Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions

Tomai, Fabrizio; Reimers, Bernhard; Luca, Leonardo De; Galassi, Alfredo R.; Gaspardone, Achille; Ghini, Anna S.; Ferrero, Valeria; Favero, Luca; Gioffrè, Gaetano; Prati, Francesco; Tamburino, Corrado; Ribichini, Flavio

doi:10.2337/dc07-1377

Cited by 37 publications

(35 citation statements)

References 19 publications

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“…14 Studies with intraindividual design are a valuable adding to investigations of device efficacy. [6][7][8] To the best of our knowledge, studies exploring BVS and DES in the same patient receiving multilesion PCI have not been performed. Against this background, this report investigates the intraindividual performance of BVS and DES in patients receiving multilesion PCI and subsequent angiographic surveillance.…”

Section: Discussionmentioning

confidence: 99%

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Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Cassese

Hoppmann

Kufner

et al. 2016

Circ: Cardiovascular Interventions

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Background-The performance of everolimus-eluting bioresorbable vascular scaffold (BVS) versus drug-eluting metallic stent (DES) in the same individual receiving multilesion percutaneous coronary intervention (PCI) remains poorly studied. This report investigates the intraindividual performance of BVS and DES in patients receiving multilesion PCI and follow-up angiography. Methods and Results-Data of patients undergoing BVS implantation for de novo lesions from 2012 to 2014 at 2 centers in Munich, Germany, were prospectively collected. Individuals receiving multilesion PCI with BVS and DES and follow-up angiography at 6 to 8 months were studied. Primary end point was in-device late lumen loss. Secondary end points were binary restenosis, target lesion revascularization, and definite stent/scaffold thrombosis. A total of 90 PCI patients with 239 lesions received BVS (n=112) and DES (n=127). Follow-up angiography after a median of 6.6 months (5.

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Section: Discussionmentioning

confidence: 99%

“…6 Previous intraindividual studies of DES efficacy have generally shown similar outcomes to randomized trials comparing stents. [6][7][8] However, angiographic and clinical outcomes of BVS and DES in the same individual receiving multilesion percutaneous coronary intervention (PCI) have yet to be investigated.…”

Section: See Editorial By Ormiston and Webstermentioning

confidence: 99%

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Cassese

Hoppmann

Kufner

et al. 2016

Circ: Cardiovascular Interventions

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“…Such findings are reinforced by the use of an intraindividual design, previously validated in other studies on multivessel patients undergoing PCI aimed to evaluate the angiographic or clinical performance of coronary stents. 15,32,33 All these studies suggested that this comparison design may allow the obviation of the multiple and unpredictable baseline differences in high-risk populations, including patients with acute coronary syndrome who have thrombotic burden and nonculprit lesions. According to this particular study protocol, both Xience V and Multi-Link Vision stents were implanted in the same patient for at least 2 significant coronary lesions in 2 major epicardial vessels, by randomizing for coronary vessels.…”

Section: Discussionmentioning

confidence: 99%

“…This intraindividual design has been previously validated in diabetic patients with multivessel coronary artery disease undergoing multiple PCI. 15 The study protocol and related materials were approved by the institutional review boards and ethical committees of all participating centers. The protocol was attributed at http://clinicaltrials.gov, Unique identifier: NCT 00818792.…”

Section: Methodsmentioning

confidence: 99%

Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study

et al. 2014

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Background-Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with baremetal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. Methods and Results-Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the SameMultivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006). Conclusions-This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease. Clinical Trial Registration-URL:http://.clinicaltrials.gov. Unique identifier: NCT00818792.

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“…[1][2][3][4] Preferably, the influence of lesionrelated factors would be minimized by randomly allocating individual lesions to one or other treatment.…”

mentioning

confidence: 99%

Of Stents and Scaffolds

Ormiston

Webster

2016

Circ: Cardiovascular Interventions

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Head-to-Head Comparison of Sirolimus- and Paclitaxel-Eluting Stent in the Same Diabetic Patient With Multiple Coronary Artery Lesions

Abstract: SES directly compared with PES in the same diabetic patient is associated with a decrease in the extent of in-stent LLL at 8 months, suggesting a reduced risk of restenosis.

Cited by 37 publications

References 19 publications

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Intraindividual Comparison of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Drug-Eluting Metallic Stents

Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study

Of Stents and Scaffolds

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