Five-year results of a randomised comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularisation.

AIMS: Stents with a passive coating of titanium-nitride-oxide (TiNO) have been compared with Endeavor® zotarolimus-eluting stents (E-ZES) with regard to the primary endpoint of in-stent late lumen loss at six to eight months. The objective of the present analysis was to compare the long-term outcomes of TiNO stents with E-ZES up to five years of clinical follow-up. METHODS AND RESULTS: A total of 302 patients had been randomly allocated to treatment with TiNO or E-ZES. Up to five years of follow-up, major adverse cardiac events (MACE), the composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularisation (TLR), were observed in 27.6% of patients treated with TiNO stents and 25.3% of patients treated with E-ZES (RR 1.13, 95% CI: 0.72-1.75, p=0.60), with the majority of events related to clinically indicated TVR (TiNO 21.7% versus E-ZES 20.7%, RR 1.10, 95% CI: 0.67-1.81). There were no differences with respect to individual events including cardiac death, myocardial infarction or stent thrombosis between the two treatment arms up to five years of follow-up. A majority of patients remained free from angina throughout the entire study duration (TiNO 77.3% versus E-ZES 76.1%, p=0.92). CONCLUSIONS: Final five-year outcomes of the TIDE trial comparing TiNO stents with E-ZES revealed increased rates of MACE driven primarily by clinically indicated TVR. The TIDE trial is registered at ClinicalTrials.gov: NCT00492908.

Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial.

OBJECTIVES: This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota). BACKGROUND: Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies. METHODS: In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat. RESULTS: Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; p(noninferiority) = 0.54), and subsequent superiority testing was in favor of ZES (p(superiority) = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; p(superiority) = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; p(interaction) = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year. CONCLUSIONS: Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908).

Coronary thrombosis and myocardial infarction as the initial manifestation of protein C deficiency in a 20-year-old man.

We report on a 20-year-old man who presented with an extensive acute anteroseptal myocardial infarction (from a thrombotic occlusion of the left anterior coronary artery) as the initial manifestation of hereditary protein C deficiency. This case report, along with previous reports, indicates that a diagnosis of protein C deficiency in young patients with myocardial infarctions is essential for more appropriate management and for the prevention of recurrent events. Furthermore, family screening could lead to a prophylactic approach in carriers of this mutation.

Impact of arterial injury on neointimal hyperplasia after implantation of drug-eluting stents in coronary arteries: an intravascular ultrasound study.

AIMS: We investigated the impact of arterial injury on neointimal hyperplasia following implantation of drug-eluting stents (DES). METHODS AND RESULTS: A total of 196 patients with 223 segments (sirolimus-eluting stents [SES]: 104, paclitaxel-eluting stents [PES]: 119) underwent intravascular ultrasound eight months after DES implantation. Arterial injury was defined as the balloon-to-artery ratio (BAR). Segments were categorised into two groups: high BAR defined as BAR>1.1 (120 segments), and low BAR defined as BAR < or =1.1 (103 segments). Baseline clinical characteristics were similar for both groups. Although reference vessel diameter was smaller, stent diameter, maximal balloon pressure and balloon diameter were higher in the high BAR compared with the low BAR group. Lumen (7.10±1.91 vs. 6.25±1.69, p=0.001), stent (7.31±1.95 vs. 6.41±1.80, p=0.001), and external elastic membrane (17.1±4.9 vs. 14.8±4.0, p<0.0001) areas (mm2) were higher, but neointimal hyperplasia (0.21±0.36 vs. 0.16±0.48, p=0.42) area (mm2) was similar in the high BAR compared with the low BAR group. Arterial injury as assessed by BAR was not associated with the amount of neointimal hyperplasia (R2=0.003, p=0.40). CONCLUSIONS: Arterial injury does not correlate with the amount of neointimal hyperplasia following DES implantation. Conventionally aggressive DES implantation techniques do not adversely affect long-term outcome with respect to restenosis.

Dual low response to acetylsalicylic acid and clopidogrel is associated with myonecrosis and stent thrombosis after coronary stent implantation.

BACKGROUND: Impaired response to antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel (CLO) has been associated with an increased risk of stent thrombosis and ischemic events after coronary stent implantation. We sought to investigate whether patients with a low response (LR) to ASA or CLO are at increased risk for periprocedural and short-term ischemic events after coronary stent implantation. METHODS: A total of 219 patients pretreated with ASA and CLO underwent percutaneous coronary intervention (PCI) with stent implantation. Whole blood impedance platelet aggregometry was performed with the Multiplate analyzer (Dynabyte, Munich, Germany) to test the response to ASA (ASPI test) and CLO (ADP test) within 12 to 18 hours after PCI. Patients were classified as ASA-LR, CLO-LR, dual LR, and controls. Study end points included myocardial infarction, stent thrombosis, and death assessed during the periprocedural period and at 30 days. RESULTS: Acetylsalicylic acid-LR was present in 34 (16%), CLO-LR in 33 (15%), and dual LR in 19 (9%) patients. Percutaneous coronary intervention-related myocardial infarction was encountered in 19 (9%) patients, with the highest incidence in dual-LR group (26.3%, P = .039). Composite ischemic events at 30 days were significantly more frequent in the dual-LR group than in other groups (36.8% vs 8.8% ASA-LR vs 6.1% CLO-LR vs 6.8% controls, P < .001). In multivariable analysis, dual LR (odds ratio 7.35, 95% CI 2.21-24.42, P < .001) and multivessel PCI (odds ratio 4.56, 95% CI 1.33-15.62, P = .016) were independently associated with ischemic events at 30 days. CONCLUSION: Dual LR to ASA and CLO is associated with an increased risk for short-term ischemic events after coronary stent implantation.

Percutaneous closure of a postinfarction ventricular septal defect and an iatrogenic left ventricular free-wall perforation using two Amplatzer muscular VSD occluders.

A 83-year-old woman underwent percutaneous closure of postinfarction ventricular septal defect following anteroseptal myocardial infarction and percutaneous coronary intervention with stent implantation of the left anterior descending coronary artery. Postinfarction percutaneous ventricular septal defect closure was initially complicated by an iatrogenic left ventricular free-wall perforation. Both defects were closed using two Amplatzer muscular VSD occluders during the same session.

Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial.

OBJECTIVES: We assessed the impact of vessel size on angiographic and long-term clinical outcome after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) within a randomized trial (SIRTAX [Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization]). BACKGROUND: Percutaneous coronary intervention in small-vessel disease is associated with an increased risk of major adverse cardiac events (MACE). METHODS: A total of 1,012 patients were randomly assigned to treatment with SES (n = 503) or PES (n = 509). A stratified analysis of angiographic and clinical outcome was performed up to 2 years after PCI according to size of the treated vessel (reference vessel diameter < or =2.75 vs. >2.75 mm). RESULTS: Of 1,012 patients, 370 patients (37%) with 495 lesions underwent stent implantation in small vessels only, 504 patients (50%) with 613 lesions in large vessels only, and 138 patients (14%) with 301 lesions in both small and large vessels (mixed). In patients with small-vessel stents, SES reduced MACE by 55% (10.4% vs. 21.4%; p = 0.004), mainly driven by a 69% reduction of target lesion revascularization (TLR) (6.0% vs. 17.7%; p = 0.001) compared with PES at 2 years. In patients with large- and mixed-vessel stents, rates of MACE (large: 10.4% vs. 13.1%; p = 0.33; mixed: 16.7% vs. 18.0%; p = 0.83) and TLR (large: 6.9% vs. 8.6%; p = 0.47; mixed: 16.7% vs. 15.4%; p = 0.86) were similar for SES and PES. There were no significant differences with respect to death and myocardial infarction between the 3 groups. CONCLUSIONS: Compared with PES, SES more effectively reduced MACE and TLR in small-vessel disease. Differences between SES and PES appear less pronounced in patients with large- and mixed-vessel disease. (The SIRTAX trial; http://clinicaltrials.gov/ct/show/NCT00297661?order=1; NCT00297661).

Paradoxical emboli through the patent foramen ovale as the suspected cause of myocardial and renal infarction in a 48-year-old woman.

We review the case of a 48-year-old woman who underwent elective percutaneous patent foramen ovale closure following successive renal and myocardial infarction with normal renal and coronary arteries, probably as a consequence of paradoxical emboli.

Effects of non-ionic iodinated contrast media on patient heart rate and pressures during intra-cardiac or intra-arterial injection.

PURPOSE: To compare the effects on heart rate (HR), on left ventricular (LV) or arterial pressures, and the general safety of a non-ionic low-osmolar contrast medium (CM) and a non-ionic iso-osmolar CM in patients undergoing cardiac angiography (CA) or peripheral intra-arterial digital subtraction angiography (IA-DSA). MATERIALS AND METHODS: Two double-blind, randomized studies were conducted in 216 patients who underwent CA (n=120) or peripheral IA-DSA (n=96). Patients referred for CA received a low-osmolar monomeric CM (iomeprol-350, n=60) or an iso-osmolar dimeric CM (iodixanol-320; n=60). HR and LV peak systolic and end-diastolic pressures were determined before and after the first injection during left and right coronary arteriography and left ventriculography. Monitoring for all types of adverse event (AE) was performed for 24 h following the procedure. t-tests were performed to compare CM for effects on HR. Patients referred for IA-DSA received iomeprol-300 (n=49) or iodixanol-320 (n=47). HR and arterial blood pressure (BP) were evaluated before and after the first 4 injections. Monitoring for AE was performed for 4 h following the procedure. Repeated-measures ANOVA was used to compare mean HR changes across the first 4 injections, whereas changes after the first injection were compared using t-tests. RESULTS: No significant differences were noted between iomeprol and iodixanol in terms of mean changes in HR during left coronary arteriography (p=0.8), right coronary arteriography (p=0.9), and left ventriculography (p=0.8). In patients undergoing IA-DSA, no differences between CM were noted for effects on mean HR after the first injection (p=0.6) or across the first 4 injections (p=0.2). No significant differences (p>0.05) were noted in terms of effects on arterial BP in either study or on LV pressures in patients undergoing CA. Non-serious AE considered possibly CM-related (primarily headache and events affecting the cardiovascular and digestive systems) were reported more frequently by patients undergoing CA and more frequently after iodixanol (14/60 [23.3%] and 2/47 [4.3%]; CA and IA-DSA, respectively) than iomeprol (10/60 [16.7%] and 1/49 [2%], respectively). CONCLUSIONS: Iomeprol and iodixanol are safe and have equally negligible effects on HR and LV pressures or arterial BP during and after selective intra-cardiac injection and peripheral IA-DSA. CLINICAL APPLICATION: Iomeprol and iodixanol are safe and equally well tolerated with regard to cardiac rhythm and clinical preference should be based on diagnostic image quality alone.

Early exercise after coronary stenting is safe.

OBJECTIVES: In this study, we sought to assess safety of symptom-limited exercise stress tests the day after coronary stenting. BACKGROUND: Isolated cases of coronary stent thrombosis have been linked to early exercise stress testing, thereby questioning the safety of unrestricted physical activity after the coronary procedure. METHODS: At a single center, 1,000 patients were randomized to a symptom-limited stress test the day after coronary stenting or no stress test. The antiplatelet regimen consisted of acetylsalicylic acid and postprocedural ticlopidine or clopidogrel. The primary end point of the study was the incidence of clinical stent thrombosis at 14 days. The secondary end point was the occurrence of access site complications. RESULTS: Clinical stent thrombosis occurred in five patients (1%) undergoing stress test and in five patients (1%) randomized to no stress test (p = 1.0). Access site complications were detected in 4% and 5.2% of cases, respectively (p = 0.37). CONCLUSIONS: Symptom-limited exercise stress testing the day after coronary stenting does not increase the risk of clinical stent thrombosis or access site complications. Further investigations on safety of early vigorous exercise after coronary stenting in a non-supervised setting are warranted.

Five French versus 6 French PCI: a case control study of efficacy, safety and outcome.

We report our experience of percutaneous coronary intervention (PCI) with 5 French (Fr) guiding catheters in a retrospective analysis of consecutive cases undergoing ad hoc PCI. Results were compared with a cohort of 6 Fr PCI cases matched for age, sex and operator over the same study period. A total of 210 patients (311 lesions) underwent PCI using 5 Fr guiding catheters and 174 matched patients (300 lesions) underwent PCI with 6 Fr guiding catheters. Multivessel PCI was performed in 18% of patients in the 5 Fr group and in 26% of the 6 Fr group (p = 0.046). There was no difference in clinical, angiographic or procedural characteristics between groups. Technical success rate was superior in the 5 Fr group compared with the 6 Fr (99% versus 95%; p = 0.03). The rate of stent implantation did not differ and the 5 Fr guiding catheter did not prohibit the use of large or long stents/balloons. Failure of 5 Fr PCI in 3 cases was not due to inadequate guiding catheter support. In-hospital major adverse cardiac events (MACE) and serious femoral complications were rare and at 6-month follow-up did not differ between groups. However, compared with 6 Fr PCI, procedure time and contrast medium usage was significantly less in the 5 Fr group (contrast: 274 +/- 101 ml versus 313 +/- 124 ml; p = 0.0008; fluoroscopy time: 16 +/- 9 minutes versus 19 +/- 12 minutes; p = 0.006). We conclude that the use of 5 Fr guiding catheters is effective and safe in unselected patients undergoing PCI and may even confer certain advantages. The 5 Fr approach can be recommended for routine interventional practice.

Heparin and coumadin versus acetylsalicylic acid for prevention of restenosis after coronary angioplasty.

The purpose of the present study was to determine whether postprocedural antithrombotic therapy with prolonged heparin infusion followed by 6 months of oral anticoagulation in addition to acetylsalicylic acid (ASA) reduces the incidence of angiographic restenosis after successful PTCA. One hundred ninety-one patients with uncomplicated PTCA were randomized into two groups: one group was discharged with ASA 100 mg only (G1) and the other group was additionally treated with 12-24 hr of heparin infusion and overlapping oral anticoagulation with coumadin for 6 months (G2). The two groups were comparable with respect to age, gender, coronary risk profile, clinical presentation, and angiographic lesion characteristics. Stents were implanted in 33% and 36% of the G1 and G2 patients, respectively. In-hospital myocardial infarction occurred in 4% of the G1 and 3% of the G2 patients. One patient in G1 died of subacute stent thrombosis (day 3). Six-month angiographic follow-up was obtained in 90% of G1 patients and 94% of G2 patients. Restenosis occurred in 30% and 33% of the patients and mean diameter stenoses at follow-up were 40% +/- 28% and 39% +/- 24%, respectively. Thrombin inhibition with heparin infusion followed by 6 months of oral anticoagulation did not reduce angiographic restenosis among patients undergoing PTCA with or without stent implantation. The occurrence of acute ischemic complications was also comparable in the two groups.