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).

OBJECTIVES: 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. BACKGROUND: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. METHODS: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. RESULTS: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%). CONCLUSION: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

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).

OBJECTIVES: 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. © 2017 Wiley Periodicals, Inc.

Clinical findings after bioresorbable vascular scaffold implantation in an unrestricted cohort of patients with ST-segment elevation myocardial infarction (from the RAI registry).

BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12 h from symptom onset; 64 (20.2%) were late-comers (>12 h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12 months (IQR 6-20 months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; p = 0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; p = 0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; p = 0.7) and cardiac death (0.6% vs. 0.6%; p = 0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; p = 0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis: A Multicenter Italian Experience.

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.

Early mobilization after percutaneous catheterization and vascular closure with a novel device (Star-Close).

Arteriotomy closure devices used to obtain hemostasis at the end of cardiac catheterization represent a valid alternative to manual compression. We are the first to report on a series of 60 patients in whom a novel system was used, Star-Close, which obtains vessel closure by deployment of a clip at the puncture site. Subsequent early (2 hours) mobilization was obtained in 55 patients (92%). Unsuccessful device deployment occurred in 5 patients. We conclude that Star-Close is a novel arteriotomy closure device that, in selected patients, is safe and allows early deambulation after diagnostic cardiac catheterization.

Predictive value of associations between carotid and coronary artery disease in patients with acute coronary syndromes.

The present study evaluated the association among sonographic characteristics of carotid plaques, angiographic morphology of coronary lesions, and outcomes of patients who had acute coronary syndromes. In treatment-stratified Cox's proportional hazards regression analysis, hard carotid plaques and coronary lesions of complex morphology were found to be independent predictors of future cardiac events.

Impact of carotid arterial narrowing on outcomes of patients with acute coronary syndromes.

The present prospective observational study was conducted in 323 consecutive patients with acute coronary syndrome, 101 (31%) of whom were diagnosed with carotid arterial narrowing by ultrasonography. At follow-up, patients with carotid disease had a greater incidence of cardiovascular events than did those with normal carotid arteries. Outcomes of patients with concomitant carotid disease who underwent cardiac revascularization were similar to those who received conservative treatment.

The efficacy of statin therapy in patients with acute coronary syndromes and concomitant carotid disease.

BACKGROUND: Statins prevent recurrent ischemic coronary events after acute coronary syndrome (ACS) and improve cardiovascular outcome of patients with peripheral artery disease. AIM: We sought to evaluate the interrelationship between statin use, phenotype of carotid plaques as assessed by ultrasound, and outcome of patients with ACS and concomitant carotid disease. METHODS: A total of 337 consecutive patients with ACS were assessed by coronary angiography and Doppler ultrasound of the carotid arteries and followed up for a median period of 19 months. RESULTS: Carotid plaques were detected in 144 (42%) patients. Of these patients, 99 (69%) had echogenic carotid plaques and 45 (31%) had echolucent plaques. The groups did not differ significantly with regard to the lipid profiles, the prevalence of risk factors, and 1-vessel, 2-vessel, or 3-vessel coronary artery disease. During follow-up, 227 (67%) patients were receiving statins. We observed 14 cardiac deaths and 17 myocardial infarctions. After adjustment for treatment strategy (medical therapy or myocardial revascularization), patients with echolucent carotid plaques receiving statin therapy (n = 32, 71%) showed a better event-free survival than did patients with echolucent plaques not treated with statins (log-rank P = .038). In patients with echogenic carotid plaques, the benefit of statin therapy on event-free survival was less evident (log-rank P = .56). CONCLUSION: In patients with ACS and echolucent carotid plaques, statin therapy is associated with better event-free survival, while in patients with ACS and echogenic carotid plaques no clear benefit of statins is observed.

The extent of perfusion-F18-fluorodeoxyglucose positron emission tomography mismatch determines mortality in medically treated patients with chronic ischemic left ventricular dysfunction.

OBJECTIVES: The purpose of this study was to assess the determinants of mortality in a large group of patients with ischemic cardiomyopathy who are treated medically and the impact of the extent of viable tissue on prognosis. BACKGROUND: Whether the presence of viability drives mortality in patients with ischemic cardiomyopathy who are treated medically and whether the extent of viability is important are issues that are currently unclear. METHODS: Two hundred sixty-one patients with ischemic cardiomyopathy underwent positron emission tomography (PET) for assessment of viability. Prospective follow-up was obtained. RESULTS: Ninety-four patients were revascularized and 167 were not. The cardiac death rate was significantly less in the revascularized patients as compared with medically treated patients (13% vs. 24%, p < 0.05). In the revascularized patients, there was a trend toward better survival in patients with viable myocardium as compared with nonviable myocardium (3.5-year survival, 85% and 75% respectively, p = NS). In the medically treated group, age (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.2 to 3.7), presence of left bundle branch block (HR 3.4, 95% CI 1.6 to 7.2) and extent of perfusion-metabolism mismatch on PET (HR 1.36, 95% CI 1.1 to 1.6) predicted cardiac death during a median follow-up period of 2.1 years. The risk of cardiac death was not significantly increased when the extent of mismatch was < or =20% (HR 0.97, 95% CI 0.46 to 2.05) but was significantly increased when the extent of mismatch was >20% (HR 3.21, 95% CI 1.38 to 7.49). CONCLUSIONS: Medically treated patients with ischemic cardiomyopathy and large areas of viable myocardium on PET are at high risk for cardiac death.