Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy: insights from a multicenter, propensity score-matched registry.

BACKGROUND: The biodegradable polymer drug-eluting stents have been proposed as an alternative to durable polymer DES, theoretically improving vessel healing and reducing the need for prolonged double anti platelet therapy (DAPT), however clinical significance of this technology is under debate. Therefore, we sought to compare the clinical outcomes of two Paclitaxel eluting stents (PES) containing different polymer-based eluting matrices. METHODS: In this multicenter registry of 392 consecutive patients who underwent PCI between June 2006 and September 2008, we included patients with stable angina or NSTE-ACS displaying at least one significant lesion (>50% diameter stenosis) in native coronary arteries. RESULTS: Biodegradable polymer PES (BP-PES, LUC Chopin(2) , Balton, Poland) was implanted in 206 patients, whereas durable polymer PES (DP-PES, Taxus, Boston Scientific, USA) was implanted in 186 patients. There were no significant differences in baseline characteristics between groups with the exception of increased diabetes and number of lesions for BP-PES. In risk-unadjusted analysis at 1-year follow-up, there were no significant differences in TLR (BP-PES: 8.4% vs. DP-PES: 6%; P = 0.36), TVR (BP-PES: 11.1% vs. DP-PES: 8.4%; P = 0.36) and incidence of stent thromboses (BP-PES: 2.15% vs. DP-PES: 3.4%; P = 0.42) between groups. There was also no difference in MACCE between groups (17.6% vs. 14.4%, P = 0.49). The mean dual antiplatelet therapy (DAPT) compliance at 1 year was 77% for BP-PES versus 92% for DP-PES (P = 0.03). Kaplan-Meier analysis showed a significantly higher long-term stroke free survival in BP-PES (P = 0.04). After adjustment, this was sustained with an additional tendency toward higher MI free survival for BP-PES (P = 0.059). CONCLUSIONS: In this observational analysis, BP-PES were comparable to DP-PES, with regard to incidence of repeated revascularizations, stent thromboses and MACCE despite earlier DAPT discontinuation.

Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions.

BACKGROUND: The TAXUS II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based TAXUS paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. METHODS AND RESULTS: This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare TAXUS SR (n=131) and TAXUS MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of TAXUS II. At 5 years, both TAXUS SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, TAXUS SR, and TAXUS MR groups, respectively. The rates of all-cause death and myocardial infarction were low and similar between groups, with 2 stent thromboses with bare-metal stents compared with no event beyond 2 years with either of the TAXUS stents. CONCLUSIONS: TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.

Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality.

AIMS: The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. METHODS AND RESULTS: The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. CONCLUSION: In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.

Two-year serial coronary angiographic and intravascular ultrasound analysis of in-stent angiographic late lumen loss and ultrasonic neointimal volume from the TAXUS II trial.

Late loss has been used as a reliable surrogate end point for evaluation and differentiation of short-term performance of drug-eluting stents. This study investigated the consistency between angiographic and intravascular ultrasound (IVUS) outcomes of late lumen loss (late loss) and neointimal growth to measure restenotic plaque load in TAXUS and bare metal stents. The randomized TAXUS II trial evaluates the polymer-based paclitaxel-eluting TAXUS stent in slow- and moderate-release formulations. Serial angiographic and IVUS analyses were available in 155 event-free patients (bare metal stent, 74; TAXUS stent, 81) after the procedure, at 6 months, and at 2 years. For this subanalysis, quantitative coronary angiographic (QCA) and IVUS measurements were used to derive late loss and neointimal volume. From after the procedure to 6 months, quantitative coronary angiography and IVUS showed matching results for the 2 groups with significant decreases in late loss and neointimal volume in the TAXUS versus the control group. From 6 months to 2 years, QCA and IVUS measurements also showed results similar to those in the control group, demonstrating neointimal compaction over time. However, in the TAXUS group, QCA late loss showed a nonsignificant decrease from 6 months to 2 years, whereas IVUS neointimal volume increased. In conclusion, although QCA and IVUS results were similar over the first 6 months, long-term assessment of changes in restenotic plaque load showed discrepant findings for the TAXUS. These findings suggest the need for critical reevaluation of current end points and the use of more precise techniques to detect lumen and stent boundaries.

Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: insights from serial intravascular ultrasound analysis in the TAXUS II study.

BACKGROUND: The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents. METHODS AND RESULTS: TAXUS II is a randomized, double-blind trial comparing slow-release (SR) and moderate-release (MR) TAXUS stents with bare-metal control stents (BMSs). One hundred sixty-one event-free patients (SR, 43; MR, 41; and BMS, 77) underwent serial intravascular ultrasound (IVUS) analysis after the procedure and at 6 months and 2 years. At 2 years, neointimal responses continued to be significantly suppressed in the SR and MR groups when compared with the BMS group (BMS, 1.49+/-1.12 mm2; SR, 0.94+/-0.76 mm2 [P=0.004]; and MR, 1.06+/-0.90 mm2 [P=0.02]). Between 6 months and 2 years, the BMS group showed compaction of the neointima (Delta, -0.22+/-1.05 mm2 [P=0.08]). In contrast, both the SR and MR groups exhibited an increase (Delta SR, 0.30+/-0.76 mm2 (P=0.01); MR, 0.41+/-0.94 mm2 [P=0.009]). Between 6 months and 2 years, the initial increase in plaque outside the stent regressed in the BMS and SR groups to levels comparable to those after the procedure, whereas expansive remodeling partially regressed in the MR group (Delta between after the procedure and 2 years BMS, -0.34+/-1.28 mm2 [P=0.05]; SR, -0.02+/-1.40 mm2 [P=0.93]; MR, 0.32+/-1.56 mm2 [P=0.27]). CONCLUSIONS: The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.

Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.

BACKGROUND: Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. METHODS AND RESULTS: We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients. CONCLUSIONS: Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.

Primary stenting versus MIDCAB: preliminary report-comparision of two methods of revascularization in single left anterior descending coronary artery stenosis.

BACKGROUND: Percutaneous revascularization is a well-accepted method of treatment for a single left anterior descending coronary artery (LAD) stenosis. With the introduction of primary stenting, it has become the treatment of choice for a LAD lesion. In the last few years however, the introduction of minimally invasive cardiac surgery, video-assisted left internal thoracic artery (LITA) harvesting, and robotic surgery have raised the question as to whether minimally invasive surgical revascularization would be competitive with percutaneous coronary interventions in cases of single-vessel stenoses. METHODS: A group of 100 patients with Canadian Cardiovascular Society class II to IV, and angiographically confirmed single critical stenosis of the LAD (type A or B), were treated with direct primary stenting (group 1, n = 50), or with endoscopic atraumatic coronary artery bypass grafting (group 2, n =50). RESULTS: All patients in a group 1, obtained a very good angiographic and clinical effect. No acute postoperative complications were noted at 1 month of follow-up. However, at 1 month of follow-up, 3 patients (6%) developed restenosis of the LAD, and at 6 months follow-up, 6 patients (12%), developed restenosis of the LAD. In these cases, repeated percutaneous coronary interventions of the target vessel were successfully performed. In group 2, very good operative results were observed. In 1 and 6 months of follow-up, all patients remained asymptomatic. Critical stenosis of the left internal thoracic artery-LAD anastomosis was angiographically documented in 1 case (2%). This patient was successfully treated with balloon angioplasty. CONCLUSIONS: The study results document the superiority of endoscopic atraumatic coronary artery bypass grafting over direct primary stenting in LAD revascularization, along with the slightly higher costs of the surgical procedure.

Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization.

OBJECTIVE: Minimally invasive direct coronary artery bypass (MIDCAB) through the anterolateral minithoracotomy has become a promising therapeutic option in patients with lesion in left anterior descending artery (LAD), especially in multimorbid, elderly and reoperated patients with type C or B lesions. To expand the benefits of MIDCAB concept to patients with multivessel disease, a hybrid myocardial revascularization procedure (HMR) combining surgery of the LAD with interventional procedures for additional coronary lesions has recently been introduced. METHODS: Between January 1999 and September 2001, 50 patients (37 male, 13 female, mean age 54.8+/-20.1 years) underwent an HMR procedure. MIDCAB with endoscopic left internal thoracic artery (LITA) harvesting, followed by percutaneous coronary intervention (PCI) for additional coronary lesions and percutaneous transluminal coronary angioplasty (PTCA), was performed in 11 patients (22%) and stenting in 39 patients (78%). Angiographic assessment of graft patency was performed in all patients during the PCI procedure. The clinical follow-up period was 3-32 months. RESULTS: There were no early and late deaths. Baseline Canadian Cardiology Society (CCS) class was 2.8+/-0.7 versus 1.1+/-0.9 (P<0.001) 30 days after HMR procedure. There were no major acute in-hospital cardiac events. Angiographic studies showed patent LIMA-LAD graft in 50 patients (100%). We showed good quality of anastomosis in 49 patients (98%). There was a moderate graft stenosis in one patient (2%). At long term follow-up, the rate of major cardiac events was 12%. Five patients (10%) developed restenosis after PCI, and one patient (2%) developed significant stenosis in site of LITA-LAD anastomosis; redo PCI was performed successfully. CONCLUSIONS: The hybrid procedure is a safe and effective method for complete revascularization in selected patients with double-vessel coronary artery disease (patients with type B or C lesions in the proximal LAD). This method allows performance of complete revascularization with minimization of surgical trauma. So far, long-term results of HMR are limited by the results of PCI.

Prognostic value of troponin I after elective percutaneous coronary interventions.

BACKGROUND: A mild and asymptomatic increase in the troponin level following elective percutaneous coronary interventions (PCI) has been widely reported, however, the prognostic role of this finding has not yet been well established.Aim. To assess prognostic value of troponin I level increase following elective PCI. METHODS: The study group consisted of 90 consecutive patients who underwent elective PCI in our institution. Troponin I level (normal values <0.1 ug/L) was assessed at baseline and 12 as well as 24 hours after the procedure. In addition, CK-MB level was measured 12 and 24 hours following PCI. Left ventricular (LV) systolic performance was assessed echocardiographically at baseline and after 12 months. The incidence of major adverse coronary events (MACE) during one-year follow-up was also evaluated. RESULTS: An increase in troponin I level >0.1 ug/L was observed in 66 (73%) patients; of whom, 8 patients had a marked (>1.0 ug/L) increase of troponin I, with a concomitant significant elevation of the CK-MB level. Patients with a positive troponin test developed systolic LV abnormalities more often than patients with a normal troponin I level following PCI (p<0.001). There were 10 MACE in the troponin-positive group and 2 in the troponin-negative patients (NS). Seven MACE occurred in patients with marked increase in troponin I level (>1.0 ug/L) which was significantly more often than in the troponin-negative patients (p<0.001). CONCLUSIONS: A mild increase in troponin I level following elective PCI was frequent and did not predict poor outcome, however, was associated with the development of LV systolic impairment. A marked (>1.0 ug/L) increase in troponin I level identified patients at risk of MACE. An increase in troponin I level was similar following various types of PCI.

Primary direct stenting versus endoscopic atraumatic coronary artery bypass surgery in patients with proximal stenosis of the left anterior descending coronary artery--a prospective, randomised study.

BACKGROUND: The dynamic development of interventional cardiology resulted in an increasing proportion of patients treated with various forms of coronary angioplasty instead of surgery. On the other hand, it has been well established that the results of coronary artery by-pass surgery of the left anterior descending (LAD) coronary artery with the use of the internal mammary artery are excellent. AIM: To compare the results of primary direct stenting (PDS) and endoscopic atraumatic coronary artery bypass (EACAB) surgery in patients with an isolated proximal LAD type A or B1 lesion. METHODS: This prospective and randomised study included 100 patients with an isolated critical (> or =70%) LAD stenosis who underwent PDS (n=50) or EACAB (n=50). RESULTS: After a six-month follow-up period, 32 (64%) PDS patients and 47 (94%) EACAB patients were angina-free. The rate of major cardiac adverse events (MACE) was significantly higher in the PDS group than in surgically treated patients (p<0.05). After one year of follow-up, 40 (80%) PDS-treated patients and all 50 EACAB patients had no recurrences of angina. After two-year follow-period, the survival rate without MACE was significantly higher in the EACAB group than in the PDS-treated patients (94% vs 76%, p<0.05). CONCLUSIONS: Minimally invasive cardiac surgery is an alternative method to direct stenting in the treatment of patients with proximal LAD stenosis.

[Results of treating myocardial infarction patients with ST segment elevation in Górnoslaskim Osrodku Kardiologii in Katowice]. / Wyniki leczenia chorych z zawalem serca z uniesieniem odcinka ST w Górnoslaskim Osrodku Kardiologii w Katowicach.

BACKGROUND: Reperfusion therapy reduces mortality rate in patients with acute myocardial infarction with ST-segment elevation (STEMI). AIM: The aim of the study was to access the early outcome of patiens (pts) with STEMI admitted to Upper Silesian Cardiology Centre in 2002. METHODS: 957 pts with AMI were enrolled into the study. The influence of several factors on in-hospital mortality was analised. RESULTS: Out of 957 pts 51 died during hospitalization (5,3%). Coronary angiography was performed in 98,0% of pts. Primary PTCA was performed in 94,5% of pts. Stents were implanted in 85,9% of patients who underwent PTCA. The following factors significantly contributed to increased mortality among pts with acute myocardial infarction: female sex (p<0,02), multivessel disease (p<0,05), age above 65 yrs (p<0,001), time from the onset of chest pain above 6 hours (p<0,01) and 12 hours (p<0,001). The use of GP IIB/IIIA inhibitors significantly reduced the mortality rate (p<0,05). Cardiogenic shock was the only independent factor of the increased risk of mortality in multivariate regression analysis (p<0,0001) with relative risk of death (RR 33,5). The mortality rate in pts with shock was 40,2%: 70,8% in case of conservative treatment, 70% in the group of failed PTCA and only 17,2% in the group of successful PTCA. Among pts who underwent primary PTCA the failure to restore coronary blood flow of the infarct related artery contributed to increased relative risk of death (RR 14,5) (p<0,001). Stents improved the survival rate (p<0,01). In PTCA group cardiogenic shock and failed PTCA were independent risk factors in multivariate regression analysis. CONCLUSIONS: The results of our study show low rate of in-hospital mortality in pts without cardiogenic shock (1,2%). PTCA is highly successful method of treatment of pts with shock with mortality rate 17,2% in pts who underwent successful procedure.

Prediction of left ventricular remodeling in patients with STEMI treated with primary PCI: use of quantitative myocardial contrast echocardiography.

OBJECTIVES: We sought to determine the frequency of left ventricular remodeling in the 6-month follow-up after anterior ST elevation myocardial infarction and the value of quantitative parameters of perfusion contrast echocardiography for prognosis of left ventricular remodeling against other established risk. METHODS: A total of 60 patients with anterior ST elevation myocardial infarction treated by primary percutaneous intervention were examined. In 28 patients, thromboaspiration was performed before stent implantation with Driver catheter. Before and after successful angioplasty, perfusion in myocardial blush grade (MBG) scale was assessed. Various electrocardiogram parameters were analyzed. Resting perfusion with myocardial contrast echocardiography was performed. RESULTS: Logistic regression has permitted one to conclude that higher value of MBG, higher left ventricular ejection fraction at discharge, and higher value of parameter A at quantitative echocardiography in dysfunctional segments were prognostic for lack of remodeling over 6 months. The receiver operating characteristics curves for parameters of quantitative perfusion echocardiography (A, ß, A×ß) allowed us to conclude that value A>1.96 dB, value ß>0.155 s, and value A×ß>0.57 dB/s are optimal cut-off points prognostic for remodeling. Area under the curve was 0.8 for A and 0.85 for ß. CONCLUSION: The best predictors of remodeling in 6 months' observation have appeared to be lower left ventricular ejection fraction at discharge, poorer perfusion assessed angiographically (MBG scale), and the rate of signal intensity increase reflecting the mean bubble velocity of the myocardium by contrast as assessed by contrast echocardiography. Quantitative perfusion angiography independently has high predictive value for the development of remodeling in long-term follow-up.

Long-term follow-up of the randomised controlled trial to evaluate the safety and efficacy of the zotarolimus-eluting driver coronary stent in de novo native coronary artery lesions: five year outcomes in the ENDEAVOR II study.

AIMS: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor(tm) zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. METHODS AND RESULTS: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. CONCLUSIONS: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease.

Direct stenting with TAXUS stents seems to be as safe and effective as with predilatation. A post hoc analysis of TAXUS II.

BACKGROUND AND METHOD: Although direct coronary stenting does not improve angiographic outcome, it makes sense by reducing procedure times, radiation exposure and costs. Other potential advantages of direct stenting may be a reduction of myocardial ischemia time, which could be clinically relevant in high-risk patients. With the introduction of drug-eluting stents, however, concern arose that direct stenting would possibly damage the polymer coating and change or diminish the efficacy of the programmed drug release. Also, concerns about safety by preventing optimal apposition of single stent struts developed. It is the purpose of this paper to retrospectively analyze the data from the TAXUS-II Trial (536 patients) regarding patients with and without direct stenting. While predilatation was recommended per protocol, direct stenting was not forbidden: thus, direct stenting was performed in 49 patients (TAXUS n = 23, control n = 26). RESULTS: In the TAXUS groups, there was no significant difference regarding major adverse cardiac events (MACE; 7.5% vs. 4.3%), angiographic restenosis in the analysis segment (4.8% vs. 4.3%), late loss (0.28 +/- 0.36 vs. 0.33 +/- 0.30 mm) or intravascular ultrasound-(IVUS-)measured volume obstruction (7.95 +/- 9.84% vs. 5.61 +/- 7.91%) at six months between the predilated and directly stented patients. The same was true for the patients receiving the control stent. Compared with the directly stented control group, the statistically significant positive effects of TAXUS direct stenting were maintained, regarding angiographic restenosis in the analysis segment (4.3% vs. 30.8%), late loss (0.33 +/- 0.30 vs. 0.80 +/- 0.62 mm) or IVUS-measured volume obstruction (5.61 +/- 7.91% vs. 22.50 +/- 21.62%) at six months. MACE was reduced from 19.2% to 4.3%; due to the small number of patients this trend did not reach statistical significance. After predilatation, all parameters were significantly improved by the TAXUS stent. CONCLUSION: Comparison of patients receiving TAXUS stents with or without predilatation revealed no differences in clinical, angiographic or IVUS parameters at six months. This suggests that direct stenting with the polymer-based paclitaxel-eluting TAXUS stent is feasible, safe and equally effective. Randomized trials comparing stenting after predilatation versus direct stenting with drug-eluting stents are warranted.