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].

Staged carotid angioplasty and stenting followed by cardiac surgery in patients with severe asymptomatic carotid artery stenosis: early and long-term results.

BACKGROUND: The strategy for treating patients with severe asymptomatic carotid artery stenosis and cardiac disease remains unresolved. Staged or combined carotid endarterectomy in these patients offers the potential benefit of decreased neurological morbidity during and after cardiac surgery; however, in high-risk patients with severe coronary artery disease, chronic obstructive pulmonary disease, or renal impairment, the incidence of death and stroke is significantly higher. METHODS AND RESULTS: We report the results of a prospective, single-center study designed to evaluate the feasibility and safety of carotid artery angioplasty and stenting (CAS) before cardiac surgery in neurologically asymptomatic patients. The periprocedural and long-term outcomes of 356 consecutive patients who underwent CAS before cardiac surgery were analyzed. The procedural success rate of CAS was 97.7%. The death and stroke rate from time of CAS to 30 days after cardiac surgery was 4.8% (n=17). The myocardial infarction rate from time of CAS to 30 days after cardiac surgery was 2.0% (n=7), and the combined death, stroke, and myocardial infarction rate was 6.7% (n=24). Distal embolic protection devices were used in 40% of the cases. CONCLUSIONS: This large cohort of asymptomatic patients who underwent staged CAS and cardiac surgery experienced a low periprocedural complication rate. The high rate of freedom from death and stroke during the 5 years of follow-up supports the long-term durability of this approach. Our findings suggest that this new strategy may become a valuable alternative in the treatment of patients with combined carotid and cardiac disease.

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.

Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study.

BACKGROUND: Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions may decrease the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. METHODS: In a prospective, randomized trial, balloon angioplasty was compared with stent implantation for the treatment of chronic total occlusions. Patients were followed for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis was performed by an independent core lab. RESULTS: A total of 200 patients were enrolled. Baseline characteristics were evenly distributed. After the procedure the mean minimal luminal diameter in the conventional group was 2.34 +/- 0.46 mm versus 2.90 +/- 0.41 mm in the stented group (P <.0001). The 6-month angiographic follow-up showed a mean minimal luminal diameter of 1.57 +/- 0.74 mm in the conventional group versus 1.93 +/- 0.85 mm in the stented group (P =.009) and a mean diameter stenosis of 44.7% +/- 25.0% versus 35.5% +/- 26.5% (P =.036). Binary angiographic restenosis (>50% diameter stenosis) was seen in 33% in the conventional group versus 22% in the stented group (P =.137). The reocclusion rates were 7.3% and 8.2%, respectively (P = 1.00). At 12 month follow-up, the rate of target lesion revascularization was significantly higher in the conventional group (29% versus 13%, P <.0001). CONCLUSION: These data demonstrate that stenting of chronic total occlusions is superior to balloon angioplasty alone with a statistically significant reduction in the need for target lesion revascularization and a lower, but not significant, restenosis rate.

Carotid artery stenting and cardiac surgery in symptomatic patients.

OBJECTIVES: The purpose of this study was to evaluate the feasibility and safety of the combined outcome of carotid artery stenting (CAS) and coronary artery bypass graft (CABG) surgery in neurologically symptomatic patients. BACKGROUND: The risk of perioperative stroke in patients undergoing CABG who report a prior history of transient ischemic attack or stroke has been associated with a 4-fold increased risk as compared to the risk for neurologically asymptomatic patients. It seems appropriate to offer prophylactic carotid endarterectomy to neurologically symptomatic patients who have significant carotid artery disease and are scheduled for CABG. The CAS-CABG outcome for symptomatic patients remains underreported, notwithstanding randomized data supporting CAS for high-risk patients. METHODS: In a prospective, single-center study, the periprocedural and long-term outcomes of 57 consecutive patients who underwent CAS before cardiac surgery were analyzed. RESULTS: The procedural success rate of CAS was 98%. The combined death, stroke, and myocardial infarction rate was 12.3%. The death and major stroke rate from time of CAS to 30 days after cardiac surgery was 3.5%. The myocardial infarction rate from time of CAS to 30 days after cardiac surgery was 1.5%. CONCLUSIONS: This is the first single-center study reporting the combined outcome of CAS-CABG in symptomatic patients. The periprocedural complication rate and long-term results of the CAS-CABG strategy in this high-risk population support the reliability of this approach. In such a high-risk population, this strategy might offer a valuable alternative to the combined surgical approach; however, a large randomized trial is clearly warranted.

CT measurement of changes in cerebral perfusion in patients with asymptomatic carotid artery stenosis undergoing carotid stenting prior to cardiac surgery: "proof of principle".

AIMS: To identify asymptomatic patients with impaired cerebral perfusion using CT perfusion (CTP) technique during staged carotid stenting (CAS) and cardiac surgery. METHODS AND RESULTS: This is a prospective, non-randomised study in 16 neurologically asymptomatic patients designed to analyse cerebral perfusion using CTP before and after CAS. Mean transit time (MTT) was significant lower and cerebral blood flow (CBF) was significantly higher in the non-target hemisphere compared to the target hemisphere before treatment (4.64 ± 1.08 s vs. 5.67 ± 1.29 and 57.37 ± 24.90 s vs. 48.19 ± 13.02, respectively). Mean dMTT (absolute difference in MTT values between treated and untreated hemisphere) decreased from 0.92 ± 1.08 s before to 0.04 ± 0.30 s after carotid revascularisation (p<0.05) and mean relative CBF (ratios of the treated to the untreated hemisphere) increased from 0.92 ± 0.12 to 1.04 ± 0.12 after revascularisation (p<0.05). Subgroup analysis based on pre-treatment dMTT showed significant changes in 50% of the patients with larger dMTT. There was one transient ischaemic attack reported 30 days after combined procedure. CONCLUSIONS: A significant improvement of cerebral perfusion after carotid stenting is shown in about 50% of the asymptomatic patients in this study. This suggests the potential presence of a compromised cerebral circulation in asymptomatic patients with severe carotid artery disease scheduled for cardiac surgery.

Double-trouble: three cases with simultaneous stent thrombosis in different coronary arteries.

We report about three cases with a unique simultaneous double- trouble stent thrombosis in different coronary arteries. Although the triggering mechanism remains purely speculative, it is possible that suboptimal stent size and perhaps underexpansion caused the stent thrombosis in one stent resulting in a heightened platelet activation and impaired hemodynamics causing the second stent thrombosis.

Prediction of early cerebral outcome by transcranial Doppler monitoring in carotid bifurcation angioplasty and stenting.

OBJECTIVE: The outcomes of carotid angioplasty and stenting (CAS) are, in addition to patient baseline characteristics, highly dependent on the safety of the endovascular procedure. During the successive stages of CAS, transcranial Doppler (TCD) monitoring of the middle cerebral artery was used to assess the association of cerebral embolism and hemodynamic changes with transient (amaurosis fugax and transient ischemic attack) and persistent (minor and major stroke) cerebral deficits, and death. METHODS: By use of a prospectively completed database of 550 patients, the association of various TCD emboli and velocity variables with periprocedural cerebral outcome 5) at postdilation after stent deployment (odds ratio [OR] 2.6, 95% confidence interval [CI], 1.3 to 5.1), particulate macroembolus (OR, 27.0; 95% CI, 4.5 to 157), and massive air embolism (OR, 51.4; 95% CI, 5.4 to 492), as well as angioplasty-induced asystole and prolonged hypotension with a >70% reduction of middle cerebral artery blood flow velocities (OR, 6.4; 95% CI, 2.3 to 17.8) were independently associated with cerebral deficits. The ROC area of this model was 0.72. Of the patient characteristics, only preprocedural cerebral ischemia (OR, 5.0; 95% CI, 2.4 to 10.4) was associated with outcome. Adding this patient characteristic to the model, the area under the ROC curve increased to 0.80. CONCLUSIONS: In CAS, in addition to such obviously adverse events as particulate macroembolism and massive air embolism, multiple microemboli (>5 showers) at postdilation after stent deployment and angioplasty-induced asystole and hypotension with a significant reduction of middle cerebral artery blood flow velocities are associated with periprocedural cerebral deficits. In combination with the presence of preprocedural cerebral symptoms, these four TCD monitoring variables reasonably differentiate between patients with and without adverse cerebral outcome. TCD monitoring provides insight into the pathogenesis of CAS related adverse cerebral events.

Stenting for restenotic lesions with the BARD XT stent.

BACKGROUND: Conventional PTCA for the treatment of restenotic lesions is associated with a high rate of recurrence (30-50%). Primary stenting decreases the restenosis rate at long-term follow-up. METHODS: One-hundred consecutive patients with restenosis received a Bard XT stent. Follow-up angiography was performed after 6 months. Angiograms were compared by means of computed quantitative analysis. RESULTS: The mean pretreatment reference diameter was 2.88 +/- 0.51 mm. The mean minimal luminal diameter (MLD) increased from 1.09 +/- 0.57 mm to 2.70 +/- 0.44 mm. The percent diameter stenosis decreased from 66 +/- 13% to 15 +/- 10%. The procedural success rate was 99%. At 6 month follow-up repeat angiography was performed in 86 patients. The mean MLD was 1.74 +/- 0.67 mm with a mean diameter stenosis of 41 +/- 20%. Residual anginal complaints were reported in 29% of patients. In-stent restenosis (defined as diameter stenosis of more than 50%) occurred in 18% of the patients. CONCLUSION: Placement of the Bard XT stent in restenotic lesions is feasible, has an excellent short term outcome and yields a favorable result at 6 month follow-up angiography.

Cutting balloon for in-stent restenosis: acute and long-term results.

INTRODUCTION: Conventional percutaneous coronary intervention for the treatment of in-stent restenosis (ISR) has shown a high rate of ISR (30-55%). Considering the need for both extrusion of hyperplastic intima and additional stent expansion, a cutting balloon might be more effective for the treatment of ISR. METHODS: We prospectively assessed the immediate and 8-month outcome of balloon angioplasty using the Barath Cutting Balloon in 100 consecutive patients (mean age: 60.5 +/- 10.8 years, 71% male). RESULTS: In 73 lesions (73%), a good result was reached with the cutting balloon only. In 21 lesions (21%) postdilatation and in 6 lesions (6%) predilatation with a conventional balloon was necessary. The mean inflation pressure was 8.7 +/- 2.0 (range: 6.0-18.0) atm. Before the procedure the mean minimal luminal diameter (MLD) was 0.95 +/- 0.45 mm. Quantitative coronary analysis showed a mean diameter stenosis of 65%+/- 16%. Immediately after the procedure the mean MLD was 2.42 +/- 0.54 mm with a mean diameter stenosis of 19%+/- 13%. Two patients died during the follow-up period (1 stroke, 1 nonvascular). At 8-month follow-up 26 patients (26%) reported to have anginal complaints CCS class II-IV of whom 16 (16%) needed target lesion revascularization. CONCLUSION: Treatment of ISR using the Barath Cutting Balloon can be performed safely with good immediate results and a relatively low need for repeated target lesion revascularization at 8-month follow-up.

Is direct stent implantation without predilatation safe? Acute and long-term outcome.

Direct stenting could potentially lead to a reduction in dissections, time, and restenosis at 6-month follow-up. Using the premounted Palmaz-Schatz Crown stent elective stenting was performed without predilatation in 61 consecutive patients who were compared with a control group of provisional stenting. All patients underwent clinical and angiographic follow-up at 6 months. Direct stenting was successful in 81% of patients. In 16% of the patients predilatation was needed. In 3% the stent could not be implanted despite predilatation. Stent dislodgment occurred in 2% of patients, without embolization. Six-month angiographic follow-up was performed in 51 (84%) of 61 patients. In the direct stenting group the mean preprocedural minimal luminal diameter (MLD) increased from 0.96 +/- 0.47 to 3.09 +/- 0.54 mm directly after the procedure. At 6-month follow-up the MLD measured 2.32 +/- 0.79 mm. In the provisional stenting group the mean MLD increased from 0.92 +/- 0.51 to 2.44 +/- 0.58 mm and was 1.84 +/- 0.70 mm at 6-month follow-up. Restenosis, defined as a diameter stenosis > 50%, occurred in 8% of the direct stenting group compared with 28% in the provisional stenting group (P < 0.001). Direct coronary stent implantation can be attempted safely and efficaciously. The risk of stent loss is low. The initial and long-term angiographic results are significantly better as compared with provisional stenting. The risk of restenosis is significantly lower.