Adjunct PTCA Research Articles

Clinical and Angiographic Results of Percutaneous Excimer Laser Versus Balloon Angioplasty for Coronary Intra-Stent Restenosis

Treatment of in-stent restenosis (ISR) with conventional PTCA causes significant recurrent neointimal tissue growth in 30-85% of the cases. Therefore, laser ablation of intra-stent neointimal hyperplasia prior to balloon dilatation can be an attractive alternative. However, the long-term outcomes of such treatment have not been studied thoroughly enough. This prospective case-control study evaluated angiographic and clinical outcomes of PTCA alone and a combination of excimer laser coronary angioplasty (ELCA) and adjunct PTCA in 125 patients with ISR. ELCA was performed prior to balloon dilatation in 67 patients, PTCA alone was performed in 58 patients. Basic demographic and clinical data were comparable in both groups. Lesions included in ELCA group were longer (17.1±9.9 mm versus 13.6±9.1 mm; p=0.034), more complex (36.5% type-C stenoses versus 14.3%; p=0.006) and more frequently had reduced distal blood flow (TIMI < 3: 18.9% versus 4.8%; p=0.025) compared to lesions in PTCA group. Immediate angiographic results of PTCA and ELCA+PTCA appeared to be comparable. PTCA alone was successful in 57 patients (98.3%), ELCA+PTCA - in 66 patients (98.5%). The rates of hospital complications were comparable (3.0% in ELCA group versus 8.6% in PTCA group). The 1 year-follow-up showed that the rates of MACE were comparable in the two groups (37.3% in ELCA group versus 46.6% in PTCA group). The rates of TVR within 1 year after the intervention were also similar in ELCA and PTCA groups (32.8% versus 34.5%). The data mean that ELCA in patients with complex ISR is efficient and safe. Despite a higher complexity of lesions in ELCA group, no increase in the rate of complications was registered.

Percutaneous transluminal therapeutic ultrasound for high-risk thrombus-containing lesions in native coronary arteries.

We assessed the short-term outcome of percutaneous coronary ultrasound thrombolysis (CUT) for high-risk thrombus-containing lesions in native coronaries in the setting of acute coronary syndromes (ACS). Data were prospectively collected in a multicenter (n = 32) registry of consecutive ACS patients. The study population (n = 126) had mostly (84%) totally occluded vessels. The mean age of clot was 5.7 +/- 9.5 days (range, 0-60 days). CUT (41 kHz, 18 W) led to device success in 112 (89%) patients, with a residual stenosis of 69% +/- 20%. Adjunct PTCA or stenting was used in 97% of the patients. Procedural success was achieved in 124 (98%) patients, with a final residual stenosis of 6% +/- 10%. There were no major adverse clinical events during hospitalization. Ultrasound thrombolysis is a feasible procedure that offers a safe and probably effective adjuvant device solution for the treatment of high-risk, thrombus-containing lesions in the native coronary arteries.

Rotational atherectomy for in-stent restenosis: acute and long-term results of the first 100 cases

Objectives. This study evaluated the clinical safety and long-term results of rotational atherectomy (RA) followed by low-pressure balloon dilatation (percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of in-stent restenosis (ISR).Background. In-stent restenosis is associated with a high incidence of recurrence after interventional treatment. Because ISR is due to neointimal hyperplasia, rotational ablation may be a more effective treatment than PTCA.Methods. Between November 1995 and November 1996, 100 consecutive patients with first-time ISR were treated by RA. Quantitative coronary angiography and intravascular ultrasound (IVUS) were used to analyze the acute procedural results. The incidence of repeat in-stent restenosis and target vessel revascularization (TVR) at follow-up was determined.Results. Procedural success without any major in-hospital complications was achieved in 100% of cases. Slow flow was observed in 3% and creatine kinase-MB enzyme elevation >3× normal occurred in 2%. The mean burr-to-artery ratio was 0.68 ± 0.18 and adjuvant balloon dilatation was performed at 4.2 ± 2.1 atm. Minimum luminal diameter increased from 0.86 ± 0.28 mm to 1.89 ± 0.21 mm after RA and to 2.56 ± 0.29 mm after adjunct PTCA. Quantitative IVUS analysis showed that 77% of the luminal gain occurred due to rotational ablation of the restenotic tissue and only 23% occurred after adjunct balloon dilation, and further stent expansion did not contribute to the luminal enlargement. At a mean follow-up of 13 ± 5 months, repeat in-stent restenosis occurred in 28% of patients with TVR of 26%. Univariate predictors of repeat restenosis were burr-to-artery ratio <0.6, ISR in <90 days of stenting, ostial lesion, stent for a restenotic lesion and diffuse type ISR.Conclusions. Rotational atherectomy is a safe and feasible technique for treatment of ISR and is associated with a relatively low recurrent restenosis in comparison to historical controls of balloon angioplasty.

Early lumen loss after treatment of in-stent restenosis: an intravascular ultrasound study.

Mechanisms of recurrence after treatment of in-stent restenosis are unknown. We prospectively performed quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) in 37 lesions with Palmaz-Schatz stents enrolled in a study of intracoronary radiation for in-stent restenosis. Primary treatment was at the discretion of the operator: PTCA (n=8) or ablation+adjunct PTCA (n=29). Lesions were studied before intervention, immediately after primary intervention, and 42+/-8 minutes later. QCA measurements included minimal luminal diameter and diameter stenosis. Planar IVUS measurements included arterial, stent, lumen, and in-stent tissue areas. Stent, lumen, and in-stent tissue volumes were calculated by use of Simpson's rule. Compared with immediately after intervention, the delayed (42+/-8 minutes) minimal lumen area decreased by 20% (5.8+/-1.9 to 4.5+/-1.3 mm2, P<0.0001) and the lumen volume by 12% (58+/-41 to 52+/-37 mm3, P=0.0001). Ten lesions (27%) had a > or = 2.0-mm2 decrease in minimum lumen area. Lumen loss (1) resulted from increased tissue with the stent, (2) correlated with lesion length and preintervention in-stent tissue, and (3) was not seen angiographically. There is significant tissue reintrusion shortly after catheter-based treatment of in-stent restenosis. This was greater in longer lesions and those with a larger in-stent tissue burden, was not reflected in the QCA measurements, and may contribute to recurrence.

Is the response to high pressure adjunct PTCA stent design specific? A sequential intravascular ultrasound study

Is the response to high pressure adjunct PTCA stent design specific? A sequential intravascular ultrasound study

Is the Response to High Pressure Adjunct PTCA Stent Design Specific? A Sequential Intravascular Ultrasound Study

Is the Response to High Pressure Adjunct PTCA Stent Design Specific? A Sequential Intravascular Ultrasound Study

730-2 Acute Angiographic, Intravascular Ultrasound and Clinical Results of Directional Atherectomy in the Optimal Atherectomy Restenosis Study

The Optimal Atherectomy Restenosis Study (OARS) is a 200 patient multicenter (4 sites) registry designed to assess an intravascular ultrasound (IVUS) guided “optimal” directional atherectomy (DCA) on acute angiographic results, in-hospital complications, and late outcomes. At present, preliminary acute results are available for 155 lesions in 146 consecutively treated patients. Baseline patient characteristics were age 58 ± 11 years, male gender 74%, LAD treatment vessel 54%, CCVS angina class III or IV 75%, diabetes 15%, and prior PTCA 23%. Pre-treatment target lesions were 7.9 ± 2.6 mm in length, 63% were eccentric, 13% were ulcerated, and 20% had either moderate or severe calcification. Overall, procedure success (&lt; 50% final stenosis without major complications) was achieved in 143 (98%) patients and there were in-hospital major complications in 3 (2.1%) patients including no deaths 10%). Q wave MI in 1 (0.7%), and emergency CABG in 2 (1.4%). Significant angiographic dissections ( ≥ grade C) after DCA were present in 9 (5.9%) patients and bailout stents were used to treat dissections in 4 (2.7%) without subsequent ischemic events. There was 1 perforation 10.7%) treated successfully with PTCA. Quantitative angiography was performed using an automated edge detection algorithm (CMS); reference diameter was 3.23 ± 0.48 mm and pre-treatment minimum lumen diameter (MLD) increased from 1.18 ± 0.44 mm to 2.74 ± 0.69 mm after DCA, and furtherto 3.14 ± 0.56 mm after adjunct PTCA (performed in 89% of treated lesions). Similarly, diameter stenosis was reduced from 63 ± 12% pre-treatment to 19 ± 19% after DCA to 7 ± 12% after adjunct PTCA. Sequential IVUS revealed an increase in lesion site cross-sectional area from 8.2 mm 2 following DCA to 9.0 mm 2 after adjunct PTCA (proximal reference area 10.5 mm 2 ). Despite the large final lumen dimensions (14% final cross-sectional area stenosis by IVUS). % cross-sectional narrowing (residual plaque burden) still averaged 57%. We conclude: (1) “optimal” DCA can be performed with high procedure success and few major in-hospital complications; (2) adjunct PTCA is usually required to achieve maximum lumen dimensions, and (3) despite these favorable angiographic results, IVUS reveals considerable residual plaque burden ( &gt; 50%) after “optimal” DCA.

720-3 Predictors for Adverse Clinical Events are Different in Stents and PTCA: Results from the STent REStenosis Study

Although well established biologic, anatomic, and angiographic predictors of adverse clinical events are known for PTCA, there are a paucity of data after stent (S) implantation. Therefore we compared independent predictors for adverse clinical events (procedural failure, restenosis, and late complications) after S (N = 205) vs PTCA (N = 202) treatment from the randomized multicenter St ent Res tenosis S tudy (STRESS) by performing multivariate logistic analysis. Independent Predictors PTCA (OR, Pvalue) 5tent (OR, Pvalue) Procedure Failure: (final stenosis &gt; 50% andlor death/MI/CABG andlor bailout S) Dissection (362, &lt; 0.005) Final MLD (006, P &lt; 0.005) Angiographic Restenosis: ( ≥ 50% diameter stenosis at follow-up angiogram) Diabetes (2.84, P&lt; 005) Relerence size (0.31, P&lt; 0.05) (0.47, P &lt; 0.05) LAD (2.41, P &lt; 005) Final MLD Late Complications: (out-ai-hospital death/ MI/CABG or repeat PTCA, mean follow-up time = 8.8 ± 3.4 months) None Final MLD (0.32, P &lt; 005) Recent( &lt; 6 weeks)M I (2.71, P &lt; 005) In S pts, final minimal lumen diameter (MLD) strongly influenced procedure failure, angiographic restenosis, and late complications. In PTCA pts, postPTCA dissection predicted procedural failure; diabetes, reference size, and LAD predicted restenosis: there were no predictors of late complications. The multivariate analysis of STRESS pt outcomes indicates 1) predictors for adverse clinical events were different for Sand PTCA, 2) S neutralized the deleterious impact of biologic and anatomic factors on angiographic restenosis and 3)final MLD after S placement, an operator-controlled variable, strikingly predicted all adverse clinical outcomes. Therefore, meticulous operator attention to optimize final MLD after S placement with appropriate adjunct PTCA may further improve clinical outcomes.

1018-49 Assessing a Strategy of Stand-alone Extraction Atherectomy Followed by Staged Stent Placement in Degenerated Saphenous Vein Graft Lesions

Previously, we reported the high incidence of ischemic complications due to distal embolization (DE) following extraction atherectomy (TEC) of degenerated saphenous vein grafts (DSVG: grafts with lumen ectasia or irregularities comprising ≥50% of the graft length), frequently caused by adjunct PTCA (Group I). To assess whether a staged strategy (initial stand-alone TEC ± lyric therapy, followed by coumadin and stenting 1–2 months later) could reduce ischemic complications, we performed a pilot study in 28 pts with DSVG (Group II). Demographics and graft age (100 ± 47 vs. 99 ± 42 months) were similar, except for more recent MI in Group II (58.3% vs. 22.7%, P = 0.03). Group I (n = 44) Group II (n = 28) % DS (Pre/Final) 79 ± 14/30 ± 24 * 80 ± 17/45 ± 19 DE (%) 22.7 ** 10.7 Any In-hospital Complications 11.4% *** 0% Death/CABG/MI (%) 6.8/2.3/4.5 0/0/0 DS = diameter stenosis * p &lt; 0.001 ** p = 0.20 *** p = 0.15 vs. Group II Among 27 pts in Group II eligible for follow-up (&gt; 1 month), there were no major ischemic complications. There were 4 total occlusions [1 non-Q wave MI at 4 months and 3 silent occlusions at 6 weeks (1) and 2 months (2)]. 9 without clinical indication for additional therapy, 11 staged procedures with stenting (follow-up % DS = 56 ± 30%), and 3 without significant stenosis on follow-up angiography. We conclude that this staged angioplasty strategy in degenerated saphenous vein graft lesions: 1) may reduce distal embolization, but most importantly , avoids major in-hospital ischemic complications during the initial procedure: but 2) at the expense of ≈15% graft occlusions, which occurred more than 6 weeks after the initial procedure: and 3) prevented any deaths either during the initial procedure or during the follow-up period. These results underscore the importance of early (1 month) follow-up in all patients undergoing this staged TEC, followed by stent procedure in treating complex degenerated saphenous vein graft lesions.