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The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients. In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6–8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324. We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; pnon-inferiority=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (pnon-inferiority=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; psuperiority<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups. By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. Deutsches Herzzentrum.

Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm2 [SD 1·15] post-procedure vs 6·21 mm2 [1·22] at 6 months) with a low mean neointimal area (0·08 mm2 [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Biotronik AG.

Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Background Drug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed. Methods The data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors. Results All patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups ( p  < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939–17.567 P  < 0.001) and length of lesion (OR:1.046 95% CI: 1.001–1.093 P  = 0.046) were associated risk factors. Conclusions The longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings. Trial registration No.: NCT04213378, first posted date (30/12/2019).

Incidence, predictors, and impact on prognosis of target lesion revascularization (TLR) for patients treated with second-generation drug-eluting stents (DESs) on unprotected left main (ULM) remain to be defined. The present study is a multicenter study including patients treated with a second-generation DES on ULM from June 2007 to January 2015. Rate of TLR was the primary end point. All cause death, myocardial infarction, target vessel revascularization, and stent thrombosis were the secondary end points. A total of 1,270 patients were enrolled: after a follow-up of 650 days (230 to 1,170), 47 (3.7%) of them underwent a re–percutaneous coronary intervention TLR on the left main, 22 during a planned angiographic follow-up. Extent of coronary artery disease was similar among groups (median value of Syntax of 27 ± 10 vs 26 ± 9, p = 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM, 56% presented with a focal restenosis, 33% diffuse and 10% proliferative. At multivariate analysis, insulin-dependent diabetes mellitus increased risk of TLR (hazard ratio [HR] 2.0: 1.1 to 3.6, p = 0.04), whereas use of intravascular ultrasound resulted protective (HR 0.5: 0.3 to 0.9, p = 0.02). At follow-up, rates of cardiovascular death did not differ among the 2 groups (4% vs 4%, p = 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1 to 1.6, p = 0.22), whereas cardiogenic shock and III tertile of Syntax portended a worse prognosis (HR 4.5: 2.1 to 10.2, p = 0.01 and HR 1.4: 1.1 to 1.6, p = 0.03, respectively). In conclusion, repeated revascularization after implantation of second-generation DES on ULM represents an unfrequent event, being increased in insulin-dependent patients and reduced by intravascular ultrasound. Impact on prognosis remains neutral, being related to clinical presentation and extent of coronary artery disease.

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

•Randomized multicenter clinical trial comparing a sirolimus eluting balloon with standard of care (including at least 80% drug-eluting stents and up to 20% balloon angioplasty) for treatment of in-stent restenosis with 1 or 2 layers of previous stents.•The study will assess noninferiority of the sirolimus-eluting balloon with the current standard of care as the primary endpoint.•In sequential testing the study will also assess noninferiority and then superiority of the sirolimus eluting balloon versus drug-eluting stents in patients with single previous layer of stent. Repeat drug-eluting stenting is superior to balloon angioplasty for prevention of recurrent in-stent restenosis (ISR), but carries a potential disadvantage of multiple layers of stent. The safety and effectiveness of a sirolimus drug-eluting balloon as an alternative has not been assessed. The SELUTION4ISR trial is a prospective, multicenter, single-blinded, randomized, controlled trial. A total of 418 subjects with bare metal or drug-eluting stent (DES) ISR with up to 2 previous stent procedures at the target lesion, lesion length <26 mm and reference diameter ≥2.0 mm - ≤4.5 mm will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB (SLR DEB) or standard of care (SOC), which includes either repeat DES or balloon angioplasty without drug coating. A subset of subjects will undergo planned angiographic and optical coherence tomography follow-up. The primary endpoint will be target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months follow-up. The study will sequentially assess noninferiority of the SLR DEB to SOC in the overall cohort, followed by noninferiority then superiority of the SLR DEB to DES in the cohort with only 1 previous stent at the target lesion. The trial is registered at Clinicaltrials.gov (NCT04280029). The trial completed enrollment in July 2024. The SELUTION4ISR study will evaluate the safety and effectiveness of SLR DEB in a prospective, randomized, international, multicenter trial for treatment of coronary ISR.

Sirolimus-eluting stents and paclitaxel-eluting stents both reduce the risk of restenosis after percutaneous coronary intervention as compared with bare-metal stents. In a randomized trial, the two types of drug-eluting stents were compared in patients undergoing revascularization. The sirolimus-eluting stents were associated with fewer major adverse cardiac events at nine months, primarily as a result of reductions in the rates of clinical and angiographic restenosis. The two types of drug-eluting stents were compared in patients undergoing revascularization. The sirolimus-eluting stents were associated with fewer major adverse cardiac events, primarily as a result of reductions in the rates of clinical and angiographic restenosis. The use of drug-eluting stents that deliver site-specific, controlled release of therapeutic agents 1 – 10 has significantly reduced the problem of restenosis inherent to bare-metal stents. 11 – 16 As compared with a bare-metal stent, a polymer-encapsulated stent releasing sirolimus reduced the rate of angiographic and clinical restenosis in several randomized trials. 1 , 2 , 5 , 7 , 9 Similarly, a polymer-based, paclitaxel-eluting stent consistently reduced the rate of restenosis and the need for repeated revascularization procedures, as compared with a bare-metal stent. 3 , 4 , 10 A recent meta-analysis of trials of drug-eluting stents confirmed that sirolimus-eluting stents and paclitaxel-eluting stents reduced the rate of restenosis. 17 The . . .

Drug-eluting coronary-artery stents are more effective than bare-metal stents in reducing the frequency of coronary restenosis in patients with diabetes. In a randomized, controlled trial in patients with diabetes, the sirolimus-eluting stent was associated with a smaller extent of late luminal loss than was the paclitaxel-eluting stent, suggesting that the risk of restenosis was also reduced. In patients with diabetes, the sirolimus-eluting stent was associated with a smaller extent of late luminal loss than was the paclitaxel-eluting stent, suggesting that the risk of restenosis was also reduced. Coronary artery disease is a major cause of complications and death among patients with diabetes mellitus. 1 In particular, patients with diabetes are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. 2 – 4 Percutaneous coronary intervention and aortocoronary bypass surgery are recommended revascularization strategies for such patients. However, because of the increased risk of restenosis after percutaneous coronary interventions in these patients, 5 – 7 aortocoronary bypass surgery has been considered to be the preferred revascularization strategy for many. 8 , 9 Drug-eluting stents markedly reduce the incidence of restenosis as compared with bare-metal stents, both in . . .

In-stent restenosis (ISR) still occurs after percutaneous coronary intervention (PCI). Few studies have compared the outcomes of PCI for de novo stenosis with those of PCI for ISR, and the results are conflicting. The present study aimed to conduct this comparison. Using patient-level data from the randomized all-comer SORT OUT studies III to X, we included all patients with previous PCI and either an ISR or a de novo lesion as the study target lesion. Outcomes of interest were major adverse cardiac events (MACE) and target lesion revascularization (TLR) after 5 years. Of the 2,928 patients with a previous PCI included in the SORT OUT studies, 491 (17%) were treated for ISR and 2,437 (83%) for a de novo stenosis. Baseline characteristics did not differ significantly. At 5 years, MACE occurred in 148 patients (32%) in the ISR group and 654 patients (28%) in the de novo stenosis group (crude and adjusted hazard ratio 1.16 [95% confidence interval (CI) 0.97 to 1.38] and 1.16 [95% CI 0.97 to 1.38]). The risk of TLR was higher in the ISR group compared with the de novo stenosis group (crude and adjusted hazard ratio 1.64 [95% CI 1.24 to 2.17] and 1.71 [95% CI 1.27 to 2.30]). In conclusion, the risk of MACE was similar between PCI for ISR and PCI for de novo lesions after 5 years. However, the risk of TLR was higher in the ISR group compared with the de novo stenosis group.