dp-SES) demonstrated safety and efficacy in all-comers population, [8][9][10][11][12] in patients with CTOs the bp-SES reported higher rates of in-segment late lumen loss and higher rates of binary restenosis compared with the thin-strut durable-polymer Everolimus-eluting stent (dp-EES) with a higher rate of target lesion revascularization at 3 years. [13][14][15] Recently, the stent recoil of the dp-ZES and the bp-SES was evaluated in CTO lesions and the ultra-thin strut bp-SES proved to be a predictor of high absolute and high relative focal stent recoil. 6 However, the stent expansion of the dp-ZES, the dp-EES, and the bp-SES has not yet been evaluated in the specific setting of calcific CTO lesions.…”

Section: Introductionmentioning

confidence: 99%

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms

Scarparo

Schermers

Improta

et al. 2023

Cathet Cardio Intervent

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ObjectivesTo evaluate the stent expansion of the durable‐polymer Zotarolimus‐eluting stent (dp‐ZES), the durable‐polymer Everolimus‐eluting stent (dp‐EES), and the bioabsorbable‐polymer Sirolimus‐eluting stent (bp‐SES) in calcified coronary chronic total occlusions (CTO).BackgroundThe newer generation stents with ultrathin struts might raise concerns regarding reduced radial strength and higher stent recoil (SR) when implanted in calcified CTOs.MethodsBetween January 2017 and June 2021 consecutive patients with CTO undergoing percutaneous coronary intervention with dp‐ZES, dp‐EES, or bp‐SES were evaluated. The analysis was performed in calcific and in noncalcific CTOs. Quantitative coronary angiography analysis was used to assess diameter stenosis (DS), absolute and relative SR, absolute and relative focal SR, absolute and relative balloon deficit (BD), and absolute and relative focal BD. The primary endpoint was DS.ResultsA total of 213 CTOs were evaluated, 115 calcific CTOs (dp‐ZES:25, dp‐EES:29, bp‐SES:61) and 98 non‐calcific CTOs (dp‐ZES:41, dp‐EES:11, bp‐SES:46). In calcific CTOs, residual DS was lower in dp‐ZES than in dp‐EES and bp‐SES (−1.00% [−6.50–6.50] vs. 13.00% [7.0–19.00] vs. 15.00% [5.00–20.00]; p < 0.001). Dp‐ZES was also an independent predictor of residual DS ≤ 10% (OR 11.34, 95% CI 2.6–49.43, p = 0.001). Absolute and relative focal SR and absolute and relative SR were similar between dp‐ZES, dp‐EES, and bp‐SES (p = 0.913, p = 0.890, p = 0.518, p = 0.426, respectively). In noncalcified CTOs, the residual DS was similar in the three groups (p = 0.340). High relative focal SR was less frequent in dp‐ZES than in dp‐EES and in bp‐SES (19.5% vs. 54.5% vs. 37.0%; p < 0.048).ConclusionsThe three stent platforms demonstrated an overall low residual DS when implanted in CTOs. However, dp‐ZES was associated with the lowest residual DS and identified as independent predictor of residual DS ≤ 10% in patients with calcific CTOs. Dp‐ZES was associated with a lower incidence of high relative focal stent recoil, in noncalcific CTOs. Balloon deficit might be considerate as a surrogate for stent expansion in calcified CTOs.

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Section: Introductionmentioning

confidence: 99%

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms

Scarparo

Schermers

Improta

et al. 2023

Cathet Cardio Intervent

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Comparative effectiveness of ultrathin vs. standard strut drug-eluting stents: insights from a large-scale meta-analysis with extended follow-up

Hassan,

Amin,

Gadelmawla

et al. 2024

Eur J Med Res

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Background Newer generation ultrathin strut stents are associated with less incidence of target lesion failure (TLF) in patients undergoing percutaneous coronary intervention (PCI) in the short term. However, its long-term effect on different cardiovascular outcomes remains unknown. Objectives We aim to identify the effects of newer-generation ultrathin-strut stents vs. standard thickness second-generation drug-eluting stents (DES) on long-term outcomes of revascularization in coronary artery disease. Methods We searched PubMed, Web of Science, Cochrane Library databases, and Scopus for randomized controlled trials (RCTs) and registries that compare newer-generation ultrathin-strut (< 70 mm) with thicker strut (> 70 mm) DES to evaluate cardioprotective effects over a period of up to 5 years. Primary outcome was TLF, a composite of cardiac death, target vessel myocardial infarction (TVMI) or target lesion revascularization (TLR). Secondary outcomes included the components of TLF, stent thrombosis (ST), and all-cause death were pooled as the standardized mean difference between the two groups from baseline to endpoint. Results We included 19 RCTs and two prospective registries (103,101 patients) in this analysis. The overall effect on the primary outcome was in favor of second-generation ultrathin struts stents in terms of TLF at ≥ 1 year, ≥ 2 years, and ≥ 3 years (P value = 0.01, 95% CI [0.75, 0.96]), P value = 0.003, 95% CI [0.77, 0.95]), P value = 0.007, 95% CI [0.76, 0.96]), respectively. However, there was no reported benefit in terms of TLF when we compared the two groups at ≥ 5 years (P value = 0.21), 95% CI [0.85, 1.04]). Some of the reported components of the primary and secondary outcomes, such as TLR, target vessel revascularization (TVR), and TVMI, showed the same pattern as the TLF outcome. Conclusion Ultrathin-strut DES showed a beneficial effect over thicker strut stents for up to 3 years. However, at the 5-year follow-up, the ultrathin strut did not differ in terms of TLF, TLR, TVR, and TVMI compared with standard-thickness DES, with similar risks of patient-oriented composite endpoint (POCE), MI, ST, cardiac death, and all-cause mortality.

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Comparative Effectiveness of Ultrathin vs. Standard Strut Drug-Eluting Stents: Insights from a Large-Scale Meta-Analysis with Extended Follow-up

Hassan,

Amin,

Gadelmawla

et al. 2024

Preprint

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Background: Newer generation ultrathin strut stents are associated with less incidence of target lesion failure (TLF) in patients undergoing percutaneous coronary intervention (PCI) in the short term. However, its long-term effect on different cardiovascular outcomes remains unknown. Objectives: We aim to identify the effects of newer-generation ultrathin-strut stents vs. standard thickness second-generation drug eluting stents (DES) on long term outcomes of revascularization in coronary artery disease. Methods: We searched PubMed, Web of Science, Cochrane Library databases, and Scopus for randomized controlled trials (RCTs) and registries that compare newer-generation ultrathin-strut (<70 mm) with thicker-strut (>70 mm) DES to evaluate cardioprotective effects over a period of up to 5 years. Primary outcome was TLF, a composite of cardiac death, target vessel myocardial infarction (TVMI) or target lesion revascularization (TLR). Secondary outcomes included the components of TLF, stent thrombosis (ST), and all-cause death were pooled as the standardized mean difference between the two groups from baseline to endpoint. Results: We included 19 RCTs and two prospective registries (96756 patients) in this analysis. The overall effect on the primary outcome was in favor of second-generation ultrathin struts stents in terms of TLF at ≥ one year, ≥ two years, and ≥ three years (P value= 0.01, 95% CI [0.75, 0.96]), P value=0.003, 95% CI [0.77, 0.95]), P value= 0.007, 95% CI [0.76, 0.96]), respectively. However, there was no reported benefit in terms of TLF when we compared the two groups at ≥ five years (P value= 0.21), 95% CI [0.85, 1.04]). Some of the reported components of the primary and secondary outcomes, such as TLR, target vessel revascularization (TVR), and TVMI, showed the same pattern as the TLF outcome. Conclusion: Ultrathin-strut DES showed a beneficial effect over thicker strut stents for up to three years. However, at the 5-year follow-up, the ultrathin strut did not differ in terms of TLF, TLR, TVR, and TVMI compared with standard-thickness DES, with similar risks of patient-oriented composite endpoint (POCE), MI, ST, cardiac death, and all-cause mortality.

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Very Long-Term Outcome of the PRISON-IV Trial: 5-Year Clinical Follow-Up of Ultra-Thin Struts in CTO-PCI

Cited by 3 publications

References 4 publications

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms

Stent expansion in calcified coronary chronic total occlusions: The impact of different stent platforms

Comparative effectiveness of ultrathin vs. standard strut drug-eluting stents: insights from a large-scale meta-analysis with extended follow-up

Comparative Effectiveness of Ultrathin vs. Standard Strut Drug-Eluting Stents: Insights from a Large-Scale Meta-Analysis with Extended Follow-up

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