Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial.

BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.

Impact of established cardiovascular disease on outcomes in the randomized global leaders trial.

OBJECTIVE: To investigate the impact of different anti-platelet strategies on outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD). METHODS: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. Established CVD was defined as ≥1 prior myocardial infarction, PCI, coronary artery bypass operation, stroke, or established peripheral vascular disease. The primary endpoint was a composite of all-cause death or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5 bleeding. Exploratory secondary endpoints were the patient-orientated composite endpoint and net adverse clinical events. RESULTS: Among the 15,761 patients in this cohort were 6,693 patients (42.5%) with established CVD. Compared to those without established CVD, these patients had significantly higher rates of the primary (5.1 vs. 3.3%, HR1.59[1.36-1.86], p < .001) and secondary composite endpoints with no significant differences in bleeding. There was a nonsignificant reduction in the primary endpoint in patients with established CVD receiving the experimental treatment (4.6 vs. 5.6%, HR0.82[0.66-1.02], p = .07). When comparing patients without CVD to those with one or three territories of CVD, the hazard ratio for the primary endpoint increased in unadjusted and adjusted models. CONCLUSIONS: The poorer outcomes in patients with established CVD are not mitigated by prolonged monotherapy with a potent P2Y12 inhibitor suggesting a greater need to focus on modifiable risk factors.

Randomized comparison of everolimus- and paclitaxel-eluting stents: pooled analysis of the 2-year clinical follow-up from the SPIRIT II and III trials.

AIMS: To investigate the clinical impact of the following observations in the randomized SPIRIT II and III trials: an incremental increase in in-stent neointima between 1 and 2 years with the everolimus-eluting stent (EES) but not with the paclitaxel-eluting stent (PES) in SPIRIT II; a tendency of lower stent thrombosis in EES than in PES among those who first discontinued a thienopyridine after 6 months. METHODS AND RESULTS: A pooled analysis was performed using the 2-year clinical data from the SPIRIT II and III trials randomizing a total of 1302 patients with de novo coronary artery lesions either to EES or to PES. Inclusion and exclusion criteria were comparable between two trials. Major adverse cardiac event (MACE) was defined as cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularization (TLR). At 2 years, MACE rates were 7.1% in EES vs. 12.3% in PES, respectively (log-rank P = 0.0014), without late increase in TLR. Among those who first discontinued a thienopyridine after 6 months, Academic Research Consortium (ARC) definite or probable stent thrombosis was 1.1% in EES vs. 1.3% in PES (P = 1.00). CONCLUSION: The benefits of EES in reducing TLR were robust between 6 months and 2 years. No significant difference in the thrombosis rate among those who first stopped a thienopyridine after 6 months was observed.

MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses.

AIMS: To report the 4-month angiographic and 6-month clinical follow-up in first-in-man study using the tacrolimus-eluting bioabsorbable polymer-coated cobalt-chromium MAHOROBA stent. METHODS AND RESULTS: A total of 47 patients with either stable angina or unstable angina, or silent myocardial ischaemia, based on a de novo coronary stenosis that could be covered by a single 18 mm stent in a native coronary artery with a diameter between 3.0 and 3.5 mm were enrolled at three sites. The primary endpoint was in-stent late loss at 4 months. The secondary endpoints include %volume obstruction of the stents assessed by intravascular ultrasound (IVUS) at 4 months and major adverse cardiac events (MACE) at 6 months. Forty-seven patients were enrolled. Procedural success was achieved in 97.9%. At 4-month follow-up, in-stent late loss was 0.99 +/- 0.46 mm, whereas in-stent %volume obstruction in IVUS was 34.8 +/- 15.8%. At 6 months, there were no deaths, but 2 patients suffered from a myocardial infarction and 11 patients required ischaemia-driven repeat revascularization. The composite MACE rate was 23.4%. CONCLUSION: This tacrolimus-eluting stent failed to prevent neointimal hyperplasia, despite the theoretical advantages of the tacrolimus, which has less inhibitory effects on endothelial cells than smooth muscle cells.

DAPT Score and the Impact of Ticagrelor Monotherapy During the Second Year After PCI.

OBJECTIVES: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population. BACKGROUND: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown. METHODS: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score. RESULTS: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups. CONCLUSIONS: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.

Mechanical properties and performances of contemporary drug-eluting stent: focus on the metallic backbone.

INTRODUCTION: Drug-eluting stents (DES) are still the standard of care in percutaneous coronary intervention (PCI) since the fall of bioresorbable scaffolds with respect to safety. The unbeatable advantage of a metallic stent when compared with a scaffold is a stronger mechanical property and more sustainable vascular support. Recent development of contemporary metallic stent has focused on the reduction of strut thickness. However, there will always be a trade-off between improvement in deliverability, flexibility, and radial strength. AREAS COVERED: This review aims to discuss the designs of metallic stent platform and mechanical properties as well as mechanical performance of contemporary DES from bench studies and clinical trials. EXPERT OPINION: Mechanical properties of stents affect short- and long-term clinical outcomes. Ultrathin-strut DES have become popular and clinical trials have shown impressive results. Thinner struts may improve device flexibility and deliverability but the radial strength and longitudinal integrity might have been compromised as well. Ultrathin-strut cobalt chromium or platinum chromium DES will become standard of care in PCI practice in the near future. Information on the stent design, stent material and mechanical properties of the stent are essential for a rational selection of the appropriate stent in selected lesions and patients.

Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study.

BACKGROUND: Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. METHODS: Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0-30 days) and late (>30 days) stent thrombosis and between SES and PES. FINDINGS: Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1.3 per 100 person-years; cumulative incidence at 3 years 2.9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0.6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1.1%) and PES (1.3%), but late stent thrombosis was more frequent with PES (1.8%) than with SES (1.4%; p=0.031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0.0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2.28, 95% CI 1.29-4.03) and diabetes (2.03, 1.07-3.83). INTERPRETATION: Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis.

Four-year clinical follow-up of the rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital registry.

Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem.

Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries).

Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups.

Use of bioresorbable vascular scaffold: a meta-analysis of patients with coronary artery disease.

BACKGROUND: Differences in outcomes between bioresorbable vascular scaffold (BVS) systems and drug-eluting metal stents (DES) have not been fully evaluated. We aimed to compare clinical and angiographic outcomes in randomised studies of patients with coronary artery disease (CAD), with a secondary analysis performed among registry studies. METHODS: A meta-analysis comparing outcomes between BVS and DES in patients with CAD. Overall estimates of treatment effect were calculated with random-effects model and fixed-effects model. RESULTS: In 6 randomised trials (3818 patients), BVS increased the risk of subacute stent thrombosis (ST) over and above DES (OR 2.14; CI 1.01 to 4.53; p=0.05), with a trend towards an increase in the risk of myocardial infarction (MI) (125 events in those assigned to BVS and 50 to DES; OR 1.36; CI 0.97 to 1.91; p=0.07). The risk of in-device late lumen loss (LLL) was higher with BVS than DES (mean difference 0.08 mm; CI 0.03 to 0.13; p=0.004). There was no difference in the risk of death or target vessel revascularisation (TVR) between the two devices. In 6 registry studies (1845 patients), there was no difference in the risk of death, MI, TVR or subacute ST between the two stents. Final BVS dilation pressures were higher in registry than in randomised studies (18.7±4.6 vs 15.2±3.3 atm; p<0.001). CONCLUSIONS: Patients treated with BVS had an increased risk of subacute ST and slightly higher LLL compared with those with DES, but this might be related to inadequate implantation techniques, in particular device underexpansion.

Under-diagnosis of diabetes mellitus in patients with coronary artery disease.

BACKGROUND: The uptake of medical treatment in patients with coronary artery disease may be suboptimal. Our intention was to review the medical treatment of these patients in the light of current evidence. METHODS: One hundred ninety six consecutive patients with known or suspected coronary artery disease attending a tertiary centre for day case cardiac catheterisation were assessed. Fasting blood samples were sent for glucose and cholesterol. The results of coronary angiography and left ventriculography and any changes in medications were noted. RESULT: One hundred eighty two patients (93%) had fasting blood samples taken. The management of cholesterol in patients with coronary artery disease has improved since 1994. We have demonstrated the benefit of taking fasting blood samples in patients attending for day case angiography: 10% of non-diabetics actually had fasting blood glucose levels of greater than 7.0 mmol/l. All of these newly diagnosed diabetics had coronary artery disease. A further 9% of non-diabetics had impaired fasting glycaemia; 69% had coronary artery disease and 8% had left ventricular dysfunction. Among patients with coronary artery disease, there was a statistically significant increase on most categories of medications on discharge compared to admission. For those with left ventricular dysfunction, there was a statistically significant increase in the use of Angiotensin-Converting-Enzyme (ACE)-inhibitors. CONCLUSION: Diabetes mellitus is under-diagnosed in patients with coronary heart disease. They are at higher risk of coronary artery disease and therefore need intensive management. Testing all patients attending for day case cardiac catheterisation for fasting glucose would enable diagnosis and initiation of treatment of a high-risk group.

Novel oral anticoagulants in acute coronary syndrome.

Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide with a prevalence that has now reached pandemic levels as a consequence of the rapid modernization of the developing world. Its presentation as an acute coronary syndrome (ACS) is a frequent reason for hospital admission and of profound implications for personal, societal and global health. Despite improvements in the management of ACS with anti-platelet and anticoagulant therapy and revascularization techniques, many patients continue to suffer recurrent ischemic events. The need to reduce future cardiovascular events has led to the development of novel therapies to prevent coronary thrombosis, targeting thrombin-mediated pathways. These include direct Xa inhibitors (apixaban, rivaroxaban and darexaban), direct thrombin inhibitors (dabigatran) and PAR 1 antagonists (vorapaxar and atopaxar). This article critically reviews the comparative mechanisms of action, the risks and benefits, together with the clinical evidence base for the use of these novel oral agents in the management of ACS patients.

Use of thrombectomy devices in primary percutaneous coronary intervention: a systematic review and meta-analysis.

AIMS: Primary percutaneous coronary intervention (PPCI) has become the treatment of choice in patients with ST-elevation myocardial infarction (STEMI) over the recent years. A number of studies have demonstrated a morbidity and mortality benefit over thrombolysis, which has been attributed to better coronary perfusion in patients undergoing PPCI. However although PPCI usually achieves normal flow in the affected epicardial vessel, myocardial reperfusion is not fully restored in a significant percentage of patients. This is commonly the result of distal thrombus embolization with subsequent impairment of myocardial microcirculation. Recognition of this has led to the development of a number of devices with different mechanisms of action that aim to reduce such distal embolization and therefore improve end myocardial perfusion. Recent studies indeed demonstrate that the use of such devices offer additional clinical advantage in patients undergoing PPCI compared to the current practice. This report focuses on thrombectomy devices and reviews the evidence that advocates their routine use in PPCI patients. METHODS AND RESULTS: We have performed a systematic review of currently available thrombectomy devices. We also performed a literature search, using the terms "thrombectomy" and "thrombus aspiration" in PubMed and EMBASE. Thrombectomy devices were divided in "manual" and "non-manual" groups. We performed a meta-analysis of the available randomized control trials that compared adjunctive thrombectomy in PPCI to standard PPCI. The use of manual thrombectomy devices is associated with significant improvements in ST-segment resolution (STR) (p<0.00001), Myocardial Blush Grade (MBG) 3 (p<0.00001), Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow (p=0.01) as well as clinical parameters (43% reduction in mortality, p=0.04) in patients undergoing PPCI. CONCLUSION: Current evidence advocates the routine use of manual thrombectomy devices in PPCI. Non-manual (mechanical) thrombectomy may have a role in selected PPCI patients with large caliber vessels and heavy thrombus burden although their routine use is not presently supported.

Single-vessel or multivessel PCI in patients with multivessel disease presenting with non-ST-elevation acute coronary syndromes.

AIMS: Coronary artery disease is often diffuse and patients with non-ST-segment acute coronary syndromes (NSTE-ACS) demonstrate multivessel coronary disease. The purpose of this study was to clarify whether interventions on stable chronic non-culprit lesions in patients with NSTE-ACS can prevent future adverse events. METHODS AND RESULTS: We performed a retrospective cohort study of 990 consecutive patients who underwent either single-vessel PCI (SVPCI: n=379) or multivessel PCI (MVPCI: n=611) in a setting of NSTE-ACS. Cox proportional hazards regression analysis was performed to compensate for differences in baseline characteristics between the groups. To minimise the impact of confounding factors, we performed propensity matching (SVPCI: n=230, MVPCI: n=230). Patients who had MVPCI had a lower rate of prior interventional treatment or myocardial infarction, and more complex lesions than patients with SVPCI. At three years, all-cause mortality was significantly lower in the MVPCI group than the SVPCI group (13.0% vs. 18.3%, p=0.02, adjusted HR 0.55, 95% CI: 0.38-0.80), while the rates of target vessel revascularisation and a composite of all-cause death or myocardial infarction were not different between the groups. In the propensity-matched cohort, all-cause death remained significantly lower in the MVPCI group (adjusted HR 0.41, 95% CI: 0.22-0.75) compared to the SVPCI group. CONCLUSIONS: In this retrospective study, multivessel PCI reduced all-cause mortality in a setting of NSTE-ACS compared to single-vessel PCI. Further investigations to confirm these results are warranted.

Three-year clinical event rates in different age groups after contemporary percutaneous coronary intervention.

AIMS: As the global population ages, elderly patients will form an increasing proportion of those undergoing percutaneous coronary intervention (PCI). We investigated the safety and efficacy of bare metal stents (BMS) and DES in all patients undergoing PCI at our institution, stratified by age. METHODS AND RESULTS: We investigated three sequential groups of consecutive patients treated exclusively with BMS (n=2,194; January 2000 to April 2002), sirolimus-eluting stents (SES, n=834; April 2002 to February 2003) and paclitaxel-eluting stents (PES, n=2,841; February 2003 to December 2005). The primary endpoint was all-cause mortality. Secondary endpoints included target vessel revascularisation (TVR) and composite major adverse cardiac events (MACE, defined as all-cause death, any nonfatal myocardial infarction or TVR). Patients were followed up for a median of 1,366 days. Patients were stratified into equal quintiles based on age (<51.8, 51.8-58.4, 58.4-65.4, 65.4-73.0 and >73.0 years). All-cause mortality was significantly higher in the eldest two groups, while TVR rates were similar across all age groups. DES were associated with reductions in TVR and MACE and a trend towards reduced mortality in all age groups. CONCLUSIONS: DES are safe and effective when compared to BMS, irrespective of age.

Drug-eluting balloon: new tool in the box.

Percutaneous coronary intervention has revolutionized coronary revascularization therapy. It is increasingly becoming an attractive alternative to medical therapy and surgical revascularization in the treatment of coronary artery disease. Restenosis is a major challenge, and has been described as the Achilles heel of the procedure. It is a serious occurrence that can lead not only to recurrent angina and repeat revascularization, but also to acute coronary syndromes. Newer devices and strategies are being continuously sought to try and overcome these hurdles. Drug-eluting balloon technology is one such device that can potentially provide the solutions to these problems. This review focuses on the limitations associated with the use of drug-eluting stents in treating in-stent restenosis, and the concept and the available evidence for the use of drug-eluting balloons, particularly the paclitaxel-eluting balloons, in coronary and peripheral revascularization.

Optical coherence tomography for the assessment of pericardium covered stents for the treatment of degenerated saphenous vein grafts.

AIMS: Pre- and post-interventional optical coherence tomography (OCT) assessment of degenerated saphenous vein grafts (SVG) treated with implantation of pericardium covered stents. Percutaneous treatment of SVG represents one of the major challenges of current percutaneous coronary interventions (PCI). Artificial membrane-covered stents have failed to show additional benefit over conventional stents. METHODS AND RESULTS: Six cases of PCI of de novo lesions in degenerated SVGs were successfully treated with a novel pericardium covered stent (PCS). Successful deployment was achieved in all cases. Large emboli were retrieved in a distal filter in one case with a long degenerated lesion. Pre- and postinterventional OCT was performed to assess the lesion characteristics and vessel diameter before stenting and the pericardium layer integrity, strut apposition and presence of plaque prolapse after stenting. In order to better understand the OCT images, three PCS of different diameters were deployed in silicone tubes of 700 microm thickness wall with inner tube diameter matching the stent diameter. OCT was repeated after spreading a thin layer of gel inside the tube, mimicking the toothpaste-like plaque observed in SVG. In vivo and in vitro OCT images excluded the presence of plaque prolapse in all but one case and detected a characteristic pattern with bulging of the pericardium between struts, possibly due to trapping of soft intraluminal plaque (or gel) behind the pericardial layer. CONCLUSIONS: These cases offer insight into the mechanism of protection against distal embolisation, elucidated by the appearance of these stents after deployment in vivo and in vitro.

The GuideLiner "child" catheter for percutaneous coronary intervention - early clinical experience.

The failure to deliver a stent across the target lesion during percutaneous coronary intervention, especially in arteries with calcified tortuous anatomy, is often due to insufficient back-up support from the guiding catheter. Deep-vessel intubation with the guiding catheter may overcome this problem, but risks coronary dissection. The Heartrail II (Terumo, Japan) "five-in-six catheter system" (or "mother-and-child" catheter) comprises a flexible-tipped long 5 Fr catheter advanced through a standard 6 Fr guiding catheter to deeply intubate the target vessel, thus providing enough back-up support to enable stent delivery. Here we describe a newly developed "child" support catheter (The GuideLiner; Vascular Solutions, Inc., Minneapolis, Minnesota), report its successful use in a series of 4 difficult cases and discuss practical tips to optimize its performance.

Simple versus complex approaches to treating coronary bifurcation lesions: direct assessment of stent strut apposition by optical coherence tomography.

INTRODUCTION AND OBJECTIVES: Stenting of coronary bifurcation lesions carries an increased risk of stent deformation and malapposition. Anatomical and pathological observations indicate that the high stent thrombosis rate in bifurcations is due to malapposition of stent struts. METHODS: Strut apposition was assessed with optical coherence tomography (OCT) in bifurcation lesions treated either using the simple technique of stent implantation in the main vessel only or a complex technique (i.e. Culotte's). A strut was regarded as malapposed if the gap between its endoluminal surface and the vessel wall was greater than its thickness plus an OCT resolution error margin of 15 microm. RESULTS: Simple and complex (i.e. Culotte's) approaches were used in 17 and 14 patients, respectively. Strut malapposition was significantly more frequent for the half of the bifurcation on same side as the vessel side branch (median, 46.1%; interquartile range [IQR], 35.3-62.5%) than for the half opposite the side branch (9.1%; IQR, 2.2-21.6%), the distal segment (7.5%; IQR, 2.3-20.2%) or the proximal segment (12.6%; IQR, 7.8-23.1%; P< .0001); the gap between strut and vessel wall in malapposed struts was significantly greater in the first segment than the others: 98 microm (IQR, 37-297 microm) vs. 31 microm (IQR, 13-74 microm), 49 microm (IQR, 20-100 microm) and 38 microm (IQR, 17-90 microm), respectively (P< .0001). Using the complex technique had no effect on the prevalence of strut malapposition in the four segments relative to the simple technique (P=.31) but was associated with a smaller gap in the proximal segment (47 microm vs. 60 microm; P=.0008). CONCLUSIONS: In coronary bifurcation lesions, strut malapposition occurred most frequently and was most significant close to the side branch ostium. The use of Culotte's technique did not significantly increase the prevalence of strut malapposition compared with a simple technique.