Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Relationship between n-3 Polyunsaturated Fatty Acids and Extent of Vessel Disease in Patients with ST Elevation Myocardial Infarction.

A relationship between serum polyunsaturated fatty acids (PUFAs) and cardiovascular disease has been reported; however, the existence of a relationship between serum PUFAs and extent of vessel disease (VD) in patients with ST elevation myocardial infarction (STEMI) remains unclear.Between July 2011 and June 2015, 866 consecutive STEMI patients underwent emergent percutaneous coronary intervention, 507 of whom were enrolled and classified into three groups according to the initial angiograms: 1VD, 294 patients; 2VD, 110 patients; and 3VD/left main trunk disease (LMTD), 103 patients. Serum levels of PUFAs, including eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and arachidonic acid, and other laboratory data during hospitalization were evaluated.The serum EPA level in the 3VD/LMTD group was significantly lower than that in the 1VD group (55.5 ± 22.1 versus 66.2 ± 28.7, P = 0.002) and was slightly lower than that in the 2VD group (55.5 ± 22.1 versus 65.2 ± 28.9, P = 0.0167). Multivariate adjustment analysis revealed that age ≥ 70 years (odds ratio, 1.72; 95% confidence interval, 1.03-2.89; P = 0.038) and a low serum EPA level (odds ratio, 0.98; 95% confidence interval, 0.99-1.00; P = 0.023) were independent risk factors for 3VD/LMTD, while a low serum DHA level was not.A low serum EPA level may be more strongly related than a low serum DHA level to the extent of VD in STEMI patients. Age ≥ 70 years and a low serum EPA level may be independent risk factors for 3VD/LMTD.

Ten-year clinical outcomes after sirolimus-eluting stent implantation: Impact of an in-stent restenosis target lesion.

UNLABELLED: Little is known about the long-term outcomes after first-generation sirolimus-eluting stent (SES) implantation. We aimed to investigate the clinical outcomes up to 10 years after SES implantation. METHODS: The study population comprised 342 patients (504 lesions) who underwent SES implantation between January 2002 and December 2004. The median duration of follow-up was 3816 days (interquartile range [Q1-Q3], 3,705-3,883 days). RESULTS: The cumulative event rate of definite stent thrombosis was 3.9%. The cumulative rate of target lesion revascularization (TLR) at 1, 5, and 10 years was 8.7%, 18.8%, and 31.1%, respectively, and the annual rate of TLR was 3.1%. Clinically driven TLR occurred at relatively constant rate during 10 years (2.0% per year). In a multivariate analysis, higher body mass index, hemodialysis, in-stent restenosis (ISR) target lesion, and total stent length >30 mm were independent risk factors of TLR within 5 years. An independent risk factor of TLR beyond 5 years was ISR target lesion. CONCLUSIONS: Late TLR after SES implantation is a long-term hazard, lasting up to 10 years. The ISR target lesion is a risk factor of TLR during 10 years.

Predictors of Worsening Renal Function in Patients With Acute Decompensated Heart Failure Treated by Low-Dose Carperitide.

BACKGROUND: Predictors of worsening renal function (WRF: increase in serum creatinine ≥ 0.3 mg/dl from the value on admission) in patients with acute decompensated heart failure (ADHF) treated by low-dose carperitide (0.01-0.05 µg/kg/min) are unclear. METHODS AND RESULTS: We retrospectively investigated predictors of WRF within the first 24 h of low-dose carperitide therapy in 205 patients (mean age, 75.6 ± 12.1 years) hospitalized for ADHF and treated with low-dose carperitide between January 2006 and April 2014. WRF occurred in 14 patients (7%). A multivariate adjustment analysis showed that independent predictors of WRF within 24 h were hypotension (systolic blood pressure <90 mmHg) within 12 h (odds ratio, 8.7; 95% confidence interval, 2.38-35.88; P=0.0012) and serum creatinine on admission (odds ratio, 3.64; 95% confidence interval, 1.84-7.67; P=0.0003). In patients with estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m(2), the rate of WRF occurrence was higher in those complicated by hypotension than in those without hypotension (22.6% [7/31 patients] vs. 4.4% [5/113 patients], P=0.0041). In contrast, in patients with eGFR ≥ 60 ml/min/1.73 m(2), hypotension did not influence the occurrence of WRF (0% [0/9 patients] vs. 3.9% [2/51 patients], P=NS). CONCLUSIONS: Hypotension within 12 h and renal dysfunction on admission are independent predictors of WRF within 24 h in patients with ADHF treated by low-dose carperitide. Hypotension may not cause WRF in patients with eGFR ≥ 60 ml/min/1.73 m(2).

A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan.

AIMS: Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown. METHODS AND RESULTS: ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001). CONCLUSION: In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs. CLINICAL REGISTRATION: ClinicalTrials.gov, number NCT01844284.

Successful rescue of stuck rotablator burr entrapment using a Kiwami straight catheter.

Rotational atherectomy is an indispensable modality for percutaneous coronary intervention of severely calcified lesions. An entrapped rotablator burr is a rare but life-threatening complication because retrieval is difficult. Although emergent surgical removal is a reliable option for this complication, it is invasive. There are various methods to retrieve an entrapped burr by bailout endovascular approaches. We present two cases of successful rescue of stuck rotablator burr entrapment using a Kiwami straight catheter (4 Fr, Heartrail II, Terumo, Tokyo, Japan).

Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial.

PURPOSE: Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN). METHODS: Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification. RESULTS: A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician's assessment was improved in 87.9 % of the patients. CONCLUSIONS: We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.

Correction of Stent Distortion and Overhanging Stent Struts during Left Main Bifurcation Stenting by Selective Distal Stent Cell Re-Wiring: A Novel Guidewire Approach.

UNLABELLED: Stent malapposition and overhanging stent struts in front of the side branch (SB) ostium are not uncommon following bifurcation stenting that might lead to stent thrombosis. We herein present 2 cases, in which optical frequency domain imaging and intravascular ultrasound effectively revealed stent malapposition and overhanging struts inside the ostium of the SB following left main coronary artery stenting. Therefore, we introduced a novel technique for rectification of these incidental findings by selective SB re-wiring through the most distal stent cell with the adjunctive help of a double lumen microcatheter. KEY WORDS: Distal stent strut; Left main bifurcation; Overhanging struts; Side branch re-crossing; Stent optimization.

Impact of statin therapy on patients with coronary heart disease and aortic aneurysm or dissection.

OBJECTIVE: The impact of statin therapy on cardiovascular outcome in coronary artery disease (CAD) patients with aortic aneurysm or dissection (AD) is still unclear. The aim of this study was to elucidate the effect of statins at discharge to improve outcomes in CAD patients with AD. METHODS: Among 14,834 consecutive patients who underwent first coronary revascularization in the CREDO-Kyoto PCI/CABG registry, we identified 699 patients (4.7%) with AD. The primary outcome measure was defined as a composite of all-cause death, myocardial infarction, and stroke. The effect of statin therapy was assessed by a Cox proportional hazards model incorporating clinically relevant factors. RESULTS: The risk for the primary outcome measure was significantly higher in patients with AD (adjusted hazard ratio [HR], 1.43; 95% confidence interval [CI], 1.23-1.66; P < .0001). In patients with AD, 215 patients (31%) had already undergone aneurysm repair, and only 274 patients (39%) were treated with statins at discharge. Patients treated with statins were younger, had higher body mass index, and were more often treated with percutaneous coronary intervention. Heart failure, anemia, and hemodialysis were more prevalent in patients treated without statins. In patients without AD, 7014 patients (50%) were treated with statins. Patients treated with statins were younger and had higher body mass index, and more patients were treated for CAD due to myocardial infarction. Heart failure, prior stroke, hemodialysis, anemia, and malignant disease were more prevalent in patients treated without statins. The use of statins was associated with lower risk for the primary outcome measure in patients with AD (adjusted HR, 0.71; 95% CI, 0.51-0.99; P = .045) as well as in patients without AD (adjusted HR, 0.79; 95% CI, 0.73-0.85; P < .0001). The effect size of statin use was similar between the patients with AD and those without AD (P interaction = .69). CONCLUSIONS: CAD patients with AD had significantly higher long-term risk for cardiovascular events. Statin therapy was associated with lower risk for cardiovascular events in patients with CAD with AD as well as in patients without AD.

Low systolic blood pressure on admission predicts mortality in patients with acute decompensated heart failure due to moderate to severe aortic stenosis.

BACKGROUND: We investigated the relationship between admission systolic blood pressure (SBP) and all-cause mortality in patients hospitalized for acute decompensated heart failure (ADHF) because of aortic stenosis (AS). METHODS AND RESULTS: We retrospectively reviewed the data for 71 consecutive patients (mean age 85±7 years) who had been hospitalized for ADHF because of AS between January 2006 and August 2012. The primary endpoint of the study was the 1-year all-cause mortality. Clinical outcomes of patients who survived and those who died during a 1-year period were compared. Low admission SBP was defined as <120 mmHg. During the 1-year period, 26 (37%) of the 71 patients died, including 16 (57%) of 28 patients with low SBP and 10 (23%) of 43 patients with normal or high SBP (log-rank P=0.0065). In both the patients who survived and those who died, there were significant differences in admission SBP (152±43 vs. 116±32 mmHg, P<0.001), estimated glomerular filtration rate on admission (43.2±20.3 vs. 28.2±22.2 ml·min(-1)·1.73 m(-2), P=0.005), and left ventricular ejection fraction <50% (33% [15/45] vs. 65% [17/26], P=0.013). Low admission SBP independently predicted 1-year all-cause mortality (adjusted hazard ratio: 2.41, 95% confidence interval: 1.04-5.57, P=0.033). CONCLUSIONS: Low admission SBP is associated with significantly higher 1-year all-cause mortality in patients hospitalized for ADHF because of AS.

Comparison of long-term outcome after percutaneous coronary intervention for stent thrombosis between early, late, and very late stent thrombosis.

BACKGROUND: Differences in long-term outcome between early stent thrombosis (EST), late stent thrombosis (LST), and very late stent thrombosis (VLST) are unknown. METHODS AND RESULTS: A total of 152 patients who had undergone percutaneous coronary intervention for stent thrombosis between January 2001 and October 2011 were enrolled, and the clinical outcome compared between EST (55 patients), LST (34 patients), and VLST (63 patients) after drug-eluting stent (DES) and bare-metal stent (BMS) implantation. Major adverse cardiac events (MACE), including cardiac death, recurrent stent thrombosis, non-fatal myocardial infarction, and target lesion revascularization (TLR), were evaluated at 5 years. The in-hospital mortality was similar between EST, LST, and VLST (P=0.37). The incidence of MACE was significantly lower in VLST (21.9%) than in EST (66.9%, P<0.001) and LST (66.6%, P<0.001), mainly because of a lower TLR rate after VLST (11.1%) than after EST (50.8%, P<0.001) and LST (52.2%, P<0.001). The 5-year mortality rate was also significantly lower in VLST (14.7%) than in EST (29.3%, P=0.049) and LST (41.6%, P=0.025). The incidence of MACE was similar between DES and BMS (46.2% vs. 50.0%, P=0.82), and this finding was observed in EST (P=0.83), LST (P=0.77), and VLST (P=0.57). CONCLUSIONS: Compared with EST and LST, long-term outcome was markedly better in VLST, mainly because of a lower TLR rate, whether after DES or BMS implantation.

Thirty-day outcome of transcatheter aortic valve implantation with the edwards SAPIEN XT prosthesis via the transiliofemoral approach.

BACKGROUND: Few data exist on the results of transcatheter aortic valve implantation (TAVI) via the transfemoral approach in small slightly built Japanese patients with severe aortic stenosis who are ineligible or at high-risk for conventional surgical aortic valve replacement (SAVR). Therefore, the purpose was to investigate the early outcomes of TAVI using the transiliofemoral approach in Japan. METHODS AND RESULTS: Between June 2010 and June 2013, 21 consecutive patients (mean age, 81.0 years; 81.0% female) underwent TAVI with Edwards SAPIEN XT valves using the transiliofemoral approach. The mean body surface area was 1.44±0.15m(2). The device success rate was 90.5%. Although 2 patients did not meet the echocardiographic criteria for device success, no failure to deliver and deploy a valve occurred. The mean effective aortic valve area increased from 0.54±0.12cm(2) at baseline to 1.46±0.29cm(2) after the procedure (P<0.001), and the mean aortic transvalvular pressure gradient decreased from 51.0±15.6 at baseline to 11.2±3.6 after the procedure (P<0.001). The 30-day mortality and combined safety endpoint rates were 0% and 4.8%, respectively. All patients achieved New York Heart Association functional class I or II at 30 days. CONCLUSIONS: Early outcome of TAVI with the Edwards-SAPIEN XT valve via the transiliofemoral approach at Kurashiki Central Hospital is satisfactory for patients who are ineligible or at high risk for SAVR.

The collateral circulation of the heart in coronary total arterial occlusions in man: systematic review of assessment and pathophysiology.

BACKGROUND: Anatomical and functional assessment of the collateral circulation of the heart in total arterial occlusions is challenging, and this is particularly true of the microcirculation. The pathophysiology of the collateral circulation has historically been and remains of considerable research focus but with diverging and sometimes conflicting results. Our purpose was to conduct a systematic review on the assessment and pathophysiology of the collateral circulation of the heart in total coronary arterial occlusions. METHODS: We extracted data from Pubmed, Ovid, EMBASE, and Cochrane database from 1966 to December 2012. Two investigators independently reviewed the identified articles for eligibility and extracted the data. RESULTS: Seventy-seven studies met inclusion criterion. An invasive assessment of the collateral circulation with pressure and/or Doppler wires is the gold standard in the assessment of collateral physiology and anatomy, although this can only be undertaken after successful passage of the sensor in the true lumen of the occluded vessel. A collateral circulation can provide resting metabolic requirements for the heart but invariably cannot meet demands on stress irrespective of the degree of collateralization as assessed by coronary angiography. In the case of myocardium subtending a totally occluded epicardial artery coronary collateral grading systems or physiological assessment of collateral flow is only moderately sensitive and poorly specific at predicting viability. Regression of collaterals seems more profound in totally occluded arteries versus nonoccluded lesions postrevascularization. CONCLUSIONS: Key controversies in the assessment and pathophysiology of the collateral circulation of the heart in total coronary arterial occlusions are systematically evaluated.

A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis.

BACKGROUND: The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR). METHODS: This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up. RESULTS: Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03). CONCLUSIONS: This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB.

Long-term outcome of transcatheter polytetrafluoroethylene-covered stent implantation in a giant coronary aneurysm of a child with Kawasaki disease.

We report the long-term outcome of a child with Kawasaki disease (KD), who had a giant aneurysm with stenotic lesions in the right coronary artery, resulting in the transcatheter implantation of a polytetrafluoroethylene (PTFE)-covered stent at the age of 8. Quantitative coronary angiography analysis later showed the increase of the diameter stenosis at both stent edges for the first 10 months after implantation; however, the stenosis did not develop thereafter. Coronary perfusion was still well maintained at follow-up coronary angiography 5.5 years after implantation (diameter stenosis was 36.5% at proximal and 37.4% at distal edge, respectively). Although further follow-up is necessary, the long-term outcome of a PTFE-covered stent implantation for a KD patient is satisfactory in this instance. Implantation of a covered stent in a giant aneurysm is considered a promising treatment option.

Experience with a novel retrograde wiring technique for coronary chronic total occlusion.

OBJECTIVES: We report our evaluation of a novel retrograde wiring technique known as the Rendezvous method. BACKGROUND: Different strategies of retrograde approaches can be used to improve the success rate of recanalization of coronary chronic total occlusion (CTO). We previously introduced the Rendezvous technique as an alternative final step for a retrograde CTO procedure. METHODS: From July 2007 to May 2010, 20 CTO patients were treated in two medical centers using the Rendezvous method, which is an alternative to the conventional final externalization method to complete the retrograde CTO procedure. It involves crossing of the guidewire through the CTO segment using 2 microcatheters. RESULTS: The majority of the CTO sites were in the proximal right coronary artery (50.0%). Most of the lesions had mild to moderate calcification (95.0%) and revealed an abrupt stump with a side branch at the occlusion site. The lesion length of the occlusion was relatively long (median 27.6 mm; range of 7.1-87.3 mm). No adverse cardiac events occurred during hospitalization. CONCLUSION: The Rendezvous method used during the retrograde approach can be performed as an alternative to the conventional "externalization method" after the guidewire and microcatheter have crossed the occluded proximal segment into the opposite guiding catheter.

Difference in clinical and angiographic characteristics of very late stent thrombosis between drug-eluting and bare-metal stent implantations.

BACKGROUND: Limited data are available with which to compare the clinical characteristics of patients with very late stent thrombosis (VLST) after drug-eluting stent (DES) or bare-metal stent (BMS) implantation. The purpose of this study was to investigate the differences in the characteristics of VLST after DES and BMS implantation by reviewing the clinical and angiographic data. METHODS AND RESULTS: A total of 28 patients (30 lesions) with VLST after DES implantation and 33 patients (33 lesions) with VLST after BMS implantation were identified. The occurrence of VLST after BMS implantation (2,647±996 days) was much later than that after DES implantation (1,194±558 days, P<0.001). The number of VLST after DES implantation increased gradually each year; however VLST after BMS implantation started to occur >50 months later, and its number increased subsequently. The prevalence of VLST related to surgical procedures involving discontinuation of antiplatelet therapy in VLST patients was higher after DES implantation (14.3%) than after BMS implantation (0%, P=0.039). Angiographic stent fracture was seen in 36.7% of VLST lesions after DES implantation at different times (464-2,102 days after procedure), while none was seen in VLST lesions after BMS implantation (P<0.001). CONCLUSIONS: The timing of VLST was different after DES and BMS implantation. Stent fracture was a specific finding of VLST after DES implantation.

Seven-year clinical outcomes of unprotected left main coronary artery stenting with drug-eluting stent and bare-metal stent.

BACKGROUND: The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) 7 years after unprotected left main coronary artery (LMCA) stenting has not been investigated. METHODS AND RESULTS: From 2003 to 2005, 182 patients underwent stent implantation for unprotected LMCA disease (DES, 96 patients; BMS, 86 patients; acute coronary syndrome cases excluded), and the 7-year clinical outcomes between the DES and BMS groups were compared. The incidence of cardiac death or non-fatal myocardial infarction was similar between the DES and BMS groups (11.0% vs. 13.5%, P=0.78). The incidence of target lesion revascularization (TLR) at 7 years was significantly lower in the DES group than in the BMS group (26.4% vs. 40.5%, P=0.009); the incidence from 1 to 4 years and that beyond 4 years were similar between the DES and BMS groups (8.9% vs. 7.9%, P=0.97; 10.0% vs. 8.7%, P=0.74, respectively). Among patients with bifurcation lesions, whereas the incidence of 7-year TLR was significantly lower in the DES group than the BMS group in patients undergoing single-stent procedures (15.9% vs. 48.6%, P=0.002), it was similar between the 2 groups in patients undergoing 2-stent procedures (38.5% vs. 39.3%, P=0.49). CONCLUSIONS: With the exception of the 2-stent procedure, the 7-year outcomes after DES implantation for LMCA disease were superior to those after BMS implantation because of the lower TLR rate, when considering TLR during the late phase.

Incidence, risk factors, and clinical sequelae of angiographic peri-stent contrast staining after sirolimus-eluting stent implantation.

BACKGROUND: We have noted abnormal angiographic findings--at the sites of drug-eluting stent implantation, suggesting contrast staining outside the stent struts--that do not fulfill the classic definition of coronary artery aneurysm. We propose a new term, peri-stent contrast staining (PSS), for these abnormal angiographic findings and assess their incidence, risk factors, and clinical sequelae. METHODS AND RESULTS: Peri-stent contrast staining was defined as contrast staining outside the stent contour extending to ≥20% of the stent diameter. The study population consisted of 3081 lesions (1998 patients) that were treated exclusively with sirolimus-eluting stents and were evaluated by follow-up angiography within 12 months after sirolimus-eluting stent implantation in a single center. Late acquired PSS was observed in 58 lesions (1.9%) in 49 patients (2.5%). Independent risk factors of PSS included chronic total occlusion, whereas negative risk factors for PSS were left circumflex coronary artery lesion and in-stent restenosis lesion. Stent fracture was more frequently observed in lesions with PSS than in lesions without PSS (43.1% versus 5.4%, P<0.0001). Excluding 269 lesions with target-lesion revascularization within 12 months, the study population for long-term follow-up consisted of 51 lesions (42 patients) with PSS and 2761 lesions (1751 patients) without PSS. Cumulative incidence of target-lesion revascularization and definite very late stent thrombosis at 3 years in the PSS group was higher than that in the non-PSS group (15.0% versus 6.5%, and 8.2% versus 0.2%, respectively). CONCLUSIONS: Peri-stent contrast staining found within 12 months after sirolimus-eluting stent implantation appeared to be associated with subsequent target-lesion revascularization and very late stent thrombosis.

Randomized comparison of the Nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries.

OBJECTIVES: The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher). BACKGROUND: The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent. METHODS: We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months. RESULTS: At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient. CONCLUSIONS: Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.