Johannes Bennett

Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial

AIMS Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons (DEB) and the second generation of drug-eluting stents (DES) when used to treat in-stent restenosis (ISR). In this study, we set out to compare prospectively the healing characteristics, as assessed by optical coherence tomography (OCT), of DEB versus DES after treatment of ISR in bare metal stents (BMS). METHODS AND RESULTS Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent (EES). The primary endpoint was the percentage of uncovered struts, assessed with OCT at nine months, as a marker of vessel wall healing. A mean of 366±135 and 636±184 struts were analysed per patient in the DEB and EES groups, respectively. The percentage of uncovered struts per patient was significantly lower with DEB vs. EES (1.4% vs. 3.1%, p=0.025). Mean neointimal hyperplasia area was 2.4±1.08 mm in DEB vs. 1.92±0.67 mm in EES (p=0.1806), while the percentage of malapposed struts per patient was very low in both groups (0.2% vs. 0.3%, p=0.699). At nine months, angiographic in-stent MLD (minimum lumen diameter) was lower (2.13 vs. 2.54 mm, p=0.006), while diameter stenosis (26.4 vs. 11.4%, p=0.002), and LLL (0.28 vs. 0.07 mm, p=0.1) were higher after DEB compared to EES. During one-year follow-up, we did not observe differences in the rates of death, TLR (target lesion revascularisation) or stent thrombosis. CONCLUSIONS DEB appears to be associated with better healing characteristics, as assessed by stent strut coverage with OCT, but tended to be slightly less effective compared to EES. These findings give support to the use of either DEB or EES as valuable treatment options for ISR. CLINICAL TRIAL REGISTRATION http://www.clinicaltrials.gov. Unique identifier: NCT 01065532.

A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease.

The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.

Circumflex coronary artery injury after mitral valve surgery: A report of four cases and comprehensive review of the literature.

As the LCx is closely related to the mitral valve annulus, it is susceptible to perioperative injury. Various underlying mechanisms, predisposing factors, and therapeutic strategies have been suggested but disagreement exists. Using a MeSH terms‐based PubMed search, 44 cases of mitral valve surgery‐related LCx injury were detected, including our 4 cases. We provide a comprehensive review of current knowledge regarding mitral valve surgery‐related left circumflex coronary artery (LCx) injury. Preoperative coronary angiography was performed in 55% (n = 24). Coronary abnormalities were present in 11% (n = 5). Coronary dominance was reported in 73% (n = 32), predominantly showing left (69%, n = 22) or balanced (19%, n = 6) circulations. Right coronary dominance was present in 12% (n = 4). Ischemia was detected in the perioperative or early postoperative phase in 86% (n = 30). Delayed symptoms were present in 14% (n = 5). Echocardiography demonstrated new regional wall motion abnormalities in 80% (n = 24), but was negative in 20% (n = 6) despite coronary compromise. Electrocardiography showed myocardial ischemia in 97% (n = 34), including regional ST‐segment elevations in 68% (n = 23). Primary treatment was surgical in 42% (n = 15) and percutaneous in 58% (n = 21), reporting success ratios of 87% (n = 13) and 81% (n = 17), respectively. We confirm an augmented risk of mitral valve surgery‐related LCx injury in balanced or left‐dominant coronary circulations. Preoperative knowledge of coronary anatomy does not preclude LCx injury. An anomalous LCx arising from the right coronary cusp was identified as a possible specific high‐risk entity. Electrocardiographic monitoring and intraoperative echocardiography remain paramount to ensure a timely diagnosis and treatment.

The apical nipple sign: a useful tool for discriminating between anterior infarction and transient left ventricular ballooning syndrome.

Aims: Even after coronary angiography, transient left ventricular ballooning syndrome (TLVBS) can be misdiagnosed as ST-elevation myocardial infarction (STEMI) caused by transient thrombotic occlusion of the left anterior descending artery, as the appearance of the left ventricular angiograms is often very similar. As prognosis and antithrombotic treatment of these two conditions differ widely, it is desirable to make a correct diagnosis as early as possible. Methods: Between January 1998 and August 2012, we identified 145 patients diagnosed with TLVBS in a single tertiary hospital, based on the Mayo criteria and (near) normalization of left ventricular function over weeks. For 119 of these patients, coronary and left ventricular angiograms were available for detailed study. Results: In 27 (22.7%) patients, mid-ventricular ballooning was observed, with preserved contractility of the apex, while in 92 (77.3%) typical apical ballooning was seen, with extensive akinesis of the apex. In 28 of the patients with typical apical ballooning (30.4%), we observed the presence of a very small zone with preserved contractility in the most apical portion of the left ventricle. We coined this phenomenon ‘apical nipple sign’. For comparison, we reviewed the left ventricular angiograms of 405 patients who had been treated for anterior STEMI by emergency percutaneous intervention on the left anterior descending artery in our hospital between February 2007 and October 2012. On careful review, the apical nipple sign was not seen in any of these. Conclusion: While discrimination between TLVBS and anterior STEMI is warranted as early as possible after admission, this is very difficult, especially in the majority of cases presenting with the classical apical ballooning phenotype. By observing the herein-described apical nipple sign, the attending physician can make the diagnosis of TLVBS with virtual certainty in almost one-third of cases.

Very late bare metal stent thrombosis due to neoatherosclerotic plaque rupture: an optical coherence tomography finding

Very late stent thrombosis (VLST) is a rare but potentially catastrophic complication occurring after percutaneous coronary intervention. The mechanisms involved in VLST in bare metal stents (BMS) are poorly understood. A 50-year-old man presented with an inferior ST-elevation myocardial infarction

Absorb Bioresorbable Vascular Scaffold in Complex Coronary Bifurcation Interventions: Insights From an In Vivo Multimodality Imaging Study

Background—Although bioresorbable scaffolds offer potential advantages compared with metallic drug-eluting stents in the treatment of complex coronary bifurcation lesions, there are concerns that the polymeric scaffold integrity may be compromised. This in vivo study sought to provide insights about the feasibility of performing complex bifurcation stenting with Absorb bioresorbable vascular scaffolds (Abbott Vascular, Santa Clara, CA). Methods and Results—Twenty New Zealand white rabbits underwent stenting of the nondiseased aortoiliac bifurcation with bioresorbable vascular scaffolds using provisional (PS, n=5), culotte (n=5), modified-T (n=5), or T-and protrusion (n=5) stenting techniques. Angiography, optical coherence tomography, and microcomputed tomography were performed. Angiographic results were excellent without evidence of dissection or side branch (SB) compromise. PS optimally opened the SB ostium without deforming the main vessel (MV) bioresorbable vascular scaffolds, avoiding malapposition, and revealing a single connector fracture in 1 of 5 cases on microcomputed tomography. Culotte stenting resulted in complete bifurcation coverage with extensive segments of double-layered struts and inappropriately apposed struts at the bifurcation level in 3 of 5 cases. On microcomputed tomography, there was MV and SB scaffold distortion at the bifurcation with single strut fractures in 4 of 5 and double fractures in 1 of 5. Modified-T and T-and protrusion resulted in complete bifurcation coverage and in minimal double-strut layers at the neocarina. On microcomputed tomography, no strut fractures were present after modified-T, whereas in 3 of 5 T-and protrusion procedures single strut fractures were noted. Conclusions—Bifurcation stenting using bioresorbable vascular scaffolds is feasible with excellent angiographic results. PS with additional T-and protrusion whenever needed seems a reasonable approach. Whenever a 2-stent technique is planned, modified T-stenting appears the most promising.

Complex bifurcation lesions: Randomized comparison of a fully bioresorbable modified t stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds, an OCT study: Rationale and design of the COBRA II trial

There is an ongoing controversy regarding the efficacy and safety of different percutaneous stenting techniques for coronary bifurcation lesions needing >1 stent. The promise of safe vessel restoration with bioresorbable scaffolds (BRS) may not be transferable to complex double BRS bifurcation techniques, and permanent metallic scaffolding of the bifurcation core may be needed. We identified modified‐T stenting as the most promising fully bioresorbable 2‐stent strategy in a preclinical setting. The objective of this study is to assess acute performance and compare long‐term vessel healing with this strategy, versus an approach combining BRS with a dedicated metallic drug‐eluting bifurcation stent.

Drug-eluting versus bare metal stents after rotational atherectomy: clinical outcome in a single centre.

Purpose Heavily calcified atherosclerotic plaques can be prepared for stenting by rotational atherectomy (RA). Clinical outcomes with drug-eluting stents (DES) versus bare-metal stents (BMS) after RA have not been investigated sufficiently. We present a single-centre study comparing the efficacy and long-term outcome of DES versus BMS after RA. Methods and results We performed a retrospective cohort study of all patients who were treated with RA at our institution between January 2004 and March 2012. Clinical follow-up was obtained at 1 year. Procedural success (defined as a residual stenosis < 30%) was recorded, as was the 1-year incidence of myocardial infarction (MI), stent thrombosis (ST) and major adverse cardiac events (MACE), a composite end point of cardiac death, MI or target lesion revascularization (TLR). Eighty-five patients underwent RA followed by stenting, 30 receiving a BMS and 55 a DES, and completed 1-year clinical follow-up. Baseline clinical and angiographic characteristics were similar, and procedural success was achieved in 99% of the patients. At 1 year the overall incidence of MACE was 19%, and no significant differences in clinical outcome between DES and BMS were seen (MACE: 9 (16%) vs 7 (23%), P= 0.44; cardiac death: 3 (5%) vs 0 (0%); MI: 4 (7%) vs 5 (17%), P= 0.2; TLR: 2 (4%) vs 3 (10%), P= 0.25; ST: 2 (4%) vs 2 (7%), P= 0.52, respectively). Conclusions In this study, no significant differences in medium-term clinical outcomes between DES and BMS after RA were observed, although there was a definite trend to improved outcomes with DES.

Percutaneous coronary intervention, a historical perspective looking to the future

Although coronary artery disease (CAD) mortality rates have declined, CAD remains the leading cause of death worldwide, contributing to over 7.2 million deaths annually (1). Percutaneous coronary intervention (PCI) has made significant progress in the management of obstructive CAD over the past three decades. Since the introduction of percutaneous balloon angioplasty by Gruntzig in 1977, PCI techniques have evolved dramatically. In 1986, Puel and Sigwart deployed the first coronary stent to act as a scaffold, thus preventing vessel closure during PCI, and reducing the incidence of restenosis, which was occurring in up to 40% of cases (2). Bare metal stents (BMS), however, were still associated with intra-stent restenosis rates of 20-30% requiring re-intervention (3). Such restenosis occurred as a result of neointimal hyperplasia within the stent, caused by the migration and proliferation of vascular smooth muscle cells. In 2002, drug-eluting stents (DES), which inhibit the development of neointimal hyperplasia by releasing anti-proliferative and anti-inflammatory drugs directly into the vessel wall, were introduced as a strategy to minimize restenosis and hence the necessity for re-intervention.

5-Year clinical follow-up of the COBRA (complex coronary bifurcation lesions: Randomized comparison of a strategy using a dedicated self-expanding biolimus A9-eluting stent vs. a culotte strategy using everolimus-eluting stents) study

We evaluated healing responses with optical coherence tomography, and long‐term clinical outcomes after treatment with a dedicated stent versus a conventional culotte technique.