A meta-analysis of randomized controlled trials to compare long-term clinical outcomes of bioabsorbable polymer and durable polymer drug-eluting stents

Mridha, N.; Subhaharan, Deloshaan; Niranjan, S.; Rashid, Mohammed; Psaltis, Peter J.; Singh, Kuljit

doi:10.1093/ehjqcco/qcy036

Cited by 19 publications

(13 citation statements)

References 22 publications

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“…A meta-analysis of randomized clinical trials looking at the long-term outcomes after DES implantation (3-5 years after PCI) did not identify any differences in the risk of cardiac mortality, ST, target lesion revascularization, target vessel failure and Re-infarction between BP-and PP-DES. 18 Recently, the long-term follow-up data from the ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) trial did not show differences in clinical outcomes among patients treated with BP-or PP-DES up to 10 years. 19 The low rates of definite ST and restenosis in this study are remarkable and further corroborate the excellent safety performance of newer generation DES.…”

Section: Discussionmentioning

confidence: 99%

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR)

Buccheri

James

Lindholm

et al. 2019

European Heart Journal

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Aims Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated. Methods and results From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan–Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74–1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57–1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82–1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93–1.19; P = 0.404). Conclusion In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up.

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Section: Discussionmentioning

confidence: 99%

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR)

Buccheri

James

Lindholm

et al. 2019

European Heart Journal

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“…Prior meta-analyses has established the superiority of BP-DES over BMS and rst generation DP-DES, and similar safety and e cacy pro les with secondary generation DP-DES [15,16] . The short-term follow-up results showed BP-DES had higher de nite ST rate [17] and mortality rate [16] .…”

Section: Discussionmentioning

confidence: 99%

Five Years Sustained Clinical Safety and Efficacy of An Abluminal Biodegradable-Polymer Coated Sirolimus-Eluting Stent: A Randomized Controlled Trial

Mingkun

Yin

Zhou

et al. 2021

Preprint

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Background Drug-eluting stent (DES) with durable polymers have been proven to cause late or very late adverse events. Biodegradable polymer-coated DES was developed to address the risk by avoiding persistent inflammatory irritation from persistent polymers. However, it is unknown whether the benefits of biodegradable polymer DES will occur over longer time. Methods The trial was a prospective, multicenter and randomized non-inferiority clinical trial done in China. Patients with indications for stent implantation were assigned into Cordimax and Xience V group in a 2:1 allocation. The composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularisation (CI-TLR) was the primary endpoint target lesion failure (TLF). The pre-specified endpoint at five years was major adverse cardiac event (MACE) which was defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and CI-TLR. Results 3266 patients (88.3%) completed 5-year follow-up. No difference was observed for TLF between Cordimax (7.5%) and Xience V (8.3%) group (RR: 0.90, 95% CI: 0.70 to 1.15, P = 0.39). MACE occurred in 280 patients (11.4%) in Cordimax group and 162 patients (13.1%) in Xience V group (RR: 0.85, 95% CI: 0.69 to 1.05, P = 0.13). The incidence of definite or probable stent thrombosis did not differ in both groups (Cordimax 0.7%, Xience V 0.9%; RR: 0.78, 95% CI: 0.36 to 1.66; P = 0.51). Conclusion The biodegradable polymer Cordimax stent showed a comparable result to the durable polymer Xience V stent at 5 years, showing its long-term safety and efficacy performance. Trial registration: This study is registered with ClinicalTrials.gov, number NCT03185221 (14/06/2017).

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“…On top of that, the study findings add further evidence supporting the use of SYNERGY BP‐DES in higher risk patients and lesions, but the evidence of its superiority lacks. A recent meta‐analysis of more than 15.000 patients enrolled in other randomized‐controlled trials had confirmed equivalent clinical outcomes between BP‐DES and DP‐DES over mid and long‐term follow‐up (up to 5 years) 5 …”

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confidence: 94%

“…A recent meta-analysis of more than 15.000 patients enrolled in other randomized-controlled trials had confirmed equivalent clinical outcomes between BP-DES and DP-DES over mid and long-term follow-up (up to 5 years). 5 In conclusion, the current TWILIGHT sub analysis is important because gives more light cues on the way of the reduction of TLF adding evidence on the importance of the pharmaco-invasive therapy that should not be uncoupled to solve the remaining challenges and improve the care of coronary artery disease patients.…”

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confidence: 99%

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Tarantini

Fraccaro

2021

Cathet Cardio Intervent

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Key Points The TWILIGHT‐SYNERGY subgroup analysis demonstrated comparable safety and efficacy of the bioabsorbable polymer (BP) everolimus‐eluting stent versus durable polymer DES in high‐risk patients undergoing PCI, as well as advantage of 3 months DAPT followed by ticagrelor monotherapy, as compared with long term DAPT, in term of ischemic and hemorrhagic profile irrespective of DES type. This study confirms and extends previous evidences about safety profile of BP‐DES and short term DAPT also in high risk patients. Future studies should focus on further technological improvements and on particular clinical setting where these devices could prove potential superiority.

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A meta-analysis of randomized controlled trials to compare long-term clinical outcomes of bioabsorbable polymer and durable polymer drug-eluting stents

Abstract: There were no differences in clinical outcomes between BP-DESs and DP-DESs over mid and long-term follow-up.

Cited by 19 publications

References 22 publications

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR)

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR)

Five Years Sustained Clinical Safety and Efficacy of An Abluminal Biodegradable-Polymer Coated Sirolimus-Eluting Stent: A Randomized Controlled Trial

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