Western Denmark Heart Registry Research Articles

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

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. 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. 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. 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.

Comparison of zotarolimus-eluting and sirolimus-eluting coronary stents: a study from the Western Denmark Heart Registry

BackgroundWe evaluated the effectiveness and safety of a zotarolimus-eluting (ZES) versus a sirolimus-eluting (SES) coronary stent in a large cohort of patients treated with one of these stents in Western Denmark.MethodsA total of 6,122 patients treated with ZES (n=2,282) or SES (n=3,840) were followed for up to 27 months. We ascertained clinical outcomes based on national medical databases.ResultsIncidence of target lesion revascularization (no. per 100 person-years) was 5.3 in the ZES group compared to 1.9 in the SES group (adjusted hazard ratio (HR)=2.19, 95% confidence intervals (CI): 1.39-3.47; p=0.001). All-cause mortality was also higher in the ZES group (ZES: 6.3; SES: 3.3; adjusted HR=1.34, 95% CI: 1.05-1.72; p=0.02), while stent thrombosis (ZES: 1.2; SES: 0.5; adjusted HR=1.98, 95% CI: 0.75-5.23; p=0.14) did not differ significantly.ConclusionsIn agreement with previously published randomised data, this observational study indicated that the ZES was associated with an increased risk of death and TLR in a large cohort of consecutive patients.

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

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). 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). 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.

Culprit only or multivessel percutaneous coronary interventions in patients with ST-segment elevation myocardial infarction and multivessel disease

In patients with ST-segment elevation myocardial infarction (STEMI), timely reperfusion with primary percutaneous coronary intervention (PPCI) is the preferred treatment. However, it remains unclear whether the optimal strategy is complete revascularisation or culprit vessel PPCI only. From January 2002 to June 2009 all patients treated with PPCI were identified from the Western Denmark Heart Registry. We examined mortality according to timing of multivessel PCI: acute procedure, staged procedure during the index hospitalisation, or staged procedure performed within 60 days. The hazard ratio (HR) for death was estimated using a time-dependent Cox regression model, with time of PCI for the non-culprit lesion as the time-dependent variable. The study cohort consisted of 5,944 patients, of whom 4,770 (80%) had single-vessel disease and 1,174 (20%) had multivessel PCI within 60 days. Among 354 (30.2%) patients with acute multivessel PCI, 194 (16.5%) patients with multivessel PCI during the index hospitalisation, and 626 (53.3%) patients with multivessel PCI within 60 days after the index hospitalisation, the adjusted HRs for one-year mortality were 1.53 (95% confidence interval (CI): 1.07-2.18), 0.60 (95% CI: 0.28-1.26), and 0.28 (95% CI: 0.14-0.54), respectively, compared to patients with single vessel disease. Acute multivessel PCI in patients with STEMI was associated with increased mortality.

Transfusion of blood during cardiac surgery is associated with higher long-term mortality in low-risk patients

Numerous reports have emphasized the need for reduction in transfusions of allogeneic red blood cells (RBC) due to increased morbidity and mortality. Nevertheless, transfusion rates are still high in several cardiac surgery institutions. Reports on long-term survival after cardiac surgery and RBC transfusion are few. Data from the Western Denmark Heart Registry (WDHR) were used to identify all (25,117) adult cardiac surgery performed in four centres during 1999-2010. Patients with multiple entries (1049), re-do cardiac surgery (985), special/complex procedures (2329), dying within 30 days (668) and not eligible for follow-up (85) were excluded leaving a cohort of 20,001. Registration in the WDHR is mandatory. WDHR and the unique Danish Civil Registration System with continuous sequential updates of the Danish population ensure that all patients and outcomes are accounted for. Kaplan-Meier survival plot for low-risk patients (EuroSCORE 0-4), undergoing simple cardiac surgery showed a significantly lower estimated survival after >4500 days (0.637 vs. 0.745) when receiving perioperative RBC transfusion (P<0.0001). The difference was less evident in patients with EuroSCORE 5-9 (0.373 vs. 0.4436, P<0.0001), while high-risk patients showed no difference. Adjusted risk ratio, after RBC transfusion, containing among others age, sex, EuroSCORE and diabetes, was 1.83 (95% CI (confidence interval) 1.67-2.01). The survival rate was independent of up till six units of RBC. Long-term follow-up of low-risk patients undergoing simple cardiac surgery demonstrates a more than 10% higher mortality when receiving perioperative RBC transfusion. Even transfusion of 1-2 units seems to carry a risk of that magnitude.

Influence of Diabetes Mellitus on Clinical Outcomes Following Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

Patients with diabetes mellitus (DM) have a worse outcome after percutaneous coronary intervention (PCI) than nondiabetic patients. The purpose of this study was to compare rates of stent thrombosis, myocardial infarction (MI), target lesion revascularization (TLR), and death in diabetic and nondiabetic patients treated with primary PCI for ST-segment elevation MI (STEMI) in Western Denmark. From January 2002 through June 2005, 3,655 consecutive patients with STEMI treated with primary PCI and stent implantation (316 patients with DM, 8.6%; 3,339 patients without DM, 91.4%) were recorded in the Western Denmark Heart Registry. All patients were followed for 3 years. Cox regression analysis was used to compute hazard ratios (HRs), controlling for potential confounding. Three-year rates of definite stent thrombosis were 1.6% in the DM group and 1.5% in the non-DM group (adjusted HR 1.15, 95% confidence interval [CI] 0.50 to 2.67). The rate of MI was 12.3% in the DM group versus 5.6% in the non-DM group (adjusted HR 2.56, 95% CI 1.81 to 3.61). Rates of TLR were 12.1% in the DM group and 8.7% in the non-DM group (adjusted HR 1.55, 95% CI 1.14 to 2.11). All-cause mortality was 23.7% in patients with DM versus 12.7% in patients without DM (adjusted HR 2.03, 95% CI 1.59 to 2.59). In conclusion, stent thrombosis rate was similar in patients with and without DM and STEMI treated with primary PCI, whereas the presence of DM increased the risk of MI, TLR, and death.

The EuroSCORE in Western Denmark: A Population-Based Study

The present study aimed to examine the predictive performance of the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) in a large cohort of patients undergoing cardiac surgery from 1999 through 2010 because methodologic shortcomings have hampered many previous studies questioning its predictive performance. Population-based prospectively registered data. The Western Denmark Heart Registry, a multi-institutional registry. Twenty-one thousand six hundred sixty-four patients. On-pump cardiac surgery. The predictive ability of the logistic EuroSCORE was assessed using the area under the curve (AUC) for the discrimination test, the Hosmer-Lemeshow (HL) calibration test, and the mean estimated-to-observed mortality ratio (E/O). The overall AUC was 0.79 (95% confidence interval [CI] 0.77-0.81; HL test, p < 0.01; E/O 1.9). For coronary artery bypass grafting, the AUC was 0.78 (95% CI 0.75-0.81; HL test, p < 0.01; E/O 2.3). For coronary artery bypass grafting plus valve replacement, the AUC was 0.69 (95% CI 0.65-0.73; HL test, p = 0.02; E/O 1.5). For aortic valve replacement, the AUC was 0.76 (95% CI 0.72-0.80; HL test, p < 0.01; E/O 2.5). The overall and procedural specific E/O ratios tended to increase from 1999 to 2010. Mortality was overestimated across all levels of estimated risk, and in low-to-medium-risk patients, this overestimation increased most notably with time. The EuroSCORE provides moderate-to-good discrimination and poor calibration. Despite substantial changes in risk factors during the study period, the EuroSCORE consistently overestimated 30-day mortality independent of the preoperative risk level and surgical procedure performed, indicating improved quality of surgery and patient care.

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)

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.

Nonsteroidal Antiinflammatory Drug Use and Cardiovascular Risks After Coronary Stent Implantation

To determine whether use of nonselective nonsteroidal antiinflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2)-selective inhibitors in patients with coronary stents increased the 3-year rate of major adverse cardiovascular events (MACE). Population-based cohort study. The Danish National Patient Registry, the Western Denmark Heart Registry, the Danish Nationwide Prescription Database, the Danish Civil Registration System, and the National Registry of Causes of Deaths. A total of 13,001 patients who underwent first-ever percutaneous coronary intervention with stent implantation between January 1, 2002, and June 30, 2005. All patients were followed for 3 years after stent implantation for MACE, defined as the first occurrence of myocardial infarction, stent thrombosis, target-lesion revascularization, or cardiac death. Patients' comorbidities were identified from the hospital registries; time-varying use of NSAIDs and concomitant drugs was determined from the Danish Nationwide Prescription Database. For each clinical outcome (MACE), the 3-year risk was computed. We used Cox proportional-hazards regression analysis to compute hazard ratios (HRs) as a measure of relative risk, controlling for potential confounders. During the follow-up period, 5407 patients (41.6%) redeemed at least one NSAID prescription. There were 686 hospitalizations for myocardial infarction (5.3% of patients), 146 for stent thrombosis (1.1%), and 1091 for target-lesion revascularization (8.4%). A total of 1220 patients (9.4%) died during the follow-up period; 637 (4.9%) died of cardiac causes. Compared with no NSAID use, the adjusted HR for MACE was 1.04 (95% confidence interval [CI] 0.83-1.31) for nonselective NSAID use and 1.00 (95% CI 0.81-1.25) for COX-2 inhibitor use. Use of nonselective NSAIDs or COX-2 inhibitors was not associated with an increased rate of MACE in patients with coronary stents. However, we cannot rule out small risks associated with individual NSAIDs.

Variation in use of peroperative inotropic support therapy in cardiac surgery: time for reflection?

There is no well-established evidence-based clinical guidelines on the most appropriate use of peroperative inotropic support in cardiac surgery. We aimed to identify patient- and procedure-related factors associated with the use of peroperative inotropic support and to estimate physician-level variation. A population-based study using data from the Western Denmark Heart Registry on 3585 consecutive cardiac surgery cases from three university hospitals. Inotropic support was defined as infusion of inotropic drugs or nor epinephrine at the separation from cardiopulmonary bypass. Poisson's regression modelling was used to determine predictors of inotropic support and to compare use of high-dose inotropic support among experienced cardiac anaesthesiologists. We identified a range of factors that were independently associated with an increased use of inotropic support therapy including pre-operative left ventricular dysfunction, pre-operative renal dysfunction, complex procedures, prior cardiac surgery, emergency surgery, pre-operative pulmonary hypertension, critical pre-operative state, extended extra corporal circulation-time and female gender. Further, we found substantial variation in use of inotropic support both at hospital- and at physician-level. The adjusted odds ratio of high-intensity inotropic support varied significantly at physician level from 2.3 [95% confidence interval (CI) 1.83-2.71] to 0.3 (95% CI 0.15-0.61) when the individual physicians were compared with the rest. The use of inotropic support during cardiac surgery is associated with the pre-operative state of the patient, as well as type of surgery. However, the present study indicates that use of peroperative inotropic support is also highly dependent on physician's preferences, indicating the need for an evidence-based approach when initiating inotropic therapy in cardiac surgery.

TCT-88: Primary Percutaneous Coronary Intervention in Octogenarians and Nonagenarians with ST Segment Elevation Myocardial Infarction From Western Denmark Heart Registry

TCT-88: Primary Percutaneous Coronary Intervention in Octogenarians and Nonagenarians with ST Segment Elevation Myocardial Infarction From Western Denmark Heart Registry

Existing data sources for clinical epidemiology: The Western Denmark Heart Registry

The Western Denmark Heart Registry (WDHR) has not previously been described as a research tool in clinical epidemiology. We examined the setting, organization, content, data quality, and research potential of the WDHR. We collected information from members of the WDHR organization, including the committee of representatives, the board, the data management group, and physicians reporting to the database. We retrieved 2008 data from the WDHR to illustrate database variables. The WDHR is a clinical database within a population-based health care system. It was launched on 1 January 1999 to monitor and improve the quality of cardiac intervention in Western Denmark (population: 3.3 million) and to allow for clinical and health-service research. More than 200,000 interventions, with 50-150 variables each, have been registered. The data quality is ensured by automatic validation rules at data entry combined with systematic validation procedures and random spot-checks after entry. The WDHR is a valuable research tool because it provides ongoing longitudinal registration of detailed patient and procedural data. The Danish national health care system enables this research because it allows complete follow-up for medical events after cardiac intervention by linkage with multiple medical databases.

Long-Term Outcomes After Percutaneous Coronary Intervention in Patients With and Without Diabetes Mellitus in Western 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.

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

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).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).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.

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

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

Spontaneous coronary artery dissection: A Western Denmark Heart Registry Study

Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome (ACS) that associates with a high acute-phase mortality rate, whereas long-term outcome is less well described. To describe the incidence, predictors, and prognosis of SCAD. Retrospective case-identification study from the Western Denmark Heart Registry and the database of the Forensic Institute at Aarhus University from 1999 through 2007. SCAD was documented in 22 of 32,869 (0.7 per thousand) angiograms in the angiographic registry. The SCAD incidence among cases of ACS was 22 of 11,175 (2.0 per thousand). None was seen in the forensic database. The mean age was 48.7 +/- 8.9 years (range: 37-71 years). Females constituted 17 of 22 (77%) patients and all had undergone one or more pregnancies; two cases occurred in the postpartum period. The left descending artery (LAD) was the predominant site of entry. The age distribution, prevalence of the cardiovascular risk factors, presence of coronary atherosclerosis, and entry of the dissection were comparable among genders. Treatment was percutaneous coronary intervention in 13 of 22 (59%), coronary artery bypass operation in 2 of 22 (9%), and medical treatment in 7 of 22 (32%) patients. The mean follow-up period was 3.6 +/- 2.9 years. One patient suffered from recurrent SCAD; another patient died suddenly. The MACE- (cardiac death, nonfatal myocardial infarction, and new revascularization) free survival was 81% after 24 months. SCAD is a rare disease that mainly affects younger women. Compared with earlier reports, the prognosis seems to be improved by early diagnosis and interventional treatment.

2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents: Results From the WDHR (Western Denmark Heart Registry)

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). Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. 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. 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. 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.

Clinical Outcome After Primary Percutaneous Coronary Intervention With Drug-Eluting and Bare Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction

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 (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted RR=1.13; 95% CI=0.81 to 1.59; P=0.47). All-cause 2-year mortality was 7.8% in the DES group and 11.4% in BMS group (P<0.004; adjusted RR=0.79; 95% CI=0.60 to 1.04; P=0.09). The 2-year incidence of target lesion revascularization was 7.2% in the DES group and 8.7% in the BMS group (P=0.09; adjusted RR=0.70; 95% CI=0.52 to 0.92; P=0.012). In ST-segment elevation myocardial infarction patients treated with primary PCI, target lesion revascularization was reduced by 30% in patients treated with a DES. The risk of very late definite stent thrombosis was low but increased in patients treated with DES. DES was not associated with increased risk of myocardial infarction or death, when compared with BMS.

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Endeavor Zotarolimus-Eluting Coronary Stent

Initial trials comparing stenting with balloon angioplasty demonstrated improved angiographic and clinical outcomes with the former.1–3 The main clinical problem with bare metal stents (BMS) became the development of in-stent restenosis.4–6 Early data suggested that drug-eluting stents (DES) could mitigate, if not abolish, this problem.7–9 Since the approval of DES, these devices have become the predominant stents used in percutaneous coronary interventions, regardless of indication. As of September 2007, the Cypher sirolimus-eluting stent (SES) (Cordis Johnson & Johnson, Miami Lakes, Fla) had been deployed in >3 million patients worldwide,10 and the millionth Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Mass) was implanted as of January 2005.11 Over the past 2 years, numerous reports of very late stent thrombosis (ST) with first-generation DES have surfaced. This highly morbid complication and data suggesting that death and myocardial infarction (MI) may be more common with DES12,13 have altered the focus of trials and registries working to determine optimal DES use. There is a hope that second-generation DES will be less prone to ST as a result of differences in drug, stent design, and polymer. Medtronic, Inc (Minneapolis, Minn) presented safety and efficacy data to a public meeting of the US Food and Drug Administration (FDA) Circulatory System Devices Panel (CSDP) in October 2007 on its Endeavor zotarolimus-eluting stent (ZES), seeking approval for the indication of treating de novo native coronary lesions ≤27 mm with reference vessel diameters of 2.5 to 3.5 mm. The FDA asked the CSDP to determine whether the data presented demonstrated a reasonable level of safety and effectiveness, with clinical benefits clearly outweighing short- and long-term risks of ZES use. Important efficacy end points included ischemia-driven target lesion revascularization (TLR) or target vessel revascularization (TVR); safety end points included death, MI, and ST. The …

Stent Thrombosis, Myocardial Infarction, and Death After Drug-Eluting and Bare-Metal Stent Coronary Interventions

The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. 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. 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). The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.