Prognostic Impact of Drug-Coated Balloons in Patients With Diabetes Mellitus: A Propensity-Matched Study.

Patients with diabetes mellitus (DM) are at higher risk of restenosis and stent thrombosis after percutaneous coronary intervention (PCI) and drug-eluting stent (DES) positioning. Whether drug-coated balloons (DCB) can offer any benefit in this subset of patients has been seldom cleared out and was the aim of the present propensity-matched cohort study, that compared the prognostic impact of DCB versus DES in patients with DM who underwent PCI. Patients with DM enrolled in the NOvara-BIella-TREnto (NOBITRE) Registry were identified and matched according to propensity score, to a control population of patients with DM treated with DES. The primary study end point was the occurrence of major adverse cardiovascular events (MACEs). A total of 150 patients were identified in the DCB group and matched with 150 DES-treated patients. Patients treated with DCB displayed more often a previous cardiovascular history and received a more complete pharmacological therapy. Target vessel diameter and the percentage of stenosis were lower in patients with DCB, whereas binary in-stent restenosis was more common (p <0.001, p = 0.003, and p <0.001, respectively). Paclitaxel-eluting balloon represented the most common strategy in the DCB group, whereas Zotarolimus-eluting stents were used in half of the DES population. At a median follow-up of 545.5 days, MACE occurred in 54 (19.4%) of patients, with no difference according to the PCI strategy (21.6% vs 17.3%, adjusted hazard ratio [95% confidence interval] 1.51 [0.46 to 4.93], p = 0.50). Major ischemic end points were slightly increased in patients treated with DCB, whereas overall death was significantly reduced (3.6% vs 10.9%; adjusted hazard ratio [95% confidence interval] 0.27 [0.08 to 0.91], p = 0.03). In conclusion, the present propensity-matched study shows that, in patients with DM who underwent PCI for in-stent restenosis or de novo lesions, the use of DCB is associated with a similar rate of MACE and a modest increase in target lesion failure, but a significantly improved survival as compared with DES.

Impact of age on pre-procedural TIMI flow in STEMI patients undergoing primary percutaneous coronary intervention.

BACKGROUND: Advanced age is a major determinant of impaired prognosis among patients with ST-segment elevation myocardial infarction (STEMI). However, the mechanisms associated with suboptimal reperfusion and enhanced complications are still largely undefined. The aim of the present study was to assess the impact of age on the angiographic findings and the procedural results of primary percutaneous coronary intervention (pPCI) in patients with STEMI. METHODS: A consecutive cohort of patients admitted for STEMI treated with pPCI were included. Infarct-related artery (IRA) patency was defined for preprocedural TIMI flow 3. RESULTS: We included 520 patients, divided according to age tertiles (<61; 61-72; ≥73). Elderly patients were more often females, with hypertension, renal failure, prior myocardial infarction or PCI, with lower rates of smoking history, haemoglobin, leukocytes and cholesterol (P < 0.001), lower ejection fraction (P = 0.02), higher use of renin angiotensin system inhibitors, statins, ASA, calcium antagonists, diuretics and beta blockers. At angiography, for the IRA, percentage of thrombus (P = 0.02) and stenosis (P = 0.01), direct stenting (P = 0.02) and glycoprotein IIb-IIIa inhibitors (P = 0.04) inversely related with age, but for higher restenosis (P = 0.04). IRA patency was more common in patients aged ≥73 years (27.9% vs. 32.3% vs. 41.1%, P = 0.01). The impact of age on preprocedural TIMI flow was confirmed at multivariate analysis [adjusted odds ratio (95% confidence interval) = 0.68 (0.47-0.98), P = 0.04]. CONCLUSION: The present study shows that among STEMI patients undergoing primary PCI, more advanced age represents an independent predictor of preprocedural IRA patency. Future studies will define the implications on procedural results and long-term prognosis.

Managing Congenital Heart Defects in Elderly: The Platypnea-Orthodeoxia Syndrome in Underestimated Patent Foramen Ovale.

The platypnea-orthodeoxia syndrome (POS) is a rare and often suboptimally managed condition with a complex diagnostic workup, conversely displaying an easy treatment and a good recovery of symptoms, especially if consequent to an intracardiac shunt. However, its identification is challenging, due to the several clinical manifestations, the multiple etiologies, representing often the delayed presentation of a congenital heart disease. We present a case report and review of available literature on patients with the POS secondary to a patent foramen ovale successfully treated with its closure.

Long-Term Outcomes With Drug-Eluting Balloon for the Treatment of In-Stent Restenosis and De Novo Lesions: The Novara-Biella-Trento (NOBITRE) Registry.

Drug-coated balloons (DCBs) have emerged for percutaneous coronary interventions (PCI) of in-stent restenosis or particular anatomical subsets. We provide a real-world analysis of the prognostic determinants and long-term outcomes of patients treated with DCB for any lesion in a comprehensive multicenter registry. The primary study endpoint was the occurrence of major cardiovascular events (MACE: composite of all-cause death, myocardial infarction, and target vessel revascularization) at the longest available follow-up. We included 267 patients (196 treated for in-stent restenosis and 71 for de novo lesions), with a median follow-up of 616 [368-1025] days. MACE occurred in 70 (26.2%) of the patients and related with higher rates of in-stent restenosis (P = .04), longer and more type C lesions (P = .05 and P = .04). At multivariate Cox-regression, type C lesions emerged as the only independent predictor of MACE (adjusted OR [95% CI] = 1.83[1.13-2.97], P = .014), mainly driven by target vessel revascularization (adjusted OR[95% CI] = 1.78[1.05-2.95], P = .03) not conditioning survival. In-stent restenosis emerged as major determinant of TLF (adjusted OR[95% CI] = 2.59[1.17-5.75], P = .02). DCBs represent a treatment option for any lesion; however, type C and restenotic lesions are associated with an increased risk of MACE and target lesion failure, where the optimal strategies for patients' selection and lesion preparation are still undefined.

Impact of Sex on the Functional Assessment of Intermediate Coronary Lesions by Instantaneous Wave-Free Ratio.

Sex differences in coronary physiology and in the pathogenesis of coronary artery disease (CAD) have been previously described. Contrasting data have been reported, so far, about the impact of sex on the assessment of the functional significance of intermediate coronary stenoses by fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR). The present study aimed at assessing the sex differences in the results of iFR in a cohort of patients undergoing coronary angiography. METHODS: We included patients undergoing coronary angiography and the functional assessment of intermediate (40 to 70%) coronary lesions in 2 centers. iFR measurement was performed by pressure-recording guidewire and automatically calculated at the core laboratory using the manufacturers' dedicated software. Quantitative parameters of the coronary lesions were calculated by an automatic edge-detection system. Minimal luminal diameter (MLD), reference diameter (RD), percent diameter stenosis, and length of the lesion were measured. Positive iFR was considered for values < 0.90. RESULTS: We included 325 patients undergoing coronary angiography and iFR evaluation of 371 intermediate coronary stenoses, including 20.6% of women. Females were older, displayed lower body weight and hemoglobin, lower rate of active smoking (p < 0.001) and previous PCI (p = 0.04), lower platelet count (p = 0.001) and creatinine (p = 0.02). Systolic blood pressure and heart rate at admission were more elevated in women (p = 0.001 and p = 0.05, respectively). At angiography, multivessel coronary artery disease was more uncommon (p = 0.001) and proximal lesions were more frequently assessed by iFR (p = 0.04). Mean values of iFR did not differ with sex and neither the percentage of positive iFR (19.1% vs 18.8%, p = 0.99, adjusted OR[95%CI] = 0.51[0.18-1.48], p = 0.22). CONCLUSION: Among patients undergoing functional assessment of intermediate coronary lesions by instantaneous wave-free ratio, no impact of sex was observed on the absolute values or the rate of positivity of iFR.

Preprocedural ß-Blockers in the Functional Assessment of Intermediate Coronary Lesions by Instantaneous Wave-Free Ratio.

AIM: Instantaneous wave-free ratio (iFR) has emerged as the strategy of choice for the assessment of intermediate coronary lesions. The impact of preprocedural ß-blockers therapy on the iFR was the aim of this study. METHODS: We included patients undergoing functional assessment of intermediate (40%-70%) coronary lesions in 2 centers. The iFR measurement was performed by pressure-recording guidewire and calculated at the core laboratory using the manufacturers' dedicated software. Minimal luminal diameter, reference diameter, percent diameter stenosis, and length of the lesion were measured. Positive iFR was considered for values <0.90. RESULTS: We included 197 patients undergoing functional evaluation of 223 coronary lesions. Patients on ß-blockers (69%) had more frequently hypertension (P = .05); previous myocardial infarction (P = .01); therapy with clopidogrel (P = .02), statins, and aspirin; and acute coronary syndrome at presentation (P < .001, respectively). Mean iFR values were slightly higher in patients on ß-blockers (0.94 ± 0.06 vs 0.92 ± 0.06, P = .11). The rate of positive iFR was significantly lower with ß-blockers (14.9% vs 27.5%, P = .04). On multivariate analysis, ß-blockers use was a predictor of the significance of coronary stenoses (odds ratio [OR] = 0.48; 95% CI = 0.23-0.98; P = .05) together with lesion length (OR = 1.04; 95% CI = 1.01-1.07; P = .007). CONCLUSION: Among patients undergoing iFR, preprocedural ß-blockers are associated with higher absolute values and a lower rate of positive iFR.

The FAST-STEMI Network in Biella From 2013 to 2019: Impact of the Delocalization of the Hospital Facilities on Ischemia Time and In-hospital Outcomes.

BACKGROUND: The optimization of the strategies for myocardial revascularization has improved the outcomes of patients with ST-segment elevation myocardial infarction. In Piedmont, the FAST-STEMI regional network was created for improving the management and transportation of ST-segment elevation (STEMI) patients to primary percutaneous coronary intervention facilities, reducing the time to reperfusion. Within this network, the Hospital of Biella was delocalized in December 2014 to a new suburban structure designed for an easier access, which might have shortened the duration of patients' transportation and ischemia, with potential positive prognostic effects. The aim of the present study was to define the impact of the decentralization of the hospital structure on the time to reperfusion and in-hospital outcomes among STEMI patients admitted to the Hospital of Biella. METHODS: We included STEMI patients admitted to our urban hospital between 2013 and 2019 and included in the FAST-STEMI database. The primary endpoint was the duration of ischemia, defined as pain to balloon (PTB). The primary outcome endpoint (PE) was in-hospital mortality. RESULTS: We included 276 consecutive patients with STEMI undergoing primary percutaneous coronary intervention between 2016 and 2019 in the new hospital facility, which were compared with 170 patients treated between 2013 and June 2014 in the prior structure. Patients' characteristics included a mean age of 67.5 ± 12.5 years, 72.1% males and 18.7% patients with diabetes. In the new facility, the median PTB was 188 minutes [interquartile range: 125-340 min], reduced as compared with the period 2013-2014 [215 (128.5-352 min), P = 0.002]. The median in-hospital stay was also shorter (P = 0.004), whereas a nonsignificant improvement was noted for ejection fraction (EF) at discharge (P = 0.14). A linear relationship was demonstrated between PTB and the EF (r = -0.183, P = 0.003) in patients treated between 2016 and 2019 while not affecting the length of hospitalization or in-hospital outcomes. In fact, in-hospital death occurred in 36 patients, 8% in the new structure versus 7.7% in 2013-2014 [hazard ratio (HR) (95% confidence interval [CI]) = 1.20 (0.59-2.42), P = 0.62]. The independent predictors of mortality were patients' age and EF at discharge (age ≥ 75 y: adjusted HR [95% CI] = 6.75 [1.51-30.1], P = 0.01; EF: adjusted HR [95% CI] = 0.91 [0.88-0.95], P < 0.001). CONCLUSIONS: The present study shows that, among the STEMI patients treated in our center, the delocalization of the hospital facilities and the optimization of the FAST-STEMI network reduced the duration of ischemia, with positive effects on left ventricular function at discharge. However, this did not translate into a significant benefit in survival, which was instead conditioned by the aging of the population.

Coronary stents and vascular response to implantation: literature review.

Drug-eluting stents (DESs) have minimized the limitations of bare-metal stents (BMSs) after percutaneous coronary interventions. Nevertheless, serious concerns remain about possible late complications of stenting, such as stent thrombosis (ST) and in-stent restenosis (ISR), although the introduction of second-generation DESs seems to have softened the phenomenon, compared to the first-generation ones. ST is a potentially catastrophic event, which has been markedly reduced by optimization of stent implantation, novel stent designs, and dual antiplatelet therapy. The exact mechanism to explain its occurrence is under investigation, and, realistically, multiple factors are responsible. ISR of BMSs has been previously considered as a stable condition with an early peak (at 6 months) of intimal hyperplasia, followed by a regression period beyond 1 year. On the contrary, both clinical and histologic studies of DESs have demonstrated evidence of continuous neointimal growth during long-term follow-up, named "late catch-up" phenomenon. The acknowledgment that ISR is a relatively benign clinical condition has been recently challenged by evidences which reported that patients with ISR can experience acute coronary syndromes. Intracoronary imaging is an invasive technology that allows identifying features of atherosclerotic plaque of stent implanted and of vascular healing after stenting; it is often used to complete diagnostic coronary angiography and to drive interventional procedures. Intracoronary optical coherence tomography is currently considered a state-of-the-art imaging technique; it provides, compared to intravascular ultrasound, better resolution (at least >10 times), allowing the detailed characterization of the superficial structure of the vessel wall. Imaging studies "in vivo," in agreement with histological findings, suggest that chronic inflammation and/or endothelial dysfunction may induce late de novo "neoatherosclerosis" inside both BMSs and DESs. So, neoatherosclerosis has become the prime suspect in the pathogenesis of late stent failure.

Impact of drug-eluting balloon (pre- or post-) dilation on neointima formation in de novo lesions treated by bare-metal stent: the IN-PACT CORO trial.

UNLABELLED: The efficacy of DEB in modifying the high restenosis risk associated with BMS implantation is doubtful. Optical coherence tomography (OCT) may allow precise assessment of neointimal formation after stent implantation. We performed a single-center, prospective, 1:2 randomized trial comparing BMS implantation alone (BMS group) vs. additional DEB (DEB group). DEB patients were further randomized 1:1 to DEB before stenting (pre-DEB group), or after stenting (post-DEB group). Primary endpoint was OCT-assessed neointimal hyperplasia (expressed both as mean in-stent neointimal area and as percentage obstruction of the mean stent area) at 6 months. Secondary endpoints were the percentage of uncovered and malapposed stent struts. Thirty patients were enrolled and randomized to BMS (n = 10), pre-DEB (n = 10), post-DEB (n = 10). At 6-month OCT follow-up, DEB significantly reduced neointimal area compared with BMS: mean neointimal area 2.01 ± 0.89 vs. 3.03 ± 1.07 mm(2) (p = 0.02), percentage area obstruction 24.56 ± 12.50 vs. 37.51 ± 12.26 % (p = 0.02). The percentage of uncovered and malapposed stent struts did not differ significantly between BMS and DEB. In the comparison between pre-DEB and post-DEB, no significant difference was observed for both primary and secondary endpoints. In de novo coronary lesions treated with BMS, DEB use could be associated with a mild reduction in neointimal hyperplasia at 6 months; this effect could be unrelated to the timing of DEB dilation (pre- or post-stenting). CLINICAL TRIAL REGISTRATION INFORMATION: http://www.clinicaltrials.gov . Identifier: NCT01057563.

Comparison of Right and Left Upper Limb Arterial Variants in Patients Undergoing Bilateral Transradial Procedures.

BACKGROUND: Transradial approach (TRA), when compared with transfemoral, improves the safety of percutaneous coronary procedures. Arterial axis variants are known to hinder the performance of transradial approach percutaneous coronary procedures. Data on the occurrence of arterial axis variants in the right and left arm arterial axes of individual patients are lacking. METHODS AND RESULTS: From a single-center prospective registry, we selected all patients in whom bilateral upper limb arterial anatomy was assessed based on the performance of left and right radial catheterization obtained during the same or during repeat coronary diagnostic or interventional procedure(s). The occurrence of upper right and left limb arterial axis variants was classified according to the previously described operative ABC classification. A total of 610 patients were identified. An ABC upper limb arterial axis variant was detected in 156 (25.6%) patients. Variants were right-sided only in 65 (11.0%), left-sided only in 40 (6.6%), and bilateral in 46 (7.5%) patients. Thus, arterial axis variants were significantly more common in the right side (P=0.02). Bilateral arterial variants were significantly associated with age, female sex, and valvulopathy. Both A (radial/brachial) and B (axillary/subclavian/innominate) variants exhibited concordance across the 2 sides (odds ratio, 7.2; 95% confidence interval, 4.1-12.7 and 8.0; 95% confidence interval, 2.1-30.9, respectively). CONCLUSIONS: The occurrence of an anatomic variant potentially hindering transradial approach coronary diagnostic or interventional procedures is bilateral in <8% of cases and is more common in the right arm. Such information may guide, during the clinical practice, the access selection in the case of repeat procedures or need for additional accesses.

Dual role of circulating endothelial progenitor cells in stent struts endothelialisation and neointimal regrowth: a substudy of the IN-PACT CORO trial.

BACKGROUND: Endothelialisation is a crucial event after percutaneous coronary intervention (PCI). Endothelial progenitor cells (EPCs) are bone marrow derived elements with reparative properties. We aimed to assess the relationship between circulating EPC levels and stent neointimal hyperplasia (NIH) using frequency domain optical coherence tomography (FD-OCT). METHODS: Patients undergoing elective PCI to native vessels and randomised to bare metal stent (BMS) alone versus BMS plus drug coated balloon (DCB) were included. At six months, angiographic follow-up and FD-OCT were performed to measure percentage neointimal hyperplasia volume obstruction (%NIHV), and percentage of uncovered stent struts (%US). Venous blood samples were obtained before the procedure and at six months to detect CD34+CD45dimKDR+ EPC levels. RESULTS: Twenty patients were enrolled. A significant relationship was observed between baseline EPC levels and %NIHV (R: 0.63, p: 0.03) and %US (R: -0.56, p: 0.01) at follow-up. Both EPC levels and DCB use were independently related to %NIHV (ß: 0.55; p < 0.001 and ß: -0.51; p: 0.001, respectively), while only EPC levels were independently associated to %US (ß: -0.52; p: 0.01). Higher %NIHV (p: 0.004) and lower %US (p: 0.005) were observed in patients with stable or increasing EPC level. CONCLUSION: Our study shows a relationship between EPC levels and stent strut coverage, supporting a dual role for these cells in favouring stent endothelialisation but also NIH growth.

Multisite artery disease: a common and challenging clinical condition calling for specific management.

'Multisite' artery disease is defined as the simultaneous presence of clinically significant atherosclerotic lesions in at least two major vascular territories. The management of patients with multisite artery disease represents a common challenge in clinical practice, since they are at increased risk for both vascular and coronary surgery. Preliminary experiences suggest that percutaneous treatment may represent a promising strategy for patients with multisite artery disease. In this review, the prevalence and management of multisite artery disease are discussed with particular attention to coronary and peripheral revascularization related issues.

Impact of operator experience and wiring technique on procedural efficacy of trans-radial percutaneous chronic total occlusion recanalization performed by dedicated radialists.

BACKGROUND: The efficacy of trans-radial approach (TRA) in chronic total occlusions (CTO) percutaneous coronary interventions (PCI) is not well established. Thus, we sought to review the feasibility and long-term results of TRA for CTO PCI performed by dedicated TRA operatorsof our center. METHODS: CTO PCI performed by dedicated radialists were considered. Primary end-points were "PCI success" (stent implantation with residual stenosis < 20% and TIMI 3) and "patient success" (PCI success in a first or second attempt). Vascular complications and major adverse cardiac events (MACE) were also assessed. Procedures were divided into: Period 1 - no systematic adoption of TRA nor systematic wire selection, and Period 2 - systematic TRA with stepwise wire selection. The starting guidewire was initially an intermediate wire (Period 2a), and, thereafter, a tapered soft polymeric guidewire (Period 2b). RESULTS: Two operators performed 167 TRA PCI on CTO in 158 patients. PCI success rate was 74.3% and patient success rate was 78.5%. Drug-eluting stents were implanted in 95.1% of successful procedures. One (0.6%) patient had a (minor) vascular complication. After a mean follow-up of 580 days, 93.7% of patients were free from MACE. PCI success (57.1% in Period 1 vs. 76.5% in Period 2a vs. 80.5% in Period 2b, p = 0.029) and patient success (62.5% in Period 1 vs. 77.8% in Period 2a vs. 86.1% in Period 2b, p = 0.025) significantly improved during the study. CONCLUSIONS: CTO PCI by TRA is safe and feasible. Its efficacy seems to be strongly dependenton operator experience with CTO techniques and may be influenced by the strategy of guidewire selection.

Management and timing of access-site vascular complications occurring after trans-radial percutaneous coronary procedures.

BACKGROUND: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary procedures are rare but may have relevant clinical consequences. Data regarding the optimal management of radial-access-related ASVC are lacking. METHODS: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complication requiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timing of diagnosis: "very early" (in the cath lab), "early" (after cath lab discharge, but during the hospital stay) and "late" (after hospital discharge). The need of surgery (primary end-point) and the development of neurological hand deficit (secondary end-point) were assessed. RESULTS: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases (11%), the remaining patients receiving successful conservative management (which included prolonged local compression). Three patients (who received surgery) exhibited a mild neurological hand deficit in the follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of 26 patients (3.8%) with "very early" diagnosis, in 1 of 21 patients (4.8%) with "early" diagnosis, and in 4 of 10 patients (40%) with "late" diagnosis (p=0.026). CONCLUSIONS: ASVC are diagnosed with different timing after trans-radial procedures. Conservative management including local compression allows successful management in the majority of ASVC. Prompt recognition is pivotal as late diagnosis is associated to the need for surgery.

The occurrence of radial artery occlusion following catheterization.

Radial artery occlusion (RAO) is a usually silent complication of transradial approach that may prevent future transradial procedures. It is caused by intimal hyperplasia, intima-media thickening and luminal thrombosis. RAO incidence has been reported with a wide range, probably due to different catheterization protocols and diagnosis tests adopted. Since simple pulse check at the level of radial cannulation is not reliable, plethysmography and duplex ultrasound are required to assure diagnosis. Besides the relevance of other clinical and procedural factors, inadequate heparinization and occlusive hemostasis constitute the main modifiable factors associated with risk of RAO. Finally, RAO should not be regarded as an irreversible condition since ulnar artery compression may restore patency in the case of early diagnosis, and recanalization techniques have been recently proposed to allow successful recatheterization in RAO patients.

INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial.

BACKGROUND: Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies. METHODS/DESIGN: We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months. DISCUSSION: Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia. TRIAL REGISTRATION: Clinicaltrials.gov NCT01057563.

Impact of radial-to-aorta vascular anatomical variants on risk of failure in trans-radial coronary procedures.

OBJECTIVES: To assess the impact of an "operative" classification of vascular anatomic variants on the feasibility of trans-radial approach. BACKGROUND: Vascular anatomic variants located from the wrist to the aorta may influence the feasibility of trans-radial procedures. Recently, a new "operative" classification of these variants was proposed. METHODS: Consecutive trans-radial diagnostic or interventional catheterizations were considered. Vascular anatomic variants were classified according to 10 categories and sub-grouped according to the ABC classification (A: radial-brachial arterial axis; B: axillary-subclavian-anonymous axis; C: aortic arch). Primary study end-point was failure of trans-radial approach (necessity to cross-over to another approach to complete the procedure). RESULTS: Three thousand four hundred seventy-seven consecutive radial procedures were considered. Anatomic variants were diagnosed in 308 procedures (8.8%): A variants: 7.2%, B variants: 1.9%; C variants: 0.3%. Failure occurred in 2.0% of procedures. Failure rate was 0.7% in the absence of variants vs.15.2% in the presence of any variant (P < 0.0001, OR 27.7, 95%CI 16.3-46.9). Each of the 10 variants was significantly associated with increased failure rate. Each of the three level-subgroups of variants was significantly associated to the risk of failure (failure 14.7% in A level, 13.9% in B level, 33.3% in C level; P < 0.0001 vs. absence of variants). CONCLUSIONS: Failure of trans-radial procedures is associated to anatomic variants located from the wrist to the aorta. The "operative" ABC classification of anatomic variants is useful not only to categorize these anatomic variants, but also to predict the risk of failure of trans-radial approach.

Outcome of non-cardiac surgery after stent implantation in the DES era: results of the Surgery After Stent (SAS) registry.

BACKGROUND: Optimal management of patients needing non-cardiac surgery after coronary stenting has not been established. Objective. To assess the perioperative outcome of patients undergoing non-cardiac surgery after coronary bare-metal stent (BMS) or drug-eluting stent (DES) implantation. METHODS: We enrolled consecutive patients undergoing non-cardiac surgery (up to 2008) after coronary stenting in a single-center registry, prospectively registering clinical and procedural data about revascularization and retrospectively recording surgical details, perioperative therapy and in-hospital outcome after surgery. At our institution, we implant BMS for planned surgery at time of revascularization, and use antiplatelet therapy for surgery required within 1 month of BMS or within 12 months of DES implantation. The primary endpoint was defined as perioperative occurrence of major adverse events, both cardiovascular (death, myocardial infarction, stent thrombosis and repeated revascularization) and hemorrhagic (bleeding requiring transfusions or surgical hemostasis). RESULTS: We enrolled 101 patients: 70 treated with BMS (group 1) and 31 with DES (group 2). The mean interval between stenting and surgery was 288 days. The average number of antiplatelet drugs used during the operative period was higher in group 2 than group 1 (p = 0.02). Fifteen patients (15%) experienced major adverse events (5.9% had non-ST elevation myocardial infarction, 12% received blood transfusions), without a significant difference between the two groups (p = 0.72). At multivariate analysis, the predictor of primary endpoint was time interval between stenting and surgery (p = 0.022). CONCLUSION: We found similar outcomes for non-cardiac surgery after coronary stenting when BMS were selected for planned surgery and dual antiplatelet therapy was used, if indicated, during the operative period.