Durable Polymer Drug-eluting Stents Research Articles

COMPARISON OF LONG-TERM OUTCOMES WITH BIODEGRADABLE POLYMER DRUG ELUTING STENTS AND DURABLE POLYMER DRUG ELUTING STENTS: AN UPDATED META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Long term outcomes of biodegradable polymer drug-eluting stents (BP-DES) compared to durable polymer drug-eluting stents (DP-DES), are not well described. A comprehensive search in clinicalTrials.gov, PubMed, EBSCO, Web of Science, google scholar and Ovid was performed for RCTs comparing BP-DES and

Comparison of 9-Month Angiographic Follow-Up and Long-Term Clinical Outcomes of Biodegradable Polymer Drug-Eluting Stents and Second-Generation Durable Polymer Drug-Eluting Stents in Patients Undergoing Single Coronary Artery Stenting.

The durable polymers (DP) used in first-generation drug-eluting stents (DESs) were associated with long-term cardiovascular events, and thus biodegradable polymer DESs (BP-DESs) and second-generation DP-DESs were designed to overcome this problem. In this study, we compared angiographic follow-up and long-term clinical outcomes between patients who received BP-DESs or second-generation DP-DESs. We enrolled 436 patients with single coronary lesions who received a second-generation DP-DES or BP-DES between June 2009 and October 2012. All patients received follow-up angiography when new clinical events developed or at 9 months after index stenting. All participants received follow-up for 5 years. There were no significant differences in patient and lesion characteristics between the two groups. The 9-month angiographic follow-up showed a lower net gain in the second-generation DP-DES group (2.19 mm vs. 2.41 mm, p = 0.040), but a similar binary restenosis rate between the two groups (5.4% vs. 8.7%, p = 0.276). During the 5-year follow-up period, no significant differences were observed between the two groups in major adverse cardiac events (MACEs), cardiovascular death, nonfatal myocardial infarction (MI), target vessel revascularization (TVR), all revascularization, stent thrombosis (ST), or MACE-free survival. No significant differences were observed in cardiovascular death, nonfatal MI, TVR, all revascularization, ST, or MACE-free survival between the patients undergoing single coronary artery stenting with BP-DESs and second-generation DP-DESs.

Polymer free drug-eluting stents versus durable polymer drug-eluting stents in elective percutaneous coronary interventions in patients with stable coronary artery disease patients

Abstract Aim To compare the inflammatory response of polymer-free versus permanent polymer drug-eluting stents in patients with stable coronary artery disease undergoing elective PCI, and the effect of this inflammatory response on the 6 month clinical outcomes. Methods This randomized prospective comparative study was conducted on 100 patients with stable coronary artery disease planned for elective PCI divided into 50 patients with deployed permanent polymer DES (PP-DES) groups and 50 patients with polymer free DES (PF-DES). Blood samples were taken to assess serum level of hsCRP before the procedure and the first day after the procedure. The target end points were the recurrence of effort angina, incidence of target lesion revascularization (TLR) over a period of 6 months and the inflammatory response by measuring the percentage of rise in hsCRP level. Results There was no statistically significant difference in the clinical outcome in the first six months between the patients who had PP-DES and the patients who had PF-DES regarding recurrence of effort angina (p-value = 0.822) and TLR (p-value = 0.727), with no patients developing myocardial infarction or stent thrombosis. There was a statistically significant inflammatory response after stent deployment in both groups represented by a significant rise in the serum level of hsCRP on the first day after the procedure in both groups (p-value < 0.001), but there was no statistically significant difference in the inflammatory response between PP-DES and PF-DES (p-value = 0.978). The number of patients having recurrence of anginal symptoms and TLR with hsCRP rise ≥ 11.36% was higher than those having the same with hsCRP < 11.36%. However, this difference was not statistically significant regarding recurrence of anginal symptoms (p = 0.057) and TLR (p = 0.092). Conclusion The PF-DES was proved to be non-inferior to PP-DES regarding the short-term clinical outcome and the early inflammatory response. It was concluded that the presence of polymeric coating in PP-DES did not add to the magnitude of the inflammatory response and it did not significantly increase the incidence of recurrence of anginal symptoms and TLR in this group of patients.

Three-year follow up of biodegradable polymer cobalt-chromium sirolimus-eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials.

To analyze the 3-year outcomes of the biodegradable polymer cobalt-chromium sirolimus-eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. Though approved by CFDA, the long-term safety and efficacy of EXCROSSAL is still unknown. CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3-year follow-up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) (all-cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3-year follow-up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi-lesion PCI, and multi-vessel disease. The 3-year follow-up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug-eluting stent.

P269 Mid-term clinical outcomes of biodegradable polymer everolimus-eluting stents compared with durable polymer everolimus-eluting stents: a propensity-matched study

Abstract Background Introduction: Several studies have reported that durable polymer drug-eluting stents could cause delayed healing and late catch-up. Although biodegradable polymer everolimus-eluting stents (BP-EES) might solve these problems, there is few data about mid-term clinical outcomes of BP-EES compared with durable polymer everolimus-eluting stents (DP-EES). Purpose This study aimed to compare mid-term clinical outcomes between BP-EES and DP-EES. Methods Between January to December 2016, 206 consecutive patients were treated with BP-EES and 177 consecutive patients were treated with DP-EES in our Heart Center. The primary endpoint was 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel-related myocardial infarction and clinical-driven target lesion revascularization. Moreover, clinical-driven target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated. Results After propensity score matching, 160 patients were selected in each group. At 3 years, the cumulative incidences of TLF were 4.1% in BP-EES group vs. 7.9% in DP-EES (p = 0.12). Similarly, those of clinical-driven TVR were not different between the 2 groups (10.9% vs. 8.0%, p = 0.39). The incidence of definite ST in BP-EES tended to be higher than in that of DP-EES (BP-EES vs. DP-EES; 0% vs. 1.8%, p = 0.06). Conclusions There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in mid-term. Abstract P269 Figure.

Long-Term Outcomes of Biodegradable Versus Second-Generation Durable Polymer Drug-Eluting Stent Implantations for Myocardial Infarction

ObjectivesThis study sought to compare outcomes between biodegradable polymer drug-eluting stent (BP-DES) and second-generation durable polymer drug-eluting stent (DP-DES) implantations for acute myocardial infarction (MI) using a nationwide dataset. BackgroundData regarding outcomes of BP-DES versus second-generation DP-DES are inconclusive. MethodsAmong 13,104 patients with acute MI in a nationwide registry who underwent percutaneous coronary intervention (November 2011 to December 2015), BP-DES and second-generation DP-DES were implanted in 2,261 (21.7%) and 8,182 patients (78.3%), respectively. Major adverse cardiac events (MACE) (all-cause death, recurrent MI, or any revascularization) were compared in multivariable Cox regression, propensity score (PS) matched, and underwent PS-adjusted analyses. ResultsMACE occurred in 1,492 (14.3%) patients during a median 723-day follow-up. MACE were less frequent with BP-DES implantation than with second-generation DP-DES implantation (entire cohort hazard ratio [HR]: 0.845; 95% confidence interval [CI]: 0.740 to 0.965; PS-matched HR: 0.669; 95% CI: 0.550 to 0.814). Risk of all-cause death (entire cohort HR: 0.831; 95% CI: 0.692 to 0.997; PS-matched HR: 0.752; 95% CI: 0.495 to 0.931), cardiac death (entire cohort HR: 0.685; 95% CI: 0.542 to 0.865; PS-matched HR: 0.613; 95% CI: 0.463 to 0.872), recurrent MI (entire cohort HR: 0.662; 95% CI: 0.466 to 0.941; PS-matched HR: 0.611; 95% CI: 0.427 to 0.898), and heart failure readmission (entire cohort HR: 0.625; 95% CI: 0.447 to 0.875; PS-matched HR: 0.584; 95% CI: 0.385 to 0.887) was less with BP-DES implantation. There were no significant group differences in the incidences of any revascularization, stroke, and definite or probable stent thrombosis. ConclusionsIn patients with acute MI who underwent percutaneous coronary intervention, BP-DES implantation is associated with improved outcomes compared with second-generation DP-DES implantation.

Comparison of efficacy and safety between ultrathin bioresorbable polymer sirolimus-eluting stents and thin durable polymer drug-eluting stents: a systematic review and meta-analysis of the literature.

Ultrathin bioresorbable polymer sirolimus-eluting stents (BP SES) have been proposed as an alternative to thin durable polymer drug-eluting stents (DP DES). Although BP SES show a significant decrease in target lesion failure rates, clear superiority with respect to efficacy and safety of BP SES in comparison to DP EES has not been consistently proven. A comprehensive search of several electronic databases identified studies that assessed efficacy and safety of BP SES, compared with DP EES. Relative risks (RRs) were pooled across studies using a fixed-effects model and a random-effect model, respectively, calculating pooled RRs and associated 95% confidence intervals (CIs). The I statistic was used to assess heterogeneity. We retrieved six studies enrolling >7000 patients. BP SES significantly reduced the risk of target vessel myocardial infarction (RR, 0.79; 95% CI, 0.64-0.97; I = 0%; Test for overall effect: z = 2.24, P = 0.03) in comparison with DP EES using a random-effects model. Use of BP SES was associated with a significant reduction in any myocardial infarction (RR, 0.83; 95% CI, 0.70-0.98; I = 12%; Test for overall effect: z = 2.19, P = 0.03), using a fixed-effects model. The subgroup analyses demonstrated, following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES (RR, 1.27; 95% CI, 1.01-1.60; I = 0%; Test for overall effect: z = 2.08, P = 0.04). No differences in cardiac death, stent thrombosis events (STE), target lesion revascularization (TLR) and target vessel revascularization (TVR) between BP SES and DP EES were observed. BP SES significantly reduced the risk of any myocardial infarction and target vessel myocardial infarction in comparison with DP EES. There were no differences in cardiac death, STE, TLR, TVR and all-cause death with its follow-up time <2 year between BP SES and DP EES. Following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES was observed.

P3386Angioscopic comparison between polymer-free biolimus A9-coated stent and durable polymer drug-eluting stent 10 months after the implantation

Abstract 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&lt;0.001), while NIC was more heterogeneous in DCS than in BP-DES (P=0.001, Figure). Maximum yellow color of stented segment was similar between DCS and DP-DES (P=0.09). 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

P6241Two-year clinical outcomes of biodegradable polymer versus durable polymer drug-eluting stent implantation in hemodialysis patients after percutaneous coronary intervention

Abstract 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

P2796Biodegradable polymer everolimus-eluting stents versus durable polymer everolimus-eluting stents in diabetic patients: a 3-year propensity-matched study

Abstract 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.

3334Updated meta-analysis of biodegradable polymer drug-eluting stent versus second-generation durable polymer drug-eluting stent implantations

Abstract 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 (&lt;6 months vs. &gt;6 months), or the drug release duration (&lt;6 months vs. &gt;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 &lt;70μm; OR 0.81, 95% CI 0.68–0.97) were predictive for lower risk of MI. 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.

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

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 5years. 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. 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. At 5years of follow-up, the safety and efficacy of BP-DES are clinically comparable to those of second-generation DP-DES.

P2799Long-term outcomes after percutaneous coronary intervention with biodegradable polymer drug-eluting stent versus second-generation durable polymer drug-eluting stent: evidence from a meta-analysis

Abstract 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 (&lt;6 months vs. &gt;6 months) or the drug release duration (&lt;6 months vs. &gt;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 &lt;100μm; OR 0.83, 95% CI 0.70–0.97), or ultrathin strut (defined as &lt;70μm; OR 0.78, 95% CI 0.64–0.94) were associated with lower rates of MI than did second-generation DP-DES. Moreover, BP-DES with circumferential drug distribution (OR 0.82, 95% CI 0.69–0.98) was predictive for reduced rates of TVR. 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.

TCT-305 Real-World Experience of Biodegradable-Polymer Drug Eluting Stents Versus Second-Generation Durable-Polymer Drug-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

The use of biodegradable-polymer drug-eluting stents (BP-DES) has been associated with early endothelialization and improved vascular healing. The authors aim to study the real-world clinical outcome of patients who received BP-DES versus second-generation durable-polymer drug-eluting stents (DP-DES

Five-year clinical efficacy and safety of contemporary thin-strut biodegradable polymer versus durable polymer drug-eluting stents: a systematic review and meta-analysis of 9 randomized controlled trials.

Very long-term data of the biodegradable polymer drug-eluting stents (BP-DES) in comparison with the contemporary durable polymer DES (DP-DES) are still to be investigated. We aimed to investigate the very long-term clinical performance of contemporary BP-DES against the DP-DES. We performed a systematic review to evaluate very long-term clinical outcomes of BP-DES versus DP-DES. Inclusion criteria were randomized design comparing BP-DES against DP-DES and follow-up duration ≥ 36months. MEDLINE, EMBASE, and CENTRAL without restricting language or publication status were searched up to December 2018. The primary efficacy and safety endpoints were target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization) and definite/probable stent thrombosis (ST), respectively. Primary analysis was done for the contemporary thin-strut BP- and DP-DES (strut thickness < 100µm). A total of 9 trials comprising 10,699 patients (BP-DES, n = 6241 versus DP-DES, n = 4458) were analyzed. The mean follow-up duration was 63months. No significant difference was found in TLF [Odds ratio (95% CI) 1.04 (0.89-1.21)] and definite/probable ST (odds ratio (95% CI) 0.78 (0.59-1.01)] between the BP- and DP-DESs. The present meta-analysis suggested that the contemporary thin-strut BP- and DP-DES have similar efficacy and safety profile at 5-year follow-up.Clinical trial registration PROSPERO; CRD42018101983 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=101983.

Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT

ObjectivesThe aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). BackgroundThe BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES. MethodsA total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis. ResultsThree-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (plog rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, plog rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. ConclusionsDespite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Thromboresistance and functional healing in the COBRA PzF stent versus competitor DES: implications for dual antiplatelet therapy.

The aim of this study was to investigate the COBRA PzF stent (C-PzF) with respect to thrombogenicity and healing versus conventional drug-eluting stents (DES) in dedicated preclinical models to evaluate their suitability for short-term dual antiplatelet therapy (DAPT). To examine acute thrombogenicity, the C-PzF durable polymer drug-eluting stent (DP-DES), and a bioabsorable polymer DES (BP-DES) were compared in a porcine arteriovenous shunt model and in a rabbit model to evaluate endothelial coverage at 14 days. Barrier function at 28 days in the rabbit was assessed in the former stents as well as in a polymer-free DES (PF-BES). The number of clots by scanning electron microscopy (SEM) was significantly less in the C-PzF and DP-EES versus the BP-EES. Endothelial coverage at 14 days was significantly greater in the C-PzF versus the DP-EES and BP-EES by CD31/PECAM-1 positive area in confocal microscopy (CM) (24.7% vs 11.9% vs 3.7%, respectively) and SEM (99.0% vs 29.6% vs 17.7%, respectively). Barrier protein expression by CM for p120/vascular-endothelial cadherin complex was significantly greater in the C-PzF versus the DP-EES, BP-EES, and PF-BES (82.6% vs 12.8% vs 14.4% vs 18.1%, respectively). The percentage of Evan's Blue positive area was least in the C-PzF versus all groups (22.0% vs 70.7% vs 66.4% vs 55.2%, respectively). The C-PzF demonstrated a unique combination of thrombogenicity and healing advantages compared to contemporary DES and may be uniquely suitable for very short-term DAPT.

Biodegradable polymer drug-eluting stent vs. contemporary durable polymer drug-eluting stents in patients with diabetes: a meta-analysis of randomized controlled trials.

The biodegradable polymer drug-eluting stents (BP-DES) offer controlled drug elution and complete degradation of the polymer over time, eventually lowering the risk for chronic inflammation and neoatherosclerosis, which can be particularly helpful in patients with diabetes. While BP-DES and durable polymer drug-eluting stents (DP-DES) have demonstrated comparable efficacy in all-comers population, their efficacy and safety in patients with diabetes remains uncertain. Electronic databases were systematically searched for randomized controlled trials (RCTs) comparing BP-DES with contemporary DP-DES in patients with diabetes. Study investigators were contacted to obtain additional data. The primary outcome was efficacy in terms of target-vessel revascularization (TVR) and target-lesion revascularization (TLR). We also evaluated the following safety outcomes separately: all-cause mortality, cardiac mortality, myocardial infarction (MI), and definite or probable stent thrombosis. Eleven RCTs including 5190 diabetic patients were included. At the longest available follow-up (mean 2.7 years), there was no significant difference in TLR [relative risk (RR): 1.02, 95% confidence interval (CI): 0.85-1.24; P = 0.80] or TVR (RR: 1.04, 95% CI: 0.81-1.34; P = 0.76). Safety outcomes of all-cause mortality, cardiac mortality, and MI were similar between the two groups. Stent thrombosis rates were also similar between BP-DES and DP-DES groups (1.66% vs. 1.83%; RR: 0.84, 95% CI: 0.54-1.31; P = 0.45). The heterogeneity was low and fixed-effect model yielded similar results. Meta-regression analysis showed no relationship between insulin requiring diabetes and difference in TLR or stent thrombosis between BP-DES and DP-DES. Overall, BP-DESs have similar safety and efficacy profiles compared to contemporary DP-DES in patients with diabetes.

Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels

Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019. Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods. In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis. Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts. ClinicalTrials.gov identifier: NCT01674803.

Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico?

Introduction and objectivesOutcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. MethodsPatients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. ResultsA total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). ConclusionsIn patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.