Salvatore Geraci

Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective

AIMS Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. METHODS AND RESULTS Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. CONCLUSIONS Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.

Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score

AIMS The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the models usefulness in predicting adverse cardiac events. METHODS AND RESULTS The implantation technique and clinical outcomes of 1,736 lesions treated with BVS were analysed using the GHOST-EU registry. Predilation, scaffold sizing, and post-dilation (PSP) were scored according to the hazard model derived from the weight of these variables. The primary endpoint was a one-year device-oriented composite endpoint (DoCE) composed of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation. Definite/probable scaffold thrombosis was also evaluated as defined by the Academic Research Consortium. The PSP model performance was evaluated by internal validation. Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of one-year DoCE (HR 0.75, 95% CI: 0.61-0.93; p=0.007), but with poor calibration and discrimination (AUC 0.611, 95% CI: 0.545-0.677). No patient with a maximum PSP-1 score had scaffold thrombosis, compared to those with a non-maximum PSP-1 score (0% vs. 2.3%; p=0.095). CONCLUSIONS At one-year follow-up, the PSP-1 score was an independent predictor of DoCE. External validation and prospective studies are needed to determine the clinical usefulness of this score.

Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions: Insights from the GHOST-EU registry

AIMS We aimed to investigate the outcomes of bioresorbable vascular scaffolds (BVS) in coronary ostial lesions. Ostial lesions represent a challenging angiographic subset, with higher event rates compared with non-ostial lesions. BVS might be associated with advantages over the long term, but their safety in this setting remains to be explored. METHODS AND RESULTS Procedural and 12-month follow-up data from consecutive patients treated with BVS for lesions located at the ostium of the right (RCA), left anterior (LAD) or circumflex (LCX) coronary in 11 European centres were collected. The primary device-oriented endpoint was defined as a combination of cardiovascular death, target vessel myocardial infarction or target lesion revascularisation. The database included a total of 1,549 lesions in 1,304 patients with a mean age of 62±11years. There were 90 ostial lesions (5.8%) in 84 patients (6.4%) located at the ostial RCA (14; 16%), LCX (29; 32%), or LAD (47; 52%). Patients presenting with ostial lesions did not differ from the remaining cohort except for a higher incidence of prior revascularisation. Predilation was performed in 97% of the lesions (vs. 96% in non-ostial, p=0.618), post-dilation in 43% (versus 58% in the non-ostial group, p=0.008). At quantitative coronary angiography, treatment of ostial lesions was associated with higher residual stenosis (30% [23-41] vs. 26% [20-37], p=0.035), but no difference in minimum lumen diameter existed (p=0.447). Follow-up data were available at 385 [362-465] days. The 12-month Kaplan-Meier estimated rates of scaffold thrombosis were 4.9% and 2.0% (ostial and non-ostial lesion groups, respectively, log-rank p=0.005). The device-oriented composite endpoint occurred, respectively, in 12.6% and 4.6% at 12 months (log-rank p=0.001). Treatment of ostial lesions was an independent predictor of this endpoint (p=0.0025, HR 2.65 [1.41-4.97]). CONCLUSIONS In combination with a suboptimal implantation technique, treatment of coronary ostial lesions was an independent predictor of clinical events in a cohort of patients treated with BVS.

Bioresorbable vascular scaffold use for coronary bifurcation lesions: A substudy from GHOST EU registry

The aim of this study was to evaluate midterm outcomes of bioresorbable vascular scaffolds (BVS) implanted in bifurcation lesions.

1-Year Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents: A Propensity-Matched Comparison of the GHOST-EU and XIENCE V USA Registries.

OBJECTIVES The purpose of this study was to compare the 1-year outcomes of the ABSORB everolimus-eluting bioresorbable scaffold (BRS) (Abbott Vascular, Santa Clara, California) and the XIENCE everolimus-eluting stent (EES) (Abbott Vascular) in patients undergoing percutaneous coronary intervention. BACKGROUND Randomized studies of the ABSORB BRS have been performed in selected patient and lesion scenarios. The available registries of the ABSORB BRS reflect real-world practice more closely compared with randomized studies, but most of them are limited by the small sample size and the lack of comparative outcomes versus second-generation drug-eluting stents. METHODS A total of 1,189 consecutive patients treated with ABSORB BRS from the GHOST-EU (Gauging coronary Healing with bioresorbable Scaffolding plaTforms in EUrope) registry and 5,034 patients treated with XIENCE EES from the XIENCE V USA registry were analyzed. Clinical outcomes were compared with the use of propensity-score matching techniques and reported as Kaplan-Meier estimates and absolute risk difference (D) with 95% confidence intervals (CIs). The primary endpoint was a device-oriented composite endpoint, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1-year follow-up. RESULTS After propensity score matching was performed for the entire population (N = 6,223), there were 905 matched pairs of patients. In the matched cohort (N = 1,810), there was no significant difference between ABSORB BRS and XIENCE EES in the risk of device-oriented composite endpoint at 1 year (5.8% vs. 7.6%, D = -1.8 [95% CI: -4.1 to 0.5]; p = 0.12). Cardiac death was less likely to occur in the ABSORB BRS group (0.7% vs. 1.9%, D = -1.2 [95% CI: -2.2 to 0.2]; p = 0.03), and a trend toward a reduction in myocardial infarction was noted with ABSORB BRS compared with XIENCE EES (2.4% vs. 4.0%, D = -1.6 [95% CI: -3.2 to 0.0]; p = 0.07). Conversely, no differences in ischemia-driven target lesion revascularization (4.6% vs. 3.5%, D = 1.1 [95% CI: -0.7 to 2.9]; p = 0.22) and definite or probable device thrombosis (1.8% vs. 1.1%, D = 0.7 [95% CI: -0.4 to 1.8]; p = 0.23) were detected between ABSORB BRS and XIENCE EES. CONCLUSIONS In a contemporary large cohort of patients undergoing percutaneous coronary intervention with ABSORB BRS, the combined rate of ischemic events at 1 year was low and nonsignificantly different compared with matched patients treated with XIENCE EES.

Impact of overlapping on 1‐year clinical outcomes in patients undergoing everolimus‐eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST‐EU registry

Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. Objective: To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no‐overlap BRS. Methods: We analyzed the 1‐year clinical outcomes of 1,477 patients treated with BRS in the GHOST‐EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all‐cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. Results: A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no‐overlap BRS (no‐overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre‐ and postdilatation. At 1‐year, there were no differences in PoCE between the overlap versus no‐overlap group (18.4% vs. 18.2%; HR 1.07, [0.80–1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48–2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one‐month (1.3% vs. 1.5%, P = 0.769) or at 1‐year (1.9% vs. 2.1%, P = 0.823). Conclusions: In “Real‐world” clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no‐overlapping BRS. These preliminary data should be confirmed.

Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: The "no more metallic cages" multicentre pilot experience

AIMS Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). METHODS AND RESULTS A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. CONCLUSIONS Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes.

Acute coronary syndrome due to early multiple and complete fractures in sirolimus‐eluting stent: A case report and brief literature review

Despite drug eluting stents (DES), as compared to bare metal stents, have reduced in‐stent restenosis, complex and long lesions remains a challenge for interventional cardiologist. Their treatment is often associated with an unfavorable outcome, related to in‐stent restenosis, stent thrombosis, and target lesion revascularization. These complications may derive from the contact between metallic structures and coronary artery endothelium, and consequent overexpression of platelet activating factors, growth factors, and inflammatory cytokines. Recently, an additional mechanism has emerged as new cause of these complications: “stent fracture.” Several factors are involved in this phenomenon including material and stent platform, target vessel features, stent implantation technique, and implant duration. We reported a case of 69 years old man with rare early and complex DES fractures on right coronary that caused acute coronary syndrome 36 hr after a previous percutaneous coronary intervention.© 2012 Wiley Periodicals, Inc.

Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica

Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.

Twelve-month outcomes after bioresorbable vascular scaffold implantation in patients with acute coronary syndromes. Data from the European Multicenter GHOST-EU Extended Registry

AIMS The aim of this study was to report on the midterm outcomes of patients undergoing percutaneous coronary intervention with bioresorbable vascular scaffolds (BVS) for the treatment of acute coronary syndromes (ACS) and compare with those of patients with stable coronary artery disease (sCAD). METHODS AND RESULTS One thousand four hundred and seventy-seven (1,477) patients underwent implantation of one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 11 European centres and were included in the GHOST-EU registry. Admissions comprised 47.1% of the patients (951 BVS) with ACS, and 52.8% (1,274 BVS) with sCAD. During a median follow-up of 384 (359-460) days, patient-oriented endpoints (PoCE), including all-cause death, any infarction, any revascularisation, were recorded in 271 patients (12-month incidence in ACS patients: 18.5% vs. 11.6% in the sCAD group, p<0.001). Device-oriented composite endpoints (DoCE), cardiac death, target vessel infarction and target lesion revascularisation, were observed in 98 patients (12-month incidence of 4.2% in the sCAD group, 6.4% in the ACS group; p=0.052). The 12-month incidence of definite scaffold thrombosis was 2.6% in ACS patients and 0.8% in XIENCE patients (p=0.006). In multivariate analysis, ACS was a predictor of DoCE (HR: 2.26 [1.34-3.81], p=0.002), PoCE (HR: 1.71 [1.13-2.58], p=0.011), and stent thrombosis (HR: 2.51 [1.13-5.60], p=0.025). In contrast, the incidence of target lesion revascularisation was not different between groups. There was no difference in the incidence of any of these endpoints among the different clinical presentations (unstable angina, non-ST-elevation infarction and ST-elevation infarction). CONCLUSIONS PoCE, DoCE and scaffold thromboses were more frequent in ACS patients, without any difference among different forms of ACS.