Bruno Loi

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: Results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS)

BACKGROUND Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Simplifying clinical risk prediction for percutaneous coronary intervention of bifurcation lesions: the case for the ACEF (age, creatinine, ejection fraction) score.

AIMS We aimed to appraise the predictive accuracy of a novel and user-friendly risk score, the ACEF (age, creatinine, ejection fraction), in patients undergoing PCI for coronary bifurcations. METHODS AND RESULTS A multicentre, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 in 22 Italian centres. Patients with complete data to enable computation of the ACEF score were divided into three groups according to tertiles of ACEF score. The primary endpoint was 30-day mortality. The discrimination of the ACEF score as a continuous variable was also appraised with area under the curve (AUC) of the receiver-operating characteristic. A total of 3,535 patients were included: 1,119 in the lowest tertile of ACEF score, 1,190 in the mid tertile, and 1,153 in the highest tertile. Increased ACEF score was associated with significantly different rates of 30-day mortality (0.1% in the lowest tertile vs. 0.5% in the mid tertile and 3.0% in the highest tertile, p<0.001), with similar differences in myocardial infarction (0.3% vs. 0.7% and 1.8%, p<0.001) and major adverse cardiac events (MACE, 0.5% vs. 1.2% and 4.3%, p<0.001). After an average follow-up of 24.4±15.1 months, increased ACEF score was still associated with a higher rate of all-cause death (1.3% vs. 2.4% and 11.0%, p<0.001), cardiac death (0.9% vs. 1.4% and 7.2%, p<0.001), myocardial infarction (3.4% vs. 2.7% and 5.7%, p<0.001), MACE (13.6% vs. 15.9% and 22.3%, p<0.001), and stent thrombosis (2.3% vs. 1.8% and 5.0%, p<0.001). Discrimination of ACEF score was satisfactory for 30-day mortality (AUC=0.82 [0.77-0.87], p<0.001), 30-day MACE (AUC=0.73 [0.67-0.78], p<0.001), long-term mortality (AUC=0.77 [0.74-0.81], p<0.001), and moderate for long-term MACE (AUC=0.60 [0.57-0.62], p<0.001). CONCLUSIONS The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality.

Early and long-term outlook of percutaneous coronary intervention for bifurcation lesions in young patients

BACKGROUND Coronary artery disease is most common in older patients, but may occur in younger subjects. The outlook of young patients after percutaneous coronary intervention (PCI) of challenging lesion subsets such as coronary bifurcations, is not established. We thus aimed to appraise the early and long-term results of PCI for bifurcations in young patients. METHODS A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between 2002 and 2006 in 22 Italian centers. Patients were divided in 2 groups: age ≤ 45 years, and age > 45 years. The primary end-point was long-term rate of major adverse cardiac events (MACE). RESULTS 4,314 patients were included: 195 (4.5%) in the younger group, and 4119 (95.5%) in the older group. 30-day outcomes did not show significant differences in MACE rates, with 1.0% in the ≤ 45 years group and 2.1% in the >45 years group (p=0.439), with death in 0.5% and 1.2% (p=0.388). At long-term follow-up (24.4 ± 15.1 months), younger patients showed similar rates of MACE, (12.8% vs. 16.6%, p=0.161), myocardial infarction (3.1% vs. 3.7%, p=0.633), target lesion revascularization (11.3% vs. 12.5%, p=0.627), or stent thrombosis (1.5% vs. 2.8%, p=0.294), despite an increased risk of death in older patients (1.0% vs. 5.0%, p=0.012). Even at extensive multivariable analysis, younger patients still faced a similar risk of MACE (HR=0.78 [0.48-1.27], p=0.318). CONCLUSIONS Despite their low age, young patients undergoing PCI for bifurcation face a significant risk of early and late non-fatal adverse events. Thus, they should not be denied careful medical management and follow-up.

Impact of Drug-Eluting Stents and Diabetes Mellitus in Patients With Coronary Bifurcation Lesions: A Survey From the Italian Society of Invasive Cardiology

Background—We investigated the long-term impact of different stent types and diabetes mellitus (DM) in patients undergoing percutaneous coronary intervention (PCI) of bifurcation lesions, based on a large multicenter survey endorsed by the Italian Society of Invasive Cardiology. Methods and Results—Relative benefits of drug eluting stent (DES) over bare metal stent (BMS) in patients with (n=1049) and without (n=3020) DM were analyzed with extensive multivariable adjustment. At 3 years, stenting with DES was associated with lower adjusted risk of major adverse cardiac events (MACE, adjusted hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.15 to 0.49, P<0.001), cardiac death, and target lesion revascularization in DM patients but failed to demonstrate any significant benefit in patients without DM. Conclusions—In a large observational registry with admitted potential for selection bias and residual confounding, DES in DM patients with coronary bifurcation lesions were associated with improved outcomes in terms of MACE, cardiac death, and repeat revascularization at long-term follow up. These figures were not replicated in non-DM subjects.

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.

Does pre-existing aortic regurgitation protect from death in patients who develop paravalvular leak after TAVI?

OBJECTIVE The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. METHODS AND RESULTS We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m2) showed better survival than those without dilatation (HR 8.63, p=0.001). CONCLUSIONS In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.

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.

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

One-year clinical performance of ABSORB bioresorbable vascular scaffold in patients presenting with acute coronary syndromes: Results from the RAI registry

To report 1‐year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population.

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies

Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non‐SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern.