Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: A randomized PIPA trial

Objectives : To compare the safety and efficacy of the new Coroflex? Please stents with conventional Taxus? Liberte stents in patients with coronary artery lesions. Background : The Coroflex? Please stent is a new version of paclitaxel‐eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first‐generation stents. However, it has not been directly compared with the early generation paclitaxel‐eluting stents in a multicenter, prospective, and randomized study. Methods : We randomly assigned 319 patients to receive Coroflex? Please stents (159 patients; 198 lesions) or Taxus? Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in‐segment late luminal loss at 9 months. Results : Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex? Please and Taxus? Liberte stents showed similar in‐segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in‐segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow‐up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target‐lesion revascularization (7.5% vs. 7.5%, P = 0.99). Conclusions : The Coroflex? Please stent resulted in similar angiographic and clinical outcomes as the Taxus? Liberte stent in patients with coronary artery lesions. © 2012 Wiley Periodicals, Inc.     

Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial

Background

There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent‐polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions.

Methods

A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non‐inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow‐up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients.

Results

The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in‐stent late lumen loss in BMS + PCB was comparable and non‐inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P_non‐inf < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3–2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4–6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4–4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5–7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38).

Conclusions

Paclitaxel delivery via drug coated balloon or polymer‐stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail‐out for PCB alone angioplasty.

     

The paclitaxel‐eluting coroflex™ please stent study (PECOPS I): The 3‐year clinical follow‐up

Background : The evaluation of drug‐eluting devices in humans should include longterm follow‐up owing to risk of late target vessel thrombosis with the possible fatal sequel. Methods and Results : Therefore, the three‐year clinical outcome of the paclitaxeleluting Corofiex^® Please stent in patients with de‐novo coronary lesions was evaluated in the single‐arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 ± 0.12 years following stent deployment. In the intention‐to‐treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in‐segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 ± 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (?3.0 ± 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3‐year MACE rate was 22/123 (17.9%). Conclusion : The present study describes the paclitaxel‐eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low. © 2009 Wiley‐Liss, Inc.     

Angiographic outcomes with biodegradable polymer and permanent polymer drug‐eluting stents

Background : In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents (ISAR‐TEST‐4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus‐eluting stent to permanent polymer (PP) sirolimus/everolimus‐eluting stent (Cypher/Xience‐V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR‐TEST‐4 patients with paired angiographic studies. Methods : Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in‐stent late lumen loss, in‐segment binary restenosis, and restenosis morphology at 6–8‐month follow‐up angiogram. Results : Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST‐4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6–8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in‐stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in‐segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79). Conclusion : Angiographic characteristics of restenosis after BP‐based limus‐eluting stents are similar to those of PP‐based limus‐eluting stents. © 2011 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.     

Infrapopliteal drug‐eluting stents for chronic limb ischemia

Objective: We report our experience with the elective placement of below‐knee, drug‐eluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3‐year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug‐eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug‐eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n = 1) or limb‐threatening ischemia (n = 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug‐eluting stents were electively placed in 12 below‐knee arteries in 10 patients, resulting in an average of 1.7 ± 0.7 stents per patient. The mean lesion length was 24.8 ± 10.9 mm, the mean total stent length was 38.3 ± 19.1 mm, and the mean nominal stent diameter was 2.8 ± 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 ± 6.5 months of follow‐up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug‐eluting stent patency in each case. Conclusions: The use of below‐knee drug‐eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. © 2008 Wiley‐Liss, Inc.     

Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating

Background: Permanent polymers used in current drug‐eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. Objectives: We sought to evaluate a novel, potentially innately anti‐inflammatory, bioabsorbable salicylate‐based polymer as a DES coating, in a clinically relevant animal model. Methods: Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer‐only coated metal stents (SA/AA); biostable polymeric sirolimus‐eluting stents (Cypher?); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 μg/mm of stent length (similar to Cypher?) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. Results: Both SA/AA + S and Cypher? stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer‐only groups (6 ± 4% and 5 ± 4% vs. 15 ± 7% and 16 ± 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher? than for BMS (0.14 ± 0.06 and 0.13 ± 0.04 mm vs. 0.23 ± 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher? when compared with BMS (22 ± 7% and 23 ± 6% vs. 33 ± 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher? groups (P = 0.072). Conclusions: This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate‐based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices. © 2008 Wiley‐Liss, Inc.     

Comparison of 3‐Year Clinical Outcomes Between Resolute™ Zotarolimus‐ and Sirolimus‐Eluting Stents for Long Coronary Artery Stenosis

Objectives

Long‐term clinical outcomes were evaluated in long coronary artery stenosis treated with different types of drug‐eluting stents.

Background

Long‐term follow‐up data to compare clinical outcomes between Resolute? zotarolimus‐eluting stent (R‐ZES) versus sirolimus‐eluting stent (SES) implantation for long coronary artery stenosis is insufficient.

Methods

A total of 254 patients (307 lesions) treated with R‐ZES and 265 patients (303 lesions) treated with SES for long coronary lesions (total stent length ≥30 mm) were enrolled, and long‐term (3 years) clinical outcomes were compared between the 2 groups. Efficacy (target lesion revascularization [TLR]) and safety (the composite occurrence of cardiovascular death, target lesion–related myocardial infarction, or target lesion–related definite stent thrombosis) were assessed.

Results

The 2 groups had similar baseline characteristics except for the duration of dual antiplatelet therapy (23.4 ± 11.2 months in R‐ZES‐treated patients vs. 27.4 ± 13.9 months in SES‐treated patients, P < 0.001). Total stent length was similar in R‐ZES‐treated patients (45.0 ± 19.0 mm) and SES‐treated patients (45.4 ± 18.6 mm) (P = 0.464). The cumulative TLR rate was 4.6% in R‐ZES‐treated patients versus 4.6% in SES‐treated patients (P = 0.911). For safety parameters, R‐ZES‐treated patients showed a significantly lower rate of the composite occurrence of cardiovascular death, target lesion–related myocardial infarction, or target lesion–related definite stent thrombosis than SES‐treated patients (0.4% vs. 2.4%, P = 0.042). Particularly, the occurrence of target lesion–related definite stent thrombosis was significantly lower in R‐ZES‐treated patients than in SES‐treated patients (0.0% vs. 2.0%, P = 0.028).

Conclusions

R‐ZES stents showed superior long‐term safety than SES for treating long coronary lesions, while maintaining a similar clinical efficacy.

     

In‐Hospital and 12‐Month Postprocedural Clinical Outcome of Coronary Bifurcational Lesion Treatment with the Endeavor Stent

Background: The zotarolimus‐eluting stent (ZES) has been documented as significantly reducing restenosis and target lesion revascularization (TLR) requirement compared to bare metal stents (BMS). Methods: In this single‐centered, prospective study we sought to evaluate the short‐ and medium‐term outcomes of ZES placement in bifurcated coronary artery lesions. Between August 2006 and December 2007, 107 consecutive patients (110 bifurcations) were recruited to have ZES placement in the lesion. The provisional T stenting (PTS) technique was used in 96.3%. Angiographic success was 100% in main vessel (MV) cases and 97.2% in that of side branch (SB). Results: With a mean follow‐up of 12.4 ± 1.77 (mean ± SD) months there were four deaths, three from cardiac cause (2.85%). There were 18 patients (19 bifurcations) requiring TLR (17.59%) for clinical reasons. The only predictor of TLR was the use diameter of ZES ≤3 mm. Conclusion: ZES can be used for bifurcation lesions using the PTS technique with a high rate of intraprocedural success; however, frequency of TLR is high, especially for stents with a diameter ≤3 mm. (J Interven Cardiol 2010;23:188‐194)     

One‐Year Results of the CRISTAL Trial,a Randomized Comparison of Cypher Sirolimus‐Eluting Coronary Stents versus Balloon Angioplasty for Restenosis of Drug‐Eluting Stents

Objectives: We compared the efficacy of the Cypher Select? (Cordis Corporation, Bridgewater, NJ, USA) sirolimus‐eluting stent (SES) versus balloon angioplasty (BA) in in‐stent restenosis (ISR) of Taxus? or Taxus Liberté? paclitaxel‐eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Background: Optimal treatment strategies have not been identified for drug‐eluting stent (DES) ISR. Methods: Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. Results: 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12‐month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end‐point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in‐stent binary restenosis (11.1% vs. 14%, P = 0.59). Target‐lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. Conclusions: In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed Abstract Optimal treatment strategies have not been identified for sirolimus‐ (SES) or paclitaxel‐eluting stent (PES) in‐stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end‐point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow‐up MLD and immediate and net gain favored SES. (J Interven Cardiol 2012;25:586–595)     

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.     

The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up.

BACKGROUND AND OBJECTIVES: Various active stent coatings significantly reduce restenosis rates and target lesion revascularization compared to bare metal stents. Therefore, the procedural and 6-month performance of the new paclitaxel-eluting Coroflex. Please stent was investigated. METHODS: Ninety-seven patients (66 +/- 7.6 years, 34/97(35.1%) diabetics, 11/97(11.3%) unstable angina) were enrolled per protocol for elective single stent deployment into native coronary de-novo or post-PTCA restenotic lesions (stenosis: >or= 70%, < 100%; reference diameter >or= 2.25 mm and <3.3 mm; lesion length 相似文献   

Prospective randomized comparison of sirolimus‐ versus paclitaxel‐eluting stents for the treatment of acute ST‐elevation myocardial infarction

Objective: The aim of this study was to compare effectiveness of the Sirolimus‐ (SES) and Paclitaxel‐eluting stent (PES) in primary angioplasty for acute ST‐elevation myocardial infarction (STEMI). Background: It has been reported that SES and PES have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug‐eluting stents in terms of efficacy in the setting of acute STEMI. Methods: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow‐up was performed at 6 months and clinical follow‐up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months. Results: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in‐segment restenosis (5.9% vs. 14.8%, P = 0.03) and in‐segment late loss (0.09 ± 0.45 vs. 0.33 ± 0.68 mm, P = 0.002) than PES group on follow‐up angiography. Twelve‐month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07). Conclusion: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12‐month MACE. However, binary angiographic in‐segment restenosis and in‐segment late loss were significantly lower in the SES group. © 2008 Wiley‐Liss, Inc.     

First‐in‐Man Study of Dedicated Bifurcation Sirolimus‐eluting Stent: 12‐month Results of BiOSS LIM® Registry

Objectives

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent ‐ sirolimus‐eluting BiOSS LIM® (Balton, Poland) in 12‐month Registry.

Background

The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.

Methods

This was the international, 3‐center registry, which enrolled patients with non‐ST‐elevation acute coronary syndrome (NSTE‐ACS) and stable angina. Provisional T‐stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.

Results

A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE‐ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug‐eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow‐up (11 ± 1 months) there was 1 non‐cardiac death (1.7%), 1 non‐ST‐elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in‐stent thrombosis. Overall TLR was 8.3% (clinically driven TLR – 1.7%, angiographically driven – 6.6%). Mean late lumen loss was as follows: In main vessel – 0.35 ± 0.33 mm, in main branch – 0.34 ± 0.27 mm and in side branch – 0.18 ± 0.38 mm.

Conclusion

Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long‐term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis. (J Interven Cardiol 2015;28:51–60)

     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

One‐Year Clinical Outcome of a Randomized Trial of Polymer‐Free Paclitaxel‐Eluting Stents Versus Biodegradable Polymer‐Based Rapamycin‐Eluting Stents in Patients with Coronary Heart Disease

Background: More widespread use of drug‐eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer‐free and biodegradable polymer‐based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear. Methods and Results: To assess whether polymer‐free paclitaxel‐eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end‐point was major adverse cardiac events (MACE). The secondary end‐points included stent thrombosis events, all‐cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one‐year MACE according to a noninferiority or equivalence margin of 0.1. One‐year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one‐sided 95% confidence interval was ?0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [?0.0698, 0.0742] (P₁=0.004 and P₂=0.007 from 2 times the 1‐sided test for equivalence). There was no statistically significant difference in thrombosis events, all‐cause death, and rehospitalization (all P > 0.05). Conclusions: In this small randomized trial, polymer‐free paclitaxel‐eluting stents appear to be noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents. (J Interven Cardiol 2012;25:604–610)     

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.     

Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.     

Analysis of left main coronary artery bifurcation lesions treated with biolimus‐eluting DEVAX AXXESS plus nitinol self‐expanding stent: Intravascular ultrasound results of the AXXENT trial

Objective: To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS. Background: The treatment of LMCA bifurcation lesions remains challenging even with the use of drug‐eluting stents. The AXXESS system is a biolimus A9‐eluting self‐expanding stent, dedicated to the treatment of bifurcation lesions. Methods: Data were obtained from the AXXENT trial, a prospective, single‐arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6‐months follow‐up. Volumetric and cross‐sectional analyses within the AXXESS stent, and cross‐sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed. Results: Within the AXXESS stent, percent neointimal volume obstruction was (3.0 ± 4.1)% with a minimal lumen area of 10.3 ± 2.6 mm². AXXESS stent volume showed an 12.4% increase at follow‐up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow‐up (3.6 ± 1.3 mm² vs. 5.5 ± 2.0 mm², P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 ± 1.20 mm² vs. 0.30 ± 0.36 mm², P = 0.0003). Conclusions: The AXXESS stent in the LMCA showed enlargement through 6‐months follow‐up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium. © 2008 Wiley‐Liss, Inc.     

Risk Factors and Clinical Impacts of Peri‐Stent Contrast Staining After Second‐Generation Drug‐Eluting Stent Implantation

Background

Peri‐stent contrast staining (PSS) after sirolimus‐eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second‐generation DES implantation remain unclear.

Methods and Results

This study comprised 2,090 patients with 2,883 lesions treated with second‐generation DES from April 2009 to February 2013. Angiographic findings and clinical outcomes were compared between PSS and non‐PSS groups. Follow‐up angiography was available for 2,411 lesions. PSS was observed in 23 lesions: 4 in biolimus‐eluting stents, 4 in zotarolimus‐eluting stents (ZES), and 15 in everolimus‐eluting stents (EES). Right coronary artery lesions, chronic total occlusion (CTO), and lesions with severe angulation (>90°) were more frequent in the PSS group compared with the non‐PSS group. Lesions were longer and the cumulative TLR incidence at 3 years was higher in the PSS group than those in the non‐PSS group (27.9 mm vs. 19.4 mm, P < 0.0001; 27.4% vs. 8.6%, P = 0.0002). There was no significant difference in stent thrombosis between the two groups. Multivariable analysis identified CTO [odds ratio (OR) 3.75, 95%CI 1.52–8.88, P = 0.005] as an independent predictor of PSS.

Conclusions

PSS after second‐generation DES implantation was associated with an increased risk of subsequent TLR. CTO was the independent predictor of PSS. (J Interven Cardiol 2016;29:179–187)