Abstract:Objectives
The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.
Methods
Patient-level data from two all-comers observational studies (
ClinicalTrials.gov
Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification… Show more
“…Using clopidogrel rather than ticagrelor had no effect on MACE, bleeding, and thrombotic events in stable CAD or ACS patients [ 16 , 17 ]. As observed in our study, compared with 6 months of DAPT, 3–6 months of DAPT did not increase the risk of cardiovascular death, myocardial infarction, target vessel revascularization (TVR), definite and probable stent thrombosis, and Bleeding Academic Research Consortium (BARC) 1 year after PF-SES implantation [ 18 , 19 ].…”
Objectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background. The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and “all-comers” observational studies. Methods. For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results. 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%,
p
= 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%,
p
= 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%,
p
= 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%,
p
= 0.073). Conclusions. The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.
“…Using clopidogrel rather than ticagrelor had no effect on MACE, bleeding, and thrombotic events in stable CAD or ACS patients [ 16 , 17 ]. As observed in our study, compared with 6 months of DAPT, 3–6 months of DAPT did not increase the risk of cardiovascular death, myocardial infarction, target vessel revascularization (TVR), definite and probable stent thrombosis, and Bleeding Academic Research Consortium (BARC) 1 year after PF-SES implantation [ 18 , 19 ].…”
Objectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background. The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and “all-comers” observational studies. Methods. For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results. 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%,
p
= 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%,
p
= 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%,
p
= 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%,
p
= 0.073). Conclusions. The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.
“…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%
“… Fig. 1 Factors impacting on clinical outcomes after DES procedures (based on Krackhardt et al [ 20 ]) …”
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.
“…In comparison to first-generation DP-DES, early-generation BP-DES demonstrated superior safety and a decrease in patient-centered outcomes. However, it has been demonstrated that more recent generations of durable polymers are thromboresistant and even safer than BMS [ 5 ]. PF-DES was developed to provide similar benefits to BMS (lower chances of stent thrombosis) and DP-DES (less risk of lesion revascularization).…”
Drug-eluting stents have transformed the treatment of coronary artery disease (CAD), and there are two types: polymer-free and polymer-coated stents. Polymer-free stents have a coating that is quickly absorbed by the body, whereas polymer-coated stents have a coating that remains on the stent surface. This meta-analysis and systematic review aimed to compare the clinical outcomes of these two stent types in patients with coronary artery disease. The literature and abstracts from significant databases were reviewed to compare polymer-free drug-eluting stents (PF-DES) and polymer-coated drug-eluting stents (PC-DES) for the treatment of coronary artery disease (CAD). The primary efficacy endpoints of the study were all-cause mortality and deaths from cardiovascular and non-cardiovascular causes. Among the secondary outcomes were incidences of myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, stroke, and major adverse cardiovascular events (MACEs). In terms of the primary outcomes, the combined analysis revealed a marginally lower risk of all-cause mortality (relative risk, RR (95% CI) = 0.92 (0.85, 1.00), p = 0.05, I
2
= 0%) with the use of PF-DES versus PC-DES. Nonetheless, there was no significant difference in cardiovascular mortality (RR (95% CI) = 0.97 (0.87, 1.08)) or non-cardiovascular mortality (RR (95% CI) = 0.87 (0.69, 1.10), p = 0.25, I
2
= 9%) between the groups. Furthermore, univariate meta-regression revealed that male gender and prior myocardial infarction were independently associated with an increased risk of all-cause mortality and cardiovascular disease. According to the current meta-analysis, no statistically significant differences existed in PF-DES and PC-DES outcomes. More extensive research is needed to investigate these findings further and establish their validity.
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