SMART: The microstent's ability to limit restenosis trial

Heuser, Richard R.; Lopez, Alejandro; Kuntz, Richard; Reduto, Lawrence A.; Badger, Rodney S.; Coleman, Patrick L.; Whitlow, Patrick L.; Iannone, L.A.; Safian, Robert D.; Yeung, Alan C.; Moses, Jeffrey W.

doi:10.1002/ccd.1063

Cited by 16 publications

(7 citation statements)

References 17 publications

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“…From January 1996 to April 1997, 2,758 patients were enrolled in four trials sanctioned by the Food and Drug Administration to examine the safety and efficacy of four stent designs: the ACS MultiLink Stent Clinical Equivalence in De Novo Lesions Trial (ASCENT) [14], a registry evaluating the ACS RX MultiLink stent [10], the NIR Vascular Advanced North American Trial (NIRVANA) [15], and the Study of Micro Stent's Ability to Limit Restenosis (SMART) [16]. Of the 2,758 patients in these studies, 1,348 were mandated by protocol to undergo repeat angiography at 6 months.…”

Section: Patient Populationmentioning

confidence: 99%

Incidence and predictors of late total occlusion following coronary stenting

Shah

Cutlip

Popma

et al. 2003

Cathet Cardio Intervent

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To determine the incidence and predictors of total occlusion in-stent restenosis, we reviewed three randomized stent vs. stent trials and one stent registry, which provided 955 coronary artery lesions with 6-month angiographic follow-up. Fifteen (1.6%) of the 955 stented lesions were totally occluded at 6-month follow-up. Most patients with total occlusion presented with recurrent angina at the time of repeat angiography (60.0%) while no patient presented with an acute ST segment elevation myocardial infarction. The univariate predictors of total occlusion following elective coronary stenting included stenting for restenosis after a previous percutaneous intervention (P = 0.001), longer stent length (P < 0.001), longer lesion length (P < 0.001), smaller reference vessel diameter (P = 0.022), smaller preprocedure minimum lumen diameter (MLD; P = 0.004), and smaller postprocedure MLD (P = 0.036). Stepwise multiple logistic regression analysis demonstrated that stenting for restenotic lesions (P = 0.004), longer stent length (P < 0.001), and smaller preprocedure MLD (P = 0.012) were independent predictors of total occlusion following coronary stenting.

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Section: Patient Populationmentioning

confidence: 99%

Incidence and predictors of late total occlusion following coronary stenting

Shah

Cutlip

Popma

et al. 2003

Cathet Cardio Intervent

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“…4,11,12,22,42,50 Data were derived from the total study sample of 7244 patients and the subgroup with mandated angiographic follow-up (nϭ3138) performed at 6 months after the index procedure for bare-metal stent studies and at 8 months for drug-eluting stent studies. The end point of interest, in-stent late loss, was complete in 2426 (77%) of those eligible for angiographic follow-up.…”

Section: Harvard Clinical Research Institute Stent Databasementioning

confidence: 99%

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials

Mauri¹,

Orav²,

Candia³

et al. 2005

Circulation

118

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Background-Binary angiographic and clinical restenosis rates can vary widely between clinical studies, even for the same stent, influenced heavily by case-mix covariates that differ among observational and randomized trials intended to assess a given stent system. We hypothesized that mean in-stent late loss might be a more stable estimator of restenosis propensity across such studies. Methods and Results-In 46 trials of drug-eluting and bare-metal stenting, increasing mean late loss was associated with higher target lesion revascularization (TLR) rates (PϽ0.001). When the class of bare-metal stents was compared with the class of effective drug-eluting stents, late loss was more discriminating than TLR as measured by the high intraclass correlation coefficient () (late loss, ϭ0.71 versus TLR, ϭ0.22; 95% CI of differenceϭ0.33, 0.65). When the individual drug-eluting stents and bare-metal stents were compared, late loss was a better discriminator than TLR (0.68 versus 0.19; 95% CI of differenceϭ0.24, 0.60). Greater adjustments of study covariates are needed to stabilize assessments of TLR compared with late loss because of greater influence of reference vessel diameter on TLR than on in-stent late loss. Optimization of late loss with the use of a novel method of standardization according to diabetes prevalence and mean lesion length resulted in minor adjustments in late loss (Ͻ0.08 mm for 90% of reported trials) and an ordered array of mean late loss values for the stent systems studied. Conclusions-Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug-eluting stent platforms across studies and might be the optimum end point for evaluating drug-eluting stents in early, nonrandomized studies.

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“…The individual studies included 1 trial comparing directional atherectomy with balloon angioplasty (Balloon vs Optimal Atherectomy Trial [BOAT]), 7 4 randomized trials and their associated registries comparing new stent designs (MultiLink, NIR, Bard XT, and AVE Micro II) with the Palmaz-Schatz stent, 8 -10 2 additional stent registries (Crossflex and GFX), 10 and the Stent Antithrombotic Regimen Study (STARS), which compared 3 antithrombotic regimens after successful Palmaz-Schatz coronary stenting. 11 Each of these trials had similar inclusion and exclusion criteria.…”

Section: Patient Populationmentioning

confidence: 99%

Impact of Smoking on Clinical and Angiographic Restenosis After Percutaneous Coronary Intervention

et al. 2001

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Background-Recent studies have suggested that smokers may require less frequent repeated revascularization after percutaneous coronary intervention (PCI) compared with nonsmokers. However, the mechanism of this phenomenon is unknown. Methods and Results-We examined the association between smoking and restenosis using pooled data from 8671 patients treated with PCI in 9 multicenter clinical trials. Clinical restenosis was examined in the cohort of 5682 patients who were assigned to clinical follow-up only. Angiographic restenosis was evaluated in the subset of 2989 patients who were assigned to mandatory angiographic restudy. Among those patients assigned to clinical follow-up only, target lesion revascularization (TLR) occurred in 6.6% of smokers and 10.1% of nonsmokers (PϽ0.001). After adjustment for baseline clinical and angiographic differences, the rate of TLR remained significantly lower in smokers with an adjusted relative risk of 0.69 (95% CI, 0.54 to 0.88). Among the angiographic cohort, there were no differences in the rates of angiographic restenosis or follow-up diameter stenosis in either univariate or multivariate analyses. This dissociation between clinical and angiographic restenosis was explained in part by reduced sensitivity to restenosis on the part of smokers and by the greater reluctance of smokers to seek medical attention despite recurrent angina. Conclusions-In patients undergoing contemporary PCI, cigarette smoking is associated with a lower rate of subsequent TLR without affecting angiographic restenosis. These findings have important implications for the follow-up of smokers after PCI and suggest that cross-study comparisons of rates of clinical restenosis must account for the potential confounding effect of smoking.

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SMART: The microstent's ability to limit restenosis trial

Cited by 16 publications

References 17 publications

Incidence and predictors of late total occlusion following coronary stenting

Incidence and predictors of late total occlusion following coronary stenting

Robustness of Late Lumen Loss in Discriminating Drug-Eluting Stents Across Variable Observational and Randomized Trials

Impact of Smoking on Clinical and Angiographic Restenosis After Percutaneous Coronary Intervention

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