Hendrik M. Nathoe

First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes

OBJECTIVES The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI). BACKGROUND Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis. METHODS In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed. RESULTS Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C. CONCLUSIONS In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).

Randomized Comparison Between Stenting and Off-Pump Bypass Surgery in Patients Referred for Angioplasty

Background—Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery. Methods and Results—Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P =0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P =0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P <0.01). Stenting reduced overall costs by

A multicenter randomized comparison of drug‐eluting balloon plus bare‐metal stent versus bare‐metal stent versus drug‐eluting stent in bifurcation lesions treated with a single‐stenting technique: Six‐month angiographic and 12‐month clinical results of the drug‐eluting balloon in bifurcations trial

2933 (26.2%) per patient (

Coronary collaterals improve prognosis in patients with ischemic heart disease.

8276 versus

Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study.

11 209; P <0.01). Stenting was more cost-effective in 95% of the bootstrap estimates. Conclusions—At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.

Inflammation in new-onset atrial fibrillation after cardiac surgery: a systematic review.

Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug‐eluting stents (DES). Paclitaxel drug‐eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T‐stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T‐stenting technique with a DEB plus bare‐metal stent (BMS) versus BMS versus paclitaxel DES.

The Octopus Study: Rationale and Design of Two Randomized Trials on Medical Effectiveness, Safety, and Cost-Effectiveness of Bypass Surgery on the Beating Heart

BACKGROUND The recruitment of coronary collateral vessels results from an endogenous adaptation to ischemic heart disease (IHD). Presence of collaterals may exert protection at the time of acute or chronic obstructive coronary disease. The protective role of collaterals in patients with extensive coronary artery disease however, has been disputed. We examined the effects of coronary collateral circulation on cardiovascular outcomes, with an emphasis on clinical prognostic value and on a putative role of IHD burden. METHODS Data analyzed were obtained in the REGRESS study, involving 879 male participants undergoing coronary angiography and being followed for 24 months. Presence of coronary collaterals spontaneously visible on angiography was assessed. Events included: myocardial infarction (MI), coronary heart disease death and percutaneous or surgical coronary intervention. Estimates of relative risks of outcome events were calculated using proportional hazard analysis, with adjustments for confounding factors and stratification for initial revascularization strategy and factors reflecting extent of IHD burden. RESULTS Event-free survival after two years was 84% in patients without collaterals, and 92% in patients with collaterals (p=0.0020). The crude HR was 0.48 (95% CI: 0.30-0.77), and 0.38 (0.23-0.65) after adjustment for confounders and cardiovascular risk factors. The protective effect of coronary collaterals was not modified by the extent of IHD burden (interaction p=0.99). CONCLUSION The angiographical presence of coronary collaterals is a clinical predictor of cardiovascular prognosis. Collaterals exert a protective effect on outcome in a broad spectrum of patients. Our data suggest that this protective effect is independent of disease burden, and remains present in patients with extensive IHD.

Role of Coronary Collaterals in Off-Pump and On-Pump Coronary Bypass Surgery

BACKGROUND It is uncertain whether a diagnostic strategy supplemented by early coronary computed tomography angiography (CCTA) is superior to contemporary standard optimal care (SOC) encompassing high-sensitivity troponin assays (hs-troponins) for patients suspected of acute coronary syndrome (ACS) in the emergency department (ED). OBJECTIVES This study assessed whether a diagnostic strategy supplemented by early CCTA improves clinical effectiveness compared with contemporary SOC. METHODS In a prospective, open-label, multicenter, randomized trial, we enrolled patients presenting with symptoms suggestive of an ACS at the ED of 5 community and 2 university hospitals in the Netherlands. Exclusion criteria included the need for urgent cardiac catheterization and history of ACS or coronary revascularization. The primary endpoint was the number of patients identified with significant coronary artery disease requiring revascularization within 30 days. RESULTS The study population consisted of 500 patients, of whom 236 (47%) were women (mean age 54 ± 10 years). There was no difference in the primary endpoint (22 [9%] patients underwent coronary revascularization within 30 days in the CCTA group and 17 [7%] in the SOC group [p = 0.40]). Discharge from the ED was not more frequent after CCTA (65% vs. 59%, p = 0.16), and length of stay was similar (6.3 h in both groups; p = 0.80). The CCTA group had lower direct medical costs (€337 vs. €511, p < 0.01) and less outpatient testing after the index ED visit (10 [4%] vs. 26 [10%], p < 0.01). There was no difference in incidence of undetected ACS. CONCLUSIONS CCTA, applied early in the work-up of suspected ACS, is safe and associated with less outpatient testing and lower costs. However, in the era of hs-troponins, CCTA does not identify more patients with significant CAD requiring coronary revascularization, shorten hospital stay, or allow for more direct discharge from the ED. (Better Evaluation of Acute Chest Pain with Computed Tomography Angiography [BEACON]; NCT01413282).

Effects of Dexamethasone on Cognitive Decline after Cardiac Surgery A Randomized Clinical Trial

Postoperative new‐onset atrial fibrillation (PNAF) is the most common complication following cardiac surgery. The pathogenesis of PNAF is multifactorial. The concept of the postoperative inflammatory response, as a potential underlying mechanism has been extensively studied. This review aims to provide a comprehensive summary of literature relevant to the association between the inflammatory response following cardiac surgery and PNAF.

The combined use of aspirin, a statin, and blood pressure-lowering agents (polypill components) and the risk of vascular morbidity and mortality in patients with coronary artery disease

The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609