Impact of calcium on procedural and clinical outcomes in lesions treated with bioresorbable vascular scaffolds - A prospective BRS registry study

Background: There is limited data on the impact of calcium (Ca) on acute procedural and clinical outcomes in patients with lesions treated with bioresorbable vascular scaffolds (BRS). We sought to evaluate the effect of calcium on procedural and clinical outcomes in a 'real world' population. Methods: Clinical outcomes were compared between patients with at least 1 moderately or heavily calcified lesion (Ca) and patients with no/mild calcified lesions (non-Ca) enrolled in our institutional BRS registry. Results: 455 patients (N) with 548 lesions (L) treated with 735 BRS were studied. Patients in the Ca group (N = 160, L = 200) had more complex (AHA B2/C lesion: 69.0% in Ca vs 14.9% in non-Ca, p. <. 0.001) and significantly longer lesions (27.80. ±. 15.27 vs 19.48. ±. 9.92. mm, p. <. 0.001). Overall device success rate was 99.1% with no significant differences between the groups. Despite more aggressive lesion preparation and postdilation compared to non Ca, acute lumen gain was significantly less in Ca lesions (1.50. ±. 0.66 vs 1.62. ±. 0.69. mm, p = 0.040) with lower final MLD (2.28. ±. 0.41 vs 2.36. ±. 0.43, p = 0.046). There were no significant differences in all-cause mortality, total definite scaffold thrombosis (ST), target lesion revascularization and myocardial infarction between the 2 groups. Late ST was more frequent in the Ca group compared to non Ca group (late ST: 2.1 vs 0%, p = 0.02). Conclusions: Clinical outcomes after BRS implantation in calcified and non-calcified lesions were similar. A remarkable difference in timing of thrombosis was observed, with an increased rate of late thrombosis in calcified lesions

Are BVS suitable for ACS patients? Support from a large single center real live registry

Objectives To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. Background Robust data on the outcome of BVS in the setting of ACS is still scarce. Methods Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. Results From September 2012-Octob

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction

Aims: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI). Methods and results: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure. Conclusions: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes

Conformability in everolimus-eluting bioresorbable scaffolds compared with metal platform coronary stents in long lesions

The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm−1, p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (media

Bioresorbable Polymer Coated Metallic Stents and Fully Bioresorbable Scaffolds: Benefits and limitations in different coronary lesion subsets, -clinical and intracascular imaging results-

Percutaneous coronary intervention (PCI) which involves the deployment of devices such as metallic drug eluting stents (DES) in coronary artery lesions and concomitant dual antiplatelet therapy (DAPT) is one of the mainstays of management of coronary artery disease and has become one of the most common treatment procedure in contemporary medicine. Despite relatively good clinical results, contemporary metallic DES still face limitations such as a cumulative lifelong risk of restenosis requiring revascularisation and mechanical issues such as long term risk of strut fracture. Newer devices have since emerged such as newer generation DES with very thin struts with bioresorbable polymer as well as completely bioresorbable vascular scaffolds (BRS) which represent a novel approach in the treatment of coronary artery disease, by initially performing the function of metallic DES and yet having the potential for eventual device resorption avoiding a permanent nidus for very late clinical events. This thesis aims to investigate the outcomes and limitations of DES with bioresorbable polymer and BRS in the different clinical scenarios and lesions subsets using a combination of advanced imaging modality (Optical Coherence Tomography) and clinical registries to evaluate device performance such as BRS in specific clinical settings and larger patient populations respectively. OCT has been used to evaluate emerging technologies such as BRS and has become a safe and standard imaging modality to evaluate acute stent or scaffold performance in simple and complex lesions such as calcified lesions. While BRS implantation was associated with good acute procedural outcomes and satisfactory vessel healing at 6 months in certain clinical subsets such as ST elevation myocardial infarct (STEMI), clinical midterm follow-up data have highlighted cautionary findings such as increased risk of device thrombosis. The reasons for this are multifactorial and may be in part due to suboptimal implantation technique and cessation of DAPT before complete vessel healing takes place. Optimizing implantation technique and prolonged DAPT may improve clinical results. The impact of a dedicated implantation technique on clinical outcomes may be seen in newer prospective clinical trials involving the use of newer iterations of BRS and mandating the use of accurate vessel sizing, appropriate lesion selection and preparation and aggressive scaffold postdilation supported by the use of OCT. Till then, it remains highly likely that OCT and registry based studies would once again play a fundamental role in the evaluation of the next generation of BRS and help determine the optimal implantation strategy for future use

Review on Non-Invasive Risk Stratification of Sudden Cardiac Death

Sudden cardiac death (SCD) is one of the most significant and challenging problems facing modern medicine today given its unpredictable nature. The evaluation of the patient at risk for sudden cardiac death still remains a complex task. The use of ICDs (implantable cardioverter defibrillators) remains the mainstay of primary prevention of sudden cardiac death. However, much remains to be determined on how best to identify patients at high risk of sudden cardiac death who would most benefit from ICD implantations. This paper will review the current issues in the risk assessment of sudden cardiac death and non-invasive markers of sudden death

Conformability in everolimus-eluting bioresorbable scaffolds compared with metal platform coronary stents in long lesions

The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm-1, p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (median diastolic curvature from 0.305 to 0.283 cm-1, p = 0.056). Median Percentage relative change in diastolic curvature was lower in the BRS group compared with the MPS group (BRS vs. MPS: 7.48 vs. 29.4%, p = 0.013). By univariate analysis, use of MPS was an independent predictor of change in diastolic curvature (p = 0.022). In the deployment of long coronary scaffolds/stents (28 mm in length), BRS provides better conformability compared with MPS

Impact of Calcium on procedural and clinical Outcomes in Lesions treated with bioresorbable vascular Scaffolds - A prospective BRS Registry Study

BACKGROUND: There is limited data on the impact of calcium (Ca) on acute procedural and clinical outcomes in patients with lesions treated with bioresorbable vascular scaffolds (BRS). We sought to evaluate the effect of calcium on procedural and clinical outcomes in a 'real world' population. METHODS: Clinical outcomes were compared between patients with at least 1 moderately or heavily calcified lesion (Ca) and patients with no/mild calcified lesions (non-Ca) enrolled in our institutional BRS registry. RESULTS: 455 patients (N) with 548 lesions (L) treated with 735 BRS were studied. Patients in the Ca group (N=160, L=200) had more complex (AHA B2/C lesion: 69.0% in Ca vs 14.9% in non-Ca, p<0.001) and significantly longer lesions (27.80+/-15.27 vs 19.48+/-9.92mm, p<0.001). Overall device success rate was 99.1% with no significant differences between the groups. Despite more aggressive lesion preparation and postdilation compared to non Ca, acute lumen gain was significantly less in Ca lesions (1.50+/-0.66 vs 1.62+/-0.69mm, p=0.040) with lower final MLD (2.28+/-0.41 vs 2.36+/-0.43, p=0.046). There were no significant differences in all-cause mortality, total definite scaffold thrombosis (ST), target lesion revascularization and myocardial infarction between the 2 groups. Late ST was more frequent in the Ca group compared to non Ca group (late ST: 2.1 vs 0%, p=0.02). CONCLUSIONS: Clinical outcomes after BRS implantation in calcified and non-calcified lesions were similar. A remarkable difference in timing of thrombosis was observed, with an increased rate of late thrombosis in calcified lesions