Increased restenosis rates 12 months after coronary implantation of the sirolimus-eluting YUKON-choice stent compared to the paclitaxel-eluting TAXUS Stent.

BACKGROUND: Previously the polymer-free sirolimus-eluting YUKON-Choice stent (A) has demonstrated noninferiority compared to the polymer-based paclitaxel-eluting TAXUS stent (B). To test for long-term equivalency in unselected real-world coronary lesions of various complexities, we retrospectively compared both stents. METHODS: A total of 410 patients with symptomatic coronary artery disease (CAD) were treated with stent A (n = 205) or stent B (n = 205). Baseline clinical characteristics, lesion location, and length and the number of stents implanted per lesion were equally distributed. Clinical follow-up with assessment of major adverse cardiac events (MACE) and noncardiac deaths was obtained at 9 and 12 months. RESULTS: Nominal stent diameter and nominal length of the stented segment were without differences between the groups. The incidence of MACE after 12 months was significantly higher in group A (35.1%) compared to group B (16.6%, P = .001). This was mainly due to increased rates of target-lesion revascularizations in group A (13.7%) vs group B (4.4%, P = .005). No significant differences in target-vessel revascularizations and non-target-vessel revascularizations were observed. In group B, 1 stent thrombosis was documented (0.5%) vs none in group A (P > .05); in each group 1 myocardial infarction (MI), but no cardiac deaths occurred; 3 noncardiac deaths in group A (1.5%) vs 7 in group B (3.4%) were observed (P = .3). CONCLUSIONS: In contrast to our previous findings indicating no differences in MACE between patients treated with the polymer-free sirolimus-eluting YUKON-Choice stent and the polymer-based paclitaxel-eluting TAXUS stent at 6 months, we herewith show that 12 months after percutaneous coronary intervention (PCI) of real-world coronary lesions the YUKON stent appears to be inferior due to increased target-lesion revascularization (TLR) rates as a consequence of delayed restenosis.

Comparison of a polymer-free rapamycin-eluting stent (YUKON) with a polymer-based paclitaxel-eluting stent (TAXUS) in real-world coronary artery lesions.

BACKGROUND: In selected patient cohorts the polymer-free rapamycin-eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer-based paclitaxel-eluting TAXUS stent (B). To test for equivalency in unselected real-world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. METHODS: A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA-analysis at baseline. Clinical follow-up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. RESULTS: Nominal stent diameter was 2.96 +/- 0.38 mm in Group A vs. 3.05 +/- 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 +/-13.0 mm vs. 23.63 +/- 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). CONCLUSIONS: Up to 6 months after PCI of real-world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer-free rapamycin-eluting YUKON stent and the polymer-based paclitaxel-eluting TAXUS stent.

Four-year results after brachytherapy for diffuse coronary in-stent restenosis: will coronary radiation therapy survive?

BACKGROUND: Prior to the introduction of drug-eluting stents (DES), diffuse coronary in-stent restenosis (ISR) was mainly treated by brachytherapy (BT), with good short-term and mid-term results. However, there exist limited data on the long-term effects of BT that justify its continuous use. MATERIALS AND METHODS: Two hundred patients with diffuse ISR treated with intravascular BT were retrospectively followed over 4 years. Group A (n=134) was treated with the noncentered (90)Sr/Y BetaCath radiation system, whereas Group B (n=66) was treated with the centered 32P Galileo source wire system. Primary endpoints after 4 years were target lesion restenosis (TLS) and target lesion revascularization (TLR). Secondary endpoints were target vessel revascularization (TVR) and nontarget vessel revascularization (NTVR), as well as major adverse cardiac events (MACE). RESULTS: Follow-up at 4 years yielded a TLS rate of 37.6% (Group A, 40.8%; Group B, 31.1%; P=.48). TLR was performed in 34.8% of patients (37.5% in Group A vs. 29.5% in Group B; P=.55). Ten percent of patients underwent coronary bypass surgery. Percutaneous coronary intervention was performed more often in Group A (27.5%) than in Group B (19.7%), while TVR was less frequent in Group A (10.0%) than in Group B (18.0%). NTVR was undertaken in 25.0% of Group A patients versus 21.3% of Group B patients, and MACE occurred in 1.7% of Group A patients versus 3.3% of Group B patients. These differences were not statistically significant (P>.05). CONCLUSIONS: While excellent short-term and mid-term results after coronary BT are widely accepted, a high TLS rate can be observed after 4 years. The potential superiority of DES to BT will depend on the availability of long-term clinical data.

Closure of guide wire-induced coronary artery perforation with a two-component fibrin glue.

Perforation or rupture of a coronary artery with subsequent pericardial effusion and cardiac tamponade is a potentially life-threatening complication of percutaneous coronary intervention (PCI). Several emergency treatment strategies exist to close the perforation including reversal of anticoagulation, prolonged balloon inflation, implantation of stent grafts, local injection of thrombogenic molecules, placement of microcoils, or open heart surgery. Here we report on a 66-year-old patient who underwent urgent PCI for acute stent thrombosis in the proximal LAD. The artery was reopened, a new stent implanted successfully, and a GPIIb/IIIa-antagonist was given. Shortly thereafter the patient suffered from cardiac tamponade requiring pericardiocentesis and pericardial drainage. The coronary angiogram indicated a severe guide wire-induced perforation and pericardial effusion originating from a distal diagonal branch segment. Prolonged balloon inflation did not stop the leakage. Therefore the monorail balloon was exchanged for an over-the-wire balloon. A two-component commercial fibrin glue consisting of fibrinogen and thrombin was rapidly but separately injected through the wire channel of the balloon into the distal segment of the diagonal branch. The coronary leak was successfully closed and the patient recovered quickly. In comparison with the previously reported cases of thrombin injection important differences should be noticed: (1) a two-component hemostatic seal was used without reversal of anticoagulation, (2) rapid injection instead of prolonged infusion of the hemostatic drugs was performed, and (3) the rescue technique was applied in a cath lab that routinely uses monorail catheter systems. Therefore we consider this a novel and effective approach for closure of coronary ruptures.

Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials).

The everolimus-eluting stent (EES) has been shown to significantly decrease neointimal proliferation at 6 months compared with the bare metal stent (BMS) in patients with de novo coronary lesions. We report mid-term outcomes based on different vessel sizes in the combined FUTURE I and II trials. In the prospective, randomized, FUTURE I trial (single center) and expanded FUTURE II trial (multicenter), 106 patients (107 lesions) were randomized to EESs (n = 49 lesions) or BMSs (n = 58 lesions). Patients were categorized into 3 groups based on preprocedure reference diameter as assessed by quantitative coronary angiography (small vessel < 2.75 mm, medium vessel 2.75 to 3.25 mm, and large vessel > 3.25 mm). At 6-month follow-up, EESs decreased in-stent late lumen loss (decreased rate range of 78% to 94%), resulting in significantly larger minimum lumen area as assessed by intravascular ultrasound (increased range of 34% to 42%) compared with the BMS across all vessel sizes. There were no cases of in-stent restenosis with EESs at any vessel size but 8 cases with BMSs (5 in small vessels). No stent thrombosis, aneurysm formation, or late stent incomplete apposition was observed in any group. The EES appears to be effective for treatment of de novo coronary lesions in decreasing neointimal proliferation at 6-month follow-up compared with BMSs, regardless of vessel size.

One-year clinical outcomes after complete arterial coronary revascularization.

BACKGROUND: Conventional coronary bypass surgery applies single internal mammary arteries and saphenous vein graft conduits for revascularization of occluded coronary arteries. While the use of saphenous vein grafts is limited by early graft occlusion, little data exist on clinical experiences with complete arterial revascularization. PATIENTS AND METHOD: From January 2003 to July 2004, 390 patients were transferred from Red Cross Hospital Cardiology Center to the Rotenburg Cardiovascular Center for coronary bypass operation. From these patients, 200 were selected for complete arterial revascularization. Mean age of the patients was 66.7+/- 8.0 years; 80.5% were male; 68.5% had triple-vessel disease, 31% had two-vessel disease, and 0.5% had single-vessel disease; 32% were diabetic; and 6.5% had a previous bypass operation. Left ventricular ejection fraction was >50% in 85.5% and 30-50% in 14.5%. Double internal mammary artery grafts were used in 98% and single internal mammary artery grafts in 2%. In 51%, the right internal mammary artery was connected with the left internal mammary artery as a T-graft and in 17%, it was used as a free aortocoronary graft. Radial artery grafts were used in 4%. The average number of anastomoses per patient was 3.4. RESULTS: During the primary in-hospital stay, 1.5% of the patients had to undergo reoperation, 3.5% had myocardial infarctions, 3.5% had wound healing complications, 1.0% experienced an ischemic stroke, and 1 patient died following an acute myocardial infarction. At 12 months, 1.0% underwent percutaneous reinterventions, 0.5% had to be reoperated, 0.5% had a myocardial infarction, and 1.0% died. The actuarial survival rate at 12 months was 99%. CONCLUSION: When both the internal mammary arteries are used as the preferred surgical strategy, complete arterial revascularization can be performed with excellent clinical results over 12 months.

Percutaneous saphenous vein graft interventions with and without distal filter wire protection.

BACKGROUND: Embolic protection during SVG interventions using distal balloon occlusion and aspiration has shown to reduce periprocedural complications compared to unprotected SVG interventions. A similar effect is expected from filter wires. PATIENTS AND METHODS: A total of 174 SVG interventions carried out with (group A; n=87) or without distal filter wire protection (group B; n=87) were retrospectively matched for the location of distal graft anastomosis and analyzed for baseline and procedural characteristics, for TIMI flow grade before and after PCI, for the post-procedural CK elevation, and for major adverse cardiac events at 30 days and 6 months (primary end point). Location of distal graft anastomosis was the left anterior descending artery in 19.6%, the left diagonal branch in 6.9%, the left marginal branch in 17.2%, the left posterolateral branch in 24.2%, the mid-segment of the right coronary artery in 28.7%, and the posterior descending artery in 3.4%. RESULTS: Baseline clinical demographics showed no relevant differences between both the groups. Mean age of vein grafts was 11.7+/- 4.3 years in group A versus 10.6+/- 4.9 years in group B (P=0.15). The number of stents per lesion was 1.4+/- 0.8 in group A versus 1.0+/- 0.8 in group B (P<0.01). The total length of stents was 32.2+/- 16.2 mm in group A versus 20.9+/-12.1 mm in group B (P<0.01). TIMI flow grade pre was 2.5+/-0.8 in group A versus 2.7+/- 0.6 in group B (P<0.05). TIMI flow grade post was 2.9+/- 0.3 versus 2.9+/- 0.2. Improvement of TIMI flow grade after SVG intervention was 0.4+/- 0.7 in group A versus 0.2+/- 0.6 in group B (P<0.05). Post-procedural CK-MB elevations were observed in 17 patients of group A versus 14 patients of group B (P=0.18). At 30 days, there were no myocardial infarctions (MIs) and no deaths in either group. One patient of group A had to be reoperated and four patients of group A underwent repeat PCI (4.6%) versus one patient of group B (1.2%). At 6 months, there were again no MIs and no deaths in either group. Target lesion revascularization rate was 17.3% in group A versus 11.5% in group B (P <0.02). CONCLUSION: When distal filter wire protection is used in high risk SVG lesions, the clinical outcome of percutaneous interventions may be equal to low risk SVG lesions without filter wire protection.

Comparison of a centered 32P source wire system with a noncentered 90Sr/Y brachytherapy system for intracoronary beta-radiation following PCI of diffuse in-stent restenosis.

BACKGROUND: We investigated the potential impact of differences in effective radiation dose between the centered Guidant 32P source wire system and the noncentered Novoste 90Sr/Y BetaCath system on clinical and angiographic outcomes of intracoronary brachytherapy for the prevention of in-stent restenosis. METHODS: From 10/00 to 05/04, a total of 400 patients underwent percutaneous coronary intervention (PCI) with brachytherapy for diffuse in-stent restenosis at our institution. Following balloon dilatation, patient Group A (n=200) was treated with the centered 32P Galileo source wire system, patient Group B (n=200) was treated with the noncentered 90Sr/Y BetaCath radiation system. In Group A, the prescribed dose of 20 Gy was applied in 1-mm depth of the vessel wall. In Group B, the prescribed dose of 18.4 Gy was applied for visual reference vessel sizes >2.7 and <3.35 mm, 23 Gy for >3.36 and <4.00 mm, and 25.3 Gy for >4.00 mm, each calculated at a distance of 2 mm from the center line of the radiation source. Patients received aspirin and clopidogrel over 12 months. Primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints were the binary restenosis rate and major adverse cardiac event (MACE) at 30 days and 6 months. RESULTS: At 30 days, one patient of each group underwent PCI at a nontarget lesion (0.5%). At 6 months, MACEs were equally distributed in both groups. Target lesion revascularization at 6 months was 5.9% in Group A and 9.2% in Group B (P=.08). Binary angiographic restenosis rate at 6 months was 5.5% in Group A and 11.2% in Group B (P=.014). CONCLUSION: Intracoronary beta-radiation using the centered 32P source wire system yielded a significant reduction of recurrence rate compared to the noncentered 90S/Y BetaCath system after PCI of diffuse in-stent restenosis. There was a nonsignificant trend toward reduction of TLR among patients treated with the centered 32P source wire system.

Relationship between size of myocardial infarctions assessed by delayed contrast-enhanced MRI after primary PCI, biochemical markers, and time to intervention.

BACKGROUND: The quantitative assessment of myocardial infarctions using delayed contrast-enhanced magnetic resonance imaging (MRI) has recently been validated using postmortem histopathological animal studies. In a prospective study, we investigated the correlation between infarct size as assessed by delayed contrast-enhanced MRI, elevation of creatine kinase (CK), and c-reactive protein (CRP) as well as the time from onset of symptoms to intervention. METHODS: Four to 10 days after immediate PCI in 45 acute ST-segment elevation myocardial infarction (STEMI) patients (<24 hour) with stenting of the infarct-related artery and treatment with abciximab, we performed gadolinium contrast-enhanced three-dimensional inversion recovery gradient-echo MR sequences with complete coverage of the LV-myocardium in short-axis slices. The mass of infarcted tissue based on the volume of hyperenhanced myocardium was calculated and linear regression analysis was performed to assess the correlation between absolute size of infarctions (g) as well as relative size (LV%) with peak values of CK, CRP, and the time to PCI. RESULTS: There was a significant correlation between absolute size of infarctions (g) and peak CK values (r = 0.72; P < 0.001) as well as the relative size (LV%) and peak CK (r = 0.77; P < 0.001). No correlations were found between absolute size (r = 0.33) as well as relative size (r = 0.27) of infarctions and peak CRP. There was also no correlation between absolute (r = 0.29) as well as relative size of infarctions (r = 0.27) and the time from onset of symptoms to PCI. CONCLUSIONS: In patients with acute STEMI (<24 hour) undergoing immediate PCI with stenting and treatment with abciximab, peak CK values correlated well with infarct size as assessed by delayed contrast-enhanced MRI. There were no correlations between infarct size and peak CRP as well as the time to intervention.

Clinical experiences using everolimus-eluting stents in patients with coronary artery disease.

Despite the growing use of drug-eluting stents, restenosis remains to occur especially in high risk subgroups like patients with diffuse in-stent restenosis. This observation is supporting the search for new and potentially even more effective drug eluting stent systems. Everolimus has been used in conjunction with a new bioabsorbable polymer and gave promising results in initial clinical studies. In FUTURE I, a single-center, single-blinded randomized safety and feasibility study enrolling 15 patients with bare metal stents and 27 patients with everolimus-coated stents, 30-day MACE rate was 0% in both groups. In-stent late loss at six months was 0.83 mm in the control group and 0.10 mm in the everolimus group (p < 0.0001). In FUTURE II, a randomized multi-center study, a total of 64 patients were enrolled confirming safety and feasibility. After 6 months late loss was 0.85 mm in the control group and 0.12 mm in the everolimus group (p < 0.001).

Long-term outcome after implantation of bare metal stents for the treatment of coronary artery disease: rationale for the clinical use of antiproliferative stent coatings.

BACKGROUND: The widespread use of drug-eluting stents in patients with coronary artery disease (CAD) is hampered by unequal regulations for reimbursement. Identification of patients with maximal benefit from this technology may be achieved by assessing long-term clinical outcome after implantation of uncoated bare metal stents. PATIENTS AND METHODS: A consecutive series of 1,000 patients with CAD treated with bare metal coronary stents of various designs from January 1995 to December 1995 was retrospectively followed over 4 years. The primary end points of the study were major adverse cardiac events. RESULTS: The mean age of patients was 62 +/- 10.3 years, 77.5% were male, and 18% were diabetic. Clinical follow-up was obtained in 821 patients (82.1%) after 4.6 +/- 1.1 years. During this period of time, 31.8% were admitted for repeat PCI, 15.1% underwent CABG operation, 3.5% had myocardial infarctions, and 3.7% died. At 4 years, 46.3% of diabetic patients survived without event versus 57.6% of nondiabetic patients (P < 0.05). Patients with CAD I survived without event in 65.3% versus 54.0% of patients with CAD II and 48.5% of patients with CAD III (P < 0.02). CONCLUSION: Implantation of uncoated stents provides the worst long-term clinical outcome in patients with diabetes and those with multivessel CAD. Both groups of patients appear to be primary candidates for the use of drug-eluting stents.

Comparison of stainless steel stents coated with turbostratic carbon and uncoated stents for percutaneous coronary interventions.

BACKGROUND: Stent coating with turbostratic carbon was supposed to minimize the local inflammatory response after stent implantation and to thereby also reduce the rates of restenosis and clinical events. METHODS AND RESULTS: From October, 1999 to February, 2002, a total of 329 patients with symptomatic coronary artery disease (CAD) eligible for single-lesion PCI were randomized for implantation of either a CarboStent (C; n = 168) or a stainless-steel stent (S; n = 161). The stainless-steel stents were Tristar stents in 60.2%, Tetra stents in 17.4% and Penta stents in 22.4%. Both groups showed no differences in baseline clinical and angiographic characteristics. Angiographic follow-up (FU) was obtained after 6 months in 287 patients (87.2%), clinical FU in 295 patients (89.7%). With the exception of a smaller post-procedure minimal luminal diameter (MLD) in the C group (2.59 0.43 mm versus 2.72 0.46 mm in the S group; p = 0.01), there were no significant differences between the C and S groups in lesion length (10.28 4.45 mm versus 10.37 4.79 mm, respectively), reference diameter (2.92 0.59 mm versus 2.89 0.53 mm, respectively), pre-procedure MLD (0.77 0.36 mm versus 0.84 0.36 mm, respectively), MLD at FU (1.67 0.64 mm versus 1.68 0.57 mm, respectively), late loss (0.93 0.63 mm versus 1.05 0.59 mm, respectively), late loss index (0.51 0.32 versus 0.57 0.32, respectively) and restenosis rate (18.1% versus 20.6%, respectively). There were also no significant differences regarding major adverse cardiac events (MACE) between the C and S groups, i.e., occurrence of death (0% versus 0.7%, respectively), myocardial infarction (0% versus 0.7%, respectively), coronary artery bypass graft (0.7% versus 1.4%, respectively) and target lesion revascularization (16.4% versus 21.5%, respectively). CONCLUSION: Coronary stents coated with turbostratic carbon gave no clinically relevant reduction of in-stent restenosis and MACE rates when compared to uncoated stents.