Five-year results of the complete versus culprit vessel percutaneous coronary intervention in multivessel disease using drug-eluting stents II (CORRECT II) study: a prospective, randomised controlled trial.

OBJECTIVES/BACKGROUND: In patients with multivessel coronary artery disease (MVD) the decision whether to treat a single culprit vessel or to perform multivessel revascularisation may be challenging. The purpose of this study was to evaluate the long-term outcome of multivessel percutaneous coronary intervention (MV-PCI) versus culprit vessel only (CV-PCI) in patients with stable coronary artery disease or non-ST elevation acute coronary syndrome. METHODS: In this dual-centre, prospective, randomised study a total 215 patients with MVD were randomly assigned to MV-PCI or CV-PCI. The primary endpoint was the occurrence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), and repeat revascularisation. Secondary endpoints were the combined endpoint of death or MI, the individual components of the primary endpoint, and the occurrence of stent thrombosis. Patients were followed up to 5 years after enrolment. RESULTS: The occurrence of the primary endpoint was similar at 28% versus 31% in the MV-PCI and CV-PCI group, respectively (hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.53-1.44, p = 0.59). The rate of repeat revascularisation was 15% versus 24% (HR 0.59, 95% CI 0.32 to 1.11, p = 0.11), whereas definite or probable stent thrombosis occurred in 2% versus 0% (p = 0.44). CONCLUSIONS: In this randomised study comparing the strategies for MV-PCI and CV-PCI in patients with MVD, no difference was found in the occurrence of MACE after 5 years. We observed a numerically higher rate of death or MI and a lower rate of repeat revascularisation after MV-PCI, although these findings were not statistically significant.

Impact of percutaneous coronary intervention timing on 5-year outcome in patients with non-ST-segment elevation acute coronary syndromes. The 'wait a day' approach might be safer.

BACKGROUND: The OPTIMA trial was a randomised multicentre trial exploring the influence of the timing of percutaneous coronary intervention (PCI) on patient outcomes in an intermediate to high risk non-ST-elevation acute coronary syndrome (NSTE-ACS) population. In order to decide the best treatment strategy for patients presenting with NSTE-ACS, long-term outcomes are essential. METHODS: Five-year follow-up data from 133 of the 142 patients could be retrieved (94 %). The primary endpoint was a composite of death and spontaneous myocardial infarction (MI). Spontaneous MI was defined as MI occurring more than 30 days after randomisation. Secondary endpoints were the individual outcomes of death, spontaneous MI or re-PCI. RESULTS: No significant difference with respect to the primary endpoint was observed (17.8 vs. 10.1 %; HR 1.55, 95 % CI: 0.73-4.22, p = 0.21). There was no significant difference in mortality rate. However, spontaneous MI was significantly more common in the group receiving immediate PCI (11.0 vs. 1.4 %; HR 4.46, 95 % CI: 1.21-16.50, p = 0.02). We did not find a significant difference between the groups with respect to re-PCI rate. CONCLUSION: There was no difference in the composite of death and spontaneous MI. The trial suggests an increased long-term risk of spontaneous MI for patients treated with immediate PCI.

Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions. Clinical and angiographic results of the ENDEAVOR II Trial.

AIM: The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months. METHODS: Patients (n =1,197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n= 598) or the same bare metal stent but without the drug or the polymer coating (n=599). RESULTS: The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03+/-0.58 to 0.61+/-0.46 (P<0.001) in stent and from 0.72+/-0.61 to 0.36+/-0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001). CONCLUSIONS: Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

Outpatient coronary stent implantation.

OBJECTIVES: This study was performed to explore the feasibility of coronary Palmaz-Schatz stent implantation on an outpatient basis. BACKGROUND: To optimize the applicability of coronary stenting by limiting bleeding complications and length of hospital stay, the transradial approach has been demonstrated to be an effective technique. Immediate ambulation opens the way to outpatient treatment. METHODS: Patients selected for Palmaz-Schatz stent implantation received anticoagulation with Coumadin. At an international normalized ratio > 2.5, stenting was performed through the radial approach. Starting in December 1994, patients were treated with Ticlopidin. Heparin was administered during the procedure. Suitability for same-day discharge was assessed on the basis of preprocedural, postprocedural and periprocedural criteria. Patients were mobilized after immediate sheath removal, followed by same-day discharge. Follow-up examinations were performed the next day, at 2 weeks and at 1 month after stenting. RESULTS: Of 188 patients who underwent Palmaz-Schatz coronary stent implantation through the radial artery between May 1994 and July 1995, 88 remained in the hospital for various reasons. In the 100 outpatients (Canadian Cardiovascular Society classes III and IV, n = 90 [90%]), 125 stents had been implanted to cover 110 lesions. No cardiac or bleeding events were encountered within 24 h (95% confidence interval 0 to 3.6) of stenting. At 2-week follow-up, one patient was readmitted (day 4) because of a bleeding abdominal aortic aneurysm requiring operation. Two patients were readmitted 2 weeks after discharge, one with subacute thrombosis and one with angina and anemia that was treated with blood transfusions. At 1-month follow-up, no complications were observed. CONCLUSIONS: After an optimal transradial Palmaz-Schatz coronary stent result, patients can safely be discharged on the day of treatment.

A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study.

OBJECTIVES: This study sought to compare procedural and clinical outcomes of percutaneous transluminal coronary angioplasty (PTCA) performed with 6F guiding catheters introduced through the radial, brachial or femoral arteries. BACKGROUND: Transradial PTCA has been demonstrated to be an effective and safe alternative to transfemoral PTCA; however, no randomized data are currently available. METHODS: A randomized comparison between transradial, transbrachial and transfemoral PTCA with 6F guiding catheters was performed in 900 patients. Primary end points were entry site and angioplasty related. Secondary end points were quantitative coronary analysis after PTCA, procedural and fluoroscopy times, consumption of angioplasty equipment and length of hospital stay. RESULTS: Successful coronary cannulation was achieved in 279 (93.0%), 287 (95.7%) and 299 (99.7%) patients randomized to undergo PTCA by the radial, brachial and femoral approaches, respectively. PTCA success was achieved in 91.7%, 90.7% and 90.7% (p = NS) of patients, with 88.0%, 87.7% and 90.0% event free at 1-month follow-up, respectively (p = NS). Major entry site complications were encountered in seven patients (2.3%) in the transbrachial group, six (2.0%) in the transfemoral group and none in the transradial group (p = 0.035). Transradial PTCA led to asymptomatic loss of radial pulsations in nine patients (3%). Procedural and fluoroscopy times were similar, as were consumption of guiding and balloon catheters and length of hospital stay ([mean +/- SD] 1.5 +/- 2.5, 1.8 +/- 3.8 and 1.8 +/- 4.2 days, respectively). CONCLUSIONS: With experience, procedural and clinical outcomes of PTCA were similar for the three subgroups, but access failure is more common during transradial PTCA. Major access site complications were more frequently encountered after transbrachial and transfemoral PTCA.

Restenosis after coronary angioplasty: the paradox of increased lumen diameter and restenosis.

Restenosis after coronary angioplasty is the single complication that most limits this revascularization procedure in clinical practice. The process is largely unpredictable and the lesion-related factors predisposing to restenosis are poorly understood, with little consensus in published reports. In this study using detailed quantitative angiographic measurements to assess 490 lesions, the simple lesion characteristics associated with restenosis were defined and the relation to the restenosis process documented. Restenosis was defined as an absolute deterioration in the minimal lumen diameter by greater than or equal to 0.72 mm, a criterion based on the 95% confidence intervals for repeat angiographic measurements. This was chosen in an attempt to separate spurious changes due to a poor angiographic result and the variability of angiographic measurements from significant changes due to the restenosis process. The principal determinants of restenosis were found to be a large improvement in the minimal lumen diameter at the time of dilation (1.13 mm for the restenosis group compared with 0.86 mm for the no restenosis group [p less than 0.0001]) and an optimal postangioplasty result (minimal lumen diameter 2.28 mm in the restenosis group compared with 2.05 mm [p less than 0.001] in the no restenosis group, corresponding to a 25% and a 30% diameter stenosis, respectively [p less than 0.0001]). These observations reported for the first time suggest that the distinction needs to be made between a "clinical restenosis" of greater than or equal to 50% diameter stenosis and the "restenosis process" as measured by the absolute changes occurring during and after angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS)

Recombinant hirudin (lepirudin) for the improvement of thrombolysis with streptokinase in patients with acute myocardial infarction: results of the HIT-4 trial.

OBJECTIVES: The purpose of this study was to compare recombinant hirudin and heparin as adjuncts to streptokinase thrombolysis in patients with acute myocardial infarction (AMI). BACKGROUND: Experimental studies and previous small clinical trials suggest that specific thrombin inhibition improves early patency rates and clinical outcome in patients treated with streptokinase. METHODS: In a randomized double-blind, multicenter trial, 1,208 patients with AMI < or =6 h were treated with aspirin and streptokinase and randomized to receive recombinant hirudin (lepirudin, i.v. bolus of 0.2 mg/kg, followed by subcutaneous (s.c.) injections of 0.5 mg/kg b.i.d. for 5 to 7 days) or heparin (i.v. placebo bolus, followed by s.c. injections of 12,500 IU b.i.d. for 5 to 7 days). A total of 447 patients were included in the angiographic substudy in which the primary end point, 90-min Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 of the infarct-related artery, was evaluated, while the other two-thirds served as "safety group" in which only clinical end points were evaluated. As an additional efficacy parameter the ST-segment resolution at 90 and 180 min was measured in all patients. RESULTS: TIMI flow grade 3 was observed in 40.7% in the lepirudin and in 33.5% in the heparin group (p = 0.16), respectively. In the entire study population the proportion of patients with complete ST resolution at 90 min (28% vs. 22%, p = 0.05) and at 180 min (52% vs. 48%, p = 0.18) after start of therapy tended to be higher in the lepirudin group. There was no significant difference in the incidence of hemorrhagic stroke (0.2% vs. 0.3%) or total stroke (1.2% vs. 1.5%), reinfarction rate (4.6% vs. 5.1%) and total mortality rate (6.8% vs. 6.4%) at 30 days, as well as the combined end point of death, nonfatal stroke, nonfatal reinfarction, rescue-percutaneous transluminal coronary angioplasty and refractory angina (22.7 vs. 24.3%) were not statistically different between the two groups. CONCLUSIONS: Lepirudin as adjunct to thrombolysis with streptokinase did not significantly improve restoration of blood flow in the infarct vessel as assessed by angiography, but was associated with an accelerated ST resolution. There was no increase in the risk of major bleedings with lepirudin compared to heparin.

Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training.

Interventional cardiology is an expanding field within cardiovascular medicine and today it is generally accepted that cardiologists require specific training, knowledge and skills. Hospitals where coronary interventions are performed must be properly equipped and able to provide specialised care. Percutaneous coronary interventions are frequently used for coronary revascularisation. The public should have confidence in the uniformity of high quality care. Therefore, such quality of care should be maintained by certification of the individual operators, general guidelines for institutional requirements and formal audits. The Netherlands Society of Cardiology (NVVC) will be implementing a new registration system for cardiologists with a subspecialisation that will include registration for interventional cardiology. The NVVC asked the Working Group of Interventional Cardiology (WIC) to update the 1994 Dutch guidelines on operator and institutional competence, and requirements for training in interventional cardiology in order to incorporate them into the official directives. The present guidelines represent the expert opinion of the Dutch interventional cardiology community and are in accordance with international regulations. After two rounds of discussion, the NVVC approved the guidelines in November 2004 during the autumn meeting.

Inadequate exercise leads to suboptimal imaging. Thallium-201 myocardial perfusion imaging after dipyridamole combined with low-level exercise unmasks ischemia in symptomatic patients with non-diagnostic thallium-201 scans who exercise submaximally.

This study was undertaken to establish the additional value of 201TI imaging after dipyridamole in combination with low-level exercise in 15 symptomatic patients with non-diagnostic 201TI scans, who exercised submaximally. Most patients had angina, ST-segment depression and even exertional hypotension and were referred for stress 201TI testing for determining the functional significance of known coronary artery disease. Six patients with a normal exercise 201TI test and one patient with an apical defect only were found to have 37 segments (of 105 segments) with reversible perfusion defects after dipyridamole infusion. One patient showing two reversible defects after exercise had five reversible segments after dipyridamole. Seven patients with fixed defects in 28 segments after exercise and two with small areas of border zone ischemia in seven additional (sub)segments, demonstrated fixed in defects in only nine segments but reversible defects in 40 segments after dipyridamole. Quantitative analysis resulted in 24.8 +/- 28.5 (mean value) sample points below -2 s.d. of the mean normal uptake after exercise, which increased to 72 +/- 26.5 after dipyridamole infusion (p less than 0.005). The washout analysis resulted in a mean value of 5.5 +/- 8.1 sample points below -2 s.d. after exercise, increasing to 33.3 +/- 22.1 after dipyridamole (p less than 0.005). Thallium-201 myocardial perfusion imaging after dipyridamole combined with low-level upright bicycle exercise may unmask scintigraphic evidence for ischemia in symptomatic patients who would otherwise have non-diagnostic imaging studies during submaximal exercise.

Quantitative angiographic assessment of elastic recoil after percutaneous transluminal coronary angioplasty.

Little is known about the elastic behavior of the coronary vessel wall directly after percutaneous transluminal coronary angioplasty (PTCA). Minimal luminal cross-sectional areas of 151 successfully dilated lesions were studied in 136 patients during balloon inflation and directly after withdrawal of the balloon. The circumvent geometric assumptions about the shape of the stenosis after PTCA, a videodensitometric analysis technique was used for the assessment of vascular cross-sectional areas. Elastic recoil was defined as the difference between balloon cross-sectional area of the largest balloon used at the highest pressure and minimal luminal cross-sectional area after PTCA. Mean balloon cross-sectional area was 5.2 +/- 1.6 mm2 with a mean minimal cross-sectional area of 2.8 +/- 1.4 mm2 immediately after inflation. Oversizing of the balloon (balloon artery ratio greater than 1) led to more recoil (0.8 +/- 0.3 vs 0.6 +/- 0.3 mm, p less than 0.001), suggestive of an elastic phenomenon. A difference in recoil of the 3 main coronary branches was observed: left anterior descending artery 2.7 +/- 1.3 mm2, circumflex artery 2.3 +/- 1.2 mm2 and right coronary artery 1.9 +/- 1.5 mm2 (p less than 0.025). The difference was still statistically significant if adjusted for reference area. Thus, nearly 50% of the theoretically achievable cross-sectional area (i.e., balloon cross-sectional area) is lost shortly after balloon deflation.

Usefulness of repeat coronary angiography 24 hours after successful balloon angioplasty to evaluate early luminal deterioration and facilitate quantitative analysis.

Because of the unavoidable occurrence of vessel disruption after successful coronary balloon angioplasty, the reliability of quantitative angiographic analysis in that setting has been questioned. For this reason and the suggested occurrence of delayed elastic recoil, repeat angiography at 24 hours has been advocated in clinical interventional trials. In this study, these issues are confronted by performing comprehensive quantitative analysis (Cardiovascular Angiographic Analysis System) of coronary angiograms, acquired in multiple identical projections immediately after and 24 hours after angioplasty, in 102 patients with 110 successfully dilated lesions. Vasomotion was controlled by intracoronary nitrate before angiography and all patients were fully anticoagulated (activated partial thromboplastin time 85 to 120 seconds) for > 24 hours. Paired Student's t tests applied to angiographic measurements revealed that there was no significant deterioration in minimal luminal diameter or cross-sectional area from immediately after angioplasty to 24 hours later. It can thus be inferred that there is no phenomenon of delayed elastic recoil, at least during this time period. Measurement accuracy and precision of the Cardiovascular Angiographic Analysis System from the postangioplasty angiogram are highly acceptable, at < 0.01 and +/- 0.20 mm, respectively. Therefore, it is concluded that routine repeat 24-hour angiography is not indicated after successful angioplasty. A highly significant increase (p < 0.001) in reference diameter (+0.11 +/- 0.18 mm) was responsible for the apparent increase in percent diameter stenosis (2.4 +/- 7%), a finding that demonstrates the potential for error by selective application of percent diameter stenosis measurements alone. Preferential use of absolute luminal measurements is thus strongly recommended for clinical trials with angiographic monitoring.

Ischemic ST-segment changes after dipyridamole infusion.

Thirty consecutive patients were studied by thallium-201 myocardial imaging after dipyridamole infusion and by coronary angiography because of syndromes of chest pain. Eight patients (27%) had ischemic ST-segment changes after the infusion of dipyridamole. They all had significant coronary arterial disease. It is suggested that the combination of visual analysis of myocardial imaging and analysis of ST-segment changes be used after dipyridamole infusion to improve the sensitivity of this non-invasive test.

Ridogrel as an adjunct to thrombolysis in acute myocardial infarction.

An open pilot study was performed to assess the safety and preliminary efficacy of ridogrel, a selective thromboxane-A2 synthetase inhibitor and thromboxane-A2/prostaglandin endoperoxide receptor blocker, as adjunct to thrombolysis, with alteplase and heparin. In 50 patients with acute myocardial infarction, 300 mg ridogrel was injected intravenously in addition to alteplase and heparin. Ridogrel was continued orally (300 mg) twice daily for 5 days. Patency rate at initial (90 min) angiography, defined as thrombolysis in myocardial infarction perfusion grades 2 or 3, was 86%. Rescue percutaneous transluminal coronary angioplasty was performed in 10 patients; immediate results were good in nine, while a large dissection occurred in one patient. New ischemia occurred in 10 patients within 24 h, and after the second angiogram in seven cases. Three underwent coronary artery bypass grafting and seven percutaneous transluminal coronary angioplasty without further complication. Patency rate at second angiography (between 6 and 24 h) was 94%. New Q-waves appeared in 56% of the patients; 36% had a non-Q-wave infarction and 8% had no enzyme rise. Enzymatic infarct size, estimated by the cumulative quantity of alpha-hydroxybutyrate dehydrogenase released in 72 h, was substantially smaller than in comparable studies with rt-PA and heparin. One patient died due to a cerebrovascular hemorrhage. No other deaths occurred. Bleeding complications were seen in 18 patients (36%), necessitating blood transfusion in three. Reinfarction did not occur. Eventually 49 patients were discharged in good condition. Safety with regard to bleeding complications of ridogrel in conjunction with alteplase is about the same as that of aspirin. Immediate and late patency rates were high. Rescue percutaneous transluminal coronary angioplasty could be performed with relative safety and early reocclusion could be successfully dealt with by repeat percutaneous transluminal coronary angioplasty. Further studies with this or similar compounds seem warranted.

Dipyridamole thallium testing: noncardiac side effects, cardiac effects, electrocardiographic changes and hemodynamic changes after dipyridamole infusion with and without exercise.

Thallium-201 scintigraphy in combination with intravenous dipyridamole has been reported to be useful in patients who are unable to perform maximal exercise stress testing. Few reports have dealt with side effects in large numbers of patients. For that reason noncardiac side effects, cardiac effects, electrocardiographic changes, as well as hemodynamic changes were studied in 301 consecutive patients, examined by dipyridamole thallium-201 imaging because of suspected coronary artery disease. The patients were divided into two groups (A and B). Patients in group A (101 patients) received an infusion of 0.14 mg/kg per minute dipyridamole for four minutes. Patients in group B (200 patients) received the same dose of dipyridamole followed by low level exercise (60 rpm/30 Watts) for three minutes to achieve maximal coronary blood flow and to diminish thallium-201 uptake in the gastrointestinal organs. The likelihood of having hemodynamically significant coronary artery disease was the same in both groups. Patients in group B experienced significantly less side effects than patients in group A (11% vs 43%, P less than 0.05). In group B changes in systolic blood pressure (P less than 0.05), heart rate (P less than 0.05), and rate pressure product (P less than 0.05) were more distinct. The occurrence of angina was the same in both groups (47% vs 44%, NS), but ischemic ST segment changes were significantly more frequent in group B than in group A (25% vs 12%, P less than 0.05). Thus, exercise added to dipyridamole infusion compared to dipyridamole infusion alone results in fewer noncardiac side effects, the same prevalence of angina pectoris, and a higher incidence of ST segment changes.

Quantitative thallium-201 myocardial exercise scintigraphy in normal subjects and patients with normal coronary arteries.

Quantitative thallium-201 myocardial exercise scintigraphy was tested in two patient populations representing alternative standards for cardiac normality: group I comprised 18 male uncatheterized patients with a low likelihood of coronary artery disease (CAD); group II contained 41 patients with normal coronary arteriograms. Group I patients were younger, they achieved a higher rate-pressure product than group II patients; all had normal findings by physical examination and electrocardiography at rest and exercise. Group II patients comprised 21 females, 11 patients showed abnormal electrocardiography at rest, and five patients showed ischemic ST depression during exercise. Twelve patients had signs of minimal CAD. Twelve patients revealed abnormal visual and quantitative thallium findings, three of these patients had minimal CAD. Profiles of uptake and washout of thallium-201 were derived from both patient groups, and compared with normal limits developed by Maddahi et al. Furthermore, low likelihood and angiographically normal patients may differ substantially, and both sets of normal patients should be considered when establishing criteria for abnormality in exercise thallium imaging. When commercial software containing normal limits for quantitative analysis of exercise thallium-201 imaging is used in clinical practice, it is mandatory to compare these with normal limits of uptake and washout of thallium-201, derived from the less heterogeneous group of low-likelihood subjects, which should be used in selecting a normal population to define normality.

Transradial Palmaz-Schatz coronary stenting on an outpatient basis: results of a prospective pilot study.

BACKGROUND: The applicability of Palmaz Schatz coronary stent implantation is limited by bleeding complications and prolonged hospitalization. Coronary stenting on an outpatient basis, may be the ultimate means to reduce costs of this treatment. Since bleeding and stent occlusion were infrequent complications in a group of 100 ambulatory patients who underwent stent implantation via the radial artery in our department, we performed a pilot study to determine the feasibility of using coronary stenting on an outpatient basis. METHODS: Patients selected for Palmaz Schatz stent implantation, were adequately adjusted on coumadin. At an INR > 2.5, stenting was performed via the radial approach. Based on pre-, post- and procedural criteria, considering clinical status, procedural course and outcome, absence of predictors for stent occlusion and of events during 4 to 6 hours observation, patients were considered candidates for same-day discharge. Heparin was administered only during the procedure. Immediately after the procedure, the arterial sheath was removed. Patients were mobilized and were discharged with a pressure dressing over the puncture site. Follow-up was performed on the next day, at 2 weeks and at one month. RESULTS: Between May and September 1994, 47 patients underwent Palmaz Schatz stent implantation via the radial artery. Of these, 27 remained hospitalized for reasons, considered to be incompatible with outpatient treatment. Twenty patients (CCS-class III and IV; n = 17 (85%)) received 29 stents for 23 lesions, distributed in 21 vessels and were discharged the day of treatment. No cardiac or bleeding events were encountered within 24 hours. At 2 weeks follow-up, one patient was readmitted (day 4) because of a bleeding abdominal aortic aneurysm, requiring surgery. At 1 month follow-up, no bleeding, entry-site and cardiac complications were noted. CONCLUSION: Since no complications were encountered (95% confidence interval; 0-17%) in the first 24 hours after optimal coronary stent implantation in patients with an adequate preprocedural level of anticoagulation, a larger feasibility study of outpatient coronary stenting will be undertaken.

[Percutaneous transluminal coronary angioplasty in patients older than 70 years; short- and long-term results]. / Percutane transluminale coronaria-angioplastiek bij patiënten ouder dan 70 jaar; korte- en lange-termijnresultaten.

PTCA was performed in 166 patients older than 70. The primary angiographic and clinical success rates were 85% and 86%, respectively. A total of 15 major complications occurred in 10 patients (6%): 4 patients died (2%), 6 patients underwent urgent bypass surgery (4%), the incidence of acute myocardial infarction was 3% (5 patients). The 4-year survival rate was 84 +/- 8%. During the follow-up period 8 patients (5%) sustained a nonfatal myocardial infarction, 21 patients (13%) underwent a second and (or) third balloon dilatation and 17 patients (10%) underwent bypass surgery. At the end of the observation period 68% of the survivors had a sustained improvement of the functional class. This was associated with a significant reduction of the antianginal therapy. These data demonstrate that PTCA can be performed safely and effectively in patients over 70.

[Directional coronary atherectomy; initial Dutch experiences with a new percutaneous revascularization procedure]. / Directionele coronaria-atherectomie; eerste Nederlandse ervaringen met een nieuwe percutane revascularisatiemethode.

Acute complications and restenosis in the first few months after a successful procedure remain the two major limitations of coronary balloon angioplasty. New devices have been developed in order to avoid these limitations. We tested the directional atherectomy catheter clinically and compared the immediate quantitatively analysed results with two other recently developed devices and conventional balloon angioplasty. A gain in luminal diameter of 1.7 mm after atherectomy was observed in 7 patients. This is far more than could be accomplished by balloon angioplasty, stenting and rotablation. Furthermore, the size of the device in relation to the size of the obstructed vessel suggests that a Dotter effect is partly responsible for the gain in luminal diameter. Whether this large gain can prevent restenosis remains to be confirmed. Preliminary literature data suggest that this is not the case.

Safety, efficacy and costs associated with direct coronary stenting compared with stenting after predilatation: A randomised controlled trial.

OBJECTIVES: Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation. METHODS: Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups. RESULTS: Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 µg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were €2545±914 versus €2763±842 (p=0.01), despite the implantation of more stents in the directly stented group. CONCLUSION: Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting.

Critical hand ischaemia after transradial cardiac catheterisation: an uncommon complication of a common procedure.

We describe a case of critical hand ischaemia after transradial cardiac catheterisation. The patient presented with hand ischaemia 5 days after transradial coronary angiography. Urgent angiography demonstrated radial artery occlusion with embolisation to the palmar arch and digital arteries. The ischaemia was refractory to an extensive thrombolytic regimen, and subsequently, the patient was referred to the vascular surgeon for urgent thrombectomy and patch angioplasty. The patient recovered slowly and no amputation was necessary, but complaints of right hand numbness and paresthesia of all digits remained.