Safety Of Drug-eluting Stents Research Articles

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial

In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

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.

IMPACT OF DESIGN FEATURES OF CONTEMPORARY DRUG-ELUTING STENTS ON CLINICAL OUTCOMES: A COMPARATIVE META-ANALYSIS

Limited data exist on comparative efficacy and safety of drug-eluting stents (DES) with newer design features. We conducted a systematic review & network meta-analysis of randomized trials comparing two or more of the following 5 categories: 1) ultrathin-strut biodegradable polymer (BP) DES (strut

Long-Term Efficacy and Safety of Everolimus-Eluting Stent Implantation in Japanese Patients with Acute Coronary Syndrome: Five-Year Real-World Data from the Tokyo-MD PCI Study.

Background The long-term safety of first-generation drug-eluting stent (DES) in acute coronary syndrome (ACS) was controversial. Purpose The purpose of this study was to establish 5-year real-world data regarding the long-term efficacy and safety of second-generation DES in Japanese patients with ACS. Methods The Tokyo-MD PCI study is a multicenter, observational cohort study enrolling consecutive patients who underwent everolimus-eluting stent (EES) implantation. The 5-year clinical events were compared between the ACS group (n = 644) and the stable coronary artery disease (SCAD) group (n = 1255). The primary efficacy endpoint was ischemia-driven target lesion revascularization (TLR), and the primary safety endpoint was the composite of all-cause death or myocardial infarction (MI). Results The median follow-up duration was 5.4 years. The cumulative incidence of ischemia-driven TLR was similar between ACS and SCAD (1 year: 3.0% versus 2.7%; P=0.682, 1–5 years: 2.7% versus 2.9%; P=0.864). The cumulative incidence of all-cause death or MI within 1 year was significantly higher in ACS than in SCAD (7.4% versus 3.8%; P < 0.001); however, ACS did not increase the risk of all-cause death or MI after adjusting confounders (adjusted hazard ratio, 1.260; 95% confidence interval, 0.774–2.053; P=0.352). From 1 to 5 years, the cumulative incidence of all-cause death or MI was not significantly different between ACS and SCAD (11.6% versus 11.4%; P=0.706). The cumulative incidence of very late stent thrombosis was low and similar between ACS and SCAD (0.2% versus 0.2%; P=0.942). Conclusion This real-world registry suggested that EES has comparable long-term efficacy and safety in patients with ACS and SCAD.

Three-Year Outcomes of Biodegradable Polymer-Coated Ultra-Thin (60 µm) Sirolimus-Eluting Stents in Real-World Clinical Practice

Although drug-eluting stents (DES) have outclassed the use of bare metal stents, the safety and efficacy of DES at long-term follow-up has still been conflicting because of increased occurrence of late or very late restenosis and stent thrombosis after DES implantation. Hence, the present study was aimed to evaluate the 3-year safety and clinical performance of biodegradable polymer-coated ultra-thin (60 µm) sirolimus-eluting stent (SES) in real-world patients with coronary artery disease (CAD). This was a physician-initiated, retrospective, single-centre, observational study that included 237 consecutive patients who had previously undergone implantation of only Supraflex SES (Sahajanand Medical Technologies Pvt Ltd, Surat, India) for the treatment of CAD. Follow-up was received after 1 year and 3 years of stent implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR). Stent thrombosis was considered as a safety endpoint. The mean age of patients was 64.1 ± 10.2 years, and 192 (81.0%) patients were male. The average stent length and diameter were 24.4 ± 9.0 mm and 3.1 ± 0.4 mm, respectively. The cumulative MACE rate at 3 years follow-up was 6.5% which included 4 (1.8%) cardiac deaths, 6 (2.8%) MI, and 4 (1.8%) TLR. There were 2 (0.9%) cases of stent thrombosis. Treatment of patients with CAD in real-world clinical practice was associated with sustained clinical safety and low rates of restenosis, stent thrombosis and MACE up to 3 years after Supraflex SES implantation.

Drug Eluting Stents versus Bare Metal Stents in ST- Segment Elevation Myocardial Infarction

Background: The aim of this study was to compare the effectiveness and safety of drug eluting stents (DES) with bare metal stents (BMS) in patients presented with ST- segment elevation myocardial infarction (STEMI) in a real world setting. Methods: One thousand five hundred ninety six STEMI patients treated with primary percutaneous coronary intervention from January 2013 to March 2016 were enrolled to study. One thousand one hundred ninety four of them received BMS while 402 of them received DES. Patients were analyzed for major adverse cardiac events (MACE) and stent thrombosis (ST). Results: There was no difference at 30 days in relation of MACE, all cause death, re-MI, TVR, TLR and ST. The cumulative incidence of MACE was significantly higher in DES group (9,2% vs. 7,0%, p = 0.02) at 1 year. Stent thrombosis and re-MI incidence were significantly higher in DES group (4,2% vs. 2,6%, p = 0.028, 6,9% vs. 4,8%, p = 0.015) respectively at 1 year. There was no statistically significant difference in relation of all cause death, TVR and TLR at 1 year. The statistically differences between groups vanished at 2 year and the groups looked similar. Male gender (HR, 1.40; 95% CI, 1.00 to 1.94; p = 0.043) and presence of DM (HR, 1.73; 95% CI, 1.29 to 2.32; p&amp;lt;0,001) were found to be independent predictors of 2-year MACE. Conclusion: Our study showed effectiveness and safety of DES in STEMI. Despite increased incidence of MACE, re-MI and ST in 1-year, DES was found to be non-inferior to BMS at 2-year follow up.

Safety of drug-eluting stents compared to bare metal stents in patients with an indication for long-term oral anticoagulation: A propensity score matched analysis

BackgroundDrug-eluting stents (DES) reduce stent restenosis compared with bare-metal stents (BMS). However, their use in patients requiring long-term oral anticoagulation (OAC) is controversial owing to increased risk of bleeding associated with OAC plus antiplatelet treatment over time. ObjectiveTo assess the safety of DES vs BMS in patients requiring long-term OAC for any reason. MethodsProspective observational multicenter study conducted at 6 teaching centers of patients undergoing percutaneous coronary intervention who required OAC for any reason. Adverse outcomes were analyzed at 1 year of follow-up. ResultsWe identified 1002 patients requiring OAC (mean age: 72 years, male 72%). Six- hundred and thirteen patients (61.2%) received BMS and 389 (38.8%) DES. Diabetes, previous PCI, myocardial infarction and acute coronary syndrome at admission (P < 0.0001) were more common in patients with DES. Antithrombotic prescribing was similar at discharge between groups (TT: 51.5% vs 50.9%, clopidogrel plus OAC: 7.0% vs 5.0% and DAPT: 41.4% vs 42.7%, p = 0.52). DES and BMS patients showed similar rates of total bleeding (15.2% vs 13.4%, adjusted HR 0.82 [0.58–1.17, p = 0.82 and major bleeding (6.2% vs 6.0%; adjusted HR 1.22 [0.71–2.09], p = 0.46) and MACE (15.2% vs 18.6%, adjusted HR: 0.82 [0.57–1.17], p = 0.28, while restenosis was lower in patients with DES (5.3% vs 8.5%, adjusted HR. (0.52 [0.29–0.92], p = 0.02. Cox analysis after propensity score selection of 368 matched pairs demonstrated that DES use was not associated with a higher incidence of total bleeding or major bleeding. ConclusionDES use is safe in patients with an indication for long-term OAC.

Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease

BackgroundRandomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. ObjectivesThe authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. MethodsWithin a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. ResultsMore than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. ConclusionsPatency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441)

Meta-analysis of drug eluting stents compared with bare metal stents in high bleeding risk patients undergoing percutaneous coronary interventions.

To determine the efficacy and safety of drug-eluting stents (DESs) and bare metal stents (BMSs) when used with short or tailored dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. DES have been shown to reduce target lesion revascularization (TLR) as well as stent thrombosis (ST) compared to BMS in patients undergoing percutaneous coronary intervention (PCI). However, patients at HBR continue to receive BMS given the fear of bleeding or ST from premature discontinuation of DAPT in patients receiving DES. We performed a meta-analysis of randomized controlled trials by performing systematic search for studies comparing DES with BMS in HBR patients using PUBMED, MEDLINE, and Cochrane Central, reported until March 1, 2018. Three randomized controlled studies met the inclusion criteria with total of 4,460 patients; 50% received DES. Major adverse cardiovascular event (MACE); composite of death, myocardial infarction (MI), and TLR, at 1 year was significantly lower (RR = 0.63, 95% CI 0.50-0.80) in DES group compared to BMS. This difference was primarily driven by lower TLR (RR = 0.46, 95% CI 0.35-0.61) in DES group. Definite or probable ST (RR = 0.59, 95% CI = 0.32-1.08) and major (RR = 0.94, 95% CI = 0.74-1.20) bleeding were similar. DES was associated with lower MACE without increased risk of bleeding or ST compared to BMS when used with short or tailored DAPT in patients with HBR.

First-generation versus second-generation drug-eluting stents in patients with chronic kidney disease: a systematic review and meta-analysis

ABSTRACTBackground: Chronic kidney disease (CKD) patients are associated with very high rate of adverse cardiovascular outcomes after drug-eluting stents (DES) implantation. The clinical outcomes of second-generation DES versus first-generation DES in CKD patients remain controversial.Objective: The aim of the current study was to perform a systematic review and meta-analysis to assess the safety and efficacy of second-generation DES versus first-generation DES in CKD patients.Methods: A systematical search of databases of PubMed, EMBASE, and Cochrane Library was conducted for eligible studies comparing the clinical outcomes of first-generation DES versus second-generation DES. Sirolimus-eluting and paclitaxel-eluting stents were classified as first-generation DES, and everolimus-eluting, zotarolimus-eluting, and biolimus-eluting stent (BES) were classified as second-generation DES. A pooled odds ratio (OR) and 95% confidence interval (CI) were used to summary the estimates. Heterogeneity, subgroup analysis, sensitivity analysis and publication bias were also performed.Results: We identified 14 trials involving 9,542 patients with CKD undergoing percutaneous coronary intervention. First-generation DES implantation was associated with higher risk of long-term all-cause mortality (OR, 1.31; 95% CI, 1.02–1.69; P = 0.04; I2 = 0%), in stent restenosis (OR, 1.69; 95% CI, 1.14–2.49; P = 0.008; I2 = 49%) and stent thrombosis (OR, 1.64; 95% CI, 1.00–2.69; P = 0.05; I2 = 49%) compared with second-generation DES implantation. First-generation DES and second-generation DES showed similar efficacy in decreasing risk of repeat revascularization, myocardial infarction (MI), or major adverse cardiac events (MACE) between first-generation and second-generation DES implantation.Conclusions: In CKD patients, the use of second-generation DES was associated with lower risk of long-term all-cause mortality, in stent restenosis and stent thrombosis as compared with first-generation DES. No differences were found regarding repeat revascularization, MI, and MACE.

Abstract 16888: Comparing Adverse Clinical Outcomes Between Drug Eluting Stents and Bare Metal Stents in Patients Undergoing Non-Cardiac Surgery: a Meta-Analysis

Introduction: History of coronary stents is risk factor for short term adverse clinical events (ACE) after a non-cardiac surgery (NCS). Safety of Drug-Eluting Stent (DES) or Bare-Metal Stent (BMS) has been studied in such patients, but no clear optimal choice of stent type exists. Thus, we performed a meta-analysis to compare the two stents in patients undergoing NCS. Methods: PubMed, Medline, EMBASE databases were queried from inception to January 2018 for all studies comparing DES vs BMS in patients undergoing NCS. ACE was defined as 30-day event rate of myocardial infarction (MI) or death after NCS. Two subgroups created by difference in time from stent placement to NCS: Within 30-45 days and &gt;45 days after stent placement. Random effect model was used to estimate the odds ratio (OR). Two tailed p value &lt; 0.05 were considered significant. Results: Four retrospective cohort studies with 6708 patients were identified. Out of 2597 BMS patients, 8.9% had an ACE compared to rate of 6.5% ACE in DES patients (n=4111). In the overall cohort, there was no difference was observed with either stent type irrespective of duration of NCS after stent placement (OR: 0.85, 95% CI 0.70-1.03, P=0.46). In patients undergoing NCS shortly(30-45days) after stent placement, no significant difference in ACE was observed {Odds Ratio (OR): 0.90, CI 0.63-1.28, P=0.82}. Similarly, no difference was noted in ACE in patients undergoing NCS after 45 days of stent placement (OR: 0.88, CI 0.56-1.40, P=0.10). Conclusion: In patients undergoing NCS after coronary stenting, there is no difference in rate of ACE with BMS vs DES placement. Thus, choice of stent may not play a role in prediction of adverse clinical outcomes after an non-cardiac surgery.

Efficacy and safety of drug-eluting stent for the intracranial atherosclerotic disease: A systematic review and meta-analysis

Drug-eluting stent (DES) is a potential endovascular treatment for patients with symptomatic intracranial atherosclerotic disease (sICAD). However, evidence regarding the treatment of ICAD with DES is lacking. We systematically searched Pubmed, Embase, Cochrane database (before 2017-12-21) for literature reporting the application of DES in the treatment of sICAD. The main outcomes were as follows: the incidence of any stroke or death within 30 days (perioperative complications), ischemic stroke in the territory of the qualifying artery beyond 30 days (long-term complications), in-stent restenosis rate (ISR) and symptomatic ISR during follow-up. Those studies with mean stenosis rate greater than 70% and less than 70% were defined as severe and moderate stenosis group, respectively. The random effect model was used to pool the data. Of 518 articles, 13 studies were eligible and included in our analysis (N = 336 patients with 364 lesions). After the implantation of DES, perioperative complications (mortality = 0) occurred in 6.0% (95%CI 2.0%–11.9%), long-term complications occurred in 2.2% (95%CI 0.7%–4.5%), ISR rate was 4.1% (95%CI 1.6%–7.7%) and the symptomatic ISR rate was only 0.5% (95%CI 0–2.2%). In addition, subgroup analysis showed that the perioperative complication rate in severe stenosis group [10.6% (95%CI 6.5%–15.7%)] was significantly (p < 0.01) higher than that in moderate stenosis group [1.0% (95%CI 0.3%–3.5%)]. In summary, endovascular DES implantation is a relatively safe and effective method compared with stents or medical management group in SAMMPRIS and VISSIT trials. However, a higher preoperative stenosis rate may imply a higher risk of perioperative complications. Further studies are needed.

Long-Term Outcomes of Drug-Eluting Stents Versus Bare-Metal Stents in End-Stage Renal Disease Patients on Dialysis: A Systematic Review and Meta-Analysis.

There are no dedicated data to guide drug-eluting stent (DES) versus bare-metal stent (BMS) selection in patients with end-stage renal disease undergoing dialysis (ESRD-D). It is unclear whether long-term benefits of a specific stent type outweigh risks in this population at high risk for both bleeding and ischemic events. We performed a meta-analysis of nonrandomized studies extracted from PubMed, Scopus, and EMBASE, assessing the safety and effectiveness of DES versus BMS in ESRD-D patients. Odds ratios (OR) and 95% confidence intervals (CI) were computed with the Mantel-Haenszel method. Random-effects model was used for all analyses. A total of 17 nonrandomized studies (N = 63,157; 41,621 DES and 21,536 BMS) met the inclusion criteria and were included for the final quantitative analysis: median follow-up of 1 year (range: 9 months to 6 years). The use of DES in ESRD-D patients was associated with lower all-cause mortality (OR 0.75, 95% CI 0.64-0.89, P < 0.001) compared with BMS. The use of DES was also associated with lower rates of cardiovascular mortality (OR 0.75, 95% CI 0.60-0.99, P = 0.047) and target lesion/vessel revascularization (OR 0.78, 95% CI 0.64-0.94, P = 0.01). However, there were no differences in noncardiovascular mortality, myocardial infarction, stent thrombosis, stroke, or major bleeding in DES versus BMS. In this largest meta-analysis of long-term outcomes after percutaneous coronary intervention in ESRD-D patients, DES was associated with lower rates of all-cause mortality, target lesion/vessel revascularization, and cardiovascular death.

Efficacy and Safety of Drug-Eluting Stents Optimized for Biocompatibility vs Bare-Metal Stents With a Single Month of Dual Antiplatelet Therapy

A significant number of patients receive bare-metal stents (BMSs) instead of drug-eluting stents (DESs) to shorten the duration of dual antiplatelet therapy (DAPT). Emerging evidence suggests that new-generation DESs, particularly those optimized for biocompatibility, may be more efficacious and safer than BMSs, even with a single month of DAPT after stent implantation. To evaluate the efficacy and safety of DESs compared with BMSs for coronary intervention with a single month of DAPT. Human studies found in PubMed, the Cochrane databases through April 2018, and reference lists of selected articles. Randomized clinical trials were included if they enrolled patients undergoing percutaneous coronary intervention and randomly assigned each patient to treatment with either DESs or BMSs. The additional inclusion criterion was use of only 1 month of DAPT poststent implantation. Two reviewers independently extracted the data. Odds ratios (ORs) were calculated using random-effects models. The efficacy end points were major adverse cardiac events, myocardial infarction, target vessel revascularization, ischemia-driven target lesion revascularization, cardiac mortality, and all-cause mortality at 1 year. The safety outcomes were stent thrombosis and bleeding complications. Data from 3 randomized clinical trials involving 3943 patients were included (2457 men [62.3%]; mean [SD] age ranging from 75.7 [9.3] years to 81.4 [4.3] years per trial subgroup). Coronary intervention with DESs reduced the rates for major adverse cardiac events (OR, 0.68 [95% CI, 0.57-0.82]; P < .001), target lesion revascularization (OR, 0.38 [95% CI, 0.22-0.67]; P = .001), target vessel revascularization (OR, 0.50 [95% CI, 0.38-0.65]; P < .001), and myocardial infarction (OR, 0.51 [95% CI, 0.31-0.83]; P = .01) compared with BMSs at 1 year. The incidence of stent thrombosis was also lower with DESs compared with BMSs (1.8% vs 2.8%), but this difference was not statistically significant in the random-effects model. Additionally, the 2 stent types did not differ in the risks of all-cause mortality, cardiac mortality, and bleeding. In the limited number of randomized clinical trials comparing DESs with BMSs with shortened DAPT durations in patients who have high bleeding risk or are uncertain candidates for prolonged DAPT, coronary intervention with specific DESs optimized for biocompatibility is not only safe but also efficacious, even with only 1 month of DAPT.

OP-579 - Drug Eluting Stents Versus Bare Metal Stents in St- Segment Elevation Myocardial Infarction

Background: The aim of this study was to compare the effectiveness and safety of drug eluting stents (DES) with bare metal stents (BMS) in patients presented with ST- segment elevation myocardial infarction (STEMI) in a real world setting.

Comparison of drug-eluting balloon versus drug-eluting stent for treatment of coronary artery disease: a meta-analysis of randomized controlled trials

BackgroundDrug-eluting balloons (DEB) have significant value for treating coronary artery disease (CAD). However, the merits of using DEB versus drug-eluting stents (DES) to treat CAD remain controversial. Herein, we conducted a meta-analysis to compare the safety and efficacy of DEB and DES for treatment of CAD.MethodsWe searched MEDLINE, EMBASE, and CENTRAL databases for eligible trials comparing DEB with DES for treatment of CAD. The primary endpoint was major adverse cardiac events (MACE); the secondary endpoints included in-lesion late lumen loss (LLL), binary restenosis (BR), myocardial infarction (MI), target lesion revascularization (TLR) and mortality.ResultsTwenty-three trials with a total of 2712 patients were included. There were no significant differences in the primary endpoint of MACE between the DEB and DES groups (Risk Ratio (RR) 1.19; 95% confidence interval (CI) (0.87, 1.63); P = 0.27), or in the clinical outcomes of each of MACE’s components, including TLR, MI and mortality. However, efficacy was significantly different between the DEB and DES groups, especially when we compared DEB to second-generation DES: in-lesion LLL (Mean Difference (MD) 0.11; (0.01, 0.22); P = 0.03); binary restenosis (RR 1.46; (1.00, 2.13); P = 0.05).ConclusionsDEB is equivalent to DES in terms of safety for managing CAD, and DEB may be considered as an alternative choice for treatment of CAD.

Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction

Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear. To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI. Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non-ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI). Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES. Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up. Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, -3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, -2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, -0.5% [NNT, 222]; NSTEMI, -3.1% [NNT, 33]; STEMI, -4.0% [NNT, 25] and for definite or probable ST: UA, -0.4% [NNT, 278]; NSTEMI, -2.2% [NNT, 46]; STEMI, -4.0% [NNT, 25]). New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model

Introduction and objectivesNew drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. MethodsWe randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. ResultsThe stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. ConclusionsIn this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.

Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus con polímero biodegradable en el modelo preclínico

Introduction and objectivesNew drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. MethodsWe randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. ResultsThe stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. ConclusionsIn this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.Full English text available from:www.revespcardiol.org/en