Long-term effect of biodegradable vs durable polymer everolimus-eluting stents on neoatherosclerosis in ST-segment elevation myocardial infarction: the CONNECT trial.

BACKGROUND AND AIMS: Neoatherosclerosis is a leading cause of late (>1 year) stent failure following drug-eluting stent implantation. The role of biodegradable (BP) versus durable polymer (DP) drug-eluting stents on long-term occurrence of neoatherosclerosis remains unclear. Superiority of biodegradable against durable polymer current generation thin-strut everolimus-eluting stent (EES) was tested by assessing the frequency of neoatherosclerosis 3 years after primary percutaneous coronary intervention (pPCI) among patients with ST-segment elevation myocardial infarction (STEMI). METHODS: The randomized controlled, multicentre (Japan and Switzerland) CONNECT trial (NCT03440801) randomly (1:1) assigned 239 STEMI patients to pPCI with BP-EES or DP-EES. The primary endpoint was the frequency of neoatherosclerosis assessed by optical coherence tomography (OCT) at 3 years. Neoatherosclerosis was defined as fibroatheroma or fibrocalcific plaque or macrophage accumulation within the neointima. RESULTS: Among 239 STEMI patients randomized, 236 received pPCI with stent implantation (119 BP-EES; 117 DP-EES). A total of 178 patients (75%; 88 in the BP-EES group and 90 in the DP-EES group) underwent OCT assessment at 3 years. Neoatherosclerosis did not differ between the BP-EES (11.4%) and DP-EES (13.3%; odds ratio 0.83, 95% confidence interval 0.33-2.04, p=0.69). There were no differences in the frequency of fibroatheroma (BP-EES 9.1% vs DP-EES 11.1%, p=0.66) or macrophage accumulation (BP-EES 4.5% vs DP-EES 3.3%, p=0.68), and no fibrocalcific neoatherosclerosis was observed. Rates of target lesion failure did not differ between groups (BP-EES 5.9% vs DP-EES 6.0%, p=0.97). CONCLUSIONS: Use of BP-EES for primary PCI in patients presenting with STEMI was not superior to DP-EES regarding frequency of neoatherosclerosis at 3 years.

Long-term cardiovascular outcomes of biodegradable polymer drug eluting stents in patients with diabetes versus non-diabetes mellitus: a meta-analysis.

BACKGROUND: Today, diabetes mellitus (DM) has become a worldwide concern. DM is a major risk factor for the development of cardiovascular diseases (CVD). Eligible patients with CVD are treated invasively by percutaneous coronary intervention (PCI) whereby a stent is implanted inside the coronary vessel with the particular lesion to allow sufficient blood flow. Newer scientific research have shown that even though associated with a lower rate of re-stenosis, first-generation drug eluting stents (DES) were associated with a higher rate of late stent thrombosis. Recently, newer stents, namely biodegradable polymer DES (BP-DES) have been developed to overcome the safety issues of earlier generation DES. In this analysis we aimed to systematically compare the long term (≥ 12 months) adverse cardiovascular outcomes observed in DM versus non-DM patients who were implanted with BP-DES. METHODS: Cochrane central, MEDLINE (Subset PubMed), EMBASE, Web of Science, http://www. CLINICALTRIALS: gov and Google scholar were searched for relevant publications involving BP-DES in patients with DM versus non-DM and their associated adverse cardiovascular outcomes. The mean follow-up time period ranged from 12 to 120 months. Data analysis was carried out with the latest version of the RevMan software (version 5.4). Based on the Mantel-Haenszel test, risk ratios (RR) with 95% confidence intervals (CI) were calculated and used to represent the results following analysis. RESULTS: Seven (7) studies with a total number of 10,246 participants were included in this analysis. Stents which were implanted during PCI were BP-DES. Participants were enrolled from the year 2006 to 2013. Our current results showed that in patients who were implanted with BP-DES, the risks of major adverse cardiac events (RR: 1.30, 95% CI: 1.18-1.43; P = 0.00001), myocardial infarction (RR: 1.48, 95% CI: 1.14-1.93; P = 0.003), all-cause mortality (RR: 1.70, 95% CI: 1.29-2.23; P = 0.0002), cardiac death (RR: 1.93, 95% CI: 1.28-2.93; P = 0.002), target vessel revascularization (RR: 1.35, 95% CI: 1.03-1.77; P = 0.03), target lesion revascularization (RR: 1.28, 95% CI: 1.07-1.54; P = 0.007) and target lesion failure (RR: 1.79, 95% CI: 1.52-2.12; P = 0.00001) were significantly higher in the DM group. Definite and probable stent thrombosis (RR: 1.80, 95% CI: 1.28-2.55; P = 0.0009) were also significantly higher in the DM group. CONCLUSIONS: Diabetes mellitus was an independent risk factor associated with long term adverse cardiovascular outcomes following PCI with BP-DES.

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

OBJECTIVES: To 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). BACKGROUND: The newer generation stents with ultrathin struts might raise concerns regarding reduced radial strength and higher stent recoil (SR) when implanted in calcified CTOs. METHODS: Between 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. RESULTS: A 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). CONCLUSIONS: The 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.

Angioscopic Comparison of Early- and Mid-Term Vascular Responses Following Treatment of ST-Elevation Acute Myocardial Infarction With Biodegradable vs. Durable Polymer Everolimus-Eluting Stents　- A Prespecified Subanalysis of the MECHANISM AMI RCT.

BACKGROUND: The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P>0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023). CONCLUSIONS: Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

One-year outcomes of polymer-free amphilimus-eluting stents versus durable polymer zotarolimus-eluting stents in patients with diabetes mellitus: a meta-analysis.

BACKGROUND: Diabetes mellitus (DM) and cardiovascular diseases often co-exist. Today, percutaneous coronary intervention (PCI) is the preferred revascularization procedure for majority of patients with coronary artery disease. Polymer-free amphilimus-eluting stents (AES) represent a novel elution technology in the current era of drug-eluting stents. In this analysis, we aimed to systematically compare the cardiovascular outcomes which are associated with polymer-free amphilimus-eluting stents (AES) versus the durable polymer zotarolimus-eluting stents (ZES) for the treatment of patients with DM. METHODS: Http://www. CLINICALTRIALS: gov, EMBASE, Web of Science, MEDLINE, Cochrane database and Google Scholar were searched for publications comparing polymer-free AES versus durable polymer ZES in patients with DM. Selective cardiovascular outcomes were assessed. Statistical analysis was carried out by the latest version of the RevMan software. Risk ratio (RR) with 95% confidence interval (CI) was used to represent the data analysis. RESULTS: Four studies with a total number of 1795 participants with DM whereby 912 patients were assigned to be revascularized by the polymer-free AES and 883 patients were assigned to be revascularized by the durable polymer ZES were included in this analysis. In patients with DM, at one year, polymer-free AES were associated with significantly lower risk of major adverse cardiac events (MACEs) (RR: 0.69, 95% CI: 0.54-0.88; P = 0.002) and target lesion failure (TLF) (RR: 0.66, 95% CI: 0.48-0.91; P = 0.01) compared to durable polymer ZES. However, there was no significant change in all-cause mortality (RR: 0.79, 95% CI: 0.51-1.22; P = 0.28), cardiac death and the other cardiovascular outcomes. Similar risk of total stent thrombosis (RR: 1.13, 95% CI: 0.60-2.13; P = 0.70), including definite stent thrombosis (RR: 1.12, 95% CI: 0.38-3.31; P = 0.84), probable stent thrombosis (RR: 0.87, 95% CI: 0.37-2.09; P = 0.76), possible stent thrombosis (RR: 1.19, 95% CI: 0.50-2.87; P = 0.69) and late stent thrombosis (RR: 1.00, 95% CI: 0.17-5.72; P = 1.00) as between polymer-free AES and durable polymer ZES in patients with DM. CONCLUSIONS: At 1 year follow-up, polymer-free AES were associated with significantly lower MACEs and TLF compared to durable polymer ZES in these patients with DM, without any increase in mortality, stent thrombosis and other cardiovascular outcomes. However, this analysis is only based on a follow-up time period of one year, therefore, future research should focus on the long term follow-up time period.

Comparison of 1-Month and 12-Month Vessel Responses Between the Polymer-Free Biolimus A9-Coated Stent and the Durable Polymer Everolimus-Eluting Stent.

BACKGROUND: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 µm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99). CONCLUSIONS: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.

One-year outcomes of patients undergoing complex percutaneous coronary intervention with three contemporary drug-eluting stents.

OBJECTIVES: We aimed to evaluate the 1-year outcomes of three everolimus-eluting stents (EES) for complex percutaneous coronary intervention (PCI). BACKGROUND: It is controversial whether contemporary bioresorbable-polymer drug-eluting stents (BP-DES) are associated with better outcomes compared with durable-polymer DES (DP-DES). METHODS: Patients undergoing PCI with cobalt-chromium (CoCr)-DP-EES (Xience), platinum-chromium (PtCr)-DP-EES (Promus), or PtCr-BP-EES (Synergy) at one high-volume institution between 2015 and 2017 were included. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of death, myocardial infarction, and target-vessel revascularization. Associations were also examined in patients undergoing complex PCI. Multivariable analysis was conducted to adjust for baseline differences across groups. RESULTS: We included n = 5,446 patients (CoCr-DP-EES, n = 3,177; PtCr-DP-EES, n = 1,555; PtCr-BP-EES, n = 714). Patients treated with PtCr-BP-EES had higher comorbidity burden and procedural complexity. At 1 year, MACE rates were 8.9% for CoCr-DP-EES versus 8.9% for PtCr-DP-EES versus 8.6% for PtCr-BP-EES (p = .97). The incidence of definite/probable stent thrombosis (ST) was also similar (0.6 vs. 0.4 vs. 0.3%, p = .69). Complex PCI was performed in n = 2,894/5,446 (53.1%). At 1 year, MACE rates were 11.5 versus 10.7 versus 10.3%, respectively (p = .83). The incidence of definite/probable ST was also similar (0.9 vs. 0.3 vs. 0.3%, p = .22). On multivariable analysis, stent type was not an independent predictor of MACE either in the overall or in the complex PCI population. CONCLUSIONS: We observed comparable 1-year rates of MACE and definite/probable ST in patients undergoing PCI with CoCr-DP-EES, PtCr-DP-EES, and PtCr-BP-EES. Results were unchanged among patients undergoing complex PCI. Future multicenter randomized studies should confirm and extend our findings.

Safety and efficacy of the bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents in high-risk patients undergoing PCI: TWILIGHT-SYNERGY.

BACKGROUND: Data examining the safety and efficacy of the bioabsorbable polymer (BP) drug-eluting stent (DES) as compared with durable polymer (DP) DES in high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited. METHODS: We conducted a pre-specified analysis among patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES. Following successful PCI and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion. The primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)]. RESULTS: Among enrolled participants (N = 9,006), 653 were treated exclusively with the SYNERGY BP-DES and 6,404 with a comparator DP-DES. Over 15 months, TLF rates were 6.4 and 6.1% among those receiving a SYNERGY BP-DES and a DP-DES, respectively (adjusted HR 0.93; 95% CI 0.64-1.35; p = .72). The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both pint > .10). CONCLUSIONS: The safety and efficacy profile of the SYNERGY BP-DES is comparable to that of contemporary DP-DES in high-risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving SYNERGY BP-DES or DP-DES.

Comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study.

OBJECTIVES: This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS). BACKGROUND: Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS. METHODS: In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated. RESULTS: A total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), pnon-inferiority  = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 µm versus 67.2 ± 33.9 µm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005). CONCLUSIONS: Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Five-Year Outcomes of Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Durable Polymer Drug-Eluting Stents: a Meta-Analysis of Randomized Controlled Trials.

PURPOSE: We investigated the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) versus second-generation durable polymer drug-eluting stents (DP-DES) in a follow-up period of 5 years. METHODS: A meta-analysis was performed using data from the PubMed, EMBASE, and Cochrane Library databases. The primary endpoint was target lesion failure (TLF), a composite endpoint of safety and efficacy, which included cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR). Secondary endpoints were all-cause death, MI, TLR, definite or probable stent thrombosis (ST), and definite or probable very late ST. In addition, we performed subgroup analyses based on patient and stent characteristics. RESULTS: Nine randomized controlled trials (RCTs) in 11,817 patients were included in the meta-analysis. Compared with second-generation DP-DES, BP-DES was not associated with increased risk of TLF (odds ratio (OR) 1.06, 95 % confidence interval [CI] 0.94-1.20; p = 0.33), all-cause death (OR 1.04, [0.92-1.18], p = 0.49), myocardial infarction (OR 0.97, [0.83-1.13], p = 0.67), target lesion revascularization (OR 1.08, [0.94-1.23], p = 0.27), definite or probable stent thrombosis (OR 0.85, [0.66-1.11], p = 0.24), or definite or probable very late stent thrombosis (OR 0.86, [0.58-1.26],p = 0.43). Furthermore, the subgroup analyses did not reveal any statistically significant differences between the stent groups. CONCLUSION: At 5 years of follow-up, the safety and efficacy of BP-DES are clinically comparable to those of second-generation DP-DES.

Randomized comparison of novel biodegradable polymer and durable polymer-coated cobalt-chromium sirolimus-eluting stents: Three-Year Outcomes of the I-LOVE-IT 2 Trial.

OBJECTIVES: We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial. BACKGROUNDS: Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited. METHODS: A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization. RESULTS: A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms. CONCLUSIONS: In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.

Polymer-free versus permanent polymer-coated drug eluting stents for the treatment of coronary artery disease: A meta-analysis of randomized trials.

BACKGROUND: Polymer-free drug eluting stents (PF-DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer-coated DES (PP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES remaining unknown. We performed a meta-analysis of randomized trials assessing outcomes of patients receiving PF-DES versus PP-DES for treatment of coronary artery disease (CAD). METHODS: Electronic searches were performed for randomized trials comparing outcomes between PF-DES and PP-DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all-cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow-up and landmarked beyond 1-year. RESULTS: Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF-DES and PP-DES at longest follow-up (Odds Ratio [OR] 0.96, 95%CI 0.85-1.10, P = 0.59) or landmark analysis beyond 1-year (OR 0.96, 95%CI 0.76-1.20, P = 0.70). Although PF-DES were associated with a significant reduction in all-cause death (OR 0.85, 95%CI 0.72-1.00, P < 0.05), this effect was not present on landmark analysis beyond 1-year (OR 0.89, 95%CI 0.73-1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77-1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54-1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91-1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88-1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI -0.08 to 0.11, P = 0.76). CONCLUSIONS: PF-DES are as safe and efficacious as PP-DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial.

PURPOSE: Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES. METHODS: Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year. RESULTS: Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54-1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61-1.39], p = 0.69) and other secondary endpoints. CONCLUSIONS: At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.

Safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer drug-eluting stents: a meta-analysis of randomized trials.

BACKGROUND: The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs). METHODS: Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model. RESULTS: Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62-0.98; I2 = 0%; 10 fewer per 1000 [from 1 fewer to 18 fewer]; high quality) compared with the DP-DES. There was no significant difference between O-SES and DP-DES in the prevention of stent thrombosis (RR: 0.75; 95% CI: 0.52-1.08), cardiac death (RR: 0.93; 95% CI: 0.63-1.36), target lesion revascularization (RR 1.10, 95% CI 0.86-1.42) and target vessel revascularization (RR 0.97, 95% CI 0.78-1.21). CONCLUSION: Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.

Safety and efficacy profile of bioresorbable-polylactide-polymer-biolimus-A9-eluting stents versus durable-polymer-everolimus- and zotarolimus-eluting stents in patients with acute coronary syndrome.

BACKGROUND: Comparative data on long-term safety and efficacy of bioresorbable-polymer-BES versus durable-polymer-EES/ZES in ACS setting have hitherto been lacking. We sought to assess the safety and efficacy of bioresorbable-polymer-biolimus-A9-eluting stents (BES) compared with thin-strut-durable-polymer-everolimus- and zotarolimus-eluting stents (EES/ZES) in patients with acute coronary syndrome (ACS) undergoing PCI. METHODS AND RESULTS: Between 2007 and 2012, 1,547 patients were implanted with new-generation drug-eluting stents (DES). Out of these, 369 received BES and 1,178 EES/ZES. The primary endpoint was probable/definite stent thrombosis (ST) while the secondary endpoint was a composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR) and definite ST up to 5 years. As stent assignment was not random, we performed a propensity score matching (PSM), with 1:3 ratio, to account for potential confounders. Primary analysis demonstrated no significant differences between both groups for the primary endpoint of ST (BES vs. EES/ZES: 1.6% vs. 1.9%; mean-event-time = 1,797 days vs. 1,795 days, respectively; P = 0.75) and composite safety endpoint (BES vs. EES/ZES: 12.5% vs. 12.9%; mean-event-time = 1,631 days vs. 1,620 days, respectively; P = 0.88). Results regarding the 5-year-ST- and safety endpoint remained non-significant after PSM (P = 0.85, P = 0.56; respectively). After stratification based on cardiovascular risk, no difference regarding ST and composite outcome measure has been documented between both stent groups in high-risk- and low-risk patients. The type of stent did neither predict ST (HR 1.11, 95%CI 0.45-2.74, P = 0.82) nor composite safety endpoint (HR 0.93, 95%CI 0.67-1.30, P = 0.69). CONCLUSIONS: Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.

Comparison of long-term clinical outcomes of bioabsorbable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis.

BACKGROUND: One million individuals in the USA die from acute myocardial infarction (MI), which currently affects 3 million people globally. The available data about the early and late outcomes of both biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents exhibit inconsistency. We performed a meta-analysis comparing the safety and efficacy of BP-DES with DP-DES. METHODS: PubMed, Google Scholar, EMBASE, Cochrane, Ovid Medline, and Clinical Trials.gov databases were used to find out studies comparing BP-DES to DP-DES. All the analyses used the random-effects model. RESULTS: A total of 18 studies were incorporated in this meta-analysis that involved 28,874 patients, out of which 11,997 received the BP Stent, and the rest of 16,578 received the DP stent. Thorough analyses revealed that the risk of all-cause death was significantly higher in the BP-DES group (5.4% vs 2.7%) (RR 1.22, p 0.02) for two years or less than two-year follow-up. For studies with more than two years of follow-up, all-cause death was 9.07% (599/6603) in BP-DES and 9.47% (531/5602) in the DP-DES group but failed to achieve statistically significant levels (RR 0.97, p 0.58). CONCLUSIONS: The study revealed no clinically significant (P value was > 0.05) differences in all-cause death, cardiac death, target lesion revascularization (TLR), late stent thrombosis, device-oriented composite endpoint/target lesion failure (DOCE/TLF), myocardial infarction (MI), target vessel MI, target vessel revascularization (TVR), target vessel infarction (TVI) between BP-DES and DP-DES for more than two years of follow-up. Additionally, all-cause death was only outcomes which found to have a statistically significant difference for less than two years of follow-up, while remaining were statistically non-significant.

Clinical outcomes with biodegradable versus durable polymer drug-eluting stents in patients with ST-elevation myocardial infarction.

BACKGROUND: Coronary drug-eluting stents (DES) built with either durable (DP) or biodegradable (BP) polymeric coatings have been largely tested and are extensively available for routine use. However, their comparative performance remains an open question, particularly in more complex subsets of patients. AIMS: We evaluated the outcomes of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) using DP-DES versus BP-DES in a large multicenter real-world registry. METHODS: The population comprised patients with STEMI treated with pPCI within 12 h of symptoms onset. Those treated with more than one DES who received different polymer types were excluded. The final cohort for analysis was selected after propensity score matching (PSM), computed to generate similar groups of DP DES versus BP DES. Primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of total death, myocardial infarction and target lesion revascularization at 2 years. RESULTS: From January 2017 to April 2022, a total of 1527 STEMI patients underwent pPCI with a single DES type (587 DP-DES; 940 BP-DES). After PSM, 836 patients (418 patients in the DP-DES and 418 patients in the BP-DES groups), comprised the final study population. Both study groups had a similar baseline profile. Patients treated with BP-DES group had similar rates of MACE (15.3 % vs. 19.4 %, HR 0.69, 95 % CI 0.50-0.94, p = 0.022). Rates of target lesion revascularization was lower in BP DES group (0.7 % vs. 3.8 %, HR 0.17, 95 % CI 0.05-0.51, p = 0.006). CONCLUSION: In a cohort of STEMI patients submitted to pPCI, BP and DP DES had similar rates of the primary outcome. Patients treated with BP DES, however, had a decreased incidence of TLR at after 2-year follow-up.

Second-generation everolimus-eluting intracoronary stents: a comprehensive review of the clinical evidence.

Percutaneous coronary intervention with implantation of second-generation drug-eluting stents (DES) has emerged as a mainstay for the treatment of obstructive coronary artery disease given its beneficial impact on clinical outcomes in these patients. Everolimus-eluting stents (EES) are one of the most frequently implanted second-generation DES; their use for the treatment of a wide range of patients including those with complex coronary lesions is supported by compelling evidence. Although newer stent platforms such as biodegradable polymer DES may lower local vessel inflammation, their efficacy and safety have not yet surpassed that of Xience stents. This article summarizes the properties of the Xience family of EES and the evidence supporting their use across diverse patient demographics and coronary lesion morphologies.

Patients with coronary artery disease (CAD) often require treatment for symptoms caused by blockages in coronary arteries. In addition to medical therapy, available procedure options include either coronary artery bypass grafting, a major heart surgery or percutaneous coronary intervention (PCI) with stenting. PCI is a minimally invasive procedure where a metallic stent (a mesh made up of fine metallic network in a tube shape used to keep vessels open) is advanced over a wire through an artery to open the coronary artery blockage. Over the past few decades, improvements in procedure technique and stent material have made PCI a highly safe and efficacious procedure. A newer generation of stents, known as drug-eluting stents (DES), have been developed in which metallic struts are covered with a highly biocompatible polymer (a thin material coating over the metallic mesh) that releases drugs at the blockage site to prevent local cell growth in the vessel wall. Among the second-generation DES, Xience everolimus-eluting stents (EES) have shown better outcomes compared with earlier generations of stents. Another version of DES with biodegradable polymer coating is emerging but their advantage over EES remains uncertain. Currently, Xience EES are one of the most commonly used stents to treat CAD. This manuscript covers an in-depth review of clinical evidence on the performance of Xience stents in a diverse range patient populations.

Comparison of endothelial shear stress between ultrathin strut bioresorbable polymer drug-eluting stent vs durable-polymer drug-eluting stent post-stent implantation: An optical coherence tomography substudy from BIOFLOW II.

BACKGROUND: Recent clinical data indicate a different performance of biodegradable polymer (BP)-drug eluting stent (DES) compared to durable polymer (DP)-DES. Whether this can be explained by a beneficial impact of BP-DES stent design on the local hemodynamic forces distribution remains unclear. OBJECTIVES: To compare endothelial shear stress (ESS) distribution after implantation of ultrathin (us) BP-DES and DP-DES and examine the association between ESS and neointimal thickness (NIT) distribution in the two devices at 9 months follow up. METHODS AND RESULTS: We retrospectively identified patients from the BIOFLOW II trial that had undergone OCT imaging. OCT data were utilized to reconstruct the surface of the stented segment at baseline and 9 months follow-up, simulate blood flow, and measure ESS and NIT in the stented segment. The patients were divided into 3 groups depending on whether DP-DES (N = 8, n = 56,160 sectors), BP-DES with a stent diameter of >3 mm (strut thickness of 80 µm, N = 6, n = 36,504 sectors), or BP-DES with a stent diameter of ≤3 mm (strut thickness of 60 µm, N = 8, n = 50,040 sectors) were used for treatment. The ESS, and NIT distribution and the association of these two variables were estimated and compared among the 3 groups. RESULTS: In the DP-DES group mean NIT was 0.18 ± 0.17 mm and ESS 1.68 ± 1.66 Pa; for the BP-DES ≤3 mm group the NIT was 0.17 ± 0.11 mm and ESS 1.49 ± 1.24 Pa and for the BP-DES >3 mm group 0.20 ± 0.23 mm and 1.42 ± 1.24 Pa respectively (p < 0.001 for both NIT and ESS comparisons across groups). A negative correlation between NIT and baseline ESS was found, the correlation coefficient for all the stented segments was -0.33, p < 0.001. CONCLUSION: In this OCT sub-study of the BIOFLOW II trial, the NIT was statistically different between groups of patients treated with BP-DES and DP-DES. In addition, regions of low ESS were associated with increased NIT in all studied devices.