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Kenneth Tandjung,
Hanim Sen,
Ming Kai Lam,
Mounir W Z Basalus,
J Hans W Louwerenburg,
Martin G Stoel,
K Gert van Houwelingen,
Frits H A F de Man, Gerard C M Linssen,
Salah A M Saïd,
Mark B Nienhuis,
Marije M Löwik,
Patrick M J Verhorst,
Job van der Palen,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: OBJECTIVES: The aim of this study was to assess safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) and Xience V everolimus-eluting stents (EES) following strict discontinuation of dual anti-platelet therapy (DAPT) after 12 months. BACKGROUND: Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents (DES). METHODS: The randomized TWENTE (the real-world endeavor Resolute versus Xience V drug-eluting stent study in Twente) is an investigator-initiated study performed in a population with many complex patients and lesions, and only limited exclusion criteria. Patients were 1:1 randomly assigned to ZES (n=697) or EES (n=694). RESULTS: Two-year follow-up information on all patients were available. The rate of DAPT continuation beyond 12 months was very low (5.4%). The primary endpoint target-vessel failure (TVF), a composite of cardiac death, target-vessel-related myocardial infarction, and target-vessel revascularization did not differ between ZES and EES (10.8% vs. 11.6, p=0.65), despite fewer target-lesion revascularizations in EES (2.6% vs. 4.9%, p=0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p=0.75). Two-year definite-or-probable stent thrombosis rates were 1.2% and 1.4% (p=0.63), respectively. Very late definite-or-probable stent thrombosis occurred only in 2 patients of each study arm (0.3% vs. 0.3%, p=1.00). CONCLUSION: After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for DES. http://www.clinicaltrials.gov. Unique identifier: NCT01066650.
Journal of the American College of Cardiology 04/2013; · 14.16 Impact Factor
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Kenneth Tandjung,
Mounir W Z Basalus,
Hanim Sen,
Martin G Stoel,
K Gert van Houwelingen,
J Hans W Louwerenburg,
Frits H A F de Man, Gerard C M Linssen,
Salah A M Saïd,
Miep A W J Kleijne,
Job van der Palen,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND: Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE - a prospective, randomised, comparative DES trial - 'real-world' patients were stratified for gender before randomization for Resolute or Xience V stents. METHODS: Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically-indicated target vessel revascularization) after 1 year was the predefined endpoint. RESULTS: Among 1391 patients, 382 (27.5%) women were randomized to Resolute (n=192) and Xience V (n=190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9% vs. 8.4%; adjusted OR: 0.95, 95%-CI: 0.41-2.20, p=0.91) and a patient-oriented composite endpoint (13.0% vs. 12.1%, p=0.79) did not differ significantly between women in both arms. Women were older than men (p<0.01) and had more often diabetes mellitus (26.4% vs. 19.8%, p=0.01) and hypertension (63.6% vs. 52.5%, p<0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95%-CI: 0.73-1.92, p=0.50). CONCLUSION: This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute and Xience V treated females. © 2013 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 01/2013; · 2.29 Impact Factor
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Kenneth Tandjung,
K Gert van Houwelingen,
Hanneke Jansen,
Mounir W Z Basalus,
Hanim Sen,
Marije M Löwik,
Martin G Stoel,
J Hans W Louwerenburg,
Frits H A F de Man, Gerard C M Linssen,
Rogier Nijhuis,
Mark B Nienhuis,
Job van der Palen,
Ronald P Stolk,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: In patients without a history of diabetes mellitus, increased levels of glycated hemoglobin (HbA1c) are associated with higher cardiovascular risk. The relation between undetected diabetes and clinical outcome after percutaneous coronary intervention is unknown. To investigate whether these patients may have an increased risk of periprocedural myocardial infarction (PMI), the most frequent adverse event after percutaneous coronary intervention, we assessed patients of the TWENTE trial (a randomized, controlled, second-generation drug-eluting stent trial) in whom HbA1c data were available. Patients were classified as known diabetics or patients without a history of diabetes who were subdivided into undetected diabetics (HbA1c ≥6.5%) and nondiabetics (HbA1c <6.5%). Systematic measurement of cardiac biomarkers and electrocardiographic assessment were performed. One-year clinical outcome was also compared. Of 626 patients, 44 (7%) were undetected diabetics, 181 (29%) were known diabetics, and 401 (64%) were nondiabetics. In undetected diabetics the PMI rate was higher than in nondiabetics (13.6% vs 6.1%, p = 0.01) and known diabetics (13.6% vs 3.7%, p = 0.11). Multivariate analysis adjusting for covariates confirmed a significantly higher PMI risk in undetected diabetics compared to nondiabetics (odds ratio 6.13, 95% confidence interval 2.07 to 18.13, p = 0.001) and known diabetics (odds ratio 3.73, 95% confidence interval 1.17 to 11.89, p = 0.03). After 1 year, target vessel MI rate was significantly higher in undetected diabetics (p = 0.02) than in nondiabetics, which was related mainly to differences in PMI. Target vessel failure was numerically larger in unknown diabetics than in nondiabetics, but this difference did not reach statistical significance (13.6% vs 8.0%, p = 0.25). In conclusion, undetected diabetics were shown to have an increased risk of PMI.
The American journal of cardiology 08/2012; · 3.58 Impact Factor
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Hanim Sen,
Kenneth Tandjung,
Mounir W Z Basalus,
Marije M Löwik,
Gert K van Houwelingen,
Martin G Stoel,
Hans W Louwerenburg,
Frits H A F de Man, Gerard C M Linssen,
Rogier Nijhuis,
Mark B Nienhuis,
Patrick M J Verhorst,
Job van der Palen,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome. Methods and results: Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99). Conclusions: Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2012; 8(6):664-71. · 3.29 Impact Factor
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Kenneth Tandjung,
Mounir W Z Basalus,
Hanim Sen,
Gillian A J Jessurun,
Peter W Danse,
Martin Stoel, Gerard C M Linssen,
Anita Derks,
Ton T van Loenhout,
Mark B Nienhuis,
Raymond W M Hautvast,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.
DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.
DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.
American heart journal 04/2012; 163(4):557-62. · 4.65 Impact Factor
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Clemens von Birgelen,
Mounir W Z Basalus,
Kenneth Tandjung,
K Gert van Houwelingen,
Martin G Stoel,
J Hans W Louwerenburg, Gerard C M Linssen,
Salah A M Saïd,
Miep A W J Kleijne,
Hanim Sen,
Marije M Löwik,
Job van der Palen,
Patrick M J Verhorst,
Frits H A F de Man
[show abstract]
[hide abstract]
ABSTRACT: The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.
Only 1 randomized trial previously compared these stents.
This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.
Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p(noninferiority) = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.
Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650).
Journal of the American College of Cardiology 02/2012; 59(15):1350-61. · 14.16 Impact Factor
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Kenneth Tandjung,
Mounir W Z Basalus,
Esther Muurman,
Hans W Louwerenburg,
K Gert van Houwelingen,
Martin G Stoel,
Frits H A F de Man,
Hanneke Jansen,
Jennifer Huisman, Gerard C M Linssen,
Herman T Droste,
Mark B Nienhuis,
Clemens von Birgelen
[show abstract]
[hide abstract]
ABSTRACT: Background: First- and second-generation drug-eluting stents (DES) differ in coating materials, which may influence the incidence of periprocedural myocardial infarction (PMI). Objective: To compare the incidence of PMI between first- and second-generation DES, using the current Academic Research Consortium (ARC) definition of PMI. Methods: We assessed 800 patients treated with first- (Taxus Liberté or Endeavor) or second-generation DES (Xience V or Resolute). Each DES group consisted of 200 consecutive patients, who were treated during the transition from first- to second-generation DES. Routine peri-interventional assessment of cardiac biomarkers was performed to compare the incidence of PMI between DES groups according to the updated definition by the ARC: 2x upper reference limit of creatine kinase (CK), confirmed by CK-MB elevation. Results: In 800 patients, a total of 1,522 DES (363 Taxus; 385 Endeavor; 382 Xience V; 392 Resolute) were implanted to treat 1,232 lesions. Patient characteristics did not differ between groups. In patients receiving second-generation DES, more multivessel percutaneous coronary interventions were performed (P = 0.01). The overall incidence of PMI was 4.75%. Between first- and second-generation DES, there was no significant difference in PMI (5.5% vs. 4.0%; P = 0.29). In a multivariate analysis, only the total number of stents implanted (P < 0.001) and presentation with acute coronary syndrome (P = 0.02) were independent predictors of PMI. Conclusion: Using the revised ARC definition, we found no significant difference in PMI between first- and second-generation DES. Overall, PMI occurred in 4.75%, which is 58% lower than with use of the historical PMI definition. © 2011 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 11/2011; 80(4):524-30. · 2.29 Impact Factor
