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Background Invasive angiography with subsequent revascularization is a widely used treatment method in patients with coronary heart disease. Although biodegradable polymer drug eluting stents (BP-DES) have been used for almost a decade now, clinical trials regarding their long-term outcomes are both sparse and inconsistent. We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with BP-DES versus durable polymer drug eluting stents (DP-DES). Methods Among 11,517 PCIs with second generation drug eluting stents preformed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was the composite of all-cause mortality, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and coronary artery bypass grafting (CABG). Propensity score matching was used to create a well-balanced cohort. Results Mean follow up was 4.8 years. Of the 3,413 matched pairs, 21% were females, and the mean age was 66. At one year, the primary outcome occurred in 9.6% patients versus 8.3% (p=0.05), and TVR rate was 4.1% versus 3% (p=0.005) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in in 24.9% versus 24.8% (p=0.83), and the rate of TVR was 9.8% versus 9.1% (p=0.07) in patients with DP-DES and BP-DES respectively. Conclusions Similar rates of the composite outcome were observed throughout the entire follow-up. TVR rates were lower in the DP-DES group at 1-year but equalized within 5 years. Funding Acknowledgement Type of funding sources: None.

Background Polymer-free (PF) stents were designed as an alternative to durable-polymer (DP) drug-eluting stents to minimize the time on dual antiplatelet treatment for patients at high-risk of bleeding. Nonetheless, the efficacy and safety of PF vs. DP stents in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Methods We performed a metanalysis with currently available studies that assessed the effect of PF-stents vs. DP-stents after performing a systematic search. The endpoints analyzed were all-cause death, myocardial infarction, target lesion revascularization (TLR) and probable or definite stent thrombosis. The raw numbers of incident end-points reported in each study were used. We performed analyses in short and long term (1 year follow-up) studies. Results We included 12464 patients from 8 studies (5 short-term and 3 long-term): 6723 treated with PF-stents and 5741 with DP stents. Females represented 23.3% (n=3284) and 33.7% (n=4202) were included in the setting of acute coronary syndromes. As shown in the figure, PF-stents were associated to lower incidence of all-cause mortality (HR: 0.91 95% CI 0.84–0.98; p=0.016) and TLR (HR: 0.88 95% CI 0.80–0.96; p=0.003). No differences were observed in the risk of cardiovascular death (HR: 0.96 95% CI 0.86–1.06 p=0.415), myocardial infarction (HR: 0.90 95% CI 0.80–1.01; p=0.061) or probable-definite stent thrombosis (HR: 0.92 95% CI 0.74–1.14; p=0.447). Finally, no differences in the primary end-point (HR: 0.92 95% CI 0.83–1.03; p=0.143) were detected with PF-stents vs. DP-stents. No significant heterogenicity was observed in any of the endpoints, except for the incidence of stent thrombosis. Conclusions Under current PCI techniques the use of PF-stent might be associated to better outcomes, especially in terms of all-cause mortality and TLR. Funding Acknowledgement Type of funding sources: None.

Background Biodegradable polymer drug-eluting stents (BP-DES) has been developed to overcome the potential drawbacks of the first-generation durable polymer drug-eluting stents (DP-DES). However, it is still under debate whether BP-DES is associated with superior efficacy and safety over DP-DES. Purpose We sought to compare the effects of BP-DES and DP-DES in patients with coronary artery disease. Methods We performed systematic review and a meta-analysis of randomized controlled trials comparing BP-DES and DP-DES on clinical outcomes in patients with coronary artery disease using CE-mark approved drug-eluting stents (DES) with at least 1-year follow-up. We included 32 studies involving 39,686 patients (BP-DES: 21,439 patients, and DP-DES: 18,247 patients). Primary outcome measure was target vessel failure (TVF; equivalent to the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization). We performed subgroup analysis according to the DP-DES generations (newer-generation DP-DES: 15,179patients, and first-generation DP-DES: 3,068 patients), and the effects of newer-generation DP-DES was compared with the BP-DES according to the BP-DES strut thickness (Ultra-thin strut [ Results The odds for TVF was not significantly different between the BP-DES group and the DP-DES group in the entire study population (odds ratio [OR] 0.96, 95% confidence interval [CI] [0.90–1.02], P=0.20). The odds for TVF was significantly low in the BP-DES group relative to the first-generation DP-DES group, however the odds were comparable between the BP-DES group and the newer-generation DP-DES group (BP-DES versus first-generation DP-DES: OR 0.82, 95% CI [0.73–0.92], P Conclusions In this meta-analysis of randomized controlled trials evaluating clinical outcomes, there was no significant differences between BP-DES and DP-DES. We found beneficial effects of BP-DES relative to the first-generation DP-DES, however, there was no statistical differences between BP-DES and newer-generation DP-DES, irrespective of the BP-DES strut thickness. Pooled odds ratios for clinical outcomes Funding Acknowledgement Type of funding source: None

Background Orsiro ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) might facilitate early vascular healing responses that seems to be associated with improved long-term clinical outcomes. We compared the early vascular healing responses to BP-SES and Xience durable-polymer everolimus-eluting stent (DP-EES) in patients with chronic coronary syndrome (CCS) using optical coherence tomography (OCT). Methods A total of 40 patients with CCS receiving OCT-guided PCI were included. 20 patients were assigned to BP-SES, and 20 to DP-EES. OCT was performed immediately after stent placement (post-procedure) and at 1 month follow-up. Struts were recorded as uncovered if any part was visibly exposed in the lumen or covered if a layer of tissue covered all reflecting surfaces. The incidence of intrastent thrombus (IS-Th) and irregular protrusion (IRP) were also assessed. Results At 1 month, the percentage of uncovered struts was significantly lower in the BP-SES compared with the DP-EES (2.8±1.6% vs. 5.8±1.8%, respectively; p Conclusion Early vascular healing response to Orsiro BP-SES implantation was revealed in CCS patients at 1 month compared with Xience DP-EES. Orsiro BP-SES may have a potential to shorten the dual antiplatelet therapy duration. Funding Acknowledgement Type of funding source: None

Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland

Background It is yet to be known whether mechanisms underlying restenosis in newer-generation durable-polymer (DP) and biodegradable-polymer (BP) drug-eluting stents (DES) are different. Purpose This study aims to assess the incidences and predictors of early restenosis and late catch-up phenomenon after newer-generation durable-polymer (DP) and biodegradable-polymer (BP) DES. Methods Between 2010 and 2017, 13858 lesions in 6350 patients were treated with DES (4393 BP-DES, 9465 DP-DES). The early-term (within 1 year) and late-term (from 1 to 2 years) follow-up angiographies were scheduled. Late catch-up phenomenon was defined as in-stent restenosis (ISR) in lesions that evaded ISR within 1 year after stent implantation. ISR was defined as angiographic restenosis of more than 50%. Results The mean patient age was 71 years, and 76.7% were male. Early-term angiographies were performed in 10955 lesions (79.0%). Of those without early-term ISR, late-term angiographies were performed in 7771 lesions (56.1%). The incidences of mid-term restenosis and late catch-up phenomenon were 6.6% and 3.9%, respectively. In the multivariate regression analyses, history of diabetes, hemodialysis and previous PCI were independent predictors of both early restenosis and late catch-up phenomenon. Also, some lesion characteristics such as chronic total occlusion, right coronary artery ostial lesion, small vessel (defined as reference diameter 30mm) and treatment of ISR lesion were independent predictors of both early restenosis and late catch-up phenomenon. Bifurcation lesion and heavily calcified lesion treated with rotablator were independent risk of early restenosis. Bypass graft lesion was an independent predictor of late catch-up phenomenon. Early restenosis was observed less frequently in DP-DES than in BP-DES (6.3% versus 7.4%, P=0.012). On the contrary, late catch-up phenomenon was observed more frequently in DP-DES than in BP-DES (4.3% versus 2.9%, P=0.026). Conclusions Some lesion characteristics were independent predictors of early restenosis and late catch-up phenomenon after newer-generation DES implantation. The deployment of BP-DES resulted in more early restenosis and less late catch-up phenomenon compared to that of DP-DES. Early Restenosis and Late Catch-Up Funding Acknowledgement Type of funding source: None

Background New-generation biodegradable-polymer platinum chromium everolimus-eluting stent (BP-PtCr-EES) is available, which has different polymer and alloy compare to more established stent design, a durable-polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES). Purpose To compare neointimal coverage (NIC) between BP-PtCr-EES and DP-CoCr-EES by using coronary angioscopy (CAS). Methods A total of 36 patients (44 stents) with BP-PtCr-EES or DP-CoCr-EES who underwent CAS at 1 year after stenting were investigated. We compared angioscopic findings assessed by angioscopy between BP-PtCr-EES (n=18) and DP-CoCr-EES (n=26). NIC grade and yellow plaque grade (YPG) was adopted from earlier reports from grade 0 to 3. We determined maximum (max-) and minimum (min-) NIC grade and heterogeneity score (HGS = max NIC grade minus min NIC grade). We also assessed YPG and the presence of thrombus (TH). Results Six lesions (33.3%) in BP-PtCr-EES group and 7 (26.9%) lesions in DP-CoCr-EES group were culprit lesions of acute coronary syndrome, which did not statistically differ between the two groups (p=0.74). And there were no significant differences in stent diameter (BP-PtCr-EES: 2.97±0.39 mm vs DP-CoCr-EES: 3.14±0.45 mm, p=0.22) and length (BP-PtCr-EES: 26.9±7.9 mm vs DP-CoCr-EES: 28.4±8.0 mm, p=0.54). In terms of CAS findings, BP-PtCr-EES group has better neointimal coverage than DP-CoCr-EES group (max NIC grade: 2.6±0.7 vs 2.0±0.9, p=0.01. min NIC grade: 1.1±0.8 vs 0.5±0.5, p Conclusion Superior neointimal coverage and less YPG or TH were observed by CAS in the BP-PtCr-EES group at 1 year after stenting. Clinical significance was still unknown because of no clinical events in both groups. Prospective and large populations studies may be required. Funding Acknowledgement Type of funding source: None

Background Bioabsorbable polymer drug eluting stents (BP-DESs) were designed to reduce a vascular inflammatory reaction compared to durable polymer drug eluting stents (DP-DESs). However, few studies have compared vascular responses to BP-DESs and DP-DESs. Methods We enrolled 88 consecutive patients with single culprit coronary artery lesions (31 lesions with acute coronary syndrome) undergoing a single stent-implantation. BP-DESs and DP-DESs were implanted in 50 (57%) and 38 patients (43%), respectively. All lesions underwent optical coherence tomography examination at chronic phase and intrastent OCT findings at the follow-up were evaluated in every 1-mm cross-sections (CSs). Results A total of 1887 CSs (BP-DES: 1096, DP-DES: 791) were analyzed. The median period of follow-up OCT was 293 (250–374) days. There were no differences in the patient, lesion, and initial clinical presentation of acute coronary syndrome (ACS). BP-DESs had significantly higher percent neointimal hyperplasia area, defined as neointimal hyperplasia area divided by stent area x 100 (18.4±9.0% vs. 16.1±9.9%, p Conclusion BP-DESs showed homogenous neointimal growth and complete stent coverage quantitatively. Meanwhile, the significant relationships of BP-DES with LIN may suggest that the neointimal quality remains immature in BP-DESs in this period. Funding Acknowledgement Type of funding source: None

Background Data regarding clinical outcomes of biodegradable polymer drug-eluting stent (BP-DES) versus second-generation durable polymer drug-eluting stent (DP-DES) in patients undergoing percutaneous coronary intervention (PCI) are inconclusive. Purpose We aimed to perform a meta-analysis to investigate the clinical outcomes of BP-DES compared with second-generation DP-DES in patients who have undergone PCI. Methods We searched PubMed, MEDLINE, EMBASE, and Cochrane databases through January 2019 for randomized controlled trials comparing BP-DES with second-generation DP-DES in patients treated with PCI. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite/probable stent thrombosis (ST) were compared between the groups. Additionally, a landmark analysis with the landmark set at 1 year and a subgroup analysis according to stent characteristics were performed. Results Data from 23 trials including 28802 randomized patients were analyzed. At a median follow up of 3.1 years, no significant differences were found in terms of all-cause death (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.95–1.16), cardiac death (OR 1.01, 95% CI 0.87–1.17), MI (OR 0.92, 95% CI 0.82–1.03), TVR (OR 0.97, 95% CI 0.86–1.11), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.86, 95% CI 0.70–1.07) between the groups. Landmark analysis showed that there were similar risks in all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.92, 95% CI 0.67–1.28) between the groups. The similar tendency of any study endpoints between the groups was consistent in the subgroup, including stent platform (stainless steel vs. alloy), the drug coating distribution (abluminal vs. circumferential), the polymer degradation period (6 months), or the drug release duration (6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the uses of BP-DES with sirolimus-eluting (OR 0.84, 95% CI 0.72–0.98) or ultrathin strut (defined as Clinical outcomes Conclusions In our updated meta-analysis, BP-DES implantation was associated with comparable clinical outcomes compared with second-generation DP-DES implantation. However, PCI with ultrathin biodegradable polymer sirolimus-eluting stent could reduce the risk of MI.

Background Patients with diabetes mellitus (DM) remain at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with non-diabetic individuals. Among available drug-eluting stents (DES), thin-strut durable polymer everolimus-eluting stents (DP-EES) were shown to provide the best safety and efficacy profile in diabetics. Whether biodegradable polymer DES provide additional long-term clinical benefit compared with DP-EES among diabetic patients remains uncertain. Purpose To compare the long-term performance of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus DP-EES for PCI in patients with insulin-requiring and non-insulin-requiring DM. Methods We performed a prespecified subgroup analysis of the randomized, multicenter, non-inferiority BIOSCIENCE trial (NCT01443104). Patients with stable coronary artery disease or acute coronary syndrome were randomly assigned to treatment with ultrathin-strut BP-SES or thin-strut DP-EES. Patients were further divided according to diabetic status. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (MI) and clinically-indicated target lesion revascularization (TLR), within 12 months. Results Among 2'119 patients enrolled between March 2012 and May 2013, 486 (22.9%) presented with DM (insulin-requiring, 33.1%). Compared with non-diabetics, patients with DM were older and had a greater baseline cardiac risk profile, including higher prevalence of hypertension, hypercholesterolaemia, peripheral artery disease, chronic renal failure and prior PCI, coronary artery bypass graft surgery, or stroke. At 5 years, TLF occurred similarly in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (RR 1.23; 95% CI 0.87–1.73; p=0.24) in diabetics, and in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (RR 0.98; 95% CI 0.77–1.26; p=0.90) in non-diabetics (p for interaction=0.31). Cumulative incidences of cardiac death (14.9% vs. 9.5%; p=0.10), target-vessel MI (11.4% vs. 11.0%; p=0.81), clinically-indicated TLR (16.9% vs. 15.8%; p=0.68), and definite thrombosis (3.0% vs. 2.5%; p=0.63) at 5 years were similar among diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusion In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout five years between diabetic patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Acknowledgement/Funding BIOSCIENCE was an investigator-initiated trial supported by a dedicated research grant from Biotronik, Bülach, Switzerland

Background Polymer-free biolimus A9-coated stent (DCS) has currently emerged as expected better arterial healing compared to durable polymer drug-eluting stent (DP-DES). However, superiority of DCS on arterial healing over DP-DES has not been well elucidated using intracoronary images. Methods This study examined 288 stents in 224 patients with de novo coronary artery lesions. We angioscopically compared 55 DCS from 35 patients with 233 DP-DES from 189 patients 10±2 months after the implantation. We assessed thrombus adhesion, which is a marker of incomplete re-endothelialization. Dominant neointimal coverage (NIC) grade, heterogeneity of NIC and maximum yellow color of plaque underneath the stent were also evaluated. Neointimal coverage was graded as follows: grade 0, stent struts exposed; grade 1, struts bulged into the lumen, although covered; grade 2, struts embedded by the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was judged as heterogeneous when differences in the NIC grade became apparent. Yellow plaque was graded as follows: grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Thrombus adhesion was similar between DCS and DP-DES (29% versus 23%, P=0.32). Dominant NIC was greater in DCS than in BP-DES (P Conclusion DCS provided similar thrombus adhesion to DP-DES, which suggested similar re-endothelialization 10 months after implantation. However, DCS showed thick and heterogeneous NIC compared to DP-DES. The specific feature of polymer-free and Biolimus A9 would cause the difference, and further investigation is necessary to evaluate the longer-term safety and efficacy. Acknowledgement/Funding None

Background Over the last decade, drug-eluting stents (DES) have undergone substantial modifications with thinner struts and more biocompatible durable polymer (DP) or biodegradable polymer (BP). In DP-based DES, after drug elusion has been completed, DP remnants may trigger of local inflammatory vascular reactions and promote delayed healing, leading to accelerated neoatherosclerosis (NA). Thus, BPs have been developed to reduce the above-mentioned risks. Recently, poor strut coverage and in-stent NA are increasingly recognized the cause of late stent failure, but it is unclear whether BPs can reduce the incidence of NA and the poor stent coverage as compared to DPs. Objectives The purpose of this study was to compare the incidence of NA and the stent coverage using optical coherence tomography (OCT) between the DPs and the BPs. Methods Between July 2016 and April 2018, 127 consecutive patients with new-generation DES who underwent 8-month follow up OCT imaging were enrolled. Patients were divided into the two groups: DP group who had the new-generation durable polymer everolimus-eluting and zotarolimus-eluting stents and BP group who had the new-generation biodegradable polymer sirolimus-eluting and everolimus-eluting stents. We compared patient characteristics including hypertension, dyslipidemia and diabetes mellitus and 8-month follow up OCT findings including NA, uncovered struts and malapposed struts between the two groups. Results The DP group comprised 64 patients (50.4%. The incidence of NA, uncovered struts and malapposed struts were similar between the two groups (DPs vs BPs, 1.56% vs 7.94%, P=0.11; 7.80% vs 5.88%, P=0.16 and 2.76% vs 2.01%, P=0.43, respectively) (table). The other parameters were also similar between the two groups. Table 1 DP group (n=64) BP group (n=63) P value Hypertension 44 (68.8%) 50 (79.4%) 0.2251 Dyslipidemia 39 (60.9%) 37 (58.7%) 0.8573 Diabetes mellitus 25 (39.1%) 30 (47.6%) 0.3731 8 month OCT follow up findings Neoatherosclerosis 1 (1.6%) 5 (7.9%) 0.1147 Uncovered struts 7.8% (2.8–20.4) 5.9% (0.7–16.7) 0.1616 Malapposed struts 0.2% (0–2.8) 0% (0–2.8) 0.4392 Conclusions The new-generation DP based-DES may have similar effects on vascular response compared to the new-generation BP-based DES during 8-month follow-up period.

Background and introduction Diabetic patients are at high risk of adverse cardiovascular events after percutaneous coronary intervention (PCI) even with durable polymer drug-eluting stents. A biodegradable polymer everolimus-eluting stents (BP-EES) might improve clinical outcomes in patients with diabetes mellitus. Purpose This study aimed to compare the mid-term clinical outcomes between BP-EES and durable polymer everolimus-eluting stents (DP-EES) in diabetic patients. Methods We investigated consecutive 383 patients treated with BP-EES or DP-EES at our Heart Center between January and December 2016. Among these patients, 155 (40.5%) patients had diabetes mellitus. The primary endpoint was 3-year cumulative incidence of target lesion failure (TLF) defined as target vessel-related myocardial infarction (MI) and clinical-driven target lesion revascularization (TLR). Moreover, the incidence of definite stent thrombosis (ST) was also evaluated. Results After propensity score matching, 148 patients were divided into 2 groups (BP-EES; N=74, DP-EES; N=74). The 3-year cumulative incidences of TLF were significantly lower in BP-EES group than in DP-EES group (BP-EES vs. DP-EES; 1.4% vs. 11.4%, p=0.01). The incidence of cardiac death, target vessel-related MI, and definite ST were none in the both group. Figure 1 Conclusions In diabetic patients, the incidence of TLR within 3 years was significantly lower in BP-EES than in DP-EES. In PCI for diabetic patients, BP-EES might improve clinical outcomes compared to DP-EES.

Background The true benefit of biodegradable polymer drug-eluting stent (BP-DES) over second-generation durable polymer drug-eluting stent (DP-DES) expected to be represented during late period of follow-up after percutaneous coronary intervention (PCI), but prior meta-analysis only evaluated short-term outcomes. Purpose We aimed to compare the long-term clinical outcomes after PCI with BP-DES versus second-generation DP-DES by a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing BP-DES with second-generation DP-DES implantations were searched through PubMed, MEDLINE, EMBASE, and Cochrane databases. All-cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), and definite/probable stent thrombosis (ST) were compared between the groups. In addition, a landmark analysis with the landmark set at 1-year and a subgroup analysis based on stent characteristics were performed. Results Fifteen trials that included a total of 21311 randomized patients with at least 2 years follow-up were analyzed. At a median follow-up of 4.2 years, no significant differences in the risks of all-cause death (odds ratio [OR] 1.03, 95% confidence interval [CI] 0.94–1.14), cardiac death (OR 1.03, 95% CI 0.88–1.20), MI (OR 0.90, 95% CI 0.79–1.01), TVR (OR 0.96, 95% CI 0.82–1.12), TLR (OR 0.97, 95% CI 0.85–1.11), and definite/probable ST (OR 0.84, 95% CI 0.67–1.05) were found between the groups. In the 1-year landmark analysis, the rates of all-cause death (OR 1.04, 95% CI 0.93–1.17), cardiac death (OR 1.11, 95% CI 0.92–1.36), MI (OR 0.94, 95% CI 0.79–1.13), TVR (OR 0.95, 95% CI 0.73–1.23), TLR (OR 1.00, 95% CI 0.80–1.24), and definite/probable ST (OR 0.94, 95% CI 0.67–1.31) were similar between the groups. There were comparable rates of any study endpoints between the groups regardless of stent platform (stainless steel vs. alloy), the polymer degradation period (6 months) or the drug release duration (6 months) of BP-DES, or the DAPT duration (≥6 months vs. ≥12 months). However, the use of BP-DES with sirolimus eluting (OR 0.82, 95% CI 0.70–0.97), circumferential drug distribution (OR 0.79, 95% CI 0.65–0.96), thin strut (defined as Clinical outcomes Conclusions In this meta-analysis, long-term clinical outcomes were equivalent between BP-DES and second-generation DP-DES implantations. However, among BP-DESs, the improved risks of MI in those with sirolimus eluting, circumferential drug distribution, thin strut, or ultrathin strut and decreased rates of TVR in those with circumferential drug distribution were noted.

Background Biodegradable polymer drug-eluting stent (BP-DES) has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) for patients presenting coronary artery disease (CAD). Although BP-DES showed non-inferior safety and efficacy to durable polymer DES (DP-DES) in several randomized clinical trials, hemodialysis (HD) patients, who have been well known as high risk population for adverse events, were excluded in the most of trials. Therefore, there are limited data comparing the clinical outcomes between BP-DES and DP-DES in HD patients with CAD after PCI. Purpose The purpose of this study was to investigate clinical outcomes in HD patients after BP-DES implantation compared with those after DP-DES implantation. Methods We retrospectively analyzed 234 HD patients (male 74%, mean age 71±10 years) undergoing PCI for 404 lesions with 472 DESs (71 patients for 138 lesions with 170 BP-DESs [91 Ultimaster and 79 Synergy] and 163 HD patients for 266 lesions with 302 DP-DESs [219 Xience, 53 Promus and 30 Resolute]) from 2011 to 2017. Two-year clinical outcomes were compared between BP-DES group and DP-DES group. The primary outcome measure was the incidence of target lesion revascularization (TLR), while the secondary outcome measures were the occurrence of cardiac death (CD), stent thrombosis (ST), myocardial infraction (MI), target vessel revascularization (TVR), non-TVR and major adverse cardiac event (MACE) defined as a composite of CD, MI, and TVR. Outcome measures were estimated by the Kaplan-Meier method and the differences between BP-DES group and DP-DES group were assessed by the log-rank test. We also conducted Cox's proportional hazard model to identify predictors for TLR occurrence. Results Baseline patient and lesion characteristics were similar between the two groups. The two-year incidence of TLR was not significantly different between BP-DES group and DP-DES group (14.1% vs. 22.2%, p=0.391). The two-year incidences of CD (17.3% vs. 17.5%, p=0.381), ST (0% vs. 3.9%, p=0.133), MI (4.2% vs. 5.8%, p=0.965), TVR (21.3% vs. 27.5%, p=0.586), non-TVR (26.1% vs. 31.3%, p=0.439) and MACE (41.1% vs. 42.6%, p=0.526) were also not different between the two groups. After multivariate analysis, diabetes mellitus (hazard ratio 1.97; 95% confidence interval 1.03–3.78, p=0.004) was independently associated with TLR occurrence in HD patients. Two-year clinical outcomes of HD patient Conclusions At two-year follow-up after PCI, BP-DES had comparable safety and efficacy profiles to DP-DES in HD patients presenting CAD. Acknowledgement/Funding None

Background: Progress in the platforms for DES is aimed at improving safety and outcomes. Second-generation DESs have a biocompatible durable polymer (DP), in addition to bioabsorbable polymers (BP). The benefit of BP is to remove the polymer-triggered inflammatory stimulation associated with DP. There is evidence to suggest BP-DESs are non-inferior to the current generation DES at 12 months. The time course for polymer absorption varies between stents and may take from 4 to 15 months. Hence the potential benefits of BP-DES over DP-DES can only be tested over a longer period, to overcome the time taken for polymer absorption. Purpose: The purpose of the meta-analysis was to compare the safety and efficacy outcomes of BP-DES over a long-term follow-up. Methods: A thorough computer-based search using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases was conducted up to 11 November 2017. We only included randomised studies (RCT) comparing clinical outcomes between the BP-DESs and DP-DESs. Only studies where data were available for a minimum of 5 years were included. Safety (Stent thrombosis (ST) and reinfarction) and efficacy (target lesion revascularization (TLR), cardiac mortality) were analysed. Results: The literature search yielded 445 citations. After going through the abstracts and full-texts of the articles we included 5 RCTs where 5-year follow-up data was available. The information about the included studies, stent platform, drug and type of polymer is provided in Table 1.There was no difference in the ST (OR 0.71, 95% CI 0.47 –1.09, I2 = 31%, P=0.12), reinfarction (OR 1.01, 95% CI 0.85 –1.21, I2 = 0%, P=0.89), cardiac mortality (OR 1.00, 95% CI 0.81 –1.23, I2 = 0%, P=0.98), all cause mortality (OR 0.95, 95% CI 0.80 –1.14, I2 = 21%, P=0.61) and TLR (OR 0.80, 95% CI 0.58–1.11, I2 = 68%, P=0.18). Furthermore, there was no difference in the very late ST (OR 0.49, 95% CI 0.19 –1.30, I2 = 56%, P=0.15).

This editorial refers to ‘Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial’[†][1], by M. Sabate et al ., on page 229. Bioresorbable stents (BRS) represent a disruptive technology with potential for improving long-term outcomes after percutaneous intervention.1 The principal advantage of BRS compared with conventional metallic stent technology is that the device is broken down by the body after its useful function has been served, potentially restoring normal vessel anatomy over the long term and ameliorating the risk of late adverse events in the treated arterial segment.2 Two such devices have received CE mark approval for use; both are based on polylactic acid stent backbones: the everolimus-eluting Absorb stent (Abbott Vascular, Abbott Park, IL, USA) in 2011 and the novolimus-eluting DESolve stent (Elixir Medical, Sunnyvale, CA, USA) in 2013. However, current approval processes leading to CE mark are based on conformity testing (i.e. performance as intended) and assessment of safety, and generally do not require comparative efficacy assessment against existing devices.3 In fact, BRS are generally more challenging to implant in comparison with metallic stents, and careful patient and lesion selection is crucial to ensuring good results with this technology.4 Moreover, clinical experience with these devices remains rather limited, and further comparative efficacy data are required before we can be sure of the place of these devices in day-to-day practice. Encouraging results have been reported with the Absorb BRS compared with conventional metallic drug-eluting stents (DES) in small randomized trials enrolling patients presenting with stable or unstable angina.5, … [1]: #fn-2