Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions: 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial.

OBJECTIVES: The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions. BACKGROUND: The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). METHODS: A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany. RESULTS: Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported. CONCLUSIONS: The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119).

Polymer-Free Biolimus A9-Coated stents in the treatment of de novo coronary lesions: 4- and 12-month angiographic follow-up and final 5-year clinicaloutcomes of the prospective, multicenter biofreedom fim clinical trial

OBJECTIVES: The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.BACKGROUND: The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). METHODS: A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany.RESULTS: Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority)...

Mechanism of luminal patency of the self-expanding Sideguard sidebranch stent: evaluation by intravascular ultrasound and optical coherence tomography.

BACKGROUND: The Cappella Sideguard (CS) sidebranch stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions. OBJECTIVE: To evaluate the mechanism of long-term lumen patency of the novel, self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel. METHODS: We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel. Thirteen patients also had optical coherence tomography (OCT) at follow-up to evaluate neointimal hyperplasia and strut coverage. RESULTS: CS stent area at the sidebranch carina increased significantly from 3.8 ± 1.2 mm(2) postintervention to 4.6 ± 1.2 mm(2) at follow-up (P < 0.001), resulting in no change in lumen area (3.8 ± 1.2 mm(2) to 3.7 ± 1.2 mm(2) , P = 0.72) despite a neointimal area at follow-up of 0.9 ± 0.8 mm(2) . Volumetric changes were similar, and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina. Change of lumen volume inversely correlated to the neointimal volume (R = -0.48, P < 0.001), but correlated positively to the change in stent volume (R = 0.52, P < 0.0001). By OCT, most CS struts were covered (100% [98.9, 100]) at the bifurcation site, whereas 61% of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima. CONCLUSION: Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina, the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up.

A randomised comparison of novolimus-eluting and zotarolimuselutingcoronary stents: 9-month follow-up results of the EXCELLA II study

Aims: Novolimus, a macrocyclic lactone with anti-proliferative properties, has asimilar efficacy to currently available agents; however it requires a lower dose,and less polymer, and is therefore conceivably safer.Methods and results: The EXCELLA II study was a prospective, multicentre,single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardialvessels in a ratio of 2:1 to treatment with either the Elixir DESyne NovolimusEluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA)or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA,USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-monthsfollow-up. In-stent percent volume obstruction (%VO) was measured in asub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up.Clinical secondary endpoints included a device orientated composite of cardiacdeath, target vessel myocardial infarction (MI), and clinically indicated target lesionrevascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, thein-stent LLL was 0.11±0.32 mm in the NES arm, as compared to 0.63±0.42 mm inthe ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was4.5±5.1% and 20.9±11.3% for NES and ZES, respectively (p<0.001). There wasno significant difference between stent groups in the device orientated compositeendpoint (NES 2.9% vs. ZES 5.6%, –2.8% [-8.8%, 3.3%], p=0.45) or its individualcomponents of cardiac death, target vessel MI and CI-TLR.Conclusions: This non-inferiority randomised study not only met its primaryendpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

Outcome of patients after emergency conversion from transcatheter aortic valve implantation to surgery.

AIMS: To evaluate: 1) the causes of emergency conversion from transcatheter aortic valve implantation (TAVI) to surgery, 2) procedural settings, and 3) short-term outcome of converted patients. METHODS AND RESULTS: The prospective German TAVI registry was used to identify patients who underwent bail-out surgery during TAVI. Additionally, standardised questionnaires were developed and used to assess more detailed periprocedural and postprocedural data. Emergency conversion from TAVI to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Primary conversion causes were aorto-valvular complications (i.e., aortic annulus rupture, aortic perforation, or thoracic aortic dissection). This was followed by prosthesis embolisation, myocardial perforation, severe aortic regurgitation, and coronary obstructions. The mean time interval between abortions of TAVI to surgery was 19 minutes (SD ± 17 min, range 5-80 min). Four of 24 patients (16.7%) died during the initial surgery, seven of 24 (29.2%) within the first 72 hours and the 30-day mortality was 45.8%. The highest mortality was observed in patients with aortic perforation or dissection (4/5, 80%). Mortality rates for other entities were: prosthesis embolisation 40% (2/5), myocardial perforation 50% (2/4), annulus rupture 67% (2/3), severe aortic regurgitation 33% (1/3), and coronary impairment 0% (0/3). CONCLUSIONS: Emergency conversion from TAVI to surgery is a rare event carrying a mortality of around 45% after 30 days. Outcome of converted patients with prior injury of aortic, aorto-valvular, or myocardial tissue during TAVI was poor, whereas patients with severe aortic regurgitation and those with coronary complications had a more favourable outcome after 30 days. Collected procedural and outcome data demand on-site cardiac surgery as a prerequisite for TAVI and constant process optimisation efforts regarding such emergency scenarios.

Intravascular ultrasound comparison of the self-expanding Sideguard stent in the side branch versus a balloon-expandable stent in the main vessel to assess mechanisms of acute lumen gain in bifurcation lesions.

OBJECTIVES: We compared the mechanisms of lumen gain after Cappella Sideguard (CS) side branch (SB) bifurcation stent deployment versus a balloon-expandable stent in the corresponding main vessel (MV). BACKGROUND: The novel CS SB bifurcation stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the SB ostium. METHODS: In 28 bifurcation lesions, intravascular ultrasound imaging of both the SB and the MV was performed both pre- and postintervention; vessel and lumen areas were measured every 1 mm over a 5 mm segment beginning at the carina. RESULTS: Although minimum lumen area (MLA) within the distal 5 mm segment beginning at the carina increased from 2.8 ± 1.3 mm(2) to 3.8 ± 1.1 mm(2), P < 0.001, in the SB and from 3.4 ± 1.4 mm(2) to 6.0 ± 1.1 mm(2), P < 0.001, in the MV, stent expansion (minimum stent area/distal reference lumen area) was significantly less in the SB compared with the MV (77.8 ± 21.3% vs. 91.6 ± 18.4%, P = 0.02). Post stenting, the MLA site was located at the carina more frequently in the SB (85.7%) than in the MV (60.7%), P = 0.04. Plaque volume in the 5 mm proximal to carina in the MV tended to decrease, whereas plaque volume in the SB increased slightly with no change in overall plaque volume in the 5-mm-long segment distal to the carina in the MV, suggesting plaque shift from the proximal MV to the SB. CONCLUSIONS: Acute CS lumen gain is less than the lumen gain of a balloon-expandable stent in the MV because of less aggressive acute expansion and/or the plaque shift from the proximal MV to the SB.

Giant right coronary artery aneurysm in an adult male patient with non-ST myocardial infarction.

The combination of a giant coronary aneurysm with multiple coronary aneurysms in adults is an extremely rare entity--especially in atherosclerotic patients, since it is most commonly associated with Kawasaki disease in children. We report an interesting case of a 59-year-old male patient with multiple atherosclerotic aneurysms of the left coronary system and a giant aneurysm of the right coronary artery. The patient was admitted to our hospital because of a non-ST myocardial infarction. Diagnosis was established by echocardiography, computed tomography angiogram, and coronary angiography. In view of the clinical symptoms and the extent of the giant right coronary aneurysm, with the associated risk of rupture, the patient was successfully treated with urgent surgical intervention. We also present a review of the current literature on this anomaly and a statistical analysis of all atherosclerotic giant coronary artery aneurysms previously reported.

Six-month clinical and angiographic results of the STENTYS® self-apposing stent in bifurcation lesions.

AIMS: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions. METHODS AND RESULTS: The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.2%). Angiographic QCA and IVUS were used to measure acute gain and late loss. The Medina classification showed 35 patients (58%) had disease affecting the SB (true bifurcations) and 19 patients (32%) had disease in all three arms. The average bifurcation angulation pre-stenting was 60°±21°. Post-stenting, disconnection was performed on 90% of the stents implanted. In 18 cases, disconnection was followed by SB stenting with all SB stents successfully implanted. Post-stenting, the bifurcation angle was 51°. The primary clinical endpoint, cumulative MACE at six months, was low for DES (3.7%) but higher for BMS (27.3%) with the latter driven exclusively by clinically-driven TLR rates (3.7% vs. 24.2%). No cardiac deaths were recorded at six months and one patient had a non-Q wave infarct. The secondary angiographic endpoint of late luminal loss (LLL) was measured for both DES (paclitaxel) and BMS stents in the proximal main branch (MB), MB, distal MB as well as the SB. The values for DES were 0.39 mm, 0.42 mm, 0.40 mm and 0.16 mm, respectively. The values for BMS were 0.86 mm, 0.87 mm, 0.85 mm and 0.54 mm, respectively. Observed results using matched IVUS analysis at six months revealed an increase in mean stent area (mm²) for DES from 7.52±1.86 at baseline to 12.32±2.90 at six month follow-up (p <0.001); and for BMS from 7.95±1.40 to 11.56±2.22 (p <0.001), with no decrease in minimum lumen area (MLA) for DES (5.10 to 4.91) and a minimal decrease for BMS (5.74 to 5.15). CONCLUSIONS: This first-in-man (FIM) study on the STENTYS® stent showed excellent procedural success and a relatively low MACE with competitively low LLL in both MB and SB at six months for the DES version and LLL comparable to other BMS for the BMS version. The disconnectable struts offered excellent "cross over" to T- stenting when necessary and the increased gains in stent area over time.

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study.

AIMS: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up. METHODS AND RESULTS: This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%. CONCLUSIONS: This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.

Age-related differences in antithrombotic therapy, success rate and in-hospital mortality in patients undergoing percutaneous coronary intervention: results of the quality control registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

INTRODUCTION: This analysis examines the influence of age on antithrombotic therapy, success rate of percutaneous coronary intervention (PCI) and in-hospital mortality in patients with Acute Coronary Syndrome (ACS) and elective PCI. METHODS: We analysed data of 26,795 unselected patients with ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable Angina (UA) and elective PCI from the ALKK-PCI Registry 2006, a German prospective, multicentre registry. RESULTS: Elderly patients (>75) with ACS were significantly less often treated with acetylsalicylic acid intravenously and a clopidogrel loading dose of 600 mg. Moreover, the administration of GP IIb/IIIa antagonists was significantly lower in these patients. The rate of successful PCI (indicated as TIMI 3 flow) is comparable in younger and elderly patients with elective PCI, UA and NSTEMI, whereas there were more unsuccessful interventions in elderly patients with STEMI (13.2 vs. 11.0%, p < 0,033). In all indications elderly patients showed increased in-hospital mortality. CONCLUSION: In clinical practice, elderly patients with ACS undergoing PCI receive significantly less intensive antithrombotic treatment. In terms of successful PCI, there was no significant difference between the age groups in patients with elective PCI, UA and NSTEMI. The higher in-hospital mortality of the elderly in all patient groups is most likely due to a higher rate of comorbidities.

Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study.

AIMS: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. METHODS AND RESULTS: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. CONCLUSIONS: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.

A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study.

AIMS: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer. METHODS AND RESULTS: The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR. CONCLUSIONS: This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

A novel paclitaxel-eluting stent with an ultrathin abluminal biodegradable polymer 9-month outcomes with the JACTAX HD stent.

OBJECTIVES: The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions. BACKGROUND: The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent). METHODS: In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%). RESULTS: The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%. CONCLUSIONS: The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2.

BACKGROUND: The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation. METHODS AND RESULTS: We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm. CONCLUSIONS: The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

In-hospital outcomes after elective and non-elective percutaneous coronary interventions in hospitals with and without on-site cardiac surgery backup.

BACKGROUND: Guidelines recommend on-site surgery backup (SB) when elective percutaneous coronary intervention (PCI) is performed. The evidence for this recommendation is however weak. OBJECTIVES: The objective of the present study was to compare clinical outcomes in patients undergoing PCI in hospitals with SB or without surgery backup (non-SB). METHODS: Prospective German PCI registry in 36 hospitals throughout Germany. Consecutive procedures were collected and analyzed centrally. RESULTS: In 2006, a total of 23,148 patients were included; 12,465 patients (53.8%) in 11 hospitals with SB and 10,683 patients (46.2%) in 25 hospitals without on-site cardiac SB. Both patient groups were well-balanced with regard to age and gender. SB hospitals had more patients with ACS (OR 1.29; 95%CI 1.23-1.36) and less patients with stable angina (OR 0.78; 95%CI 0.74-0.82) than non-SB hospitals. There was no indication of a clinically relevant differential outcome for in-hospital death, MACE, non-fatal MI, non-fatal stroke/TIA, or emergency CABG between SB and non-SB hospitals for neither patients with ACS nor stable angina except for emergency CABG in ACS patients (more frequent in SB hospitals, OR 2.29; 95%CI 1.02-5.13). CONCLUSIONS: There was no evidence of an excess risk associated with PCI-procedures performed in non-SB hospitals.

First-in-man (FIM) study of the Stentys bifurcation stent--30 days results.

AIMS: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent. METHODS AND RESULTS: The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95 +/- 3.63 mm with a bifurcation angle of 55 degrees (range 30 degrees - 80 degrees). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure. CONCLUSIONS: This first-in-man (FIM) study demonstrates that the Stentys stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.

Angiographic results of the first human experience with the Biolimus A9 drug-eluting stent for de novo coronary lesions.

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronary lesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, < or = 24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n = 80, 82 lesions) or the control uncoated stent (n = 40). Baseline lesion and angiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 +/- 0.43 vs 0.74 +/- 0.45 mm, p < 0.001) and in the segment (0.14 +/- 0.45 vs 0.40 +/- 0.41 mm, p = 0.004). In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p = 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.

Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials).

The everolimus-eluting stent (EES) has been shown to significantly decrease neointimal proliferation at 6 months compared with the bare metal stent (BMS) in patients with de novo coronary lesions. We report mid-term outcomes based on different vessel sizes in the combined FUTURE I and II trials. In the prospective, randomized, FUTURE I trial (single center) and expanded FUTURE II trial (multicenter), 106 patients (107 lesions) were randomized to EESs (n = 49 lesions) or BMSs (n = 58 lesions). Patients were categorized into 3 groups based on preprocedure reference diameter as assessed by quantitative coronary angiography (small vessel < 2.75 mm, medium vessel 2.75 to 3.25 mm, and large vessel > 3.25 mm). At 6-month follow-up, EESs decreased in-stent late lumen loss (decreased rate range of 78% to 94%), resulting in significantly larger minimum lumen area as assessed by intravascular ultrasound (increased range of 34% to 42%) compared with the BMS across all vessel sizes. There were no cases of in-stent restenosis with EESs at any vessel size but 8 cases with BMSs (5 in small vessels). No stent thrombosis, aneurysm formation, or late stent incomplete apposition was observed in any group. The EES appears to be effective for treatment of de novo coronary lesions in decreasing neointimal proliferation at 6-month follow-up compared with BMSs, regardless of vessel size.

Angiographic results of the first Human experience with the biolimus A9 drug-eluting stent for de novo coronary lesions

This report describes angiographic findings of the first-in-human evaluation of the Biolimus A9 drug-eluting stent (Biolimus stent) in the treatment of noncomplex coronarylesions. In total, 120 patients with 122 de novo coronary lesions (2.75- to 4.00-mm vessels, <24-mm lesion length) were prospectively randomized in a 2:1 ratio to receive the Biolimus stent (n 80, 82 lesions) or the control uncoated stent (n 40). Baseline lesion andangiographic characteristics were similar between groups. At 6-month follow-up, late lumen loss was significantly decreased with the Biolimus stent in the stent (0.26 0.43 vs 0.74 0.45 mm, p <0.001) and in the segment (0.14 0.45 vs 0.40 0.41 mm, p 0.004).In-stent restenosis was 3.9% in the Biolimus stent group versus 7.7% in the control group (p 0.40). There was no exaggerated hyperplasia at the proximal and/or distal edge of the stent.