Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.     

Procedural outcome and follow-up results of balloon angioplasty versus new device interventions for treatment of true bifurcation stenoses

Strategies for dilatation of bifurcation stenoses have continued to evolve over the past several years. However, there is limited experience on the efficacy of various nonballoon interventional devices and their results in comparison with balloon angioplasty. We, therefore, analysed our data in 72 patients of coronary artery disease with true bifurcation stenoses with balloon angioplasty or new device interventions (NDI). All patients underwent dilatation of both the primary vessel and side branch ostial stenosis. Balloon angioplasty using double guidewire with sequential or simultaneous (kissing balloon) balloon inflation in the two vessels was performed in 42 patients. Thirty patients underwent NDI, using directional coronary atherectomy (DCA) in 12, rotablation in 6 and elective coronary stents in 12 patients. There were no significant differences in the baseline clinical and angiographic variables between patients in the two groups. While the preprocedural luminal diameter stenosis was similar, the residual stenosis was significantly less, both in the primary vessel and side branch, after NDI compared to balloon angioplasty. The procedure was successful in 96.6 percent patients treated with NDI and 83.3 percent with balloon angioplasty (p < 0.01) with relief of obstruction in both branches without any major complications. Freedom from subsequent coronary events in the form of angina, myocardial infarction, PTCA, bypass graft surgery of death was significantly more, both at 6 months (92% versus 65.6%, p < 0.001) and 12 months (81.8% versus 53.1%, p < 0.001) in the group of patients treated with NDI compared to balloon angioplasty. It is, therefore, concluded that NDI including DCA, rotablation and elective stenting are associated with higher rate of success, lesser complications and better event-free survival in comparison to balloon angioplasty for treatment of true bifurcation stenoses.     

Sulcus fixated posterior chamber lenses with and without suture in cases lacking capsular support

Although percutaneous transluminal coronary angioplasty (PTCA) has been an effective treatment for primary reperfusion in acute myocardial infarction, patients with thrombolytic ineligibility, thrombolytic failure, cardiogenic shock, and vein graft occlusion remain at high risk for complications with PTCA treatment. The transluminal extraction catheter may be useful for treatment for such patients owing to its ability to aspirate thrombus. At 2 clinical centers, extraction atherectomy was prospectively evaluated in 100 patients (age 62 +/- 10 years). High-risk features included thrombolytic failure in 40%, postinfarct angina in 28%, presence of angiographic thrombus in 66%, presence of cardiogenic shock in 11%, and a saphenous vein graft occlusion in 29%. Procedural success, defined as a final residual stenosis <50% and Thrombolysis in Myocardial Infarction 2 or 3 grade flow, was seen in 94%. Events during the hospitalization included death in 5%, bypass surgery in 4%, and blood transfusion in 18%. In a substudy, patients enrolled at William Beaumont Hospital (n = 65) underwent elective predischarge angiography, which revealed a patent infarct-related vessel in 95%. These patients were also followed for 6 months with angiographic follow-up in 60%. Target vessel revascularization was necessary in 38%, and 6-month mortality was 10%. Although long-term vessel patency was 90%, angiographic restenosis occurred in 68%. Acute myocardial infarction patients can be treated with extraction atherectomy with a high technical success rate and a low incidence of complication. Infarct artery patency at 1 week and 6 months was excellent; however, angiographic restenosis remains a problem. Extraction of thrombus in this high-risk group of patients is associated with low in-hospital mortality and a high rate of vessel patency at 6 months.     

Primary stenting of de novo lesions in small coronary arteries: a prospective, pilot study

Technical advancement and new anti-thrombotic regimens have recently shown so much improvement in the results of coronary stenting that the conventional contra-indication for stenting in small coronary arteries (<3 mm) needs to be revised. We undertook a prospective pilot study of elective Palmaz-Schatz stenting in de novo lesions located in coronary arteries of less than 3 mm diameter. Fifty consecutive patients (63 +/- 9 years) with stable (n = 38) and unstable angina (n = 12) were included. Philips-DCI quantitative coronary analysis was used to measure reference diameter, minimal lumen diameter and percent diameter stenosis before PTCA, after stenting and at 6-month angiographic follow-up study. All measurements were performed after intracoronary injection of nitroglycerin (300 microg). All patients received ticlopidine (250 mg/day) and aspirin (100 mg/day). The mean lesion length was 9 +/- 3 mm. The balloon size used for stent delivery was 2.75 mm in 30 patients and 2.5 mm in 20 patients and the mean balloon inflation pressure used for stent deployment was 12 +/- 2 atm. All stents were deployed successfully. In-hospital complications occurred in two patients, diagonal branch occlusion at day 2 requiring emergency PTCA in one and a hematoma at the femoral puncture site requiring surgery in the other. Major adverse cardiac event (MACE) rate remained 2% (nonfatal infarct in one). Follow-up angiography (n = 46, 92%) at 6 +/- 3 months showed a 30% restenosis rate. Target vessel revascularization (TVR) rate was 13%. We conclude that elective stenting in small coronary arteries is feasible and involves an acceptable risk of restenosis.     

Histopathology of coronary lesions with early loss of minimal luminal diameter after successful percutaneous transluminal coronary angioplasty: is thrombus a significant contributor?

BACKGROUND: Early loss of minimal luminal diameter of >0.3 mm after successful percutaneous transluminal coronary angioplasty (PTCA) is associated with a higher incidence of restenosis. The underlying mechanism of this early loss is unknown and thrombus may be a contributing factor. METHODS: We performed a prospective study using quantitative computerized planimetry on coronary tissue specimens obtained by directional coronary atherectomy of 24 lesions in which early loss occurred 22+/-9 minutes after successful PTCA. RESULTS: Thrombus was present in 9 (37%) of 24 coronary specimens. Segmental areas (mm2) and percentage of total area were distributed as follows: sclerotic tissue, 4.07+/-0.7 mm2 (63%+/-6%); fibrocellular tissue, 0.97+/-0.27 mm2 (16%+/-4%); hypercellular tissue, 0.99+/-0.29 mm2 (12%+/-3%); atheromatous gruel, 0.18+/-0.07 mm2 (3%+/-0.1%); and thrombus, 0.24+/-0.15 mm2 (6%+/-0.4%). There was no difference in the relative early loss index between lesions with or without thrombus (35%+/-7% vs 26%+/-2%, respectively; P= .87). Multiple stepwise regression analysis did not identify any histologic predictors of relative early loss index. CONCLUSION: Histopathologic analysis of coronary lesions with early loss after successful PTCA suggests that thrombus may not play a significant role in this angiographic phenomenon.     

Mechanisms of luminal enlargement and quantification of vessel wall trauma following balloon coronary angioplasty and directional atherectomy

OBJECTIVES: The purpose of this study was to assess the dual action of lumen enlargement and vessel wall damage following either balloon angioplasty or directional atherectomy, using intracoronary ultrasound, and angioscopy. BACKGROUND: Differences in the mechanisms of action of balloon angioplasty and directional atherectomy may have a significant bearing on the immediate outcome and the restenosis rate at 6 months. METHODS: A total of 36 patients were studied before and after either balloon angioplasty (n = 18) or directional atherectomy (n = 18). Ultrasound measurements included changes in lumen area, external elastic membrane area and plaque burden. In addition, the presence and extent of dissections were assessed to derive a damage score. Angioscopic assessment of the dilated or atherectomized stenotic lesions was translated into semi-quantitative dissection, thrombus and haemorrhage scores. RESULTS: Atherectomy patients had a larger angiographic vessel size compared with the angioplasty group (3.55 +/- 0.46 mm vs 3.00 +/- 0.64 mm, P < 0.05); however, minimal lumen diameter (1.18 +/- 0.96 mm vs 0.85 +/- 0.49 mm) and plaque burden (17.04 +/- 3.69 vs 15.23 +/- 4.92 mm2) measurements did not differ significantly. As a result of plaque reduction, atherectomy produced a larger increase in luminal area than the angioplasty group (5.80 +/- 1.78 mm2 vs 2.44 +/- 1.36 mm2, P < 0.0001). Lumen increase after angioplasty was the result of 'plaque compression' (50%) and wall stretching (50%). Additionally, in both groups there was indirect angioscopic evidence of thrombus 'microembolization' as an adjunctive mechanism of lumen enlargement. Angioscopy identified big flaps in six and small intimal flaps in 11 of the atherectomized patients as compared with five and 12 patients in the angioplasty group. Changes in thrombus score following both coronary interventions were identical (0.72 +/- 3.42 points atherectomy vs -0.38 +/- 3.27 points balloon angioplasty, ns). CONCLUSIONS: Lumen enlargement after directional atherectomy is mainly achieved by plaque removal (87%), whereas balloon dilation is the result of vessel wall stretching (50%) and plaque reduction (50%). Despite the fact that the luminal gain achieved by directional atherectomy is twice that achieved with balloon angioplasty, the extent of trauma induced by both techniques seems to be similar.     

The immediate results of percutaneous transluminal coronary angioplasty at Hospital San José de Monterrey

We analyzed 69 consecutive PTCA performed upon 64 patients from January 1990 to May 1992. Age was 55 +/- 12 years and 80% were male. Fifty-nine percent were smokers, 32% had hypertension, 16% a remote myocardial infarction, 14% diabetes, 12% previous PTCA, and 6% previous coronary artery bypass surgery. Total cholesterol was 238 +/- 75 mg/dl. Most of the subjects had an acute coronary syndrome, with unstable angina in 31 and a recent myocardial infarction in 23. Angiographically, 52% had single vessel disease, 39% had double vessel and 9% triple vessel disease. LVEF was 55 +/- 11%, LVEDP 17 +/- 10 mm Hg, and 44% had wall motion abnormalities. We dilated 1.4 lesions/patient (1-4), for a total of 100 lesions. Luminal stenosis was reduced from (mean +/- SEM) 88.5 +/- 1.1% to 22.6 +/- 2.2% (p < 0.0001). The procedure was a total clinical success in 85.6% of the patients and a partial clinical success in 4.3%. Complete revascularization was achieved in 62.3% and incomplete but adequate revascularization in 26%. Multiple lesions dilatation was performed in 30% of the patients and multiple vessel angioplasty in 17%. Forty-seven lesions were on the LAD distribution (91.5% angiographic success), 24 on the circumflex (95.8% angiographic success), 26% on RCA (88.4% angiographic success) and 3 in others. There was a 10% failure and 13% complication rates, but more than half of them were successfully managed medically, although 5.7% required urgent CABG. One patient died.     

A clinical trial comparing primary stenting of the infarct-related artery with optimal primary angioplasty for acute myocardial infarction: results from the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) trial

OBJECTIVES: This study sought to compare stenting of the primary infarct-related artery (IRA) with optimal primary percutaneous transluminal coronary angioplasty (PTCA) with respect to clinical and angiographic outcomes of patients with an acute myocardial infarction. BACKGROUND: Early and late restenosis or reocclusion of the IRA after successful primary PTCA significantly contributes to increased patient morbidity and mortality. Coronary stenting results in a lower rate of angiographic and clinical restenosis than standard PTCA in patients with angina and with previously untreated, noncomplex lesions. METHODS: After successful primary PTCA, 150 patients were randomly assigned to elective stenting or no further intervention. The primary end point of the trial was a composite end point, defined as death, reinfarction or repeat target vessel revascularization as a consequence of recurrent ischemia within 6 months of randomization. The secondary end point was angiographic evidence of restenosis or reocclusion at 6 months after randomization. RESULTS: Stenting of the IRA was successful in all patients randomized to stent treatment. At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p=0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p=0.001). CONCLUSIONS: Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.     

Adult moyamoya disease progressing from unilateral to bilateral involvement

The effect of domestically-manufactured excimer laser with adjunctive balloon angioplasty in achieving revascularization and reduction of residual stenosis was assessed. 20 femoral arteries with thrombosis and occlusion from 12 dogs were subject to angiography. At first excimer laser angioplasty was done followed by balloon angioplasty. The diameter and residual stenosis of revascularized vessel were measured. The result showed that 17 out of 20 vessels (85%) were revascularized. The diameter of revascularized vessel by excimer laser were 1.22 +/- 0.14 mm, while residual stenoses were 54% +/- 5%. After adjunctive balloon angioplasty the diameter and residual stenoses were 2.04 +/- 0.16 mm and 20% +/- 7% respectively (P < 0.05 and P < 0.01). Complication in form of vasoperforation occurred in 3/20 vessels (15%). It is concluded that China- manufactured excimer laser angioplasty is effective when used for revascularization. While the reduction of narrowing and residual stenoses was enhanced after adjunction of balloon angioplasty. This method can be employed in treating peripheral occlusive disease effectively and safely.     

Comparison of balloon angioplasty versus debulking devices versus stenting in right coronary ostial lesions

Angioplasty of aorto-ostial stenosis is associated with lower procedural success and a higher complication rate. The aim of the present study was to compare the acute and long-term results of balloon and new device angioplasty in 110 consecutive patients with right coronary ostial lesions. Patients were divided into 3 groups according to the angioplasty device used: group I (balloon only, n = 26), group II (debulking devices including excimer laser, directional and rotational atherectomy, n = 26), group III (stent, n = 58). Procedural success was highest in group III (96%) followed by group I (88%), and group II (77%). In-hospital complications were similar among the groups (p = NS). Patients in group III achieved the highest acute gain (2.61 mm) followed by groups II (1.92 mm), and I (1.39 mm, p <0.05). During follow up, target lesion revascularization and/or bypass surgery was required in 24% of patients in group III compared with 47% and 40% in groups I and II, respectively (p <0.05). Cardiac-event free survival was highest in the stent group (74%, p <0.005) and was similar between the balloon (39%) and debulking device groups (45%). Thus, among the currently available technologies, stenting of right coronary ostial lesions appears to provide excellent angiographic and long-term results.     

Optimal burr and adjunctive balloon sizing reduces the need for target artery revascularization after coronary mechanical rotational atherectomy

We analyzed the effect of differing burr and balloon sizes during mechanical rotational atherectomy on the need for target vessel revascularization at 6 months. The ideal burr/artery ratio and adjunctive balloon/artery ratio for optimizing acute luminal results and minimizing restenosis is unknown. Six-month clinical follow-up was obtained in 311 patients (339 lesions) treated with rotational atherectomy from August 1993 to September 1994, to determine whether procedural results or technique were related to the need for target vessel revascularization. Target vessel revascularization, defined as repeat percutaneous intervention or bypass surgery within 6 months after rotational atherectomy, occurred in 19% of patients. Larger burr/artery ratios, defined as the final burr size divided by the reference artery size, were correlated with decreased postatherectomy diameter stenosis (p <0.009) and decreased final diameter stenosis (p <0.03). However, there was no statistical association between postatherectomy or final diameter stenosis with need for revascularization (p = not significant [NS]). The need for revascularization was lowest for burr/artery ratio between 0.6 to 0.85 (15%) versus burr/artery <0.6 or >0.85 (25%) (p <0.04). Postatherectomy, smaller balloon/artery ratios, defined as the final balloon size divided by the reference artery size, were correlated with lower repeat revascularization rates. Balloon/artery ratios <0.95 (target vessel revascularization = 11% vs 25% in balloon/artery >0.95) were associated with the best luminal results and the least risk for clinical restenosis (p <0.006). For rotational atherectomy, despite improvement in acute luminal results with increased burr/artery ratio, the use of a moderate burr/artery ratio correlated with the lowest revascularization rates. There was no correlation between postatherectomy or final diameter stenosis and need for repeat interventions. However, the use of large balloon/artery ratios after rotablator was associated with higher target vessel revascularization rates.     

Ultrastructure and distribution of axon terminals from the reticular thalamic nucleus to the anteroventral thalamic nucleus of the rat

The Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, while rotated at 1,500 revolutions per minute, is advanced across the lesion over a special spiral guidewire system. We report the initial clinical experience with this device in 20 peripheral lesions in ten patients. The majority of patients were treated for limb salvage. All lesions were successfully intervened on by atherectomy followed by adjunctive balloon angioplasty. A reduction to less than 50% stenosis was achieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 lesions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0.8 +/- 0.7 mm with a reference vessel diameter of 4.2 +/- 1.7 mm (75 +/- 21% stenosis). The lumen improved to 2.0 +/- 0.8 mm (45 +/- 19% stenosis) (P < 0.001) following atherectomy and to 3.9 +/- 1.9 mm (13 +/- 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average weight of removed atheroma was 45 +/- 58 mg. All ten patients had initial improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputations. Our early clinical experience with this low profile, flexible atherectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherectomy technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation.     

Effectiveness of an antioxidant in preventing restenosis after percutaneous transluminal coronary angioplasty: the Probucol Angioplasty Restenosis Trial

OBJECTIVES: The Probucol Angioplasty Restenosis Trial was a prospective, randomized, controlled study that investigated the effectiveness of probucol therapy in reducing the rate of restenosis after percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND: Antioxidants have an inhibitory effect on smooth muscle cell growth in experiments in vitro and in vivo, which suggests a possible pharmacologic effect on restenosis after PTCA. METHODS: One hundred one patients were randomly assigned to receive 1,000 mg/day of probucol or control (no lipid-lowering) therapy 4 weeks before PTCA. After 4 weeks of premedication, both groups underwent PTCA. Probucol was continued until follow-up angiography 24 weeks after PTCA. Angiographic results were analyzed at a core laboratory by quantitative coronary angiography. RESULTS: Dilation was successful in 46 of 50 patients in the probucol group and 45 of 51 in the control group. At follow-up angiography 24 weeks after angioplasty, angiographic restenosis occurred in 9 (23%) of 40 patients in the probucol group and 22 (58%) of 38 in the control group (p = 0.001). Minimal lumen diameter was 1.49 +/- 0.75 mm (mean +/- SD) in the probucol group and 1.13 +/- 0.65 mm in the control group (p = 0.02). Percent diameter stenosis at follow-up angiography in the probucol group was significantly lower than that in the control group (43.9% vs. 56.4%, p = 0.009). The late loss was 0.37 +/- 0.69 mm in the probucol group and 0.60 +/- 0.62 mm in the control group (p = 0.13). The loss/gain ratio was 0.32 +/- 0.74 in the probucol group and 0.56 +/- 0.81 in the control group (p = 0.059). Net gain was greater in the probucol group than in the control group (0.77 +/- 0.70 vs. 0.48 +/- 0.59 mm, p = 0.053). CONCLUSIONS: Probucol administered beginning 4 weeks before PTCA appears to reduce restenosis rates.     

Magnetically labeled secretin retains receptor affinity to pancreas acinar cells

To clarify the mechanisms of restenosis, restenotic human tissue specimens obtained by directional coronary atherectomy (DCA) in 43 patients were immunohistochemically analysed for cell proliferation and deposition of PG-M/versican, an important extracellular matrix proteoglycan of the vessel wall. The patients were classified into five groups according to the period after percutaneous transluminal coronary angioplasty (PTCA): 0-1 month (N = 6), 1-3 months (N = 12), 3-6 months (N = 11), more than 6 months (N = 6) and de novo lesions (N = 8). The tissue specimens were of 35 restenotic lesions following PTCA and eight primary stenotic lesions with no prior PTCA. Total cell numbers in the atherectomy specimens increased significantly up to 3 months after PTCA. Most cells were alpha-smooth muscle actin (alpha-SMA)-positive. To evaluate cell proliferation, the specimens were immunostained for Ki-67 antigen (clone MIB-1). A significant increase in the positive ratio was observed up to 1 month after PTCA, although the labelling index was less than 1 per cent at every stage. The deposition of PG-M/versican, as analysed by immunohistochemistry, was greatest during the period 1-3 months after primary angioplasty, when restenosis detected by angiography progresses most actively. These results suggest that the peak of cell proliferation in the neointima occurs earlier than angiographic restenosis and that the deposition of PG-M/versican may be a major factor in restenosis following angioplasty.     

Differences in restenosis propensity of devices for transluminal coronary intervention. A quantitative angiographic comparison of balloon angioplasty, directional atherectomy, stent implantation and excimer laser angioplasty. CARPORT, MERCATOR, MARCATOR, PARK, and BENESTENT Trial Groups

With the increasing clinical application of new devices for percutaneous coronary revascularization, maximization of the acute angiographic result has become widely recognized as a key factor in maintained clinical and angiographic success. What is unclear, however, is whether the specific mode of action of different devices might exert an additional independent effect on late luminal renarrowing. The purpose of this study was to investigate such a difference in the degree of provocation of luminal renarrowing (or 'restenosis propensity') by different devices, among 3660 patients, who had 4342 lesions successfully treated by balloon angioplasty (n = 3797), directional coronary atherectomy (n = 200), Palmaz-Schatz stent implantation (n = 229) or excimer laser coronary angioplasty (n = 116) and who also underwent quantitative angiographic analysis pre- and post-intervention and at 6-month follow-up. To allow valid comparisons between the groups, because of significant differences in coronary vessel size (balloon angioplasty = 2.62 +/- 0.55 mm, directional coronary atherectomy = 3.28 +/- 0.62 mm, excimer laser coronary angioplasty = 2.51 +/- 0.47 mm, Palmaz-Schatz = 3.01 +/- 0.44 mm; P < 0.0001), the comparative measurements of interest selected were the 'relative loss' in luminal diameter (RLoss = loss/vessel size) to denote the restenosis process, and the 'relative lumen at follow-up' (RLfup = minimal luminal diameter at follow up/vessel size) to represent the angiographic outcome. For consistency, lesion severity pre-intervention was represented by the 'relative lumen pre' (RLpre = minimal luminal diameter pre/vessel size) and the luminal increase at intervention was measured as 'relative gain' (relative gain = gain/ vessel size). Differences in restenosis propensity between devices was evaluated by univariate and multivariate analysis. Multivariate models were constructed to determine relative loss and relative lumen at follow-up, taking account of relative lumen pre-intervention, lesion location, relative gain, vessel size and the device used. In addition, model-estimated relative loss and relative lumen at follow-up at given relative lumen pre-intervention relative gain and vessel size, were compared among the four groups. Significant differences were detected among the groups both with respect to these estimates, as well as in the degree of influence of progressively increasing relative gain, on the extent of renarrowing (relative loss) and angiographic outcome (relative lumen at follow-up), particularly at higher levels of luminal increase (relative gain). Specifically, lesions treated by balloon angioplasty or Palmaz-Schatz stent implantation (the predominantly 'dilating' interventions) were associated with more favourable angiographic profiles than directional atherectomy or excimer laser (the mainly 'debulking' interventions). Significant effects of lesion severity and location, as well as the well known influence of luminal increase on both luminal renarrowing and late angiographic outcome were also noted. These findings indicate that propensity to restenosis after apparently successful intervention is influenced not only by the degree of luminal enlargement achieved at intervention, but by the device used to achieve it. In view of the clinical implications of such findings, further evaluation in larger randomized patient populations is warranted.     

Directional coronary atherectomy for the treatment of Palmaz-Schatz in-stent restenosis

Management of in-stent restenosis has become a significant challenge in interventional cardiology. The results of balloon angioplasty have been disappointing due to the high recurrence of restenosis at follow-up. Debulking of the restenotic tissue within the stents using directional coronary atherectomy (DCA) may offer a therapeutic advantage. We report the immediate clinical and angiographic outcomes and long-term clinical follow-up results of 45 patients (46 lesions), mean age 63+/-12 years, 73% men, with a mean reference diameter of 2.9+/-0.6 mm, treated with DCA for symptomatic Palmaz-Schatz in-stent restenosis. DCA was performed successfully in all 46 lesions and resulted in a postprocedural minimal luminal diameter of 2.7+/-0.7 mm and a residual diameter stenosis of 17+/-10%. There were no in-hospital deaths, Q-wave myocardial infarctions, or emergency coronary artery bypass surgeries. Four patients (9%) suffered a non-Q-wave myocardial infarction. Target lesion revascularization was 28.3% at a mean follow-up of 10+/-4.6 months. Kaplan-Meier event-free survival (freedom from death, myocardial infarction, and repeat target lesion revascularization) was 71.2% and 64.7% at 6 and 12 months after DCA, respectively. Thus, DCA is safe and efficacious for the treatment of Palmaz-Schatz in-stent restenosis. It results in a large postprocedural minimal luminal diameter and a low rate of both target lesion revascularization and combined major clinical events at follow-up.     

The influence of coffee with milk and tea with milk on the bioavailability of tetracycline

BACKGROUND: At the initial stages of percutaneous transluminal coronary angioplasty (PTCA), several studies reported on the feasibility of coronary artery incision and dilatation leading to the extension of the PTCA technique. HYPOTHESIS: This study was designed to determine the immediate and chronic results of cutting balloon (CB) angioplasty. METHODS: This procedure was performed on 127 lesions in 110 patients (male 83%, age 61.8 +/- 9.3 years). RESULTS: The overall procedural success rates for the CB were 93.7% (119 lesions) and 92.7% (102 patients), while solitary CB without pre- and/or postdilatation was 76.4% (91 lesions). There was one major in-hospital complication (Q-wave myocardial infarction, 0.9%), but there were no deaths or emergency coronary artery bypass graftings. Significant angiographic dissections (> or = grade C) occurred in four patients, and coronary perforation occurred in one. The successfully treated CB group (95 lesions) was matched with the successful conventional angioplasty group (PTCA group) for chronic result assessment in regard to reference vessel size and lesion characteristics. In the CB group, postprocedural minimal luminal diameters were significantly larger and the percentage of stenosis at the stenotic site was significantly lower compared with the PTCA group. Restenosis occurred in 22 lesions (23.1%). This showed a significantly lower restenosis rate compared with the PTCA group (42.1%). In addition, the restenosis rate of the CB without inclusion of the pre- and/or postdilatation-treated lesions was 19.7%. CONCLUSIONS: (1) Cutting balloon angioplasty procedures can be performed with high success rates with few major inhospital events. (2) The restenosis rate in the CB group was significantly lower compared with the PTCA group.     

Impact of diabetes mellitus on percutaneous revascularization (CAVEAT-I). CAVEAT-I Investigators. Coronary Angioplasty Versus Excisional Atherectomy Trial

We examined the relation between diabetes mellitus and outcomes in patients undergoing percutaneous coronary revascularization in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I), a randomized trial comparing treatment with either percutaneous transluminal coronary angioplasty or directional atherectomy for de novo lesions in native coronary arteries. Acute success and complication rates, 6-month angiographic restenosis rates, and 1-year clinical outcomes were compared between diabetic and nondiabetic patients undergoing each procedure. Acute success rates between diabetic (n = 191) and nondiabetic (n = 821) patients were similar for both revascularization techniques. Except for the need for dialysis, complication rates were also similar. Six months after atherectomy, diabetic patients had significantly more angiographic restenosis than nondiabetics (59.7% vs 47.4%) and significantly smaller minimum luminal diameters (1.20 vs 1.40 mm). Diabetics undergoing atherectomy required more frequent bypass surgery (12.8% vs 8.5%) and more repeat percutaneous revascularizations (36.5% vs 28.1%) than nondiabetics undergoing atherectomy. Restenosis rates, minimum luminal diameters and repeat revascularizations between diabetics and nondiabetics undergoing angioplasty were similar. The higher restenosis and repeat revascularization rates and the smaller minimum luminal diameter at follow-up in diabetic patients suggest that atherectomy may provide only modest benefit for these patients. The increased restenosis rate in diabetics undergoing atherectomy (but not angioplasty) requires further evaluation.     

Baseline characteristics and therapeutic goals in the New Approaches to Coronary Intervention (NACI) registry

BACKGROUND: The New Approaches to Coronary Intervention (NACI) voluntary registry was designed to study the use, safety, and efficacy of new percutaneous transluminal interventional devices including directional coronary atherectomy, the transluminal extraction catheter, the rotablator, the Palmaz-Schatz stent, the Gianturco-Roubin stent, the Advanced Interventional Systems (AIS) laser, and the spectranetics laser. METHODS: To date, more than 3800 consecutive patients treated for the first time with a new device at 41 centers have been entered into the registry. Complete detailed information about the patient, lesions, device characteristics, reasons for device selection, and procedural data, such as adjunctive use of conventional balloon angioplasty (PTCA), was available for the first 2835 patients. RESULTS: The registry shows that 88% of the 3233 attempts with a new device were intended as a definitive treatment of target lesions, frequently in combination with adjunctive PTCA. The remaining 12% of attempts with a new device were unplanned, prompted by unexpected complications, unsuccessful attempts, or suboptimal results with PTCA. Although there was some overlap in the indications for selecting a given interventional device, the variation from device to device was sufficiently large to caution users against any direct comparison of either safety or efficacy between devices without careful attention to the differences in baseline patient and lesion characteristics, treatment plans, and the circumstances of device use. CONCLUSION: This report provides the first comprehensive overview of how new interventional devices are currently being used in the treatment of coronary artery lesions at the 41 centers participating in the NACI registry.     

Stenting after optimal lesion debulking (sold) registry. Angiographic and clinical outcome

BACKGROUND: Coronary stenting has reduced restenosis in focal de novo lesions, but its impact has been less pronounced in complex lesion subsets. Preliminary data suggest a role for plaque burden in promoting intimal hyperplasia after stent implantation. The aim of this study was to test the hypothesis that plaque removal with directional atherectomy before stent implantation may lower the intensity of late neointimal hyperplasia, reducing the incidence of in-stent restenosis. METHODS AND RESULTS: Seventy-one patients with 90 lesions underwent directional atherectomy before coronary stenting. Intravascular ultrasound-guided stenting was performed in 73 lesions (81%). Clinical success was achieved in 96% of patients. Procedural complications were as follows: emergency bypass surgery in 1 patient (1.4%), who died 2 weeks later; Q-wave myocardial infarction in 2 patients (2.8%); and non-Q-wave myocardial infarction in 8 patients (11.3%). None of the patients had stent thrombosis at follow-up. Angiographic follow-up was performed in 89% of eligible patients at 5.7+/-1.7 months. Loss index was 0.33 (95% CI, 0.26 to 0.40), and angiographic restenosis was 11% (95% CI, 5% to 20%). Clinical follow-up was performed in all patients at 18+/-3 months. Target lesion revascularization was 7% (95% CI, 3% to 14%). CONCLUSIONS: Directional atherectomy followed by coronary stenting could be performed with good clinical success rate. Also, these data point to a possible reduction in angiographic restenosis and a significant reduction in the need for repeated coronary interventions. Therefore, a randomized clinical trial seems appropriate to test the validity of this approach.