Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.

AIMS: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented. METHODS AND RESULTS: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period. CONCLUSIONS: The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months?

AIMS: The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 µg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up. METHODS AND RESULTS: One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.25-2.8 mm) were treated with the DCB. The primary endpoint was angiographic in-segment late lumen loss. The secondary endpoints encompassed all other angiographic and clinical data up to three years post intervention. In total 82/120 (68.3%) patients with a vessel diameter of 2.35±0.19 mm were treated with the DCB only, and 32/120 (26.7%) patients required additional bare metal stent (BMS) deployment. Both the 12- and 36-month major adverse cardiac event rates were 5/82 (6.1%) for DCB only and 12/32 (37.5%) for DCB+BMS, primarily due to the need for target lesion revascularisation in 4/82 (4.9%) patients and 9/32 (28.1%) (p<0.001) patients, respectively. Total MACE rate after 36 months was 18/120 (15%; intention-to-treat). CONCLUSIONS: Treatment of small vessel coronary artery disease with a paclitaxel-iopromide-coated balloon exhibited good six-month angiographic and one-year clinical data that persisted during the three-year follow-up period. Randomised trials will clarify its role as an alternative to drug-eluting stents in the treatment of small vessel coronary artery disease. (ClinicalTrials.gov Identifier: NCT00404144).

The paclitaxel-eluting coroflex stent study II (PECOPS II) acute and 6-month clinical and angiographic follow-up, 1-year clinical follow-up.

BACKGROUND AND OBJECTIVES: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex Please stent in coronary artery lesions. METHODS: One-hundred and twenty-nine patients (66.2 +/- 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 +/- 0.43 mm, the lesion length 12.51 +/- 4.6 mm, and the minimal lumen diameter 0.75 +/- 0.29 mm. Follow-up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. RESULTS: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 +/- 0.59 mm and 0.17 +/- 0.40 resulting in binary in-stent restenoses in 16/120 (13.3%) subjects and in-segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow-up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. CONCLUSION: The data of the Paclitaxel-eluting Coroflex Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent.

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter.

BACKGROUND: Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication. METHODS: One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)). The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length with a vessel diameter of 2.25-2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss. RESULTS: Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 +/- 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 +/- 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 +/- 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis. CONCLUSION: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).

Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis.

BACKGROUND: Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care. METHODS AND RESULTS: One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary end point was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months follow-up, in-segment late lumen loss was 0.38+/-0.61 mm in the drug-eluting stent group versus 0.17+/-0.42 mm (P=0.03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus 4 of 57 (7%; P=0.06). At 12 months, the rate of major adverse cardiac events were 22% and 9%, respectively (P=0.08). This difference was primarily due to the need for target lesion revascularization in 4 patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P=0.15). CONCLUSIONS: Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent. For the treatment of in-stent restenosis, inhibition of re-restenosis does not require a second stent implantation.

The paclitaxel-eluting Coroflex Please stent study (PECOPS I): the 3-year clinical follow-up.

BACKGROUND: The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel. METHODS AND RESULTS: Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%). CONCLUSION: The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.

The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I) : the one-year clinical follow-up.

BACKGROUND: The alleged superiority of drug-eluting stents over bare metal devices and those with passive coatings is diminished by a higher incidence of late target vessel thrombosis. METHODS AND RESULTS: Therefore, the one-year clinical outcome of the paclitaxel-eluting Coroflex Please stent in patients with denovo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 96/97 (99%) of the patients included per protocol and of 86/87 (98.9%) of those treated per protocol were available 13.1 +/- 1.8 months following stent deployment. In the inclusion and treatment per protocol groups the incidence of cardiac deaths was 1/96 (1%) and 1/86 (1.2%), of myocardial infarction 3/96 (3.1%) and 1/86 (1.2%), and of target lesion revascularization 9/96 (9.4%) and 8/86 (9.3%). In patients enrolled per protocol two early thromboses (2.1%) occurred one of which two days after premature discontinuation of clopidogrel. In patients treated per protocol one thrombosis was observed after 10 hours. The one-year event-free survival was 83/96 (86.5%) in patients enrolled per protocol and 75/86 (87.2%) in those treated per protocol. CONCLUSION: The one-year clinical outcome of PECOPS I was within the range of other paclitaxel-eluting coronary stents. The relative small number of patients enrolled in PECOPS I precludes to infer any further conclusions.

Risk predictors and frequency of cardiovascular symptoms occurring during cardiac rehabilitation programs in phase III-WHO.

INTRODUCTION: Rehabilitation in ambulatory heart groups has become a well established part of comprehensive cardiac treatment in Germany. Identifying patients at risk for cardiovascular symptoms is important for the efficiency and safety of the program. METHODS: Questionnaires were mailed to ambulatory heart groups in the state of Hessen, Germany, and returned by 1935/13 174 (15%) patients, age 65.9 +/- 7.6 years, 1504/1935 (77.7%) males, comprising approximately 674 000 patient exercise hours. RESULTS: 828 symptoms were reported by 538 patients, comprising dyspnea in 330/538 (61.3%), angina pectoris in 80/538 (14.9%), palpitation in 145/538 (27%), tachycardia in 59/538 (11%), dizziness in 152/538 (28.3%), fainting in 6/538 (1.1%), and others in 47/538 (8.7%). Cardiovascular symptoms occurred more frequently in patients presenting with overexertion (43/68 (63.2%), p < 0.0001, RR 4.77 [95% CI 3.01-7.56]), chronic heart failure (115/291 (39.5%) vs 419/1624 (25.8%), p < 0.0001, RR 1.88 [95% CI 1.45-2.43]), lower exercise capacity (1.49 +/- 0.4 vs 1.59 +/- 0.5 W/kg body weight, p = 0.0002, mean difference -0.096 [95% CI (-0.146) -(-0.046)]), hypertension (269/ 854 (31.5%) vs 266/1068 (24.9%), p = 0.001, RR 1.39 [95% CI 1.14-1.69]), and hyperlipidemia (280/ 907 (30.9%) vs 255/1015 (25.1%), p = 0.005, RR 1.33 [95% CI 1.09-1.63]). Cardiovascular symptoms were more frequent in women (141/431(32.7%) vs 397/1503 (26.4%), p = 0.01, RR 1.35 [95% CI 1.08-1.71]). Overexertion (p < 0.0001), heart failure (p = 0.003), and hypertension (p = 0.05) are significant independent predictors of cardiovascular symptoms, while female gender (p = 0.06), and hyperlipidemia (p = 0.07) are not as significant. Previous myocardial infarction and diabetes had no statistical significant impact on cardiovascular symptoms. CONCLUSION: Patients likely to experience cardiovascular symptoms in ambulatory rehabilitation can be identified by their medical history and perceived exertion.

The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up.

BACKGROUND AND OBJECTIVES: Various active stent coatings significantly reduce restenosis rates and target lesion revascularization compared to bare metal stents. Therefore, the procedural and 6-month performance of the new paclitaxel-eluting Coroflex. Please stent was investigated. METHODS: Ninety-seven patients (66 +/- 7.6 years, 34/97(35.1%) diabetics, 11/97(11.3%) unstable angina) were enrolled per protocol for elective single stent deployment into native coronary de-novo or post-PTCA restenotic lesions (stenosis: >or= 70%, < 100%; reference diameter >or= 2.25 mm and <3.3 mm; lesion length

The low pressure stent observational trial on the procedural and mid-term outcome of a trapezoid-shaped coronary stent (LOPSTER).

BACKGROUND: Stent design influences the procedural and mid-term results of coronary interventions. The trapezoid-shaped struts of the low pressure stent (LP-Stent) might improve the outcome by reducing the vascular trauma at deployment. METHODS: A total of 133 patients (64.5+/-8.6 years) with significant de novo coronary lesions (reference diameter >or=2.8 mm, length <15 mm, and stenosis >or=70% and <100%) were enrolled for single stent deployment and a 6-month clinical and angiographic follow-up. RESULTS: Stents were successfully deployed to 131/133 (98.5%) lesions. In one failed procedure (0.8%), the stenosis could be crossed with another device whereas in the second alternative stents also failed. Following edge dissection after LP-Stent implantation, in 9/133 (6.8%) patients additional stents were deployed. Follow-up was performed as scheduled after 5.9+/- 0.9 months in 98/122 (80.3%) patients, prematurely for in-stent restenosis in 8/122 (6.6%), and clinically only in 8/122 (6.6%). Deaths, one of cardiac origin (0.9%), occurred in 2/114 (1.8%), and myocardial infarctions in 1/114 (0.9%). The culprit stenoses were dilated from 78.4+/-9.7% to 23.3+/-11.0% recurring to 43.1+/-24.3% at scheduled follow-up. The late loss of 0.6+/-0.8 mm and late loss index of 0.3+/-0.5 translated into a binary restenosis rate of 24/98 (24.5%) requiring reintervention in 19/98 (19.4%). CONCLUSIONS: In summary, the LP-Stent is associated with reduced intimal proliferation as reflected by the low late loss index when being compared with either non-coated or passively coated devices and higher in comparison to active coated stents. The considerable dissection rate seems to be related to higher deployment pressures and warrants design modification at the stent's distal edges.

Clinical and angiographic procedural and mid-term outcome with new versus reused balloon catheters in percutaneous coronary interventions.

BACKGROUND: To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available. METHODS AND RESULTS: Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters. Crossing of the stenosis decreased from 96% with new balloon catheters to 93.2% (p=0.46), with 1 time reused balloon catheters to 81.8% (p=0.0056) with 2 times reused balloon catheters and to 80.8% (p=0.01) with 3 times reused balloon catheters. In all primary failures using resterilized balloon catheters, new ones of the same nominal diameter were successful. The 4.1 +/- 1.9 month angiographic follow-up rates were 96/124 (77.4%) for new balloon catheter, 35/44 (79.5%) for 1 time reused balloon catheters, 33/44 (75.0%) for 2 times reused balloon catheters, and 21/26 (80.8%) for 3 times reused balloon catheters (p for all >0.05). The late losses for new versus reused balloon catheters were 0.48 +/- 0.75 mm versus 0.73 +/- 0.79 mm (p=0.03). The percent stenosis was higher in reused versus new balloon catheters (51.9 +/- 23.2% v. 42.3 +/- 22.3%; p=0.0042) as was the restenosis rate [39/89 (43.8%] v. 31/96 (32.3%), p=0.13]. There was one death in reused balloon catheter category but no event of myocardial infarction. Rates of target lesion revascularizations were similar in stent recipients and more frequent after stand-alone balloon angioplasty with reused versus new balloon catheters [15/55 (27.3%) versus [5/59 (8.5%), p=0.01]. CONCLUSIONS: The use of two or three times resterilized balloon catheters of the type tested does not seem to be justified in stand-alone balloon angioplasty of de novo coronary stenoses and should be limited to stent procedures until data is available for other indications.

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).

BACKGROUND: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated. METHODS: 103 patients [63.9 +/- 11 yrs, 5/103 (4.9%) lesion type A, 52/103 (50.5%) type B1, and 46 of 103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: greater than or equal to 70%, < 100%; reference diameter greater than or equal to 2.75 mm, less than or equal to 4 mm; lesion length: < 16 mm). RESULTS: Deployment and procedural success were 100%, in 57/103 (55.3%) patients without pre-dilatation. 3/103 (2.9%) patients were lost to follow-up. During the 7.1 +/- 2.3 months clinical follow-up, 3 of 100 (3.0%) patients underwent premature target lesion revascularizations, 4 /100 (4%) had non-target lesion-related deaths, and 1 of 100 (1%) suffered myocardial infarction. Among the 77 of 100 (77.0%) patients who underwent angiographic follow-up, the initial stenosis declined from 87.3 +/- 5.7% to 14.2 +/- 8.3% after stenting, and increased to 32.8 +/- 22.7% after 6.4 +/- 1.3 months. The late loss and late loss index were 0.6 +/- 0.7 mm and 0.2 +/- 0.4, respectively; the recurrence rate was 12 of 77 (15.6%), with reintervention required in 11 of 77 (14.3%) of these patients. CONCLUSION: The Coroflex Theca-Stent provides excellent procedural results and a low restenosis rate. Further development of this polymer as the final coating and as the basis for drug-eluting stents seems justified.

Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).

PURPOSE: Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study. MATERIAL AND METHODS: Four hundred and ninety-seven patients (63.4 +/- 9.8 years) were randomized to either receive the a-SiC:H-coated Tenax stent or the stainless steel Nir stent. Lesions (diameter > or = 2.8 mm, length < 20 mm) were covered with one single stent. RESULTS: Fifty-one of 497 (10.3%) patients were excluded for protocol violation. Three hundred and forty-two of 446 (76.7%) patients presented for scheduled angiographic follow-up after 4.7 +/- 1.2 months and 29 of 446 (6.5%) prematurely. In-hospital complications comprised two deaths (0.8%) (P > 0.99) and one (0.4%) (P > 0.99) CK-elevation in each group, target lesion revascularization in 5 of 250 (2%) of the Tenax and 4 of 244 (1.6%) of the Nir sample (P > 0.99), and subacute thrombosis in 2 of 250 (0.8%) of the Tenax patients (P = 0.5). In the Tenax/Nir patients mean percent diameter stenosis decreased from 82.3 +/- 9.1%/80.7 +/- 8.4% (P = 0.49) to 17.6 +/- 5.5%/17.6 +/- 5.5% (P = 0.99) postprocedure and increased to 34.5 +/- 21.5%/34.2 +/- 23.1% (P = 0.90) at follow-up. CONCLUSIONS: Thus, there appears to be no advantage of the silicon carbide coated stent over a stainless steel stent after 4.7 +/- 1.2 months with regard to clinical and angiographic restenosis rates.

Comparison of a silicon carbide-coated stent versus a noncoated stent in human beings: the Tenax versus Nir Stent Study's long-term outcome.

BACKGROUND: Stents coated with amorphous hypothrombogenic silicon carbide (a-SiC:H) have low restenosis rates in humans. Recurrence in a-SiC:H at mid-term follow-up has been shown to be similar to a stainless steel device. The long-term outcome, however, may be different. METHODS: Four hundred ninety-seven patients (63.4 +/- 9.8 years of age) received either the a-SiC:H-coated Tenax stent (Biotronik, Berlin, Germany) or the 316L Nir stent (Boston Scientific, Maple Grove, Minn). Lesions had to be covered with one stent only (diameter > or =2.8 mm, length <20 mm). Exclusion criteria comprised acute myocardial infarction and angiographic thrombus within the target vessel. Twenty-five of 497 (5%) patients were excluded for protocol violation. Clinical follow-up was completed in 450 of 472 (95.3%) and angiographic follow-up was completed in 365 of 472 (77.3%); 22 of 472 (4.7%) patients were lost to follow-up. RESULTS: Major adverse coronary events occurred in 28 of 233 (12%) of the Tenax recipients and in 31 of 217 (14.3%) of the Nir recipients (P =.50). Acute myocardial infarctions were less frequent in the Tenax recipients after > or =60 weeks. Premature target lesion revascularization was performed in 16 of 233 (6.9%) patients in the Tenax group and 11 of 217 (5.1%) (P =.54) patients in the Nir group. Coronary bypass operations were similar after Tenax or Nir stent deployment (3/233 [1.3%] vs 6/217 [2.8%], P =.43), as were deaths in 7 of 233 (3%) versus 8 of 217 (3.7%) (P =.88), respectively. CONCLUSIONS: Both stents had a low rate of major adverse coronary events at 81 +/- 12 weeks of follow-up, with no definite superiority of any of the devices.

Change of the mechanical properties of two different balloon catheters with increasing numbers of cycles of resterilization.

An increasing number of centers are reusing PTCA catheters even though manufacturers warrant single use only. This prospective bench laboratory trial addresses the quality of PTCA balloon catheters after up to three resterilization cycles in order to determine whether a larger trial is warranted to discern whether catheters should be reused. Forty PTCA catheters from two different manufacturers (nominal diameters 1.5 and 3.0 mm) were taken from the shelf. An independent institute tested mechanical properties such as burst pressure, nominal diameter, crossing profile, and balloon surface. The crossing profile increased by 22.5%-39.2% with no additional deterioration after repeated sterilizations. The nominal diameter either increased or decreased by a maximum of 47%. In all 1.5 mm balloons, the burst pressure remained above the manufacturers' values, whereas in the 3.0 mm balloons, the value dropped below the rated burst pressure in 40%-50% of the trials. In conclusion, in both catheter types analyzed, reuse was associated with a considerably worse quality, which puts in question their routine clinical use.

Restenosis rates with flexible GFX stents (REFLEX): clinical and angiographic results.

The objective of this prospective, multicenter, observational trial was to evaluate the procedural results and longterm outcomes of the flexible AVE GFX coronary stent in native coronary lesions. The trial included 137 consecutive patients (111 [81%] men, age 63.1 +/- 9.2 years) with one vessel disease (n = 76 [55.5%]), two vessel disease (n = 31 [22.6%]), and three vessel disease (n = 30 [21.9%]) with ischemia secondary to a significant denovo lesion (diameter > or = 3 mm, length < or = 18 mm) in a native coronary artery. Stent deployment was successful in 97.8% (134/137) of patients. Angiographic follow-up at 6.1 +/- 1.2 months was available in 111 (82.8%) of 134 patients. All angiographic images were analyzed by an independent core lab. The primary end point was the binary restenosis rate. In-hospital major cardiac events occurred in 3.7%. No postdischarge major adverse cardiac events occurred, except for one abrupt closure (0.7%). Angiographic restenosis was documented in 22 (19.8%) of 111 patients. The GFX stent is easy to handle with high success and low restenosis rates in patients with simple lesions in native coronary arteries and, thus, compares favorably with other sophisticated stents.