clinical interventional cardiology

Stenting — what happens after / Clinical interventional cardiology

P2437

CLINICAL INTERVENTIONAL CARDIOLOGY

C-Reacttve protein and Interteukln levels during elective and ball-out stent implantation

N A Mfchelakakis, T.S. Apostoloo, A.S. Perplnla, M. Mykw*fls, N.B. Kafkas, A A Zacharuils. Peripheral General Hospital of Athens, Cardiac Department, Athens HeUas Introduction: Although there Is a significant decrease of restenosis in patients (pts) underwent Percutaneous Transluminal Coronary Angtopiasty (PTCA), with Elective Stent Implantation (ESI) restenosis rate of Bail-out Stenting (BUS) is high, regardless the good initial angiographic result There is a significant increase of Acute Phase Reactants (APR) after PTCA of complex lesions, indicating an Inflammatory response to the trauma caused by the procedure, implicated to the higher restenosis rate of this group of patients. The aim of this study was to assess the variations of ARP In pte with ESI and BLS. Methods: We measured C-reactive protein (CRP) and Irrterleukins (IL) 6,1/3,8 in 18 pts with ESI (group A) and 22 pts with BLS (group B). Vein blood samples were taken before, 6, 24 and 48 h after the procedure. Results: There was a significant Increase of CRP in pts of group B at 6, 24 and 48 h. IL levels Increased in both groups at 6 h but remained significantly higher in pts of group B.

16±1.5 27±4 p < 0.001

IL6(pg/f) 6h

24 h

48 h

10±2 29±8 p < 0.001

IL1/J(pg/I) 6h 24h

J. Hausteiter, J. Dirschinger, A. Kreis, A. Schomig. Deutsches Herzzentrvm MOnchen. Klinik an der Technischen UnfversttSt MQnchen, Germany For optimal intracoronary stent expansion the use of high-pressure, noncompljant balloons has been proposed. In this study, we prospectfvety investigated the angtographic results of stent implantations with compliant balloons (CB) and subsequent high-pressure dflatations with non-compliant balloons (NCB). 65 Palmaz-Schatz stent implantations were performed in 55 patients. The indications for stenting were restenosis (9), suboptimal PTCA results (10), dissections (28) and complex coronary lesions (7). Using on-line quantitative coronary angiography the pre-intervenBonal vessel size, the final balloon diameter as well as the resulting mean stent diameter (D) were determined: Results: The pre-interventtonal vessel size was 3.57 ± 0.49 mm.

6h

24 h

48 h

Group A 26±2.1 20±4.1 12±54 56±1.6 5 3±1.9 3.2±2.5 30.4±6.2 23 8±5 15±8 37±3 31±2 15 8±3.1 13.2±2.5 9.1±1.5 49.2±5 Group B 58±10 57±6 39±5 «- p < 0.001 -

NCB

11 ± 1 3 9±0.3 3.5 ±0.4 3.28 ±0.42*

14±2 3 5±0.4 3 6 ±0.3 3.39 ±0.38*

Conclusion: Using CB for stent implantations the intended overslzing of 0.33 mm (balloon/vessel ratio: 1.1) didnot occur. Furthermore, the resulting stent diameters were significantly smaBer than the vessel size. Subsequent highpressure dilatations with NCB Improved significantly the angiographic stent expansion.

P2440

Conclusions: Our results indicate a strong inflammatory reaction after stent implantation which Is stronger in Bail-out situations and may be implicated to the higher restenosis rate in this group of patients.

P2438

CB

p < 0.05;+ (or C8 « vessel steer for CB •» NCB

D-8(pg/l) 48 h

The influence of balloon material and Inflation pressure on stent expansion

Implantation of balloon expandable copper atents In porcine coronary arteries. A mode) for testing the efficacy of stent coating in decreasing stent thrombo genie tty

Krzysztof L Wilczek, Ivan K. De Scheerder, Kai Wang, Lisa Tarn, Pham N. Lan, Eric Verbeken, Etienne Schacht, Jan H. Plessens. University Hospital Gasthuisberg, Leuven, Belgium Balloon expandable copper stents are thrombogente resulting in a subacute closure within 24 hours after implantation. The potential beneficial elect of coating these stents with a poryurethane (PU) and a heparin (HEP) coating were evaluated in a porcine coronary model. PU-coated (n - 15), HEP-coated (n - 8) and bare (B) non-coated stents (n = 14) were implanted in the right coronary artery of 27 juvenile domestic pigs. Stent patency was angiographically controlled 20 mln, 7 days and 6 weeks after stent implantation. Significantly less fatal stent thrombosis occurred In the coated stent group compared to the bare copper stent group (B: n - 6; PU: n - 2; HEP: n - 0, p < 0.02). At 7 days control, 6 additional stents were occluded (B: n - 3; PU: n - 2; HEP:n-2). Histopathologlcal examination revealed organized Intraluminal thrombi accompanied by an intense inflammatory reaction in all stented arteries. In conclusion: balloon expandable copper stents Implanted in porcine coronary arteries lead to frequent thrombottc stent occlusions. Potyurethane and especially heparin coating of these stents results in a significant decrease of the thrombogenic events.

Intra-vascular ultrasound and quantitative angiographic evaluation of Wiktor stent deployment: low versus high pressure

P. Yang, A. Hassan, V. MOhtberger\ H. Sochor, F. Wefcflnger, D. Glogar for the Austrian Wiktor Stent Study Group. Dept of Cardiology, University of Vienna;' Dept of Cardiology, University of Innsbruck, Austria Current strategies of coronary stenting Include the use of high-pressure postdilatJon (HPD) to achieve optimal stent deployment. Quantitative coronary arteriography (OCA) and intravascular ultrasound (IVUS) were used to assess the eject of HPD of the Wiktor stent (WS) In a prospective randomized protocol. 120 patients (56 ± 10 years, 100 males) undergoing WS Implantation were randomized to stent deployment using tow pressure (6-10 bar, group A) or to HPD (> 12 bar, group B). IVUS studies were performed in a subset of 43 patients before and after stent implantation and following HPD. Lumlnal cross-sectional areas (CSA) were measured at the narrowest segment within the stent and at proximal and distal reference sites. In-stent CSA was also expressed as a percentage of the average from proximal and distal reference CSA (MUSIC criteria). Minimal lumen diameter (MLD) was measured by OCA in two matched views. Per-group analysis: (p = NS)

A B

MLDpre(mm)

MLD post (mm)

CSAprefmm2)

CSA post (mm2)

1.06±0.52 1.09 ±0.51

2.81 ±0.46 2.83 ±0.51

4.63 ±1.89 4.94 ± 1 04

6 03 ±1.86 7.48 ±3.10

Subgroup analysis(group B):

PreHP Pott HP P

IAD (mm)

CSA (mm2)

2.60 ±0.54 233 ±0.51 — "- -• - . -^ —

Conclusions: 1.) Almost all stem areas were smaller than the calculated areas of the balloon catheters used for stent implantation. 2.) IVUS-measurements showed frequently incomplete expansion of the stents as compared to the reference areas. 3.) The balloon catheters chosen by angiographic criteria were not undersized.

P2444

Coronary stenting with high-pressure balloon expansion and no oral antlcoagulatron In unstable angina: results In a series of one-hundred consecutive patients

F. RiWchlni, G. Steffenino, A. Dellavalle, A. vado, E. Conte, E. Ustenghi. Cardiac Catheterization Unit, and Division ol Cardiology, Ospedale Santa Croce, Cuneo, Italy Unstable angina (UA) is a risk factor for complications during balloon PTCA. Coronary stenting (CS) can improve PTCA results and reduce acute complications. Thrombo-occlusive complications are frequent in UA and may be of concern for CS. One-hundred consecutive patients (p) with UA (according to Braunwakfs classification) were treated with PTCA and elective (not In emergency) highpressure CS, wfthin 48 h of coronary angiography, after pre-treatment with iv heparin and oral Uclopidlne 500 mg/day. Fifty-three p had type B angina and 47 had type C angina (at rest within 10 days of AMI treated with systemic ivrjc therapy). PTCA was performed in 70 p after medical treatment for 48 h, as planned, [Il-B UA - 37p and Il-C UA - 33p]; in 30 p it was performed earlier, due to refractory angina [Ill-B UA - 16p and Ill-C UA = 14p]. Lesion morphology was: type A in 24p, B1 in 4Qfl, B2 In 26p and C In 10. Only proximal or mid vessels larger than 2.8 mm were treated. In §3 cases CS was decided before the procedure: 21 were recurrent lesions, 6 were vein graft stenoses and 36 were complex lesions. CS was decided after baDoon PTCA in 37p because of unsatisfactory result (residual stenosis > 30% or dissection > grade B). A total of 115 stems (90 PaJma£-Sohaiz and 25 Flexstent) were successfully deployed in 107 lesions; 14 p received multiple stenting; a mean minimum fuminal diameter of 3.18 + - 0 . 3 mm, and 11.2% residual stenosis was achieved. In-hospfta) complications were limited to the vascular puncture site (vascular repair in ip, and blood transfusion In another), 5 p developed side-effects to tkdopkfirte. reversible after drug discontinuation. No p had subacute stem thrombosis (within 2 months). At 2-month clinical follow-up no p had suffered AMI, 2p had developed CCS II angina, and other 2 had angina at rest due to eariy restenosi*. In conclusion: High-pressure CS of major epicanfial coronary arteries without subsequent oral antfcoagulatton of era exeefent results ID selected p with UA, if an optimal angiographic result is achieved, and treatment with Udoptdtne is started before the procedure and continued for 2 months.

Downloaded from http://eurheartj.oxfordjournals.org/ by guest on October 24, 2016

P2442

bdc

Clinical interventional cardiology | P2445 Use of coronary stents following failed percutaneous translumlnal coronary angloplasty In octogenarians C. Sullen, P. Urban, P. Chatelain, V. Verine, E. Rombaut, A. Arceo, P.-A. Dorsaz, W. Rutishauser. CanSology Center, University Hospital, Geneva, Switzerland

P 2 4 4 6 | Percutaneous cardiopulmonary bypass support atent Implantation In a sole remaining vessel In patients with severe left ventricular function Fayaz A. Shawl, Alain Efstratiou, Fernando Lapetina, Amy Dukovcic, Stephanie Cornell, Kathryn G. Dougherty. Washington Adventist Hospital, Takoma Park, MD, USA Percutaneous cardiopulmonary bypass supported (PCPS) coronary angloplasty (CA) has been used in pts with severe left ventricular (LV) dysfunction. Mortality has generally been related to abrupt vessel closure post CA. We reasoned that primary stenting might increase primary success and reduce mortality. We report 17 symptomatic pts (15 men, 2 women, mean age 62 ± 8 years) with LV dysfunction (mean LVEF15 ± 6%, range 8-20%) and multJvessel disease who underwent PCPS/Stent implantation. None of the pts were surgical candidates, all had a history of myocardial Infarction (including 3 in cardiogenic shock), 41 % had prior bypass surgery, 47% had chronic renal failure and 53% had severe chronic obstructive pulmonary disease. In all pis the stented vessel (6 left main, 5 LAD, 2 RCA, 4 saphenous vein grafts) was the sole remaining patent vessel. Electromechanical dissociation and ventricular ffcrillatton was noted In 11 pts (65%) within 15 seconds of balloon inflation. Procedural success was 100%, although 3 required balloon counterputeatlon to facilitate PCPS weaning and 1 of those required dialysis for persistent renal failure. On follow-up (9 ± 5 months), 1 pt suffered a fatal ventricular arrhythmia and the other 16 remain symptomatJcally improved Including 1 pt who returned for additional vessel intervention. These data indicate PCPS/Stent implantation is a safe and effective strategy for intervention in a sole remaining patent vessel in pts with severe LV dysfunction.

P 2 4 4 7 | Does coronary stenting of unprotected left main coronary artery constitute an acceptable therapy In high-risk patients? C. Karam, C. Loubeyre, C. Jordan, J. Fajadet, B. Cassagneau, J.P. Laurent, J. Marco. Cllnique Pasteur, Toulouse, France Left main coronary artery (LMCA) stenosis is associated with a poor prognosis and a high yearly mortality rate when treated medically. Surgical revascularIzation improves survival, but, In some patients (pts), extra-cardiac factors can lead to a prohibitive surgical risk. In these situations, PTCA and stenting of unprotected LMCA stenosis can be performed but it has not yet been established whether this treatment Is safe and efficient Unprotected LMCA was treated by stenting in 30 pts: 26 men, 4 women, mean age 72 ± 10 years (52-90), 63% had three-vessel and 37% had two-vessel disease. The reason for non-surgical treatment was: contra-indlcation in 21 pts, patient's choice in 6 and emergency during acute myocardial infarction (Ml) In 3 pts. Mean LMCA stenosis was 80% ± 18 (3 pts had acute closure). Angioplasty was performed with transfemoral 8 French In 24 pts and transradial 6 French approach In 6 pts. Intra-aortJc balloon was used In 2 pts. Stem used was Glanturco-Roubln (GR) in 16 pts, Palmaz-Schatz (PS) in 12 pts and Wlktor in 1 p t one pt had both GR and PS stents. Mean stent final diameter was 3.82 ± 0.47 mm. All patients received 250 mg of oral aspirin and 500 mg of tJclopidine. In-hospital major cardiac events consisted in non LMCA-related Ml In 1 pt and procedure-related death in 2 pts (7%): one cardiac death from heart failure and one gastrointestinal bleeding. Clinical follow-up (mean: 183 days) was obtained for the 28 discharged pts. We observed 4 additional death: 3 cardiac death (11%) and one pulmonary cancer Of the 24 (80%) alive pts, 17 are free of angina pectorls and 7 complain from stable functional class II angina. We conclude that even if stenting of unprotected LMCA stenosis in highsurgical risk pts is technically feasible, It is associated with high-mortality rate (17%) at follow-up. However, initial patient status should be considered in analysing this mortality rate.

P2448 Coronary angloplasty for the treatment of chronic left ventricular dysfunction In patients with coronary artery disease: predictive value of positron emission tomography F. Fath-Ordoubadl, K.J. Beatt, N. Spyrou, P.G. Camlci. MRC Clinical Sciences Centre and RPMS, Hammersmith Hospital, London, UK Several studies have proved that coronary revascularisatJon can Improve the function of chronically dysfunctional (D) myocardium In patients (pts) with coronary artery disease. In these studies, coronary bypass atone or a mixture of bypass and coronary angtoplasty (PTCA) have been used. Aim of the present study was to ascertain the value of PTCA alone to improve function in viable dysfunctJoning myocardium. Myocardial viability (MV) was assessed with PET and ieF-flurodeoxyglucose (FDG) during euglycemte hypennsulinemlc clamp (EHC) before PTCA. PET viability, was defined as the Mean Metabolic Rate of Glucose (MRG, MmoVmin/g) of < 0.26 In each SEG (i.e. the mean MRG value in normal SEG -1 SD). The functional outcome was assessed by echocardlography performed before and 3 months after PTCA. A 16 segment (SEG) left ventricular model was used for regional analysis of both quantitative PET and wall motion score (WMS). Improvement of > 1 grade in regional WMS was considered to Indicate viability. Eighteen pts (age: 60 ± 11, 1 female) who had successful PTCA were studied, 3 of which were excluded because of occurrence of restenosis at 3 months post PTCA. Out of 254 ventricular SEG, 136 (54%) were normal and 118 (47%) D. The mean MRG value was 0.36 ± 0.1 In normal and 059 ± 0.13 (p < 0.00001) in D-SEG. Both the ejection fraction (EF), 37 ± 13 Vs 41 ± 13 (p - 0.03) and WMS, 1.59 ± 0.32 Vs 1.41 ± 0.44 (p - 0.03) improved significantly after PTCA. Out of 114 SEG revascularised, 50 (44%) were D. After PTCA 26 (52%) improved, 22 (44%) remained unchanged and 2 (4%) worsened. Out of 24 D-SEG that were PET viable 22 (92%) improved after revascularisatJon. Sensitivity, specificity, and predictive values (PV) of PET are given below. SensWvtty

Specificity

Positive PV

Negative PV

92%

91%

92%

91%

Conclusions: 1- In this selected group of pts, PTCA improved function in > 90% of PET viable SEG and led to significant Improvement In EF and WMS. 2. Quantitative FDG PET during EHC has a very high accuracy in identifying myocardial viability in pts undergoing PTCA.


Balloon dilatation of the coronary arteries (PTCA) is Increasingly used in the ekferty population, thus Increasing the potential need tor coronary stem implantation In this group. We report on the feasibility and safety of coronary stenf ng for failed balloon angtoplasty in selected octogenarians. Methods: Between November 1991 and June 1995 we performed PTCA in 108 patients aged 80 or more (mean age 82 ± 2 years). Eighteen patients with a poor PTCA result required the implantation of 28 Palmaz-Schatz stents. The stented artery was the left main (n = 2), left anterior descending (n = 10), right (n = 5), and circumflex coronary artery (n - 1). Eleven procedures were for suboptimal angtographlc result and seven for true bail-out situations with impaired coronary flow. Eight patients (44%) had additional PTCA performed in another vessel during the same procedure. Results: All procedures were technically successful. There were two target vessel occlusions (11%), both on day 2, one of which was reversed by repeat PTCA. Major in-hospital complications occurred in 2 patients (11%): one bleeding-related In-hospital death and one Q-wave myocardial infard There was no need for emergent CABG. After a mean follow-up of 8 ± 8 months, one patient had died of progressive cardiac failure, 12 were free of angina and 4 had NYHA class II angina. Three patients needed re-PTCA. There was no late AMI and no need for CABG. The quality of life of survivors was excellent as measured by a median score of 4 (range 0 to 5) on the Guttman scale of Instrumental Activities of Daily Living (max. score possWe » 5). Conclusions: Coronary stenting for failed PTCA in octogenarians appears to be an effective procedure and is associated with a similar complication rate to that observed in younger patients.

457

458 P2449

Clinical interventional cardiology

Endolumlnal vessel reconstruction of coronary arteries by multiple stent placement In patients who are poor surgical candidates

P2451

Coronary stenting of chronic total occlusions without anticoagulation: Immediate and long-term outcome

Issam Moussa, Carlo Dl Mano, Lucia Di Francesco, Bemhard Reimers, Simonetta Blengino, Giovanni Martini, Jonathan Tools, Antonio Colombo. Columbus Hospital, Milan, Italy

Endolumlnal vessel reconstruction of coronary arteries by multiple stent placement is a new concept in the treatment of obstructive coronary artery disease. We currently investigate the safety and efficacy of this therapy in patients with single or multivessel disease who were refused for surgical revascuJarization. Methods: in patients with extensive single- or multi-vessel disease judged poor candidates for bypass grafting complete revascularizatton was attempted by an aggressive approach using multiple stents for endoluminal reconstruction of long lesions or totally occluded vessels. Stents were chosen ±1.5 mm larger than the reference diameter of the vessel and proximal and cfistal ends were implanted in "healthy" segments. Results: From January 1995, 27 patients have been treated. Vessel reconstruction was performed In 17 single, 6 two and 4 three-vessel cases by using Palmaz-Schatz, Micro, Wiktor and Wallstents. Stenting was technically feasible in all cases. On average 3 ± 1 stents were implanted per vessel. In-hospital complications were: death following gastric bleeding and severe hemorrhaghic shock on day 3 (1 patient) and non-Q-wave myocardial Infarction (1 patient). Complications during follow-up (mean: 7 ± 4 months) were: sudden death at 3 weeks (1 patient), restenosis requiring repeat Intervention and documented by repeat angtography (6/18 patients = 33%). In conclusion, thiese preliminary data suggest that percutaneous revascularization by muttiple single- or multi-vessel stenting can be performed in patients not considered for coronary artery bypass grafting.

Coronary angioplasty of chronic total occlusions has been disappointing because of low success rates and high restenosis. The purpose of this study was to determine the safety and efficacy of coronary stenting without anticoagulation in chronic total occlusions (>2 months in duration). We treated 94 lesions In 93 consecutive pts (mean age 56 ± 10 yr.) with stenting. Baseline proximal vessel size was 3.14 ± 0.54 mm, lesion length 18.4 ± 9.1 mm. Several types of sterrts were used (Palmaz-Schatz 44%, Wiktor stent 14%, Gianturco-Ftoubln stent 12%, Wallstem 10%, and a combination 20%) with 2.3 ± 1.6 stents per lesion. Balloon-to-vessel ratio was 1.17 ± 0.19 and maximal balloon Inflation pressure 16 ± 3 atm. The post procedure lumen diameter stenosis was -2.5 ± 14%. IVUS guidance was used in 88% of lesions, and 97% of patients did not receive warfarin.

P2450

Intra-coronary Implantation of Palmaz-Schatz stent In chronic total occlusion

M. Mori, H. Kurogane, T. Hayashi, Y. Yasaka, S. Ohta, T. Kajlya, A. Takarada, A. Yoshlda, Y. Yoshlda. Division of Cardiology, Hlmeji Cardiovascular Center, Himeji, Japan Advances in angioplasty technology and operator experience have attained the procedural success > 70%, however, restenosis Is still problematic in chronic total coronary occlusions. We compared anglographic and clinical outcome after successful revascularization of chronic total occlusions with the placement of tne Paimaz-Schatz stent and conventional balloon angioplasty. Methods: The study group consisted of 96 patients with successful revascularization of chronic total occlusions. Total occlusion was defined 100% preangioplasty diameter narrowing with either TIMI grade 0 or I antegrade flow. The duration of coronary artery occlusion was > one month in all patients. An attempt was made to match between the angioplasty group (53 patients) and the stent group (43 patients) for age, sex, nature of the cfiagnosed pathologies and severity of disease. Anglographic analysis was performed immediately before and after procedure and was repeated at six months follow-up. Quantitative analysis of the coronary segments was performed with the use of a validated edge-detection algorithm. Results:

Reference vessel (mm) Postprocsdure MLD (mm) Elastic recoH (mm) MIX) et toOow-up (mm) Late loss (mm) Restenosis at loOow-up (%) Angina at toiow-up (%) Ml Of CABG ai fotow-t* (%)

Angioplasty

Slant

P

2.7 1.7 0.9 1.1 0.6 56.6 30.2 11.3

2.8 2.6 0.3 1.8 0.8 27.9 20.9 2J

NS < 0.001 50% d&meter stenosis) was 24.6% based on a per-leslon basis. Conclusions: coronary stenting of chronic total occlusions without anticoagulation could be performed safety with a high immediate success rate and tower restenosis compared to historical results with coronary angioplasty.

P2452

Improved long-term survival In patients with anglographlcally documented patency after recanallzation of a chronic coronary occlusion by percutaneous transluminal coronary angioplasty

C. Kadel, W. Burger, C. Vallbracht', M. Kaltertoach, A.M. Zeiher. University Hospital Frankfurt;' HKZ Rotenburg, Germany The long-term survival of 179 P with successful recanallzation of a chronic coronary occlusion and angiographically confirmed patency within the first year was compared to that of 296 P with unsuccessful recanallzation and without CABG during the first year. Baseline data: male gender: 87.4%, age: 55.8 ± 9 . 3 yrs, mutttvessel disease: 47.8%, EF < 50%: 7.6%, anginal symptoms: 81.7%, signs of ischemia: 71.6%, infarct vessel recanallzation attempted: 53.7%, age of occlusion: 4 months (median). Results:

The multtvarlate analysis (Cox) determined successful recanallzation, p ° 0.001, left ventricular EF, p - 0.002, and diabetes, p - 0.02, as independent significant predictors of long-term survival. Conclusion: In patients with anginal symptoms or signs of ischemia successful recanalization of a chronic coronary occlusion by PTCA improved the long-term survival significantly.


E. Eeckhout J.-C. Staufler, P. Vogt, C. Seydoux, L Kappenberger, J.-J Goy. Cardiology Division, Centre Hospitaller Untversitaire Vaudois, Lausanne, Swrtzenand

Clinical interventional cardiology P 2 4 5 3 Coronary artery reconstruction with the freedom stent B. Chevalier, B. Glatt, T. Royer. Centre CartHotogkjue du Nord, Saint-Denis, France

P2454

Single and multiple stenting of coronary artery lesions using medtronlc Wiktor stents without oral anti coagulation

J. Haase, M. Barton. M. Krajcar, S. Gohring, R. Agrawal, P.G. Kerkar, F. Schwarz, W Preuster, H. Storger, N. Rerfart Red Cross Hospital and Heart Center, Frankfurt, Gemtany In 158 cases with coronary artery disease, 228 Wiktor stents were implanted without oral antJcoagulatJon (tictopidlne 250 mg bid + aspirin 100 mg/d). Incfication for stenting: suboptimal PTCA result In 91 pts (58%), restenosis in 19 pts (12%), threatening closure following PTCA in 25 pts (16%), acute closure after PTCA in 19 pts (12%). Vessel distribution: in 57 cases, the stented lesion was located in the LAD (36%), in 66 cases in the RCA (42%), in 28 cases in the RCX (18%), in 6 cases a venous bypass graft (4%), and in 1 case the protected left main (1%). In 105 cases (66%) a single stent was implanted, while in 53 cases (34%), multiple stenting was carried out. 2 sterrts were implanted in 40 cases (25%), 3 stents were implanted in 9 cases (6%). 4 stems were implanted in 3 (2%), and 5 stents were implanted In 1 case (1%). The maximal Inflation pressure during stent implantation was 11.2 ± 0.4 atm. Resvts:

Anglographk: success Acute stent occlusion Subacuia stem occlusion Bleeding complications Repeat PTCA CABG Non-Q-WaveMJ Q-waveMI In hospital death

Single ( n - 1 0 5 )

Multiple (n - 53)

96.2% 1(1%) 5(5%) 1(1%) 3(3%) 3(3%) 1(1%)

98.1% 1(2%) 1(2%) 1(2%) 3(6%) 1(1%) -

ns ns ns ns ns ns ns ns ns

The follow up at three months after stent implantation will be reported. Conclusion: Even in the setting of muttipte stenting, Medtronic Wiktor stents can be implanted with high initial success at low complication rates using tidoptdine instead of oral anticoagulation.

[ P 2 4 5 5 | Stenting of coronary bypass grafts without coumadin: long-term outcome Edward T A Fry, James B. Hermfller, Thomas S. Peters, Charles M. Or, James Van Tassel, Bruce F. Waller, Cass A. Pinkerton. St Vincent Hospital, Indiana Heart Institute, Indianapolis, IN, USA Coronary Intervention of lesions in bypass grafts is associated with increased rates of acute complications and restenosis compared with native arteries. Stenting in bypass grafts may attenuate these risks. However, long-term results are unknown. Accordingly, we analyzed in-hospital and long-term (3-13 months) outcomes in 39 patients undergoing stenting of bypass grafts (31 male, 8 female). All received tictopidine and aspirin post-stentlng. None received coumadin. Two biliary, 24 Palmaz-Schatz, and 20 Glanturco-Roubin stents were placed in grafts to the LAD, RCA, LCX, IMV, and diagonal In 13,12, 10, 4, and 3 patients, respectively. All but one were in vein grafts. Stents were placed into 46 lesions: 21 (45.7%) aorto-osteal, 16 (34.8%) shaft, and 3 (6.5%) distal anastomotic. Mean age of the grafts was 8.8 + 3.2 years. Mean stent size was 3.43 + 0.35 mm. All were deployed successfully, using high pressure (>15 atm.) post-deployment inflations. There was no stent thrombosis, death, Ml, repeat PTCA, or emergency CABG during hospital follow-up. Average hospital stay was 2.2 days. Bleeding complications occurred in 1 patient (2.5%). Four were lost to follow-up, 35 (89.7%) were followed for a mean of 7.7 months, of which 3 (7.5%) died, 1 (2.5%) had an Ml, 4 (10%) required target lesion revascularization (3 CABG and 1 PTCA) At follow-up, event-free survival was 80%. Thus, in conclusion, stenting of coronary bypass grafts can be performed with excellent acute results, minimal complications, and favorable long-term outcomes in the absence of coumadin.

P2456

Coronary stenting after rotational atherectomy in calcified and complex lesions: angiographic and clinical follow-up results

Issam Moussa, Carlo Di Mano, Simonetta Blengino, Massimo Ferraro, Lucia Di Francesco, Giovanni Martini, Jonathan Tools, Antonio Colombo. Columbus Hospital, Milan, Italy Treatment of calcified and complex lesions with RotaWatton before stenting has been suggested to facllltale the insertion and expansion of the stent We treated 106 lesions in 75 patients (mean age 61 ± 10) with rotablation followed by stenting. Rotablation indications were: calcified lesions 70%, long lesions (>15 mm) 10%, and other complex lesions 20%. Palmaz-Schatz stent was used in 77% of lesions (1.7 ± 1 stents per lesion). Pts were divided Into two groups: Group 1 (n - 64): Facilitated expansion, using 1 burr, and Group II (n - 42): Debulklng approach using multiple burrs. There was no significant difference between groups in regard to: procedural success (91% vs 98%), complications (non-Q wave Ml 6.8% vs 6.5%, Q-wave Ml 2.3% vs 0%, CABG 6.8% vs 0%, death 2.3% vs 0%), subacutestent thrombosis (1.6% vs 0%), and cumulative 6 month event rate (target lesion PTCA 16.9% vs 26.8%, Ml 4.9% vs 3.3%, CABG 5% vs 6.7%, death 4.9% vs 0%). Only 7% of patients received warfarin. Angiographic follow-up was performed in 82.5% of lesions (75% vs 92.7%, p = 0.02) at 4.9 ± 1.9 mo. Restenosis (as defined by > 50% diameter stenosis) was found In 22.5% (16.7% vs 28.9%, P = NS). Other data were as follows:

Proximal vessel size (mm) Lesion length (mm) Bun/vessel raik) Final stent % stenosis Residual plaque area %

Total

Group I

Group II

3.13 ±0.55 9.4 ± 6 8 0.6 ±0.1 - 3 ±14 39±13

3.05 ±0.54 8.8 ±5.6 0.6 ± 0 . 1 * - 3 ±14 39±13

3.25 ± 0.54 10.4 ±8.3 0.7 ± 0 . 1 * -3±14 38±13

•P < 0.05 Vs control Values are presented as mean ± SO.

Stepwise regression analysis showed that only two factors affect restenosis: lesion length (coef038TF~6:06). and Final stent MLD by IVUS (coef -0.32, F 5.5}-at-aP - 0.002. " Conclusions: 1- Rotablation prior to stenting is an effective method to treat calcified and complex lesions, with good immediate angiographic results and decreased angiographic restenosis rate. 2- Facilitated approach is at least as effective as aggressive debulking when it is followed by coronary stenting.


Very long coronary lesions (VLCL), as defined by a length > 25 mm is a limitation of conventional balloon angwplasty. In order to assess safety and efficacy of the stenting procedure In VLCL, we retrospectively studied 91pts (13 women, 61+-9 y.) treated with the Freedom' stent In 94 lesions. Clinical Indications were predominantly acute ischemic syndromes: unstable angina 4 1 % , recent Ml 20%, acute Ml 15%. Mean artery (LAD 40 RCA 36 Circumflex 17 Vein graft 1) diameter was 3.1+-0.5 mm. We noted thrombus in 32%, calcification In 32% and tortuosity in 20% and occlusion (TIMI flow 0 or 1) in 30%. The lesion length was 29+-14 mm (25-110). A 6F sheath was used in 91 %. After balloon PTCA (using long balloons in 71 %), stentJng indication was: de novo 40%, suboptimal result 33%, bafi-out 11%, recoil 9%, restenosls 7%. A multiple stenting was used in 26% and a single long stent in the remaining lesions (30 mm In 43%, 36 mm In 7%, 40 mm In 24%). Total stented length was 38+-13 mm (28-110). Stents were deployed with a 3.25+-0.3 mm balloon at 10.4+-2 aim. Minimal lumlnal oiameter went from 0.67+-0.35 mm up to 2.96+-0.55 mm. Technical and procedural success was obtained in all pts but three (dlstodgement of the stent In calcified arteries then stent retrieval using a microsnare): succes rate 97%. Pts received a ticlopidlne/aspirin drug regimen. One pt underwent in-lab acute closure treated with PTCA and another one had a subacute closure. We noted no clinical event (Ml, emergent CABG or death) except one case of nonQ Ml. A false aneurysm was noted In 1 patient. The assessment of late clinical event is pending. Thus, a coronary artery reconstruction Is feasible, using predominantly long balloon then single stenting with long Freedom™ stent, with excellent shortterm results. This technique might be an alternative in the treatment of cfif usety diseased arteries

459

460 P2457

Clinical interventional cardiology

Pitfalls In coronary stentlng

H. Seggewiss, S. Strick, D. Fassbender, R. Dletl, P. Zlemssen, H.K. Schmidt U. Gtetehmarm. Dept. of Cardiology, Heart Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany

S. Makowski, B. Fontanet F. Beverelll, P. Henry, K. Boughatem, A. Louall, S. Battaglia, J.Y. Pagny, D. Lancelin, B. Blanchanj, J.L Guermonprez. Broussais Hospital, Paris, France Irrtracoronary stents are used with increasing frequency not only as ball out devices but also for treatment or prevention of coronary artery restenosls. Failure of stent delivery or stent emboUzation is therefore on concern. From September 1994 to December 1995, .1516 PTCA were performed. On 758 stents Implanted In 569 patients, 15 stents (1.9%) were either not able to reach the lesion or moved from their delivery catheter during the procedure primarily due to important coronary calcification and/or excessive tortuosity. There were 13 hand-crimped stents (9 Palmaz Schatz, 4 Freedom) and 2 balloon-mounted stents (1 Wlktor and 1 Microstent). Guiding catheter size was 6 French in 13 cases and 8 French in 2. Stents were tost attempting to reach the lesion located on the right coronan/ artery in 5 cases, on the left main trunck in 2 cases and on the circumflex system In 4 cases. In order to retrieve balloon dislodged stents from patients, Goose Neck snare(GNS) catheter (Boston Scientific Corp.) were used. The GNS was passed Into the guiding catheter alongside the guide wire and positioned above the stent with the snare open. Then, the snare was withdrawn to the level of the stent and tightened at the proximal extremity. The GNS caughting procedure damaged and/or elongated stents. Therefore, the captured stents could not be pulled back Into the guiding catheter except In one cass. For that purpose, 6 French sheaths were exchanged over a 0.014 Inch wire to larger 9 to 11 French sheaths except in one case. In all cases, the retrieval procedure was successful wtth a mean procedure time including angioplasty of 127 ± 34 minutes. No cororauy or vascular complication was related to the GNS. In conclusion, Goose Neck snare is a safe and practical solution for the retrieval of dislodged stent during coronary angioplasty.

P2460 The MUST trial. In-hospltal and clinical events at six months P 2 4 5 8 | Stent dislodgement with subsequent capture or embolizatlon. A rare complication of coronary stenting? F. Alfonso, D. Martinez, J. Goicolea, R. Hernandez, J. Segovia, A. Fernandez-Ortiz, P. Phillips, C. Macaya Hospital Untversitario San Carlos, Madrid, Spain Coronary stents (ST) are widely used during coronary interventions. However, in some patients (P) the distal advancement of the ST may be diflicult resulting In ST dislodgement (DLG) from the balloon catheter. Some of these ST may be successfully captured ancUetrieved (RET) whereas others may be embolized (EMB). From 1990 to 1995, 495 consecutive P underwent coronary stenting receiving a total of 605 ST. Most ST were indicated for dissection, 191 (32%), or suboptimal result 153 (25%), whereas 261 ST (43%) were implanted electtvely. The Palmaz-Schatz (P-S) wastheSTmesHrequentty used 450 (74%)^ Of these, 392 (87%) were Implanted hand-crimped on the batoon (261 articulated, 131 nonartlcuiated) and 58 (13%) had a delivery system. In 17 P (3%), (mean age 65 ± 10 years, 3 female) ST DLG occurred (15 P-S, 2 Glanturco-Roubin). Of these, the ST was indicated etectrvely In 1 P, for suboptimal result In 3 and for dissection in 13 P. Proximal vessel turtuosities were present in 11 Pand 10 had mild proximal disease. As compared with successfully deployed ST, ST DLG occurred more frequently in the LCX [8 (47%) vs 80 (13%), p < 0.001], In bends (>45°) [12 (70%) vs 9.2 (15%), p < 0.001] and in calcified lesions [10 (59%) vs 70 (11%), p < 0.001). ST RET was always attempted in the descending aorta to prevent cerebral EMB. In 8 of the 17 P the ST could be RET using dedicated snares but ST EMB eventually occurred in 9 P. EMB occurred In 7 P-S [1/261 (0.3%) articulated, 6/131 (4.5%) nonarticuiated, p < 0.05]. The exact EMB site was identified in 4 P (3 femoral artery, 1 renal artery). No P with ST EMB had any clinical sequelae. Procedural success was obtained in 15 P (10 required implantation of a new ST), 1 P suffered a myocardlal infarction and 1 P required surgery. Thus, ST DLG with eventual EMB may complicate coronary stenting. Lesions located in the LCX, in bends or calcified lesions predispose to ST DLG.

M.C. Morice1, T. Lefevre, P. Aubry, J.P. Monassier, C. SpaukJIng, E. Benveniste, Y. Guerin, R. Falvre, C. Grenot T. Baardman. ICV Paris Sud, Antony, France The MUST trial was designed to validate the concept of coronary stenting with the association of Ttcloptdine and Aspirin as sole post stenting treatment. Population: from January to August 1995, 260 pts were Included In an open, prospective, muttjcenter observational study. Patients selected had stable or unstable angina, a single lesion on a native artery treated by elective stenting with a single 15 mm Palmaz Schatz stent (PS 153) manually crimped on a regular PTCA balloon. Medfca/ therapy: the patients had no particular pre-procedural therapy and received 100 mg Aspirin and 250 to 500 mg of TiclopicSn for one month after the procedure. Procedure: 3 (1.15%) stenting procedures failed (2 cross over to a Wrktor stent), 3 (1.15%) stents were lost 5 (1.92%) patients had a 2nd stent for dutal dissection or incomplete coverage of the lesion. In-hospital events: no patient died, 1 (0.4%) underwent emergency surgery, 9 (3.5%) had an Ml, 3 (1.15%) showed subacute thrombosis and 5 (1.9%) underwent repeat PTCA during the hospital phase. Bleeding complications included 1 (0.45%) gastrointestinal bleeding and 1 (0.45%) groin hematoma requiring blood transfusion. Mean in-hospital stay was 3.4 days. At 6 month follow-up: 139 pts fuDfflled their 6 month follow-up. There were no late death, Ml or surgery. Eleven (7.2%) had repeat PTCA at the same site. In conclusion: coronary stenting with low doses of 2 antiaggregants seems to be feasible and efficient The in-hospital event rate is acceptable and the 6 month event rate seems comparable with those of the stented arm of the Benestent stucHes.


Coronary stenting Is increasingly done after randomised trials have shown reduction of restenosls after elective stenting as wed as the incidence of subacute stem thrombosis has been markedly reduced by high pressure application and UcJopidlne treatment We report on pitfalls in coronary stenting as a result of more liberal use of self-mounted Palmaz-Schatz stents. Pitfalls in coronary stenting were seen in 35 out of 334 (10.4%) pts. (mean age 62.4 ± 9.6 years; 65% men; 44% single, 32% double, and 24% triple vessel disease). Stenting was performed because of si&optimal result (recoil) after balloon angtoplasty in 66%, bailout and elective stenting In 17%, each. In 16/35 (46%) pts. a stent could not be placed at the target lesion without stent loss, in 13/35 (37%) pts. a stem was tost during placement in 5/35 (14%) pts. a stent dislocated proximal or distal to the target lesion, and in one (3%) pt. a coronary rupture was seen after high pressure Inflation. Furthermore, balloon rupture due to high pressure inflation was seen In 34.3% of all stented pts.. In 9/16 pts. with failed stent placement it was applied proximal to the original lesion — in 2 of these pts. a second stem could be placed after change of guiding catheter- and In 7 pts. balloon catheters and mounted stents were removed without complications. Lossed stents could be saved in 6/13 pts. - 6 pts. had peripheral embolisms without adverse clinical signs and 1 p t embolism of the distal right coronary artery. In 8/13 pts. with lossed and In 2/5 pte. with dislocated stents another stent could be applied without any problem. 7/35 (20%) pts. wtth pitfalls In stenting underwent emergency CABG. 28/35 (80%) pts had good final angioplasty result and event free hospital stay. Conclusions: Due to widespread use of coronary stenting pitfalls occur in about 10% of all implantations of a self-mounted stent with a high incidence of emergency CABG. Indication for stenting and selection of the used stent-type have to consider these possible pitfalls.

P2459 Retrieval of intra-coronary migrated stents using mlcrosnare system: about 15 cases

Clinical interventional cardiology / Thrombosis and microcirculation Significant decrease in sub-acute stent thrombosis with the association tldopldine and aspirin: a single-centre one-year experience

461

P 2 4 6 3 ) Combined antiplatelet therapy without antlcoagulatlon after stent Implantation; The Ticlopkllne Aspirin Stent Evaluation (TASTE) study J.-M. Labianche, J.-L Bonnet G. Groilier, N. Danchln, M. Bedossa, A. Vahanian, E.P. Me Fadden, C. Bauters, E. Van Belle, M.E. Bertrand. University of Ulle, France

From 1/2/95 to 1/5/96, 534 stents (Palmaz-Schatz: 293, Micro-stem AVE: 235, Freedom: 6) were Implanted In 393 consecutive patients (pts), 321 males and 72 females, mean age 66 ± 10 years. Class 3 and 4 angina occurred in 60% of pts. Unstable angina was present in 129 pts and recent myocardlal Infarction (Ml) in 78. Ten pts were stented In acute phase of Ml. Significant impairment of left ventricular function (Ejection fraction 0.40 or less) was seen in 50 pts. Stents were implanted in left anterior descending-diagonal in 217 pts, right coronary artery in 201, left circumflex-marginal branch in 107, saphenous vein graft in 32 and left main In 6. Indication for stenting was de novo lesion (n - 281), dissection (n - 112) including 4 ball-out situations, sub-optimal PTCA result (n = 100) and restenosis (n - 41). Reference artery diameter was < 2.5 mm In 18 pts, 2.5 to 3.0 mm In 130. Stent deployment was done with a single inflation at 10-12 bars without systematic overexpanston, but additional inflation when needed.

The two major limitations of subacute occlusion and peripheral vascular complications associated with coronary stent implantation have been markedly reduced by the use of combined antiplatelet therapy as an alternative to classical anticoagulation. We report the current results of the TASTE registry, a prospective mutticenter French study to evaluate the efficacy of a combination of 2 antiplatelet agents, ticiopldine 500 mg and aspirin 160 mg dairy with heparin administration as for conventional angtoplasty (perprocedural and until sheath removal), after stent implantation. From November 1993 to December 1995, 1404 conventional (non-hepann coated) stents were implanted In 1064 consecutive patients (1136 vessels) for failed angtoplasty (n - 140), a suboptimal result (n - 706), or electively (n - 217). Stents used were Palmaz-Schatz (73%), Wiktor (22%), AVE (3%), Gianturco-Roubin (2%). The maximal inflation pressure used was > 14 atmospheres in 43% (range 4 to 22). Baltoon diameter was 2.5 mm (10%), 3.0 mm (50%), 3.5 mm or greater (40%). Sheath size was 6 French in 42%, and 8 French in 43%. We present the procedural, in-hospltal, and earty clinical follow-up results. Coronary events related or possibly related to stent implantation occurred in 5.7% of patients with bailout stents, 2.1% of patients with stents for suboptimal results, and In 0.9% of electively stented patients. In a multivariate analysis, factors related to stent occlusion were stent implant for post-procedural occlusion outside the cath lab (p - 0.0001), residual dissection or haziness after stenting (p •= 0.002), and placement of > 1 stent (p = 0.03). Serious vascular complications (requinng surgery or transfusion) occurred In 1.0%. Neither stent thrombosis nor serious bleeding occurred after elective stenting Mean hospital stay decreased from 6.2 days to 3.4 days. A combination of 2 antiplatelet agents can be employed in the vast majority of patients after coronary stent implantation. Subacute occlusion rates and bleeding complications compare favourably with those reported using conventional therapy and the duration of hospitalisation is reduced.

Seventy-five percent of stents Implanted were short stents, less than 12 mm long. Hundred and eight pts had muttistents (84 pts: 2 stents, 17: 3, 5: 4 and 2: 5). No intravascular ultrasound was performed. Antiplatelet treatment was based on the association Aspirin (A) 250 mg/day and TidopJdlne (T) 500 mg/day. T was started either 48 hours before procedure or on the day of stent implantation. Heparln was given per-procedure (bolus 7500-10000 Ul) and then stopped for sheaths removal at six hours. Low-motecular weight heparln was given until hospital discharge at day 4. Acute occlusion ( 1 mm cfiameter (quantitative angtography). The Indication for stenting was: dissection 46 W (73%), sub-optimal result 9 W (14%), and elective 8 W (13%). SB TIMI flow grade was analysed before PTCA, after baDoon dilation and after stenting. Angtography was repeated at 6 months follow-up or earlier in case of evidence of ischemia. Results: Thirty-four (40%) SB had > 50% ostlal stenosis. Before PTCA, 72 (84%) SB had TIMI III flow. After balloon dilation flow worsened in 14 (19%) of these and Improved to TIMI III In 9 of 14 (64%). After W, 63 of 67 (94%) maintained TIMI III. As 2 of the 4 cases with flow reduction after stenting, had pre-PTCA TIMI < III, we may consider that an adverse immediate effect of W occurred in only 2 of 67 (3%) cases. Additionally there was improvement to TIMI III in 5 of 19 (26%) post-PTCA TIMI < III SB. In the group with worsening of flow or non-restoration of a normal pre-PTCA flow after stenting, the Incidence of ostial branch disease was greater (64% vs 35%, p - 0.08). An unfavourable SB evolution was more frequent when W was used to treat dissection (21% vs 4%, p - 0.05). The foflow-up angiogram was performed at 167 ± 42 days and results are now available for the first 37 SB. Of these, 29 had TIMI III flow after W implantation. Twenty-six (90%) of these maintained TIMI III at follow-up and there was recovery of TIMI III flow In 3 (38%) of 8 with TIMI < III after W placement Conclusions: W has not Immediate or long-term significant adverse effects on SB flow. Worsening of flow after stenting may be associated with intrinsic ostial disease.

THROMBOSIS AND MICROCIRCULATION P2464 Enhanced antithrombotic potency of fibrin-targeted recomblnant hlrudin in a non-human primate model C. Bode 1 , P. Mehwald 1 , K. Peter1, T. Nordt1, L A Harker 2 , S.R. Hanson 2 , M.S. Runge 3 . 1 Univ. of Heidelberg, Germany:2 Emory University, Atlanta; 3 UTMB Galveston, USA To explore the effect of targeting an antithrombin to the surface of a thrombus, recomblnant hlrucfin (Hlr) was covalentty linked to the Fab' fragment of fibrinspecific monoclonal antibody 59D8 (Fab) resulting in a stable conjugate (HirFab). In vitro, Hir-Fab was 9-times more efficient than Hir alone in Inhibiting fibrin deposition on experimental dot surfaces In human or baboon plasma (p < 0.01). To validate these results In vivo, Hlr-Fab was compared to Hir in a baboon model. The deposition of 111-ln-labeled platelets onto a segment of Dacron vascular graft present in an extracorporeal arterlovenous shunt was measured. Blood flow rate was 40 mi/min. One hour local Infusions of 4500 ATU of either Hir-Fab or Hir resulted in deposition of 0.16 x 10 s and 2.17 x 109 platelets, respectively. Equieffective dosages were 2000 ATU Hlr-Fab and 9000 ATU Hlr resulting in deposition of 1.06 x 10" and 0.93 x 10» platelets, respectively. Based on full dose response curves (n - 1 4 ) , Hir-Fab was found to be > 4.5-fold more potent (based on activity) than Hlr. Because of the small total amounts of antithrombins used and the short duration of these experiments, no significant systemic effects were observed. Thus, fibrin-targeted recombinant hlrudin prevents platelet deposition and thrombus formation more effectively than uncoupled hinxfin in vitro and In an In vivo primate model.


P. Rossi, A. Bouharaoua, F. Collet J J- Leandri, J.C. Nebunu, A. Comen, R. Bonello, C. Boyer, H. Escojido. Centre de Carctiotogie Interventionnelle, Clinique Clairval, Marseille, France