Antithrombotic therapy in patients undergoing TAVI: an overview of Dutch hospitals.

PURPOSE: To assess current antithrombotic treatment strategies in the Netherlands in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: For every Dutch hospital performing TAVI (n = 14) an interventional cardiologist experienced in performing TAVI was interviewed concerning heparin, aspirin, thienopyridine and oral anticoagulation treatment in patients undergoing TAVI. RESULTS: The response rate was 100 %. In every centre, a protocol for antithrombotic treatment after TAVI was available. Aspirin was prescribed in all centres, concomitant clopidogrel was prescribed 13 of the 14 centres. Duration of concomitant clopidogrel was 3 months in over two-thirds of cases. In 2 centres, duration of concomitant clopidogrel was based upon type of prosthesis: 6 months versus 3 months for supra-annular and intra-annular prostheses, respectively. CONCLUSIONS: Leaning on a small basis of evidence and recommendations, the antithrombotic policy for patients undergoing TAVI is highly variable in the Netherlands. As a standardised regimen might further reduce haemorrhagic complications, large randomised clinical trials may help to establish the most appropriate approach.

Acute and subacute stent thrombosis after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: incidence, predictors and clinical outcome.

BACKGROUND: Early coronary stent thrombosis occurs most frequent after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). OBJECTIVES: To identify the specific predictors of, respectively, acute and subacute stent thrombosis in patients after primary PCI for STEMI. PATIENTS/METHODS: Consecutive STEMI patients with angiographically confirmed early stent thrombosis were enrolled and compared in a 2 : 1 ratio with a matched control group. Clinical outcome was collected up to 1 year. RESULTS: Of 5842 STEMI patients treated with primary PCI, 201 (3.5%) presented with a definite early stent thrombosis. Of these, 97 (1.7%) had acute stent thromboses and 104 (1.8%) had subacute stent thromboses. Postprocedurally discovered dissection, undersizing and smaller stent diameter were the strongest predictors for acute stent thrombosis. No glycoprotein IIb/IIIa therapy and the use of drug-eluting stents were also associated with acute stent thrombosis. Lack of clopidogrel therapy in the first 30 days after the index PCI was the strongest predictor for subacute stent thrombosis. Mortality rates at 1-year follow-up were lower for acute stent thrombosis than for subacute stent thrombosis (8.3% vs. 13.2%, P = 0.294). The incidence of definite recurrent stent thrombosis at 1-year follow up was significantly lower after a first definite acute stent thrombosis than after a first definite subacute stent thrombosis (6.4% vs. 19.3%, P = 0.007 at 1 year). CONCLUSIONS: The specific risk factors for, respectively, acute and subacute stent thrombosis after primary PCI vary greatly. Mortality rates are high for both categories of stent thrombosis. However, recurrent stent thrombosis occurs more frequently after subacute stent thrombosis.

Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry.

OBJECTIVES: This study sought to comprehensively identify predictors of stent thrombosis (ST). BACKGROUND: Given the devastating consequences of ST, efforts should be directed toward risk stratification to identify patients at highest risk for ST. METHODS: Consecutive patients with angiographic ST were enrolled. Patients who did not suffer from a ST were randomly selected in a 2:1 ratio and were matched for: 1) percutaneous coronary intervention (PCI) indication; 2) same date of index PCI; and 3) same interventional center. RESULTS: Of 21,009 patients treated with either a bare-metal or drug-eluting stent, 437 patients (2.1%) presented with a definite ST. A total of 140 STs were acute, 180 were subacute, 58 were late, and 59 were very late. Undersizing of the coronary stent, Thrombolysis In Myocardial Infarction flow grade <3, present malignancy, presence of intermediate coronary artery disease proximal and distal to the culprit lesion, dissection, lack of aspirin, bifurcation lesions, ejection fraction <30%, and younger age were associated with ST. The lack of clopidogrel therapy at the time of ST in the first 30 days after the index PCI (hazard ratio [HR]: 36.5, 95% confidence interval [CI]: 8.0 to 167.8), between 30 days and 6 months after the index PCI (HR: 4.6, 95% CI: 1.4 to 15.3), and beyond 6 months (HR: 5.9, 95% CI: 1.7 to 19.8) after the index PCI was strongly associated with ST. CONCLUSIONS: Important correlates of ST were identified. Discontinuation of clopidogrel, undersizing of the coronary stent, present malignancy, and intermediate (>or=50% to <70% stenosis) coronary artery disease proximal to the culprit lesion were the strongest predictors of ST.

Long-term clinical outcome after a first angiographically confirmed coronary stent thrombosis: an analysis of 431 cases.

BACKGROUND: There are limited data on the long-term clinical outcome after an angiographically confirmed (definite) stent thrombosis (ST). METHODS AND RESULTS: Four hundred thirty-one consecutive patients with a definite ST were enrolled in this multicenter registry. The primary end point was the composite of cardiac death and definite recurrent ST. Secondary end points were all-cause death, cardiac death, definite recurrent ST, definite and probable recurrent ST, any myocardial infarction, and any target-vessel revascularization. The primary end point occurred in 111 patients after a median follow-up of 27.1 months. The estimated cumulative event rates at 30 days and 1, 2, and 3 years were 18.0%, 23.6%, 25.2%, and 27.9%, respectively. The cumulative incidence rates of definite recurrent ST, definite or probable recurrent ST, any myocardial infarction, and any target-vessel revascularization were 18.8%, 20.1%, 21.3%, and 32.0%, respectively, at the longest available follow-up. Independent predictors for the primary end point were diabetes mellitus, total stent length, severe calcification, American College of Cardiology/American Heart Association B2-C lesions, TIMI (Thrombolysis In Myocardial Infarction) flow grade <3 after percutaneous coronary intervention, and left ventricular ejection fraction <45%. The implantation of an additional coronary stent during the first ST was also associated with unfavorable outcome. Clinical outcome was not affected by the type of previously implanted stent (drug-eluting or bare-metal stent) or the category of ST (early versus late). CONCLUSIONS: The long-term clinical outcome after a first definite ST is unfavorable, with a high mortality and recurrence rate. Diabetes mellitus, left ventricular ejection fraction <45%, long total stent length, complex coronary lesions, TIMI flow grade <3 after percutaneous coronary intervention, and implantation of an additional coronary stent during the emergent percutaneous coronary intervention for the ST were associated with this unfavorable outcome.

Long-term follow-up of coronary angioplasty in patients with diabetes compared with nondiabetics.

BACKGROUND: Some reports have indicated that in patients with diabetes mellitus and multivessel disease, coronary artery bypass surgery is preferred over percutaneous coronary intervention (PCI). We retrospectively compared outcome PCI in diabetic and nondiabetic patients. METHODS: Ninety-seven diabetics and 971 nondiabetics were included and randomised before PCI to aspirin alone or aspirin plus coumadin. Fifty diabetics and 481 nondiabetics underwent follow-up angiography. The primary endpoint comprised all-cause mortality, myocardial infarction or targetvessel revascularisation. RESULTS: Baseline characteristics were similar between the groups except for significantly more males and smokers among the nondiabetics. The diabetics had significantly more previous strokes, more left anterior descending coronary artery disease as well as more restenotic lesions and multivessel disease. At 30 days, the primary endpoint had occurred in five diabetics (5.2%) and 47 nondiabetics (4.9%), (p=0.8) and at one year in 17 (17.5%) and in 165 (17.1%), respectively (p=0.9). Event-free survival remained comparable during long-term follow-up (four years). Multivariate analysis showed no differences for the occurrence of any event (p=0.9, 95% CI 0.6-1.7). At six months, the minimal luminal diameter was significantly smaller in the diabetics (1.55±0.76 mm vs. 1.78±0.66 mm, p=0.01). Diabetics also had more restenosis (41% vs. 23%, p=0.003). CONCLUSION: Despite angiographical differences at six months between the diabetics and nondiabetics, both short-term and long-term clinical follow-up appeared to be similar.

Long term follow up after elective percutaneous coronary intervention for unprotected non-bifurcational left main stenosis: is it time to change the guidelines?

BACKGROUND: According to the American College of Cardiology/American Heart Association guidelines, percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) stenosis is contraindicated and coronary artery bypass graft surgery (CABG) is preferred. However, PCI of the LMCA is performed under exceptional circumstances. OBJECTIVE: To analyse the data of patients who underwent PCI of the unprotected LMCA in St Antonius Hospital, Nieuwegein, Netherlands. RESULTS: In a database of 17 683 PCI procedures, 71 patients (0.4%) were found with non-bifurcational LMCA stenosis who underwent an elective PCI between 1991 and 2001. Ages ranged from 26.7-86.5 years. Severe concomitant disease was the most frequent argument in favour of PCI instead of CABG. PCI consisted of only balloon angioplasty in 23 cases (32.4%). A stent was used in 46 cases (64.4%). Average follow up was 43 months (range 0-121 months). One patient died one day after the procedure. The total one year survival rate was 98.6% (70/71). Seven patients died during the follow up period, mostly because of non-cardiac reasons. The annual mortality rate was 2.5%. Recurrent elective percutaneous transluminal coronary angioplasty for restenosis of the LMCA was performed in one patient (1.4%) six weeks after the initial procedure. CABG was required in 13 patients (18.3%) throughout the follow up period. CONCLUSION: These results suggest that at highly experienced centres, elective PCI of the non-bifurcational LMCA can be performed safely where the anatomy is suitable.

How good are experienced cardiologists at predicting the hemodynamic severity of coronary stenoses when taking fractional flow reserve as the gold standard.

BACKGROUND: Coronary angioplasty should be based on documented ischemia. However, in daily clinical practice the indication for angioplasty is often based on eyeball assessment of the severity of the stenosis. This study was performed to assess the accuracy of eyeball estimation of coronary stenosis when taking functional flow reserve (FFR) as gold standard. METHODS: Study lesions were where no mutual agreement on the severity of the stenosis was obtained. The procedure consisted of a repeat control angiogram, FFR measurement and in case of FFR<75% percutaneous coronary intervention. The eyeball assessment of the stenosis was written down before further execution of the procedure. FFR was measured with a pressure monitoring guide. Maximal myocardial hyperemia was induced by intravenous adenosine infusion. RESULTS: Fifty-two patients were studied. Agreement between eyeball assessment and FFR existed in a total of 36 cases (69.2%). Over estimation of hemodynamic severity occurred in six cases (11.5%) and under estimation in 10 cases (19.2%). Consequently, the positive predictive value of eyeball assessment for pressure-derived FFR was 63% and the negative predictive value 76%. CONCLUSION: The assessment of the hemodynamic severity of intermediate coronary stenosis should not be based on eyeball assessment even by experienced interventional cardiologists.

How good are experienced interventional cardiologists in predicting the risk and difficulty of a coronary angioplasty procedure? A prospective study to optimize surgical standby.

The prediction of the risk of a percutaneous transluminal coronary angioplasty has either been based on coronary lesion morphology or on clinical parameters, but a combined angiographic and clinical risk assessment system has not yet been evaluated prospectively. Five experienced interventionalists categorized 7,144 patients with 10,081 stenoses (1.4 lesion/patient) for both the risk and the difficulty of the procedure. Risk categories are as follows: 1 = low risk; 2 = intermediate risk; 3 = high risk. This division was made for percutaneous transluminal coronary angioplasty planning purposes. Category 1 patients denotes those in whom surgical standby is not required; category 2 patients, surgical standby not required but available within 1 hr; category 3 patients, surgical standby required. Difficulty categories are as follows: 1 = easy lesion; 2 = moderately difficult lesion; 3 = difficult lesion. Success was defined as a reduction of the degree of stenosis to less than 50%, without acute myocardial infarction, emergency redilatation, emergency bypass grafting, or death within 1 week. The procedure was not successful in difficulty category 1 in 1.6%, in category 2 in 3.5%, and in category 3 in 9.9%. Complications occurred in risk category 1 in 3.5%, in category 2 in 5.2%, and in category 3 in 12.4%. All differences were statistically significant (P < 0.05). Experienced cardiologists can well predict the risk and success of a coronary angioplasty procedure. This helps to optimize surgical standby, although even in the lowest-risk category complications can occur.

Are there differences in late outcome after PTCA for angina pectoris after non-Q wave vs Q wave myocardial infarction?

AIMS: Revascularization is thought to improve prognosis better if ischaemia persists after so-called non-Q wave myocardial infarction, than after Q-wave myocardial infarction, because it is assumed that prognosis is better where there is less left ventricular function loss. This study evaluates the differences in clinical outcome between patients with Q wave and those with non-Q wave myocardial infarction who underwent percutaneous transluminal coronary angioplasty because of recurrent ischaemia. METHODS: We retrospectively analysed two consecutive groups of patients who underwent percutaneous transluminal coronary angioplasty for ischaemia after either a non-Q wave (n = 175) or a Q wave (n = 175) myocardial infarction, and who were followed for 4 years. RESULTS: Initial angioplasty success rates were similar in both groups. At follow-up there were no significant differences between the two patient groups in rates of death (9% vs 11%, P = ns), myocardial infarction (3% vs 7%, P = ns) and target vessel revascularization by repeat percutaneous angioplasty (11% vs 15%, P = ns) or coronary bypass surgery (both 7%). CONCLUSION: We conclude that elective coronary angioplasty in patients with angina pectoris after non-Q wave myocardial infarction does not lead to a better prognosis than after Q wave myocardial infarction. Thus, management strategies after myocardial infarction should not be based on the absence or presence of Q waves on the electrocardiogram.