6-month Restenosis Research Articles

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Preventing Restenosis after Implantation of Bare Stents with Oral Rapamycin: A Randomized Angiographic and Intravascular Ultrasound Study with a 5-Year Clinical Follow-Up

Objectives: To establish the efficacy of oral rapamycin at a dose of 2 mg for 1 month at reducing the 6-month restenosis rate after the implantation of bare metal stents. Methods: A prospective, 1:1 randomized, single-blind, placebo-controlled study was conducted in 108 consecutive patients assigned immediately after stent implantation to oral rapamycin (4 mg loading dose followed by 2 mg daily for 30 days) or a placebo. Results: Rapamycin was maintained in 98% of patients. Angiographic in-stent binary restenosis was 14.3% in the rapamycin group versus 32.1% in the placebo group, with a relative risk (RR) of 0.45 (95% CI 0.24–0.84, p = 0.015). The rapamycin blood concentration at 15 days correlated with binary restenosis (p = 0.044). The volume obstructions found by intravascular ultrasound for the rapamycin and the placebo groups were 18.1±10.7 and 27.1±15.7% (p = 0.002), respectively. Major adverse cardiac events at a 5-year follow-up were 31.5% for the rapamycin group and 50.0% for the placebo group (RR 0.63, 95% CI 0.39–1.01, p = 0.078). Conclusions: Oral rapamycin significantly reduces the incidence of restenosis at follow-up compared to a placebo.We believe these findings deserve further testing in larger trials.

AS-42: A Randomized Comparison of Triple Antiplatelet Therapy with Dual Antiplatelet Therapy in Patients at High-Risk of Restenosis after Drug-Eluting Stent Implantation: 2-year Clinical Outcomes of DECLARE-DIABETES and LONG Trials

Although cilostazol has reduced 6-month restenosis and 9-month target lesion revascularization in patients at high risk of restenosis after DES implantation, it is not known whether this effect is durable at 2 years after DES implantation.

Clinical and Angiographic Outcomes With Sirolimus-Eluting Stents in Total Coronary Occlusions: The ACROSS/TOSCA-4 (Approaches to Chronic Occlusions With Sirolimus-Eluting Stents/Total Occlusion Study of Coronary Arteries-4) Trial

We sought to examine angiographic and clinical outcomes with sirolimus-eluting stents (SES) in total coronary occlusion (TCO) revascularization. Despite evaluation of drug-eluting stents beyond approved indications, few studies have evaluated their clinical benefit in TCO revascularization. Among 15 centers in North America, 200 consecutive TCO patients (78.8% >6 weeks TCO age) were enrolled for treatment with SES. The primary end point was 6-month angiographic binary restenosis within the treated segment. Patient characteristics included: diabetes, 24.5%; prior infarction, 33.5%; and stent length, 45.9 mm median (quartile 1, 30.2 mm; quartile 2, 62.1 mm). A total of 199 patients (99.5%) were treated with SES, and procedural success was 98.0%. The 6-month binary restenosis rates were 9.5% in-stent, 12.4% in-segment, and 22.6% in-"working length" representing the entire treatment segment. Rates of 1-year target lesion revascularization, myocardial infarction, and target vessel failure were 9.8%, 1.0%, and 10.9%, respectively. Stent thrombosis occurred in 2 patients (1.0%). Using logistic regression modeling with propensity score adjustment, the absolute reduction in binary restenosis with SES compared with a historical bare-metal stent control was 37.7% (95% confidence interval [CI]: 27.2% to 48.3%, p < 0.001; odds ratio: 0.17, 95% CI: 0.09 to 0.30, p < 0.0001). Among 32 patients (16%) identified with stent fracture, target lesion revascularization was more common than patients without fracture (25.0% vs. 6.7%, p = 0.005). Despite greater lesion complexity than prior TCO trials, percutaneous revascularization with SES appears safe and results in substantial reductions in angiographic restenosis and failed patency and a low rate of repeat revascularization. These findings support the use of SES in TCO revascularization. (The ACROSS/TOSCA Trial; NCT00378612).

Interventional catheter treatment of bypass graft stenosis: comparison of intracoronary stent implantation and balloon angioplasty

Balloon angioplasty of a stenosed bypass graft has a much higher risk of recurrent stenosis than dilatation of a stenosed native coronary artery. Intracoronary stent implantation has established itself as the better treatment of native coronary artery stenosis than conventional balloon angioplasty. However, there is still uncertainty whether intracoronary stent implantation in stenosed bypass vessels gives better long-term results than conventional balloon angioplasty. Results were retrospectively analyzed of unrandomized 224 primarily successful interventions--122 balloon dilatations and 102 stent implantations--performed between January 1996 and June 1998 on stenosed coronary bypass grafts, re-examined by coronary angiography an average of 6 months later. All but 11 patients were on combined aspirin and ticlopidine antiplatelet aggregation treatment. There was a significantly lower 6-month restenosis rate (30.4%) after stent implantation than after balloon dilatation (51.6%). The re-intervention rate was also significantly lower after stent implantation. These data suggest that stent implantation of stenosed coronary bypass grafts under cover of platelet-aggregation inhibition with aspirin and ticlopidine provides a lower restenosis and thus higher revascularization rate than conventional balloon dilatation.

Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus: The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients)

We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 +/- 0.53 mm vs. 0.38 +/- 0.54 mm, p = 0.025) and in-segment (0.42 +/- 0.50 mm vs. 0.53 +/- 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

De Novo Superficial Femoropopliteal Artery Lesions: Peripheral Cutting Balloon Angioplasty and Restenosis Rates—Randomized Controlled Trial

To prospectively determine, in a randomized controlled trial, whether cutting balloon angioplasty (CBA) yields superior morphologic and clinical outcomes at 6 months compared with the 6-month outcomes after conventional percutaneous transluminal angioplasty (PTA) in patients with short de novo superficial femoropopliteal artery (SFA) lesions. This study was approved by the ethics committees of the two participating centers, and informed consent was obtained from all patients. The authors randomly assigned 43 patients (26 men, 17 women; median age, 69 years) who had 5 cm or shorter de novo SFA lesions in association with intermittent claudication or chronic limb ischemia to undergo CBA or PTA. The patients were followed up clinically, and restenosis was assessed with duplex ultrasonography (US) at 6 months. chi(2) and Mann-Whitney U tests were used to compare data between the two treatment groups. The US-determined 6-month restenosis rate was 32% (seven patients) in the PTA group versus 62% (13 patients) in the CBA group (P = .048). Sixteen (73%) PTA group patients versus eight (38%) CBA group patients were asymptomatic at follow-up (P = .059). There was no significant difference in ankle-brachial index (median, 0.83 vs 0.77 for PTA vs CBA group, respectively; P = .56) or pain-free walking distance (median, >1000 m vs 600 m for PTA vs CBA group, respectively; P = .17) between the two groups. CBA did not prove to be superior to conventional PTA for treatment of short de novo SFA lesions and yielded increased restenosis rates at 6 months.

Treatment of diffuse IN-stent restenosis with Drug-Eluting stents vs. intracoronary bEta-raDiation therapy: INDEED Study

BackgroundWe compared sirolimus-eluting stent (SES) implantation and intracoronary brachytherapy (ICBT) for diffuse bare metal in-stent restenosis (ISR) to identify more effective treatment modality. MethodsPatients (n=129) with diffuse ISR (lesion length≥10 mm) were randomly assigned to either SES implantation (n=65, group I) or beta-radiation with 188Re–MAG3-filled balloon (n=64, group II). The radiation dose was 20 Gy at a depth of 1.0 mm into the vessel wall. The primary end point was late loss in analysis segment at 6 months. The secondary end points were 6-month angiographic restenosis and 1-year major adverse cardiac events (MACE) including myocardial infarction (MI), cardiac death, and target lesion revascularization (TLR). ResultsBaseline characteristics were similar between two groups. The lesion length was 27.52±13.98 mm in group I and 27.75±14.25 mm in group II (p=0.927). Late loss in analysis segment at 6 months was smaller in group I than in group II (0.15±0.62 vs. 0.55±0.69 mm, p=0.003). Angiographic restenosis for analysis segment at 6 months was 8.0% (4/50) in group I and 30.2% (16/53) in group II (p=0.006). One MI and two deaths (all from group I) occurred during follow-up. TLR (4.6% vs. 18.8%, p=0.014) and MACEs (7.7% vs. 18.8%, p=0.073) were lower in group I than group II at 1 year. ConclusionCompared to ICBT, SES implantation for diffuse bare metal ISR showed less late loss, lower restenosis, and a trend toward lower 1-year MACEs. SES implantation appears to be superior to ICBT for treating diffuse ISR.

Comparison of Long-Term Angiographic Follow-Up After Sirolimus-Eluting Stent and Bare-Metal Stent Implantation

The sirolimus-eluting stent (SES) has dramatically reduced the rate of restenosis in comparison to that with the bare-metal stent (BMS). In previous studies, the minimal luminal diameter (MLD) of lesions treated with a BMS was shown to improve from 6 months to 1 year. To evaluate 6-month and 1-year outcomes, angiographic follow-up data were analyzed for 285 patients (451 lesions) who underwent successful SES implantation compared to follow-up data for 2,561 patients (3,367 lesions) who underwent BMS implantation. Angiographic follow-up was performed at 6 months for 396 SES-treated lesions and 2,628 BMS-treated lesions and at 1 year for 322 SES-treated lesions and 1,540 BMS-treated lesions. The 6-month angiographic restenosis rate was significantly lower for SES-treated lesions than for BMS-treated lesions (4.8% vs. 23.4%, p<0.01). From immediately after stent implantation to 6 months, quantitative coronary angiography revealed a significantly larger decrease in MLD of BMS-treated lesions than in MLD of SES-treated lesions (p<0.01). In BMS-treated lesions in which repeat revascularization was not performed at 6 months, MLD increased significantly from 2.08+/-0.63 mm at 6 months to 2.11+/-0.61 mm at 1 year (p<0.01). In SES-treated lesions, however, MLD decreased significantly from 2.55+/-0.56 mm at 6 months to 2.44+/-0.61 mm at 1 year (p<0.05). From 6 months to 1 year, stenosis of BMS-treated lesions regressed, but stenosis of SES-treated lesions progressed.

Association of OAZ1 Gene Polymorphisms With Subclinical and Clinical Vascular Events

Proliferation and migration of vascular smooth muscle cells (VSMCs) are striking features shared by vascular ageing, atherosclerosis, and in-stent restenosis. VSMC biology depends in part on polyamines whose metabolism is closely regulated by ornithine decarboxylase antizyme 1 (OAZ1). Therefore, we sought for association between OAZ1 gene polymorphisms and various outcomes involving VSMC proliferation. Systematic screening of the OAZ1 gene enabled to detect 21 variants. The impact of 4 selected tag polymorphisms (+849C/T, +851G/T, +1804G/A, and +2222A/G) was evaluated in 3 independent association studies. In a sample of 205 patients, the +2222G allele was associated with an increased risk of 6-month coronary in-stent restenosis (OR [95%CI]=2.1 [1.2 to 3.6]; P=0.0071). In a sample of 1001 subjects participating to the EVA study, the +2222G allele was longitudinally associated with a 4-year increase in common carotid intima-media thickness (P=0.047). In a case-control study (466 cases versus 466 controls), the risk of coronary heart disease associated with the +2222G allele was 1.3 (95%CI=[1.1 to 1.6]; P=0.026). No other significant association was consistently detected. We identified the OAZ1+2222A/G polymorphism as a potential genetic marker of vascular events. Our findings strengthen the hypothesis that the polyamine metabolism plays a role in vascular diseases.

Increased Late Mortality After Sirolimus-Eluting Stents Versus Bare-Metal Stents in Diseased Saphenous Vein Grafts: Results From the Randomized DELAYED RRISC Trial

We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial. We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES. A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization. Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively). In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a “real world” setting: six-month follow-up results

Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n = 93, Firebird group) or Excel stents (n = 97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups. Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P > 0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 +/- 0.21) mm versus (0.14 +/- 0.20) mm (P = 0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.

Significance of Additional ST Segment Elevation in Patients with No Reflow After Angioplasty for Acute Myocardial Infarction

We sought to evaluate the incidence, timing, and clinical significance of additional increase in ST segment elevation (ST-SE) in patients showing no reflow after angioplasty for acute myocardial infarction. We studied 26 patients with acute myocardial infarction showing myocardial contrast echocardiography no reflow after successful angioplasty. Baseline and 6-month 2-dimensional echocardiograms were obtained in 21 surviving patients. After angioplasty, 13 patients showed greater than 30% additional increase in ST-SE (group 1), whereas 13 did not (group 2). Baseline clinical, echographic, and angiographic characteristics, and 6-month patency and restenosis rate, were similar between the two groups. From baseline to 6 months, a similar global and regional systolic function was found between the two groups, whereas a higher increase in left ventricular end-diastolic volume occurred in group 1 (135 +/- 45 vs 168 +/- 42 mL, P = .033). The additional increase in ST-SE was not associated with more severe microvascular damage (myocardial contrast echocardiography score index: 0.14 +/- 0.26 vs 0.22 +/- 0.27), higher peak creatine kinase value (4888 +/- 2533 vs 3109 +/- 2055 U/L, P = .061), higher incidence of left ventricular remodeling (73% vs 60%, P = .537), or worse outcome (26 +/- 24 months) such as death (15% vs 23%, P = .619), hospitalization for heart failure (8% vs 23%, P = .277), or reinfarction (8% vs 0%, P = .308). Our data show that in patients showing no reflow after angioplasty a transient additional increase in ST-SE occurs in half of patients. The prognostic value of additional increase in ST-SE remains uncertain in the era of primary angioplasty.

Impact of 6-Month Angiographic Restenosis Inside Bare-Metal Stents on Long-Term Clinical Outcome in Patients With Coronary Artery Disease

This study enrolled 536 patients who underwent successful coronary stenting with bare-metal stents and 6-month angiographic follow-up examinations between 1998 and 2000. Baseline characteristics and angiographic and procedural parameters for these patients were obtained. Primary endpoints were all-cause mortality and nonfatal myocardial infarction. Patients were assigned to instent restenosis or non-instent restenosis groups based on 6-month angiographic follow-up results. Restenosis inside a bare-metal stent was defined as more than 50% stenosis at the intervention site. In total, 178 (33.2%) patients had restenosis inside bare-metal stents, while 358 (66.8%) patients were without. At mean follow-up of 56.8 +/- 20.3 months, 36 (6.7%) patients had a primary endpoint event while 500 (93.3%) patients had no primary endpoint event. Survival rates for patients free from primary endpoints in the instent restenosis and non-instent restenosis groups were 96.0 versus 99.4% at 1 year and 89.8% versus 94.8% at 5 years, respectively (P = 0.0033). Survival rates for patients free of all-cause mortality in the instent restenosis and non-instent restenosis groups were 96.0% versus 99.4% at 1 year and 91.6% versus 96.3% at 5 years, respectively (P = 0.0079). Multivariate Cox regression analysis showed that restenosis inside bare-metal stents was an independent predictor of primary endpoint events (odds ratio: 2.053; 95% CI: 1.048-4.022; P = 0.036) and was a predictor of total mortality with borderline significance (odds ratio: 2.036; 95% CI: 0.936-4.431; P = 0.073). In conclusion, in this study, restenosis inside bare-metal stents at 6-month angiographic follow-up was an independent predictor of long-term outcome-all-cause mortality and nonfatal myocardial infarction. Thus, this study provides clinical evidence that patients with restenosis inside bare-metal stents at 6-month angiographic follow-up likely warrant aggressive follow-up.

Safety and Efficacy of the 2.25-mm Sirolimus-Eluting Bx Velocity Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions: the SIRIUS 2.25 Trial

Smaller reference vessel diameter is a recognized determinant of in-stent restenosis. The SIRIUS 2.25 trial was a prospective, nonrandomized study including 100 patients (mean age 63.4 years; 64% men, 40% with diabetes mellitus) assessing the safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in patients with de novo native coronary lesions. Using propensity score matching for gender, diabetes mellitus, left anterior descending artery target vessel, lesion length, and reference vessel diameter, the outcomes were compared with historical control groups (angioplasty and Palmaz-Schatz stent arms from the STRESS/BENESTENT I/II trials and the Bx Velocity bare metal stent arm from the RAVEL and SIRIUS trials having a reference vessel diameter <3 mm). Use of the 2.25-mm sirolimus-eluting Bx Velocity stent was associated with a high rate of procedural success (97%) and a low rate of in-hospital major adverse cardiac events (2%). The primary end point, 6-month in-lesion binary angiographic restenosis, occurred less frequently in patients treated with the 2.25-mm sirolimus-eluting Bx Velocity stent than in each of 3 historical controls (16.9% vs 30.6%, p = 0.12; 36.5%, p <0.001; 45.9%, p <0.001, respectively). This translated into lower rates of 6-month target lesion revascularization in the 2.25-mm sirolimus-eluting Bx Velocity stent group (4.0% vs 15.0% in each of 3 control groups, p = 0.01 to <0.001). By multivariate analysis, in-lesion binary restenosis was predicted by multiple implanted stents (odds ratio 10.4, p = 0.002). Four of 13 patients who developed restenosis (30.8%) had a diffuse pattern of restenosis. In the long lesion tertile (mean lesion length 19.5 mm), the in-lesion binary restenosis rate was 27.6%. In conclusion, use of the 2.25-mm sirolimus-eluting Bx Velocity stent was safe and provided favorable 6-month clinical outcomes. Use of multiple stents (in longer lesions) was an independent predictor of in-lesion restenosis.

Use of Taxus polymer‐coated paclitaxel‐eluting stents for treatment of in‐stent restenosis in real world patients: Results of clinical and angiographic follow‐up at six months in a single‐center registry

To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.

Sirolimus‐Eluting Stent in Chronic Total Occlusion: The SICTO Study

Coronary stenting can significantly reduce the restenosis and reocclusion rates after successful balloon angioplasty for chronic total occlusions (CTO). Nevertheless, recanalization of CTO remains among the worst predictors for in-stent restenosis and reocclusion. This multicenter, nonrandomized study assessed the safety and effectiveness of the CYPHER sirolimus-eluting stent in reducing angiographic in-stent late loss in totally occluded native coronary arteries. A total of 25 eligible patients were treated with the CYPHER sirolimus-eluting stent. Baseline clinical and angiographic data were collected and 6-month follow-up angiography and intravascular ultrasound (IVUS) were performed. Clinical follow-up was required at 30 days, 6, 12, 18, and 24 months. Study stent implantation was successful in all patients, with a mean stent length of 28.4 +/- 11 mm. Six-month angiographic outcomes showed that mean lumen diameter stenosis did not change (2.22 +/- 0.56 mm postprocedure; 2.26 +/- 0.60 mm at 6 months follow-up; P = NS). Similarly, mean percent diameter stenosis did not change significantly (15.7 +/- 8.6% postprocedure, 19.3 +/- 11% at follow-up; P = NS). The absolute late lumen loss was -0.03 +/- 0.28 mm with a 6-month in-stent restenosis rate of 0%. IVUS follow-up revealed in-stent obstruction volume of only 4.9 +/- 6.8%. Long-term clinical follow-up showed target lesion revascularization at 12 months was only 4%, with target vessel revascularization of only 12%. The CYPHER sirolimus-eluting stent was safe and effective in the treatment of CTO compared to historical data with bare metal stents.

Drug‐eluting stent supported percutaneous coronary intervention for unprotected left main disease

This study sought to determine the clinical and angiographic outcomes of unselected patients receiving drug-eluting stents for unprotected left main disease. The results of several series of percutaneous coronary intervention (PCI) for left main disease in the pre-drug-eluting stent era have arisen concerns on the safety and mid-term efficacy of PCI. Consecutive patients with unprotected left main disease were considered eligible for drug-eluting stent supported PCI. The surgical risk score (risk of death within 1 month) of each patient was calculated according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) model. One-hundred and one patients with unprotected left main disease underwent PCI. The mean EuroSCORE was 19 +/- 23. Successfully left main stenting was performed in 98 patients (primary success rate 97%). The overall 1-month mortality rate was 9.9%. The 1-month mortality rate was 50% in patients with acute myocardial infarction (AMI) on presentation, and 4.5% in patients without AMI on presentation. The 1-month mortality rate of patients with a risk score <13 was 3%, while it was 21% in patients with a risk score >or=13. At 6 months, the mortality rate of the entire cohort of patients increased to 12.8%, and the one of the non-AMI patients to 7.8%. Survival rate was 86% +/- 4% (mean follow-up 295 +/- 175 days). Target vessel revascularization was performed in 14 patients (16%). The 6-month in-segment restenosis rate was 16%. Drug-eluting stent supported PCI may provide early and mid-term outcomes comparable or superior to those expected from coronary artery surgery. (c) 2006 Wiley-Liss, Inc.

Drug‐eluting stent‐supported percutaneous coronary intervention for chronic total coronary occlusion

This study sought to determine the clinical and angiographic outcomes after drug-eluting stent (DES)-supported percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO). There are few data about the efficacy of DES-supported PCI for CTO. All consecutive patients who had a sirolimus-eluting stent or a paclitaxel-eluting stent implanted for CTO from December 2003 to December 2004 were analyzed. Clinical and angiographic outcomes of patients treated with DES were compared with a case-matched control group of patients treated with bare metal stents (BMS) in the 12 months before the routine use of DES. Successful DES-supported PCI was performed in 92 patients and 104 CTO. The case-matched control group consisted of 26 patients and 27 CTO successfully treated with BMS. There were no differences between groups in baseline clinical and angiographic characteristics. Stent length in the DES group was higher as compared with that of BMS group (51+/-28 mm vs. 40+/-19 mm, P=0.073). The 6-month major adverse cardiac event (MACE) rate was lower in the DES group as compared with that of BMS group (9.8% vs. 23%, P=0.072). The angiographic follow-rate was 80% in the DES group and 81% in the BMS group. The 6-month restenosis rate was 19% in the DES group and 45% in the BMS group (P<0.001). By multivariate analysis, it was found that in the DES group, the only predictors of restenosis were stented segment length (OR 1.031, 95% CI 1.01-1.06, P=0.009) and a target vessel reference diameter<2.5 mm (OR 6.48, 95% CI 1.51-27.83, P=0.012), while the only predictor of MACE was stent length (OR 1.04, 95% CI 1.01-1.08, P=0.006). DES implantation for CTO decreases the risk of mid-term restenosis and MACE. Small vessels and diffuse disease requiring the implantation of multiple stents and very long stents for full coverage of the target lesion are still associated with a relatively high risk of restenosis.

Clinical and Angiographic Analysis With a Cobalt Alloy Coronary Stent (Driver) in Stable and Unstable Angina Pectoris

The Clinical and Angiographic analysis with a Cobalt Alloy Coronary Stent (Driver) (CLASS) study was a prospective, nonrandomized, multicenter study designed to assess the safety and efficacy of a cobalt-chromium alloy-based stent in patients with stable or unstable angina pectoris. A total of 203 lesions were treated in 202 enrolled patients. The percentage of major adverse cardiac event-free patients was 87.6% (177 of 202) at 6 months (primary safety end point; major adverse cardiac events were defined as death, myocardial infarction, emergency bypass surgery, or target lesion revascularization [percutaneous transluminal coronary angioplasty or coronary artery bypass grafting]). The angiographic success rate (primary efficacy end point) was 100%, and the procedural success rate was 98%. The binary in-stent restenosis rate at 6 months was 12.6%. Our results have demonstrated that the Driver cobalt-chromium alloy stent can be used with a low 6-month incidence of major adverse cardiac events, a low 6-month binary restenosis rate, and high angiographic and procedural success rates.