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Robert D. Safian - One of the best experts on this subject based on the ideXlab platform.
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influence of vessel selection on the observed Restenosis Rate after endoluminal stenting or directional atherectomy
American Journal of Cardiology, 1992Co-Authors: Richard E Kuntz, Robert D. Safian, Tomoaki Hinohara, Gregory C RobertsonAbstract:In comparing the Restenosis Rates among different interventions, 1 potential confounder might be the differences in the vessels treated, as dictated by the technical limitations of particular devices. The purpose of this study was to use current "acute gain-late loss" analysis to examine what influence vessel selection has on the Restenosis Rates seen after coronary stenting or directional atherectomy. The minimal luminal diameter of native coronary lesions was measured before and immediately after intervention in 102 single Palmaz-Schatz stents and 347 atherectomies, 367 (82%) of which had repeat angiographic measurement 6 months after intervention. Atherectomy-treated lesions had a higher proportion of left anterior descending to right coronary arteries (68 vs 24%) compared with stents (31 vs 54%), p 50% diameter stenosis) and continuous (late percent stenosis) definitions.(ABSTRACT TRUNCATED AT 250 WORDS)
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long term results of directional coronary atherectomy predictors of Restenosis
Journal of the American College of Cardiology, 1992Co-Authors: Robert F Fishman, Richard E Kuntz, Robert D. Safian, Michael J Miller, Stuart J Schnitt, Joseph P Carrozza, Cynthia Senerchia, Daniel J Diver, Donald S BaimAbstract:Objectives. This study was performed to obtain better understanding of the long-term clinical efficacy of directional coronary atherectomy. Background. Although this procedure yields favorable acute results, its acceptance has been limited by the perception that late results (that is, freedom from Restenosis) are no better than those of conventional angioplasty. Methods. A total of 225 atherectomies performed in 190 patients between August 1988 and July 1991 were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention. Results. Although most lesions (97%) had one or more characteristics predictive of unfavorable short- or long-term results after conventional angioplasty, atherectomy was successful in 205 lesions (91%) with a mean residual stenosis of 7 ± 16%. After subsequent balloon angioplasty in 16 unsuccessful atherectomy attempts, procedural success was 98%. There were no deaths or Q wave myocardial infarctions, and one patient (0.5%) underwent emergency bypass surgery. Six-month angiographic follow-up was obtained in 77% of the eligible patients. The overall angiographic Restenosis Rate was 32%. Predictors of a lower Restenosis Rate included a postprocedure lumen diameter 3 mm (24% vs. 39%, p = 0.047), serum cholesterol ≤200 mg/dl (18% vs. 40%, p = 0.018) and recent myocardial infarction (16% vs. 37%, p = 0.034). Life-table analysis showed a 2% mortality Rate and a 26% incidence of other events (myocardial infarction, repeat revascularization) within the 1st year. The annual 5% mortality Rate and 7% incidence of other events during years 2 and 3 were related in large part to the existence or progression of disease at other locations. Conclusions. Six-month angiographic follow-up of patients who underwent directional coronary atherectomy during the 1st 3 years of our experience shows an overall Restenosis Rate of 32%, with lower Rates in patients with a postatherectomy lumen diameter ≥3 mm, cholesterol level ≤200 mg/dl or a recent myocardial infarction. Few if any events relating to the site of atherectomy developed after the 1st year of follow-up.
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angiographic and clinical outcome of intracoronary stenting immediate and long term results from a large single center experience
Journal of the American College of Cardiology, 1992Co-Authors: Joseph P Carrozza, Richard E Kuntz, Robert F Fishman, Michael Mansour, Cynthia Senerchia, Daniel J Diver, Marc J Levine, Richard M Pomerantz, Michael C Gibson, Robert D. SafianAbstract:Objectives. The purpose of this study was to determine the immediate and long-term angiographic and clinical results of coronary stenting. Background. Although preliminary trials of endovascular stenting have demonstRated promising results, lack of long-term follow-up has limited the critical evaluation of the role of coronary stenting in the treatment of obstructive coronary artery disease. Methods. A total of 250 procedures using the Palmaz-Schatz stent, performed in 220 patients between June 1988 and July 1991, were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention. Results. Stent placement was successful in 246 (98%) of 250 lesions, reducing diameter stenosis from 77% to −2.5%. There were nodeaths or Q wave myocardial infarctions. One patient (0.4%) required emergency bypass surgery and one (0.4%) developed subacute thrombosis. Femoral vascular complications occurred in 36 patients (16%). Six-month angiographic follow-up was obtained in 91% of eligible patients. The overall angiographic Restenosis Rate (stenosis ≥50%) was 25%. By univariable analysis, the Rate of Restenosis was significantly higher for stents in the left anterior descending versus the right coronary artery (44% vs. 12%; p = 0.002); in diabetic patients (56% vs. 20%; p = 0.006), and in vessels with post-stent lumen diameter <3.31 mm (34% vs. 16%; p = 0.05). Stenting of the left anterior descending artery was the strongest predictor (p = 0.01) of Restenosis in a multivariable model. Total survival was 97% and event-free survival (freedom from death, myocardial infarction or revascularization) was 70% at 36 months. Conclusions. Palmaz-Schatz stents can be placed successfully with a low incidence of major complications. The angiographic Restenosis Rate was 25%, and 70% of patients remained free of cardiovascular events at 3 years. Diabetes, small postprocedure lumen diameter and stenting of the left anterior descending artery are associated with higher Rates of Restenosis.
Antonio Colombo - One of the best experts on this subject based on the ideXlab platform.
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randomized study of the crush technique versus provisional side branch stenting in true coronary bifurcations the cactus coronary bifurcations application of the crushing technique using sirolimus eluting stents study
Circulation, 2009Co-Authors: Antonio Colombo, E Bramucci, Eberhard Grube, Salvatore Sacca, Roberto Violini, Corrado Lettieri, Roberto Zanini, Imad Sheiban, Leonardo Paloscia, Joachim SchoferAbstract:Background— Sirolimus-eluting stents have been reported to be effective in the treatment of coronary bifurcations. Still, it has not been fully clarified which stRategy would provide the best results with true bifurcation lesions. Methods and Results— The CACTUS trial (Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents) is a prospective, randomized, multicenter study comparing 2 different techniques of stenting, with mandatory final kissing-balloon inflation, in true bifurcations: (1) elective “crush” stenting and (2) stenting of only the main branch, with provisional side-branch T-stenting. From August 2004 to June 2007, 350 patients were enrolled in 12 European centers. The primary angiographic end point was the in-segment Restenosis Rate, and the primary clinical end point was the occurrence of major adverse cardiac events (cardiac death, myocardial infarction, or target-vessel revascularization) at 6 months. At 6 months, angiographic Restenosis Rates were not d...
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clinical and angiographic outcome after implantation of drug eluting stents in bifurcation lesions with the crush stent technique importance of final kissing balloon post dilation
Journal of the American College of Cardiology, 2005Co-Authors: Flavio Airoldi, Matteo Montorfano, Alaide Chieffo, Nicola Corvaja, Ioannis Iakovou, John Cosgrave, Iassen Michev, Giuseppe Sangiorgi, Mauro Carlino, Antonio ColomboAbstract:Objectives The purpose of this research was to evaluate the long-term outcomes after implantation of drug-eluting stents (DES) in bifurcation lesions with the “crush” technique. Background The long-term outcome of “crush” stenting technique has yet to be determined. Methods We identified 181 consecutive patients who were treated with DES with the “crush” stent technique from April 2002 to April 2004. Based on the usage of final kissing balloon post-dilation (FKB), the patients were divided into an FKB group (n = 116) and a non-FKB group (n = 65). Results Clinical follow-up at nine months was available in all patients, and angiographic follow-up in 80% of patients. Three cases (1.7%) of intraprocedural stent thrombosis and five (2.8%) cases of postprocedural stent thrombosis occurred. Restenosis Rate of the main branch in the entire cohort lesions was 11.5%. Restenosis Rate of the side branch was lower in the FKB group than that in the non-FKB group (11.1% vs. 37.9%, p Conclusions Compared to the absence of FKB, the “crush” stenting technique with FKB appears to be associated with more favorable long-term outcomes. When utilizing the “crush” stenting technique, FKB is mandatory.
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lower Restenosis Rate with stenting following aggressive versus less aggressive rotational atherectomy
Catheterization and Cardiovascular Interventions, 1999Co-Authors: Yoshio Kobayashi, Tatsuro Akiyama, Bernhard Reimers, Carlo Di Mario, Issam Moussa, Joseph De Gregorio, Nobuyuki Kobayashi, Leo Finci, Antonio ColomboAbstract:The present study evaluated the acute and follow-up results of stenting following aggressive rotational atherectomy compared with stenting following less aggressive rotational atherectomy. Recent work has demonstRated that stenting following rotational atherectomy is a promising stRategy for complex and calcified lesions. However, there is little information available regarding the optimal procedural technique of rotational atherectomy to be employed before stent implantation. Between May 1995 and February 1997, 162 lesions in 126 patients were stented following rotational atherectomy because of the presence of severe calcification on fluoroscopy or intravascular ultrasound (95%). The lesions were divided as to whether aggressive rotational atherectomy was performed or not. Aggressive rotational atherectomy, defined as the use of a final burr size ≥2.25 mm and/or final burr/vessel ratio ≥0.8, was performed in 56 lesions. A less aggressive rotational atherectomy stRategy was performed in 106 lesions. Procedural Q-wave (8.9% vs. 1.9%, P < 0.05) and non–Q-wave (11% vs. 1.9%, P < 0.05) myocardial infarctions were observed more frequently after aggressive rotational atherectomy; there was no significant difference in the incidence of other procedural complications. Although there was no significant difference in minimal lumen diameter after the procedure (3.11 ± 0.68 vs. 2.99 ± 0.48 mm, NS), at follow-up a greater minimal lumen diameter was observed in the lesions treated with aggressive rotational atherectomy compared to those treated with less aggressive rotational atherectomy (2.12 ± 1.31 vs. 1.56 ± 0.89 mm, P < 0.01). Restenosis Rates were 50.0% in the lesions treated without aggressive rotational atherectomy and 30.9% in those treated with aggressive rotational atherectomy (P < 0.05). There was no significant difference in the incidence of Restenosis with a focal pattern between the two groups (25.0% vs. 21.4%, NS). In contrast, Restenosis with a diffuse pattern was lower in lesions treated with aggressive rotational atherectomy than in those without aggressive rotational atherectomy (9.5% vs. 25.0%, P < 0.05). Aggressive rotational atherectomy followed by stenting is a promising stRategy to reduce the Restenosis Rate in calcified lesions. However, the aggressive stRategy is associated with an increased risk of procedural myocardial infarction. Cathet. Cardiovasc. Intervent. 46:406–414, 1999. © 1999 Wiley-Liss, Inc.
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Angiographic and intravascular ultrasound predictors of in-stent Restenosis
Journal of the American College of Cardiology, 1998Co-Authors: Shunji Kasaoka, Jonathan M. Tobis, Tatsuro Akiyama, Bernhard Reimers, Carlo Di Mario, Nathan D. Wong, Antonio ColomboAbstract:Abstract Objectives. This study was performed to determine predictors of in-stent Restenosis from a high volume, single-center practice. Background. Intracoronary stents have been shown to reduce the Restenosis Rate as compared with balloon angioplasty, but in-stent Restenosis continues to be an important clinical problem. Methods. Between April 1993 and March 1997, 1,706 patients with 2,343 lesions were treated with a variety of intracoronary stents. The majority of stents were placed with high pressure balloon inflations and intravascular ultrasound (IVUS) guidance. Angiographic follow-up was obtained in 1,173 patients with 1,633 lesions (70%). Clinical, angiographic and IVUS variables were prospectively recorded and analyzed by univariate and multivariate models for the ability to predict the occurrence of in-stent Restenosis defined as a diameter stenosis ≥50%. Results. In-stent Restenosis was angiographically documented in 282 patients with 409 lesions (25%). The Restenosis group had a significantly longer total stent length, smaller reference lumen diameter, smaller final minimal lumen diameter (MLD) by angiography and smaller stent lumen cross-sectional area (CSA) by IVUS. In lesions where IVUS guidance was used, the Restenosis Rate was 24% as compared with 29% if IVUS was not used (p Conclusions. Achieving an optimal stent lumen CSA by using IVUS guidance during the procedure and minimizing the total stent length may reduce in-stent Restenosis.
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low Restenosis Rate in lesions of the left anterior descending coronary artery with stenting following directional coronary atherectomy
Catheterization and Cardiovascular Diagnosis, 1998Co-Authors: Yoshio Kobayashi, Tatsuro Akiyama, Bernhard Reimers, Carlo Di Mario, Issam Moussa, Leo Finci, Antonio ColomboAbstract:The present study evaluated acute and late results with stenting following directional coronary atherectomy (DCA) for the lesions in the left anterior descending coronary artery (LAD). Between April 1995 and January 1997, 200 LAD lesions with > or =3 mm reference vessel diameter were treated with coronary stents. The lesions were divided as to whether or not DCA was performed before stenting; 1) stenting alone (n = 163) and 2) debulking and stenting (n = 37). There were no significant differences in the incidences of complications except for non-Q-wave myocardial infarction that was more frequent in patients with debulking and stenting than in those with stenting alone (13.5% vs. 2.4%, P or =3 mm reference vessel diameter.
Maarten J Suttorp - One of the best experts on this subject based on the ideXlab platform.
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primary stenting of totally occluded native coronary arteries iii prison iii a randomised comparison of sirolimus eluting stent implantation with zotarolimus eluting stent implantation for the treatment of total coronary occlusions
Eurointervention, 2013Co-Authors: Ben J L Van Den Branden, Paul Vermeersch, Johannes C Kelder, Benno J Rensing, Koen Teeuwen, Jacques Koolen, Rene J Van Der Schaaf, Jose P S Henriques, Jan G P Tijssen, Maarten J SuttorpAbstract:Background—Sirolimus-eluting stents markedly reduce the risk of Restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. Methods and Results—In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n100) were randomly assigned to receive bare metal BxVelocity stents and half (n100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment Restenosis Rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent Restenosis Rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary Restenosis Rate of 7% compared with 36% in the bare metal stent group (P0.001). The in-segment binary Restenosis Rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P0.0001), resulting in a target lesion revascularization Rate of 4% in the sirolimus group versus 19% in the bare metal group (P0.001). Patients who received the drug-eluting stent also had significantly lower Rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. Conclusions—In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary Restenosis, resulting in significantly less need for target lesion and target vessel revascularization. (Circulation. 2006;114:921-928.)
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primary stenting of totally occluded native coronary arteries ii prison ii a randomized comparison of bare metal stent implantation with sirolimus eluting stent implantation for the treatment of total coronary occlusions
Circulation, 2006Co-Authors: Maarten J Suttorp, Gert Jan Laarman, Braim M Rahel, Johannes C Kelder, Mike A R Bosschaert, Ferdinand Kiemeneij, Jur Ten M Berg, Egbert T Bal, Benno J Rensing, Frank D EeftingAbstract:Background— Sirolimus-eluting stents markedly reduce the risk of Restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. Methods and Results— In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n=100) were randomly assigned to receive bare metal BxVelocity stents and half (n=100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment Restenosis Rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent Restenosis Rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary Restenosis Rate of 7% compared with 36% in the bare metal st...
Andres Iniguez - One of the best experts on this subject based on the ideXlab platform.
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first in man randomised comparison of the buma supreme biodegradable polymer sirolimus eluting stent versus a durable polymer zotarolimus eluting coronary stent the pioneer trial
Eurointervention, 2018Co-Authors: Clemens Von Birgelen, Taku Asano, Giovanni Amoroso, Adel Aminian, Salvatore Brugaletta, Mathias Vrolix, Rosana Hernandezantolin, Pim Van De Harst, Andres Iniguez, Luc JanssensAbstract:Aims: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. Methods and results: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary Restenosis Rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). Conclusions: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in Restenosis Rate or impairment in 12-month clinical outcomes.
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stenting for elastic recoil during coronary angioplasty of the left main coronary artery
American Journal of Cardiology, 1992Co-Authors: Carlos Macaya, Fernando Alfonso, Andres Iniguez, Javier Goicolea, R Hernandez, Pedro ZarcoAbstract:Abstract Conventional percutaneous transluminal coronary angioplasty (PTCA) of the left main coronary artery (LMCA) constitutes a therapeutic challenge because it is associated with significant immediate morbidity and mortality and a high Restenosis Rate.1–4 Special difficulties may arise during PTCA of ostial LMCA lesions including technical problems concerning precise balloon location and the possible appearance of elastic recoil despite the use of adequate-sized balloons.4 We report 3 patients with “unprotected” ostial lesions of the LMCA in whom significant elastic recoil after PTCA was successfully managed with coronary stenting. In each patient the stRategy for stent deployment consisted in leaving the proximal edge of the stent slightly protruding into the aortic root. This was successfully accomplished and subsequently confirmed in the 3 cases.
Luc Janssens - One of the best experts on this subject based on the ideXlab platform.
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first in man randomised comparison of the buma supreme biodegradable polymer sirolimus eluting stent versus a durable polymer zotarolimus eluting coronary stent the pioneer trial
Eurointervention, 2018Co-Authors: Clemens Von Birgelen, Taku Asano, Giovanni Amoroso, Adel Aminian, Salvatore Brugaletta, Mathias Vrolix, Rosana Hernandezantolin, Pim Van De Harst, Andres Iniguez, Luc JanssensAbstract:Aims: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. Methods and results: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary Restenosis Rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). Conclusions: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in Restenosis Rate or impairment in 12-month clinical outcomes.