Bare-metal Stents In Patients Research Articles

Covered versus bare-metal stenting of the mesenteric arteries in patients with chronic mesenteric ischaemia (CoBaGI): a multicentre, patient-blinded and investigator-blinded, randomised controlled trial

Mesenteric artery stenting with a bare-metal stent is the current treatment for atherosclerotic chronic mesenteric ischaemia. Long-term patency of bare-metal stents is unsatisfactory due to in-stent intimal hyperplasia. Use of covered stents might improve long-term patency. We aimed to compare the patency of covered stents and bare-metal stents in patients with chronic mesenteric ischaemia. We conducted a multicentre, patient-blinded and investigator-blinded, randomised controlled trial including patients with chronic mesenteric ischaemia undergoing mesenteric artery stenting. Six centres in the Netherlands participated in this study, including two national chronic mesenteric ischaemia expert centres. Patients aged 18 years or older were eligible for inclusion when an endovascular mesenteric artery revascularisation was scheduled and a consensus diagnosis of chronic mesenteric ischaemia was made by a multidisciplinary team of gastroenterologists, interventional radiologists, and vascular surgeons. Exclusion criteria were stenosis length of 25 mm or greater, stenosis caused by median arcuate ligament syndrome or vasculitis, contraindication for CT angiography, or previous target vessel revascularisation. Digital 1:1 block randomisation with block sizes of four or six and stratification by inclusion centre was used to allocate patients to undergo stenting with bare-metal stents or covered stents at the start of the procedure. Patients, physicians performing follow-up, investigators, and radiologists were masked to treatment allocation. Interventionalists performing the procedure were not masked. The primary study outcome was the primary patency of covered stents and bare-metal stents at 24 months of follow-up, evaluated in the modified intention-to-treat population, in which stents with missing data for the outcome were excluded. Loss of primary patency was defined as the performance of a re-intervention to preserve patency, or 75% or greater luminal surface area reduction of the target vessel. CT angiography was performed at 6 months, 12 months, and 24 months post intervention to assess patency. The study is registered with ClinicalTrials.gov (NCT02428582) and is complete. Between April 6, 2015, and March 11, 2019, 158 eligible patients underwent mesenteric artery stenting procedures, of whom 94 patients (with 128 stents) provided consent and were included in the study. 47 patients (62 stents) were assigned to the covered stents group (median age 69·0 years [IQR 63·0-76·5], 28 [60%] female) and 47 patients (66 stents) were assigned to the bare-metal stents group (median age 70·0 years [63·5-76·5], 33 [70%] female). At 24 months, the primary patency of covered stents (42 [81%] of 52 stents) was superior to that of bare-metal stents (26 [49%] of 53; odds ratio [OR] 4·4 [95% CI 1·8-10·5]; p<0·0001). A procedure-related adverse event occurred in 17 (36%) of 47 patients in the covered stents group versus nine (19%) of 47 in the bare-metal stent group (OR 2·4 [95% CI 0·9-6·3]; p=0·065). Most adverse events were related to the access site, including haematoma (five [11%] in the covered stents group vs six [13%] in the bare-metal stents group), pseudoaneurysm (five [11%] vs two [4%]), radial artery thrombosis (one [2%] vs none), and intravascular closure device (none vs one [2%]). Six (13%) patients in the covered stent group versus one (2%) in the bare-metal stent group had procedure-related adverse events not related to the access site, including stent luxation (three [6%] vs none), major bleeding (two (4%) vs none), mesenteric artery perforation (one [2%] vs one [2%]), mesenteric artery dissection (one [2%] vs one [2%]), and death (one [2%] vs none). The findings of this trial support the use of covered stents for mesenteric artery stenting in patients with chronic mesenteric ischaemia. Atrium Maquet Getinge Group.

Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease

BackgroundEndovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS). ObjectivesThe purpose of this study was to compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials. MethodsPatient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE). ResultsThe primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months. ConclusionsIn a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis vs BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments.

Angiographic and clinical outcomes in patients with versus without diabetes mellitus after revascularization with BioMime sirolimus-eluting stent.

Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes. This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure. Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P < 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups. BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.

Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis

In-stent restenosis (ISR) is the primary reason for stroke recurrence after intracranial stenting in patients who were treated with a standard bare-metal stent (BMS). Whether a drug-eluting stent (DES) could reduce the risk of ISR in intracranial atherosclerotic stenosis (ICAS) remains unclear. To investigate whether a DES can reduce the risk of ISR and stroke recurrence in patients with symptomatic high-grade ICAS. A prospective, multicenter, open-label randomized clinical trial with blinded outcome assessment was conducted from April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting. Patients with symptomatic high-grade ICAS were enrolled, randomized, and followed up for 1 year. Intention-to-treat data analysis was performed from April 1 to May 22, 2021. Patients were randomly assigned to receive DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system) treatment in a 1:1 ratio. The primary efficacy end point was ISR within 1 year after the procedure, which was defined as stenosis that was greater than 50% of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety end point was any stroke or death within 30 days after the procedure. A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group. The 1-year ISR rate was lower in the DES group than in the BMS group (10 [9.5%] vs 32 [30.2%]; odds ratio, 0.24; 95% CI, 0.11-0.52; P < .001). The DES group also had a significantly lower ischemic stroke recurrence rate from day 31 to 1 year (1 [0.8%] vs 9 [6.9%]; hazard ratio, 0.10; 95% CI, 0.01-0.80; P = .03). No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46). This trial found that, compared with BMSs, DESs reduced the risks of ISR and ischemic stroke recurrence in patients with symptomatic high-grade ICAS. Further investigation into the safety and efficacy of DESs is warranted. ClinicalTrials.gov Identifier: NCT02578069.

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction

BackgroundOutcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. ObjectivesThe aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. MethodsThe EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. ResultsComplete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. ConclusionsAt 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315)

Abstract 17081: Outcomes of Percutaneous Coronary Intervention in Cirrhosis: Does the Stent Type Matter?

Methods: National Inpatient Sample was queried from 2016-2017 for discharges of adult patients with cirrhosis who underwent percutaneous coronary intervention (PCI) with placement of drug-eluding-stents (DES) and bare-metal-stents (BMS) using ICD-10CM/PCS-codes. Patients were subsequently divided between compensated/decompensated cirrhosis as per the BAVENO Score. The primary outcome was in-hospital mortality. Secondary outcomes were post-procedural complications, length of stay (LOS), total hospital charges/costs. Multivariate logistic regression analysis was performed to adjust for confounders. Results: 899,899 PCIs were identified out of which 0.6% (n=5,983) had concomitant cirrhosis. Patients with compensated and decompensated cirrhosis had higher odds of BMS placement when undergoing PCI when compared with patients without cirrhosis [aOR 1.57; (P&lt;0.01)], [aOR 1.54; (P=0.05) respectively]. There was no significant difference in mortality between BMS and DES in patients with compensated-cirrhosis, and similar results were obtained in patients with decompensated-cirrhosis. DES was associated to higher LOS when compared to BMS in patients with decompensated-cirrhosis [4.93; (P:&lt;0.01)], and higher total hospital costs [16, 031.94; (P:&lt;0.01)]. Patients with decompensated-cirrhosis and DES had higher risk of post-procedure bleeding when compared with BMS [aOR 4.22; (P:&lt;0.01)]. Conclusions: Patients admitted for PCI with decompensated-cirrhosis have higher LOS and total hospitalization costs when DES is placed. Likely driven by higher post-procedural bleeding in this set of patients, requiring further intervention. BMS seemed to be safe when used in patients with cirrhosis and is not associated with higher in-hospital mortality even in patients with decompensated-cirrhosis.

Final 5-year results of the TRIAS-LR: a multi-centre, randomized trial comparing the Genous endothelial progenitor cell capturing stent with bare metal stents in patients with low risk for restenosis

Abstract Introduction The Genous stent is a bare metal stent (BMS) together with a technique of capturing endothelial progenitor cells. The successor of the Genous endothelial progenitor cell capturing (EPC) stent, the COMBO stent, combines this technique with the drug eluting polymer. The current studies showed promising results of the COMBO stent, however the additional value of EPC technique in overcoming neointimal hyperplasia has yet to be proven. Purpose This study sought to evaluate the efficacy and safety of the Genous EPC stent compared to BMS in a patient population with low risk for restenosis. Methods TRIAS-LR was an investigator-initiated, prospective, multicentre, single blind trial randomizing patients with low risk of restenosis 1:1 to Genous ECS or BMS. Patients were recruited between 2007 and 2014 at 31 sites across Europe. The study enrolment was terminated at 70% of the planned inclusion due to slow enrolment and change of guidelines. Patients or lesions were considered low risk if all of the following criteria were met: 1) reference vessel diameter &amp;gt;2.8mm, 2) lesion length &amp;lt;20mm, 3) no thrombolysis in myocardial infarction (TIMI) flow of 0, and 4) patient without diabetes mellitus. Clinical follow-up was obtained yearly. The trial was monitored and independent clinical event committee adjudicated serious adverse clinical events. The primary endpoint was target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR) at 1 year. Secondary endpoint included the composite of death or MI at 5-year follow-up. Results In total, 838 patients were enrolled of whom 422 patients with 476 lesions were randomly assigned to Genous EPC stent and 416 patients with 480 lesions to BMS. The mean age was 64 years, 74% were males and in 76% patients were treated in elective setting. At 1 year TLF had occurred in 3.6% (n=15) of the Genous arm and in 6.1% (n=25) of the BMS arm (p=0.094; risk difference of −2.5%). However, this difference disappeared, at 5-years of follow-up; TLF rate was 12.6% (n=51) in the Genous arm versus 14.3% (n=58) in the BMS arm (p=0.385; risk difference of −1.7%). The secondary objective of the composite death or MI at 5 years occurred in 11.6% (n=47) in the Genous arm and 9.9% (n=40) in the BMS arm (p=0.479; risk difference of 1.7%). At 5 years definite stent thrombosis (ST) occurred in 0.5% (n=2) of the Genous arm, no definite ST had occurred in the BMS arm (p=0.162). Conclusion TRIAS-LR trial showed no differences between Genous EPC and BMS throughout 5-year follow-up in patients considered as low risk of restenosis. Kaplan-Meier plot of composite endpoints Funding Acknowledgement Type of funding source: Private company. Main funding source(s): OrbusNeich Medical BV

Safety and efficacy of drug eluting stents vs bare metal stents in patients with atrial fibrillation: A systematic review and meta-analysis

ObjectiveA systematic review and meta-analysis was performed to evaluate the safety and efficacy of drug-eluting stents (DES) vs bare-metal stents (BMS) in atrial fibrillation (AF) patients. MethodsWe systematically searched 5 engines until May 2019 for cohort studies and randomized controlled trials (RCTs). Primary outcomes were major bleeding and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target vessel revascularization (TVR) or stent thrombosis. Effects of inverse variance random meta-analyses were described with relative risks (RR) and their 95% confidence intervals (CI). We also stratified analyses by type (triple [TAT] vs dual [DAT]) and duration (short-vs long-term) of antithrombotic therapy. ResultsTen studies (3 RCTs; 7 cohorts) including 10,353 patients (DES: 59.6%) were identified. DES did not show higher risk of major bleeding than BMS (5.6% vs 6.9%, RR 1.07; 95%CI, 0.89–1.28, p = 0.47; I2 = 0%) or MACE (12% vs 13.6%; RR 0.96; 95%CI 0.81–1.13, p = 0.60; I2 = 44%). Although, DES almost decreased TVR risk (6.4% vs 8.4%, RR 0.78; 95%CI, 0.61–1.01, p = 0.06; I2 = 15%). Stratified analyses by type and duration of antithrombotic therapy showed no differences in major bleeding or MACE between both types of stents. In DES, long-term TAT showed higher major bleeding risk than long-term DAT (7.7% vs 4.7%, RR 1.48, 95%CI 1.08–2.03, p = 0.01; I2 = 12%). For both types of stents, MACE risk was similar between TAT and DAT. ConclusionsIn patients with AF undergoing PCI, DES had similar rate of major bleeding and MACE than BMS. DAT seems to be a safer antithrombotic therapy compared with TAT.

Factors Associated With the Use of Bare Metal Stents in Patients With ST Elevation Myocardial Infarction

BackgroundDrug eluting stents (DES) are used in the majority of patients undergoing percutaneous coronary intervention (PCI). Factors associated with the use of bare metal stents (BMS) for patients undergoing primary PCI for ST elevation myocardial infarction (STEMI) have not been adequately explored. The objective of this study was to evaluate factors associated with BMS use in STEMI patients undergoing primary PCI. MethodsPatients undergoing primary PCI for STEMI between January 2008 and February 2015 were retrospectively identified. Patients who received both a DES and BMS were included in the DES group and patients receiving balloon angioplasty only were excluded. Baseline demographics, angiographic variables, procedure related variables and in-hospital events were collected. Multivariate analysis was performed to identify factors associated with BMS use. ResultsEight hundred and sixty-five patients underwent primary PCI for STEMI during the study period. Seventy-two patients (8.3%) received balloon angioplasty only and were excluded, yielding 793 patients for the study cohort. Three hundred fifty-two patients (44%) received BMS and 441 patients (56%) received DES. Patients receiving DES had a higher prevalence of diabetes mellitus, prior myocardial infarction, prior PCI, left anterior descending artery culprit location and Medicaid Insurance compared to those receiving BMS. Patients receiving BMS had a higher prevalence of cardiogenic shock and right coronary artery culprit location. Unadjusted in-hospital mortality was significantly higher for patients receiving BMS compared to patients receiving DES, 11.1% vs 3.2%, respectively, p < 0.0001. Multivariate predictors of BMS use were cardiogenic shock (OR 30.3; 95% CI 11.25 to 81.73) and diabetes mellitus (OR 2.99; 95% CI 1.04 to 8.64). ConclusionIn a contemporary series of patients undergoing primary PCI for STEMI, BMS were used in 44% of patients and independent factors associated with BMS use were cardiogenic shock and diabetes mellitus.

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk

BackgroundPolymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.MethodsIn an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus–coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.ResultsA total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P=0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P=0.007 for noninferiority).ConclusionsAmong patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.)

Long-term results of coronary artery bypass graft surgery after stenting of obstructed artery with bare metal stent in patients with acute coronary syndrome and multivessel disease

Non-optimal long-term results of endovascular interventions using bare metal stents and their wide use in Russia in acute coronary syndrome (ACS) make it important to study the influence of the mentioned interventions on the results of coronary artery bypass graft surgery (CABG) performed after stenting of the obstructed artery in patients with ACS and multivessel disease.&#x0D; Aim. To study the results of CABG performed at our department in early periods of ACS after stenting of an obstructed artery with bare metal stents versus the results of use of drug coated stents of the 2nd generation, on the basis of the data of NORSTENT study.&#x0D; Materials and Methods. The work presents the results of a two-year observation of stepwise treatment of 97 patients with ACS and multivessel disease who were performed stenting of an obstructed artery for life-saving indications followed by CABG not later than in 90 days. Patients of the main group had three-vessel disease of coronary arteries with severity of damage 26.03.2 points on SYNTAX scale. The time from the moment of stenting to complete revascularization was 6417 days. Clinico-demographic parameters of the main group were comparable with those of the comparison group (data of NORSTENT study).&#x0D; Results. During observation time two cases of acute myocardial infarction occurred. Repeat revascularization was required in 14 patients (14.4%). The rate of MACCE was 0.1443. Odd ratio (OR) of the risk of MACCE occurrence was 1.61 (95% CI [1.14;2.78]).&#x0D; Conclusion. Surgical revascularization of the coronary bed in early periods after stenting of the obstructed artery with bare metal stents in patients with ACS and multivessel disease has 1.6 times (95% CI 1.14;2.78) higher risk for initiation of adverse cardiovascular events, in comparison with endovascular revascularization with use of drug coated stents of the 2nd generation.

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.

SWEDEHEART-1-year data show no benefit of newer generation drug-eluting stents over bare-metal stents in patients with severe kidney dysfunction following percutaneous coronary intervention.

We hypothesized that the transition from bare-metal stents (BMS) to newer generation drug-eluting stents (n-DES) in clinical practice may have reduced the risk also in patients with kidney dysfunction. Observational study in the national SWEDEHEART registry, that compared the 1-year risk of in-stent restenosis (RS) and stent thrombosis (ST) in all percutaneous coronary intervention treated patients(n = 92 994) during 2007-2013. N-DES patients were younger than BMS, but had more often diabetes, previous myocardial infarction, previous revascularization and were more often treated with potent platelet inhibition. N-DES versus BMS, was associated with lower 1-year risk of RS in patients with estimated glomerular filtration rate (eGFR) >60 with a cumulative probability of 2.1% versus 5.3%, adjusted hazard ratio 0.30, 95% CI (0.27-0.34) and with eGFR 30-60: 3.0% versus 4.9%; hazard ratio 0.46 (0.36-0.60) but not in patients with eGFR <30: 8.1% versus 6.0%; hazard ratio 1.32 (0.71-2.45) (pinteraction = 0.009) as well as lower risk of ST for eGFR >60 and eGFR 30-60: 0.5% versus 0.9%; hazard ratio 0.52 (0.40-0.68) and 0.6% versus 1.3%; hazard ratio 0.54 (0.54-0.72) but not for eGFR <30; 2.1% versus 1.1%; hazard ratio 1.49 (0.56-3.98) (pinteraction = 0.027). N-DES is associated with lower 1-year risk of in-stent restenosis and stent thrombosis in patients with normal or moderately reduced kidney function but not in patients with severe kidney dysfunction, where stenting is associated with worse outcomes regardless of stent type.

One-Year clinical outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Background: Drug-eluting stents (DESs) have been shown to reduce the risk of restenosis and other adverse cardiac events after percutaneous coronary intervention (PCI) as compared with bare-metal stents (BMSs). However, the superiority of DES over BMS has been questioned in large vessels. We evaluated the risks and benefits of the use of DES versus BMS in patients who undergo stenting of large coronary arteries (≥3.5 mm) up to 1-year follow-up. Materials and Methods: This was a prospective study carried out in all-comer patients enrolled between January 2015 and December 2015. The patients with the variable indication for PCI, multivessel involvement, prior revascularization, and adjuvant drugs such as GP IIb–IIIa inhibitors were included in the study. However, patients who did not provide written informed consent and received both DES and BMS were excluded from the study. The clinical outcomes were evaluated at 1 year. Results: A total of 266 lesions (240 patients) in the large coronary arteries were stented, of which 130 lesions were treated with BMS and 136 lesions were treated with DES. At 1-year follow-up, target lesion revascularization/target vessel revascularization (P = 0.6492) and all-cause death (P = 0.7098) did not differ significantly between the two groups. In addition, no significant difference was found in patients requiring medical management (P = 0.3937) as well as number of asymptomatic patients (P = 0.2027). Conclusions: At 1-year follow-up, BMSs and DESs showed similar clinical outcomes in large coronary arteries. Hence, the use of BMS in large coronary arteries (≥3.5 mm) should not be discouraged unless clinically indicated.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial

BackgroundChronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS). The Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI) trial is designed to prospectively assess the patency of CS versus BMS in patients with atherosclerotic CMI.Methods/designThe CoBaGI trial is a randomized controlled, parallel-group, patient- and investigator-blinded, superiority, multicenter trial conducted in six centers of the Dutch Mesenteric Ischemia Study group (DMIS). Eighty-four patients with a consensus diagnosis of atherosclerotic CMI are 1:1 randomized to either a balloon-expandable BMS (Palmaz Blue with rapid-exchange delivery system, Cordis Corporation, Bridgewater, NJ, USA) or a balloon-expandable CS (Advanta V12 over-the-wire, Atrium Maquet Getinge Group, Hudson, NH, USA). The primary endpoint is the primary stent-patency rate at 24 months assessed with CT angiography. Secondary endpoints are primary stent patency at 6 and 12 months and secondary patency rates, freedom from restenosis, freedom from symptom recurrence, freedom from re-intervention, quality of life according the EQ-5D-5 L and SF-36 and cost-effectiveness at 6, 12 and 24 months.DiscussionThe CoBaGI trial is designed to assess the patency rates of CS versus BMS in patients treated for CMI caused by atherosclerotic mesenteric stenosis. Furthermore, the CoBaGI trial should provide insights in the quality of life of these patients before and after stenting and its cost-effectiveness. The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis.Trial registrationClinicalTrials.gov, ID: NCT02428582. Registered on 29 April 2015.

THE RESULTS OF STEP-BY-STEP MYOCARDIAL REVASCULARIZATION IN PATIENTS WITH ACUTE CORONARY SYNDROME AND MULTIVESSEL CORONARY ARTERY DISEASE: EARLY PERFORMING CORONARY ARTERY BYPASS SURGERY AFTER STENTING USING BARE-METAL STENTS

Objective: To compare the long-term results of coronary artery bypass grafting performed in the early period after stenting for acute coronary syndrome by bare-metal stents with the results of coronary artery bypass grafting in patients with coronary heart disease.Material and Methods. The results of 24-month follow-up of step-by-step treatment of patients with acute coronary syndrome and multivessel lesion who received stenting of clinical-dependent artery with bare-metal stents as the first step and, then, underwent functional myocardial revascularization by aortocoronary bypass surgery within 90 days were analyzed. Results are presented as mean value and standard deviation (M±SD) in case of normal distribution and median with interquartile range in the form of 25 and 75 percentiles in case of non-normal distribution. The type of distribution of quantitative variables was assessed by the Lilliefors-corrected Kolmogorov–Smirnov test. Efficacy and safety assessments were carried out according to the criteria of non-inferiority in comparison with the literature data of myocardial revascularization by stenting. The differences were estimated using a two-way 95% confidence interval of the difference in adverse events based on the selected noninferiority design.Results. Surgical revascularization of the coronary bed in the early period after stenting of the clinically dependent artery using bare-metal stents in patients with acute coronary syndrome and multivessel lesion was equivalent to coronary artery bypass grafting, except for the rate of repeated revascularization.

Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial

The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.

Drug-eluting compared to bare metal stents in patients with end-stage renal disease on dialysis: a meta-analysis.

To systematically review literature comparing bare metal stent (BMS) to drug-eluting stent (DES) in end-stage renal disease (ESRD) patients on dialysis. ESRD patients on dialysis often suffer from accelerated atherosclerosis and higher rate of stent-related complications including major adverse cardiovascular events. Because dialysis usually qualifies ineligibility for randomized clinical trials, an evidenced-based stent choice for these patients is scarce. PUBMED, CINHAL, COCHRANE, EMBASE and WEB OF SCIENCE were searched for studies comparing BMS vs. DES outcome in ESRD patients on dialysis. Twenty studies including 64 232 patients were considered. The use of DES was significantly associated with a reduction in all-cause mortality [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.76-0.89], death from a cardiovascular cause (OR 0.80, 95% CI 0.76-0.84) and target lesion revascularization/target vessel revascularization (OR 0.73, 95% CI 0.53-1.00). No significant difference was found in stent thrombosis (OR 1.08, 95% CI 0.50-2.33) and myocardial infarction incidence (OR 0.91, 95% CI 0.69-1.20). Our meta-analysis shows a significant reduction in all-cause and cardiovascular mortality with the use of DES over BMS in dialyzed patients. Despite the lack of randomized studies, systematic use of DES in these high-risk patients should thus reasonably be considered as a first option in percutaneous coronary intervention candidates.

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.