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G J Laarman

Publications and source records attributed to G J Laarman.

At least 19 recordsLinked to original sources

Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events: six month results of a randomized trial.

STUDY OBJECTIVE: To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. PATIENT POPULATION AND METHODS: Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. RESULTS: Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). CONCLUSIONS: Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.

Angina Pectoris↗

Direct coronary stenting compared with stenting after predilatation is feasible, safe, and more cost-effective in selected patients: evidence to date indicating similar late outcomes.

OBJECTIVES: To review the currently available data from studies assessing feasibility, safety, clinical outcome and cost-effectiveness of direct stenting. BACKGROUND: With technical advances of stent designs and their delivery systems a new strategy has become increasingly popular: direct stent implantation without prior balloon dilatation. METHODS: The Medline database was searched from January 1996 to March 2001 for clinical trials investigating direct stenting using the index terms direct stenting, coronary intervention, percutaneous transluminal coronary angioplasty (PTCA), PCI, angioplasty and ischemic heart disease. Studies were chosen based on the number of patients involved and endpoints mentioned. Data not yet published but presented at recent international meetings were also included. A comparison between direct stenting and stenting with predilatation was performed using for the latter results of the randomized trials supplemented with Benestent II data. RESULTS: At least 26 studies have investigated direct stenting, showing high primary and final success rates with few complications. Direct stenting provides a way to reduce costs, shorten procedural and fluoroscopy times and lower material consumption. Immediate and long-term clinical outcomes appear to be similar to stenting with predilatation. Preliminary results of large randomized trials with angiographic follow-up indicate that restenosis rates are similar to those of conventional stenting strategies. CONCLUSIONS: Direct stenting compared with stenting with predilatation is feasible, safe, faster and more cost-effective. The evidence to date shows similar late outcomes.

Angioplasty, Balloon, Coronary↗

Actual outpatient PTCA: results of the OUTCLAS pilot study.

This study tested the safety and feasibility of coronary angioplasty on an outpatient basis. The purpose of this approach includes cost-effectiveness and patient comfort. Included were 159 patients treated with balloon angioplasty or intracoronary stent placement, all performed via the radial artery with 6 French guiding catheters. Patients were selected for same-day discharge based on the absence of any adverse predictor for subacute occlusion or unfavorable clinical outcome during the first 24 hr after successful PTCA. One hundred and six (66%) patients were discharged 4-6 hr after PTCA. Stents were used in 40% of patients. There were no cardiac or vascular complications. We conclude that outpatient PTCA, performed via the radial artery, is both safe and feasible in a large part of a routine PTCA population.

Ambulatory Surgical Procedures↗

Safety and efficacy of AVE gfx stent implantation via 6 Fr guiding catheters.

This prospective study was designed to determine the feasibility of AVE gfx premounted stent systems in combination with 6 Fr guides. Between 1 April and 12 August 1997, 230 patients underwent AVE gfx coronary stent implantation via 6 Fr guides. The radial approach was used in 146 patients (63.5%). In 230 procedures (293 lesions), 237 guiding catheters were used. A total of 331 AVE gfx stents were implanted, 1.4 per patient. Backup, opacification, and friction were considered good in 85.8%, 96.4%, and 76.7%, respectively. Slight and severe friction was felt during combined use of long (> or = 18 mm), large-sized (3.5 mm) stents and small-sized guiding catheters (inner diameter, 0.061-0.062"). The presence of a second protecting guidewire impaired passage of the AVE gfx stent, also in large 6 Fr guides (ID 0.064"). Of 331, 320 (96.7%) stents were successfully deployed at the initial attempt. Ten stents (3%) had to be retrieved. Six of these were successfully placed at a second attempt and three slipped off the balloon, all successfully retrieved from the patient's circulation. At 1 month, 217 patients (94.4%) were free of events. The AVE gfx stent is compatible with 6 Fr guiding catheters. Use of new-generation, large-bore 6 Fr gc (> or = 0.064") is recommended.

Adult↗

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.

Adult↗

Assessment of coronary angiograms prior to and after treatment with abciximab, and the outcome of angioplasty in refractory unstable angina patients. Angiographic results from the CAPTURE trial.

BACKGROUND: The CAPTURE study (c 7E3 A nti P latelet T herapy in U nstable Re fractory angina) was designed to assess outcome in patients with refractory angina undergoing angioplasty, receiving either abciximab or placebo. METHODS: One thousand two hundred and sixty-five patients with refractory unstable angina, defined as recurrent myocardial ischaemia despite medical treatment including heparin and nitrates were enrolled. After angiography, patients received an infusion of abciximab or placebo over 18-24 h preceding angioplasty, continuing until 1 h after the procedure. In 1197 patients undergoing angioplasty the angiographic committee centrally reviewed the baseline as well as the procedural angiograms. Coronary flow and lesion characteristics were assessed in the baseline angiogram as well as before intervention. Angiographic outcome, reason for failure as well as complications were assessed after angioplasty. RESULTS: At 30 days follow-up, patients receiving abciximab (n=595) compared with placebo (n=602) had a 30% reduction in the composite primary end-point death, myocardial infarction or urgent (re)intervention: 10.8% vs 15.4% (P=0.017). Baseline demographics were identical in the angiogram available group compared with the total study group. At 30 days, the non-angiogram available patients showed a higher incidence of events compared to those in whom the angiogram was reviewed: 19.4 vs 13.1% (P=ns). Lesion characteristics and coronary flow were not different at baseline between the placebo and abciximab groups. A primary end-point was reached in 9.6% of both placebo and abciximab patients with type A or B(1)lesions, in 17.0% vs 12.0% with type B(2)lesions, and in 19.1% vs 11.5% with type >B(2)or C lesions. Sixty-one percent of placebo and abciximab patients had TIMI 3 flow at baseline angiography. Pre-angioplasty TIMI 3 flow was observed in 69% and 72% respectively. The thrombus was resolved between the angiograms in 22% and 43% respectively, in the placebo and abciximab groups (P=0. 033). Angiographic success of the procedure was achieved in 88% and 94% in the placebo and abciximab patients, respectively (P<0.001). Stents were implanted in the ischaemia-related artery in 56 and 60 patients, respectively. However, failure of the stent procedure was more frequent in the placebo group than in the abciximab group, nine vs no patients (P=0.003). CONCLUSION: More frequent thrombus resolution was observed and a higher angiographic success rate was achieved in patients treated with abciximab before and during angioplasty compared with placebo. Patients with complex lesions as the underlying pathology reached fewer end-points if treated with abciximab before and during angioplasty.

Abciximab↗

Incidence and outcome of radial artery occlusion following transradial artery coronary angioplasty.

Coronary angioplasty with 6F guiding catheters via the radial artery is associated with a minimal risk for major entry site-related complications. Although the incidence of radial artery occlusion (RAO) in the literature is approximately 30% after prolonged cannulations, little is known about the incidence and its clinical consequences of RAO following transradial percutaneous coronary angioplasty. In a prospective study, 563 patients with a normal Allen test were evaluated on patency and function of the radial artery after transradial angioplasty, by physical and ultrasound examination at discharge, and at 1 month follow-up. At discharge, 30 patients (5.3%) had clinical evidence of RAO. At follow-up, persistent RAO was found in 16 patients (2.8%). In this study we found a low incidence of RAO after transradial percutaneous coronary angioplasty. None of the patients with temporary or persistent RAO had any major clinical symptoms. Therefore, the occurrence of RAO can be considered a minor complication in patients with a previously good double blood supply to the hand.

Aged↗

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.

Aged↗

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.

Angioplasty, Balloon, Coronary↗

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.

Adult↗

A comparison of hirudin with heparin in the prevention of restenosis after coronary angioplasty. Helvetica Investigators.

BACKGROUND: The likelihood of restenosis is a major limitation of coronary angioplasty. We studied whether hirudin, a highly selective inhibitor of thrombin with irreversible effects, would prevent restenosis after angioplasty. We compared two regimens of recombinant hirudin with heparin. METHODS: We randomly assigned 1141 patients with unstable angina who were scheduled for angioplasty to receive one of three treatments: (1) a bolus dose of 10,000 IU of heparin followed by an intravenous infusion of heparin for 24 hours and subcutaneous placebo twice daily for three days (382 patients), (2) a bolus dose of 40 mg of hirudin followed by an intravenous infusion of hirudin for 24 hours and subcutaneous placebo twice daily for three days (381 patients), or (3) the same hirudin regimen except that 40 mg of hirudin was given subcutaneously instead of placebo twice daily for three days (378 patients). The primary end point was event-free survival at seven months. Other end points were early cardiac events (within 96 hours), bleeding and other complications of the study treatment, and angiographic measurements of coronary diameter at six months of follow-up. RESULTS: At seven months, event-free survival was 67.3 percent in the group receiving heparin, 63.5 percent in the group receiving intravenous hirudin, and 68.0 percent in the group receiving both intravenous and subcutaneous hirudin (P = 0.61). However, the administration of hirudin was associated with a significant reduction in early cardiac events, which occurred in 11.0, 7.9, and 5.6 percent of patients in the respective groups (combined relative risk with hirudin, 0.61; 95 percent confidence interval, 0.41 to 0.90; P = 0.023). The mean minimal luminal diameters in the respective groups on follow-up angiography at six months were 1.54, 1.47, and 1.56 mm (P = 0.08). CONCLUSIONS: Although significantly fewer early cardiac events occurred with hirudin than with heparin, hirudin had no apparent benefit with longer-term follow-up.

Angina, Unstable↗

Percutaneous transradial coronary Palmaz-Schatz stent implantation, guided by intravascular ultrasound.

Intravascular ultrasound (IVUS) allows accurate assessment of stent deployment, its use being confined to the use of 8 French (F) guiding catheters. We evaluated the feasibility of combining transradial artery Palmaz-Schatz stent implantation through 6F guiding catheters with IVUS for assessment of stent diameter after delivery at moderate inflation pressures (10-12 atmospheres [atm]) with compliant balloons and after high pressure dilatations with balloons of intermediate compliance. In 8 consecutive patients, 12 stents were delivered with Scimed Express balloon catheters at 10-12 atm followed by IVUS (EndoSonics CathScanner; Visions FX 3.5F 20 MHz transducer). An ultrasound study was repeated after high pressure dilatations (16-20 atm) with Schneider Magical Speedy balloon catheters. The balloon diameters were derived from manufacturer provided specifications. In all patients the transducer could easily be advanced through the guiding catheters. Reference diameter of the stented segment was 3.7 +/- 0.5 mm (2.7-4.5) and the diameter of Scimed Express balloons during inflation was 4.0 +/- 0.3 mm (3.6-4.7). Stent diameter was 3.0 +/- 0.1 mm (2.8-3.2) (P < 0.001 compared to the reference and the balloon diameter). The diameter of the Schneider Magical Speedy balloons at secondary dilatations with 16 +/- 3 atm (14-20) was 4.1 +/- 0.4 mm (3.3-4.5) (P = 0.50 compared to the initial balloon diameter). Final stent diameter was 3.3 +/- 0.4 mm (2.9-4.1) (P = 0.02 compared to the initial stent diameter). All stents were symmetrically deployed and well apposed. No damage to vessel or stents was detected after passage of the transducer.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Cost comparison between two modes of Palmaz Schatz coronary stent implantation: transradial bare stent technique vs. transfemoral sheath-protected stent technique.

Coronary Palmaz Schatz stent implantation is usually performed by using the sheath protected stent delivery system (SDS) via the percutaneous transfemoral route. However, downsizing of PTCA equipment made transradial coronary stenting feasible. Bare stent implantation, 6F technique, increased patient mobility, reduced vascular complications and reduced hospital stay may increase cost effectiveness of this novel technique. Two well-documented patient groups selected for elective single vessel and single lesion Palmaz Schatz stent implantation were retrospectively compared. Group A (transradial stenting; n = 35) was compared to Group B (transfemoral stenting; n = 25) derived from the Benestent population, included in our hospital. A comparison was made for three areas of interest: (1) procedural consumption of material (the number of guiding catheters, guidewires, balloon catheters and stents), (2) postprocedural need for diagnostic and therapeutic procedures for stent-related complications, and (3) duration of hospital stay. Differences between these subjects in Group A and B were translated to hospital costs. Although more guiding catheters were used in group A (1.69 +/- 0.87 vs. 1.08 +/- 0.28; P = 0.001), the use of the SDS contributed importantly to higher material costs in group B (cost reduction in group A; 13%). Less patients in group A required diagnostic (2 vs. 7; P = 0.027) and therapeutic (0 vs. 5; P = 0.01) procedures for bleeding complications (cost reduction; 93%). Hospitalization in Group A was shorter (6.4 +/- 4.7 vs. 11.6 +/- 9.9 days; P = 0.005), caused by early and safe mobilization, less vascular complications, and preprocedural adjustment on coumadin (cost reduction; 45%).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Transradial artery coronary angioplasty.

This study explored the feasibility and safety of percutaneous coronary balloon angioplasty (PTCA) with miniaturized PTCA equipment via the radial artery. Coronary angioplasty (PTCA) via the femoral or brachial arteries may be associated with rare vascular complications such as bleeding and damage to the artery and adjacent structures. It was postulated that PTCA via the radial artery with miniaturized angioplasty equipment is feasible and that no major puncture site-related complications occur because hemostasis is obtained easily and because no major structures are near the radial artery. With double blood supply to the hand, radial artery occlusion is well tolerated. In 100 patients with collateral blood supply to the right hand, PTCA was attempted with 6F guiding catheters and rapid-exchange balloon catheters for exertional angina (87 patients) or nonexertional angina (13 patients). Angioplasty was attempted in 122 lesions (type A n = 67 [55%], Type B n = 37 [30%], and type C n = 18 [15%]). Pre- and post-PTCA computerized quantitative coronary analysis was performed. Radial artery function and structure were assessed clinically and with Doppler and two-dimensional ultrasound on the day of discharge. Coronary catheterization via the radial artery was successful in 94 patients (94%). The 6 remaining patients had successful PTCA via the femoral artery (n = 5) or the brachial artery (n = 1). Procedural success (120 of 122 lesions) was achieved in 92 patients (98%) via the radial artery and in 98 patients of the total study population.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Transradial artery Palmaz-Schatz coronary stent implantation: results of a single-center feasibility study.

The purpose of this study was to evaluate the feasibility and safety of implantation of unsheathed Palmaz-Schatz coronary stents introduced via the radial artery. Anticoagulation after coronary stenting carries the risk of vascular complications if large-bore guiding catheters are introduced via the femoral artery. These complications have serious local sequelae and lead to suboptimal anticoagulation and prolonged hospitalization. By combining 6F guiding catheters and low-profile dilatation catheters mounted with Palmaz-Schatz stents, smaller vessels such as the radial artery can be selected as the entry site. It is hypothesized that with this technique major puncture site-related complications rarely occur because hemostasis is easily achieved and because no veins and nerves are near this artery. With the double blood supply to the hand, radial artery occlusion is well tolerated. In 100 consecutive patients, stent implantation was attempted for 122 lesions in 104 vessels. Immediately after stent implantation and final angiography, the introducer sheath was withdrawn and intense anticoagulation and mobilization initiated. The radial artery puncture site was studied by two-dimensional and Doppler ultrasound. Successful stent implantation via the radial artery was achieved in 96 patients. In 2 patients, arterial puncture failed but was followed by successful stenting via another entry site. In 1 patient, stent implantation was achieved with a stent delivery system via the femoral artery after a failed attempt to cross the lesion with a bare stent via the radial approach, complicated by groin bleeding requiring transfusions and vascular surgery.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Angiographic dose-finding study with r-hirudin (HBW 023) for the improvement of thrombolytic therapy with streptokinase (HIT-SK). Interim results.

To evaluate the efficacy and safety of hirudin, a direct thrombin inhibitor, in patients with acute myocardial infarction, a dose-finding, angiography study was carried out. After a pilot phase in 10 patients treated with a bolus of 0.1 mg.kg-1 and a continuous infusion of 0.06 mg.kg-1.h-1 (dose group I), two doses of hirudin, bolus 0.2 mg.kg-1.h-1 (DG II), and bolus 0.4 mg.kg-1 with 0.15 mg.kg-1.h-1 (DG III) were tested and compared with heparin as an adjunct to streptokinase and aspirin. This interim analysis was mandatory due to puncture-site related bleedings. Early and complete patency was achieved in 30% of 35 heparin patients, in 40% of 10 DG I, in 47% of 58 DG II and in 62% of 14 DG III patients. A dose-response relationship particularly between DG I and DG II, was also observed in the anti-thrombotic activity monitored by the aPTT. Apart from the catheter-related bleedings, there were low rates of serious adverse events.

Adult↗