Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry

Objective : This study evaluates the safety and efficacy of the XIENCE V® 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background : In the SPIRIT III trial, the XIENCE V® everolimus‐eluting stent (EES), compared with the TAXUS EXPRESS² paclitaxel‐eluting stent (PES) in 2.5–3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods : The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions ≤28 mm in length and reference vessel diameter 3.75–4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8‐month in‐segment LL compared with the randomized PES arm. Results : In‐segment LL was 0.17 ± 0.38 mm in the 4.0 mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1‐year rates of ischemia‐driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8‐month LL or 1‐year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions : In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. © 2009 Wiley‐Liss, Inc.     

The EXTREME registry: Titanium‐nitride‐oxide coated stents in small coronary arteries

Objectives : We sought to explore the immediate results of Titan2^® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background : The safety of Titan2^® stent has been confirmed in several studies in real‐life unselected populations. Methods : We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2^® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results : The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2^® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions : Titan2^® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up. © 2010 Wiley‐Liss, Inc.     

Long‐term clinical,angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents

Background: The residual drug carriers on drug‐eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus‐eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long‐term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single‐center registry. Antiplatelet protocol was 6‐month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in‐segment and in‐stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target‐lesion revascularizations due to in‐stent restenosis (ISR). All patients received follow‐up up to 24 ± 0.4 months and no cardiac death, MI, and in‐stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in‐stent lesion restenosis, 5.4% (6/112) in‐segment lesion restenosis, 0.12 ± 0.34 mm in‐stent late lumen loss, and 0.08 ± 0.35 mm in‐segment late lumen loss. Conclusions: In this single‐center experience with complex patients and lesions, the EXCEL^TM stent implantation with 6‐month dual antiplatelet treatment proved to markedly reduce the incidence of 24‐month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials. © 2008 Wiley‐Liss, Inc.     

Five‐year clinical follow‐up after implantation of the endeavor zotarolimus‐eluting stent: ENDEAVOR I,first‐in‐human study

Objective : To evaluate the 5‐year clinical outcomes of patients treated with the Endeavor zotarolimus‐eluting stent (ZES) in the ENDEAVOR I first‐in‐human study. Background : ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. Methods : Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have ≥50% stenosis, be ≤15 mm in length, and located in a vessel with a reference diameter of 3.0–3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. Results : The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non‐Q‐wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. Conclusions : Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

Lack of clinical long‐term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts

Background: Small randomized trials have shown short‐term improved outcome with drug‐eluting stents (DES) over bare metal stent (BMS) in saphenous vein graft (SVG) interventions by reducing in‐stent restenosis and target vessel revascularization (TVR). It is not clear, however, if these benefits are maintained long term. The aim of this study is to compare the outcome in a larger cohort of patients undergoing SVG stent implantation with DES or BMS, at 2 years. Methods: From among 250 patients who underwent SVG stenting, 225 patients with available follow‐up were selected from data bases at the three participating institutions. One‐hundred‐six patients had DES (sirolimus, paclitaxel or tacrolimus eluting stent) and 119 patients had any available BMS from April 2002 to December 2006. The primary endpoint was MACE rate, a combination of cardiac death, S‐T elevation myocardial infarction (STEMI) and target lesion revascularization. Secondary end points were the individual components of the primary endpoint. Follow‐up was obtained by mailed interviews or telephone calls and review of the hospital chart. Results: The DES and BMS groups had similar age (71 ± 8 years vs. 70 ± 7 years, P = 1.0), diabetes (45% vs. 36%, P = 0.3), history of MI (58% vs. 51%, P = 0.6), EF (44% vs. 47%, P = 0.2) and previous PCI (40% vs. 35%, P = 0.4). Reference vessel diameter (3.15 ± 0.5 mm vs. 3.5 ± 0.5 mm. P = 0.001) and stent size (3.3 ± 0.4 mm vs. 3.9 ± 0.5 mm, P = 0.001) were smaller in the DES group; however, the BMS were longer (24 ± 10 mm vs. 21 ± 6 mm, P = 0.05). At one year there was a trend (P = 0.1) for lower MACE rate in the DES group, but at two years there was no difference in MACE free survival between the DES and BMS groups (81 % vs. 82%, P = 0.9). The death rate was similar (6% each) with three patients having STEMI (two in the DES and one in the BMS). TVR was also similar (14% in each group). Conclusion: In patients undergoing treatment of SVG disease with a stent, the marginal benefit of DES seen at 1 year was lost at 2‐year follow‐up. © 2008 Wiley‐Liss, Inc.     

A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study)

AimsEvaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform.Methods and resultsSafety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm.At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up.ConclusionsIn this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up.     

Intravascular ultrasound for evaluation of initial vessel patency and early outcome following directional coronary atherectomy

Elastic recoil and thrombus formation may potentially occur following directional coronary atherectomy (DCA) confounding the assessment of late vascular remodeling. Since intravascular ultrasound (IVUS) data on early outcome of DCA is not available, we used IVUS to investigate whether elastic recoil or thrombus formation can affect early (4 hr) outcome. Quantitative coronary angiography (QCA) and IVUS were performed in high-grade coronary lesions in 32 consecutive patients before, immediately after, and 4 hr after DCA. Late clinical follow-up was obtained after a maximum interval of 2 years. Significant acute elastic recoil was observed by both IVUS (19% ± 14%) and QCA (19% ± 12%), but there was no further recoil after 4 hr. DCA reduced plaque area by 51% ± 13%, an effect that was stable after 4 hr, indicating the absence of relevant thrombus formation. Residual area stenosis by IVUS was not related to the occurrence of late clinical events (n = 8). Mechanical recoil or thrombus formation do not hamper initial lumen gain achieved by DCA. Although QCA significantly underestimated residual plaque burden after DCA when compared to IVUS, the degree of residual area stenosis did not identify patients suffering from cardiac events on follow-up.Cathet. Cardiovasc. Intervent. 47:14–22, 1999. © 1999 Wiley-Liss, Inc.     

Comparison of 2‐year outcomes between zotarolimus‐eluting and everolimus‐eluting new‐generation cobalt–chromium alloy stents in real‐world diabetic patients

Background : To date, it remains unknown whether different types of new‐generation drug‐eluting stents have a differential impact on long‐term outcomes in diabetic patients. Methods and Results : In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new‐generation CoCr zotarolimus‐eluting stents (R‐ZES: 136 patients, 196 lesions) or everolimus‐eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2‐year follow‐up period. MACE was defined as all‐cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R‐ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2‐year follow‐up, there was no significant difference in occurrence of MACE (R‐ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all‐cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity‐score matching did not alter the aforementioned associations. Conclusion : After 2 years of follow up similar outcomes (MACE, all‐cause mortality/MI, TLR) were observed in real‐world diabetic patients, including those with complex lesions and patient characteristics, treated with R‐ZES and EES. © 2015 Wiley Periodicals, Inc.     

Thrombus predicts ischemic complications during percutaneous coronary intervention in saphenous vein grafts: Results from TARGET (do tirofiban and reopro give similar efficacy trial?)

Background : Saphenous vein graft (SVG) percutaneous coronary intervention (PCI) carries a high risk of ischemic complications. However, there are scant recent data to identify which SVG lesions carry particularly high risk in recent years. We studied demographic and angiographic factors associated with ischemic complications after SVG PCI without distal protection in the TARGET (do tirofiban and reopro give similar efficacy trial?) study. Methods : TARGET was a multicenter double‐dummy, double‐blinded study randomizing 4,809 PCI patients to tirofiban or abciximab. Of these, 254 patients underwent PCI involving an SVG lesion. The primary endpoint of this analysis was major adverse cardiac events (MACEs) at 30 days, including death, nonfatal myocardial infarction (MI), and urgent target vessel revascularization. Results : No demographic characteristic was associated with 30‐day MACE. Lesion length > 20 mm (odds ratio [OR] = 2.7, P = 0.03), thrombus (OR = 3.9, P = 0.003), eccentricity (P = 0.001), thrombolysis in myocardial infarction flow < 3 postprocedure (OR = 5.6, P = 0.037), and >1 target lesion (OR = 2.5, P = 0.035) were univariate variables associated with 30‐day MACE. Multivariate analysis associated only thrombus (OR = 3.8, P = 0.015) with 30‐day MACE. No difference in outcomes was noted between patients receiving abciximab and tirofiban. SVG patients had lesser angiographic success (95.6% vs. 98%, P = 0.04) and increased 30‐day Q‐wave MI (2.5% vs. 0.9%, P = 0.039) compared with non‐SVG patients, but a similar incidence of death (0% vs. 0.4%), non‐Q‐MI (5.9% vs. 4.5%), and target vessel revascularization (0.5% vs. 1%). Conclusion : In the era of routine stenting and GpIIb/IIIa inhibitors, thrombus is the angiographic characteristic most closely associated with adverse outcomes of SVG PCI © 2006 Wiley‐Liss, Inc.     

Titanium-nitride-oxIde-coated stents multicenter registry in diaBEtic patienTs: the TIBET registry

We sought to explore the immediate clinical and angiographic results of the Titan^? stent implantation in diabetic patients, as well as the major adverse cardiac events (MACE) at 6-month follow-up. We enrolled 156 consecutive diabetic patients admitted to undergo percutaneous intervention for at least one significant (50%) coronary lesion. All lesions were treated with the Titan^? stent implantation according to the contemporary interventional techniques. Patients were prospectively followed-up for at least 6?months. The primary endpoint was MACE at 6-month follow-up [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, TLR at 6-month follow-up, and stent thrombosis. The mean age was 66.7?±?9.6?years, (68.4% males). A total of 197 Titan^? stents were implanted in 163 lesions. Direct stenting was performed in 45.2% of the cases. The mean stent diameter was 3.1?±?0.61?mm, and the mean length was 18.0?±?8.9?mm. Average stent deployment pressure was 13.9?±?4.2 bars. Angiographic procedural success was achieved in 154 (98.7%) cases, and clinical procedural success was achieved in 153 (98.1%) cases. One patient developed in-hospital non-Q-wave MI following the procedure. Clinical follow-up was completed in 155 (99.4%) patients. Three patients (1.9%) died of a cardiac or unknown cause, and two (1.3%) developed MI. TLR was performed in 11 patients (7.1%). Cumulative MACE at 6-month follow-up occurred in 16 (10.3%) patients. No patient suffered stent thrombosis. Titan^? stent implantation in diabetic patients achieves an excellent immediate clinical and angiographic outcome, with a low incidence of MACE at mid-term follow-up.     

Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub‐analysis

Objectives

We sought to assess the clinical outcomes when intravascular ultrasound (IVUS) was used prior to orbital atherectomy treatment (OA) versus angiography alone for lesion assessment.

Background

Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with high rates of major adverse cardiac events (MACE). IVUS provides additional diagnostic information to optimize PCI.

Methods

ORBIT II was a single‐arm study of 443 patients with de novo, severely calcified coronary lesions treated with OA before stent placement. Patients with IVUS imaging prior to OA (N = 35) were compared to patients without IVUS imaging for initial lesion assessment (N = 405). In this post‐hoc sub‐analysis procedural outcomes and the 3‐year MACE rate were evaluated.

Results

The rates of severe angiographic complications were low in patients with and without IVUS imaging prior to OA. There was a significant reduction in the number of stents used in patients with IVUS imaging prior to OA (1.0 ± 0.2 vs 1.3 ± 0.6; P = 0.006) and increased post‐OA mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs 1.2 ± 0.5 mm; P < 0.001). The 3‐year MACE rate was similar in both groups (IVUS: 14.3% vs No IVUS: 24.2%; P = 0.26).

Conclusions

There were significantly fewer stents placed, increased post‐OA MLD, and similar 3‐year MACE outcomes in patients with IVUS assessment of the degree of lesion calcification prior to OA as compared to patients with angiographic assessment of the degree of lesion calcification. Further studies are needed to determine the optimal integration of intravascular imaging with OA.

     

Safety and efficacy of drug eluting stents compared with bare metal stents for saphenous vein graft interventions: A comprehensive meta‐analysis of randomized trials and observational studies comprising 7,994 patients

Background: Saphenous vein graft (SVG) lesions remain amongst the most challenging lesions for percutaneous coronary intervention (PCI). It is unknown whether drug eluting stents (DES) are superior to bare metal stents (BMS) for such lesions. Our objective is to determine the safety and efficacy of DES compared with BMS for SVG lesions by performing a meta‐analysis of clinical trials and observational studies. Data Sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and internet‐based resources of clinical trials. Study Selection: Studies comparing DES vs. BMS for SVG lesions with at least > 30 patients in each study reporting the outcomes of interest [death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST), and the composite of death, TVR and MI (major adverse cardiac events; MACE)] with at least 6 months clinical follow‐up. The primary outcome of interest was death. Results: Two randomized trials, one subgroup analysis of a randomized trial and 26 observational studies comprising a total of 7,994 patients (4,187 patients in DES and 3,807 patients in BMS group) were included in the analysis .Mean follow‐up duration was 21 ± 11 months (6–48 months). In the overall population, MACE events were 19% in DES and 28% in BMS with a risk ratio (RR) of 0.7 (0.6, 0.8) P < 0.00001. This effect of MACE was sustained in studies with >2 years follow‐up with RR of 0.77 (0.65, 0.91) P = 0.003. Death rate was 7.8% in DES and 9% in BMS with a RR of 0.82 (0.7, 0.97) P = 0.02. MI rate was 5.7% in DES and 7.6% in BMS with RR of 0.72 (0.57, 0.91) P = 0.007. TVR was 12% in DES and 17% in BMS with RR of 0.71 (0.59, 0.85) P = 0.0002. ST was 1% in DES and 1.7 % in BMS RR of 0.61 (0.35, 1.06) P = 0.08. Specifically in randomized controlled trials, DES were associated with no significant differences in overall mortality [RR = 1.97; 95% confidence interval (CI), 0.17–23; P = 0.58] or MI (RR = 1.24; 95% CI, 0.3–5.5; P = 0.78) compared with BMS. Conclusions: Based on the results of this meta‐analysis, DES may be considered as a safe and efficacious option for the percutaneous intervention of SVG lesions. © 2010 Wiley‐Liss, Inc.     

Use of a self‐expanding super‐elastic all‐metal endoprosthesis; To treat degenerated SVG lesions: The SESAME first in man trial

We prospectively evaluated a novel nano‐synthesized, membrane‐covered self‐expanding super‐elastic all‐metal endoprosthesis stent (SESAME Stent?) in patients undergoing percutaneous intervention (PCI) of degenerated saphenous vein graft (SVG) lesions. Methods : SESAME investigators prospectively enrolled 20 patients/21 lesions at 2 outside United States (OUS) centers, between February 2005 and August 2005. Patients underwent elective intervention of symptomatic SVG lesions with ≥50% stenosis. PCI was performed without embolic protection devices. The primary end point was technical and procedural success. Secondary end points included major adverse cardiac events (MACE) at 30 days and 9 months. Results : Twenty patients (twenty‐one SVG lesions) received SESAME stents. The acute success was 100%. No procedural or in hospital complications occurred. One patient underwent a planned staged PCI at 28 days in a separate SVG. Follow‐up was present in 20 patients at 30 days, with clinical (n = 19) and angiographic evaluation (18 patients/19 lesions) at 9 months. No MACE events occurred at 30 days. At 9 months, 3 patients underwent repeat PCI. One TLR (restenosis at the overlap of two stents) and two nonindex lesion TVR for a MACE rate of 14% at 9 months. Conclusions : This study demonstrated the ABPS SESAME Stent? has excellent acute success, low 30 day MACE rates and 9 month patency of the SESAME is similar to balloon expandable stents without embolic protection.© 2010 Wiley‐Liss, Inc.     

Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents

ObjectivesTo assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions.Material and methodsIn this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported.ResultsA total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported.ConclusionsThree years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.     

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention

Objectives: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. Background: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. Methods: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS‐guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1‐year follow‐up was systematically indexed and a propensity score was performed with regard to the use of IVUS‐guided PCI. Results: Patients undergoing IVUS‐guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS‐guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS‐guided and no‐IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. Conclusion: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI. © 2009 Wiley‐Liss, Inc.     

Six‐month clinical follow‐up of the tryton side branch stent for the treatment of bifurcation lesions

Background: Treatment of bifurcation lesions with the Tryton Sidebranch stent has been shown to be feasible with an acceptable clinical outcome and low side branch late loss in the first in man trial. Objective: To report acute procedural and six month clinical follow‐up after the use of the Tryton Sidebranch stent in an “all comer” registry. Methods: The first 100 coronary bifurcation lesions assigned for treatment with the Tryton stent were included in a prospective registry. Procedural and angiographic success rates were determined from patient charts and pre‐ and postprocedural quantitative coronary angiography. Results: Totally, 96 patients with 100 lesions were included in the study. Seventy‐two percent presented with stable angina, 25% with unstable angina/NSTEMI, and 3% STEMI. The bifurcation was located in the left main in 8%. Two lesions were chronic total occlusions. Sixty‐nine percent were true bifurcation lesions. One failure of stent delivery occurred. Acute gain in SB was 0.76 ± 0.64mm and three patients had residual stenosis of >30%. Angiographic success rate was 95%; procedural success rate reached 94%. Peri‐procedural MI occurred in two and there was one cardiac death during hospitalization. At a median six months follow‐up, TLR rate was 4%, MI 3%, and cardiac death 1%. The percentage MACE‐free survival at six months was 94%. No cases of definite stent thrombosis occurred. Conclusions: In a real world the use of the Tryton Sidebranch stent is associated with good procedural safety and angiographic success rate and acceptable outcome at six months of follow‐up. © 2011 Wiley‐Liss, Inc.     

Late target lesion revascularization after implantation of sirolimus‐eluting stent

Objectives : We evaluated the incidence, clinical presentation, and angiographic in‐stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus‐eluting stent (SES) implantation. Background : Late TLR is an unusual finding beyond 6–9 months after bare‐metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. Methods : The study population consisted of 804 patients with 1,020 native lesions that were patent at 6‐month follow‐up angiogram after SES implantation. Results : Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 ± 2.6 months (range; 18–30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 ± 0.5 mm immediately after SES implantation, 2.4 ± 0.4 mm at 6‐month follow‐up and 0.7 ± 0.6 mm at 24‐month follow‐up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019–1.061). Conclusions : Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6‐month follow‐up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two‐thirds of late TLR lesions had a focal angiographic ISR pattern. © 2007 Wiley‐Liss, Inc.     

Outcomes of patients with acute myocardial infarction rom a saphenous vein graft culprit undergoing percutaneous coronary intervention

Objectives : We sought to describe characteristics of patients presenting with an acute MI from a SVG culprit, compared with a native culprit. Background : Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) results in worse outcomes than native vessel PCI, but outcomes of such patients with acute myocardial infarction (MI) setting are not well‐described. Methods : Patients presenting with ST‐elevation or non‐ST‐elevation MI undergoing PCI from 2000 to 2010 were retrospectively analyzed to identify the culprit as a SVG vs. native vessel. Multiple linear regression was used to identify predictors of peak troponin‐I level. Cox proportional hazards regression was used to identify predictors of 30‐day mortality and 1‐year major adverse cardiac events (MACE). Results : 192 patients underwent PCI for a SVG culprit, compared with 4,001 with a native culprit. After multivariable adjustment, SVG culprit remained significantly associated with lower levels of the logarithm of the peak troponin (β = ?0.17, SE = 0.07, P = 0.02). The likelihood of MACE was higher in SVG vs. native culprits in patients with small to modest troponin elevations. Patients with a SVG culprit also suffered higher unadjusted rates of mortality at 30 days (14.3% vs. 8.4%, P = 0.03) and MACE at 1 year (36.8% vs. 24.5%, P = 0.005); a modest effect upon mortality and MACE remained after multivariable adjustment. Conclusion : Even minimal elevations of troponin in patients with a SVG culprit may portend a poorer prognosis than in patients with a native culprit. The risk of PCI in this setting is driven by mortality and arises from both substantial comorbidities and the SVG itself. © 2011 Wiley‐Liss, Inc.     

Feasibility, safety, and preliminary efficacy of a novel ePTFE-covered self-expanding stent in saphenous vein graft lesions: the Symbiot II trial.

Compared with percutaneous interventions in native coronary arteries, revascularization of saphenous vein graft (SVG) lesions is associated with increased rates of immediate and long-term major adverse cardiac events (MACE). The Symbiot II trial was a multicenter prospective study designed to evaluate the feasibility and safety of a novel self-expanding polytetrafluoroethylene (ePTFE)-covered stent in the treatment of de novo and restenotic SVG lesions. The primary endpoint was MACE through 30 days postprocedure. Successful Symbiot stent deployment was achieved in 75 of 77 patients (97.4%) with SVG lesions < or = 35 mm in length (visual assessment). The procedural success rate (defined as < 30% residual stenosis at the target site and no clinical complications) was 83%, and all study device procedures provided grade 3 TIMI flow postprocedure. Within the first 30 days postprocedure, four patients (5.2%) experienced MACE (defined as death, Q-wave or non-Q-wave myocardial infarction, and clinically driven target vessel revascularization), of whom three patients (3.9%) experienced periprocedural non-Q-wave myocardial infarction. No subacute stent thrombosis was observed over the 6-month follow-up period. No relevant luminal loss at the target site (mean, 0.3 +/- 0.9 mm) was observed in the 58 patients (77.3% of enrolled patients) who underwent quantitative coronary angiography at 6 months. The incidences of binary in-stent restenosis, in-segment restenosis, and target vessel failure (defined as acute and late-term MACE through 6 months postprocedure) were low (7.0%, 8.6%, and 14.3%, respectively). The Symbiot self-expanding ePTFE membrane-covered stent was associated with a high procedural success rate (97.4%), low incidences of MACE at 30 days (5.2%) and 6 months (14.3%), suggesting that it is safe and effective in the treatment of SVG disease.