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12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry.

ABSTRACT: Background:Amphilimus-eluting stent (AES) is a novel polymer-free drug eluting stent that combines sirolimus with fatty acid as antiproliferative drug and has shown promising results in percutaneous coronary intervention.We evaluated the clinical safety and efficacy of AES in an all-comers South-East Asian registry. Methods:Between May 2014 to April 2017, 268 patients (88% male, mean age 60.1?±?10.8?years) with 291 coronary lesions were treated with AES. The primary endpoint was major adverse cardiac events (MACE) ie a composite of cardiovascular mortality, myocardial infarction (MI) and target lesion revascularization (TLR) at 12-month follow-up. Results:The majority of patients presented with acute coronary syndrome (75%) and 75% had multi-vessel disease on angiography. Diabetes mellitus was present in 123 patients (46%). The most common target vessel for PCI was left anterior descending artery (43%) followed by right coronary artery (36%), left circumflex (10%) and left main (6%).The majority of lesions were type B-C (85%) by ACC/AHA lesion classification. An average of 1.25?±?0.5 AES were used per patient, with mean AES diameter of 3.1?±?0.4?mm and average total length of 34.8?±?19.4?mm.At 12-month follow-up, 4% of patients developed MACE. MACE was mainly driven by cardiovascular mortality (1.5%), MI (2%) and TLR (1.5%). The rate of stent thrombosis was 1.5%. Conclusion:In a contemporary all-comers South-East Asian registry with high rate of diabetes mellitus, AES was found to be efficacious with a low incidence of MACE observed at 12-month follow-up.

SUBMITTER: Ho HH

PROVIDER: S-EPMC6993003 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry.

Ho Hee Hwa HH Sinaga Dasdo Antonius DA Arshad Mohd Kamal Mohd MKM Kasim Sazzli S Lee Jin Hyun JH Khoo Deanna Zhi Lin DZL Loh Kwok Kong KK Jafary Fahim Haider FH Ong Paul Jau Lueng PJL Lo Simon Soo Siong SSS

International journal of cardiology. Heart & vasculature 20200123

<h4>Background</h4>Amphilimus-eluting stent (AES) is a novel polymer-free drug eluting stent that combines sirolimus with fatty acid as antiproliferative drug and has shown promising results in percutaneous coronary intervention.We evaluated the clinical safety and efficacy of AES in an all-comers South-East Asian registry.<h4>Methods</h4>Between May 2014 to April 2017, 268 patients (88% male, mean age 60.1 ± 10.8 years) with 291 coronary lesions were treated with AES. The primary endpoint was m ...[more]

PMID: 32021903

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Project description:ObjectiveTo compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.DesignMixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials.Data sources and study selectionPubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.OutcomesLong term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.ResultsFrom 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.ConclusionsBiodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven.

Dataset Information

12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry.

Publications

12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry.

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