Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry results.

OBJECTIVES: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS). BACKGROUND: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant. METHODS: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up. RESULTS: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%. CONCLUSIONS: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.

Transradial versus transfemoral ancillary approach in complex structural, coronary, and peripheral interventions. Results from the multicenter ancillary registry: A study of the Italian Radial Club.

OBJECTIVES: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. BACKGROUND: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. METHODS: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings. RESULTS: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients. CONCLUSIONS: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.

New CoreValve Evolut 23 mm technology for treatment of degenerated bioprosthesis.

The treatment of degenerated surgical bio-prosthetic heart valves (BHV) has been reported as a novel indication for TAVI. The intervention may be complicated by high residual transvalvular gradients and coronary ostia obstruction, especially in small size BHV. We report two cases of BHVs treated with the new CoreValve Evolut 23 mm highlighting the importance of fluoroscopic guidance, based on BHV markers, in achieving a correct TAVI implantation. The small dimensions of the new CoreValve Evolut 23 allowed us to obtain low residual gradients even in this particular subset of degenerated BHV.

Transcatheter aortic valve implantation for severe regurgitation in native and degenerated bioprosthetic aortic valves.

OBJECTIVES: We evaluated transcatheter aortic valve Implantation (TAVI) in high-risk patients with severe aortic regurgitation (AR) in native or degenerated bioprosthetic valves. BACKGROUND: TAVI has emerged as a viable treatment modality for severe aortic stenosis in inoperable or high-risk patients. The use of TAVI for treatment of severe AR has remained largely unexplored. METHODS: Eight patients (age 79.6 years ± 5.75 years) with severe AR underwent TAVI at six tertiary hospitals between April 2010 and May 2011. All patients were considered to be at prohibitive risk for surgical aortic valve replacement (SAVR).TAVI with the nitinol based Core Valve bioprosthesis (CRS) (Medtronic) was performed in all patients. RESULTS: Transfemoral access was used in all cases. Procedural success was obtained in all cases without any intraprocedural complications. There was no in hospital or 30-day mortality. There were no cases of atrioventricular blocks requiring permanent pacemaker implantation. At a mean follow up of 15.5 ± 15 months; all patients had improvement in New York Heart Association functional class. Follow up echocardiography revealed improved or stable left ventricular ejection fraction and optimal device function in all cases. CONCLUSIONS: TAVI with the CRS bioprosthesis is feasible and effective in appropriately selected cases of severe aortic regurgitation in native and bioprosthetic aortic valves.

Clinical outcomes following percutaneous coronary intervention with drug-eluting stents versus bare metal stents in patients on chronic hemodialysis.

BACKGROUND: Patients on chronic hemodialysis (HD) are recognized as a high-risk group for adverse events after percutaneous coronary intervention, and whether drug-eluting stents (DES) are associated with improved outcomes over bare metal stents (BMS) is still uncertain. The purpose of this study was to assess the efficacy of DES compared with BMS at short- and long-term follow-up (FU) in an unselected sample of HD patients. METHODS AND RESULTS: In the time period 2005-2010, consecutive patients on chronic HD treated with percutaneous coronary intervention (PCI) and stent implantation were retrospectively selected and analyzed. A total of 169 patients were selected, 77 treated exclusively with BMS and 92 exclusively with DES. Baseline clinical characteristics were similar in the 2 groups as well as the number of treated vessels, treated lesions, and the stent per patient ratio. At longest available FU, no difference between the 2 study groups was found in terms of cardiac death (18.2% vs 16.3%, P=0.83), myocardial infarction (2.5% vs 8.6%, P=0.09), cerebrovascular accidents (0% vs 1.1%, P=0.98), and target vessel revascularization (TVR) (9.1% vs 16.3%, P=0.17). Major adverse cardiac and cerebrovascular events-free survival at 1,500 days in the BMS and DES groups was 57.6% and 50.9% (P=0.11), respectively. CONCLUSIONS: PCI in patients on chronic HD treatment is associated with a high incidence of adverse events at FU, mainly represented by death. In our study, the use of DES was not associated with a reduction of target lesion revascularization (TLR) and TVR.

Matryoshka procedure for Valve-in-Valve TAVI failure.

Valve-in-valve transcatheter valve implantation (ViV-TAVI) procedures for deteriorated bioprosthesis are an established therapeutic option for high-risk patients. The presence of the fixed sewing ring of the bioprosthesis can hamper appropriate expansion of the TAVI. We present a case of a ViViV-TAVI, as a salvage procedure for acute ViV-TAVI failure.

Adherence of ticagrelOr in real world patients with aCute coronary syndrome: The AD-HOC study.

Background: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor antagonist is the cornerstone of therapy in patients with acute coronary syndrome (ACS). Adherence to medical therapy is an important issue, as premature DAPT discontinuation increases the risk of new ischemic events. The aim of the present observational prospective multicenter study was to evaluate in the real-world incidence and discontinuation patterns of ticagrelor during the first 12 months after ACS. Methods: We analyzed 431 ACS patients, discharged with ticagrelor, by 7 Italian centers. The primary end-point was the incidence of cessation of ticagrelor up to 12 months from the index event. Results: Definitive ticagrelor cessations occurred in 52 patients (12.1%), of which 35 were discontinuations (clinically driven) and 17 disruptions (due to acute events). Temporary cessation occurred in 14 cases (3.3%). Age ≥ 80 years and anticoagulant therapy were independent predictors of premature discontinuation. Bleeding occurred in 74 patients, of which 25 suffered a BARC ≥ 2 bleeding event. Bleeding were more frequent in female sex (27.0% vs 17.2%, p-value 0.049) and in patients with a history of bleeding (8.1% vs 2.9%, p-value 0.035). Conclusions: Our study found that the adherence to DAPT with ticagrelor after an ACS is still an important issue, premature discontinuation occurred mainly in fragile patients, like elderly, who suffered a previous bleeding or underwent previous percutaneous coronary intervention.

[Percutaneous treatment of acute pulmonary embolism: state of the art]. / Trattamento transcatetere dell'embolia polmonare acuta: stato dell'arte.

Acute pulmonary embolism (PE) is a common disease associated with high mortality rates that vary widely according to patient clinical presentation and hemodynamic status. According to international guidelines, systemic thrombolysis (ST) is the mainstem treatment in patients with high risk PE and intermediate-high risk PE evolving towards hemodynamic decompensation, showing lower mortality compared with anticoagulant therapy alone despite a high rate of bleeding events. Considering that a large proportion of patients presents contraindication to ST, catheter-directed therapies (CDTs) could tackle some unsolved issues, targeting the treatment to the pulmonary arteries, avoiding the dreaded complications of ST.The aim of this review is to describe the current indication for CDTs in terms of patient selection and timing of treatment, to describe contemporary available medical devices and techniques, discussing current knowledge of safety and efficacy and the importance of multidisciplinary team in PE management.

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy.

BACKGROUND: Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact. OBJECTIVES: The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography. METHODS: The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population. RESULTS: Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (Pinteraction = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44). CONCLUSIONS: Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).

Early angio-guided complete revascularization versus culprit vessel PCI followed by ischemia-guided staged PCI in STEMI patients with multivessel disease.

BACKGROUND: Optimal management of multivessel disease (MVD) in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PCI) is still unclear. OBJECTIVES: To compare short- and long-term clinical outcomes of early-staged, angio-guided approach and delayed, ischemia-guided treatment of non-infarct-related arteries (IRAs). METHODS: Consecutive patients with STEMI and MVD treated with primary PCI in 6 tertiary care centers were retrospectively selected and analyzed. Major adverse cardiac events (MACE) were defined as the composite end-point of death, MI, and repeat revascularization. All the events were adjudicated according to the Academic Research Consortium (ARC) definitions. RESULTS: In the time period 2004-2008, 800 primary PCIs in STEMI patients with MVD were performed. Four hundred and seventeen were addressed to early-staged, angio-guided PCI of non-IRAs (CR group) and 383 to an incomplete revascularization (IncR group). During the hospital stay, no difference in terms of death and repeat revascularization was found between groups but the incidence of periprocedural MI/reinfarction and MACE was significantly higher in the CR group (13.9% vs. 3.1%, P = 0.01 and 14.1% vs. 9.1%, P = 0.017, respectively). At a mean follow-up of 642 ± 545 days, no difference in terms of death and MI was found between the CR and IncR group. The MACE-free survival was significantly higher in the IncR group (73.8% vs. 57%, log rank 0.05), mainly driven by the lower incidence of re-PCI. CONCLUSIONS: Early complete revascularization based only on angiographic findings in patients with STEMI and MVD is associated with an excess of periprocedural/re-MI and with a significantly higher incidence of MACE at follow-up.

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.

AIMS: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system. METHODS AND RESULTS: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%. CONCLUSIONS: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.

First in human evaluation of a novel Sirolimus-eluting ultra-high molecular weight bioresorbable scaffold: 9-, 24-and 36-months imaging and clinical results from the multi-center RENASCENT study.

BACKGROUND: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-µm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. METHODS: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. RESULTS: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. CONCLUSIONS: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry.

OBJECTIVES: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR). BACKGROUND: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality. METHODS: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019. RESULTS: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19). CONCLUSIONS: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.

New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-comers, international, multicenter DELTA-2 registry.

BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

[Updated SICI-GISE position paper on institutional and operator requirements for transcatheter aortic valve implantation]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

Effects of drug-eluting stents after rotational atherectomy: evidence from a multicenter experience.

AIMS: Rotational atherectomy is used as an adjuvant tool for percutaneous coronary interventions, especially in case of highly calcific atherosclerotic plaques. Subsequent drug-eluting stent (DES) implantation is common; however, there is a paucity of clinical evidence to support this practice. METHODS: From the databases of four high-volume Italian centers, we analyzed the angiographic outcome of patients who underwent rotational atherectomy in native coronary vessels followed by DES or bare metal stent (BMS) implantation. Primary study endpoint was late lumen loss at the longest available follow-up. Other analyses consisted of the evaluation of in-stent percentage diameter stenosis, binary restenosis, major adverse cardiovascular events, and stent thrombosis at angiographic control. RESULTS: Between 2006 and 2011, 672 patients with 734 lesions treated had complete angiographic follow-up and were enrolled into this study; 385 lesions were treated with DES and 349 with BMS. The average follow-up length was 9 ±â€Š5 months. Only a few significant differences regarding baseline clinical and angiographic characteristics were observed. Late lumen loss result significantly improved after DES implantation in comparison with BMS (0.54 ±â€Š0.79 vs. 1.01 ±â€Š1.13; P = 0.001), as well as in-stent percentage diameter stenosis (P = 0.01) and binary restenosis (P = 0.007). Major adverse cardiovascular events did not differ significantly, but showed an improved trend in the DES group, driven by a significantly lower target lesion revascularization (6.9 vs. 11.6%; P = 0.04). CONCLUSION: In a cohort of patients treated with rotational atherectomy and with complete angiographic follow-up, DES implantation is associated with improved late lumen loss over BMS. However, the DES effect in terms of angiographic endpoints seems mitigated if compared to previous studies.

The DELTA 2 Registry: A Multicenter Registry Evaluating Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents in Patients With Obstructive Left Main Coronary Artery Disease.

OBJECTIVES: The aim of this study was to evaluate clinical outcomes of unprotected left main coronary artery percutaneous coronary intervention (PCI) with new-generation drug-eluting stents in a "real world" population. BACKGROUND: PCI of the unprotected left main coronary artery is currently recommended as an alternative to coronary artery bypass grafting (CABG) in selected patients. METHODS: All consecutive patients with unprotected left main coronary artery stenosis treated by PCI with second-generation drug-eluting stents were analyzed in this international, all-comers, multicenter registry. The results were compared with those from the historical DELTA 1 (Drug Eluting Stent for Left Main Coronary Artery) CABG cohort using propensity score stratification. The primary endpoint was the composite of death, myocardial infarction (MI), or stroke at the median time of follow-up. RESULTS: A total of 3,986 patients were included. The mean age was 69.6 ± 10.9 years, diabetes was present in 30.8%, and 21% of the patients presented with acute MI. The distal left main coronary artery was involved in 84.6% of the lesions. At a median of 501 days (≈17 months) of follow-up, the occurrence of the primary endpoint of death, MI, or cerebrovascular accident was lower in the PCI DELTA 2 group compared with the historical DELTA 1 CABG cohort (10.3% vs. 11.6%; adjusted hazard ratio: 0.73; 95% confidence interval: 0.55 to 0.98; p = 0.03). Of note, an advantage of PCI was observed with respect to cerebrovascular accident (0.8% vs. 2.0%; adjusted hazard ratio: 0.37; 95% confidence interval: 0.16 to 0.86; p = 0.02), while an advantage of CABG was observed with respect to target vessel revascularization (14.2% vs. 2.9%; adjusted hazard ratio: 3.32; 95% confidence interval: 2.12 to 5.18; p < 0.0001). CONCLUSIONS: After a median follow-up period of 17 months, PCI with new-generation drug-eluting stents was associated with an overall low rate of the composite endpoint of death, MI, or cerebrovascular accident.

Drug-eluting stent use after coronary atherectomy: results from a multicentre experience - The ROTALINK I study.

AIMS: Until now, there is no medium- to long-term clinical evidence of the best treatment after rotational atherectomy. METHODS: From the databases of seven high-volume centres, years 2005-2010, we retrospectively analysed the long-term outcome of patients who had undergone rotational atherectomy followed by plain-balloon angioplasty or implantation of drug-eluting stent (DES) or bare metal stent (BMS). Primary endpoint was the incidence of major adverse cardiovascular events (MACE: death, myocardial infarction, target-lesion-revascularization) at longest available follow-up. RESULTS: In this registry, we enrolled 1397 patients with 1605 lesions, followed for 28.4 ±â€Š21 months. DES-treated patients were more frequently diabetic, had more lesions treated and received a higher number of stents. In-hospital MACEs were significantly higher in DES patients (7.6 vs. 2.6 vs. 2.9%, respectively, P = 0.0001 for both), mainly due to a higher incidence of myocardial infarction (6.4 vs. 1.2 vs. 2.1%, P = 0.0001). The 2-year follow-up showed a significantly lower incidence of MACE in DES patients (15.1 vs. 24.2 vs. 20.8%, P = 0.001 for both), driven by a lower incidence of target-lesion revascularization (8 vs. 14.6 vs. 13.9%, P = 0.002). Myocardial infarction rate was lower in the DES group as well (0.4 vs. 3.1% in BMS, P = 0.001). At multivariate analysis, BMS implantation and balloon angioplasty were independent predictors of long-term MACE. DES implantation was associated with a lower risk of long-term myocardial infarction [hazard ratio 0.15, 95% confidence interval (95% CI) 0.04-0.67] and target-lesion revascularization (hazard ratio 0.42, 95% CI 0.21-0.82). Male sex and DES use were independent predictors of the absence of MACE. CONCLUSION: After rotational atherectomy, DES implantation appears to be a preferable strategy, as it is associated with lower long-term MACE, despite an unexpected increase in periprocedural myocardial infarction.

Biolimus-Eluting StenT For de-novo coRonary artery dIsease in patiENts with Diabetes mellituS: the BESTFRIENDS multicentre registry.

AIMS: Coronary inflammation and healing influence outcomes of diabetic patients treated with Percutaneous coronary revascularization (PCI). Stents covered with biodegradable polymers (bp) may offer advantages over nonerodible polymer ones, because polymer reabsorption extinguish coronary inflammation and favours healing. Aim of our study was to assess the safety and efficacy of bp-biolimus-eluting stent (bp-BES) in a large series of consecutive diabetic patients. METHODS: From 2009 to 2013 we retrospectively enrolled consecutive diabetic patients treated with PCI and bp-BES implantation. Primary end points were target lesion revascularization (TLR) and stent thrombosis rates. RESULTS: Study cohort counted 747 patients. Multivessel disease was present in 48.2% with a mean stent/patient ratio of 1.860.78. During the hospital stay no stent thrombosis occurred. At 3-year follow-up we observed a 1.5% cumulative incidence of cardiac death, 1.1% of myocardial infarction and 6.3% of TLR. Stent thrombosis occurred in 1.1% of patients, all in the first 2 years of follow-up. Kaplan-Meier analysis showed a TLR-free survival at 1 and 3 years of 97.2 and 96.1%, respectively. CONCLUSION: PCI with bp-BES seems to be well tolerated and effective in a large unselected population of diabetic patients. The good results observed were maintained at 3 years of follow-up.

Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: the DEMONSTRATE study.

BACKGROUND: It has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent (DES) implantation. We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3 months, compared to Vision/Multilink8 Bare Metal Stent (BMS) at 1month. METHODS: The ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation (DEMONSTRATE) was a multicenter, randomized, parallel group study. Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 (19) or Vision/Multilink8 (19) stent placement at 6 OCT-experienced centers. Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of <30%, determined by OCT at 3 and 1 months for Cre8 and Vision/Multilink8, respectively. Percentage of uncovered/malapposed stent struts, neointimal growth and thickness were the main secondary end-points. RESULTS: The primary end-point of RUTTS score<30% occurred in 99.8% (899/901) of Cre8 struts and in 99.6% (1116/1121) of Vision/Multilink8 struts (difference 0.2, CI 95% -0.2 to 0.6, p for noninferiority<0.001). The percentage of uncovered/malapposed struts was comparable (0.36±0.64 vs. 0.12±0.24, p=0.145) in the two study groups, while both neointimal percentage area (8.46±5.29 vs. 19.84±15.93, p<0.001) and thickness (0.07±0.04 vs. 0.16±0.12, p<0.001) were significantly reduced by Cre8 stent. CONCLUSIONS: The Cre8 DES at 3 months has comparable strut coverage to Vision/Multilink8 BMS at 1 month while preserving a greater efficacy in neo-intima formation reduction. Further studies to assess clinical implication of these Cre8 characteristics are warranted.