Paclitaxel in endovascular devices. Identikit of a “serial killer”?

Recent developments in the management of peripheral artery disease have been momentous, and a key advance has been the introduction of drug-coated balloons, which capitalise on the mechanical effects of angioplasty balloons, and on the pharmacologic effects of anti-restenotic drugs [1,2]. Indeed, single reports from randomized trials and pooled estimates from meta-analyses have clearly showed that paclitaxel-coated balloons reduce the risk of restenosis and repeat revascularization, while improving patency, limb salvage, and freedom from claudication

Veneto's successful lesson for a world shocked by COVID-19: think globally and act locally

Severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2) infection has wreaked havoc globally, with an ominous morbidity and mortality impact.1,2 Indeed, croronavirus disease 2019 (COVID-19) still represents a formidable challenge for pathophysiology, prognostication, management, and rehabilitation. This holds even truer given the conflicting reports accrued so far for several purportedly effective interventions.1,3,4 Although substantial steps have been accomplished in terms of diagnostic yield, even recognizing early infection is still quite challenging. Each country has addressed COVID-19 in its own way, with variable results. Perusing data on China’s experience with the virus brings forward several questions in terms of completeness and truthfulness of reporting, with substantial skepticism despite several authoritative reports.5 For instance, to date, China has reported fewer COVID-19-related deaths than many smaller countries where COVID-19 spread much later (eg, The Netherlands). Countries and healthcare systems that have acted with a global vision, but also with a firm and proactive local hand, have seen the best results in terms of deaths and system derangement. Conversely, countries with a loose policy (either initially such as the United Kingdom or throughout such as Sweden) have already paid an enormous toll of life and pain, and hypothetically will continue to do so

SARS-CoV-2 and COVID-19. Facing the pandemic together as citizens and cardiovascular practitioners

Despite their highbrow name, coronarvirus have proved eminently disruptive in recent years. Since the epidemic of severe respiratory distress syndrome (SARS) due to the SARS-related coronavirus (SARS-CoV) infection and the Middle East respiratory syndrome (MER S) due to the MER S-related coronavirus (MER S-CoV), several experts could expect the advent of additional epidemics due to coronaviruses. Yet, the ongoing pandemic of coronavirus-associated disease 2019 (COVID -2019) due to the infection from SARS-CoV-2 (also known as 2019-nCoV) has wreaked havoc worldwide (Figure 1). As Italian citizens and cardiovascular practitioners, we are now facing this storm, with a mix of incredulity, fear, boldness, and sense of duty

Optimal stent design for high bleeding risk patients: Evidence from a network meta-analysis

Objective. To determine the best stent design for high bleeding risk (HBR) patients. Background. Polymer-free (PF) drug eluting stent (DES) devices have a proven benefit over bare-metal stent (BMS) devices in previous trials. It is unknown, however, whether polymer-based (PB)-DES devices are as safe as PF-DES devices. Methods. A network meta-analysis including all randomized controlled trials (RCTs) that compared different stent technology in HBR patients with a 1-month course of dual-antiplatelet therapy (DAPT) was performed. The main efficacy outcome was major adverse cardiac event (MACE) rate, defined as the composite of all-cause mortality, myocardial infarction (MI), and target-lesion revascularization (TLR). Secondary efficacy events included all-cause and cardiac mortality, MI, stroke, TLR, and target-vessel revascularization (TVR). Safety outcomes included all bleeding, major bleeding, and stent thrombosis (ST). Results. A total of 4 RCTs with 6456 patients were included. PF-DES and PB-DES yielded a reduced rate of MACE, MI, TLR, and TVR events compared with BMS (all P<.05). ST events were reduced in PB-DES compared with BMS (P=.01). No differences were found in all-cause death, cardiac death, or stroke events in PF-DES and PB-DES compared with BMS. Furthermore, no differences were found between PF-DES and PB-DES regarding any of the outcomes. Conclusion. DES devices were associated with lower MACE and TVR rates compared with BMS, whereas there were no statistical differences in other efficacy endpoints. Also, PB-DES were associated with fewer ST events compared with BMS. There were no statistical differences between PB-DES and PF-DES with regard to any of the endpoints. t 2021 HMP Comm Personal Use Onl

Right versus left radial artery access for coronary procedures: an international collaborative systematic review and meta-analysis including 5 randomized trials and 3210 patients

BACKGROUND: Radial artery access is a mainstay in the diagnosis and treatment of coronary artery disease. However, there is uncertainty on the comparison of right versus left radial access for coronary procedures. We thus undertook a systematic review and meta-analysis comparing right versus left radial access for coronary diagnostic and interventional procedures. METHODS: Pertinent studies were searched in CENTRAL, Google Scholar, MEDLINE/PubMed, and Scopus, together with international conference proceedings. Randomized trials comparing right versus left radial (or ulnar) access for coronary diagnostic or interventional procedures were included. Risk ratios (RR) and weighted mean differences (WMD) were computed to generate point estimates (95% confidence intervals). RESULTS: A total of 5 trials (3210 patients) were included. No overall significant differences were found comparing right versus left radial access in terms of procedural time (WMD=0.99 [-0.53; 2.51]min, p=0.20), contrast use (WMD=1.71 [-1.32; 4.74]mL, p=0.27), fluoroscopy time (WMD=-35.79 [-3.54; 75.12]s, p=0.07) or any major complication (RR=2.00 [0.75; 5.31], p=0.49). However, right radial access was fraught with a significantly higher risk of failure leading to cross-over to femoral access (RR=1.65 [1.18; 2.30], p=0.003) in comparison to left radial access. CONCLUSIONS: Right and left radial accesses appear largely similar in their overall procedural and clinical performance during transradial diagnostic or interventional procedures. Nonetheless, left radial access can be recommended especially during the learning curve phase to reduce femoral cross-overs

Remote ischaemic preconditioning in coronary artery bypass surgery: a meta-analysis

Aim Randomised trials exploring remote ischaemic preconditioning (RIPC) in patients undergoing coronary artery bypass graft (CABG) surgery have yielded conflicting data regarding potential cardiovascular and renal protection, and are individually flawed by small sample size. Methods Three investigators independently searched the MEDLINE, EMBASE and Cochrane databases to identify randomised trials testing RIPC in patients undergoing CABG. Results Nine studies with 704 patients were included. Standardised mean difference of troponin I and T release showed a significant decrease ( 120.36 (95% CI 120.62 to 120.09)). This difference held true after excluding the trials with cross-clamp fibrillation, the study with off-pump CABG and studies using a flurane as anaesthetic agent ( 120.41 (95% CI 120.69 to 120.12), 120.38 (95% CI 120.70 to 120.07) and 120.37 (95% CI 120.63 to 120.12), respectively). A similar trend was also obtained for patients with multivessel disease ( 120.41 (95% CI 120.73 to 120.08)). The trials evaluating postoperative creatinine reported a non-significant reduction (0.02 (95% CI 120.09 to 0.13)). Moreover, the length of in-hospital stay was not influenced by the kind of treatment (weighted mean difference 0.27 (95% CI 120.24 to 0.79)). Conclusion RIPC reduced the release of troponin in patients undergoing CABG. Larger randomised trials are needed to clarify the presence of a causal relationship between RIPC-induced troponin release and clinical adverse events

Use and misuse of multivariable approaches in interventional cardiology studies on drug-eluting stents: a systematic review.

Aims: Randomized clinical trials (RCTs) are the most reliable evidence, even if they require important resource and logistic efforts. Large, cost-free and real-world datasets may be easily accessed yielding to observational studies, but such analyses often lead to problematic results in the absence of careful methods, especially from a statistic point of view. We aimed to appraise the performance of current multivariable approaches in the estimation of causal treatment and effects in studies focusing on drug-eluting stents (DES). Methods and Results: Pertinent studies published in the literature were searched, selected, abstracted, and appraised for quality and validity features. Six studies with a logistic regression were included, all of them reporting more than 10 events for covariates and different length of follow-up, with an overall low risk of bias. Most of the 15 studies with a Cox proportional hazard analysis had a different follow-up, with less than 10 events for covariates, yielding an overall low or moderate risk of bias. Sixteen studies with propensity score were included: the most frequent method for variable selection was logistic regression, with underlying differences in follow-up and less than 10 events for covariate in most of them. Most frequently, calibration appraisal was not reported in the studies, on the contrary of discrimination appraisal, which was more frequently performed. In seventeen studies with propensity and matching, the latter was most commonly performed with a nearest neighbor-matching algorithm yet without appraisal in most of the studies of calibration or discrimination. Balance was evaluated in 46% of the studies, being obtained for all variables in 48% of them. Conclusions: Better exploitation and methodological appraisal of multivariable analysis is needed to improve the clinical and research impact and reliability of nonrandomized studies. (J Interven Cardiol 2012;**:1-1

Comparative indoor pollution from Glo, Iqos, and Juul, using traditional combustion cigarettes as benchmark. Evidence from the randomized sur-vapes air trial

Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) are appealing alternatives to combustion cigarettes. Limited between-and within-device comparative data are available on MRP. We aimed at comparing indoor particulate matter (PM) emissions measured in a randomized trial enforcing standardized smoking sessions, testing different devices and flavors of MRP, using traditional combustion cigarettes (TCC) as benchmark. Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP < 100 µg/m3, and for TCC > 1000 µg/m3). Despite this, significant differences among MRP were found, with Iqos appearing associated with a significantly lower burden of emissions for all the monitored fractions of PM, including total PM (all p < 0.05). Precisely, during use, PM ≤ 1 µm (PM1) emissions were 28 (16; 28) µg/m3 for Glo, 25 (15; 57) µg/m3 for Iqos, and 73 (15; 559) µg/m3 for Juul (p < 0.001 for Glo vs. Iqos, p <0.001 for Glo vs. Juul, and p = 0.045 for Iqos vs. Juul). Exploratory within-MRP analyses suggested significant differences between flavors, favoring, for instance, Ultramarine for Glo, Bronze for Iqos, and Mango for Juul, even if results varied substantially according to individual smoker. In conclusion, leading MRP have significantly less intense and persistent effects on indoor pollution in comparison to TCC. Yet, when focusing solely on MRP, between-product and between-flavor differences appear, with quantitative estimates suggesting lower polluting effects with Iqos. These results, if confirmed externally, could be used to individualize product and flavor choice to minimize the untoward effects of EVC and HNBC on indoor pollution