Balloon-Assisted Tracking to Overcome Radial Spasm during Transradial Coronary Angiography: A Case Report.

Spasm of the radial artery is the most important cause of failure to perform coronary angiography via the transradial approach. Spasmolytic cocktail may prevent radial artery spasm but is relatively contraindicated in patients with aortic stenosis or diminished left ventricular function. In this case report we describe a recently published technique to overcome severe radial spasm during transradial coronary angiography in a patient with moderate aortic valve stenosis.

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.

Coronary air embolism treated with aspiration catheter.

Coronary air embolism remains a recognised complication of coronary catheterisation despite a strong emphasis on prevention. Current treatment consists of supportive measures with 100% oxygen and analgesia. Recent case reports describe the use of mechanical treatments aimed at dispersing or removing the air embolus with variable success. A case of coronary air embolism causing an acute coronary syndrome is described that was definitively treated with an aspiration system. The effectiveness of the aspiration system in the distal section of an obtuse marginal artery indicates that such dedicated aspiration systems may prove useful in the standard treatment of air embolism.

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.

Continued benefit of coronary stenting versus balloon angioplasty: five-year clinical follow-up of Benestent-I trial.

OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.

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.

Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS).

BACKGROUND: Although the association of ticlopidine and aspirin has been shown to be superior to anti-vitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently. METHODS AND RESULTS: We randomized 350 high-risk patients within 6 hours after stent implantation to receive during 30 days either aspirin 250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and oral anticoagulation (A+OAC group) targeted at an international normalized ratio of 2.5 to 3. The primary composite end point was defined as the occurrence of cardiovascular death, myocardial infarction, or repeated revascularization at 30 days. Patients were eligible if (1) the stent(s) were implanted to treat abrupt closure after PTCA; (2) the angiographic result after implantation was suboptimal; (3) a long segment was stented (>45 mm and/or >/=3 stents); or (4) the largest balloon inflated in the stent had a nominal diameter of

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

First international new intravascular rigid-flex endovascular stent study (FINESS): clinical and angiographic results after elective and urgent stent implantation. The FINESS Trial Investigators.

OBJECTIVES: The purpose of this study was to determine the feasibility, safety and efficacy of elective and urgent deployment of the new intravascular rigid-flex (NIR) stent in patients with coronary artery disease. BACKGROUND: Stent implantation has been shown to be effective in the treatment of focal, new coronary stenoses and in restoring coronary flow after coronary dissection and abrupt vessel closure. However, currently available stents either lack flexibility, hindering navigation through tortuous arteries, or lack axial strength, resulting in suboptimal scaffolding of the vessel. The unique transforming multicellular design of the NIR stent appears to provide both longitudinal flexibility and radial strength. METHODS: NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter international registry from December 1995 through March 1996. Nine-, 16- and 32-mm long NIR stents were manually crimped onto coronary balloons and deployed in native coronary (94%) and saphenous vein graft (6%) lesions. Seventy-four percent of patients underwent elective stenting for primary or restenotic lesions, 21% for a suboptimal angioplasty result and 5% for threatened or abrupt vessel closure. Fifty-two percent of patients presented with unstable angina, 48% had a previous myocardial infarction, and 45% had multivessel disease. Coronary lesions were frequently complex, occurring in relatively small arteries (mean [+/-SD] reference diameter 2.8 +/- 0.6 mm). Patients were followed up for 6 months for the occurrence of major adverse cardiovascular events. RESULTS: Stent deployment was accomplished in 98% of lesions. Mean minimal lumen diameter increased by 1.51 +/- 0.51 mm (from 1.09 +/- 0.43 mm before to 2.60 +/- 0.50 mm after the procedure). Mean percent diameter stenosis decreased from 61 +/- 13% before to 17 +/- 7% after intervention. A successful interventional procedure with < 50% diameter stenosis of all treatment site lesions and no major adverse cardiac events within 30 days occurred in 95% of patients. Event-free survival at 6 months was 82%. Ninety-four percent of surviving patients were either asymptomatic or had mild stable angina at 6 month follow-up. CONCLUSIONS: Despite unfavorable clinical and angiographic characteristics of the majority of patients enrolled, the acute angiographic results and early clinical outcome after NIR stent deployment were very promising. A prospective, randomized trial comparing the NIR stent with other currently available stents appears warranted.

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.