Benno J. Rensing

Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study.

OBJECTIVES This study sought to determine the diagnostic accuracy of 64-slice computed tomographic coronary angiography (CTCA) to detect or rule out significant coronary artery disease (CAD). BACKGROUND CTCA is emerging as a noninvasive technique to detect coronary atherosclerosis. METHODS We conducted a prospective, multicenter, multivendor study involving 360 symptomatic patients with acute and stable anginal syndromes who were between 50 and 70 years of age and were referred for diagnostic conventional coronary angiography (CCA) from September 2004 through June 2006. All patients underwent a nonenhanced calcium scan and a CTCA, which was compared with CCA. No patients or segments were excluded because of impaired image quality attributable to either coronary motion or calcifications. Patient-, vessel-, and segment-based sensitivities and specificities were calculated to detect or rule out significant CAD, defined as >or=50% lumen diameter reduction. RESULTS The prevalence among patients of having at least 1 significant stenosis was 68%. In a patient-based analysis, the sensitivity for detecting patients with significant CAD was 99% (95% confidence interval [CI]: 98% to 100%), specificity was 64% (95% CI: 55% to 73%), positive predictive value was 86% (95% CI: 82% to 90%), and negative predictive value was 97% (95% CI: 94% to 100%). In a segment-based analysis, the sensitivity was 88% (95% CI: 85% to 91%), specificity was 90% (95% CI: 89% to 92%), positive predictive value was 47% (95% CI: 44% to 51%), and negative predictive value was 99% (95% CI: 98% to 99%). CONCLUSIONS Among patients in whom a decision had already been made to obtain CCA, 64-slice CTCA was reliable for ruling out significant CAD in patients with stable and unstable anginal syndromes. A positive 64-slice CTCA scan often overestimates the severity of atherosclerotic obstructions and requires further testing to guide patient management.

Coronary angiography with multi-slice computed tomography

BACKGROUND A new generation of subsecond multi-slice computed tomography (MSCT) scanners, which allow complete coronary coverage, are becoming widely available. We investigated the potential value of MSCT angiography in a range of coronary disorders. METHODS We studied 35 patients, including 11 who had undergone percutaneous transluminal coronary angioplasty and four who had had coronary-artery bypass grafts, by both MSCT and conventional coronary angiography. After intravenous injection of a non-ionic contrast medium with high iodine content, the entire heart was scanned within a single breath-hold. The total examination time was no more than 20 min. The retrospective electrocardiographically gated reconstruction source images and three-dimensional reconstructed volumes were analysed by two investigators, unaware of the results of conventional angiography. FINDINGS In the 31 patients without previous coronary surgery, 173 (73%) of the 237 proximal and middle coronary segments were assessable. In the assessable segments, 17 of 21 significant stenoses (>50% reduction of vessel diameter) were correctly diagnosed. The non-assessable segments included four lesions. Misinterpretations were mainly the result of severe calcification of the vessel wall. Segments with implanted stents were poorly visualised, but stent patency could be assessed in all cases. Of the 17 segments of bypass grafts, 15 were assessable and four of five graft lesions were detected. Two cases of anomalous coronary anatomy could be visualised well. INTERPRETATION These preliminary data suggest that MSCT allows non-invasive imaging of coronary-artery stenoses and has potential to develop into a reliable clinical technique.

Comparison of Platelet Function Tests in Predicting Clinical Outcome in Patients Undergoing Coronary Stent Implantation

Context High on-treatment platelet reactivity is associated with atherothrombotic events following coronary stent implantation. Objective To evaluate the capability of multiple platelet function tests to predict clinical outcome. Design, Setting, and Patients Prospective, observational, single-center cohort study of 1069 consecutive patients taking clopidogrel undergoing elective coronary stent implantation between December 2005 and December 2007. On-treatment platelet reactivity was measured in parallel by light transmittance aggregometry, Verify Now P2Y12 and Platelet works assays, and the IMPACT-R and the platelet function analysis system (PFA-100) (with the Dade PFA collagen/adenosine diphosphate (ADP) cartridge and Innovance PFA P2Y). Cutoff values for high on-treatment platelet reactivity were established by receiver operating characteristic curve (ROC) analysis. Main Outcome Measurement The primary end point was defined as a composite of all-cause death, nonfatal acute myocardial infarction, stent thrombosis, and ischemic stroke. The primary safety end point included TIMI (Thrombolysis In Myocardial Infarction) criteria major and minor bleeding. Results Kaplan-Meier analysis demonstrated that at 1-year follow-up, the primary end point occurred more frequently in patients with high on-treatment platelet reactivity when assessed by light transmittance aggregometry (52 [11.7%; 95% confidence interval {CI}, 8.9%-15.0%] vs 36 [6.0%;95%CI, 4.2%-8.2%] P.001; n=1049),Verify Now (54 [13.3%; 95% CI, 10.2%-17.0%] vs 37 [5.7%; 95% CI, 4.1%-7.8%]P.001; n=1052), Platelet works (33 [12.6%; 95% CI, 8.8%-17.2%] vs 21 [6.1%;95% CI, 3.8%-9.2%] P=.005; n=606), and Innovance PFA P2Y (18 [12.2%; 95%CI; 7.4%-18.6%] vs 28 [6.3%; 95% CI, 4.3%-8.9%] P=.02; n=588). ROC-curve analysis demonstrated that light transmittance aggregometry (area under the curve[AUC], 0.63; 95% CI, 0.58-0.68), Verify Now (AUC, 0.62; 95% CI, 0.57-0.67), and Platelet works (AUC, 0.61; 95% CI, 0.53-0.69) had modest ability to discriminate between patients with and without primary end point at 1-year follow-up. The IMPACT-R(n=905) and the Siemens PFA Collagen/ADP (n=812) were unable to discriminate between patients with and without the primary end point at 1-year follow-up (all AUCs included 0.50 in the CI). None of the tests identified patients at risk for bleeding. Conclusions Of the platelet function tests assessed, light transmittance aggregometry,Verify Now, Platelet works, and Innovance PFA P2Y were significantly associated with the primary end point. However, the predictive accuracy of these 4 tests was only modest. None of the tests provided accurate prognostic information to identify patients at higher risk of bleeding following stent implantation. Trial Registration clinical trials.gov Identifier: NCT00352014 [corrected].

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.

Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II) A Randomized Comparison of Bare Metal Stent Implantation With Sirolimus-Eluting Stent Implantation for the Treatment of Total Coronary Occlusions

Background— Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. Methods and Results— In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n=100) were randomly assigned to receive bare metal BxVelocity stents and half (n=100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P<0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P<0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P<0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. Conclusions— In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.

Non-invasive coronary angiography with multislice spiral computed tomography: impact of heart rate

Objective: To evaluate the impact of heart rate on the diagnostic accuracy of coronary angiography by multislice spiral computed tomography (MSCT). Design: Prospective observational study. Patients: 78 patients who underwent both conventional and MSCT coronary angiography for suspicion of de novo coronary artery disease (n=53) or recurrent coronary artery disease after percutaneous intervention (n=25). Setting: Tertiary referral centre. Methods: Intravenously contrast enhanced MSCT coronary angiography was done during a single breath hold, and ECG synchronised images were reconstructed retrospectively. All coronary segments of ≥ 2.0 mm without stents were evaluated by two investigators and compared with quantitative coronary angiography. Patients were classified according to the average heart rate (mean (SD)) into three equally sized groups: group 1, 55.8 (4.1) beats/min; group 2, 66.6 (2.8) beats/min; group 3, 81.7 (8.8) beats/min. Results: Image quality was sufficient for analysis in 78% of the coronary segments in patients in group 1, 73% in group 2, and 54% in group 3 (p < 0.01). The sensitivity and specificity for detecting significant stenoses (≥ 50% lumen reduction) in these assessable segments were: 97% (95% confidence interval (CI) 84% to 100%) and 96% in group 1; 74% (52% to 89%) and 94% in group 2; and 67% (33% to 90%) and 94% in group 3 (p < 0.05). Accounting for all segments of ≥ 2.0 mm, including lesions in non-assessable segments as false negatives, the sensitivity decreased to 82% (28/34 lesions, 95% CI 69% to 91%), 61% (14/23 lesions, 42% to 77%), and 32% (6/19 lesions, 15% to 50%), respectively (p < 0.01). Conclusions: MSCT allows reliable coronary angiography in patients with low heart rates.

The effect of completeness of revascularization on event-free survival at one year in the arts trial ☆

OBJECTIVES We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial. BACKGROUND There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome. METHODS After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. RESULTS Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%). CONCLUSIONS Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

Prevention of Restenosis After Percutaneous Transluminal Coronary Angioplasty With Thromboxane A2-receptor Blockade - a Randomized, Double-blind, Placebo-controlled Trial

BackgroundGR32191B is a novel thromboxane A2-receptor antagonist with potent antiaggregational and antivasoconstrictive properties. We have conducted a randomized, doubleblind, placebo-controlled trial to study its usefulness in restenosis prevention. Methods and ResultsPatients received either GR32191B (80 mg orally before angioplasty and 80 mg/day orally for 6 months) or 250 mg i.v. aspirin before angioplasty and placebo fo6 months. Coronary angiograms before angioplasty, after angioplasty, and at 6-month follow-up were quantitatively analyzed. Angioplasty was attempted in 697 patients. For efficacy analysis, quantitative angiography at follow-up was available in 522 compliant patients (261 in each group). Baseline clinical and angiographic parameters did not differ between the two treatment groups. The mean difference in coronary diameter between postangioplasty and follow-up angiogram (primary end point) was −0.31 + 0.54 mm in the control group and −0.31 + 0.55 mm in the GR32191B group. Clinical events during 6-month follow-up, analyzed on intention-totreat basis, were ranked according to the highest category on a scale ranging from death (control, six; GR32191B, four) to nonfatal infarction (control, 22; GR32191B, 18), bypass grafting (control, 19; GR32191B, 22) and repeat angioplasty (control, 52; GR32191B, 48). No significant difference in ranking was detected. Six months after angioplasty, 75% of patients in the GR32191B group and 72% of patients in the control group were symptom free. ConclusionsLong-term thromboxane A2-receptor blockade with GR32191B does not prevent restenosis and does not favorably influence the clinical course after angioplasty.

Intravenous electron-beam computed tomographic coronary angiography for segmental analysis of coronary artery stenoses.

OBJECTIVES We sought to identify and localize significant coronary stenoses on a segmental basis by electron-beam computed tomography (EBCT) and intravenous administration of a contrast agent. BACKGROUND The clinical applicability and limitations of intravenous EBCT coronary angiography have not been defined. METHODS EBCT was performed within 24 h of selective coronary angiography (SCA) in 28 patients (19 men and 9 women, mean [+/-SD] age 60 +/- 10 years). After examination for coronary calcium, EBCT coronary angiography was performed using overlapping slices (in-plane resolution 0.34 to 0.41 mm) with a nominal slice thickness of 1 mm. Based on quantitative analysis of SCA, lumen diameter narrowing > or = 50% (i.e., significant stenoses) was evaluated in 8 (major) or 12 (including side branches) coronary artery segments, using both two-dimensional (tomographic) and three-dimensional (volume) data sets. RESULTS Of the 330 segments assessable by SCA, 237 (72%) were visualized by EBCT. The sensitivity (+/-SE) for detection of significant stenoses was 82 +/- 6%; specificity was 88 +/- 2%; positive and negative predictive values were 57 +/- 7% and 96 +/- 2%, respectively; and overall accuracy was 87 +/- 2%. If only eight (major) coronary artery segments were considered, 194 (88%) of 221 segments were visualized, and the overall accuracy was 90 +/- 2%. Seven (18%) of 38 significantly stenotic segments were classified as having < 50% stenoses by EBCT. Six of these segments (86%), but only 9 (29%) of the 31 correctly classified stenotic segments, were severely calcified (area > 20 mm2, p = 0.02). In 23 (12%) of 199 nonstenotic segments falsely classified as having > or = 50% stenosis by EBCT, the lumen diameter was significantly smaller than that of the segments correctly classified as negative (mean [+/-SD] 1.5 +/- 0.8 vs. 2.9 +/- 1.1 mm, p < 0.001). CONCLUSIONS Intravenous EBCT coronary angiography allows for accurate segmental evaluation of significant disease in the major coronary arteries and may be of value for ruling out significant disease. The main determinant of false negative results is substantial segmental calcification, whereas the main determinant of false positive results is small vessel size.

Luminal narrowing after percutaneous transluminal coronary angioplasty. A study of clinical, procedural, and lesional factors related to long-term angiographic outcome. Coronary Artery Restenosis Prevention on Repeated Thromboxane Antagonism (CARPORT) Study Group.

BACKGROUND The renarrowing process after successful percutaneous transluminal coronary angioplasty (PTCA) is now believed to be caused by a response-to-injury vessel wall reaction. The magnitude of this process can be assessed by the change in minimal lumen diameter (MLD) at follow-up angiography. The aim of the present study was to find independent patient-related, lesion-related, and procedure-related risk factors for this luminal narrowing process. A model that accurately predicts the amount of luminal narrowing could be an aid in patient or lesion selection for the procedure, and it could improve assessment of medium-term (6 months) prognosis. Modification or control of the identified risk factors could reduce overall restenosis rates, and it could assist in the selection of patients at risk for a large loss in lumen diameter. This population could then constitute the target population for pharmacological intervention studies. METHODS AND RESULTS Quantitative angiography was performed on 666 successfully dilated lesions at angioplasty and at 6-month follow-up. Multivariate linear regression analysis was performed to obtain variables with an independent contribution to the prediction of the absolute change in minimal lumen diameter. Diabetes mellitus, duration of angina < 2.3 months, gain in MLD at angioplasty, pre-PTCA MLD, lesion length > or = 6.8 mm, and thrombus after PTCA were independently predictive of change in MLD. Overall prediction of the model was poor, however, percentage-correct classification for a predicted change between -0.1 to -0.4 mm was approximately 10%. Lesions showing no change or regression (change > -0.1 mm) and lesions showing large progression (< or = -0.4 mm) were more predictable (correct classification, 59.5% and 49.7%, respectively). CONCLUSIONS Renarrowing after successful PTCA as determined with contrast angiography is a process that cannot be accurately predicted by simple clinical, morphological, and lesion characteristics.