Comparison of three‐year clinical outcomes between sirolimus‐versus paclitaxel‐eluting stents in diabetic patients: Prospective randomized multicenter trial

Background : Three‐year follow‐up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) implantation have not been reported. Methods : Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES. Results : Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three‐year follow‐up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25–22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07–29.44, P < 0.001) during the three‐year follow‐up. Conclusions : The rates of MACEs, TVR, and stent thrombosis during the three‐year follow‐up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three‐year follow‐up after either SES or PES implantation. © 2009 Wiley‐Liss, Inc.     

Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

Background : There are limited data on the long‐term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Objective : We aimed to assess the 4‐year clinical outcome in patients who received a bare‐metal stent (BMS), sirolimus‐eluting stent (SES), or a paclitaxel‐eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000–2005. Methods : In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI‐cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). Results : At 4 years follow‐up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47–0.81; HR = 0.67, 95% CI: 0.55–0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target‐vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37–0.75; HR = 0.71, 95% CI: 0.62–0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. Conclusion : These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow‐up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI. © 2010 Wiley‐Liss, Inc.     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

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.     

Rotablation in the Drug Eluting Era: Immediate and Long‐Term Results from a Single Center Experience

The aim of this study was to investigate the immediate and long‐term outcome of patients who were treated with rotational atherectomy (RA) to facilitate the delivery of drug eluting stents (DES) in heavily calcified lesions. We analyzed 150 consecutive patients who underwent RA and subsequently DES implantation in our institution. The patients had heavily calcified coronary artery lesions requiring plaque modification prior to conventional angioplasty and stent implantation. Rotational atherectomy was performed using the standard Boston Scientific Rotablator^® system. A 2‐burr stepped approach was selected in most of the cases. Following successful modification of the plaque, the angioplasty was performed with a balloon at low pressure to avoid dissection and a DES was implanted. The mean follow up period was 3 years (max. 78 months). Follow‐up data included all cause death, stroke, myocardial infarction (MI), recurrent angina, re‐hospitalization, target lesion revascularization (TLR), target vessel revascularization (TVR), and long‐term duration of dual antiplatelet therapy. The rate of recurrent angina and MI during follow up was low (3.3%) and the overall major adverse cardiac events (MACE) rate was 11.3%. No MACE occurred during hospitalization. There was no relationship between discontinuation of clopidogrel and occurrence of death or MI. The combined approach of RA‐DES has a favorable effect when dealing with heavily calcified lesions in both the angiographic and clinical outcomes. No safety concerns are observed up to 6 years. (J Interven Cardiol 2010;23:249–253)     

Selective drug‐eluting stent implantation for high‐risk patients with acute ST‐elevation myocardial infarction: Rationale and safety

Background : A selective policy of drug‐eluting stent (DES) implantation in ST‐elevation myocardial infarction (STEMI) patients at high risk of restenosis may maximize the benefit from restenosis reduction and minimize risk from late stent thrombosis (LaST). Objectives : We sought to prospectively determine the safety of selective DES implantation for long lesions (>20 mm), small vessels (<2.5 mm) and diabetic patients in patients with STEMI using a prospective single‐center registry. Methods : A total of 252 patients who underwent primary PCI between January 2005 and December 2006 were included: 126 consecutive patients receiving DES were compared with 126 age‐, sex‐, and vessel‐matched controls with STEMI who received bare‐metal stents. Composite major adverse cardiovascular events (MACE) (death, AMI, and target vessel revascularization) were used as the primary outcome measure. Results : Baseline clinical and angiographic characteristics and outcomes were similar between groups except for the prespecified diabetes, lesion length, and maximum stent diameter. Long‐term outcomes at a median follow up of 34 ± 6 months showed significant reductions in reinfarction (2% vs. 11%, P = 0.03), target vessel revascularization (TVR) (10% vs. 24%, P = 0.02), and composite MACE (18% vs. 31%, P = 0.03) with DES, with no excess of death (9% vs. 7%, P = NS) or LaST (2% vs. 1%, P = NS). In a Cox multivariate model, clopidogrel cessation at long‐term follow‐up was the most powerful predictor of hierarchical MACE (HR: 5.165; 95%CI: 2.019–13.150, P = 0.001). Conclusions : Selective DES implantation in patients with high‐risk STEMI appears safe, and exposes fewer patients to the risk of LaST. A randomized comparison of selective versus routine DES use in patients with STEMI should be considered. © 2010 Wiley‐Liss, Inc.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Backgrounds : Relative efficacy and safety of sirolimus‐eluting stents (SES) compared with paclitaxel‐eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. Objectives : The meta‐analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Methods : Five head‐to‐head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta‐analysis. Mean follow‐up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main‐branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Results : Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38–0.70, P < 0.001), main‐branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18–0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42–0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40–0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Conclusions : Compared with PES, SES reduced the incidence of TLR, main‐branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups. © 2011 Wiley Periodicals, Inc.     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

Clinical impact of sirolimus‐eluting stent in ST‐segment elevation myocardial infarction: A meta‐analysis of randomized clinical trials

Objectives: To evaluate outcome of patients undergoing sirolimus‐eluting stent (SES) as compared to bare‐metal stent (BMS) implantation during primary angioplasty for ST‐segment elevation myocardial infarction (STEMI). Background: The role of SES in primary percutaneous coronary intervention setting is still debated. Methods: We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow‐up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target‐vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI). Results: Six trials were included in the meta‐analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12‐month follow‐up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24–0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52–1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52–1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45–1.11], P = 0.13) between the two groups. Conclusion: SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow‐up. Further studies with larger population and longer follow‐up time are needed to confirm our findings. © 2009 Wiley‐Liss, Inc.     

Two‐Year Clinical Registry Follow‐up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus‐Eluting Bioabsorbable Polymer‐Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction

Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate‐term efficacy and safety of EPC stent and compared that with sirolimus‐eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single‐center clinical registry. The study end‐points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post‐procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2‐year follow‐up, the EPC group showed favorable, single‐digit TVR rate and stent thrombosis remained a low‐event occurrence. (J Interven Cardiol 2010;23:101‐108)     

Everolimus- and zotarolimus-eluting stents for bare metal stent in-stent restenosis treatment: a prospective study

Background: Treatment of in‐stent restenosis (ISR) is a challenging clinical problem. Recent studies have verified the safety and efficacy of first‐generation DES for the treatment of ISR. The safety and effectiveness of new‐generation drug‐eluting stents (nDES) for ISR has not been previously investigated. The aim of the present study was to prospectively evaluate the clinical outcomes after treatment with nDES implantation in patients with bare metal stent (BMS) ISR. Methods: Consecutive patients with ISR after BMS implantation were included. Primary end‐point was a major adverse cardiac event (MACE), defined as death, myocardial infarction (MI), or target vessel revascularization (TVR). The incidence of stent thrombosis was also evaluated. Results: A total of 46 consecutive patients were enrolled for the treatment of ISR, 23 patients from ZES and 23 from EES group. There were two (8.7%) cases of TVR in ZES cohort due to proliferative ISR at 6 and 7 months after DES implantation, and none in EES. One (4.3%) patient underwent percutaneous coronary intervention and the other (4.3%) was treated surgically. Neither acute nor subacute thrombosis was observed during the 13.3±6.3 months follow‐up period. In all other patients, stress test was negative for ischemia at 6 months. Conclusions: In this prospective study, we showed that direct nDES implantation is highly effective for ISR and seems to be a promising management for the treatment of ISR.     

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.     

Prediction of Clinical Outcomes in Patients with Unprotected Left Main Trifurcation Lesions Treated by Drug‐Eluting Stents: Importance of 2‐Stent Technique and SYNTAX Score

Background: There were insufficient data on the prognosis of stenting for patients with trifurcated unprotected left main lesions (UPLMS). Methods: From the SPEED (stents for percutaneous treatment of coronary artery disease) registry of all percutaneous coronary interventions (PCI) for all types of UPLMS, data of 44 patients with trifurcated UPLMS were selected and analyzed. Results: Patients were divided into one‐stent (N = 23) or 2‐stent (N = 21) groups. Clinical follow‐up was available for 100%, and angiographic follow‐up at 8 month was available for 91.3%. There were no differences in myocardial infarction, cardiac death, and stent thrombosis between groups. However, the target lesion revascularization (TLR) and target vessel revascularization (TVR) in the 1‐stent group was lower when compared to the 2‐stent group (13.0% vs. 23.8%, P = 0.004; 13.0% vs. 28.6%, P = 0.003, respectively). Cumulative survival free from major adverse cardiovascular events (MACE) in the 1‐stent group was higher than the 2‐stent group (65.2% vs. 57.1%, P = 0.033). Analysis of the receiver operator curve (ROC) of the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score showed the area under the curve was 0.414 (standard error = 0.089, 95% CI 0.240–0.589, P = 0.348). Conclusions: In patients with trifurcated UPLMS, higher TLR/TVR and lower cumulative survival from MACE were seen in the 2‐stent group when compared to the 1‐stent group. The SYNTAX scoring system had no predictive value of outcomes for patients with stenting of trifurcated UPLMS. (J Interven Cardiol 2010;23:352–357)     

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.     

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Objectives

We aimed to test a novel stent‐less revascularization strategy using a combination of excimer laser coronary angioplasty (ELCA) and drug‐coated balloon (DCB) for patients with acute coronary syndrome (ACS).

Background

Percutaneous coronary intervention with drug eluting stents is a standard invasive treatment for ACS. Some unsolved issues however remain, such as stent thrombosis and bleeding risks associated with dual antiplatelet therapy.

Methods

Consecutive ACS patients were planned to receive either a DCB application following ELCA without a stent implantation or conventional revascularization with a coronary stent. The endpoints were (i) major cardiac adverse events (MACEs), defined as the composite of cardiac death, myocardial infarctions, and target lesion revascularization; (ii) target vessel revascularization (TVR); and (iii) angiographic outcome.

Results

Since a greater than expected number of patients allocated to the stent‐less treatment arm eventually received a bailout stenting, the following 3 as‐treated groups were compared; DCB with ELCA group (N = 60), Stent with ELCA group (N = 23), and Stent without ELCA group (N = 85). During a mean follow‐up period of 420 ± 137 days, and with angiographic 6‐ and 12‐month‐follow‐up rates of 96.7%, 87%, and 81.2%, and 50%, 65.2%, and 45.9%, respectively, the MACE rate did not differ across the groups (10%, 4.3%, and 3.5%; P = 0.22) while an incidence of TVR was more common (15%, 0, and 4.7%; P = 0.02) and the diameter stenosis at 6‐months of follow‐up was greater (25.7 ± 18.2, 14.9 ± 13.1 and 16.2 ± 15.4%; P = 0.002) in the DCB with ELCA group.

Conclusions

The stent‐less revascularization strategy with DCB and ELCA was associated with a higher occurrence of restenosis in ACS patients.

     

Angiographic and Clinical Outcomes after Implantation of Drug Eluting Stents in Bifurcation Lesions with Crush or Kissing Stent Technique

Background

Long‐term outcome after bifurcation stenting with drug‐eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6–9‐month angiographic follow‐up and long‐term clinical outcomes after implantation of drug‐eluting stents by crush and kissing stent technique for coronary bifurcation lesions.

Methods

Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow‐up was obtained at 6–9 months and clinical follow‐up completed for a median of 38 months.

Results

A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow‐up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow‐up was available for a median duration of 38 months. During follow‐up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow‐up.

Conclusion

Bifurcation stenting with crush or kissing stent technique is safe and associated with a low rate of TLR and MACE on long‐term follow‐up. Crush stenting is associated with a significantly higher rate of side branch restenosis compared to kissing stent technique. FKB is associated with significant reduction in MACE during follow‐up. (J Interven Cardiol 2013;26:145–152)

     

Comparison of clinical outcomes of coronary artery stent implantation in patients with end‐stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer‐EES,platinum chromium‐EES,and cobalt chrome‐EES

Backgrounds

New‐generation bioresorbable polymer‐everolimus eluting stents (BP‐EES) are available. This study aimed to compare the clinical outcomes for BP‐EES compared to more established stent designs, namely the platinum chromium‐EES (PtCr‐EES) and cobalt chrome‐EES(CoCr‐EES) in patients with the end‐stage chronic kidney disease (CKD) including hemodialysis (HD).

Methods

One‐hundred‐forty‐one consecutive stents (BP‐EES [n = 44], PtCr‐EES [n = 45], and CoCr‐EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow‐up coronary angiography at 12 months after implantation. End‐stage CKD was defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or the need for HD. The following outcome variables were compared among the three stent groups after implantation and the 12‐month follow‐up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter‐stenosis (%DS) were measured using quantitative coronary angiography.

Results

The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12‐month follow‐up, a tendency towards higher TLR was observed for the BP‐EES group (22.7%) compared with the PtCr‐EES (8.8%) and CoCr‐EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP‐EES (0.51 ± 0.64 mm) group than either the PtCr‐EES (0.20 ± 0.61 mm) and CoCr‐EES (0.25 ± 0.70 mm) groups (P = 0.03).

Conclusions

BP‐EES might increase the risk of in‐stent restenosis in patients with end‐stage of CKD or the need for HD.     

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.     

Five‐year long‐term clinical follow‐up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT FIRST trial

Background : Drug‐eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long‐term follow‐up data are scarce and only available for sirolimus‐ and paclitaxel‐eluting stents. Aim : To assess the feasibility and performance of the XIENCE V everolimus‐eluting stent (EES) versus an identical bare metal stent after a 5‐year follow‐up period. Methods : SPIRIT FIRST was a First in Man, multicentre, prospective, single‐blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent. Results : At 5‐year clinical follow‐up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1‐ and 5‐year follow‐up. The 5‐year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2‐ and 5‐year follow‐up. No additional clinically driven TVR events were observed between 3‐ and 5‐year follow‐up. The 5‐year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years. Conclusion : The favorable 5‐year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow‐up. © 2010 Wiley‐Liss, Inc.