Drug-eluting Stents In Patients Research Articles

Role of Self Expandable Drug Eluting Stent in Patients with Atypical Coronary Anatomy Short and Mid Term Clinical Outcome

Role of Self Expandable Drug Eluting Stent in Patients with Atypical Coronary Anatomy Short and Mid Term Clinical Outcome

Drug-Coated balloons vs drug-eluting stents for the treatment of small coronary artery disease: A meta-analysis of randomized trials.

There is conflicting evidence about the effects of drug-coated balloons (DCB) compared with drug-eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all-cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in-segment restenosis, in-segment percentage-diameter stenosis, in-segment late lumen loss, in-segment net luminal gain, and in-segment minimal lumen diameter. Five trials enrolling 1,459 patients were included. Mean clinical follow-up was 10.2months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p=.92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p=.33), all-cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p=.98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p=.06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p=.04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p=.64), comparable late luminal loss (standardized mean difference (SMD): -0.18; 95% CI: -0.39 to 0.03; p=.09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: -0.52; 95% CI: -0.86 to -0.18; p=.003). Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

Drug Eluting Versus Covered Metal Stents in Malignant Biliary Strictures-Is There a Clinical Benefit?: A Systematic Review and Meta-Analysis.

Patients with malignant biliary obstruction (MBO) often require transpapillary stenting for symptomatic relief and biliary decompression. Plastic stents and uncovered metal stents are now replaced by covered self-expanding metal stents (SEMS). However, stent occlusion from tumor overgrowth and chronic inflammation continues to be an issue. Drug-eluting stents (DES), through an antitumor paclitaxel membrane, have been used to combat this problem. The aim of this study was to conduct a meta-analysis comparing DES to SEMS in MBO. Multiple databases were searched to identify studies that compared the clinical outcomes of SEMS and DES in patients with MBO. Random-effects model was used to calculate the pooled odds ratio and the pooled individual outcomes. Our primary goals were to assess the stent patency and overall survival in days. Secondary outcomes assessed the individual reported adverse events and/or complications. Five studies including 348 patients (175 males and 173 females) were included. The pooled odds ratio of stent patency was 1.03 (95% confidence interval: 0.68-1.54, P=0.9) and overall survival was 1.16 (95% confidence interval: 0.63-2.11, P=0.6). The pooled rate of stent patency was 168.3 (95% 140.7-196.4) days for DES and 149.4 (117.6-181.2) days for SEMS. The pooled rate of overall survival was 267.2 (206.2-328.2) days for DES and 218.2 (148.5-287.8) days for SEMS. On the basis of this meta-analysis, DES and SEMS seem to demonstrate comparable clinical outcomes in patients with malignant biliary strictures. Reported adverse events and/or complications were comparable as well.

Su1574 DRUG-ELUTING METAL STENTS IN MALIGNANT BILIARY STRICTURES AND HOW THEY COMPARE TO COVERED SELF-EXPANDING METAL STENTS: A META-ANALYSIS

Patients with malignant biliary obstruction (MBO) often require transpapillary stenting for symptomatic relief and biliary decompression. The evolution of stent selection in treating MBO has quickly evolved over time. Plastic stents and uncovered metal stents are now replaced by covered self-expanding metal stents (SEMS). However, despite these advances stent occlusion from tumor overgrowth and chronic inflammation continues to be an issue. Drug-eluting stents (DES), through an antitumor paclitaxel membrane, have been used to combat this problem. It is yet to be determined if these novel DES can indeed surpass SEMS. The aim of this study was to conduct a meta-analysis comparing DES to SEMS in MBO. Multiple databases were searched to identify studies that compared the clinical outcomes of SEMS and DES in patients with MBO. Random-effects model was used to calculate the pooled odds ratio (OR) and the pooled individual outcomes. Heterogeneity was assessed using I2 statistics. Our primary goals were to assess stent patency and overall survival in days. Secondary outcomes assessed the individual reported adverse events and/or complications. Five studies including 348 patients (175 Males, 173 Females) were included in the final analysis. All studies were conducted in South Korea. Average age ranged from 58.9 to 79.1 years. The mean follow up period ranged from 143 days to 329 days. 43% (n=151) and 57% (n=197) of patients underwent placement of SEMS and DES, respectively. The pooled OR of stent patency was 1.03 (95% CI 0.68-1.54, I2=0, p=0.9) and overall survival was 1.16 (95% CI 0.63-2.11, I2=65, p=0.6). The pooled rate of stent patency was 168.3 (95% 140.7-196.4, I2=76) days for DES and 149.4 (117.6-181.2, I2=0) days for SEMS. The pooled rate of overall survival was 267.2 (206.2-328.2, I2=88) days for DES and 218.2 (148.5-287.8, I2=66) days for SEMS. Pooled results of individual adverse events and/or complications are summarized in table 1. Based on this meta-analysis, DES and SEMS seem to demonstrate comparable clinical outcomes in patients with malignant biliary strictures. Reported adverse events and/or complications were comparable as well. Given our results, a cost-effectiveness analysis of using DES is warranted in this patient population.

Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: ameta-analysis of clinical trials.

Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results. This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions. The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters >2.5 mm. Three RCTs and one non-RCT with atotal of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with astandardized mean difference (SMD) of -0.07 (95% confidence interval [CI]: -0.31, 0.316; P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with arisk ratio (RR) of 1.17 (95% CI: 0.46, 2.95; P = 0.746). This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6-9months after percutaneous coronary intervention in patients presenting with coronary artery disease.

Bioabsorbable‐polymer drug‐eluting stents in acute myocardial infarction: Insights from the ULLISE registry

Limited information is available about the performance of bioabsorbable-polymer drug-eluting stents in the setting of acute myocardial infarction. Patients treated with these stents presenting with acute myocardial infarction are at higher risk of adverse events compared with stable patients. Further clinical trials are needed to fully understand the role of bioabsorbable-polymer drug-eluting stents in patients presenting with acute myocardial infarction.

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.

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups. At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

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 &amp;lt; 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 &amp;lt; 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.

Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design

Aim Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain at high risk of cardiovascular events despite the use of contemporary drug-eluting stents (DES). This trial aim to compare the clinical efficacy of 2 novel second-generation DES in patients with DM. Methods and results The Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial ( ClinicalTrials.gov NCT03321032) is an investigator-initiated, prospective, randomized, controlled, multicenter study conducted exclusively in patients with DM. This study allows inclusion of the entire spectrum of patients with DM undergoing PCI, and the only exclusion criteria are shock at presentation, inability to consent or a life expectancy Conclusions SUGAR is the first randomized head-to head trial comparing second-generation DES in an all-comer diabetic population undergoing PCI.

Comparison of drug-eluting and bare-metal stents in patients with saphenous vein graft stenosis

BackgroundThe use of drug-eluting stents (DES) during the percutaneous coronary intervention of patients with degenerated saphenous vein graft (SVG) is uncertain. Although previous studies showed that DES might decrease the rate of re-intervention in patients with SVG stenosis, randomized controlled trials comparing bare-metal stents (BMS) and DES in SVG lesions have been inconclusive.ObjectiveThe purpose of this study was to compare the outcomes in patients undergoing SVG stent implantation treated with DES or BMS.Patients and methodsThis was a retrospective observational study that included 60 patients who underwent percutaneous coronary intervention for SVG lesions, comprising 30 patients who were treated with BMS and 30 patients who were treated with DES at National Heart Institute from March 2015 to March 2018. Three years of outcome and major adverse cardiac event (MACE) were recorded. MACE was defined as death, myocardial infarction (MI), target vessel revascularization, and stroke.ResultsAfter three years, there was no significant difference between the two groups in MACE. MACE was reported in five (16.6%) patients in the DES group vs eight (26.6%) patients in the BMS group (P>0.05). Death was reported in one (3.3%) patient in each group. MI was reported in two (6.6%) patients in the DES group vs three (10%) patients in the BMS group (P>0.05). One (3.3%) patient developed stroke in the DES group vs two (6.6%) patients in the BMS group (P>0.05). The need for repeat revascularization was reported in one (3.3%) patient in the DES group vs two (6.6%) patients in the BMS group (P>0.05). Stent thrombosis was reported in six (20%) patients in the DES group vs four (13.3%) patients in the BMS group (P>0.05)ConclusionOur results in this study showed that there was no significant difference between BMS and DES in patients undergoing percutaneous coronary intervention for SVG lesions for MACE, such as death, target vessel revascularization, and MI.

P6517Three-year clinical outcome of patients with abnormal glucose metabolism treated with contemporary drug-eluting stents

Abstract Background/Introduction Patients with coronary artery disease that have an abnormal glucose metabolism are known to have more extensive and complex atherosclerotic coronary disease. In patients without previously known diabetes, abnormal glucose metabolism was shown to be independently associated with an up to four-fold higher event risk during the first year after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Purpose To examine the 3-year clinical outcome after stenting with contemporary DES in patients with abnormal glucose metabolism, either detected by oral glucose tolerance testing (OGTT) or by glycated haemoglobin A1c (HbA1c) and fasting plasma glucose. Methods The present analysis is a local substudy of the BIO-RESORT randomised trial. OGTT and HbA1c with fasting plasma glucose were prospectively assessed in 988 trial participants without previously known diabetes. The main clinical endpoint was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction or target vessel revascularisation at 3-years. Results In one out of three study participants (330/988), abnormal glucose metabolism was detected by either OGTT or HbA1c and fasting plasma glucose. Three-year follow up was available in 99.8% of these patients. The rate of target vessel failure was significantly higher in patients with abnormal glucose metabolism versus normoglycaemic patients (8.8% vs. 5.5%, p=0.044; Figure). This difference was driven by the incidence of periprocedural myocardial infarction that was higher in patients with abnormal glucose metabolism than in patients with normoglycaemia (4.5% vs. 1.4%, p=0.002). Target vessel failure at 3-years Conclusion Abnormal glucose metabolism was associated with a significantly higher risk of target vessel failure at 3-years; this difference was driven by higher rates of periprocedural myocardial infarction. Acknowledgement/Funding The present substudy received no additional funding. The BIO-RESORT trial was equally funded by Biotronik, Boston Scientific, and Medtronic.

Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up

Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease. ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

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

TCT-48 Bioresorbable Scaffold Versus Metallic Drug-Eluting Stent in Patients at High Risk of Restenosis (COMPARE-ABSORB trial): Very Late Device Thrombosis While on Extended DAPT

The COMPARE-ABSORB trial has shown noninferiority between the bioresorbable vascular scaffold (BVS) and the metallic everolimus-eluting stents (EES) at 1 year in composite safety and effectiveness outcomes, although BVS carries a higher device thrombosis rate than EES. Several studies indicated an

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices

PurposePatient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.MethodsData from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan–Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.ResultsIn the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality.ConclusionAnalyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality.Level of EvidenceZilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.

Clinical outcomes of contemporary drug-eluting stents in patients with and without diabetes mellitus: Multigroup propensity-score analysis using data from stent-specific, multicenter, prospective registries.

Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial. From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes. In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes.

Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study

BackgroundDrug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available. ObjectivesThe aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis. MethodsPatients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation. ResultsA total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50). ConclusionsDCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630)

Prognostic Analysis of Drug-Eluting Balloon Catheter and Drug-Eluting Stent for In-Stent Restenosis of Drug-Eluting Stent

Although the development of Drug-eluting stent (DES) improved the ISR significantly more than the Bare metal stent (BMS), the coronary stent restenosis (ISR) treatment still has a high recurrence rate. This study is compared the efficacy of DEB with that of DES implantation in patients with ISR. Among 4,316 patients who underwent coronary stent implantation at the Chonnam National University Hospital between November 2012 and December 2016, 187 patients developed ISR on follow-up coronary angiography (66.3 ± 11.0 years, 123 males) were enrolled and divided into two groups according to revascularization method as group I (DEB group; n= 127) and group II (DES group; n= 60). Primary end point was defined as major adverse cardiac events (MACEs), composite of cardiac death (CD), myocardial infaction (MI), target lesion revascularization (TLR) and stent thrombosis (ST) during two-year follow-up between the two groups. There were no differences in the baseline characteristics and angiographic findings except that prevalence of device length was shorter (21.1 ± 5.3 vs. 25.3 ± 9.6 mm, p<0.002) in group I.Two-year MACE were not different in the two groups (8.7%vs.10.0%, p=0.789). The incidences of cardiac death (0%vs.0%, p=1.000), MI (1.6%vs.6.7%, p=0.085), TLR(8.7% vs. 10.0%, p=0.789) and ST (0% vs. 0%, p=1000). DEB demonstrated comparable risk reduction for MACEs compared with DES in patients with ISR during two-year follow-up. DEB might be good alternative for the treatment of ISR in patients with ISR

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.