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.

Antithrombotic therapy in patients undergoing TAVI: an overview of Dutch hospitals.

PURPOSE: To assess current antithrombotic treatment strategies in the Netherlands in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: For every Dutch hospital performing TAVI (n = 14) an interventional cardiologist experienced in performing TAVI was interviewed concerning heparin, aspirin, thienopyridine and oral anticoagulation treatment in patients undergoing TAVI. RESULTS: The response rate was 100 %. In every centre, a protocol for antithrombotic treatment after TAVI was available. Aspirin was prescribed in all centres, concomitant clopidogrel was prescribed 13 of the 14 centres. Duration of concomitant clopidogrel was 3 months in over two-thirds of cases. In 2 centres, duration of concomitant clopidogrel was based upon type of prosthesis: 6 months versus 3 months for supra-annular and intra-annular prostheses, respectively. CONCLUSIONS: Leaning on a small basis of evidence and recommendations, the antithrombotic policy for patients undergoing TAVI is highly variable in the Netherlands. As a standardised regimen might further reduce haemorrhagic complications, large randomised clinical trials may help to establish the most appropriate approach.

Diagnostic and therapeutic approach of congenital solitary coronary artery fistulas in adults: Dutch case series and review of literature.

BACKGROUND: Coronary artery fistulas (CAFs) are infrequent anomalies, coincidentally detected during coronary angiography (CAG). AIM: To elucidate the currently used diagnostic imaging modalities and applied therapeutic approaches. MATERIALS AND METHODS: Five Dutch patients were found to have CAFs. A total of 170 reviewed subjects were subdivided into two comparable groups of 85 each, treated with either percutaneous 'therapeutic' embolisation (PTE group) or surgical ligation (SL group). RESULTS: In our series, the fistulas were visualised with several diagnostic imaging tests using echocardiography, multidetector computed tomography, and CAG. Four fistulas were unilateral and one was bilateral; five originated from the left and one originated from the right coronary artery. Among the reviewed subjects, high success rates were found in both treatment groups (SL: 97% and PTE: 93%). Associated congenital or acquired cardiovascular disorders were frequently present in the SL group (23%). Bilateral fistulas were present in 11% of the SL group versus 1% of the PTE group. The fistula was ligated surgically in one and abolished percutaneously in another. Medical treatment including metoprolol was conducted in two, and watchful waiting follow-up was performed in one. CONCLUSIONS: Several diagnostic imaging techniques are available for assessment of the anatomical and functional characteristics of CAFs.

Immediate versus deferred coronary angioplasty in non-ST-segment elevation acute coronary syndromes.

BACKGROUND: The field of acute coronary syndromes is characterised by an increasing tendency towards early invasive catheter-based diagnostics and therapeutics-a practice based on observational and retrospective data. OBJECTIVE: To compare immediate versus deferred angioplasty in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) METHODS: A randomised, prospective multicentre trial was performed in patients admitted with NSTE-ACS, eligible for percutaneous coronary intervention (PCI). Interim analysis was performed after enrolment of 251 patients; PCI was appropriate in 142 patients. These patients were randomised to immediate PCI (n = 73) or deferred PCI (24-48 h) (n = 69). Patients received protocol-driven glycoprotein IIb/IIIa blockers, aspirin and clopidogrel. The primary end point was a composite of death, non-fatal myocardial infarction (MI) or unplanned revascularisation, at 30 days. After hospital discharge outpatient follow-up was performed at 30 days and 6 months. RESULTS: The incidence at 30 days of the primary end point was 60% in the group receiving immediate PCI and 39% in the group receiving deferred PCI (relative risk (RR) = 1.5, 95% CI 1.09 to 2.15; p = 0.004). No deaths occurred in either group. MI was significantly more common in the group receiving immediate PCI (60% vs 38%, RR = 1.6, 95% CI 1.12 to 2.28, p = 0.005). Unplanned revascularisation was similar in both groups. The observed difference was preserved over 6-months' follow-up. CONCLUSIONS: Immediate PCI was associated with an increased rate of MI in comparison with a 24-48 h deferred strategy, despite aggressive antithrombotic treatment. The results suggest that PCI for high-risk patients with non-refractory NSTE-ACS should be delayed for at least 24 h after hospital admission. TRIAL REGISTRATION NUMBER: ISRCTN80874637.

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.

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.

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.

Measurement of radial artery spasm using an automatic pullback device.

Current evaluation of radial artery spasm (RAS), a frequent finding during the transradial approach for coronary angiography and angioplasty (TRA), is subjective. A quantitative measure of RAS will help in evaluation and comparison of management strategies. The objectives of the study were to assess the feasibility and safety of using an automatic pullback device (APD) for removal of transradial introducer sheaths and to establish a parameter to quantify RAS. In 50 consecutive transradial procedures, the APD was used to measure the force required for sheath removal. The mean maximal pullback force (MPF) was 0.53 +/- 0.52 kg (range, 0.1-3.0 kg). In 48 (96%) cases, the MPF was reached within the first 5 sec of pullback. All patients with clinical RAS (n = 4) had an MPF greater than 1.0 kg, while the remaining had an MPF less than 1.0 kg. All patients with severe pain during sheath removal (n = 3) had an MPF greater than 1.0 kg, while no patient with an MPF less than 1.0 kg had severe pain. It is feasible and safe to remove transradial introducer sheaths using the APD. The MPF is achieved within the first 5 sec of pullback and is a reliable parameter to quantify RAS. An MPF more than 1.0 kg correlates with clinical RAS and is associated with severe pain during sheath removal.

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.

Direct coronary stent implantation: safety, feasibility, and predictors of success of the strategy of direct coronary stent implantation.

This prospective study was designed to evaluate the feasibility, safety, predictive factors of success, and 6-month follow-up of stent implantation without balloon predilatation (direct stenting) in 250 patients undergoing elective stent implantation. Balloon dilatation prior to stent implantation was a prerequisite to facilitate passage and deployment of the stent. Stent technology has changed tremendously, resulting in stents with improved properties, which may allow stent placement without prior balloon dilatation. Patients with coronary lesions suitable for elective stent implantation were included in this trial. Coronary interventions were undertaken predominantly via the transradial route using 6 Fr guiding catheters. Direct stent implantation was attempted using AVE GFX II coronary stent delivery systems. Upon failure, predilatation was undertaken before reattempting stent implantation. Patient data and ECGs were obtained from case records and from personal or telephone interviews 6 months after the procedure. Values were presented as mean +/- standard deviation. Student's t-test, two-tailed at 5% level of significance, was used to compare the difference of two means. Multivariate logistic regression analysis was performed to establish predictive factors for failure of direct stenting. Two hundred and sixty-six direct stent implantations were attempted in 250 patients. Direct stenting was successful in 226 (85%) cases. Out of 40(15%) cases where direct stenting failed, balloon predilatation facilitated stent implantation in 39. In one lesion, stent implantation was not possible despite adequate predilatation. Predictive factors for failure of direct stenting on multivariate analysis were LCx lesions (P < 0.01), complex lesions (P < 0.01), and longer stents (P < 0.001). Minimal luminal diameter and percentage diameter stenosis of lesions in the successful and the failure group were not significantly different (0.94 +/- 0.39 mm vs. 0.84 +/- 0.41 mm, P = NS, and 70.2 +/- 11.2 vs. 73.2 +/- 11.2, P = NS). Stent loss occurred in five (2.0%) cases, with successful retrieval in four. One stent was lost permanently in a small branch of the radial artery. Post-percutaneous coronary intervention (post-PCI) myocardial infarction occurred in four (1.6%) patients. There were no other in-hospital events. Six-month-follow up information was obtained in 99% of patients. Subacute stent thrombosis was noted in four (1.6%) cases. Target vessel-related myocardial infarction rate was 3.2%, of which half was caused by subacute stent thrombosis. The overall reintervention rate (coronary artery bypass grafting or PCI) was 9.7%. Target lesion revascularization by PCI occurred in only 4.0%. At 6 months, overall mortality was 2.0%, of which 1.2% was due to coronary events. Direct stent implantation is safe and feasible in the majority of cases with low rate of complications. Unfavorable factors include circumflex lesion, more complex lesion morphology, and increasing length of stent. Severity of stenosis does not appear to be of predictive value. Long-term outcome is favorable with a low target lesion revascularization rate.

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.

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.

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.

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.

Mode of deployment of coronary Palmaz-Schatz stents after implantation with the stent delivery system: an intravascular ultrasound study.

The stent delivery system (SDS) is a sheath-covered Palmaz-Schatz stent mounted on a 3.0, 3.5, or 4.0 mm compliant polyethylene balloon catheter; the balloon resists maximal inflation pressures of 5.7, 6.2, or 6.0 atm, respectively. It is postulated that these pressures are too low to obtain optimal stent deployment. Because optimal stent deployment is a prerequisite for optimal short- and long-term outcome, we performed an intravascular ultrasound study to the mode of stent deployment after delivery with the SDS and after high-pressure dilatations with low-compliant, oversized balloon catheters. In 23 patients an intravascular ultrasound study (30 MHz, 4.3F transducer) was performed to the geometry of 29 stents immediately after delivery with the SDS and after successive high-pressure inflations with low-compliant balloons. After delivery with the SDS (3.3 +/- 0.4 mm), stent diameter was 3.0 +/- 0.4 mm. After high-pressure dilatations (12.4 +/- 1.4 atm) with low-compliant balloons (3.9 +/- 0.5 mm), stent diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Only 8 (28%) stents were completely and symmetrically expanded to the corresponding reference diameter with good apposition after delivery with the SDS. Diameter of incomplete deployed stents (n = 16) was 2.8 +/- 0.3 mm. After high-pressure dilatations with low-compliant balloons (3.9 +/- 0.5 mm), diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Now 20 (69%) stents (p = 0.004) became completely and symmetrically expanded to a diameter corresponding to the reference diameter. In conclusion, most stents are suboptimally deployed after delivery with the stent delivery system.(ABSTRACT TRUNCATED AT 250 WORDS)

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)