Treatment of the chronic total occlusion: a call to action for the interventional community.

There is substantial evidence that recanalization of a chronic total occlusion is beneficial; nonetheless, it is generally underutilized in clinical practice. We consider the Aesop's fable of the "Fox and the Grapes" as analogous to the current situation in interventional cardiology. The technical challenges in achieving CTO recanalization has led interventionalists, clinical cardiologists, and sometimes even patients to believe that CTO recanalization is not effective, and, therefore, not needed.

The ROX coupler: creation of a fixed iliac arteriovenous anastomosis for the treatment of uncontrolled systemic arterial hypertension, exploiting the physical properties of the arterial vasculature.

Objectives: Uncontrolled hypertension, whether due to drug resistance or poor adherence and persistence, remains a problem in many patients. The ROX coupler is a novel technology designed to reduce arterial blood pressure consequent to the predicted physical effects of reducing vascular resistance and improving arterial compliance. This article describes the technical aspects of the device and implantation procedure, results from a preclinical study, patient selection criteria, and potential complications of this therapy for uncontrolled hypertension.

First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients.

Background: First-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to their long-term safety. Second-generation DES were designed to overcome safety issues, but the results of randomised clinical trials remain conflicting.

The efficacy and safety of the "hybrid" approach to coronary chronic total occlusions: insights from a contemporary multicenter US registry and comparison with prior studies.

Background: Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is challenging and has been associated with low success rates. However, recent advancements in equipment and the flexibility to switch between multiple technical approaches during the same procedure ("hybrid" percutaneous algorithm) have dramatically increased the success of CTO-PCI. We sought to compare the contemporary procedural outcomes of hybrid CTO-PCI with previously published CTO-PCI studies.

Meta-analysis of the effect of renal denervation on blood pressure and pulse pressure in patients with resistant systemic hypertension.

Data comparing the effect of renal denervation (RD) with those of maximal medical therapy (MMT) have shown conflicting results. Also, effect of RD on pulse pressure (PP) has not been evaluated. The aim of this meta-analysis was to compare the effect of RD with that of MMT on blood pressure (BP) and PP at 6-month follow-up in patients with resistant hypertension.

Percutaneous Treatment of Coronary Chronic Total Occlusion Part 2: Technical Approach.

Dual injection is recommended for nearly all chronic total occlusion (CTO) percutaneous coronary intervention (PCI) to determine the optimal crossing strategy and guide wire advancement into the distal true lumen. Strategies that provide enhanced guide catheter support (such as long sheaths, large-bore guiding catheters, use of guide catheter extensions, and anchor techniques) are important for maximising the success rate and efficiency of CTO PCI. Use of a microcatheter or over-the-wire balloon is strongly recommended in CTO PCI for enhancing the penetrating power of the guidewire, enabling change in tip shape and allowing guidewire change (stiff CTO guidewires are not optimal for crossing non-occluded coronary segments).

Percutaneous Treatment of Coronary Chronic Total Occlusions Part 1: Rationale and Outcomes.

Coronary chronic total occlusions (CTOs) are commonly encountered in patients with coronary artery disease. Compared to patients without coronary CTOs, those with CTO have worse clinical outcomes and lower likelihood of complete coronary revascularisation. Successful CTO percutaneous coronary intervention (PCI) can significantly improve angina and improve left ventricular function.

Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3.

Background: Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure.

Objectives: SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization.

Application of the "hybrid approach" to chronic total occlusions in patients with previous coronary artery bypass graft surgery (from a Contemporary Multicenter US registry).

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) has been traditionally associated with lower success rates in patients with previous coronary artery bypass graft surgery (CABG). We sought to examine the success and complication rates of CTO PCI using the "hybrid" crossing algorithm among patients with a history of previous CABG. The procedural outcomes of 496 consecutive CTO PCIs performed at 5 high-volume PCI centers in the United States from January 2012 to August 2013 were assessed.

A controlled trial of renal denervation for resistant hypertension.

Background: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.

Methods: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure.

The efficacy of "hybrid" percutaneous coronary intervention in chronic total occlusions caused by in-stent restenosis: insights from a US multicenter registry.

Objectives: To examine the success and complication rates in percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) caused by in-stent restenosis (ISR).

Background: PCI for in-stent total occlusive disease has traditionally been associated with low success rates. We sought to examine angiographic and procedural outcomes of patients who underwent CTO PCI due to ISR using the novel "hybrid" algorithm, and compare them with patients with de novo CTOs.

The impact of residual coronary lesions on clinical outcomes after percutaneous coronary intervention: Residual SYNTAX score after percutaneous coronary intervention in patients from the Efficacy of Xience/Promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) registry.

Background: The SYNTAX score (SS) is used in preprocedural evaluation for percutaneous coronary intervention (PCI); it assesses the complexity of coronary lesions and predicts PCI outcome. However, the usefulness of the residual SS (rSS), which can be calculated after PCI and may reflect the completeness of revascularization, has not been fully investigated in an enriched PCI population.

Methods And Results: The baseline SS and rSS were determined in 5,088 patients (3,046 everolimus-eluting stents and 2,042 sirolimus-eluting stents) from the EXCELLENT registry.

Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients.

Background: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy and safety profile of polymer-free vs. durable polymer DES by a comprehensive meta-analysis of RCTs.

Methods: MEDLINE, Google Scholar, EMBASE and Cochrane databases were searched for RCTs comparing polymer-free to durable polymer DES.

Transradial versus transfemoral method of two-stent implantation for true bifurcation lesions: comparison of immediate and long-term outcomes.

Background: The feasibility, safety, and efficacy of two-stent implantation for true bifurcation disease through transradial (TR) versus transfemoral (TF) approaches have not been thoroughly investigated.

Methods And Results: We compared procedural and long-term outcomes of a two-stent strategy percutaneous revascularization in 805 consecutive patients with true bifurcation lesions requiring two-stent implantation via either a TR (n = 508) or TF (n = 297) approach from 2004 to 2009. Clinical and angiographic characteristics, procedural outcomes, and in-hospital and long-term clinical events were compared according to vascular access strategy.

Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions.

In clinical practice we pay close attention to choosing an appropriate intervention for patients and performing it safely. We may put less thought into how to measure the effect without bias. Clinical practice involving noisy values such as blood pressure requires intelligent processing to avoid confusing patients, but applying such discretion in clinical trials may inadvertently disrupt quantification of the benefit of the intervention, in unblinded trials.

Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis.

Background: The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework.

Methods And Results: Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected.

Temporal trends of fluoroscopy time and contrast utilization in coronary chronic total occlusion revascularization: insights from a multicenter United States registry.

Background: The impact of operator experience on fluoroscopy time and contrast utilization during percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTOs) has received limited study.

Methods: We evaluated temporal trends in fluoroscopy time and contrast utilization among 1,363 consecutive CTO PCIs performed at three US institutions between January 2006 and November 2011.

Results: Mean age was 65 ± 11 years, 85% of patients were men, 40% had diabetes, 37% had prior coronary artery bypass graft surgery, and 42% had prior PCI.

Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis.

Objectives: To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES).

Design: Network meta-analysis of randomised controlled trials.

Data Sources And Study Selection: Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES.

First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries).

Objectives: This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.

Background: Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.

Methods: We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.

Usefulness of the SYNTAX and clinical SYNTAX scores in predicting clinical outcome after unrestricted use of sirolimus- and everolimus-eluting Stents.

Background: The SYNTAX score (SS) and clinical SS (cSS) can assess coronary lesion complexity and are useful indices in predicting outcomes after percutaneous coronary intervention. However, their validity has not been fully investigated in daily practice where "limus"-eluting stents are used.

Methods And Results: The SS and cSS were independently assessed from the Efficacy of Xience/Promus vs.

Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials.

Background: The safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and efficacy of DES in female patients during long-term follow-up.

Catheter-based Renal Sympathetic Denervation - Long-term Symplicity™ Renal Denervation Clinical Evidence, New Data and Future Perspectives.

Hypertension is one of the most prevalent chronic diseases worldwide and the incidence of resistant hypertension is increasing. Catheter-based renal denervation (RDN) offers a new approach to reaching blood pressure goals by targeting the renal nerves. The technique has demonstrated significant and sustained reductions in blood pressure (BP) in the Symplicity HTN-1 and Symplicity HTN-2 clinical trials.

First report of a novel polymer-free dual-drug eluting stent in de novo coronary artery disease: results of the first in human BICARE trial.

Background: Persistence of stent polymer coating has been associated with incomplete endothelialization, expansive vessel remodeling, neoatherosclerosis, and delayed healing associated with inflammation that may contribute to late adverse events.

Methods: The BICARE (Lepu Medical, Beijing, China) stent is a novel polymer-free, nanotechnology-based stent eluting sirolimus and probucol. As a first in human feasibility study, patients with a single de novo native coronary stenosis <30 mm in length and with reference vessel diameter from 2.