[Show abstract][Hide abstract] ABSTRACT: The effectiveness of SES to reduce the risk of restenosis was initially demonstrated in short lesions using stent implantation with routine pre-dilatation and post-dilatation. This intravascular ultrasound (IVUS) substudy of the E-SIRIUS trial sought to evaluate local arterial responses to sirolimus-eluting stents (SES) delivered with a stent implantation technique allowing direct stenting and only selectively applying high-pressure post-dilatation.
IVUS was performed immediately after intervention and at 8-month follow-up in 51 patients randomised to either bare-metal stents (BMS; Bx-Velocitytrade mark; N=20) or SES (Cyphertrade mark N=31). Direct stenting was allowed (24%) and post-dilation was performed only selectively (32%). Lumen dimensions, intimal hyperplasia and vessel remodeling were compared between SES and BMS. Subsequently, results of SES in the E-SIRIUS IVUS substudy (N=31) were compared to those of SES in the IVUS substudy of the SIRIUS trial (N=137). SES in SIRIUS IVUS substudy were delivered with 100% pre-dilatation and 77% post-dilatation. Baseline stent and reference segment measurements were similar between BMS and SES in E-SIRIUS IVUS patients. Using SES there was a 96% reduction in intimal hyperplasia volume within the stented segment (1.8+/-4.9 vs 50.6+/-39.7 mm3, P<0.001) and a significantly larger minimal lumen cross sectional area at 8-month follow-up (4.5+/-1.1 vs 2.3+/-0.9 mm2, P<0.001). No vessel remodeling was observed with the use of SES. The applied stent implantation technique resulted in a minimal stent/reference vessel area ratio of 0.75+/-0.17 in E-SIRIUS SES as compared to 0.84+/-0.23 in SIRIUS SES (P=0.046). Mean intimal hyperplasia cross-sectional area at follow-up was 0.1+/-0.2 mm2 in the SES group of E-SIRIUS and 0.5+/-0.8 mm2 in the SES group of SIRIUS (P=0.003).
An implantation technique of SES which includes direct stenting and minimizes the use of high-pressure post-dilatation results in less optimal stent expansion. However, follow-up results compare very favourable to those of BMS and are characterised by even less intimal hyperplasia than after a more forceful implantation of SES.
[Show abstract][Hide abstract] ABSTRACT: The long-term (five-year) comparative results of treatment of multivessel coronary artery disease with stenting or coronary artery bypass grafting (CABG) is at present unknown.
The Arterial Revascularization Therapies Study (ARTS) was designed to compare CABG and stenting in patients with multivessel disease.
A total of 1,205 patients with the potential for equivalent revascularization were randomly assigned to CABG (n = 605) or stent implantation (n = 600). The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events (MACCE) at one year; MACCE at five-year follow-up constituted the final secondary end point.
At five years, there were 48 and 46 deaths in the stent and CABG groups, respectively (8.0% vs. 7.6%; p = 0.83; relative risk [RR], 1.05; 95% confidence interval [CI], 0.71 to 1.55). Among 208 diabetic patients, mortality was 13.4% in the stent group and 8.3% in the CABG group (p = 0.27; RR, 1.61; 95% CI, 0.71 to 3.63). Overall freedom from death, stroke, or myocardial infarction was not significantly different between groups (18.2% in the stent group vs. 14.9% in the surgical group; p = 0.14; RR, 1.22; 95% CI, 0.95 to 1.58). The incidence of repeat revascularization was significantly higher in the stent group (30.3%) than in the CABG group (8.8%; p < 0.001; RR, 3.46; 95% CI, 2.61 to 4.60). The composite event-free survival rate was 58.3% in the stent group and 78.2% in the CABG group (p < 0.0001; RR, 1.91; 95% CI, 1.60 to 2.28).
At five years there was no difference in mortality between stenting and surgery for multivessel disease. Furthermore, the incidence of stroke or myocardial infarction was not significantly different between the two groups. However, overall MACCE was higher in the stent group, driven by the increased need for repeat revascularization.
Journal of the American College of Cardiology 09/2005; 46(4):575-81. DOI:10.1016/j.jacc.2004.12.082 · 16.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal stents (BMS) and survey the clinical significance of ISA over a period of 12 months.
TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This intravascular ultrasound (IVUS) substudy included patients who underwent serial IVUS examination after the procedure and at 6 months (BMS, 240 patients; SR, 113; MR, 116). The qualitative and quantitative analyses of ISA were performed by an independent, blinded core laboratory. More than half of the instances of ISA observed after the procedure resolved at 6 months in all groups. No difference in the incidence of late-acquired ISA was observed among the 3 groups (BMS, 5.4%; SR, 8.0%; MR, 9.5%; P=0.306), with a similar ISA volume (BMS, 11.4 mm3; SR, 21.7 mm3; MR, 8.5 mm3; P=0.18). Late-acquired ISA was the result of an increase of vessel area without change in plaque behind the stent. Predictive factors of late-acquired ISA were lesion length, unstable angina, and absence of diabetes. No stent thrombosis occurred in the patients diagnosed with ISA over a period of 12 months.
The incidence and extent of late-acquired ISA are comparable in paclitaxel-eluting stents and BMS. ISA is a pure IVUS finding without clinical repercussions.
[Show abstract][Hide abstract] ABSTRACT: To evaluate the impact of the extent of coronary disease (single- or multivessel) and of fluvastatin treatment on the incidence of long-term cardiac atherosclerotic complications in the Lescol Intervention Prevention Study (LIPS).
A total of 1063 patients with single-vessel disease and 614 patients with multivessel disease were randomized to receive fluvastatin (40 mg bid) or placebo for at least 3 years following a first successful percutaneous coronary intervention. The incidence of cardiac atherosclerotic events (cardiac death, non-fatal myocardial infarction, and coronary re-interventions not related to restenosis) was evaluated.
Patients with multivessel disease tended to be older and presented a higher prevalence of associated risk factors and cardiovascular antecedents. The presence of multivessel disease markedly increased the risk of cardiac atherosclerotic events compared with single-vessel disease among patients allocated to placebo (RR 1.67 [95% CI: 1.24-2.25]; p<0.001). In patients treated with fluvastatin, however, no significant differences in long-term outcomes were observed between patients with multivessel disease and patients single-vessel disease (RR 1.28 [95% CI: 0.90-1.81]; p=0.2).
Multivessel coronary disease impaired the 4-year outcomes after percutaneous intervention. However, the hazardous effect of multivessel disease was significantly reduced by long-term fluvastatin treatment.
International Journal of Cardiology 03/2005; 98(3):479-86. DOI:10.1016/j.ijcard.2003.11.031 · 4.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The effect of body mass index (BMI) on outcomes after coronary artery revascularization remains controversial. We studied 1,203 patients who had multivessel coronary artery disease and underwent stenting (n = 599) or coronary artery bypass grafting (CABG; n = 604) in the Arterial Revascularization Therapies Study. Patients were assigned to 1 of 3 groups according to BMI: <25, 25 to 30, and >30 kg/m(2). At 3-year follow-up, the incidence of death, cerebrovascular events, or myocardial infarction was similar for these BMI categories regardless of the revascularization technique used. Rates of repeat revascularization procedures were significantly higher among patients who had been randomized to stenting but were similar across BMI groups. For patients who had been randomized to undergo CABG, there was a significant decrease in repeat revascularization procedures in obese patients (p = 0.03). Among patients who underwent stenting, BMI had no effect on the 3-year combined end point of rate of major adverse cardiac or cerebrovascular events. Among patients who underwent CABG, major adverse cardiac or cerebrovascular event rates were significantly lower for patients who were obese (11%) or overweight (16%) compared with patients who had a normal BMI (24%; p = 0.008). Thus, in a large cohort of patients who had multivessel coronary artery disease and underwent surgical or percutaneous revascularization, BMI had no effect on 3-year outcome of those who underwent stenting. Conversely, among patients who underwent CABG, those who were overweight or obese had a significantly better outcome than did those who had a normal BMI with regard to survival without major adverse cardiac or cerebrovascular events, mainly due to lower rates of repeat revascularization procedures.
The American Journal of Cardiology 02/2005; 95(4):439-44. DOI:10.1016/j.amjcard.2004.10.007 · 3.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The long-term effect of stents in patients with multivessel disease involving the proximal left anterior descending artery was investigated. At 3 years, there was no difference in the combined incidence of death, stroke, and myocardial infarction in either group, but the need for repeat revascularization was more frequent in the group with stenting than in the group with coronary artery bypass grafting.
The American Journal of Cardiology 10/2004; 94(5):627-31. DOI:10.1016/j.amjcard.2004.05.028 · 3.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Rupture of thin-cap fibroatheromatous plaques is a major cause of acute myocardial infarction (AMI). Such plaques can be identified in vitro by 3D intravascular palpography with high sensitivity and specificity. We used this technique in patients undergoing percutaneous intervention to assess the incidence of mechanically deformable regions. We further explored the relation of such regions to clinical presentation and to C-reactive protein levels.
Three-dimensional palpograms were derived from continuous intravascular ultrasound pullbacks. Patients (n=55) were classified by clinical presentation as having stable angina, unstable angina, or AMI. In every patient, 1 coronary artery was scanned (culprit vessel in stable and unstable angina, nonculprit vessel in AMI), and the number of deformable plaques assessed. Stable angina patients had significantly fewer deformable plaques per vessel (0.6+/-0.6) than did unstable angina patients (P=0.0019) (1.6+/-0.7) or AMI patients (P<0.0001) (2.0+/-0.7). Levels of C-reactive protein were positively correlated with the number of mechanically deformable plaques (R2=0.65, P<0.0001).
Three-dimensional intravascular palpography detects strain patterns in human coronary arteries that represent the level of deformation in plaques. The number of highly deformable plaques is correlated with both clinical presentation and levels of C-reactive protein. Further studies will assess the potential role of the technique to identify patients at risk of future clinical events
[Show abstract][Hide abstract] ABSTRACT: On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents.
TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54+/-2.1 mm2) and MR (-0.88+/-1.9 mm2) groups compared with the BMS (-1.02+/-1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91+/-2.0 mm2, P<0.0001); this decrease was significantly attenuated with SR (0.08+/-2.0 mm2) and MR (-0.19+/-1.7 mm2) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48+/-2.2 mm2, P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents.
The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.
[Show abstract][Hide abstract] ABSTRACT: Polymer-controlled paclitaxel-eluting stents have shown a pronounced reduction in neointimal hyperplasia compared with bare metal stents (BMS). The aim of this substudy was to evaluate local arterial responses through the use of serial quantitative intravascular ultrasound (IVUS) analyses in the TAXUS II trial.
TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This IVUS substudy included patients treated with one study stent who underwent serial IVUS examination after the procedure and at 6-month follow-up (BMS, 152 patients; SR, 81; MR, 81). The analyzed stented segment (15 mm) was divided into 5 subsegments in which mean vessel area (VA), stent area (SA), lumen area (LA), intrastent neointimal hyperplasia area (NIHA), and peristent area (VA-SA) were measured. NIHA was significantly reduced in SR (0.7+/-0.9 mm2, P<0.001) and MR (0.6+/-0.8 mm2, P<0.001) compared with BMS (1.9+/-1.5 mm2), with no differences between the two paclitaxel-eluting release formulations. Longitudinal distribution of neointimal hyperplasia throughout the paclitaxel-eluting stent was uniform. Neointimal growth was independent of peristent area at postprocedure examination in all groups. There were progressive increases in peristent area from BMS to SR to MR (0.5+/-1.7, 1.0+/-1.8, and 1.4+/-2.0 mm2, respectively; P<0.001). The increase in peristent area was directly correlated with increases in VA.
Both SR and MR paclitaxel-eluting stents prevent neointimal formation to the same degree compared with BMS. However, the difference in peristent remodeling suggests a release-dependent effect between SR and MR.
[Show abstract][Hide abstract] ABSTRACT: Restenosis and consequent adverse cardiac events are increased in diabetics undergoing percutaneous coronary intervention. Use of intracoronary stents may ameliorate such risks; however, factors influencing the likelihood of restenosis after stent deployment in this high-risk patient subgroup are unknown.
We retrospectively analyzed all stented diabetic patients in 16 studies of percutaneous coronary intervention, all of which underwent core angiographic analysis at Cardialysis, Rotterdam. Univariate and multivariate analyses, with 37 clinical and angiographic variables, compared those with and without restenosis and predicted restenosis rates calculated through the use of reference charts derived from angiographic data. Within the studies, 418 of 3090 (14%) stented patients with 6-month angiographic follow-up had diabetes. Restenosis (> or =50% diameter stenosis at follow-up) occurred in 550 of 2672 (20.6%) nondiabetic and 130 of 418 (31.1%) diabetic patients (P<0.001). Univariate predictors of restenosis in diabetics were smaller vessel reference diameter (RD) (P<0.001), smaller minimal luminal diameter before stenting (P=0.01), smaller minimal luminal diameter and percent diameter stenosis after stenting (P<0.001, P=0.04), greater stented length of vessel (P<0.001), and reduced body mass index (BMI) (P=0.04). With the use of multivariate analysis, only smaller RD (P=0.003), greater stented length of vessel (P=0.04), and reduced BMI (P=0.04) were associated with restenosis. Reference charts demonstrated an incremental risk of restenosis that appears solely dependent on vessel RD.
Restenosis after stent deployment is significantly increased in diabetic patients. Vessel caliber, stented length of vessel, and lower BMI are predictors of in-stent restenosis in patients with diabetes. Furthermore, vessel caliber affected the predicted risk of restenosis incrementally.
[Show abstract][Hide abstract] ABSTRACT: In the main publication for LIPS (Lescol Intervention Prevention Study), a 22% relative risk (RR) reduction for major adverse cardiac events (MACE) was found among those who used fluvastatin after a successful first percutaneous coronary intervention (PCI). However, intent-to-treat (ITT) analysis of clinical studies generally provides an observed treatment effect that is likely to underestimate what the treatment effect would be if compliance were perfect, because compliance in a clinical trial is invariably <100% during long-term follow-up.
The aim of this study was to analyze the relationship between compliance and treatment effect in LIPS.
In LIPS, patients who had undergone a successful first PCI were randomized to receive fluvastatin 40 mg BID or placebo BID for 3 to 5 years. The primary end point was survival time free of MACE (ie, cardiac death, nonfatal myocardial infarction, or reintervention procedure), and a Cox proportional hazards regression model with time-dependent covariates was used to predict the effect that fluvastatin would have had if trial medication had been continued. Logistic regression was used to determine factors influencing discontinuation of trial medication.
A total of 1677 patients were enrolled in LIPS: 844 in the fluvastatin group and 833 in the placebo group. In the fluvastatin group, 294 patients (34.8%) discontinued taking trial medication and 73 (8.6%) switched to another lipid-lowering medication, compared with 353 (42.4%) and 187 (22.4%) patients in the placebo group, respectively. The risk factor-adjusted RR of MACE with fluvastatin treatment was 0.74 (P = 0.004; 95% CI, 0.61-0.91). When also adjusted for noncompliance, the RR for fluvastatin versus placebo was 0.68 (P = 0.002; 95% CI, 0.53-0.86). Discontinuing fluvastatin without switching to another lipid-lowering medication increased the risk of MACE compared with that of patients who stayed on fluvastatin (RR = 2.27; P < 0.001; 95% CI, 1.60-3.23) and the increase in the risk of MACE was greater than that associated with discontinuing placebo (P = 0.032).
The present study found a 32% RR reduction for experiencing MACE during fluvastatin treatment after a successful PCI in LIPS, when analysis allowed for noncompliance. This suggests that the ITT analysis discussed in the main LIPS publication underestimated the benefit of fluvastatin treatment. Our survival model also provided tentative evidence that discontinuing lipid-lowering medication might lead to a potentially harmful rebound effect in this patient group.
[Show abstract][Hide abstract] ABSTRACT: The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results. We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis (ISR).
The TAXUS III trial was a single-arm, 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length < or =30 mm, 50% to 99% diameter stenosis, and vessel diameter 3.0 to 3.5 mm. They were treated with one or more TAXUS NIRx paclitaxel-eluting stents. Twenty-five patients completed the angiographic follow-up at 6 months, and 17 of these underwent intravascular ultrasound (IVUS) examination. No subacute stent thrombosis occurred up to 12 months, but there was one late chronic total occlusion, and additional 3 patients showed angiographic restenosis. The mean late loss was 0.54 mm, with neointimal hyperplasia volume of 20.3 mm3. The major adverse cardiac event rate was 29% (8 patients; 1 non-Q-wave myocardial infarction, 1 coronary artery bypass grafting, and 6 target lesion revascularization [TLR]). Of the patients with TLR, 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents. Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up (1 incomplete apposition and 1 insufficient expansion of the stent).
Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR. IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention.
[Show abstract][Hide abstract] ABSTRACT: Restenosis remains the major limitation of coronary catheter-based intervention. In small vessels, the amount of neointimal tissue is disproportionately greater than the vessel caliber, resulting in higher restenosis rates. In the Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL) trial, approximately 40% of the vessels were small (<2.5 mm). The present study evaluates the relationship between angiographic outcome and vessel diameter for sirolimus-eluting stents.
Patients were randomized to receive either an 18-mm bare metal Bx VELOCITY (BS group, n=118), or a sirolimus-eluting Bx VELOCITY stent (SES group, n=120). Subgroups were stratified into tertiles according to their reference diameter (RD; stratum I, RD <2.36 mm; stratum II, RD 2.36 mm to 2.84 mm; stratum III, RD >2.84 mm). At 6-month follow-up, the restenosis rate in the SES group was 0% in all strata (versus 35%, 26%, and 20%, respectively, in the BS group). In-stent late loss was 0.01+/-0.25 versus 0.80+/-0.43 mm in stratum I, 0.01+/-0.38 versus 0.88+/-0.57 mm in stratum II, and -0.06+/-0.35 versus 0.74+/-0.57 mm in stratum III (SES versus BS). In SES, the minimal lumen diameter (MLD) remained unchanged (Delta -0.72 to 0.72 mm) in 97% of the lesions and increased (=late gain, DeltaMLD <-0.72 mm) in 3% of the lesions. Multivariate predictors for late loss were treatment allocation (P<0.001) and postprocedural MLD (P= 0.008).
Sirolimus-eluting stents prevent neointimal proliferation and late lumen loss irrespective of the vessel diameter. The classic inverse relationship between vessel diameter and restenosis rate was seen in the bare stent group but not in the sirolimus-eluting stent group.
[Show abstract][Hide abstract] ABSTRACT: The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels.
In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures.
The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.
European Heart Journal 10/2002; 23(17):1351-9. DOI:10.1053/euhj.2001.3153 · 15.20 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We sought to determine the incidence and causes of geographical miss (GM) and to evaluate its impact on edge restenosis after intracoronary beta-radiation therapy.
Edge restenosis is a limitation of intracoronary beta-radiation therapy. Geographical miss is the situation in which the radiation source does not fully cover the injured segment and may lead to edge restenosis.
We analyzed 175 vessels treated according to the Beta-Radiation In Europe (BRIE) study protocol. The effective irradiated segment (EIRS) and both edges were studied with quantitative coronary angiography. The edges of the EIRS that were injured constituted the GM edges. Restenosis was defined as diameter stenosis >50% at follow-up. Geographical miss was determined by simultaneous electrocardiographic-matched, side-by-side projection of the source and balloons deflated at the injury site, in identical angiographic projections surrounded by contrast.
Geographical miss affected 41.2% of the edges and increased edge restenosis significantly compared with non-GM edges (16.3% vs. 4.3%, respectively, p = 0.004). Restenosis was increased both in the proximal (p = 0.05) and distal (p = 0.02) GM edges compared with noninjured edges. Geographical miss associated with stent injury significantly increased edge restenosis (p = 0.006), whereas GM related to balloon injury did not significantly increase edge restenosis (p = 0.35). The restenosis in the EIRS was similar between vessels with and without GM (24.3% and 21.6%, respectively, p = 0.8).
Geographical miss is strongly associated with restenosis at the edges of the EIRS. This effect is more prominent when caused by stenting. Geographical miss does not increase restenosis in the EIRS.
Journal of the American College of Cardiology 09/2001; 38(2):415-20. DOI:10.1016/S0735-1097(01)01381-X · 16.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVESThis study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years.BACKGROUNDThe size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation.METHODSData at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle.RESULTSNo significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance.CONCLUSIONSThe original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.
Journal of the American College of Cardiology 06/2001; 37(6-37):1598-1603. DOI:10.1016/S0735-1097(01)01207-4 · 16.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Beta radiation is effective in reducing vascular neointimal proliferation in animals after injury caused by balloon angioplasty. However, the lowest dose that can prevent restenosis after coronary angioplasty has yet to be determined.
After successful balloon angioplasty of a previously untreated coronary stenosis, 181 patients were randomly assigned to receive 9, 12, 15, or 18 Gy of radiation delivered by a centered yttrium-90 source. Adjunctive stenting was required in 28 percent of the patients. The primary end point was the minimal luminal diameter six months after treatment, as a function of the delivered dose of radiation.
At the time of follow-up coronary angiography, the mean minimal luminal diameter was 1.67 mm in the 9-Gy group, 1.76 mm in the 12-Gy group, 1.83 mm in the 15-Gy group, and 1.97 mm in the 18-Gy group (P=0.06 for the comparison of 9 Gy with 18 Gy), resulting in restenosis rates of 29 percent, 21 percent, 16 percent, and 15 percent, respectively (P=0.14 for the comparison of 9 Gy with 18 Gy). At that time, 86 percent of the patients had had no serious cardiac events. In 130 patients treated with balloon angioplasty alone, restenosis rates were 28 percent, 17 percent, 16 percent, and 4 percent, respectively (P=0.02 for the comparison of 9 Gy with 18 Gy). Among these patients, there was a dose-dependent enlargement of the lumen in 28 percent, 50 percent, 45 percent, and 74 percent of patients, respectively (P<0.001 for the comparison of 9 Gy with 18 Gy). The rate of repeated revascularization was 18 percent with 9 Gy and 6 percent with 18 Gy (P=0.26).
Intracoronary beta radiation therapy produces a significant dose-dependent decrease in the rate of restenosis after angioplasty. An 18-Gy dose not only prevents the renarrowing of the lumen typically observed after successful balloon angioplasty, but actually induces luminal enlargement.
New England Journal of Medicine 01/2001; 344(4):243-9. DOI:10.1056/NEJM200101253440401 · 55.87 Impact Factor