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.

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.

Protamine usage following implantation of drug-eluting stents: a word of caution.

The treatment of hemorrhagic complications of percutaneous interventions with protamine is an accepted practice. Concerns exist about the increased thrombo-genicity of drug-eluting stents. We report two cases of acute stent thrombosis following drug-eluting stent implantation related to protamine administration.

History of vasomotor symptoms, extent of coronary artery disease, and clinical outcomes after acute coronary syndrome in postmenopausal women.

OBJECTIVE: Vasomotor symptoms (VMS) during menopausal transition have been linked to a higher burden of cardiovascular risk factors, subclinical vascular disease, and subsequent vascular events. We aim to investigate the association of VMS with the extent of coronary disease and their prognostic role after an acute coronary syndrome. METHODS: The Ladies Acute Coronary Syndrome study enrolled consecutive women with an acute coronary syndrome undergoing coronary angiography. A menopause questionnaire was administered during admission. Angiographic data underwent corelab analysis. Six out of 10 enrolling centers participated in 1-year follow-up. Outcome data included the composite endpoint of all-cause mortality, recurrent myocardial infarction, stroke, and rehospitalization for cardiovascular causes within 1 year. RESULTS: Of the 415 women with available angiographic corelab analysis, 373 (90%) had complete 1-year follow-up. Among them, 202 women had had VMS during menopausal transition. These women had the same mean age at menopause as those without VMS (50 years in both groups), but were younger at presentation (median age 71 vs 76 years; P < 0.001), despite a more favorable cardiovascular risk profile (chronic kidney dysfunction 4.5% vs 15.9%; P = 0.001; prior cerebrovascular disease 4.5 vs 12.2%; P = 0.018). Extent of coronary disease at angiography was similar between groups (mean Gensini score 49 vs 51; P = 0.6; mean SYNTAX score 14 vs 16; P = 0.3). Overall cardiovascular events at 1 year did not differ between groups (19% vs 22%; P = 0.5). CONCLUSIONS: In postmenopausal women with an acute coronary syndrome, a history of VMS was associated with younger age at presentation, despite a lower vascular disease burden and similar angiographically defined coronary disease as compared with women without VMS. No difference could be found in terms of overall clinical outcomes. These results should be interpreted cautiously as all analyses were unadjusted and did not account for risk factor differences between women with and without a history of VMS.

Age at menopause, extent of coronary artery disease and outcome among postmenopausal women with acute coronary syndromes.

BACKGROUND: Early menopause has been associated with increased cardiovascular mortality, but prospective studies investigating outcomes of postmenopausal women with acute coronary syndromes (ACS) in relation to menopausal age are lacking. METHODS: We analyzed the 1-year outcome of 373 women with acute myocardial infarction enrolled in the Ladies ACS study. All patients underwent coronary angiography, with corelab analysis. Menopause questionnaires were administered during admission. Menopausal age below the median of the study population (50 years) was defined as "early menopause". The composite 1-year outcome included all-cause mortality, recurrent myocardial infarction and stroke. RESULTS: The mean age at index ACS was 73 years (IQR 65-83) for women with early menopause, and 74 (IQR 65-80) for those with late menopause. Patients with early menopause had more prevalent chronic kidney disease (12.8% vs 5.9%, p = 0.03), whereas there were no differences in all other clinical characteristics, extent of coronary disease at angiography (as assessed by Gensini and SYNTAX scores), as well as interventional treatments. Within 1 year, women with late menopause had significantly better outcome as compared with those with early menopause (6.5% vs 15.3%, p = 0.007). At logistic regression analysis, late menopause was independently associated with better outcome (OR 0.28; 95% CI 0.12-0.67; p = 0.004). With each year's delay in the menopause the adjusted risk decreased by 12% (OR 0.88, 0.77-0.99, p = 0.040). CONCLUSION: Despite comparable clinical and angiographic characteristics, women with late menopausal age experience better outcomes after an ACS as compared with those with early menopause.

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.

Age at Menopause and Extent of Coronary Artery Disease Among Postmenopausal Women with Acute Coronary Syndromes.

BACKGROUND: Epidemiological studies have shown a higher risk of cardiovascular mortality associated with early menopause, but the relation between menopausal age and extent of coronary artery disease after menopause is unknown. We assessed the relation between menopausal age and extent of coronary disease in postmenopausal women with an acute coronary syndrome. METHODS: A prospective study was conducted in patients ≥55 years old undergoing coronary angiography for an acute coronary syndrome. Enrollment was stratified by sex (women/men ratio 2:1) and age (55-64, 65-74, 75-85, and >85 years). Women were administered menopause questionnaires during admission. An independent core lab quantified coronary artery disease extent using the Gensini Score, which classifies both significant (>50%) and nonsignificant lesions. Linear correlation was used to appraise the association between the Gensini score and menopausal age. RESULTS: We enrolled 675 patients, 249 men and 426 women (mean age 74 years). The mean Gensini score was 60 ± 36 in men vs 50 ± 32 in women (P <.001), being higher among men at any age. The median menopausal age of women was 50 years. Risk factors and age at first acute coronary syndrome were identical among women below and above the median menopausal age. The Gensini score in women showed a weak association with age (R = 0.127; P = .0129), but not with menopausal age (R = 0.063; P = .228). At multivariable analysis, ejection fraction, female sex, and ST elevation myocardial infarction were independent predictors of the Gensini score in the overall population. CONCLUSIONS: Menopausal age was not associated with the extent of coronary artery disease. Age at first acute coronary syndrome presentation, risk factors, and prior cardiovascular events were not affected by menopausal age. (The LADIES ACS study: NCT01997307).

Dual antiplatelet therapy after percutaneous coronary intervention with stent implantation in patients taking chronic oral anticoagulation.

OBJECTIVES: The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. BACKGROUND: The optimal antithrombotic strategy after percutaneous coronary intervention (PCI) for patients receiving AC is unclear. METHODS: Consecutive patients who underwent stent implantation and were discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC) were analyzed. RESULTS: Of the 127 patients with 224 lesions, 86.6% were men, with a mean age of 69.9 +/- 8.8 years. Drug-eluting stents (DES) were positioned in 71 (55.9%), and bare-metal stents (BMS) were positioned in 56 (44.1%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment. The mean triple therapy duration was 5.6 +/- 4.6 months, and clinical follow-up was 21.0 +/- 19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (5.6% vs. 3.6%, respectively, p = 1.0) and minor (1.4% vs. 3.6%, respectively, p = 0.57) bleeding and mortality (5.6% vs. 1.8%, respectively, p = 0.39). A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 26.8%, p = 0.041). CONCLUSIONS: While receiving triple therapy, major bleeding occurred in 4.7% of patients; one-half of the events were lethal, and most occurred within the first month.