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

OBJECTIVES: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BACKGROUND: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. METHODS: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. RESULTS: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). CONCLUSIONS: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.

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.

Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection.

OBJECTIVES: The authors sought to understand the clinical and angiographic outcomes of dissections left after drug-coated balloon (DCB) angioplasty. BACKGROUND: Second-generation DCB may be an alternative to stents in selected populations for the treatment of native coronary lesions. However, the use of these devices may be hampered by a certain risk of acute vessel recoil or residual coronary dissection. Moreover, stenting after DCB has shown limited efficacy. Little is known about when a non-flow-limiting dissection is left after DCB angioplasty. METHODS: This was a prospective observational study whose aim was to investigate the outcome of a consecutive series of patients with native coronary artery disease treated with second-generation DCB and residual coronary dissection at 2 Italian centers. We evaluated patient clinical conditions at 1 and 9 months, and angiographic follow up was undertaken at 6 months. RESULTS: Between July 2012 and July 2014, 156 patients were treated with DCB for native coronary artery disease. Fifty-two patients had a final dissection, 4 of which underwent prosthesis implantation and 48 were left untreated and underwent angiographic follow-up after 201 days (interquartile range: 161 to 250 days). The dissections were all type A to C, and none determined an impaired distal flow. Complete vessel healing at angiography was observed in 45 patients (93.8%), whereas 3 patients had persistent but uncomplicated dissections, and 3 had binary restenosis (6.2%). Late lumen loss was 0.14 mm (-0.14 to 0.42). Major adverse cardiovascular events occurred in 11 patients in the entire cohort and in 4 of the dissection cohort (7.2% vs. 8.1%; p = 0.48). We observed 8 and 3 target lesion revascularizations, respectively (5.3% vs. 6.2%; p = 0.37). CONCLUSIONS: In this cohort of consecutive patients treated with new-generation DCB and left with a final dissection, this strategy of revascularization seemed associated with the sealing of most of dissections and without significant neointimal hyperplasia.

Late Malapposition After Bare-Metal Stent, But Not Bioresorbable Scaffold: Insights on Intraindividual Heterogeneity in Plaque and Device Response.

We present a case of late acquired bare-metal stent malapposition and uncovered struts, visible at angiography and confirmed by optical frequency domain imaging. In the same patient, an everolimus-eluting biovascular scaffold in another vessel was well apposed and all struts were covered. This case highlights the potential heterogeneity in the evolution of atherosclerotic plaques and response to different devices in the same patient.

Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Effective Treatment of Intermediate-Risk Pulmonary Embolism by Manual Thrombus Aspiration. A Report of Two Cases.

Manual thrombectomy, part of the armamentarium of interventional cardiologists, might also be considered as an effective and safe alternative to manage intermediate/high risk acute PE patients with contraindications to thrombolysis or with acute haemodynamic decompensation. We here describe two cases with intermediate risk pulmonary embolism and severe hypoxaemia where manual thrombectomy with a 10F dedicated catheter was effective and improved clinical and haemodynamic parameters. Currently, there's no clear and effective treatment for these patients, thus we believe that this therapy, as current ESC guidelines suggest, should become a possible alternative to systemic thrombolysis and anticoagulant regimen.

Immediate and midterm outcomes following primary PCI with bioresorbable vascular scaffold implantation in patients with ST-segment myocardial infarction: insights from the multicentre "Registro ABSORB Italiano" (RAI registry).

AIMS: In this multicentre prospective registry we sought to evaluate the immediate and midterm clinical outcomes following single or multiple overlapping bioresorbable vascular scaffold (BVS) implantation in the STEMI setting. METHODS AND RESULTS: A prospective cohort analysis was performed on all STEMI patients who underwent primary PCI with BVS implantation. Between December 2012 and February 2014, 1,232 STEMI patients underwent primary PCI at the participating centres. Of these, 74 (6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping. Procedural success was obtained in 72 (97.3%) cases without differences between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One patient experienced a reinfarction due to subacute BVS thrombosis which was successfully managed with balloon-only PCI while the other patient had a "slow-flow" phenomenon (final TIMI flow 2). At six-month follow-up, two non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and one subacute BVS thrombosis were reported in three patients (one [5.6%] overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the events were successfully managed with re-PCI. CONCLUSIONS: BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.

Late coronary BVS malapposition and aneurysm: A Time for Appraisal.

Late strut malapposition of currently available stents is a major issue, associated with an increased risk of stent thrombosis. To this day, biovascular scaffolds showed an increased immediate risk of struts malapposition, that however resulted reduced after a few months. Little is known about late acquired struts malapposition of biovascular scaffolds. We here describe two cases that recently occurred in our patients, and we speculate on possible mechanisms for this unexpected and potentially lethal complication.

Comparison of risk of acute kidney injury after primary percutaneous coronary interventions with the transradial approach versus the transfemoral approach (from the PRIPITENA urban registry).

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication.

Direct stenting after thrombus removal before primary angioplasty in acute myocardial infarction.

OBJECTIVES: To verify whether direct stenting (DS) after thrombus removal during primary angioplasty (PPCI) in patients with ST-elevation acute myocardial infarction (STEMI) can improve myocardial reperfusion and prevent distal embolization compared to conventional stent implantation. BACKGROUND: Both mechanical removal and DS reduce thrombus dislodgment and improve microcirculatory reperfusion during PPCI. However, the additional effect of DS after thrombus removal has not been definitely assessed. METHODS: The DEAR-MI study included 148 consecutive STEMI patients who were randomly assigned to undergo or not thrombus aspiration before PPCI. For the purpose of the present study, we interrogated the DEAR-MI data bank to compare the occurrence of complete (>70%) ST-segment resolution (STR), myocardial blush grade (MBG)-3, no-reflow, and angiographic embolization in patients treated and untreated with DS. RESULTS: Clinical and angiographic characteristics were similar in the two groups. Comparing DS and no-DS groups, complete STR was found in 67% versus 51% (P = 0.08), MBG-3 in 86% versus 49% (P < 0.001), no-reflow in 1% versus 14% (P < 0.01), angiographic embolization in 3% versus 19% (P < 0.01), TIMI flow-3 in 89% versus 70% (P < 0.01), and the corrected TIMI frame count was 16.2 versus 18.8 (P < 0.05). Among patients undergoing thrombus aspiration, the odds ratio of DS for MBG-3 and distal embolization was 4 (95% CI 1-16.6) and 0.10 (95% CI 0.01-0.93), respectively. At multivariable analysis, thrombus aspiration (P < 0.001) and DS (P < 0.05) independently predicted MBG-3, while thrombus aspiration was the only independent predictor of DS. CONCLUSIONS: DS during PPCI reduces distal embolization and improves myocardial reperfusion. This effect is significantly more relevant after thrombus aspiration.

Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study.

OBJECTIVES: This study sought to test the hypothesis that thrombus removal, with a new manual thrombus-aspirating device, before primary percutaneous coronary intervention (PPCI) may improve myocardial reperfusion compared with standard PPCI in patients with ST-segment elevation acute myocardial infarction (STEMI). BACKGROUND: In STEMI patients, PPCI may cause thrombus dislodgment and impaired microcirculatory reperfusion. Controversial results have been reported with different systems of distal protection or thrombus removal. METHODS: One-hundred forty-eight consecutive STEMI patients, admitted within 12 h of symptom onset and scheduled for PPCI, were randomly assigned to PPCI (group 1) or manual thrombus aspiration before standard PPCI (group 2). Patients with cardiogenic shock, previous infarction, or thrombolytic therapy were excluded. Primary end points were complete (>70%) ST-segment resolution (STR) and myocardial blush grade (MBG) 3. RESULTS: Baseline clinical and angiographic characteristics were similar in the 2 groups. Comparing groups 1 and 2: complete STR 50% versus 68% (p < 0.05); MBG-3 44% versus 88% (p < 0.0001); coronary Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 78% versus 89% (p = NS); corrected TIMI frame count 21.5 +/- 12 versus 17.3 +/- 6 (p < 0.01); no reflow 15% versus 3% (p < 0.05); angiographic embolization 19% versus 5% (p < 0.05); direct stenting 24% versus 70% (p < 0.0001); and peak creatine kinase-mass band fraction 910 +/- 128 mug/l versus 790 +/- 132 mug/l (p < 0001). In-hospital clinical events were similar in the 2 groups. After adjusting for confounding factors, multivariate analysis showed thrombus aspiration to be an independent predictor of complete STR and MBG-3. CONCLUSIONS: Manual thrombus aspiration before PPCI leads to better myocardial reperfusion and is associated with lower creatine kinase mass band fraction release, lower risk of distal embolization, and no reflow compared with standard PPCI. (Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction; http://clinicaltrials.gov/ct/show/NCT00257153).

Efecto de la adenosina sobre la P50 y su relación con el 2, 3-difosfoglicerato / The efect of adenosin on the P50 and its relationship with the 2, 3 diphosphoglyceric acid

En 17 perros anestesiados mantenidos en condiciones estables de ventilación, temperatura y equilibrio ácido base, estudiamos los efectos de dosis crecientes de adenosina administrada por infusión continua, sobre la posición de la curva de disociación de la hemoglobina (CDH) y su relación con los niveles intraeritrocíticos de 2,3 difosfo glicerato (2,3 DPG). en todos los perros la CDH (en sangre arterial y venosa) se desplazó a la izquierda en forma significativa, excepto a la dosis de 120 ug/kg/min, en que la CDH se desplazó a la derecha, y a partir de 240 ug/kg/minla CDH se estabilizó en un nivel inferior al control. Estos cambios fueron paralelos con los experimentos, la frecuencia cardiaca y la presión arterial disminuyeron significativamente. Concluimos que la adenosina modifica la CDH desplazándola en general hacia la izquierda, y que ésto parece estar en relación con un cambio en los niveles intraeritrocíticos de 2,3-DPG