European Heart Journal (2003) 24, 266–273

Outcome after treatment of coronary in- restenosis

Results from a systematic review using meta-analysis Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 techniques

P.W. Radkea,b*, A. Kaisera,b, C. Frostc, U. Sigwarta a Royal Brompton & Harefield NHS Trust, London, UK b Department of Cardiology, RWTH University Hospital Aachen, Aachen, Germany c London School of Hygiene and Tropical Medicine, Medical Statistics Unit, London, UK

Received 19 December 2001; accepted 27 February 2002

KEYWORDS Aims To evaluate the clinical outcome after treatment of coronary in-stent restenosis. Stent; Methods and results For identification of the relevant literature a specific search Restenosis; strategy was conducted and explicit inclusion criteria were defined to avoid selection Treatment; bias. Based on the selected literature, a systematic review using descriptive statistics Outcome; and meta-analysis methods regarding the outcome after treatment of coronary Review; in-stent restenosis was performed. The proportion of patients experiencing a major Meta-analysis adverse cardiac event (MACE) as defined by death, , and target lesion revascularization was the main outcome measure. A total of 1304 citations were identified. Among these, 28 studies (six different treatment modalities) including a total of 3012 patients met the inclusion criteria and were incorporated into this analysis. The estimated average probability of experiencing a major cardiac adverse event after treatment for in-stent restenosis with a follow-up period of 9±4 months was 30.0% (25.0–34.9%, 95% confidence interval) with strong evidence for hetero- geneity between study specific results (Pϭ0.0001). The clinical outcome was not significantly different between treatment modalities. After adjustment for confound- ing factors (i.e. lesion length), however, patients undergoing intracoronary radiation showed an estimated advantage of 16.9% (−37.7±4.0%, 95% confidence interval) in MACE free survival, as compared to balloon . The post-interventional diameter was the only independent predictor for the long-term outcome after treatment of in-stent restenosis. Conclusions Treatment of in-stent restenosis is associated with an overall 30% rate of major adverse cardiac events. Currently, repeat angioplasty is the treatment option of choice, especially when a sufficient acute procedural result can be achieved. Intracoronary radiation should be considered in cases with therapy refractory forms of diffuse in-stent restenosis. © 2003 Published by Elsevier Science Ltd on behalf of The European Society of Cardiology.

This work was supported in part by a fellowship of the German Cardiac Society and the RWTH University Aachen, Germany (P.W.R.). * Corresponding author. Department of Cardiology, RWTH University Hospital, Pauwelsstrasse 30. D-52057 Aachen, Germany E-mail address: [email protected]

0195-668X/03/$ - see front matter © 2003 Published by Elsevier Science Ltd on behalf of The European Society of Cardiology. doi:10.1016/S0195-668X(02)00202-6 Outcome after treatment of coronary in-stent restenosis 267

Introduction follow-up period ≥3 months; (5) that provided infor- mation on the rate of major adverse cardiac events The introduction of intracoronary into (MACE) as defined by death, myocardial infarction clinical practice has dramatically changed treat- or target lesion (vessel) revascularization. These ment of obstructive coronary disease. Since criteria were established in an attempt to control having been shown to significantly reduce resten- for a potential publication bias, to allow for an 1,2 osis as compared to PTCA in selected lesions, the operator learning curve, and to define a clinically indication for stent implantation has been widened relevant and uniformly applicable outcome substantially. As a result of a dramatic increase in measure. Two investigators (P.W.R. and A.K.) implantation numbers worldwide in less selected independently assessed study eligibility. and more complex lesions (bypass grafts, resten- The proportion of patients experiencing a major ostic lesions, unstable , myocardial infarc- adverse cardiac event was defined as the main Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 tion), in-stent restenosis has been disclosed as a outcome measure. This proportion (and standard new entity with significant clinical and socio- error) was obtained for each study. Where the economic implications. Despite a variety of differ- 3,4 event rate was zero the number of events was taken ent therapeutic options (reviewed in ), the most to be 0.5 in order to calculate the standard error. effective treatment modality for ‘in-stent resten- Random effect meta-analysis6 was used to combine osis’ has as yet not been identified. This is, in part, results both for individual treatment modalities and due to a lack of randomized, controlled trials for overall. This random effects analysis was extended most of the existing treatment modalities. At the using meta-regression7 to evaluate and adjust for moment, repeat balloon angioplasty is considered the effects of patient, lesion and procedural vari- to be the first line treatment option, especially in ables on the primary outcome measure. Analyses focal lesions. First clinical data using intracoronary were also carried out using over-dispersed logistic suggest beneficial effects in regression models as a validation of the consistency patients with longer and more diffuse restenotic 5 of these findings. stents. To evaluate the quality of the studies identified, With more than 1 000 000 stent implantations the selected literature was screened for validity by per year and an estimated overall clinical resten- applying a series of weighted criteria.8 Thereby, osis rate of 15–25%, between 150 000 and 250 000 quality assessment of the literature selected be- patients will present with in-stent restenosis in the 3,4 comes a reproducible and quantitative process. The year 2002 and require treatment. At present, no modified validity score used here had a maximal clear recommendations are available for this im- possible score of 25 points (Table 1). portant patient group. In an attempt to partially Analysis was performed with stata™ (Stata overcome this paucity of comparative data, we Corporation, College Station, TX, USA) and spss performed a systematic review using descriptive (SPSS UK Ltd, Surrey, UK). statistics and meta-analysis methods regarding the outcome after treatment of coronary in-stent restenosis. Results

Material and methods The MEDLINE search revealed 1189 citations. After hand searching the reference lists, a total of 1304 For identification of the relevant literature a citations were identified using our search strategy. specific search strategy was conducted and explicit Among these citations, 28 papers including a total inclusion criteria were defined to avoid selection of 3012 patients met the inclusion criteria and were bias. A MEDLINE search from January 1987 to March therefore incorporated into this analysis. Within 2001 was performed with restrictions (type of those papers, results from a total of six different study: human) using a combination of the terms treatment modalities have been reported (stent- ‘Coronary’, ‘Stent’, ‘Restenosis’, and ‘Treatment’. in-stent therapy,9–11 rotational atherectomy,12–19 The reference lists of all retrieved articles were balloon angioplasty,9,12,17,19–28 excimer laser hand-searched for additional relevant articles. This angioplasty,16,20,28–31 directional coronary atherec- analysis intended to include all clinical trials tomy,27,32 and intracoronary radiation33–36). The conducted since 1987 (a) that described a study baseline patient characteristics of the entire cohort population treated for in-stent restenosis in a ran- are provided in Table 2 together with two historical domized or non-randomized fashion; (b) that used a patient populations (BENESTENT1 and ARTS specified technique to treat in-stent restenosis; (c) study37). A separate comparison of baseline, pro- that enrolled ≥30 patients; (4) that included a cedural and outcome characteristics of the 268 P.W. Radke et al.

Table 1 Methodologic quality assessment ing a major adverse cardiac event (Fig. 2(b)). For every 1.0% decrease in diameter stenosis post inter- Study characteristic Score vention, the rate of MACE was estimated to be Population reduced by 0.9%. All other tested variables were Reproducible description of population, severity of 5 not significantly associated with the occurrence of disease, comorbidity MACE, however, there was a trend towards a better Intervention outcome with an increase in vessel size (Fig. 2(d)). Experimental manoeuvre was explicit and 2 reproducible The modified validity score used in this analysis There was a control group 3 including all 28 studies revealed an overall score of Outcome 18±3 (mean±SD). The values for the different treat- Outcome measures were explicit and reproducible ment modalities are: (1) balloon angioplasty: 18±2; Mortality 3 (2) stent-in-stent technique: 17±0; (3) rotational Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 ICU length of stay, hospital length of stay 2 atherectomy: 17±3; (4) excimer laser angioplasty: Design 19±2; (5) directional coronary atherectomy: 20±1; Random allocation to groups 3 (6) intracoronary radiation: 22±3. Cointerventions identified 2 Follow-up 90–100% 5 Discussion 80–90% 3 <80% 1 Restenosis remains the major limitation of intra- Maximum score 25 implantation. The aim of this sys- ICU, intensive care unit. tematic review using meta-analysis techniques was to characterize the outcome after treatment of in-stent restenosis and to identify predictors of major adverse cardiac events after such treatment. six different treatment modalities is provided in Table 3. Clinical characteristics of patient The estimated average probability of experienc- undergoing treatment for in-stent ing a major cardiac adverse event (MACE) after restenosis treatment for in-stent restenosis with a follow-up period of 9±4 months was 30.0% (25.0–34.9%, 95% Overall, treatment of in-stent restenosis is charac- CI, Fig. 1) with strong evidence for heterogeneity terized by a 30% rate of major cardiac events 9±4 between study specific results (Pϭ0.0001). The month post procedure (Fig. 1, Table 2). In 90% of results of separate meta-analyses within the cases, the rate of MACE is driven by the need for different treatment groups are provided in Table 4 target lesion revascularization (Table 2), most along with estimated differences in the probability often as a result of recurrent restenosis. This un- of MACE for each treatment modality compared favourable outcome is likely to reflect the baseline to balloon angioplasty obtained from the meta- patient and lesion characteristics of the entire regression model. population. Patients with in-stent restenosis have Before adjustment for clinical confounding already qualified as a ‘high-risk’ population for factors the differences between modalities were recurrent restenosis by developing in-stent re- small (differences do not exactly equate to those stenosis in the first place. In addition, patients calculable from the modality specific effects be- developing in-stent restenosis have a more sig- cause the meta-regression model, unlike the sep- nificant co-morbidity (Table 2) as compared to arate meta-analyses, assumes a constant between patients undergoing primary stent implantation in study variance). After adjusting for clinical con- highly selected lesions (BENESTENT population1)or founding factors (lesion length, pre-interventional even patients with multi-vessel disease undergoing diameter stenosis, prevalence of diabetes mellitus) stent implantation as studied in the ARTS trial.37 the differences between modalities were larger This includes longer lesions, smaller vessel diam- but still not statistically significant. In particular, eters, higher pre-interventional diameter stenosis, intra-coronary radiation therapy showed a 16.9% and a higher proportion of diabetic and hyperten- advantage compared to balloon angioplasty in the sive patients. All those factors have been suggested probability of MACE. to contribute to an unfavourable outcome after Meta-regression analysis showed a significant stent implantation.3 The lower rates for MACE (20 and positive correlation between diameter stenosis and 25% vs 30%), therefore, partially reflect those post intervention and the probability of experienc- differences in baseline characteristics. Moreover, it Outcome after treatment of coronary in-stent restenosis 269

Table 2 Baseline characteristics of patients undergoing percutaneous treatment for in-stent restenosis included in the meta-analysis as compared to patients undergoing stent implantation in the BENESTENT and ARTS trial Meta analysis ISR BENESTENT1 ARTS34 Patients (n) 3012 259 600 Male (%) 72 82 77 Stent length (mm) 24.0±6.8 na na Lesion length (mm) 16.4±4.5 7.1±2.6 na Hypertension (%) 61 31 45 Diabetes mellitus (%) 29 7 19 Hyperlipidemia (%) 55 34 58 Unstable angina (%) 36 6 37 LAD location (%) 48 64 90* Vessel size (mm) 2.8±0.2 3.0±0.5 na Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 DS pre intervention (%) 74±7 64±10 >50% DS post intervention (%) 17±7 22±8 na Time to FU (month) 9±4 7 12 MACE (%) 30±14 20 25 TLR (%) 27±12 15 17 DS, diameter stenosis; FU, follow-up; ISR, in-stent restenosis; LAD, left anterior descending coronary artery; MACE, major adverse cardiac events; TLR, target lesion revascularization. *, Inclusion of patients with multivessel disease.

Table 3 Summary of baseline, procedural, and outcome characteristics of patients with in-stent restenosis undergoing percutaneous treatment using six different treatment modalities Treatment modality BA SIS HSRA ELCA DCA ICR Patients (n) 1305 200 675 474 75 283 Male (%) 68±30 74±6 75±9 72±10 75±2 69±8 Diabetes (%) 22±6 19±9 37±9 33±7 41±4 29±8 LAD (%) 45±12 45±3 55±16 50±6 39±8 37±12 SVG (%) 16±17 14±6 2±2 37±37 9* 16±17 Lesion length (mm) 14±4 13* 20±4 15±3 14±1 20±6 Vessel size pre (mm) 2.9±0.1 3.0±0.1 2.7±0.3 2.7±0.1 2.7±0.3 2.8±0.1 DS pre (%) 72±8 77±1 76±5 74±7 77±3 65±4 DS post (%) 19±8 4±2 18±6 17±7 18±1 17±7 MI (%) 2±4 3±1 4±6 1±1 7* 7±5 Death (%) 2±1 1±1 2±2 4±5 0* 4±4 BA, balloon angioplasty; CI, confidence interval; DCA, directional coronary atherectomy; DS, diameter stenosis; ELCA, excimer laser angioplasty; FU, follow-up; HSRA, high speed rotational atherectomy; ICR, intra-coronary radiation therapy; LAD, left anterior descending artery; MACE, major adverse cardiac events; MI, myocardial infarction; SIS, stent-in-stent; SVG, saphenous vein graft. Data are expressed as mean±SD when applicable. *, Results derived from one study only. P<0.05 as compared to balloon angioplasty.

is rather likely that the introduction of potent were not equally distributed. Patients undergoing antiplatelet drugs and high-pressure stent implan- intra-coronary radiation therapy (as compared to tation into clinical practice has resulted in even those treated by balloon angioplasty) were more lower MACE rates in ‘BENESTENT’ patients cur- often diabetic (29±8 vs 22±6%) and presented with a rently undergoing primary stent implantation.38,39 longer in-stent lesion length (20±6 vs 14±4 mm). Adjustment for those confounding factors revealed Random effect meta-analysis and an estimated reduction of 16.9% in the probability meta-regression analysis of MACE for patients undergoing intra-coronary radiation therapy as compared to balloon angi- An important finding of this meta-analysis is the oplasty. This outcome, even though not statisti- comparable rate of major adverse cardiac events cally significant, supports first comparative between the different treatment modalities. Base- data suggesting an improved long-term outcome line characteristics between studies, however, for patients treated with gamma-radiation as 270 P.W. Radke et al.

absence of antiplatelet therapy have been identi- fied;35 however, additional randomized trials are needed. The meta-regression analysis revealed that the post-procedural diameter stenosis is the strongest, and only significant, predictor of the rate of MACE in patients undergoing treatment for in-stent re- stenosis (Fig. 2). The lower the final diameter stenosis, the lower the MACE rate, or ‘the bigger the better’. The importance of the acute pro- cedural result in determining the outcome after percutaneous coronary interventions has initially Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 been demonstrated for coronary atherectomy, conventional balloon angioplasty and stent implantation.40

Differences in study validity

Despite the magnitude of the clinical and economic problem ‘in-stent restenosis’, only two randomized controlled clinical trials have been reported thus far33,35 and the majority of data originates from retrospectively analysed databases. Both trials evaluated the effects of intracoronary radiation therapy (gamma-radiation) and may well be consid- ered as ‘evidence-based’. As a result, differences in the modified validity score between the group of studies using balloon angioplasty as compared to intracoronary radiation therapy study are statisti- Fig. 1 Probability of major adverse cardiac events (MACE) after cally significant (18±2 vs 22±3, P<0.01). This finding treatment of in-stent restenosis using different treatment and differences in baseline characteristics have to modalities: overall meta-analysis including 3012 patients. The be taken into account when interpreting the similar average probability of experiencing a major cardiac adverse long-term results between both groups regarding event (MACE) 9±4 months after index procedure was 30.0% the primary outcome measure ‘MACE’. No alterna- (25.0–34.9%, 95% CI) with strong evidence for heterogeneity between study specific results (Pϭ0.0001). tive debulking technique has undergone a rand- omized comparison against intracoronary radiation or re-dilatation thus far. Two randomized, control- led clinical trials comparing rotational atherectomy compared to placebo (balloon angioplasty).33,35 with balloon angioplasty, however, have been con- Randomized data for beta-radiation were not ducted recently and preliminary results have been available for this analysis, however, effects are presented.41,42 expected to be similar.34,36 Notably, intracoronary radiation still bears How to treat in-stent restenosis? potentially hazardous problems. The rate of MACE in patients undergoing intra-coronary radiation This analysis clearly suggests that balloon angi- therapy is not entirely driven by the need for recur- oplasty should be considered as the treatment rent revascularization as a result of restenosis. Late option of choice, especially in short and focal (>1 month) after intra-coronary radi- lesions, as long as a sufficient acute procedural ation therapy, often leading to acute MI, is a result can be achieved. Re-dilatation is safe, pro- threatening side effect with an incidence of up to vides high procedural success, and produces favour- 10%.33 As a result, the rates for MI in patients able long-term results in localized lesions. This is a undergoing intra-coronary radiation therapy com- cost-effective approach without further personal or pare unfavourably. Potential risk factors for the infrastructural requirements. The value of debulk- development of late thrombosis like additional ing techniques is yet unclear, however, it is likely stent implantation at the time of radiation and that these procedures do not provide an additional Outcome after treatment of coronary in-stent restenosis 271

Table 4 Results from a meta-analysis exploring the probability of major cardiac events (MACE) after treatment of in-stent restenosis using six different treatment modalities Treatment modality Probability of MACE (in %) (95% CI) Comparison with BA (%) (95% CI) Not adjusted Adjusted BA 28.9 (20.1–35.1) –– SIS 31.4 (20.5–42.3) 4.5 (−15.4–24.4) 12.4 (−39.7–14.9) HSRA 29.7 (15.8–43.7) 1.7 (−11.5–15.0) 9.3 (−31.0–12.5) ELCA 34.8 (25.1–44.5) 7.0 (−8.1–22.1) 10.3 (−28.2–7.6) DCA 30.6 (20.2–41.0) 3.2 (−21.2–27.7) 12.1 (−41.0–16.8) ICR 28.9 (23.6–34.2) 1.4 (−16.2–19.1) 16.9 (−37.7–4.0) The results of individual treatment modalities were compared to balloon angioplasty before and after adjustment for clinical Downloaded from https://academic.oup.com/eurheartj/article/24/3/266/2733883 by guest on 06 October 2021 confounding factors (lesion length, prevalence of diabetes mellitus, pre-procedural diameter stenosis). BA, balloon angioplasty; CI, confidence interval; DCA, directional coronary atherectomy; ELCA, excimer laser angioplasty; FU, follow-up; HSRA, high speed rotational atherectomy; ICR, intra-coronary radiation therapy; MACE, major adverse cardiac events; SIS, stent-in-stent.

Fig. 2 Meta regression analysis: effect of in-stent restenosis lesion length, vessel size, pre- and post-interventional diameter stenosis on the probability of major adverse cardiac events (MACE) in patients treated for in-stent restenosis. A significant and positive correlation was observed between diameter stenosis post intervention and the probability of experiencing a major adverse cardiac event (b). The remaining variables were not significantly associated with the occurrence of MACE. benefit when adequate final lumen dimensions can compared to balloon angioplasty. Therefore, in be achieved with balloon angioplasty alone. Intra- patients with the therapy-refractory form of dif- coronary radiation, especially using gamma- fuse in-stent restenosis, intracoronary radiation radiation sources, is the only treatment modality should be considered. So far, however, no study has that has convincingly shown a superiority above shown a superiority of intra-coronary radiation balloon angioplasty for the treatment of in-stent therapy when other treatment modalities have restenosis in more diffuse lesions. In addition, the failed. The long-term adverse effects of intra- results of our meta-analysis indicate a substantial coronary radiation like late thrombosis and egde advantage for intra-coronary radiation therapy as stenosis, however, are still not fully understood 272 P.W. Radke et al. even though prolonged antiplatelet combination prevented in the near future, potentially by stent therapies may overcome the limitation of late coating techniques. thrombosis. As a result of the unsatisfying acute and long- References term results when treating in-stent restenosis, pre- vention of this condition has become the major 1. Serruys PW, de Jaeger P, Kiemeneij F et al. A comparison of focus of pre-clinical and clinical research. 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