Giulia Masiero

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.

Efficacy and safety of potent platelet P2Y12 receptor inhibitors in elderly versus nonelderly patients with acute coronary syndrome: A systematic review and meta-analysis

Background The use of the potent oral P2Y12 inhibitors prasugrel and ticagrelor in patients with acute coronary syndromes (ACS) has a favorable net clinical effect compared with clopidogrel and is recommended as first‐line therapy. However, the impact of these agents on ischemic and bleeding events in elderly ACS patients is not well defined. Methods We performed a systematic review of articles comparing potent P2Y12 inhibitors to clopidogrel in elderly and nonelderly patients (defined according to each study) with ACS in terms of efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (major bleeding) end points. Results A total of 7,860 elderly and 37,857 nonelderly patients from 7 studies (5 randomized control trials and 2 observational studies) were included. Potent P2Y12 inhibitors significantly reduced efficacy end point in nonelderly patients (relative risk [RR] 0.85, 95% CI 0.79–0.93) and less so in elderly patients (RR 0.95, 95% CI 0.86–1.05). No significant differences were found between potent P2Y12 inhibitors and clopidogrel in terms of safety end point in both elderly (RR 1.19, 95% CI 0.95–1.49) and nonelderly patients (RR 1.16, 95% CI 0.95–1.41). There were no significant interactions between age and treatment effect in both analyses (efficacy Pint = .16; safety Pint = .83). Conclusions The effect of more potent P2Y12 inhibitors compared with clopidogrel on efficacy and safety end points is consistent in elderly and younger patients. These data imply that potent P2Y12 inhibitors should not be withheld from eligible patients solely because of advanced age.

Current concepts on coronary revascularization using BRS in patients with diabetes and small vessels disease

Diabetes mellitus (DM) and small vessel (SV) disease are two major predictors of adverse outcome in patients treated by percutaneous coronary intervention (PCI), even when last generation metallic drug-eluting stents (DES) are used. Bioresorbable scaffold (BRS) technology has been recently developed to overcome the disadvantages of metallic DES due to their permanent struts. Through the resorption process, BRS may provide a vascular restoration that appears very attractive especially when distal or diffusely diseased coronary segments are involved, as in diabetic patients and SV disease. However, robust evidence on the use of BRS in diabetics is lacking, and recent data have raised concerns on the use of BRS in SVs, particularly when reference vessel diameter (RVD) is <2.25 mm. This review aims at summarizing current evidence related to the use of BRS in diabetics and SV disease.

Impact of atrial fibrillation on outcomes of patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis

BACKGROUND Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF. METHODS Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding. RESULTS Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P<.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P<.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P<.0001) and late follow-up (OR 1.92, P<.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002). CONCLUSIONS AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

[High-risk ST-elevation acute coronary syndrome in a patient with multivessel coronary artery disease complicated by refractory cardiogenic shock undergoing complex percutaneous coronary revascularization: role and timing of mechanical circulatory support devices]

Cardiogenic shock (CS) following acute myocardial infarction complicated by severe ventricular dysfunction remains the leading cause of death despite customized pharmacological therapy and optimal revascularization. The use of temporary mechanical circulatory support (MCS) devices during refractory CS might represent the only chance of survival to address the underlying systemic inflammatory response preventing the development of multiorgan failure. We report the case of a patient with a very-high-risk non-ST-elevation acute coronary syndrome and multivessel calcific coronary artery disease complicated by refractory CS undergoing complex percutaneous coronary revascularization. We show a gradual and complementary use of MCS devices tailored on hemodynamic monitoring, clinical and laboratory variables and multidisciplinary collaboration to early recognize the downward spiral that may ensue with multiorgan dysfunction or potential complications leading to death.

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.

TAVR with mechanically expandable prostheses: Is balloon aortic valvuloplasty really necessary?

BACKGROUND The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV. METHODS AND RESULTS Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV. Mean baseline aortic valve area was 0.41±0.14cm2/m2; mean transvalvular gradient was 50.2±16.2mmHg. All patients were successfully implanted, with 96.6% device success (VARC-2 definition) and 0% intra-procedural mortality. Partial and full valve repositioning were performed in 11 (36.7%) and 2 (6.7%) cases, respectively. Mean 30-day transprosthetic gradient was 11.3±3.6mmHg, with an effective aortic orifice area of 1.0±0.2cm2/m2, and more than mild paravalvular leakage (PVL) in only one patient. At 30days, cardiac mortality was 3.3%, and 96.3% of subjects were NYHA Class I or II. The rate of life-threatening bleeding was 10%; one patient experienced disabling stroke. Ten patients underwent new pacemaker implantation (38%). CONCLUSIONS TAVR with the mechanically expandable Lotus Valve seems feasible without performing preparatory BAV. Valve hemodynamics at 30-days were favorable, and clinical outcomes were similar to studies employing routine preparatory BAV.