Publications by authors named "Knud Noerregaard Hansen"

15 Publications

  • Page 1 of 1

The risk and prognostic impact of definite stent thrombosis or in-stent restenosis after coronary stent implantation.

EuroIntervention 2012 Sep;8(5):591-8

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI).

Methods And Results: All patients who underwent stent implantation from 2002 to 2005 were identified in the Western Denmark Heart Registry. The hazard ratio (HR) for death associated with stent thrombosis or in-stent restenosis was estimated with a Cox regression analysis with stent thrombosis or in-stent restenosis as time-dependent variables. A total of 12,277 patients were treated with stent implantation. Stent thrombosis was observed in 111 (0.9%) patients and in-stent restenosis in 503 (4.1%) patients within 12 months after the index PCI. Occurrence of stent thrombosis was associated with an increased risk of death (HR=2.71 [95% CI: 1.72-4.27]) compared to cases without stent thrombosis. In-stent restenosis had no substantial impact (HR=1.17 [95% CI: 0.79-1.75]). However, in-stent restenosis presenting as non-ST-segment elevation myocardial infarction (NSTEMI) was associated with a greater mortality risk compared with presentation of in-stent restenosis without myocardial infarction (HR=3.11 [95% CI: 1.08-8.69]; p=0.036).

Conclusions: The occurrence of stent thrombosis and in-stent restenosis presenting with NSTEMI increased the mortality risk threefold whereas in-stent restenosis without myocardial infarction was not associated with an increased mortality risk.
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http://dx.doi.org/10.4244/EIJV8I5A91DOI Listing
September 2012

Outcomes after primary percutaneous coronary intervention in octogenarians and nonagenarians with ST-segment elevation myocardial infarction: from the Western Denmark heart registry.

Catheter Cardiovasc Interv 2013 May 12;81(6):912-9. Epub 2013 Feb 12.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Elderly patients with ST segment elevation myocardial infarction (STEMI) constitute a particular risk group in relation to primary percutaneous coronary intervention (PPCI).

Objective: We examined the proportion of octogenarians and nonagenarians undergoing PPCI in Western Denmark, and their short- and long-term mortality rates.

Methods: From 2002 to 2009 all consecutive patients ≥ 80 years with STEMI treated with PPCI were identified in the population based Western Denmark Heart Registry. Cox regression analysis was used to compute hazard ratios, controlling for potential confounding.

Results: A total of 1,322 elderly (1,213 octogenarians and 109 nonagenarians), corresponding to 11.6% of the total PPCI treated STEMI population were treated with PPCI between 2002 and 2009. The annual proportion of octogenarians referred for PPCI increased from n = 52 (6.2%) in 2002 to n = 172 (11.8%) in 2009 (P < 0.01), while it remained unchanged in nonagenarians: n = 6 (0.6%) in 2002 to n = 13 (0.8%) in 2009 (P = ns). For octogenarians and nonagenarians, 30-day mortality was 17.2% versus 25.8% (log-rank P = 0.028), 1-year mortality was 27.6% versus 32.5% (log-rank P = 0.18) and 5-year mortality 53.6% versus 57.3% (log-rank P = 0.087), respectively. Adjusted 30-day hazard ratio (HR) = 1.59 (95% confidence interval = CI: 1.07-2.36), 1-year HR = 1.34 (CI: 0.95-1.90), and 5-year mortality HR = 1.39 (CI: 1.04-1.85) was higher in nonagenarians compared with octogenarians.

Conclusion: The annual proportion of octogenarians with STEMI treated with PPCI doubled from 2002 to 2009, while the proportion of nonagenarians remained unchanged. Although nonagenarians had the highest short- and long-term mortality, we found the outcome acceptable with a 5-year survival of more than 40% in both groups.
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http://dx.doi.org/10.1002/ccd.24591DOI Listing
May 2013

Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis: from Western Denmark Heart Registry.

Catheter Cardiovasc Interv 2013 Feb 8;81(2):260-5. Epub 2012 Nov 8.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis or restenosis after DES implantation for treatment of restenosis.

Methods: From January 2002 to June 2005, all consecutive patients with restenosis < 12 months after index PCI with DES or BMS implantation, were identified in the population-based Western Denmark Heart Registry. Patients were followed until 24 months after their first restenosis.

Results: A total of 589 lesions were treated for clinically driven restenosis with target lesion revascularization (TLR) within 12 months after the index PCI. Among those, 302 lesions were treated with DES (BMS-restenosis n = 244 and DES-restenosis n = 58). Admission were due to stable angina pectoris (n = 249 (82.4%)), unstable angina pectoris (n = 34 (11.3%)), or non-ST segment elevation myocardial infarction (n = 19 (6.3%)). The clinical indication was not different between patients with BMS restenosis compared to DES restenosis. In the BMS restenosis group, older age, longer lesion, longer stent length, and a higher number of stents used was observed compared to the DES restenosis group. After a first restenosis, clinically driven re-TLR was seen in 26 (8.6%) patients within the following 24 months, stent thrombosis (median duration 155 days, interquartile range (IQR) 9-627 days) was seen in 3 lesions (1.0%), and secondary restenosis (median duration 168 days, IQR 88-266 days) was seen in 23 (7.6%) [DES restenosis group 6.9% vs. BMS restenosis group 7.8%, P = 0.818] lesions.

Conclusion: The clinical presentation did not differ between BMS or DES and most patients present with stable angina pectoris. Risk of stent thrombosis or restenosis was not increased in patients with DES restenosis compared to patients with BMS restenosis treated with DES.
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http://dx.doi.org/10.1002/ccd.24398DOI Listing
February 2013

Comparison of outcomes of patients ≥ 80 years of age having percutaneous coronary intervention according to presentation (stable vs unstable angina pectoris/non-ST-segment elevation myocardial infarction vs ST-segment elevation myocardial infarction).

Am J Cardiol 2011 Nov 3;108(10):1395-400. Epub 2011 Sep 3.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Patients ≥ 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients ≥ 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (≥ 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients ≥ 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time.
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http://dx.doi.org/10.1016/j.amjcard.2011.06.062DOI Listing
November 2011

Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial.

EuroIntervention 2011 Jul;7(3):323-31

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients.

Methods And Results: In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001).

Conclusions: In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.
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http://dx.doi.org/10.4244/EIJV7I3A56DOI Listing
July 2011

Paclitaxel and sirolimus eluting stents versus bare metal stents: long-term risk of stent thrombosis and other outcomes. From the Western Denmark Heart Registry.

EuroIntervention 2010 Apr;5(8):898-905

Department of Cardiology, Odense University Hospital, Denmark.

Aims: Stent thrombosis is a serious complication of percutaneous coronary intervention (PCI). We examined the incidence of stent thrombosis and other outcomes in patients treated with PCI and paclitaxeleluting stents (PES), sirolimus-eluting stents (SES) or bare-metal stents (BMS).

Methods And Results: All patients who underwent PES, SES or BMS implantation from January 2002 to June 2005 were identified in the population-based Western Denmark Heart Registry. All were followed for 36 months. Cox regression analysis was used to estimate relative risk (RR), controlling for covariates. A total of 12,374 patients were treated with stents: 1,298 with PES, 2,202 with SES and 8,847 with BMS. The three-year incidence of definite stent thrombosis was similar in the DES group (1.1%) and in the BMS group (0.7%) (adjusted relative risk [RR]: 1.24; 95% confidence interval [CI]: 0.85-1.81). Very late definite stent thrombosis occurred more frequently in DES-treated patients (adjusted RR: 2.89, 95% CI: 1.48- 5.65). The three-year mortality rate did not differ significantly between the two groups. Target lesion revascularisation (TLR) was lower in DES-treated patients than in BMS-treated patients (adjusted RR: 0.71, 95% CI: 0.63-0.81).

Conclusions: An increased risk of very late definite stent thrombosis was observed in DES-treated patients compared with BMS-treated patients, but a similar mortality was detected. TLR continued to be lower among patients receiving DES.
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http://dx.doi.org/10.4244/DOI Listing
April 2010

Long-term outcomes after percutaneous coronary intervention in patients with and without diabetes mellitus in Western Denmark.

Am J Cardiol 2010 Jun 8;105(11):1513-9. Epub 2010 Apr 8.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Patients with diabetes mellitus have worse outcomes after percutaneous coronary intervention than patients without diabetes mellitus. We compared the risk of stent thrombosis, myocardial infarction, death, and target lesion revascularization in diabetic and nondiabetic patients after implantation of drug-eluting stents or bare metal stents. In the Western Denmark Heart Registry, 12,347 consecutive patients (1,575 with and 10,772 without diabetes) were identified and followed up for 2 years. The 2-year risk of definite stent thrombosis was 0.52% in patients with diabetes mellitus and 0.71% in nondiabetic patients (adjusted relative risk [RR] 0.74, 95% confidence interval [CI] 0.41 to 1.34, p = 0.321). The 2-year risk of myocardial infarction was greater in the diabetic patients (6.9%) than in the nondiabetic patients (3.6%; adjusted RR 1.96, 95% CI 1.58 to 2.43; p <0.001). The all-cause 2-year mortality rate was almost twice as great for the diabetic patients compared to the nondiabetic patients (12.4% vs 6.7%; adjusted RR 1.91, 95% CI 1.63 to 2.23; p <0.001). The 2-year risk of target lesion revascularization was 8.5% in the diabetic patients and 6.8% in the nondiabetic patients (adjusted RR 1.28, 95% CI 1.10 to 1.49; p <0.001). In conclusion, 2 years after drug-eluting stent or bare metal stent implantation, diabetic patients had a greater risk than nondiabetic patients of myocardial infarction and death. Drug-eluting stent treatment reduced the risk of target lesion revascularization compared to bare metal stent treatment, regardless of diabetes status.
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http://dx.doi.org/10.1016/j.amjcard.2010.01.007DOI Listing
June 2010

Outcome in high risk patients with unprotected left main coronary artery stenosis treated with percutaneous coronary intervention.

Catheter Cardiovasc Interv 2010 Jan;75(1):101-8

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objective: We examined mortality, risk of myocardial infarction (MI), and target lesion revascularization (TLR) in high-risk patients with unprotected left main (LM) percutaneous coronary intervention (PCI) in Western Denmark.

Background: PCI of left main coronary artery lesions may be an alternative to coronary artery bypass grafting in high-risk surgical patients.

Methods: From January 2005 to May 2007, all patients who had unprotected LM PCI with stent implantation were identified in the Western Denmark Heart Registry. The indications for PCI were: (1) ST segment elevation MI (STEMI), (2) non-STEMI (NSTEMI) or unstable angina, and (3) stable angina. All patients were followed up for 18 months.

Results: A total of 344 patients were treated with LM PCI (STEMI: 71, NSTEMI/unstable angina: 157, and stable angina: 116). In STEMI patients, the median logistic EuroSCORE was 22.5 (interquartile range 12.5-39.5), in non-STEMI (NSTEMI)/unstable angina patients 13.8 (4.8-23.9), and in stable angina patients 4.8 (2.2-10.4). Mortality after 18 months 38.0, 18.5, and 11.2% (P < 0.001) in patients with STEMI, NSTEMI/unstable angina, and stable angina, respectively. MI after 18 months was 9.9, 6.4, and 6.0% (P = ns), respectively. Four subacute and one late definite stent thrombosis were seen. TLR occurred in 5.6, 4.5, and 6.9% (P = ns) of patients, respectively.

Conclusion: After PCI, patients with STEMI and LM culprit lesion have a high-mortality risk, whereas long-term outcome for patients with NSTEMI and stable angina pectoris is comparable with other high surgical risk patients with unprotected left main lesion. Further, TLR rates and risk of stent thrombosis were low.
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http://dx.doi.org/10.1002/ccd.22205DOI Listing
January 2010

Serial intravascular ultrasound analysis of peri-stent remodeling and proximal and distal edge effects after sirolimus-eluting or paclitaxel-eluting stent implantation in patients with diabetes mellitus.

Am J Cardiol 2009 Apr 4;103(8):1083-8. Epub 2009 Mar 4.

Department of Cardiology, Odense University Hospital, Denmark, USA.

Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Scientific, Maple Grove, Minnesota) stents in diabetic patients. Seventy-four diabetic patients were randomly assigned to Cypher or Taxus stent implantation. Intravascular ultrasound of 5-mm long segments immediately proximal and distal to the stent was performed after the procedure and at the 8-month follow-up. The increase in peri-stent external elastic membrane (EEM) volume was more pronounced in the Taxus group (292.4 +/- 132.6 to 309.5 +/- 146.8 mm(3)) than in the Cypher group (274.4 +/- 137.2 to 275.4 +/- 140.1 mm(3); p = 0.005). Peri-stent plaque volume increased in the Taxus group (152.5 +/- 73.7 to 166.1 +/- 85.1 mm(3)), but was unchanged in the Cypher group (153.5 +/- 75.5 to 151.5 +/- 75.8 mm(3); p = 0.002). In proximal and distal reference segments, mean lumen area decreased within the entire 5-mm edge segment (proximal and distal) because of plaque progression (distal, 5.5 +/- 3.6 to 5.8 +/- 3.7 mm(2); p = 0.097; proximal, 8.1 +/- 2.7 to 8.7 +/- 2.9 mm(2); p = 0.006) without remodeling (change in EEM) in the Taxus group. Conversely, there were no significant changes in reference-segment EEM or plaque areas in the Cypher group. In conclusion, in diabetic patients, Taxus stent implantation was associated with increased (1) peri-stent EEM volume and peri-stent plaque, and (2) stent edge plaque progression accompanied by lumen reduction without remodeling. These findings were not seen in Cypher stents.
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http://dx.doi.org/10.1016/j.amjcard.2008.12.035DOI Listing
April 2009

Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial.

Eur Heart J 2008 Nov 2;29(22):2733-41. Epub 2008 Oct 2.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: Patients with diabetes have increased risk of in-stent restenosis after coronary stent implantation owing to neointimal hyperplasia (NIH). The aim of the study was to evaluate the extent and distribution of NIH with intravascular ultrasound (IVUS) after coronary artery stenting with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients.

Methods And Results: One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared with the Taxus group: median (inter-quartile range) 0.0 (0.0-0.0) vs. 8.0 mm(3) (0.1-33.0), P < 0.001. Per cent NIH volume was also significantly lower in Cypher stents compared with Taxus stents: median (inter-quartile range) 0.0 (0.0-0.0) vs. 7.5% (0.1-27.0), P < 0.001. NIH was covering 5.4% of the stent length in the Cypher stents compared with 46.1% in the Taxus stents (P < 0.001). The incidence of diffuse NIH was significantly higher for Taxus than for Cypher stents (42.9 vs. 3.5%, P < 0.001). Taxus stents had more often NIH at the proximal stent edge compared with Cypher stents (45.1 vs. 7%, P < 0.001) and no Cypher stents had NIH at the distal stent edge compared with 35.5% of the Taxus stents (P < 0.001).

Conclusion: In diabetic patients, the Cypher stent, compared with the Taxus stent, inhibited NIH more effectively and had a more focal NIH pattern including less involvement of the stent edges.
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http://dx.doi.org/10.1093/eurheartj/ehn434DOI Listing
November 2008

Intravascular ultrasound assessment of expansion of the sirolimus-eluting (cypher select) and paclitaxel-eluting (Taxus Express-2) stent in patients with diabetes mellitus.

Am J Cardiol 2008 Jul 9;102(1):19-26. Epub 2008 May 9.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Patients with diabetes have a higher risk for in-stent restenosis after coronary stent implantation. Drug-eluting stents (DES) are highly effective in reducing in-stent restenosis. Once neointimal hyperplasia is suppressed with DES, the impact of stent underexpansion becomes magnified. The aim of this study was to evaluate DES expansion in patients with diabetes. Ninety-five patients with diabetes were randomized to Cypher Select (n = 48) or Taxus Express-2 (n = 47) stent implantation. Intravascular ultrasound was performed after stent implantation. Stent expansion was defined as the ratio of measured to predicted minimum stent diameter. There was a trend for lower stent expansion in the Cypher Select stent group (0.74 +/- 0.08 vs 0.78 +/- 0.11 in the Taxus Express-2 stent group, p = 0.061). Cypher Select stents achieved a final minimal stent cross-sectional area of 5.5 +/- 1. 8 mm2, compared with 6.4 +/- 1.9 mm2 for Taxus Express-2 stents (p = 0.015). For stents with nominal diameters > or =2.75 mm (Cypher Select n = 40, Taxus Express-2 n = 38), 42.5% of the Cypher Select stents and 10.5% of the Taxus Express-2 stents did not achieve a final minimum stent area of 5 mm2 (p = 0.002). Insulin treatment (relative risk 0.31, 95% confidence interval 0.10 to 0.95, p = 0.041) and stent type (relative risk 0.15, 95% CI 0.04 to 0.53, p = 0.003) were independent predictors of not achieving a minimum stent area >5.0 mm2. In conclusion, an important percentage of DES in patients with diabetes fail to achieve the manufacturers' predicted final minimal stent diameter. Cypher Select stent and insulin treatment were independent predictors of not achieving a minimum stent area >5.0 mm2.
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http://dx.doi.org/10.1016/j.amjcard.2008.02.093DOI Listing
July 2008

Comparison of intravascular ultrasound and angiographic assessment of coronary reference segment size in patients with type 2 diabetes mellitus.

Am J Cardiol 2008 Mar 14;101(5):590-5. Epub 2008 Jan 14.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

During percutaneous coronary intervention, the reference segment is assessed angiographically. This report described the discrepancy between angiographic and intravascular ultrasound (IVUS) assessment of reference segment size in patients with type 2 diabetes mellitus. Preintervention IVUS was used to study 62 de novo lesions in 41 patients with type 2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/external elastic membrane (EEM) CSA. Using IVUS, the reference lumen diameter was 2.80 +/- 0.42 mm and the reference EEM diameter was 4.17 +/- 0.56 mm. The angiographic reference diameter was 2.63 +/- 0.36 mm. Mean difference between the IVUS EEM diameter and angiographic reference diameter was 1.56 +/- 0.55 mm. The mean difference between the IVUS reference lumen diameter and angiographic reference lumen diameter was 0.18 +/- 0.44 mm. Plaque burden in the reference segment correlated inversely with the difference between IVUS and quantitative coronary angiographic reference lumen diameter (slope = -0.12, 95% confidence interval -0.17 to -0.07, p <0.001), but it was not related to the absolute angiographic reference lumen diameter. Thus, reference segment diameters in type 2 diabetic patients were larger using IVUS than angiography, especially in the setting of larger plaque burden. In conclusion, these findings combined with inadequate remodeling may explain the angiographic appearance of small arteries in diabetic patients.
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http://dx.doi.org/10.1016/j.amjcard.2007.10.020DOI Listing
March 2008

Influence of a pressure gradient distal to implanted bare-metal stent on in-stent restenosis after percutaneous coronary intervention.

Circulation 2007 Dec 19;116(24):2802-8. Epub 2007 Nov 19.

Department of Cardiology, Catheterization Laboratory, Odense University Hospital, Sdr Blvd 29, 5000 Odense C, Denmark.

Background: Fractional flow reserve predicts cardiac events after coronary stent implantation. The aim of the present study was to assess the 9-month angiographic in-stent restenosis rate in the setting of optimal stenting and a persisting gradient distal to the stent as assessed by a pressure wire pullback recording in the entire length of the artery.

Methods And Results: In 98 patients with angina pectoris, 1 de novo coronary lesion was treated with a bare-metal stent. After stent implantation, pressure wire measurements (P(d)=mean hyperemic coronary pressure and P(a)=mean aortic pressure) were performed in the target vessel: (1) P(d)/P(a) as distal to the artery as possible (fractional flow reserve per definition); (2) P(d)/P(a) just distal to the stent; (3) P(d)/P(a) just proximal to the stent; and (4) P(d)/P(a) at the ostium. Residual abnormal P(d)/P(a) was defined as a pressure drop between P(d)/P(a) measured at points 1 and 2. Fractional flow reserve distal to the artery after stenting was significantly lower (0.88+/-0.21 versus 0.97+/-0.05; P<0.001), and angiographic in-stent binary restenosis rate was significantly higher (44.0% versus 8.1%; P<0.001) in vessels with a residual abnormal P(d)/P(a). Residual abnormal P(d)/P(a) (odds ratio, 4.39; 95% confidence interval, 1.10 to 18.16; P=0.034), reference vessel size (odds ratio, 0.17; 95% confidence interval, 0.04 to 0.69; P=0.013), and stent length (odds ratio, 1.11; 95% confidence interval, 1.03 to 1.21; P=0.009) were predictors of angiographic in-stent restenosis after 9 months.

Conclusions: A residual abnormal P(d)/P(a) distal to a bare-metal stent was an independent predictor of in-stent restenosis after implantation of a coronary bare-metal stent.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.107.704064DOI Listing
December 2007

Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions.

J Am Coll Cardiol 2007 Jul 29;50(5):463-70. Epub 2007 Jun 29.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Objectives: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS).

Background: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death.

Methods: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used.

Results: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67).

Conclusions: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.
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http://dx.doi.org/10.1016/j.jacc.2007.06.002DOI Listing
July 2007

Intravascular ultrasound assessment of remodelling and reference segment plaque burden in type-2 diabetic patients.

Eur Heart J 2007 Jul 31;28(14):1759-64. Epub 2007 May 31.

Catheterization Laboratory, Department of Cardiology, Odense University Hospital, Odense C, Denmark.

Aims: Intravascular ultrasound (IVUS) assesses arterial remodelling by comparing the lesion external elastic membrane (EEM) with the reference segments; however, reference segments are rarely disease-free. The aim was to assess lesion and reference segment remodelling and plaque burden in patients with type-2 diabetes mellitus.

Methods And Results: We used pre-intervention IVUS to study 62 de novo lesions in 43 patients with type-2 diabetes mellitus. The lesion site was the image slice with the smallest lumen cross-sectional area (CSA). The proximal and distal reference segments were the most normal-looking segments within 5 mm proximal and distal to the lesion. Plaque burden was measured as plaque CSA/EEM CSA. The remodelling index was defined as lesion EEM CSA/mean reference EEM CSA. Reference segment plaque burden measured 0.54 +/- 0.09. The majority of lesions (83.9%) had negative remodelling (lesion EEM < reference). Similarly, the slope of the regression line relating EEM to plaque CSA within the lesion was less than the reference substantiating negative remodelling. The reference segment plaque burden correlated inversely with the difference between IVUS lumen and quantitative coronary angiographic artery size [slope = -0.12 (95% CI -0.17 to -0.07); P < 0.001] in all patients with type-2 diabetes mellitus.

Conclusion: Lesions in type-2 diabetic patients are different from previous reports in non-diabetics. Lesions in type-2 diabetics are characterized by a large reference segment plaque burden and negative lesion site remodelling. These IVUS findings may explain the angiographic appearance of small arteries in diabetic patients.
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http://dx.doi.org/10.1093/eurheartj/ehm175DOI Listing
July 2007