zotarolimus and Cardiovascular-Diseases

Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.. In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.. A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).. In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Probucol; Proportional Hazards Models; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI.. The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non-ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization.. Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non-ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56).. Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.

Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Coronary Angiography; Drug-Eluting Stents; Everolimus; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Myocardial Revascularization; Netherlands; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; ST Elevation Myocardial Infarction; Thrombosis

Sirolimus-eluting stents (SES) have been shown to be superior to Endeavor zotarolimus-eluting stents (ZES) and comparable to Resolute ZES at eight-month angiography in patients treated for total coronary occlusions (TCO). This study investigated clinical outcome at three-year follow-up.. The PRISON III trial investigated the efficacy and safety of SES against ZES (Endeavor and Resolute) in two study phases. In the first phase, 51 patients were randomised to receive SES and 46 to Endeavor ZES. In the second phase, 103 and 104 patients were randomised to SES or Resolute ZES, respectively. Between one and three years there were only a few additional clinical events in all groups. As a result, the rates of target lesion revascularisation 12.2% vs. 19.6%, p=0.49, target vessel failure 14.3% vs. 19.6%, p=0.68, and definite or probable stent thrombosis 4.1% vs. 2.2% were comparable between SES and Endeavor ZES at three years. In the second study phase, the rates of target lesion revascularisation 10% vs. 5.9%, p=0.42, target vessel failure 10% vs. 7.9%, p=0.79 and definite or probable stent thrombosis 1.0% vs. 0% were similar between SES and Resolute ZES.. The present study demonstrated a low incidence of clinical events between one- and three-year follow-up with either SES compared to Endeavor ZES or SES versus Resolute ZES in patients treated for total coronary occlusions.

Topics: Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Reoperation; Sirolimus; Thrombosis

To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.. The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had "off-label" indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups.. Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Antineoplastic Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Reoperation; Sirolimus; Thrombosis; Treatment Outcome

Stents with a passive coating of titanium-nitride-oxide (TiNO) have been compared with Endeavor® zotarolimus-eluting stents (E-ZES) with regard to the primary endpoint of in-stent late lumen loss at six to eight months. The objective of the present analysis was to compare the long-term outcomes of TiNO stents with E-ZES up to five years of clinical follow-up.. A total of 302 patients had been randomly allocated to treatment with TiNO or E-ZES. Up to five years of follow-up, major adverse cardiac events (MACE), the composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularisation (TLR), were observed in 27.6% of patients treated with TiNO stents and 25.3% of patients treated with E-ZES (RR 1.13, 95% CI: 0.72-1.75, p=0.60), with the majority of events related to clinically indicated TVR (TiNO 21.7% versus E-ZES 20.7%, RR 1.10, 95% CI: 0.67-1.81). There were no differences with respect to individual events including cardiac death, myocardial infarction or stent thrombosis between the two treatment arms up to five years of follow-up. A majority of patients remained free from angina throughout the entire study duration (TiNO 77.3% versus E-ZES 76.1%, p=0.92).. Final five-year outcomes of the TIDE trial comparing TiNO stents with E-ZES revealed increased rates of MACE driven primarily by clinically indicated TVR. The TIDE trial is registered at ClinicalTrials.gov: NCT00492908.

Topics: Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Proportional Hazards Models; Reoperation; Sirolimus; Titanium; Treatment Outcome

The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice.. Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined.. We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point.. Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02).. In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067).

Topics: Aged; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Reperfusion; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

There are limited long-term outcome data comparing BioLinx polymer (B)-zotarolimus-eluting stents (ZES) with phosphorylcholine polymer (P)-ZES. The aim of this study was to compare the efficacy and safety of B-ZES with P-ZES in patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.One thousand two hundred fifty four patients who underwent PCI with P-ZES (Endeavor [ZES-E] or Endeavor sprint [ZES-S], n = 356) or B-ZES (Endeavor resolute [ZES-R] or Resolute Integrity [ZES-I], n = 889) were enrolled. The primary endpoint was major adverse cardiac events (MACE); the composite of total death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-target vessel revascularization (Non-TVR), and the secondary endpoint was stent thrombosis (ST).After PSM, 2 propensity-matched (PSM) groups (275 pairs, n = 550, C-statistic = 0.730) were generated. During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.

Topics: Aged; Cardiovascular Diseases; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Phosphorylcholine; Polymers; Propensity Score; Prosthesis Design; Reoperation; Sirolimus

Second-generation drug-eluting stents (DES) have been used widely to treat DES in-stent restenosis (ISR), which remains a clinical challenge. Knowledge of the outcomes of repeated second-generation DES implantation for focal versus nonfocal-type ISR is still missing.. In the current study, 254 patients with DES-ISR were divided into focal or nonfocal groups according to their ISR angiographic types. All patients with ISR lesions included in the current study received second-generation DES. Treatment modalities for both groups were similar without any systematic bias toward either group. The primary endpoint of the study was the occurrence of major adverse cardiac events (MACEs) over a 2-year follow-up period. MACEs were defined as cardiac death, myocardial infarction, and target lesion revascularization.. The nonfocal-type group showed significantly greater incidence of MACEs than the focal-type group (38.3 vs. 24.1%; P=0.03), in which the occurrence of target lesion revascularization was more pronounced (32.3 vs. 18.4%; P=0.02). However, this group showed a higher incidence of type B2/C lesions (69.5 vs. 41.4%; P<0.01), with longer lesion length, and received significantly more and longer reimplanted stents than the focal-type group. Cox regression analysis indicated that nonfocal-type ISR was an independent predictor of MACEs (odds ratio 2.134, 95% confidence interval 1.173-3.884; P=0.014) after adjusting for all significant variables.. In the current study, second-generation DES is more effective in the treatment of focal-type DES-ISR than nonfocal-type ISR in terms of the occurrence of MACEs. Nonfocal-type ISR is an independent predictor of MACEs after the treatment of DES-ISR with second-generation DES.

Topics: Aged; Antineoplastic Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Proportional Hazards Models; Retreatment; Retrospective Studies; Sirolimus; Treatment Outcome

Topics: Aged; Cardiovascular Diseases; Cohort Studies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Time Factors; Treatment Outcome

The impact of gender on outcomes after percutaneous coronary intervention (PCI) with second-generation drug-eluting stents is not known in Asian patients. The authors studied outcomes after PCI with zotarolimus-eluting stent in unselected consecutive series of Asian patients according to gender.. Outcomes among patients treated with zotarolimus-eluting stents from multicenter registry were evaluated by gender. The primary outcome was major adverse cardiac events, composite of cardiac death, myocardial infarction and target lesion revascularization at 1 year.. Of 2,840 patients, 855 (30.1%) were women. Comparatively, women were older; more frequently had diabetes, hypertension, and dyslipidemia; less frequently women were current smokers, had previous myocardial infarctions and previous PCIs; were more likely to have culprit lesions in left anterior descending coronary artery; and underwent more multilesion PCIs. After adjustment for baseline differences, women were still at lower risk of major adverse cardiac events (38 [4.4%] versus 137 [6.9%], adjusted hazard ratio [HR]: 0.52, 95% confidence interval [CI]: 0.30-0.89, P = 0.018), mainly driven by target lesion revascularization (24 [2.8%] versus 106 [5.3%], adjusted HR: 0.41, 95% CI: 0.24-0.70, P = 0.001) at 1 year, although rates of cardiac death, myocardial infarction and stent thrombosis were similar between genders. These results were consistent after propensity score-matched population analysis (for major adverse cardiac events, adjusted HR: 0.36, 95% CI: 0.18-0.69, P = 0.012; for target lesion revascularization, adjusted HR: 0.32, 95% CI: 0.15-0.69, P = 0.004) and were also constant among various high-risk subgroups.. Despite greater baseline clinical and angiographic risk, the use of the zotarolimus-eluting stent is associated with favorable outcomes among Asian women treated with PCI.

Topics: Aged; Asian People; Cardiovascular Diseases; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Registries; Reproducibility of Results; Republic of Korea; Risk Factors; Sex Factors; Sirolimus; Survival Rate

To evaluate the long-term follow-up of drug-eluting stents (DES) in the treatment of unprotected left main coronary artery (ULMCA).. One hundred and forty-eight patients (mean age 71 +/- 10 years) with ULMCA stenoses underwent percutaneous coronary intervention (PCI) with DES. Mean ejection fraction (EF) was 63 +/- 13% and distal ULMCA was involved in 63.5% of cases. In-hospital outcome showed one intra-procedural death, no stent thrombosis and 2% non Q-wave myocardial infarction (MI). Clinical follow-up was available in all patients (874 +/- 382 days): 10.1% of them had died, 8.8% had target lesion revascularisation (TLR) and 4.1% experienced MI. Major adverse cardiac events (MACE) occurred in 20.3%. Mortality predictors were EF < or = 55% (OR 3.6, 95%-C.I. 1.3-10.1, p = 0.016) and EuroSCORE > or = 6 (OR 3.9, 95%-CI 1.1-14.1, p = 0.037). TLR predictors were distal lesion (OR 8.5, 95%-CI 1.1-15, p = 0.041) and age < 64 years (OR 3.1, 95%-CI 1-9, p = 0.042). MACE predictor was EF < or = 55% (OR 2.4, 95%-CI 1.1-5.2, p = 0.027).. ULMCA stenting with DES is safe, with favourable in-hospital outcome. Long-term results are acceptable with a mortality rate of 10%, a TLR rate of 9%, and a MACE rate of 20%. Low EF and high EuroSCORE predict mortality, while younger age and distal lesions predict TLR. Low EF also predicts MACE.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Follow-Up Studies; Hospital Mortality; Humans; Kaplan-Meier Estimate; Middle Aged; Odds Ratio; Paclitaxel; Proportional Hazards Models; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke Volume; Time Factors; Treatment Outcome