TCT-653 Assessment of endothelial function in patients randomly treated with a polymer-free...

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Conclusions: This “trumpeting” may also partially explain the observed use of more Xience stents per lesion compared to Resolute (1.180.45 vs. 1.150.42, p0.02) in the Resolute All Comers (RAC) trial. The primary cause for secondary stenting in RAC was “to stabilize target lesion” which includes procedural complications including dissection or perforations. TCT-653 Assessment of endothelial function in patients randomly treated with a polymer-free sirolimus eluting stent and its bare-metal equivalent: results of the VESTASYNC II trial Breno Almeida 1 , Jose Costa JR 2 , Ricardo Costa 3 , Alexandre Abizaid 4 , Mirela Lima 5 , Marco Perin 1 , Amanda Sousa 6 , J Eduardo Sousa 6 1 Santa Marcelina, São Paulo, Brazil, 2 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, 3 INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA, SAO PAULO, Brazil, 4 Visiting Professor Columbia University, São Paulo, Brazil, 5 Cardiovascular Research Center, São Paulo, Brazil, 6 Dante Pazzanese, São Paulo, Brazil Background: Endothelium dysfunction is among the possible causes related to higher thrombosis rates after 1st generation DES. Whether the presence of durable polymer or high anti-proliferative drug dose, or both, can be responsible for this phenomenon is not clear. In the present study we compared the endothelial function following the implant of a polymer-free DES with a nanothin-microporous hydroxyapatite surface coating impreg- nated with a low-dose of Sirolimus (55g) to a BMS equivalent coated with a hydroxyapatite surface (Vestacor stent). Methods: The Vestasync II is a randomized, double-blinded trial with 20 pts (10 in each group) with de novo lesions in native coronary arteries of 3.0-3.5mm diameter and 14mm in length. The primary goal was to compare the vasomotricity after implantation of stents with the same platform, with and without drug elution. Endothelial function was assessed with atrial pacemaker stimulation (20 ppm over basal cardiac frequency until reach 150 ppm) and the lumen diameter was measured at 5 mm of proximal and distal stent edges and in a control segment, in different stages (at rest, at successive phases of stimulli and after nitroglycerin I.C infusion). Results: As shown in the figure, there was a negative variation in luminal diameter between basal and maximum stimulli at proximal (10%) and distal (8%) edges of both groups. Among control segments this variation was less than 3%, an acceptable variation of QCA method. Conclusions: The elution of sirolimus does not seem to interfere in endotelial function 8 months after polymer-free hydroxiapatite coating stent implantation. TCT-654 Comparison in the 5-year Outcome of Pericardium and Polytetrafluoroethylene-Covered Stents for Saphenous Vein Graft Lesions Sandeep Basavarajaiah 1 , Massimo Slavich 2 , Ahmed Rezq 3 , Tasuku Hasegawa 2 , kensuke Takagi 2 , Toru Naganuma 4 , Chiara Bernelli 5 , Azeem Latib 2 , Mauro Carlino 6 , Alaide Chieffo 7 , Matteo Montorfano 2 , Cosmo Godino 8 , Antonio Colombo 9 1 EMO-GVM Centro Cuore Columbus, Milan, Italy, 2 San Raffaele Scientific Institute, Milan, Italy, 3 Department of cardiology, Ain Shams University, Cairo, Egypt, Cairo, Egypt, 4 Ospedale San Raffaele, Milan, MI, 5 San Raffaele Scientific Institute, Milan, N/A, 6 N/A, Milan, Italy, 7 San Raffael Scientific Institute, Milan, Italy, Milan, Italy, 8 San Raffaele scientific institute, Milano, Milano, 9 EMO GVM Centro Cuore Columbus srl, Milan, Italy Background: Percutaneous intervention (PCI) for degenerated saphenous vein graft (SVG) lesions are well known for high rates of no-reflow, restenosis (ISR) and stent thrombosis. Covered stents have been tried in an aim to trap the debris to minimize no-reflow and ISR. Two types of covered stents have been used for SVG lesions: pericardium covered stent (PCS) & polytetrafluroethylene (PTFE) covered stent. We present our long-term follow-up data following the use of both types of covered stents in our practice. Methods: Between 1997 and 2004, 52 patients (mean age: 67.14 years) with 65 lesions in SVG were treated with PTFE covered stents as a part of multicenter trial (RECOV- ERS). Between 2003 and 2007, 33 patients (mean age: 67.78 years) with 48 SVG lesions were treated with pericardium-covered stents covered stents as a part of multicenter trial (SLEEVE II). Results: All case had TIMI3 flow post PCI and there were no immediate post-procedural complications. There were no significant differences in the baseline characteristics except that mean length of PCS were significantly longer than PTFE covered stents (32.3 mm vs 25.1 mm, p0.001). At 5-year follow-up, the rates of TLR was [PTFE: 12 (18.5%), PCS: 13 (27%) p0.17], TVR was [PTFE: 14 (21.5%), PCS: 16 (33%) p0.07]. During the 5-year follow-up period, 8 patients (15%) in the PTFE group and 2 patients (6%) in the PCS group had died; p0.33. The MACE defined as death, MI, clinically driven TVR occurred in 34 of 52 PTFE patients (63%) vs. 18 of 33 PCS patients (54.5%); p0.2. There were two reported cases of definite very late stent thrombosis in the PCS group, but none in the PTFE group. Conclusions: The 5 year follow-up data shows no significant differences in the clinical endpoints between the two covered stents, although numerically it was slightly worse in the PCS group. The rates of TLR and TVR are not discouraging in either stents given the complexity of SVG lesions. Considering the complexity of the lesions treated and the absence of no-reflow, covered stents may provide additional protection. Since there are no very long-term follow-up with other stents in SVG, we cannot compare these results with the traditional stents. TCT-655 Outcomes of high-risk patients undergoing percutaneous coronary interventions in the ambulatory versus in-hospital setting Mark Kahn 1 , Annapoorna Kini 1 , Ziad Sergie 1 , Roxana Mehran 1 , Samin Sharma 1 , Michael Kim 1 1 Mount Sinai School of Medicine, New York, NY Background: In this study, we investigated the safety of ambulatory percutaneous coronary intervention (PCI) in high-risk patients according to age, creatinine, ejection fraction (ACEF) scores. Methods: The ambulatory PCI group consisted of all consecutive PCI with same-day discharges at Mount Sinai Hospital from January 1, 2003 to March 31, 2011 who had follow-up data. The overnight group consisted of all PCI outpatients in 2004 who were then hospitalized for at least one night. Patients were stratified into two groups based on ACEF score: low (1.100) and high (1.100). The primary endpoint was a 30-day major adverse cardiac events (MACE: readmission, all-cause death, and myocardial infarction (MI). Results: Out of 4932 patients, 3216 or 65.2% were in the ambulatory group and the rest (1716) were in the control group. The average age was 61.5 years and were no significant differences in baseline characteristics. Overall 30-day MACE occurred in similar frequency in both groups (Table), in high and low ACEF scores. TUESDAY, OCTOBER, 23, 8:00 AM–10:00 PM www.jacc.tctabstracts2012.com B190 JACC Vol 60/17/Suppl B | October 22–26, 2012 | TCT Abstracts/POSTER/Bare Metal and Drug-Eluting Stents POSTERS

Transcript of TCT-653 Assessment of endothelial function in patients randomly treated with a polymer-free...

Page 1: TCT-653 Assessment of endothelial function in patients randomly treated with a polymer-free sirolimus eluting stent and its bare-metal equivalent: results of the VESTASYNC II trial

Conclusions: This “trumpeting” may also partially explain the observed use of moreXience stents per lesion compared to Resolute (1.18�0.45 vs. 1.15�0.42, p�0.02) in theResolute All Comers (RAC) trial. The primary cause for secondary stenting in RAC was“to stabilize target lesion” which includes procedural complications including dissectionor perforations.

TCT-653

Assessment of endothelial function in patients randomly treated with apolymer-free sirolimus eluting stent and its bare-metal equivalent: results ofthe VESTASYNC II trial

Breno Almeida1, Jose Costa JR2, Ricardo Costa3, Alexandre Abizaid4,Mirela Lima5, Marco Perin1, Amanda Sousa6, J Eduardo Sousa6

1Santa Marcelina, São Paulo, Brazil, 2Instituto Dante Pazzanese de Cardiologia,São Paulo, Brazil, 3INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA, SAOPAULO, Brazil, 4Visiting Professor Columbia University, São Paulo, Brazil,5Cardiovascular Research Center, São Paulo, Brazil, 6Dante Pazzanese, SãoPaulo, Brazil

Background: Endothelium dysfunction is among the possible causes related to higherthrombosis rates after 1st generation DES. Whether the presence of durable polymer orhigh anti-proliferative drug dose, or both, can be responsible for this phenomenon is notclear. In the present study we compared the endothelial function following the implant ofa polymer-free DES with a nanothin-microporous hydroxyapatite surface coating impreg-nated with a low-dose of Sirolimus (55�g) to a BMS equivalent coated with ahydroxyapatite surface (Vestacor stent).Methods: The Vestasync II is a randomized, double-blinded trial with 20 pts (10 in eachgroup) with de novo lesions in native coronary arteries of 3.0-3.5mm diameter and �14mm in length. The primary goal was to compare the vasomotricity after implantationof stents with the same platform, with and without drug elution. Endothelial function wasassessed with atrial pacemaker stimulation (20 ppm over basal cardiac frequency untilreach 150 ppm) and the lumen diameter was measured at 5 mm of proximal and distalstent edges and in a control segment, in different stages (at rest, at successive phases ofstimulli and after nitroglycerin I.C infusion).Results: As shown in the figure, there was a negative variation in luminal diameterbetween basal and maximum stimulli at proximal (10%) and distal (8%) edges of bothgroups. Among control segments this variation was less than 3%, an acceptable variationof QCA method.

Conclusions: The elution of sirolimus does not seem to interfere in endotelial function8 months after polymer-free hydroxiapatite coating stent implantation.

TCT-654

Comparison in the 5-year Outcome of Pericardium andPolytetrafluoroethylene-Covered Stents for Saphenous Vein Graft Lesions

Sandeep Basavarajaiah1, Massimo Slavich2, Ahmed Rezq3, Tasuku Hasegawa2,kensuke Takagi2, Toru Naganuma4, Chiara Bernelli5, Azeem Latib2,Mauro Carlino6, Alaide Chieffo7, Matteo Montorfano2, Cosmo Godino8,Antonio Colombo9

1EMO-GVM Centro Cuore Columbus, Milan, Italy, 2San Raffaele ScientificInstitute, Milan, Italy, 3Department of cardiology, Ain Shams University, Cairo,Egypt, Cairo, Egypt, 4Ospedale San Raffaele, Milan, MI, 5San Raffaele ScientificInstitute, Milan, N/A, 6N/A, Milan, Italy, 7San Raffael Scientific Institute, Milan,Italy, Milan, Italy, 8San Raffaele scientific institute, Milano, Milano, 9EMO GVMCentro Cuore Columbus srl, Milan, Italy

Background: Percutaneous intervention (PCI) for degenerated saphenous vein graft(SVG) lesions are well known for high rates of no-reflow, restenosis (ISR) and stentthrombosis. Covered stents have been tried in an aim to trap the debris to minimizeno-reflow and ISR. Two types of covered stents have been used for SVG lesions:pericardium covered stent (PCS) & polytetrafluroethylene (PTFE) covered stent. Wepresent our long-term follow-up data following the use of both types of covered stents inour practice.Methods: Between 1997 and 2004, 52 patients (mean age: 67.14 years) with 65 lesionsin SVG were treated with PTFE covered stents as a part of multicenter trial (RECOV-ERS). Between 2003 and 2007, 33 patients (mean age: 67.78 years) with 48 SVG lesionswere treated with pericardium-covered stents covered stents as a part of multicenter trial(SLEEVE II).Results: All case had TIMI3 flow post PCI and there were no immediate post-proceduralcomplications. There were no significant differences in the baseline characteristics exceptthat mean length of PCS were significantly longer than PTFE covered stents (32.3 mm vs25.1 mm, p�0.001). At 5-year follow-up, the rates of TLR was [PTFE: 12 (18.5%), PCS:13 (27%) p�0.17], TVR was [PTFE: 14 (21.5%), PCS: 16 (33%) p�0.07]. During the5-year follow-up period, 8 patients (15%) in the PTFE group and 2 patients (6%) in thePCS group had died; p�0.33. The MACE defined as death, MI, clinically driven TVRoccurred in 34 of 52 PTFE patients (63%) vs. 18 of 33 PCS patients (54.5%); p�0.2.There were two reported cases of definite very late stent thrombosis in the PCS group, butnone in the PTFE group.Conclusions: The 5 year follow-up data shows no significant differences in the clinicalendpoints between the two covered stents, although numerically it was slightly worse inthe PCS group. The rates of TLR and TVR are not discouraging in either stents given thecomplexity of SVG lesions. Considering the complexity of the lesions treated and theabsence of no-reflow, covered stents may provide additional protection. Since there are novery long-term follow-up with other stents in SVG, we cannot compare these results withthe traditional stents.

TCT-655

Outcomes of high-risk patients undergoing percutaneous coronaryinterventions in the ambulatory versus in-hospital setting

Mark Kahn1, Annapoorna Kini1, Ziad Sergie1, Roxana Mehran1, Samin Sharma1,Michael Kim1

1Mount Sinai School of Medicine, New York, NY

Background: In this study, we investigated the safety of ambulatory percutaneouscoronary intervention (PCI) in high-risk patients according to age, creatinine, ejectionfraction (ACEF) scores.Methods: The ambulatory PCI group consisted of all consecutive PCI with same-daydischarges at Mount Sinai Hospital from January 1, 2003 to March 31, 2011 who hadfollow-up data. The overnight group consisted of all PCI outpatients in 2004 who werethen hospitalized for at least one night. Patients were stratified into two groups based onACEF score: low (�1.100) and high (�1.100). The primary endpoint was a 30-day majoradverse cardiac events (MACE: readmission, all-cause death, and myocardial infarction(MI).Results: Out of 4932 patients, 3216 or 65.2% were in the ambulatory group and the rest(1716) were in the control group. The average age was 61.5 years and were no significantdifferences in baseline characteristics. Overall 30-day MACE occurred in similarfrequency in both groups (Table), in high and low ACEF scores.

TUESDAY, OCTOBER, 23, 8:00 AM–10:00 PM www.jacc.tctabstracts2012.com

B190 JACC Vol 60/17/Suppl B | October 22–26, 2012 | TCT Abstracts/POSTER/Bare Metal and Drug-Eluting Stents

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