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.

Background— The safety and efficacy of percutaneous coronary intervention in unprotected left main (ULM) coronary arteries are still a matter of debate. Methods and Results— All consecutive patients who had a sirolimus-eluting stent (Cypher, Cordis, Johnson and Johnson Co) or a paclitaxel-eluting stent (Taxus, Boston Scientific) electively implanted in de novo lesions on unprotected left main were analyzed. Patients treated with a drug-eluting stent (DES) were compared with the historical group of consecutive patients treated with bare metal stent (BMS). Eighty-five patients were treated with DES; 64 had BMS implantation. Patients treated with DES had lower ejection fractions (51.1±11% versus 57.4±13%, P =0.002) and were more often diabetics (21.2% versus 10.9%, P =0.12) with more frequent distal left main involvement (81.2% versus 57.8%, P =0.003). Furthermore, in the DES group, smaller vessels (3.33±0.6 versus 3.7±0.7 mm, respectively; P =0.0001) with more lesions (2.94±1.6 versus 2.25±1.3, P =0.004) and vessels (2.03±0.69 versus 1.8±0.72, P =0.05) were treated with longer stents (24.3±12 versus 15.8±8.6 mm, P =0.0001). Despite the higher-risk patients and lesion profiles in the DES group, the incidence of major cardiac events at a 6-month clinical follow-up was lower in the DES than in the BMS group (20.0% versus 35.9%, respectively; P =0.039). Moreover, cardiac deaths occurred in 3 DES patients (3.5%), as compared with 6 (9.3%) in the BMS group ( P =0.17). Conclusions— In this early experience with DES in unprotected left main, this procedure appears safe with favorable and improved clinical results as compared with historical control subjects with a BMS. A randomized study comparing surgery appears justified at present.

Background — The safety and efficacy of percutaneous coronary intervention of de novo lesions in unprotected left main coronary arteries remains an unresolved issue. Methods and Results — We analyzed 67 consecutive patients treated with the following devices: 39 with stents, 12 with rotational atherectomy plus stents, 13 with directional coronary atherectomy plus stents (a total of 64 patients were treated with stents), and 3 patients with directional coronary atherectomy only. The reference vessel size was 3.78±0.73 mm and lesion length was 6.6±3.0 mm. In-hospital complications were 2 coronary artery bypass grafts (CABGs) (3.0%), 2 Q-wave myocardial infarctions (MIs) (3.0%), and 3 non-Q-wave MIs (4.5%); there were no deaths. The estimated cardiac survival at 3 years was 91%. The cardiac mortality rate was higher in patients with Parsonnet score >15 versus ≤15 (21.4% versus 4.2%, P =0.02) at 3 years. The independent covariate of cardiac death was preserved left ventricular ejection fraction; for combined cardiac events (cardiac death, MI, repeat revascularization) it was large reference vessel size. Follow-up angiography at 5±2 months in 85% of eligible patients revealed 31.4% restenosis. Extending the follow-up to 31±23 months (19 patients with follow-up beyond 3 years) the cumulative event rates were 11 deaths (16.4%), 8 of them cardiac (11.9%), 2 (3.0%) MI, and 16 (23.9%) repeat revascularizations (CABG in 5 patients). Conclusions — Elective percutaneous coronary intervention of de novo lesions in left main coronary arteries is feasible, with low procedural risk. The long-term follow-up revealed a high rate of angiographic restenosis and repeat revascularization, with a relatively high incidence of cardiac death. Reference vessel size and left ventricular function are the most important predictors of favorable follow-up.

Background —Coronary perforation is a life-threatening complication of percutaneous interventions. In the past few years, the implantation of covered stents has emerged as a strategy for treatment when the traditional conservative approach (ie, prolonged balloon inflation and reversal of anticoagulation) fails. Methods and Results —Since May 1997 (when polytetrafluoroethylene [PTFE]-covered stents were available at our institutions), 11 of the 12 consecutive patients who had coronary ruptures that were unsuccessfully sealed with prolonged balloon inflation and reversal of anticoagulation were treated with 12 PTFE-covered stents (PTFE group). The efficacy of the PTFE-covered stent was compared with that of noncovered stents, which were used to treat 17 perforations (non-PTFE group). One patient sustained a very distal perforation that was not suitable for covered stent sealing and underwent emergency surgery. All vessel ruptures treated with PTFE-covered stent implantation were successfully sealed. The time necessary to deploy the stent was 10±3 minutes (range, 4 to 15 minutes). All patients but one were discharged from the hospital and had an optimal early clinical outcome. One patient underwent emergency bypass surgery and died in the intensive care unit. The occurrence of cardiac tamponade and the necessity for emergency surgery was significantly lower in the PTFE group than in the non-PTFE group. At 14±4 months, the 10 discharged patients had not experienced any major adverse cardiac events. Conclusions —This preliminary study supports the utility of the PTFE-covered stent for the nonsurgical treatment of vessel ruptures.

Background — It has been shown that antiproliferative drugs such as paclitaxel lower the amount of intimal hyperplasia after stent implantation. We report the first clinical experience of 7-hexanoyltaxol (QP2)–eluting polymer stent system (QuaDS) implantation for in-stent restenosis. Methods and Results — Fifteen consecutive patients with elective indication to percutaneous coronary intervention for in-stent restenosis were treated with the QuaDS-QP2 stent implantation. The QuaDS-QP2 stent was successfully implanted in all but 2 target lesions. In one lesion, the restenotic segment could not be completely covered by the stent, and in another lesion, a bare metal stent was implanted distally to the QuaDS-QP2 stent. One patient suffered from postprocedural non–Q-wave myocardial infarction (NQWMI). No other adverse events were observed during hospital stay. Six- and 12-month angiographic and clinical follow-up was scheduled for all patients. At 6 months, 3 patients had target lesion revascularization (20%). Two patients had restenosis (13.3%); one experienced restenosis in a gap between 2 drug-eluting stents, and the other had stent occlusion leading to NQWMI. Minimal intimal hyperplasia was observed in all the segments covered by drug-eluting stents (late loss=0.47±1.01 mm with a loss index=0.17±0.39). At 12 months, 1 patient suffered from NQWMI, and 8 of 13 patients (61.5%) had angiographic restenosis (late loss=1.36±0.94 mm with a loss index=0.62±0.44). Conclusion — This first experience with QuaDS-QP2 stent implantation for in-stent restenosis revealed minimal intimal hyperplasia at the 6-month follow-up. However, the antiproliferative effect was not maintained at the 12-month follow-up, resulting in delayed occurrence of angiographic restenosis.