Attilio Varricchio

Bioresorbable vascular scaffold implantation for the treatment of coronary in-stent restenosis: Results from a multicenter Italian experience

This multicenter experience sought to investigate the feasibility and safety of BVS for the treatment of ISR. From April 2012 to June 2014, a total of 315 patients (334 lesions) underwent PCI for ISR at the participating centers. Of those, 83 patients (90 lesions) received BVS. Procedural success was achieved in all patients. At a median of 7 (IQR 3-18) months follow-up, MACCE rate was 12%, TLR 7.7%, while one (1.1%) definite BVS-in-stent thrombosis was reported. The results of this multicenter experience suggest that BVS implantation for the treatment of coronary ISR is technically feasible and associated with favorable mid-term clinical results. These data could be considered hypothesis generating for a future randomized clinical trial.

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis

Background—Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions. Methods and Results—A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan–Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5–6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1–14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5–10.8, P=0.309). Conclusions—Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.

Bioresorbable vascular scaffolds for small vessels coronary disease: The BVS-save registry.

In this study, we investigated long‐term results following bioresorbable vascular scaffold (BVS) implantation in small coronary arteries.

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST‐elevation myocardial infarction (STEMI) patients.

Clinical outcomes of overlapping versus non-overlapping everolimus-eluting absorb bioresorbable vascular scaffolds: An analysis from the multicentre prospective RAI registry (ClinicalTrials.gov identifier: NCT02298413)

To compare clinical outcomes of patients treated with overlapping versus non‐overlapping Absorb BVS. Background: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. Methods: We compared outcomes of patients receiving overlapping or non‐overlapping Absorb BVS in the multicenter prospective RAI Registry. Results: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non‐overlap group. The most frequent overlap configuration was the marker‐to‐marker type (48%), followed by marker‐over‐marker (46%) and marker‐inside‐marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow‐up of 368 days, no difference was observed between overlap and non‐overlap groups in terms of a device‐related composite endpoint (cardiac death, TV‐MI, ID‐TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient‐related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device‐ or patient‐related composite endpoints. Conclusions: Outcomes of patients with or without overlapping BVS were comparable at mid‐term follow‐up despite higher angiographic complexity of the overlap subset.

TCT-425 Bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the Italian multicenter RAI Registry

RESULTS A total of 207 patients with at least one SV were included in this analysis. Mean follow-up time was 22.4 months 14.9 with 85.8 % of patients having at least 1 year of follow-up. Clinical presentation of pts. (72.4% male, mean age 58.5 11.7 years, 16.4% diabetics, 25.6% with previous PCI and/or CABG) was ACS in 55.1%. Multivessel treatment was perfomed in 17,9% (37 pz). Mean lesion length by QCA was 23.7 11.0 mm and mean RVD was 2.2 0.3 mm with 14.5% of moderate/sever calcification lesions and 19.8 % of bifurcation treatment. Pre-dilatation was performed in 93.2% and post-dilatation in 57.9%. The mean scaffold length was 28.1 15.0 mm with 30.9% of cases using overlapping scaffolds. OCT or IVUS was used in 26.0%. Device success was 99.0% (failure to deliver in 2 pts). Over the entire follow-up period, death occurred in 3.4 % (7/207), myocardial infarction (MI) in 5.3% (11/207), target lesion revascularization in 7.2 % (15/207), target vessel revascularization (TVR) in 8.2% (17/207), non-target vessel revascularization in 2.9 (6/207) %. Overall MACE (death, MI, TVR) rate was 12.0% (25/207). Definite stent thrombosis (ST) occurred in 6 pts. (2.9%), of whom early ST occurred in 4 pts and late ST in 2 pts.

Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry.

BACKGROUND/PURPOSE Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. METHODS/MATERIALS Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. RESULTS A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6±15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). CONCLUSIONS Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial.

Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study)

to compare the 1‐year outcome between bioresorbable vascular scaffold (BVS), everolimus‐eluting stent (EES), and drug‐eluting balloon (DEB) for in‐stent restenosis (ISR) treatment.

Meta-Analysis Comparing Outcomes After Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents in Patients with Acute Coronary Syndromes

Acute coronary syndromes (ACS) may represent an intriguing clinical scenario for implantation of bioresorbable vascular scaffold (BRS). Nevertheless, the knowledge about the performance of these devices in patients with ACS is limited. Therefore, we performed a meta-analysis of clinical studies aiming to assess the safety and efficacy of everolimus-eluting-BRS versus everolimus-eluting-metallic stents (EES) in ACS patients undergoing percutaneous coronary intervention. Six studies enrolling 2,318 patients were included and analyzed for the risk of primary safety outcome (stent or scaffold thrombosis [ST/ScT]), primary efficacy outcome (target lesion revascularisation [TLR]), and secondary outcomes (myocardial infarction, cardiac death, all-cause death). Median follow-up was 9.5 (6 to 19.5) months. Patients treated with BRS had a significantly higher risk of definite ST/ScT compared with those receiving EES (2.3% vs 1.08%, odds ratio [OR] 2.22, 95% confidence interval [CI] 1.10 to 4.45, p = 0.03, I2 = 0%). Similarly, the risk of TLR was significantly higher in the BRS compared with EES group (3.5% vs 2.5%, OR 1.79, 95% CI 1.02 to 3.16, p = 0.04, I2 = 0%). When TLRs due to thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR 1.19, 95% CI 0.48 to 2.98, p = 0.71, I2 = 25%). Risk for secondary endpoints did not differ between the 2 groups. Results were confirmed when clinical and procedural variables were tested as potential effect modifiers in the meta-regression analysis for both primary endpoints. In conclusion, compared with those receiving EES, patients with ACS treated with BRS had increased risk of definite device thrombosis and TLR at mid-term follow-up.

TCT-408 Thirty-day Outcome Following Polymeric Bioresorbable Scaffold Implantation in 347 STEMI Patients Enrolled in the Multicenter “Registro Absorb Italiano” (RAI Registry)

2.5-27; p<0.001), quantitative coronary angiography-derived reference vessel diameter less than 2.4 mm (HR 2.4; C.I. 1.9-18; p1⁄4 0.002), diabetes mellitus (HR 3.7; C.I. 1.2-11; p1⁄40.02) and lack of predilatation (HR 5.26; C.I. 1.1-25; p 0.03) were associated with increased DOCE. In OCT-guided cases (n1⁄4201), operators used larger predilatation balloons (2.86 0.40 vs 2.75 0.36 mm; p1⁄40.01), more 1:1 predilatation (55% vs 30%; p<0.001) and higher scaffold deployment pressures (14.37 1.76 atm vs 13.72 1.71 atm; p<0.001). Similar postdilatation rates (90%) were achieved in both groups. Use of OCT was associated with a significant increase in procedural time (80 18 vs 60 18 min.), x-ray exposure (10808 5131 vs 747