Michael Maeng - Academia.edu (original) (raw)

Papers by Michael Maeng

Research paper thumbnail of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation Post-PCI

Journal of the American College of Cardiology, 2019

Time in Therapeutic Range Time in therapeutic range (TTR) predicts risk of thromboembolic and ble... more Time in Therapeutic Range Time in therapeutic range (TTR) predicts risk of thromboembolic and bleeding events in patients on vitamin K antagonists (VKAs). Guidelines recommend maintaining the international normalized ratio (INR) between 2.0 to 3.0 for an average TTR $70% to prevent stroke and minimize bleeds in patients with atrial fibrillation (AF) (1). Introducing direct oral anticoagulants (DOACs) changed the landscape of stroke prevention, given their relative efficacy, safety, and convenience versus VKAs. While data suggest that differences between VKAs and DOACs are modest where TTR is >70% (2), data are limited

Research paper thumbnail of TCT-792 Everolimus-eluting versus biolimus-eluting stent implantation in unselected patients with and without diabetes: a SORT OUT VIII substudy

Journal of the American College of Cardiology, 2018

2.08% in non-diabetic patients with p¼0.139 at 1-year clinical follow-up. The incidences of ST we... more 2.08% in non-diabetic patients with p¼0.139 at 1-year clinical follow-up. The incidences of ST were comparable between DM and non-DM cohort without any significant difference reported (0.90% vs. 0.47%, p¼0.260). We further stratified the DM cohort in insulin dependent DM (138 patients) and non-insulin dependent DM (721 patients) to investigate the impact of insulin dependence in patients with DM. One-year follow-up was completed in 87.78% and 91.40% for IDDM and NIDDM cohort respectively. The rates of MACE were (5.12% vs. 2.73%, p¼0.239) for IDDM and NIDDM cohort respectively at 1-year. There was no significant difference between both cohorts. CONCLUSION This study revealed favourable clinical safety and performance of ABLUMINUS DES which treats the whole diseased area in diabetic patients with its unique fusion coating technology by reducing the rates of events to 1 year follow up.

Research paper thumbnail of Everolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus

The American Journal of Cardiology, 2019

Diabetes mellitus is associated with a higher risk of target lesion revascularization (TLR) after... more Diabetes mellitus is associated with a higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, MA, USA) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore). In total, 2,764 patients were randomized to stent implantation with EES (n=1,385, diabetes: n=250) or the BES (n=1,379, diabetes: n=262), stratified by sex and diabetes. The primary endpoint, target lesion failure (TLF), was a composite of cardiac death, target-lesion myocardial infarction, or TLR at 12 months. Secondary endpoints included individual components of TLF, all-cause death, and stent thrombosis. TLF was 2.1% lower in the EES vs the BES groups in patients with diabetes (3.6% vs 5.7%; RR 0.61, 95% confidence interval [CI] 0.27-1.41) and similar in patients without diabetes (4.1% vs 4.0%; RR 0.99, 95% CI 0.66-1.51). Among patients with diabetes, the point estimates of the individual components of TLF also favored the EES but confidence intervals were wide. No interaction between stent type and presence of diabetes was found. The current subgroup analysis found that a thin-strut EES as compared to a thicker-strut BES had a numerically lower TLF rate among patients with diabetes, but the subgroup analysis was underpowered for definite conclusions.

Research paper thumbnail of The Western Denmark Heart Registry

Journal of the American College of Cardiology, 2018

The WDHR (Western Denmark Heart Registry) is a seminational, multicenter-based registry with long... more The WDHR (Western Denmark Heart Registry) is a seminational, multicenter-based registry with longitudinal registration of detailed patient and procedure data since 1999. The registry includes as of January 1, 2017 approximately 240,000 coronary angiographies, 90,000 percutaneous coronary interventions, 60,000 cardiac computed tomographies, 40,000 cardiac operations, and 2,000 transcatheter aortic valve replacements. Positron emission tomography/ computed tomography, single-photon emission computed tomography, and magnetic resonance imaging are soon to be added. Each procedure is registered with 50 to 200 administrative, patient, and procedure variables. Lesion data are also registered for percutaneous coronary intervention, and cardiac surgeries also include variables for EuroSCORE, anesthesia, perfusion, and intensive care. The registry has high completeness and accuracy. The Danish registry infrastructure allows for complete follow-up for medical events and mortality, which greatly enhances the research potential of the data. This review describes why the WDHR is a unique data resource and how it continues to influence cardiovascular patient care.

Research paper thumbnail of Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation

The New England journal of medicine, Oct 27, 2017

Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standa... more Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding. Methods In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also ...

Research paper thumbnail of Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents: the SORT-OUT VII optical coherence tomography study

European heart journal cardiovascular Imaging, Jan 28, 2017

To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (D... more To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 µm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up. This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-...

Research paper thumbnail of TCT-261 Impact of Diabetes on Clinical Outcomes after Revascularization with Sirolimus-eluting and Birolimus-Eluting Stents with biodegradable polymer. From the SORT OUT VII Trial

Journal of the American College of Cardiology, 2016

Research paper thumbnail of Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis

Scientific reports, Jan 14, 2016

In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatel... more In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41-1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14-7.09, P = >0.99. Major bleeding occurred in 3 pat...

Research paper thumbnail of Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy

Endoscopy International Open, 2016

Research paper thumbnail of Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial

Journal of the American College of Cardiology, Jan 28, 2015

Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation r... more Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel. Such triple therapy confers an elevated bleeding risk, and its optimal duration is not known. The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC. In this randomized, open-label trial, we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013. A total of 614 patients receiving concomitant aspirin and OAC were randomized to either 6-week clopidogrel therapy (n = 307) or 6-month clopidogrel therapy (n = 307). The primary endpoint was a composite of death, myocardial infarction (MI), definite stent thrombosis, stroke, or Thrombolysis In Myocardial Infarction (...

Research paper thumbnail of Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

Circulation. Cardiovascular interventions, 2008

The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous cor... more The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjus...

Research paper thumbnail of Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study

BMC cardiovascular disorders, Jan 13, 2014

The impact of adherence to the recommended duration of dual antiplatelet therapy after first gene... more The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE ra...

Research paper thumbnail of ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting

European Heart Journal, 2015

to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.6... more to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.66, 95% CI: 0.40-6.96, P ¼ 0.49. Thrombolysis in myocardial infarction major bleeding was observed in 4 patients (0.2%) assigned to 6 months clopidogrel and 5 patients (0.3%) assigned to 12 months; HR 0.80, 95% CI: 0.21-2.98, P ¼ 0.74. Conclusions In the present trial, characterized by low event rates, we did not observe a significant difference in net clinical outcome between 6 and 12 months of clopidogrel therapy after DES implantation. However, the results of the trial must be considered in view of its premature termination and lower than expected event rates. The trial is registered with ClinicalTrials.gov, Identifier: NCT00661206.

Research paper thumbnail of Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial

JACC. Cardiovascular interventions, 2014

The study sought to compare the risk of late outcome with a focus on very late definite stent thr... more The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12)....

Research paper thumbnail of Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

The Lancet, 2013

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluti... more Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V) a randomised non-inferiority trial

Research paper thumbnail of 2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents

Journal of the American College of Cardiology, 2009

This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES),... more This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). Background Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. Results The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12-to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. Conclusions During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.

Research paper thumbnail of TCT-347 Clinical Outcome Of Biolimus-Eluting Versus Sirolimus-Eluting Coronary Stent Implantation In Patients With And Without Diabetes Mellitus: A SORT OUT V Substudy

Journal of the American College of Cardiology, 2012

Background: The purpose of this study was to assess the impact of body mass index (BMI) and diabe... more Background: The purpose of this study was to assess the impact of body mass index (BMI) and diabetes mellitus (DM) on angiographic outcomes in patients treated with different drug-eluting stents. Methods: From November 2002 to March 2011, 8567 de novo coronary lesions were treated with drug-eluting stent. Dialysis patients were excluded. Of 8567 lesions, 1934 lesions were treated with everolimus-eluting stent (EES), 1215 with paclitaxel-eluting stent (PES), and 5418 with sirolimus-eluting stent (SES). Angiographic follow-up was routinely performed at 8 months after successful procedure. The follow-up rate was 81%. The patients were classified as underweight (BMI Ͼ20), normal weight (BMI Ն20 and Ͼ25), and overweight (BMI Ն25). The patients were divided into three groups according to implanted stent type: EES, PES, and SES. Of all patients, 42% were with DM, of whom 11% were insulin-dependent. The rates of DM and insulin treatment were similar in all groups. Angiographic outcomes were compared between each group. Results: Independent predictors of binary restenosis differed in each group. In the SES group, they were BMI (depression of 5 kg/m2), DM, bifurcation, chronic total obstruction (CTO), stent size 2.5 mm, and lesion length Ն20 mm. In the PES group, they were BMI (depression of 5 kg/m2), DM, and stent size 2.5 mm. In the EES group, they were CTO, stent size 2.5 mm, and lesion length Ն20 mm. The figure shows odds ratio of BMI (depression of 5 kg/m2) and DM between each group. Conclusions: BMI and DM affect angiographic outcomes in patients treated with SES and PES but not those in patients treated with EES.

Research paper thumbnail of TCT-12 Short Versus Long-Term Clinical Outcomes In A Randomised Comparison Of Zotarolimus- and Sirolimus-Eluting Coronary Stents

Journal of the American College of Cardiology, 2013

Background: The primary endpoint of head-to-head comparisons of coronary drugeluting stents is tr... more Background: The primary endpoint of head-to-head comparisons of coronary drugeluting stents is traditionally assessed after 9-12 months. However, the optimal time point for assessment of the primary endpoint remains unsettled. Methods: We randomised 2,332 patients to zotarolimus-eluting EndeavorÔ stent (E-ZES; n¼1,162) or sirolimus-eluting CypherÔ stent (C-SES; n¼1,170) implantation. Endpoints included a composite of cardiac death, myocardial infarction or target vessel revascularization (MACE) and definite stent thrombosis. This trial is registered with ClinicalTrials.gov, number NCT00660478. Results: At 5-year follow-up, MACE rates were similar in patients treated with E-ZES and C-SES (197 [17%] vs. 182 [16%]; odds ratio [OR] ¼1.10, 95% confidence intervals [CI]: 0.88-1.37; p¼0.40). This finding reflected oppositely directed MACE rates within year 1 (93 [8%] vs. 46 [4%]; OR¼2.13, 95% CI: 1.48-3.07; p<0.001) and year >1 through 5 (104 [10%] vs. 136 [12%]; OR¼0.78, 95% CI: 0.59-1.02; p¼0.071). Definite stent thrombosis was more frequent after E-ZES than C-SES implantation at 1-year (13 [1.1%] vs. 4 [0.3%]; OR¼3.34, 95% CI: 1.08-10.3; p¼0.036) while the opposite was found for year >1 through 5 (1 [0.1%] vs. 21 [1.8%]; OR¼0.05, 95% CI: 0.01-0.35; p¼0.003). In the E-ZES and C-SES group, 26 of 88 (30%) and 54 of 70 (77%) of target lesion revascularisations occurred between 1 and 5 years, respectively. Conclusions: A traditional 1-year primary endpoint is insufficient to predict 5-year clinical outcome in patients treated with coronary drug-eluting stent implantation. Long-term clinical data from routine clinical care populations should be a prerequisite for unrestricted use of new coronary drug-eluting stents.

Research paper thumbnail of Long-Term Clinical Outcomes of Everolimus-Eluting Stents Versus Sirolimus-Eluting Stents in Patients with Coronary Artery Disease: Sort Out IV 4-YEAR

Journal of the American College of Cardiology, 2014

Background: There is limited head-to-head data on long-term safety and efficacy outcomes for ever... more Background: There is limited head-to-head data on long-term safety and efficacy outcomes for everolimus-eluting stent (EES) and sirolimuseluting stent (SES). methods: In the SORT OUT (Scandinavian Organization for Randomized Trials with Clinical Outcome) IV trial we prospectively randomized 2,774 patients. The SORT OUT IV trial demonstrated non-inferiority of the EES to the SES at 9 months. Follow-up through 4 years was complete in 2,770 (99.9%)). The 4-year pre-specified endpoint was a composite of safety and efficacy (major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization and definite stent thrombosis). results: At 4-year EES was superior to SES for the composite end point which occurred in 11.8% in the EES group and in 14.7% in the SES group (hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.65-0.98). Cardiac death (EES 3.8% vs. SES 3.9% (HR 0.98, 95% CI 0.67-1.43)) did not differ between the two groups, whereas target lesion revascularization (EES 4.2% vs. SES 6.2%, (HR 0.68, 95% CI 0.49-0.95)), myocardial infarction (EES 2.9% vs. SES 4.3%, (HR 0.67, 95% CI 0.45-1.00)) and definite stent thrombosis (EES 0.3% vs. SES 2.0%, (HR 0.15, 95% CI 0.05-0.45)) were lower in the EES group. Conclusions: At 4-year follow-up, MACE rate was significantly lower in EES treated patients compared to SES. A better safety and efficacy was found with the EES with reduced risk of myocardial infarction, definite stent thrombosis and target lesion revascularization.

Research paper thumbnail of 3-Year Clinical Outcomes in the Randomized SORT OUT III Superiority Trial Comparing Zotarolimus- and Sirolimus-Eluting Coronary Stents

JACC: Cardiovascular Interventions, 2012

Background The long-term clinical outcome in patients treated with ZES in comparison with SES is ... more Background The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear. Methods The authors randomized 2,332 patients to ZES (n ϭ 1,162) or SES (n ϭ 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis. Results At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p ϭ 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p ϭ 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p ϭ 0.0005). Conclusions Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drugeluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478) (

Research paper thumbnail of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation Post-PCI

Journal of the American College of Cardiology, 2019

Time in Therapeutic Range Time in therapeutic range (TTR) predicts risk of thromboembolic and ble... more Time in Therapeutic Range Time in therapeutic range (TTR) predicts risk of thromboembolic and bleeding events in patients on vitamin K antagonists (VKAs). Guidelines recommend maintaining the international normalized ratio (INR) between 2.0 to 3.0 for an average TTR $70% to prevent stroke and minimize bleeds in patients with atrial fibrillation (AF) (1). Introducing direct oral anticoagulants (DOACs) changed the landscape of stroke prevention, given their relative efficacy, safety, and convenience versus VKAs. While data suggest that differences between VKAs and DOACs are modest where TTR is >70% (2), data are limited

Research paper thumbnail of TCT-792 Everolimus-eluting versus biolimus-eluting stent implantation in unselected patients with and without diabetes: a SORT OUT VIII substudy

Journal of the American College of Cardiology, 2018

2.08% in non-diabetic patients with p¼0.139 at 1-year clinical follow-up. The incidences of ST we... more 2.08% in non-diabetic patients with p¼0.139 at 1-year clinical follow-up. The incidences of ST were comparable between DM and non-DM cohort without any significant difference reported (0.90% vs. 0.47%, p¼0.260). We further stratified the DM cohort in insulin dependent DM (138 patients) and non-insulin dependent DM (721 patients) to investigate the impact of insulin dependence in patients with DM. One-year follow-up was completed in 87.78% and 91.40% for IDDM and NIDDM cohort respectively. The rates of MACE were (5.12% vs. 2.73%, p¼0.239) for IDDM and NIDDM cohort respectively at 1-year. There was no significant difference between both cohorts. CONCLUSION This study revealed favourable clinical safety and performance of ABLUMINUS DES which treats the whole diseased area in diabetic patients with its unique fusion coating technology by reducing the rates of events to 1 year follow up.

Research paper thumbnail of Everolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus

The American Journal of Cardiology, 2019

Diabetes mellitus is associated with a higher risk of target lesion revascularization (TLR) after... more Diabetes mellitus is associated with a higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, MA, USA) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore). In total, 2,764 patients were randomized to stent implantation with EES (n=1,385, diabetes: n=250) or the BES (n=1,379, diabetes: n=262), stratified by sex and diabetes. The primary endpoint, target lesion failure (TLF), was a composite of cardiac death, target-lesion myocardial infarction, or TLR at 12 months. Secondary endpoints included individual components of TLF, all-cause death, and stent thrombosis. TLF was 2.1% lower in the EES vs the BES groups in patients with diabetes (3.6% vs 5.7%; RR 0.61, 95% confidence interval [CI] 0.27-1.41) and similar in patients without diabetes (4.1% vs 4.0%; RR 0.99, 95% CI 0.66-1.51). Among patients with diabetes, the point estimates of the individual components of TLF also favored the EES but confidence intervals were wide. No interaction between stent type and presence of diabetes was found. The current subgroup analysis found that a thin-strut EES as compared to a thicker-strut BES had a numerically lower TLF rate among patients with diabetes, but the subgroup analysis was underpowered for definite conclusions.

Research paper thumbnail of The Western Denmark Heart Registry

Journal of the American College of Cardiology, 2018

The WDHR (Western Denmark Heart Registry) is a seminational, multicenter-based registry with long... more The WDHR (Western Denmark Heart Registry) is a seminational, multicenter-based registry with longitudinal registration of detailed patient and procedure data since 1999. The registry includes as of January 1, 2017 approximately 240,000 coronary angiographies, 90,000 percutaneous coronary interventions, 60,000 cardiac computed tomographies, 40,000 cardiac operations, and 2,000 transcatheter aortic valve replacements. Positron emission tomography/ computed tomography, single-photon emission computed tomography, and magnetic resonance imaging are soon to be added. Each procedure is registered with 50 to 200 administrative, patient, and procedure variables. Lesion data are also registered for percutaneous coronary intervention, and cardiac surgeries also include variables for EuroSCORE, anesthesia, perfusion, and intensive care. The registry has high completeness and accuracy. The Danish registry infrastructure allows for complete follow-up for medical events and mortality, which greatly enhances the research potential of the data. This review describes why the WDHR is a unique data resource and how it continues to influence cardiovascular patient care.

Research paper thumbnail of Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation

The New England journal of medicine, Oct 27, 2017

Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standa... more Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding. Methods In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also ...

Research paper thumbnail of Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents: the SORT-OUT VII optical coherence tomography study

European heart journal cardiovascular Imaging, Jan 28, 2017

To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (D... more To show non-inferiority of the 67- or 87 µm thick, sirolimus-eluting Orsiro drug eluting stent (DES) to the 122 µm thick, biolimus-eluting Nobori DES regarding size of vessel lumen outside the stent at 13-month follow-up. This study was a substudy to the SORT-OUT VII trial, a prospective, 1:1-randomized, comparison of the two stents in patients with stable coronary artery disease or acute coronary syndrome. Optical coherence tomography was acquired after percutaneous coronary intervention and at 13-month follow-up. The substudy was powered to access non-inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-...

Research paper thumbnail of TCT-261 Impact of Diabetes on Clinical Outcomes after Revascularization with Sirolimus-eluting and Birolimus-Eluting Stents with biodegradable polymer. From the SORT OUT VII Trial

Journal of the American College of Cardiology, 2016

Research paper thumbnail of Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis

Scientific reports, Jan 14, 2016

In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatel... more In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41-1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14-7.09, P = >0.99. Major bleeding occurred in 3 pat...

Research paper thumbnail of Gastroscopy-related adverse cardiac events and bleeding complications among patients treated with coronary stents and dual antiplatelet therapy

Endoscopy International Open, 2016

Research paper thumbnail of Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial

Journal of the American College of Cardiology, Jan 28, 2015

Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation r... more Patients receiving oral anticoagulation (OAC) who undergo drug-eluting stent (DES) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel. Such triple therapy confers an elevated bleeding risk, and its optimal duration is not known. The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC. In this randomized, open-label trial, we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013. A total of 614 patients receiving concomitant aspirin and OAC were randomized to either 6-week clopidogrel therapy (n = 307) or 6-month clopidogrel therapy (n = 307). The primary endpoint was a composite of death, myocardial infarction (MI), definite stent thrombosis, stroke, or Thrombolysis In Myocardial Infarction (...

Research paper thumbnail of Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

Circulation. Cardiovascular interventions, 2008

The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous cor... more The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjus...

Research paper thumbnail of Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation: an observational study

BMC cardiovascular disorders, Jan 13, 2014

The impact of adherence to the recommended duration of dual antiplatelet therapy after first gene... more The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. We followed 4,154 patients treated with coronary drug-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. Discontinuation of clopidogrel within the first 3 months after stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE ra...

Research paper thumbnail of ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting

European Heart Journal, 2015

to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.6... more to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.66, 95% CI: 0.40-6.96, P ¼ 0.49. Thrombolysis in myocardial infarction major bleeding was observed in 4 patients (0.2%) assigned to 6 months clopidogrel and 5 patients (0.3%) assigned to 12 months; HR 0.80, 95% CI: 0.21-2.98, P ¼ 0.74. Conclusions In the present trial, characterized by low event rates, we did not observe a significant difference in net clinical outcome between 6 and 12 months of clopidogrel therapy after DES implantation. However, the results of the trial must be considered in view of its premature termination and lower than expected event rates. The trial is registered with ClinicalTrials.gov, Identifier: NCT00661206.

Research paper thumbnail of Three-year outcomes after revascularization with everolimus- and sirolimus-eluting stents from the SORT OUT IV trial

JACC. Cardiovascular interventions, 2014

The study sought to compare the risk of late outcome with a focus on very late definite stent thr... more The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. In the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES. We prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis). At 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12)....

Research paper thumbnail of Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

The Lancet, 2013

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluti... more Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V) a randomised non-inferiority trial

Research paper thumbnail of 2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents

Journal of the American College of Cardiology, 2009

This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES),... more This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). Background Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. Methods A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. Results The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12-to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. Conclusions During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.

Research paper thumbnail of TCT-347 Clinical Outcome Of Biolimus-Eluting Versus Sirolimus-Eluting Coronary Stent Implantation In Patients With And Without Diabetes Mellitus: A SORT OUT V Substudy

Journal of the American College of Cardiology, 2012

Background: The purpose of this study was to assess the impact of body mass index (BMI) and diabe... more Background: The purpose of this study was to assess the impact of body mass index (BMI) and diabetes mellitus (DM) on angiographic outcomes in patients treated with different drug-eluting stents. Methods: From November 2002 to March 2011, 8567 de novo coronary lesions were treated with drug-eluting stent. Dialysis patients were excluded. Of 8567 lesions, 1934 lesions were treated with everolimus-eluting stent (EES), 1215 with paclitaxel-eluting stent (PES), and 5418 with sirolimus-eluting stent (SES). Angiographic follow-up was routinely performed at 8 months after successful procedure. The follow-up rate was 81%. The patients were classified as underweight (BMI Ͼ20), normal weight (BMI Ն20 and Ͼ25), and overweight (BMI Ն25). The patients were divided into three groups according to implanted stent type: EES, PES, and SES. Of all patients, 42% were with DM, of whom 11% were insulin-dependent. The rates of DM and insulin treatment were similar in all groups. Angiographic outcomes were compared between each group. Results: Independent predictors of binary restenosis differed in each group. In the SES group, they were BMI (depression of 5 kg/m2), DM, bifurcation, chronic total obstruction (CTO), stent size 2.5 mm, and lesion length Ն20 mm. In the PES group, they were BMI (depression of 5 kg/m2), DM, and stent size 2.5 mm. In the EES group, they were CTO, stent size 2.5 mm, and lesion length Ն20 mm. The figure shows odds ratio of BMI (depression of 5 kg/m2) and DM between each group. Conclusions: BMI and DM affect angiographic outcomes in patients treated with SES and PES but not those in patients treated with EES.

Research paper thumbnail of TCT-12 Short Versus Long-Term Clinical Outcomes In A Randomised Comparison Of Zotarolimus- and Sirolimus-Eluting Coronary Stents

Journal of the American College of Cardiology, 2013

Background: The primary endpoint of head-to-head comparisons of coronary drugeluting stents is tr... more Background: The primary endpoint of head-to-head comparisons of coronary drugeluting stents is traditionally assessed after 9-12 months. However, the optimal time point for assessment of the primary endpoint remains unsettled. Methods: We randomised 2,332 patients to zotarolimus-eluting EndeavorÔ stent (E-ZES; n¼1,162) or sirolimus-eluting CypherÔ stent (C-SES; n¼1,170) implantation. Endpoints included a composite of cardiac death, myocardial infarction or target vessel revascularization (MACE) and definite stent thrombosis. This trial is registered with ClinicalTrials.gov, number NCT00660478. Results: At 5-year follow-up, MACE rates were similar in patients treated with E-ZES and C-SES (197 [17%] vs. 182 [16%]; odds ratio [OR] ¼1.10, 95% confidence intervals [CI]: 0.88-1.37; p¼0.40). This finding reflected oppositely directed MACE rates within year 1 (93 [8%] vs. 46 [4%]; OR¼2.13, 95% CI: 1.48-3.07; p<0.001) and year >1 through 5 (104 [10%] vs. 136 [12%]; OR¼0.78, 95% CI: 0.59-1.02; p¼0.071). Definite stent thrombosis was more frequent after E-ZES than C-SES implantation at 1-year (13 [1.1%] vs. 4 [0.3%]; OR¼3.34, 95% CI: 1.08-10.3; p¼0.036) while the opposite was found for year >1 through 5 (1 [0.1%] vs. 21 [1.8%]; OR¼0.05, 95% CI: 0.01-0.35; p¼0.003). In the E-ZES and C-SES group, 26 of 88 (30%) and 54 of 70 (77%) of target lesion revascularisations occurred between 1 and 5 years, respectively. Conclusions: A traditional 1-year primary endpoint is insufficient to predict 5-year clinical outcome in patients treated with coronary drug-eluting stent implantation. Long-term clinical data from routine clinical care populations should be a prerequisite for unrestricted use of new coronary drug-eluting stents.

Research paper thumbnail of Long-Term Clinical Outcomes of Everolimus-Eluting Stents Versus Sirolimus-Eluting Stents in Patients with Coronary Artery Disease: Sort Out IV 4-YEAR

Journal of the American College of Cardiology, 2014

Background: There is limited head-to-head data on long-term safety and efficacy outcomes for ever... more Background: There is limited head-to-head data on long-term safety and efficacy outcomes for everolimus-eluting stent (EES) and sirolimuseluting stent (SES). methods: In the SORT OUT (Scandinavian Organization for Randomized Trials with Clinical Outcome) IV trial we prospectively randomized 2,774 patients. The SORT OUT IV trial demonstrated non-inferiority of the EES to the SES at 9 months. Follow-up through 4 years was complete in 2,770 (99.9%)). The 4-year pre-specified endpoint was a composite of safety and efficacy (major adverse cardiac event (MACE): cardiac death, myocardial infarction, target vessel revascularization and definite stent thrombosis). results: At 4-year EES was superior to SES for the composite end point which occurred in 11.8% in the EES group and in 14.7% in the SES group (hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.65-0.98). Cardiac death (EES 3.8% vs. SES 3.9% (HR 0.98, 95% CI 0.67-1.43)) did not differ between the two groups, whereas target lesion revascularization (EES 4.2% vs. SES 6.2%, (HR 0.68, 95% CI 0.49-0.95)), myocardial infarction (EES 2.9% vs. SES 4.3%, (HR 0.67, 95% CI 0.45-1.00)) and definite stent thrombosis (EES 0.3% vs. SES 2.0%, (HR 0.15, 95% CI 0.05-0.45)) were lower in the EES group. Conclusions: At 4-year follow-up, MACE rate was significantly lower in EES treated patients compared to SES. A better safety and efficacy was found with the EES with reduced risk of myocardial infarction, definite stent thrombosis and target lesion revascularization.

Research paper thumbnail of 3-Year Clinical Outcomes in the Randomized SORT OUT III Superiority Trial Comparing Zotarolimus- and Sirolimus-Eluting Coronary Stents

JACC: Cardiovascular Interventions, 2012

Background The long-term clinical outcome in patients treated with ZES in comparison with SES is ... more Background The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear. Methods The authors randomized 2,332 patients to ZES (n ϭ 1,162) or SES (n ϭ 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis. Results At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p ϭ 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p ϭ 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p ϭ 0.0005). Conclusions Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drugeluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478) (