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Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study
This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension. Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent...
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Published in: | Journal of the American College of Cardiology 2005-09, Vol.46 (5), p.776-783 |
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description | This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension.
Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions.
This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months.
The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%.
In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension. |
doi_str_mv | 10.1016/j.jacc.2004.11.073 |
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Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions.
This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months.
The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%.
In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension.</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2004.11.073</identifier><identifier>PMID: 16139124</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Angioplasty ; Angioplasty, Balloon ; Atherosclerosis - surgery ; Atherosclerosis - therapy ; Blood Vessel Prosthesis Implantation ; Cardiology ; Drug therapy ; Female ; Heart attacks ; Humans ; Male ; Middle Aged ; Prospective Studies ; Renal Artery Obstruction - surgery ; Renal Artery Obstruction - therapy ; Reoperation ; Stents ; Time Factors ; Treatment Failure</subject><ispartof>Journal of the American College of Cardiology, 2005-09, Vol.46 (5), p.776-783</ispartof><rights>Copyright Elsevier Limited Sep 6, 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16139124$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rocha-Singh, Krishna</creatorcontrib><creatorcontrib>Jaff, Michael R</creatorcontrib><creatorcontrib>Rosenfield, Kenneth</creatorcontrib><creatorcontrib>ASPIRE-2 Trial Investigators</creatorcontrib><title>Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension.
Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions.
This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months.
The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%.
In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon</subject><subject>Atherosclerosis - surgery</subject><subject>Atherosclerosis - therapy</subject><subject>Blood Vessel Prosthesis Implantation</subject><subject>Cardiology</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Renal Artery Obstruction - surgery</subject><subject>Renal Artery Obstruction - therapy</subject><subject>Reoperation</subject><subject>Stents</subject><subject>Time Factors</subject><subject>Treatment Failure</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><recordid>eNpdkEFv1DAQhS0EotvCH-CALCFxS_A4ayfhVlVLW6kSqMA5mtjjNiuvs8R2pVz623GhXDiNZuabpzePsXcgahCgP-3rPRpTSyG2NUAt2uYF24BSXdWovn3JNmWiKhB9e8JOY9wLIXQH_Wt2AhqaHuR2wx53D-gzpmkOfHY83ROP6CitHIPl5ByZND1QoBif9gsF9ByXRMvKY6KQpnDH0ZWe5xCzMQV02fMRvZ-LJoa7aT56jGn9_Ef9_Pu369tdJct1tusb9sqhj_T2uZ6xn192Py6uqpuvl9cX5zfVvWwhVaa3gvpmVFZap0F1lkzfo7AEuheIgqyWNI6IbTEP0inEbpRWG5ASxdicsY9_dY_L_CtTTMNhioa8x0BzjoPulNqW6Ar44T9wP-elPB0HUEKDVq1uC_X-mcrjgexwXKYDLuvwL9fmN-rWfcg</recordid><startdate>20050906</startdate><enddate>20050906</enddate><creator>Rocha-Singh, Krishna</creator><creator>Jaff, Michael R</creator><creator>Rosenfield, Kenneth</creator><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20050906</creationdate><title>Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study</title><author>Rocha-Singh, Krishna ; Jaff, Michael R ; Rosenfield, Kenneth</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h271t-c9d0e93b5d2df6158dec99a0de1690aa0ed62ebbaa7afe12f5aa8b2d6c122a0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon</topic><topic>Atherosclerosis - surgery</topic><topic>Atherosclerosis - therapy</topic><topic>Blood Vessel Prosthesis Implantation</topic><topic>Cardiology</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Renal Artery Obstruction - surgery</topic><topic>Renal Artery Obstruction - therapy</topic><topic>Reoperation</topic><topic>Stents</topic><topic>Time Factors</topic><topic>Treatment Failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rocha-Singh, Krishna</creatorcontrib><creatorcontrib>Jaff, Michael R</creatorcontrib><creatorcontrib>Rosenfield, Kenneth</creatorcontrib><creatorcontrib>ASPIRE-2 Trial Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rocha-Singh, Krishna</au><au>Jaff, Michael R</au><au>Rosenfield, Kenneth</au><aucorp>ASPIRE-2 Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2005-09-06</date><risdate>2005</risdate><volume>46</volume><issue>5</issue><spage>776</spage><epage>783</epage><pages>776-783</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><abstract>This study sought to define the safety and durability of renal stenting after suboptimal/failed renal artery angioplasty in patients with suspected renovascular hypertension.
Few prospective multicenter studies have detailed the safety, efficacy, and long-term clinical benefits of renal artery stent revascularization in hypertensive patients with aorto-ostial atherosclerotic renal artery lesions.
This non-randomized study enrolled 208 patients with de novo or restenotic > or = 70% aorto-ostial renal artery stenoses, who underwent implantation of a balloon-expandable stent after unsuccessful percutaneous transluminal renal angioplasty (PTRA), which was defined as a > or = 50% residual stenosis, persistent translesional pressure gradient, or a flow-limiting dissection. The primary end point was the nine-month quantitative angiographic or duplex ultrasonography restenosis rate adjudicated by core laboratory analysis. Secondary end points included renal function, blood pressure, and cumulative incidence of major adverse events and target lesion revascularization at 24 months.
The stent procedure was immediately successful in 182 of 227 (80.2%) lesions treated. The nine-month restenosis rate was 17.4%. Systolic/diastolic blood pressure decreased from 168 +/- 25/82 +/- 13 mm Hg (mean +/- standard deviation) at baseline to 149 +/- 24/77 +/- 12 mm Hg at 9 months (p < 0.001 vs. baseline), and 149 +/- 25/77 +/- 12 mm Hg at 24 months (p < 0.001 vs. baseline). Mean serum creatinine concentration was unchanged from baseline values at 9 and 24 months. The 24-month cumulative rate of major adverse events was 19.7%.
In hypertensive patients with aorto-ostial atherosclerotic renal artery stenosis in whom PTRA is unsuccessful, Palmaz (Cordis Corp., Warren, New Jersey) balloon-expandable stents provide a safe and durable revascularization strategy, with a beneficial impact on hypertension.</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>16139124</pmid><doi>10.1016/j.jacc.2004.11.073</doi><tpages>8</tpages></addata></record> |
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subjects | Adult Aged Aged, 80 and over Angioplasty Angioplasty, Balloon Atherosclerosis - surgery Atherosclerosis - therapy Blood Vessel Prosthesis Implantation Cardiology Drug therapy Female Heart attacks Humans Male Middle Aged Prospective Studies Renal Artery Obstruction - surgery Renal Artery Obstruction - therapy Reoperation Stents Time Factors Treatment Failure |
title | Evaluation of the safety and effectiveness of renal artery stenting after unsuccessful balloon angioplasty: the ASPIRE-2 study |
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